(2020). "Evidence-based treatments for couples with unexplained infertility: a guideline." Fertility and Sterility 113(2): 305-322.
	Objective: To provide evidence-based recommendations to practicing physicians and others regarding the effectiveness and safety of therapies for unexplained infertility.; Methods: ASRM conducted a literature search, which included systematic reviews, meta-analyses, randomized controlled trials, and prospective and retrospective comparative observational studies published from 1968 through 2019. The ASRM Practice Committee and a task force of experts used available evidence and informal consensus to develop evidence-based guideline recommendations.; Main Outcome Measure(s): Outcomes of interest included: live-birth rate, clinical pregnancy rate, implantation rate, fertilization rate, multiple pregnancy rate, dose of treatment, rate of ovarian hyperstimulation, abortion rate, and ectopic pregnancy rate.; Result(s): The literature search identified 88 relevant studies to inform the evidence base for this guideline.; Recommendation(s): Evidence-based recommendations were developed for the following treatments for couples with unexplained infertility: natural cycle with intrauterine insemination (IUI); clomiphene citrate with intercourse; aromatase inhibitors with intercourse; gonadotropins with intercourse; clomiphene citrate with IUI; aromatase inhibitors with IUI; combination of clomiphene citrate or letrozole and gonadotropins (low dose and conventional dose) with IUI; low-dose gonadotropins with IUI; conventional-dose gonadotropins with IUI; timing of IUI; and in vitro fertilization and treatment paradigms.; Conclusion(s): The treatment of unexplained infertility is by necessity empiric. For most couples, the best initial therapy is a course (typically 3 or 4 cycles) of ovarian stimulation with oral medications and intrauterine insemination (OS-IUI) followed by in vitro fertilization for those unsuccessful with OS-IUI treatments. (Copyright © 2019 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

(2021). "A Clincal trial to study the effects of two drugs,hinguvadi taila yoni pichu and hinguvadi churna orally in moderate to severe mensstrual pain due to dysmenorrhea."
	INTERVENTION: Intervention1: Hingvadi Taila: Hingvadi Tila Yoni Pichu with 5‐10 ml taila per vaginal given for 7 days prior to menses for three consecutive cycles Control Intervention1: Hinguvadi Churna: Hinguvadi Churna given twice a day orally with lukewarm water 7 days prior to menses for three consecutive cycles CONDITION: Health Condition 1: E348‐ Other specified endocrine disorders PRIMARY OUTCOME: To evaluate the efficacy of hingvadi taila yoni pichu for relief in pain in kasthartavaTimepoint: Relief in pain after 12 week of medication SECONDARY OUTCOME: â?¢To Compare the effect of Hingvadi Taila Yoni Pichu and Hingvadi churna orally for relief in pain in Kasthtartava. ; Timepoint: Relief in pain. INCLUSION CRITERIA: Married Females in age group of 20 to 35 years Patients coming with chief complaint of kashtatrtava with irregular menses. Patients having scanty or average amount of menses along with associated symptoms : ï?? Lower abdominal pain ï?? Low back pain ï?? Nausea and vomiting ï?? Irregular Menses ï?? Diarrhoea Patients with H/O using analgesics and other drugs during menses Patients suffering from dysmenorrhea for more than 3 consecutive cycles.

(2021). "Diagnostics and treatment of provoked vestibulodynia: A Systematic Review." Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU): SBU Systematic Review Summaries.
	The aim was to assess the scientific evidence for methods of diagnosing and treating provoked vestibulodynia through a systematic review. In addition, social and ethical aspects were addressed. (Copyright © 2021 by SBU – Swedish Agency for Health Technology Assessment and Assessment of Social Services.)

(2021). "EFFORT: efficacy of Adavosertib in PARP Resistance: a Randomized 2-Arm Noncomparative Phase 2 Study of Adavosertib With or Without Olaparib in Women With PARP-Resistant Ovarian Cancer." Clinical advances in hematology & oncology 19(8): 14‐15.
	
(2021). "Erratum: efficacy of Maintenance Olaparib for Patients With Newly Diagnosed Advanced Ovarian Cancer With a BRCA Mutation: subgroup Analysis Findings From the SOLO1 Trial (J Clin Oncol DOI: 10.1200/JCO.20.00799)." Journal of Clinical Oncology 39(12): 1414.
	The October 20, 2020, article by DiSilvestro et al entitled “Effi­cacy of Maintenance Olaparib for Patients With Newly Diagnosed Advanced Ovarian Cancer With a BRCA Mutation: Subgroup Analysis Findings From the SOLO1 Trial” (J Clin Oncol 10.1200/ JCO.20.00799) was published with errors.

(2021). "Evidence-based outcomes after oocyte cryopreservation for donor oocyte in vitro fertilization and planned oocyte cryopreservation: a guideline." Fertility and Sterility 116(1): 36-47.
	Objective: To provide evidence-based recommendations to practicing physicians and others regarding the efficacy of oocyte cryopreservation (OC) for donor oocyte in vitro fertilization and planned OC.; Methods: The American Society for Reproductive Medicine conducted a literature search, which included systematic reviews, meta-analyses, randomized controlled trials, and prospective and retrospective comparative observational studies published from 1986 to 2018. The American Society for Reproductive Medicine Practice Committee and a task force of experts used available evidence and through consensus developed evidence-based guideline recommendations.; Main Outcome Measure(s): Outcomes of interest included live birth rate, clinical pregnancy rate, obstetrical and neonatal outcomes, and factors predicting reproductive outcomes.; Result(s): The literature search identified 30 relevant studies to inform the evidence base for this guideline.; Recommendation(s): Evidence-based recommendations were developed for predicting the likelihood of live births after planned OC, autologous OC in infertile women, and donor OC, as well as factors that may impact live birth rates. Recommendations were developed regarding neonatal outcomes after using fresh vs. cryopreserved oocytes in cases of autologous or donor oocytes.; Conclusion(s): There is insufficient evidence to predict live birth rates after planned OC. On the basis of limited data, ongoing and live birth rates appear to be improved for women who undergo planned OC at a younger vs. older age. Although there are no significant differences in per transfer pregnancy rates with cryopreserved vs. fresh donor oocytes, there is insufficient evidence that the live birth rate is the same with vitrified vs. fresh donor oocytes. Neonatal outcomes appear similar with cryopreserved oocytes compared with fresh oocytes. Future studies that compare cumulative live birth rates are needed. (Copyright © 2021 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

(2021). "Expression of Concern: the effects of vitamin D and evening primrose oil co-supplementation on lipid profiles and biomarkers of oxidative stress in vitamin D-deficient women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial." Endocrine research 46(1): 44.
	
(2021). "An open, randomized, controlled clinical trial to evaluate the effects of acupuncture and cupping in the treatment for postmenopausal women with stress urinary incontinence."
	INTERVENTION: Treatment group:Based on PFMT, acupuncture and cupping;Control group:Pelvic floor muscle training; CONDITION: Stress urinary incontinence in postmenopausal women PRIMARY OUTCOME: 1‐hour pad test; SECONDARY OUTCOME: International Consultation on Incontinence Questionnaire‐Short Form;Incontinence quality of life questionnaires;The average number of urinary incontinence within 24 hours;Three‐dimensional ultrasound examination of pelvic floor lesions; INCLUSION CRITERIA: 1. Conform to the diagnostic criteria of SUI in the "Guidelines for the Diagnosis and Treatment of Female Stress Urinary Incontinence (2017)"; 2. More than 12 months since the woman's last menstruation.

(2022). "Combination Vistusertib and Anastrozole Shows Benefit in Endometrial Cancer." Cancer discovery 12(7): OF20.
	The primary endpoint of 8-week progression-free rate was met with this combination. (©2022 American Association for Cancer Research.)

(2022). "Mirvetuximab soravtansine (Elahere) for ovarian, fallopian tube, and primary peritoneal cancer." The Medical letter on drugs and therapeutics 64(1665): e205-e206.
	
(2022). "Oteseconazole (Vivjoa) for recurrent vulvovaginal candidiasis." The Medical letter on drugs and therapeutics 64(1656): 124-126.
	
(2022). "Same-Day Compared With Overnight Cervical Preparation Before Dilation and Evacuation Between 16 and 19 6/7 Weeks of Gestation: a Randomized Controlled Trial: correction." Obstetrics and Gynecology 140(2): 344‐345.
	
(2023). "Additive effects of yoga in women with polycystic ovary syndrome (PCOS) with infertility." https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2023/02/049824.
	INTERVENTION: Intervention1: Yoga therapy: All the patients allocated in intervention group will be subjected to YOGA for 6 weeks before starting ovulation induction treatment (table 1) and will continue throughout the treatment duration. Control Intervention1: no yoga: Patients will be directly started on ovulation induction cycles. A maximum of 4 cycles of OVI will given to every patient CONDITION: Health Condition 1: E282‐ Polycystic ovarian syndrome PRIMARY OUTCOME: Follicular response (dominant follicle â?¥17mm) among women getting yoga therapy in addition to ; ovulation induction cycles among infertile PCOS womenTimepoint: Follicular response (dominant follicle â?¥17mm) among women getting yoga therapy in addition to ; ovulation induction cycles among infertile PCOS women at baseline, 6 weeks and 12 weeks. SECONDARY OUTCOME: Clinical parameters ( BMI, waist circumference (WC),waist hip ratio (WHR), neck circumference ; (NC) ; â?¢ Metabolic parameters ( HOMA‐IR, Lipid profile) ; â?¢ Endocrine parameters (LH/FSH ratio, AMH, SHBG, testosterone)Timepoint: AT baseline; 3 months and 6 months Duration of stimulation to achieve target follicular response ; â?¢ Clinical pregnancy rate (documented viable pregnancy on USG) ; â?¢ Ongoing pregnancy rate ; â?¢ Live birth rateTimepoint: During ovulation induction cycles monitoring To evaluate the effect of yoga on following parameters: ; â?¢ Need to add gonadotrophins to ovarian stimulation ; â?¢Timepoint: during ovulation induction cycles INCLUSION CRITERIA: Infertile PCOS women diagnosed according to modified Rotterdam criteria will be recruited for the study.

(2023). "Adjuvant Treatment In HPV-DNA Positive Patients: a Plasma Biomarker For Chemotherapy In Locally Advanced Cervical Cancer." https://clinicaltrials.gov/show/NCT05764044.
	A prospective, randomized, multicenter, national, superiority, parallel, clinical trial, design to evaluate implementation components for conducting a national clinical trial using adjuvant chemotherapy in patients with locally advanced cervical cancer, selected by cfDNA‐HPV biomarker. At the end of this pilot study, reaching feasibility goal, it is proposed to amplify size sample, with the same design. Patients will be randomized by stratified randomization process to belong to one of the groups: control (Group B) or intervention (Group C), emphasizing homogeneity of risk factors between them. A randomized list will be generated by using a suitable software, using variable size blocks (2 or 4), with stratification for site and staging. The confidentiality of the randomization list will be maintained through an automated, centralized, Internet‐based randomization system, available 24 hours a day (RedCap). Selected patients must receive standard treatment based on concomitant chemoradiotherapy regime, with dose of RT of 40‐50Gy (considering additional boost of 10‐15Gy in lymph nodes, radiologically or surgically, compromised) and brachytherapy of 30‐40Gy and cisplatin 40mg/m2 weekly. After four weeks of the end of treatment, a qualitative and quantitative research of HPV DNA in plasma of patients will be conducted. Those with a negative qualitative research result will leave the study. Patients who have positive research for plasma 16/18 HPV DNA at the end of chemoradiotherapy treatment will be randomized to receive two additional cycles of adjuvant chemotherapy or observation. Patients will be followed with conduction of computed tomography (CT) scan of the thorax and magnetic resonance (MR) of abdomen and pelvis and clinical and gynecological examination at every four months.

(2023). "Approval." Brown University Psychopharmacology Update 34(12): 8-8.
	The article focuses on the FDA's approval of zuranolone, an oral medication marketed by Sage Therapeutics, for the treatment of postpartum depression, based on successful results from two clinical trials that demonstrated its effectiveness in improving depressive symptoms compared to a placebo.

(2023). "autologous platelet rich plasma for Ovarian rejuvenation."
	INTERVENTION: Intervention1: Intraovarian injection of autologous Platelet rich plasma.: Autologous Platelet rich plasma intra ovarian injection will be given between day 7 and day 9 of periods for three consecutive cycles (cycle 1,2 and 3) in addition to Dehydroepiandrosterone (DHEA)(75 mg per day) Control Intervention1: Dehydroepiandrosterone (DHEA)(75 mg per day): Dehydroepiandrosterone (DHEA)(75 mg per day)will be administered for 3 cycles CONDITION: Health Condition 1: N978‐ Female infertility of other origin PRIMARY OUTCOME: 1.Antral Follicle Count (defined as all follicles of 2‐9 mm on day 2 scan on TVS), ; 2.Serum AMH ; 3.Serum FSH at the end of the treatment cycle. ; Timepoint: 3 months SECONDARY OUTCOME: conception rateTimepoint: after 3 months INCLUSION CRITERIA: Serum AMH (Anti Mullerian Hormone)<=1.2/ml, AFC (Antral Follicle Count) < 5(Follicles between 2‐9 mm assessed sonographically on day 2/3 of periods), Serum FSH(Follicle Stimulating Hormone) > 12, Hb >11 gm% and platelets >1.5 lakhs.

(2023). "Cabergoline: an Effective Intervention for Unwanted Lactation After Second Trimester Uterine Evacuation." OB/GYN clinical alert 40(4): 1‐8.
	
(2023). "Cannabidiol for the Treatment of Pelvic Pain in Endometriosis (DREAMLAND)."
	The Dreamland study is a two‐arm, parallel‐group, individually randomized (1:1 allocation ratio), controlled by disease stage, participant and investigator blinded, single‐site superiority trial of oral cannabis extract (CBD). CBD will be given orally starting at 10 mg daily and up‐titrated to a maximum dose of 150 mg daily. Dose up‐titration will be based on clinical response or side effects, whichever comes first. After 63 days of treatment, gradual withdrawal will be performed during one week. Then, at 70 days, there will be an open‐label extension wherein all participants from control group will be offered a course of CBD according to the same previous protocol. This research intends to : 1. Assess whether the daily use of CBD, for nine weeks, will reduce the pain level of these women. 2. Assess whether the daily use of CBD, for nine weeks, will modify pain threshold. 3. Assess whether the daily use of CBD, for nine weeks, will interfere in psychological symptoms. 4. Assess the possible adverse effects of using CBD

(2023). "CIRCUIT TRAINING EXERCISE EFFECT ON INFLAMMATORY MARKER AND INSULIN RESISTANCE ON POLYCYSTIC OVARIAN SYNDROME."
	INTERVENTION: Intervention1: CIRCUIT TRAINING: The intervention is circuit training with diet modification and physical activity recommendation.The exercise sessions are through group therapy,with direct session containing 10‐15 participatant per group .Exercise duration is one hour a day consist of 10 minutes of warm up, 40 minutes of training sessions ,10 minutes of cool down. 40 minutes of training session is divided into circuit consisting of 10 exercises (5 aerobic and 5 body weight resisted exercises).The exercises include push ups, squats, crunches, lunges, superman exercises, light jumping, running on spot, foot stamping, steps, jumping jacks. Each exercise will be done at 50‐60% of HRma Xinitially for 1‐8 weeks and 60‐70% of HRma Xduring the 9‐12 weeks of treatment peroid. Each exercises in the circuit will be provided for 30 seconds with rest peroid of 20 seconds in between.The rest period between each set is 3 minutes.Total study duration is 12 weeks, and participants of the intervention group will receive exercises session 3 days a week Control Intervention1: PHYSICAL ACTIVITY RECOMMENDATION: As per WHO 2020 recommendation ,it is strongly recommended that adults 18‐64 years, should take up regular physical activity. Adults should do atleast 150‐300 minutes of moderate intensity physical activity or an equivalent combination of moderate and vigorous intensity activity throughout the week, for substantial health benefits ,Participants will be advised to do muscle strengthening activities at moderate or greater intensity for additional health benefits. Limit the time of sedentary behavior and replace it with physical activity Control Intervention2: PHYSICAL ACTIVITY RECOMMENDATION: As per WHO 2020 recommendation ,it is strongly recommended that adults 18‐64 years, should tak CONDITION: PRIMARY OUTCOME: INSULIN RESISTANCE‐HOMAIRHIGH SENSITIVE C REACTIVE PROTIENTimepoint: BASELINE ; 12 WEEKS SECONDARY OUTCOME: ANTHROPOMETRIC MEASURESTimepoint: BASELINE WEIGHT, ; 12WEEKS INCLUSION CRITERIA: College going females of 18‐24 years of age Diagnosed case of PCOS Nulliparous women

(2023). "Clinical observation on the prevention and treatment of radioactive vaginal injury by clearing heat, detoxifying and generating muscle formula." https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2300068023.
	INTERVENTION: Test group:Clearing heat, detoxifying and muscle building formula vaginal douche;Control group:Vaginal douching with potassium permanganate 1:5000; CONDITION: Radiation vaginal injury PRIMARY OUTCOME: To observe the incidence and extent of radiation vaginal injury; SECONDARY OUTCOME: Determination of the efficacy of Chinese medical evidence;Routine examination of vaginal secretions;Quality of life questionnaire;Routine urine test;Vaginal ultrasound; INCLUSION CRITERIA: ? All cervical cancer cases had a pathological diagnosis. ?Cervical cancer patients with stage II B to III A according to the 2018 International Federation of Gynecology and Obstetrics (FIGO) staging of cervical cancer requiring vaginal brachytherapy; ?Females aged 18 to 70 years; ?Strength status (KPS) score > 70 points; ? Voluntary participation in informed consent.

(2023). "Clinical study of modified letrozole regimen in ovulation induction in patients with polycystic ovary syndrome." https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2300071007.
	INTERVENTION: Experimental group:Letrozole;Control group:Letrozole; CONDITION: polycystic ovary syndrome PRIMARY OUTCOME: Dominant follicle rate(First period);Ovulation rate after trigger(First period); SECONDARY OUTCOME: Expulsion cycle cancellation rate(First period);ovulation rate(First period);clinical pregnancy rate(First period);Biochemical pregnancy rate(First period);Early/late abortion rate(First period);Multiple pregnancy rate(First period);OHSS rate(First period);Intimal thickness(First period);Intimal morphology(First period);LUFS rate(First period);Malformation rate(First period);Cumulative dominance number of follicles;Cumulative ovulation rate;Cumulative biochemical pregnancy rate;Cumulative clinical pregnancy rate;Cumulative early/late abortion rate;Cumulative live birth rate;Cumulative multiple pregnancy rate;Cumulative OHSS rate;Cumulative LUFS rate;Live birth rate(First period); INCLUSION CRITERIA: 1.PCOS and infertility were diagnosed PCOS is diagnosed according to Rotterdam consensus as fulfilling at least two of the three criteria: (1) oligo‐anovulation or anovulation; (2) clinical or biochemical signs of hyperandrogenism; and (3) polycystic ovarian morphology on ultrasound, as defined by at least one ovary with 12 follicles or volume 10 ml. 2.Infertility due to PCOS,amenorrhea and ovulation disorder,at least one of the fallopian tubes is unobstructed,there are indications of out‐patient expulsion promotion,and no contraindication of expulsion promotion (1)To induce ovulation to guide cohabitants (2)intrauterine artificial insemination with ovulation induction 3.PCOS intended to receive CET(IVF/ICSI/PGT)for endometrial preparation with LE stimulation due to irregular menstruation and ovulation disorder 4.=38 years of age at oocyte retrieval; 5.She has not used LE/CC and other efflu Xstimulating drugs in the last 3 mon

(2023). "The clinical study on pulse acupuncture for treating TP/TC chemotherapy-induced alopecia of patients with gynecologic cancers."
	INTERVENTION: Group 1:routine acupuncture;Group 2:pulse acupuncture;Group 3:comprehensive nursing intervention; CONDITION: chemotherapy‐induced alopecia PRIMARY OUTCOME: Grading of toxic effects on the severity of hair loss in World Health Organisation (WHO)Handbook for reporting results of cancer treatment; SECONDARY OUTCOME: Hair growth rate;Condition of hair growth ;Karnofsky Performance Status (KPS) Scale;Chemotherapy‐induced Alopecia Distress Scale (CADS);quality of life index; INCLUSION CRITERIA: 1. Gynecological malignant tumors diagnosed by clinicopathology, including ovarian cancer, endometrial cancer, and cervical cancer; 2. Receive postoperative adjuvant chemotherapy or palliative chemotherapy for the first time; 3. Completed all TP (paclitaxel + cisplatin) or TC (paclitaxel + carboplatin) chemotherapy courses (4‐8 courses); 4. According to Dean's Hair Loss Scale, subjectively evaluate the degree of hair loss >= 2 grades; 5. No medical history related to obvious hair loss; 6. The general condition is good, and the Karnofsky score is greater than or equal to 60 points; 7. The expected survival period is more than 3 months; 8. Female patients aged between 18 and 70 years; 9. Patients who agree to participate in this study and sign the informed consent form.

(2023). "Clinical study on the efficacy and safety of remazolam besylate for induction and maintenance of general anesthesia in gynecological laparoscopic surgery." https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2300068042.
	INTERVENTION: Experimental group:Remazolam sedation;Control group:Propofol sedation; CONDITION: Gynecological uterine and adnexal diseases PRIMARY OUTCOME: Incidence of intraoperative hypotension; SECONDARY OUTCOME: Vital signs;Anesthesia wake time;Adverse reactions; INCLUSION CRITERIA: 1. Patients undergoing gynecological laparoscopic general anesthesia surgery (except for patients with malignant tumors); 2. Age 18‐60 years; 3 Body mass inde X(BMI): 18.5‐30 kg/m^2; 4 American Society of Anesthesiologists Grading (ASA) Grades I‐III; 5. Subjects voluntarily participate in the trial and sign the informed consent form of the trial.

(2023). "Clotrimazole treatment in vaginal Infections." https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2023/02/049628.
	INTERVENTION: Intervention1: Candimilt® 500 vaginal capsules: Single STAT dose 500 mg vaginally on day 1 alone Control Intervention1: Canesten® vaginal tablets: Single STAT dose 500 mg vaginally on day 1 alone. CONDITION: Health Condition 1: B373‐ Candidiasis of vulva and vagina PRIMARY OUTCOME: 1.Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for candidal vaginitis ; 2.Clinical response ; 3.Improvement or Resolution of Local signs of inflammation. ; 4.A vulvovaginal symptoms questionnaire (VSQ) will be done at baseline and end of the studyTimepoint: Baseline, day 7 and day 14 SECONDARY OUTCOME: 1.Changes from base line to 4 weeks in Quality of life‐ Questionnaires (Short Form Health‐12). ; 2.Photographic assessments of improvement and tablet dissolution status ‐ will be done for patients who consent for the same. ; LABORATORY STUDIES ; 3.Microbiological cure ‐ evaluation: microscopy of vaginal discharge smears will be done on Baseline and on day 7 and 14 (culture method) ; Timepoint: Baseline, day 7 and day 14 INCLUSION CRITERIA: 1. Women with the symptoms of vulvovaginal candidiasis (based on symptoms and signs after speculum examination); 2. Age at least 18 years; 3. Capable of giving written informed consent; 4. Agree to no intercourse for 8 days from the day of beginning of treatment; 5. Agree not to douche or use any intra‐vaginal products during the study period (including tampons, medications and devices); 6. Non‐pregnant Female patients aged 18 years or more and clinically diagnosed with vulvovaginal candidiasis were included; 7. Capable of giving written informed consent and willing to follow the investigational study procedures and report AEs. 8. Subjects must not be on their menstrual period on the day of screening and do not anticipate their period to begin during treatment (3 days); 9. Subjects must be using an acceptable method of birth control, willing to refrain from sexual intercourse from the da

(2023). "Comparative study between castor oil EMULGEL with clotrimazole vaginal tablet in the treatment of subjects with vulvo-vaginal candidiasis." https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2023/04/051978.
	INTERVENTION: CONDITION: Health Condition 1: N760‐ Acute vaginitis PRIMARY OUTCOME: Clinical cure rate (proportion of participants achieving clinical cure)Timepoint: At baseline, Day‐4 for Clotrimazole 200mg & Day 6 for Castor oil EMULGEL SECONDARY OUTCOME: 1. Microbiological cure rate (Direct microscopy/wet smear): Number of positive findings in direct microscopy in comparison to first visit. ; 2. Therapeutic cure rate: Clinical and microbiological cure combined. ; 3. Total Severity Score (TSS): Individual clinical signs and symptoms. ; 4. Vaginal pH: Mean vaginal pH in comparison to first visit. ; ; ; 5. Patients satisfaction: Patient will be asked how satisfied she was with the treatment received based on 8 standardized questions. ; Timepoint: Castor oil EMULGEL‐ Day‐0 First visit‐ Day‐6 end of treatment. ; Clotrimazole 200mg ‐ Day‐0 First visit‐ Day‐4 end of treatment. INCLUSION CRITERIA: 1. Female patients in reproductive age group (18‐45 years). 2. Patients willing to give written informed consent. 3. Patients with clinical signs and symptoms of vulvovaginal candidiasis (complaints of vaginal pruritus, burning sensation, vulvar soreness or thick curdy discharge).

(2023). "Comparing the effect of nettle extract with COCs on the improvement of clinical and paraclinical symptoms of polycystic ovary syndrome." https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20110606006709N25.
	INTERVENTION: Intervention 1: Nettle extract capsules (containing flavonoids, tannins and sterols) in the number of 30 capsules, one daily for three cycles, which will be prepared and packaged by Sina Navandish Company. Intervention 2: Control group: LD capsules (containing 30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel), in the number of 21 capsules along with 9 capsules containing an ineffective substance to be consumed in a cycle of 30 capsules per day for three cycles, which will be prepared and packaged by Sina Navandish Company . CONDITION: Clinical and paraclinical symptoms of polycystic ovary syndrome. ; Polycystic ovarian syndrome E28.2 PRIMARY OUTCOME: Average score of hirsutism. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Ferriman–Gallwey scale. Serum levels of DHEA and total testosterone. Timepoint: Before the start of the intervention and 3 months after the intervention. Method of measurement: By ELISA method in the central laboratory. SECONDARY OUTCOME: Normalization of menstrual cycles. Timepoint: Before the intervention, one month, two months, and three months after the intervention. Method of measurement: Questionnaire made by the researcher and Higham's chart. Serum level of fasting blood sugar. Timepoint: Before the start of the intervention and and 3 months after the intervention. Method of measurement: By spectrophotometric method in the central laboratory. Serum levels of gonadotropins (FSH and LH). Timepoint: Before the start of the intervention and and 3 months after the intervention. Method of measurement: By ELISA method in the central laboratory. INCLUSION CRITERIA: Confirming the diagnosis of PCOS according to the Rotterdam criteria (clinical or biochemical hyperandrogenism, menstrual cycle disorders or polycystic ovary ultrasound signs) Age 18 to 40 years Being literate in reading and writing BMI between 18.5 and 30 Not using hormonal contraceptives or any other type of hormonal medication currently and during the last three months Not wanting to get pregnant

(2023). "Comparing the effects of biofeedback and brain stimulation treatments on pelvic floor muscle function in women with urinary incontinence." https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20230305057630N1.
	INTERVENTION: Intervention 1: Control group: This group receives only routine exercises to strengthen the pelvic floor muscles, each session is 30 minutes and is divided into three parts: 1) Sustained contractions: Patients complete pelvic muscle contraction for 6‐10 seconds each time, then start the next contraction after 10 seconds rest, 8‐10 repetitions per set, 1‐2 sets per session. 2)Phasic contractions: Patients complete pelvic muscle contraction for 2‐5 seconds each time, then rest, rest time is twice the contraction time, 10 repetitions per set, 1‐3 sets per session. 3) Guided training: Patients are asked to simulate activities such as coughing, sneezing while contracting the pelvic floor muscles. Treatment sessions will be held in 3 sessions per week for a total period of 3 weeks. Intervention 2: First intervention group: Pelvic floor muscle strengthening exercises with biofeedback : The treatment program includes 9 sessions of combined pelvic floor rehabilitation, that is, the combination of electromyographic biofeedback and progressive exercises of the pelvic floor muscles, will be used as a therapeutic exercise program. Biofeedback takes 15 minutes. A special vaginal probe of Leukoplast combination, which is the same for all patients, will be used for electromyographic biofeedback applications. Each probe will be unique to the patient. The patient will be given the necessary training to train the pelvic floor muscles alone and using vaginal cones in treatment sessions. According to the Kegel treatment protocol, 300 contractions are performed daily. Contraction of the pelvic floor by maintaining the vaginal cone while standing, lying down, sitting and going up and down the stairs as well as running will be done gradually at home with daily progress. Each patient's in‐per CONDITION: N39.3 Urinary incontinence. ; Stress incontinence (female) (male) PRIMARY OUTCOME: Evaluation of urinary incontinence and vaginal symptoms. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: International Consultation on Incontinence Questionnaire Vaginal Symptoms Module questionnaire. The volume of urine loss. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: One hour pad test. SECONDARY OUTCOME: Bladder displacement amount. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: Ultrasonography. Strength and endurance of pelvic floor muscles. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: Biofeedback. Strength and endurance of pelvic floor muscles. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: Manual assessment with the Oxford scale. Strength and endurance of pelvic floor muscles. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: Perineometer. INCLUSION CRITERIA: Women aged 35 to 70 years with urinary incontinence as the main clinical complaint, without urgent symptoms Urine loss of more than 1 gram per hour should be confirmed by a one‐hour test pad The simultaneous presence of sexual disorders and impotence with urinary incontinence Absence of chronic degenerative diseases that affect muscle and nerve tissues Absence of any degree of pelvic organ prolapse (POP) Absence of active or recurrent urinary tract infections (UTIs) Absence of vulvovaginitis Absence of atrophic vaginitis Absence of copper IUD in the uterus Absence of pregnancy or childbirth less than 6 months Not suffering from diabetes, neurological disease, mental illness, and debilitating chronic diseases such as kidney failure and heart pacemakers. Absence of taking drugs that affect urination No history of surgical or drug treatment of SUI No history of abdominal and inguinal hernia No history of any surgery in the abdo

(2023). "Comparing the Effects of Mycozin and Clotrimazole on Vaginal Candidiasis." https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20120718010324N77.
	INTERVENTION: Intervention 1: Intervention group 1 will use Mycozin vaginal cream at bedtime for one week. Intervention 2: Intervention group 2 will use Clotrimazole 1% vaginal cream at bedtime for one week. CONDITION: B37.3 Vaginal Candidiasis. ; Candidiasis of vulva and vagina PRIMARY OUTCOME: Frequency of clinical symptoms (smell, quantity, consistency, color and appearance of vaginal secretions, vaginal inflammation, appearance of cervix). Timepoint: Before the intervention and 10 to 15 days after the intervention. Method of measurement: Clinical examination by the researcher and clinical symptoms checklist. Frequency of laboratory symptoms (negative smear and culture of vaginal secretions). Timepoint: Before the intervention and 10 to 15 days after the intervention. Method of measurement: Sampling will be done with a sterile cotton swab from the posterior fornix of the vagina, and we will dip the swab inside the blood culture tubes and gently shake it inside the solution until the sample dissolves in it. Incubation will be at 37 degrees for 2 to 4 hours, and a drop of the contents of the tube solution will be transferred on a slide. We examine the slide under the microscope with high and low magnification. Germ tube formation test is a quick test to identify Candida albicans and differentiate it from other yeasts. Frequency of patient complaints (secretions, dysuria, frequency, itching, itching during intercourse, pain in the lower abdomen, burning sensation during intercourse, and dyspareunia). Timepoint: Before the intervention and 10 to 15 days after the intervention. Method of measurement: Stated by the participants and complaints checklist. SECONDARY OUTCOME: PH of vaginal secretions. Timepoint: Before the intervention and 10 to 15 days after the intervention. Method of measurement: PH paper. Satisfaction with the treatment. Timepoint: 10 to 15 days after the intervention. Method of measurement: Satisfaction questionnaire. Side events. Timepoint: 10 to 15 days after the intervention. Method of measurement: Side events checklist. INCLUSION CRITERIA: Age 18‐45 years married Being literate in reading and writing Lack of allergy to herbal medicines Suffering from candidal vaginitis

(2023). "Comparision of the effect of vitamin D3 and probiotic containing lactic acid bacteria co-supplementation with vitamin D3 on serum 25(OH)D levels in patients with polycystic ovary syndrome." https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20221121056563N1.
	INTERVENTION: Intervention 1: Intervention group1: Probiotic group ‐ Vitamin D 50,000 IU vitamin D3 every two weeks along with one capsule of Lactofem containing Lactobacillus rhamnosus, Lactobacillus fermentum, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus gasseri and Lactobacillus bulgaricus in the amount of 109 CFU along with fructo‐oligosaccharides as prebiotics. They will receive the prebiotic daily. Intervention 2: Intervention group 2:In the vitamin D group, they will receive 50,000 IU of vitamin D3 every 2 weeks. CONDITION: Condition 1: Polycystic ovarian syndrome. Condition 2: Vitamin D deficiency, unspecified. ; Polycystic ovarian syndrome ; Vitamin D deficiency, unspecified E28.2 E55.9 PRIMARY OUTCOME: Serum level of 25 hydroxyvitamin D. Timepoint: The beginning and end of the study. Method of measurement: blood sample. SECONDARY OUTCOME: Body composition. Timepoint: The beginning and end of the study. Method of measurement: Bioelectrical Impedance Analysis. Body Mass Index. Timepoint: The beginning and end of the study. Method of measurement: Bioelectrical Impedance Analysis. Weight. Timepoint: The beginning and end of the study. Method of measurement: Scale. INCLUSION CRITERIA: Age range 18‐40 years A resident of Urmia Diagnosis of PCOS based on the Rotterdam indices. The Rotterdam criteria include having more than two of these symptoms: oligo/no ovulation, hyperandrogenism (symptoms such as hirsutism, acne, male pattern alopecia, increased free testosterone) and polycystic ovaries based on ultrasound (having 12 or more The follicle in each ovary is 2‐9 mm in size People with blood levels of 25 hydroxyvitamin D less than 30 ng/ml

(2023). "Comparison of Letrozole With Lerociclib Versus Letrozole With Placebo Control in Patients With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrial Cancer." https://clinicaltrials.gov/show/NCT05712941.
	This is a randomized, double‐blinded, placebo‐controlled Phase 3 clinical trial to compare the combination of lerociclib (administered at 150 mg twice a day (BID) with letrozole (administered at 2.5 mg once a day (QD) to that of placebo with letrozole (2.5 mg QD) in female participants with Grade 1 or Grade 2 (ie, low‐grade histology) endometrioid endometrial cancer (EC) and advanced/metastatic or recurrent disease. The study population will consist of female participants with endometrioid EC who are treatment‐naïve in the advanced/metastatic setting (ie, the first‐line [1L] population). Participants may have received prior adjuvant chemotherapy/chemoradiation for localized disease if the adjuvant therapy was administered ≥ 6 months prior. All participants must also be naïve to prior endocrine therapy for EC, and confirmed as medically postmenopausal to be eligible. The study will comprise a Screening Period of up to 28 days in duration; a Study Treatment Phase; a Safety Follow‐up Period spanning the time of study treatment discontinuation‐including discontinuation due to confirmed disease progression, as applicable‐through 28 days after the participant's last dose of any study intervention or the start of subsequent anticancer therapy (whichever occurs first); and a Survival Follow‐up Period that will continue until the participant's death or until at least 50% of all study participants have died (whichever occurs first). While receiving their randomized assigned study treatment, participants will undergo imaging assessments via computed tomography (CT) of the chest/abdomen/pelvis with contrast‐ or, if CT is medically contraindicated (eg, due to iodine allergy), via magnetic resonance imaging (MRI) with gadolinium‐every 8 weeks for the first 12 months and then every 12 weeks thereafter.

(2023). "Comparison of the effect of Agnugol, Cimifugol , Soyagol , vitagnus and EsCitalopram." https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20080902001181N4.
	INTERVENTION: Intervention 1: first intervention group: One CimiFugol coated tablet containing 6.5 mg of dry root of black cohosh plant manufactured by GolDaru Company will be taken daily for 8 weeks every night at a certain time with some water, preferably before going to bed. Intervention 2: second intervention group: One Agnugol coated tablet daily containing 4.8 mg of dry extract of the fruit of Vite Xagnus‐castus plant (standardized as 0.42‐0.58 mg of Ecobin) manufactured by GolDaru Company for 8 weeks every night at a certain time with some water preferably before going to bed. Intervention 3: The third intervention group: once a day before meals, Vitagnus coated tablets containing Vite Xagnus‐castus plant (standardized as 1.2‐3.3 mg of Ecobin) manufactured by Porsina Company will be consumed for 8 weeks. Intervention 4: 4th intervention group: They take one Soyagol coated tablet containing 50 mg of soy isoflavone, manufactured by GolDaru Company, for 8 weeks every night at a certain time with some water after meals. Intervention 5: The fifth intervention group: take one 10 mg Escitalopram tablet daily after lunch for 8 weeks. CONDITION: Menopause. ; Menopausal and female climacteric states N95.1 PRIMARY OUTCOME: Total score of menopausal symptoms. Timepoint: The total score of menopausal symptoms is checked at the beginning of the study (before the start of the intervention), the fourth and the eighth week after the start of the intervention. Method of measurement: Menopause Rating Scale (MRS). INCLUSION CRITERIA: Obtaining a score of 5 and above from the MRS questionnaire 12 months or more have passed since menopause Age between 45 and 65 years

(2023). "Comparison of the effect of Cabergoline versus Dienogest on markers in endometriosis." https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2023/04/051886.
	INTERVENTION: Intervention1: Cabergoline: 0.5mg twice weekly for 6 months Control Intervention1: Dienogest: 2mg OD for 6 months CONDITION: Health Condition 1: N801‐ Endometriosis of ovary PRIMARY OUTCOME: Change in the serum levels of pro inflammatory levels post treatment ; 1.Serum Vascular endothelial growth factor level ; 2.Serum Tumor necrosis factor alpha level ; 3.Serum high sensitivity C Reactive protein ; Timepoint: 0,6,9 months SECONDARY OUTCOME: To compare the efficacy of cabergoline with dienogest on ; 1.Reduction in post treatment pain by VAS ; 2.Reduction in post treatment volume measured on USG ; 3.Pain scoring by VAS after 3 months of stopping drug ; Timepoint: 0,3,6,9 months INCLUSION CRITERIA: Women with diagnosis of endometriosis on laparoscopy or ultrasound.

(2023). "Comparison of the Effect of Period Patch Analgesia with Mefenamic Acid in Primary Dysmenorrhea." https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20230112057117N1.
	INTERVENTION: Intervention 1: Administration of mefenamic acid, initial dose of two 250 mg capsules, then 250 mg capsule every si Xhours until pain control , maximum up to 48 hours. Intervention 2: Sticking the menstrual patch(Razan Pharmed) on the skin of the suprapubic area and changing it every eight hours to control the pain , maximum up to 48 hours. CONDITION: Condition 1: Primary Dysmenorrhea. Condition 2: Primary Dysmenorrhea. ; Primary dysmenorrhea ; Primary dysmenorrhea N94.4 PRIMARY OUTCOME: Primary Dysmenorrhea. Timepoint: Comparison of the analgesic effect of mefenamic acid and menstrual patch when used during a menstrual cycle. Method of measurement: Based on Numerical analogue pain score. INCLUSION CRITERIA: Nulipariety 18‐30 years old Regular mensturation BMI<30 Moderate dysmenorrhea atleast for one day Non OCP or IUD user Normal pelvic Exam and pelvic sonography No allergy to mefenamic acid and period patch

(2023). "Comparison of two different vaginal preparations of progesterone for prevention of recurrent preterm birth: a Randomized Controlled Trial."
	INTERVENTION: Intervention1: 200 milligrams of micronized progesterone effervescent vaginal tablet: The effervescent vaginal tablet, contains progesterone in a base of sodium bicarbonate, and an acid‐base reaction occurs when the tablet comes into contact with vaginal moisture, thus releasing carbon dioxide, which improves drug absorption across epithelium. As a result, this formulation has rapid dissolution and quick progesterone absorption. It will be given daily, per vaginally, from (16‐20 weeks Period of Gestation) till delivery Control Intervention1: 200 milligram of micronized progesterone gelatin capsule, vaginally: With repeated administration, the vaginal gel will build up in the vagina and will release progesterone gradually. It will be given daily, per vaginally, from (16‐20 weeks Period of Gestation) till delivery CONDITION: Health Condition 1: O092‐ Supervision of pregnancy with other poor reproductive or obstetric history PRIMARY OUTCOME: To compare micronized progesterone effervescent vaginal tablet with micronized progesterone gelatin capsule used vaginally, for prevention of PTB less than 37 weeks, in women with a prior spontaneous PTB or a mid‐trimester abortion.Timepoint: Till the delivery SECONDARY OUTCOME: 1 To compare the incidence of PTB less than and equal to 32 weeks (very PTB) and less than and equal to 28 weeks (extreme PTB) in the above two groups ; Timepoint: Preterm delivery less than and equal to 32 weeks and 28 weeks respectively To compare the acceptability and tolerability of the two progesterone formulations ; Timepoint: At least 15 days after using the progesterone formulations and later whenever the women complain INCLUSION CRITERIA: 1. Singleton live pregnancy between 16 to 20 weeks. 2. At least one spontaneous mid‐trimester abortion or preterm birth (â?¥16 weeks PoG to <37 weeks PoG) of a singleton infant due to spontaneous Preterm labor or Preterm premature rupture of membranes.

(2023). "Comparison of two doses of urinary human chorionic gonadotropin as trigger on ovulation induction in IUI cycles." https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2023/04/052137.
	INTERVENTION: Intervention1: 5000IU of urinary Human Chorionic Gonadotropin Intramuscular injection as trigger: 5000IU of urinary Human Chorionic Gonadotropin injection intramuscular injection as trigger, single dose when dominant follicle size â?¥18mm in intrauterine insemination cycles Control Intervention1: 10000 IU urinary Human Chorionic Gonadotropin Intramuscular injection as trigger: 10000 IU of urinary Human Chorionic Gonadotropin injection intramuscular injection as trigger, single dose when dominant follicle size â?¥18mm in intrauterine insemination cycles CONDITION: Health Condition 1: N979‐ Female infertility, unspecified PRIMARY OUTCOME: occurrence of ovulationTimepoint: 18 months SECONDARY OUTCOME: 1 Serum β hCG value after 12 hrs of trigger ; 2 Need of second trigger ; 3 Total pregnancy rate ; 4 Clinical pregnancy rate ; Timepoint: 18 months INCLUSION CRITERIA: women with patency of at least one Fallopian tube and her husband having more than 10 million sperms after sperm preparation

(2023). "comparison of two drugs for anaesthesia during dilation and curettage in females with abnormal menstrual bleeding."
	INTERVENTION: Intervention1: inj. Ketamine and Dexmedetomidine: Ketamine 1 mg/kg and Dexmedetomidine 0.5 mcg/kg combined in single syringe given IV slow over 2 min Intervention2: inj propofol and ketamine: inj propofol 1 mg/kg and ketamine 1 mg/kg given IV over 2 min Control Intervention1: inj. Ketamine and Dexmedetomidine: inj. Ketamine 1 mg/kg and Dexmedetomidine 0.5 mcg/kg given IV slow over 2 min Control Intervention2: inj ketamine and propofol: inj propofol 1 mg/kg and ketamine 1 mg/kg given IV over 2 min CONDITION: Health Condition 1: N925‐ Other specified irregular menstruation PRIMARY OUTCOME: Time to onset of sedation (Ramsay sedation score RSS 6) and recovery from sedation (RSS 3)Timepoint: Time to onset of sedation (Ramsay sedation score RSS 6) and recovery from sedation (RSS 3) SECONDARY OUTCOME: 1.Intraoperative Haemodynamics (Heart Rate, Blood Pressure, Spo2, Respiratory rate) ; 2.Post op recovery score ( Modified Aldrete Score) ; 3.Duration of analgesia ; Timepoint: 0min, 10, 20, 30 min INCLUSION CRITERIA: Patients of abnormal uterine bleeding scheduled for elective endometrial sampling American Society of Anaesthesiology I and II

(2023). "Deferred Embryo Transfer in an In Vitro Program With Single Embryo Transfer Policy." https://clinicaltrials.gov/show/NCT05721495.
	The study has been designed as a prospective, randomized, two‐arm, parallel, unblinded study, during which the investigators will include 138 couples (69 in each group) of IVF / ICSI users. Cycles canceled or punctured but without embryo transfer (either due to not obtaining oocytes, non‐fertilization or arrest of embryonic development) will not be included in the study. The assignment of the couples to each of the groups will be carried out by means of a consecutive random sampling procedure. The randomization list will be created specifically for this project and will be kept safely by someone not included in the research team: ‐ Group I (experimental): fresh transfer is not performed, the best quality embryo is cryopreserved. Elective transfer in a later cycle of the cryopreserved embryo. ‐ Group II (control): fresh transfer of the best quality embryo. Subjects of study: Patients who come to the Human Reproduction Unit of the Virgen de las Nieves University Hospital to perform a first or second cycle of IVF / ICSI. Couples will be selected according to inclusion criteria that classify them as good reproductive prognosis (which is consistent with the usual eSET practice). Couples will be able to participate in the study for only one cycle. Each couple will be interviewed to explain the characteristics of the study and will be given an Information Sheet. Written informed consent must be obtained from each couple. The person outside the research team who is guarding the randomization list will assign the corresponding treatment group. Before starting the study, ethical approval was processed by the Ethics Committee through the Ethics Portal for Biomedical Research of Andalusia. For the objective of assesing the null hypothesis that includes the equality of live birth rates in the group of women who undergo an elective deferred transfer of a single embryo and the group who undergo elective transfer of a fresh embryo, a power of 80% has been established to detect statistically significant differences by means of a bilateral Chi‐square test for two independent samples, taking into account that the level of significance is 5%, and assuming that the proportion in the group of women who undergo a fresh transfer is 50.9%, the proportion in the group of women who receive the deferred elective transfer is 78%, and that the proportion of women with respect to the total is 50%, it will be necessary to include 48 women in each group, with the objetive to obtain 96 experimental units in the study. Taking into account that the expected dropout rate is three out of ten women, it will be necessary to include 69 women per group. The 138 women will be assigned to one of the groups using a random procedure, following a sequence of random numbers generated by specific software (Epidat, Epidemiological Data Analysis Program Tabulated. Version 3.1). Methodology The patients must follow an ovulation stimulation treatment, in order to achieve multiple follicular development. A so‐called "long analog" GnRH agonist protocol will be used. This consists of administering from day 22 of the cycle 0.1 mg / day of GnRH analog (Decapeptyl 0.1; Lasa, Barcelona, Spain) until the day on which the administration of gonadotropin is started, in which the dose is reduced at 50% until the day of hCG. After 10‐14 days of administration of the agonist, the pituitary restraint is checked by means of ovarian vaginal ultrasound (absence of follicles and cysts) and serum estradiol determination (<50 pg / mL). If this medical hypophysectomy is confirmed, 300 IU of recombinant FSH (FSHr) is administered per day (Gonal F, Serono, Madrid, Spain) for two days, and 150 IU of FSHr from the 3rd to the 7th day. On this day, ultrasound monitoring of follicular development and serum estradiol determination are performed in order to once again adjust the dose of rFSH to each patient. Once the follicular response is adequate (more than 3 ovarian follicles greater than 18 mm in diameter), ovulation is triggered using 6,500 IU of hCG (Ovitrelle, Merck, Darmstadt Germany). IVF / ICSI and embryo culture will then be performed. To perform sperm microinsemination (ICSI) it is necessary to remove the cumulus and radiated crown from the oocyte. To decumulate, the crown‐oocyte cluster complex is submerged in a solution with 80 IU / mL of hyaluronidase (HYASE, IVF Science Scandinavia, Gothenburg, Sweden) for 10‐20 seconds, aspirating the complex several times using a pasteur pipette. The microinsemination technique is performed under an inverted microscope with Eppendorf and Narishigue micromanipulators and microinjectors. In Vitro Fertilization (IVF) is performed in a five‐well plate, depositing 0.5 mL of IVF medium (Vitrolife, Sweden) and 0.5 mL of Ovoil (Vitrolife, Sweden) in each well. Five cumulus are left per well and 100,000 sperm / mL are added. In both cases, the oocytes are cultured in a Thermo‐Fisher incubator, within a morphokinetic platform (PrimoVision) that takes photographs of them every 5‐10 minutes. The following days are evaluated for classification, choosing the one with the best implantation potential according to the division times measured by morphokinetics and the morphological criteria of the Spanish Association for the Study of Reproduction Biology (ASEBIR) reviewed in 2015. The embryo transfer will be carried out in group 2 on the third day choosing the best embryo according to the previous criteria. In group 1, the embryos will be cryopreserved by vitrification, selecting the best one for delayed transfer. The commercial vitrification media (Medicult Vitrification, Denmark) and the storage device will be Cryoleaf (McGill Cryoleaf, Medicult, Denmark). All cryopreserved embryos will be stored in liquid nitrogen at ‐196ºC in storage cylinders (Air Liquide, France). The day before cryotransfer the embryo is devitrified, using the thawing kit (Medicult Warming, Denmark). At the end, the embryo is washed in G2 medium (Vitrolife), leaving it in culture until the next day, after evaluating the embryo quality and cryosurvival (percentage of lysed cells). The woman's endometrium is prepared by treatment with estradiol valerate and progesterone. On the day of cryotransfer, embryo quality is assessed again, with emphasis on embryo division. Cryotransfer is performed using the same technique as transfer. Study limitations The project has been carried out taking into account the resources available in the Human Reproduction Unit of the University Hospital Virgen de las Nieves, and therefore there do not seem to be any limitations in this regard. The study could be completed by performing a preimplantation genetic diagnosis to determine if there are embryonic genetic alterations prior to intrauterine transfer, but this technique is not yet performed in our Unit. Likewise, blastocyst transfer can increase pregnancy rates, but by increasing the cancellation rate of embryo transfer, so it is not routinely performed in our Unit.

(2023). "Determination of the Effects of Autogenic Relaxation Exercise and Cold Pillow Application on Vasomotor Symptom Control and Quality of Life in Postmenopausal Women."
	Aims:The aim of this study was to determine the effect of autogenic relaxation exercise and cold pillows on vasomotor symptom control and quality of life. Hypothesis:H0‐1: In the postmenopausal period, there was no difference in the frequency of vasomotor symptoms between the group that received autogenic relaxation exercise and cold pillows and the control group. H1‐1: In the postmenopausal period, there is a time difference in vasomotor symptom frequency between the autogenic relaxation exercise and cold pillow group and the control group. H0‐2: In the postmenopausal period, there was no difference in vasomotor symptom duration between the group that was applied autogenic relaxation exercise and cold pillow and the control group. H1‐2: In the postmenopausal period, there is a time difference in vasomotor symptom duration between the autogenic relaxation exercise and cold pillow group and the control group. H0‐3: In the postmenopausal period, there was no difference in vasomotor symptom severity between the groups that received autogenic relaxation exercise and cold pillows and the control group. H1‐3: In the postmenopausal period, there is a time difference in vasomotor symptom severity between the autogenic relaxation exercise and cold pillow group and the control group. H0‐4: In the postmenopausal period, there was no difference in quality of life between the group that was applied autogenic relaxation exercise and cold pillow and the control group. H1‐4: In the postmenopausal period, there is a time difference in quality of life between the group that received autogenic relaxation exercise and cold pillows and the control group. Design: A parelel design randomised controlled study was conducted according to the CONSORT 2010 guidelines. Methods: This study was conducted in Kirikkale University Faculty of Medicine Hospital, Department of Obstetrics and Gynecology, Kirikkale, Turkey between 22.6.2018‐02.01.2019. The sample of the study consisted of women who were in the postmenopausal period, who met the inclusion criteria and who volunteered to participate in the study. Inclusion criteria in the study: Being in the first 5‐year period of postmenopause, experiencing vasomotor symptoms at least twice a day, being at least literate, living within the borders of the center of Kırıkkale province, not having a disease that mimics vasomotor symptoms, not taking hormone therapy other than estrogen in the last 12 months, not using antidepressants and anxiolytics in the last 3 months, not using herbal alternative treatment within the last 4 weeks, women who do not use other alternative and complementary treatment methods, who have a body mass index below 35 and who do not use hormone replacement therapy. Sample: A power analysis was utilised to determine the sample size using the G*Power 3.1.7 program. It was calculated that 61 people should be sampled at a significance level of 0.05 for a minimum power of 90%. In order for the number of people in both groups to be equal, 31 interventions were planned to be included in the sample group of 62 people in 31 control groups. In similar studies in the literature, loss of sample during follow‐up and since it was seen that there was a sample loss during the preliminary application of our research, it was planned to increase the number of samples by 40% and research groups were formed with 44 people in both groups. 142 women were evaluated in terms of suitability for the study, 45 of the women did not meet the inclusion criteria and 88 women could be included in the study because 9 of them did not agree to participate in the study. At different stages of the study, 10 women from the intervention group and 9 women from the control group withdrew from the study. The research was completed with 34 people in the intervention group and 35 people in the control group. After the research was completed, post‐hoc power analysis was performed using the G*power package program and the power of the study was determined as 91% for a sample group consisting of 69 peopl with a significance level of 0.05 for 34 interventions, 35 control groups and an impact width of 0.225. Intention To Treat (ITT) analysis was performed in the study because there were sample losses. Randomisation: Since the sample group was not clear before the study, it was recommended that a total of 4 papers, 2 of which were written as "intervention group" and "control group", were thrown into an envelope during the randomization process and that women should be assigned to the relevant group by selecting a paper from this envelope according to the order of participation in the study. The drawn paper was not thrown back into the envelope until the group of four was finished. After the papers in the envelope were finished, the process of assigning women to the relevant groups continued with the same method. After the women pulled the paper from the envelope, they were asked to give it to the researcher without opening the paper. After the women were invited to the study, they were taken to a separate outpatient clinic room and all procedures (randomly assigned to groups, training, teaching autogenic relaxation exercise, etc.) were performed in this room. The women were not told which group they belonged to during the study. Data collection and outcome measures:The research data were collected using the 'Identifying Features Form', 'Menopause Specific Quality of Life Scale' and 'Vasomotor Symptom and Application Follow‐up Diary'. Introductory features form: In line with the literature were created by researchers with expert opinions. The form includes a total of 28 questions about sociodemographic characteristics, general health status, medical obstetric history and menopausal history. Menopause‐specific quality of life scale: It was developed by Hilditch et al. (1996) to determine the quality of life of women related to menopause and its validity and reliability in Turkish were made by Kharbouch and Şahin (2005). In the Menopause Specific Quality of Life Scale, which consists of 29 items and 4 sub‐dimensions, each sub‐area score is ranked from 0 to 6. A score of "0" indicates that there is no problem with that issue, a score of "1" indicates that the problem is experienced but not at all, and a score of 2‐6 indicates the severity and increasing degrees of the existing problem. The total scale score is not calculated in the Menopause Specific Quality of Life Scale. Scoring is done according to scale sub‐dimensions. Vasomotor symptom and application follow‐up diary: It was created by the researchers to record vasomotor symptoms and relaxation exercise and cold pillow application applied in the research by taking expert opinions in line with the literature. Pilot test: In order to evaluate the intelligibility and usability of the data collection forms, the autogenic relaxation exercise and cold pillow application training booklet and the autogenic relaxation exercise CD to be used in the research, a pre‐application was made on 3 women from the intervention and control groups who met the inclusion criteria of the study. Women with pre‐treatment were not included in the study sample. Intervention group: After the women to be included in the intervention group were determined, individual interviews were held with the women in the room where the orogenic relaxation exercise would be performed. A quiet and dim room has been prepared for relaxation exercise. In the first interview, the introductory characteristics form was filled and the Menopause Specific Quality of Life Scale was completed. In addition, women were given training in line with the training booklet about the menopause period, autogenic relaxation exercise and cold pillow. After the training, autogenic relaxation exercise was taught accompanied by the autogenic relaxation exercise CD. The woman was informed about performing autogenic relaxation exercises 3 times a day and using a cold pillow when she experienced vasomotor symptoms. The autogenic relaxation exercise and cold pad application follow‐up chart, which was prepared for the purpose f recording the applications, was given. The women were evaluated by being invited to the hospital at 4 and 8 weeks, and they filled out the Menopause Specific Quality of Life Scale during the follow‐ups. The intervention was implemented for 8 weeks. Control group:After the women to be included in the control group were determined, individual interviews were conducted with the women in a separate room for orogenic relaxation. In the first interview, the introductory characteristics form was filled and the Menopause Specific Quality of Life Scale was completed. The women were evaluated by being invited to the hospital at 4 and 8 weeks, and they filled out the Menopause Specific Quality of Life Scale during the follow‐ups. The women were followed for 8 weeks. No other intervention was applied to the women other than the standard care they received at the hospital. The women were called every week and their vasomotor symptoms were questioned. Ethical Approval: Institutional and ethical committee permissions were obtained before starting the study (Approval number: 13/01). In addition, written consent was obtained from the scale owner of the scale to be used in the study and the participants who will participate in the study. After the implementation of the study, the women in the control group were given autogenic relaxation exercise and cold pillow application training and training materials. Statistical Analysis:Blinding was done during the evaluation of the data. Intervention and control groups were coded as 1 and 2. The analysis of the data coded in terms of groups was made by the statistician. After the statistical analysis, the coding for the intervention and control groups was explained. Statistical bias was checked with this blanking technique. The research data were transferred to the IBM Statistical Package for Social Sciences (SPSS) 26 program and analyzed. In the study, frequency distributions were used in the evaluation of categorical variables, and descriptive statistics (X̄±SD) were used for numerical variables. The scale sub‐dimension scores of the Menopause Specific Quality of Life Scale, which was used as a measurement tool in the research, were obtained by taking the sum of the related items. The mixed‐pattern anova test was used to test changes or differences in repeated measures of within‐group (in‐group effect), between‐group (time) effect, and co‐effect (group*time effect) repeated measures in intervention and control groups. The margin of error for statistical analysis results was accepted as 5%. In the evaluation of the effect size, the partial η2 value was used (small effect size=0.01, medium effect size=0.06 and large effect size=0.14). The negative (‐) value in front of the effect sizes indicates that the initiatives have a negative effect; a positive (+) value indicates that interventions have a positive effect (230). Intention To Treat (ITT) analysis was performed because there were sample losses in the study. The results of the analyzes (ITT) and Per Protocol (PP) were similar.

(2023). "Different doses of letrozole combined sequentially as letrozole+urofollitropin for treating anovulatory infertility in patients with polycystic ovary syndrome: a pragmatic randomized controlled trial." https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2300069638.
	INTERVENTION: Group A:2.5mg+FSH;GroupB:5.0mg+FSH; CONDITION: polycystic ovary syndrome PRIMARY OUTCOME: Ovulation rate;pregnancy rate;Clinical pregnancy rate;ongoing pregnancy rate; INCLUSION CRITERIA: (1) Patients with PCOS who meet the Rotterdam diagnostic criteria in 2003: (1) Patients with rare ovulation or even anovulation; (2) Clinical symptoms or biochemical manifestations of hyperandrogenism; (3) Abdominal ultrasound shows polycystic changes in the ovaries (vaginal ultrasound shows that one or even both ovaries contain more than 12 follicles with a diameter of 2‐9mm). Diagnosis can be made if two of the above three criteria are met. (2) Patients under 40 years old, with normal sexual activity and infertility for at least 1 year. (3) Hysterosalpingography shows normal uterine morphology and at least one patent fallopian tube. (4) The results of the spouse's semen analysis are normal or mildly oligoasthenozoospermia. (5) All organ functions are normal and there are no accompanying endocrine diseases such as pituitary dysfunction or hyperthyroidism. (6) The patient has been fully informed of the nature, significanc

(2023). "Effect duloxetine versus amitriptyline on clinical outcomes of female with chronic pelvic pain syndrome."
	INTERVENTION: Intervention 1: Intervention group: Duloxetine tablets 30 mg daily for one week then 60 mg daily for 8 weeks. Intervention 2: Control group: Amitriptyline tablets 25 mg daily for one week then 50 mg daily for 8 weeks. CONDITION: Chronic pelvic pain syndrome. ; Pelvic and perineal pain R10.2 PRIMARY OUTCOME: Improvement of clinical symptoms (pain, difficulty in defecation). Timepoint: Before the intervention and one and two months after that. Method of measurement: Using the National Institutes of Health Chronic Syndrome Symptom Index (NIH‐CSSI). The rate of overall response to treatment. Timepoint: Two months after the intervention. Method of measurement: Using the Global Response Assessment (GRA) questionnaire. SECONDARY OUTCOME: Occurrence of side effects (nausea, vomiting). Timepoint: one and two months after intervention. Method of measurement: With history taking. INCLUSION CRITERIA: Age 18 to 50 years Chronic pelvic pain syndrome for more than 6 months

(2023). "Effect of endometrial Scratching on pregnancy outcome after intrauterine insemination."
	INTERVENTION: Intervention 1: Endometrial scratching intervention group: Endometrial scratching is done in the intrauterine sperm injection (IUI) cycle on day 5 or 6 from the beginning of the menstrual cycle. To perform endometrial scratching, the patient is placed in a lithotomy position. Then, the speculum is slowly placed in the vagina to expose the cervix, and with the use of a flexible catheter, the endometrium is scratched in a circular position after performing aspiration. The circular movement of the catheter starts and ends in 12 o'clock position, and then the catheter is removed. If the catheter does not pass through the tenaculum, the anterior edge of the cervi Xis used to grasp the. According to the level of Anti‐Müllerian Hormone (AMH) and Ovarian Reserve Count (AFC), letrozole, Cinnal F, or Menstrual Gonadotropin (HMG) is used to stimulate the ovaries, depending on the initial response to stimulation. After starting the drugs, the follicle size is monitored. When the size of the follicles is greater than or equal to 18, two ampoules of human chorionic gonadotropin (HCG) are prescribed to release the egg, and the patient undergoes IUI after 36 hours. Intervention 2: Control group: Patients in this group will undergo a vaginal examination with a speculum and a cervical scraper will enter into the posterior forni Xwithout scratching. According to the level of Anti‐Müllerian Hormone (AMH) and Ovarian Reserve Count (AFC), letrozole, Cinnal F, or Menstrual Gonadotropin (HMG) is used to stimulate the ovaries, depending on the initial response to stimulation. After starting the drugs, the follicle size is monitored. When the size of the follicles is greater than or equal to 18, two ampoules of human chorionic gonadotropin (HCG) are prescribed to release the egg, and the patien CONDITION: Infertility needs intrauterine insemination (IUI). ; Artificial insemination Z31.1 PRIMARY OUTCOME: Clinical pregnancy rate. Timepoint: 5‐6 weeks after IUI. Method of measurement: Transvaginal sonography. SECONDARY OUTCOME: Chemical pregnancy rate. Timepoint: 14 days after IUI. Method of measurement: Measurement of beta human chorionic gonadotropin serum level (Beta HCG). Live birth rate. Timepoint: 28 weeks of pregnancy. Method of measurement: Phone based interview. INCLUSION CRITERIA: Age 20‐42 year Unexplained infertility or mild male factor infertility Failure of at least two previous intrauterine insemination (IUI) cycles

(2023). "The Effect of Escitalopram in PCOS." https://clinicaltrials.gov/show/NCT05840692.
	Clinical study Effects of antidepressive treatment on quality of life, insulin sensitivity and cortisone metabolism in PCOS. Hypothesis Participants with PCOS have increased hypothalamic‐pituitary‐adrenal activity compared to healthy women. Antidepressive treatment improves quality of life, cortisone and glucose turnover. Design A randomized controlled study in 40 PCOS patients who are treated with cipralex or placebo for 12 weeks. Before and after the treatment period the patients have a physical examination, a whole body dexa scan and fasting blood samples. Hypothalamic‐pituitary‐adrenal is measured by 24 hour samples of cortisone metabolites, 60 minutes ACTH test with basal and stimulated measurement of cortisone and 17‐hydroxyprogesterone. Glucose metabolism is examined by oral glucose tolerance test. Biopsies of muscle and fat are also performed.

(2023). "The effect of Fasting-mimicking diets on polycystic ovary syndrome." https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2300071796.
	INTERVENTION: control:Nil;Interventional group:fasting‐mimicking diet; CONDITION: polycystic ovary syndrome PRIMARY OUTCOME: Recovery of menstrual patterns; SECONDARY OUTCOME: luteinizing hormone (LH);follicle‐stimulating hormone (FSH);Estradiol (E2);Testosterone (T);Prolactin (PRL);progesterone (PROG);Fasting insulin (FINS);Fasting Plasma Glucose;Total cholesterol (TC);Triglyceride (TG);high density lipoprotein (HDL);low density lipoprotein (LDL);Insulin resistance inde X(HOMA‐IR); INCLUSION CRITERIA: 1. Female patients who meet the diagnostic criteria for PCOS in the Diagnostic Criteria and Treatment Specifications for Polycystic Ovary Syndrome formulated by Chinese experts in 2011; 2. Aged 18‐40 (Inclusion boundary value); 3. BMI: 20‐40 kg/m2 (Inclusion boundary value); 4. Patients who are willing to accept the diet intervention program; 5. Patients who volunteered to participate in this study and signed informed consent.

(2023). "The effect of grape seed extract vaginal cream on the treatment of candidal vaginitis." https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20181214041963N3.
	INTERVENTION: Intervention 1: Intervention group: grape seed cream, which will be made in Jundishapur Faculty of Pharmacy of Medical Sciences. To prepare medicine, 35 empty metal tubes of 50 grams with 2% grape seed cream will be prepared and filled with 50 grams of tube from Tolo Gostar Bukhara company/along with an applicator/one applicator should be used inside the vagina every night for seven days. Intervention 2: Control group: Clotrimazole vaginal cream 2%, which will be manufactured in Jundishapur Faculty of Pharmacy, along with an applicator, one applicator should be used inside the vagina every night for seven days. CONDITION: B37.3 Candida vaginitis. ; Candidiasis of vulva and vagina PRIMARY OUTCOME: Improvement of candidiasis signs. Timepoint: 6‐8 next days. Method of measurement: Examination and laboratory test and check list. SECONDARY OUTCOME: Improvement of disease recurrence. Timepoint: 40 days after the intervention. Method of measurement: Examination and laboratory test and checklist. INCLUSION CRITERIA: Consent to participate in research Diagnosis of candidal vaginitis (at least 3 points out of 18 symptom points), Marriage history Not being pregnant Lack of breastfeeding Not suffering from diabetes mellitus and diseases that weaken the immune system Not using broad‐spectrum antibiotics in the last 2 weeks Not using vaginal douche in the last 48 hours Not using vaginal drugs during the last week Not using hormonal drugs during the last 3 months Not having audio Not having a candidal infection more than 4 times a year

(2023). "Effect of Huoshan Dendrobium Zengye Jiedu Formula on oral mucositis and quality of life in patients with radiotherapy and chemotherapy."
	INTERVENTION: Experimental group:Huoshan Dendrobium Zengye Jiedu Formula;Control group:Kangfuxin liquid; CONDITION: Oral mucositis PRIMARY OUTCOME: Pain digital scoring;Inappropriate score;WHO classification of oral mucositis;Core scale score of quality of life for cancer patients;Immune function test; SECONDARY OUTCOME: Tumor markers;routine blood test; INCLUSION CRITERIA: 1. The age is 18‐80 years old, regardless of gender; 2. Patients with oral mucositis diagnosed clinically; 3. Patients with advanced malignant tumors confirmed by cytology or histology pathology are head and neck tumors (including nasopharyngeal cancer, esophageal cancer, etc.), lung cancer, stomach cancer, ovarian cancer, breast cancer, cervical cancer, etc. TNM stage is ? ‐ ?; ECOG score 0 1; The expected survival period is more than 6 months; 4. Those who have experienced radiotherapy or chemotherapy or concurrent radiotherapy and chemotherapy (the chemotherapy plan includes at least one or more of cyclophosphamide, methotrexate, nitrogen mustard, cisplatin, gemcitabine, cytarabine, vinblastine, podophyllotoxin, paclitaxel and other drugs) shall undergo chemotherapy; 5. The patient has clear consciousness, language expression ability or reading ability, can communicate normally, and can cooperate to complete the assessment; 6. Volunteer to join

(2023). "effect of LigaSure on post hysterectomy pain."
	INTERVENTION: Intervention 1: The first group are patients who undergo hysterectomy surgery with ligature for non‐malignant reasons. Pain after surgery 6 hours and 24 hours after surgery is compared with the opposite group that undergoes hysterectomy with the conventional method. Also, the length of stay in the hospital and the amount of painkillers used will be measured together. The amount of bleeding during the operation will also be compared between the two groups. Also, the return time of bowel function, complications such as urinary retention, re‐hospitalization due to the complications of the operation will be measured. will be compared. Intervention 2: Control group: The first group is the patients who undergo hysterectomy with conventional method for non‐malignant reasons. Pain after surgery 6 hours and 24 hours after surgery is compared with the opposite group that undergoes hysterectomy with the conventional method. Also, the length of stay in the hospital and the amount of painkillers used will be measured together. The amount of bleeding during the operation will also be compared between the two groups. Also, the return time of bowel function, complications such as urinary retention, re‐hospitalization due to the complications of the operation will be measured. will be compared. CONDITION: Hysterectomy. ; absence of both cervi Xand uterus Z90.710 PRIMARY OUTCOME: Post operation Pain. Timepoint: 6 hours after ending surgery and 24 hours after ending surgery. Method of measurement: Scale of Clinical Quality Indicators Postoperative Pain (SCQIPP) tool. The number of pain killer administration post surgery. Timepoint: During 48 hours after ending surgery. Method of measurement: Documented in medical record. SECONDARY OUTCOME: Duration of hospitalization of patient. Timepoint: The number of days of hospitalization after surgery. Method of measurement: Medical Record sheets. Duration of surgery. Timepoint: From surgery incision till end of closing it. Method of measurement: Stopwatch. The first time after surgery that patient will go out of bed. Timepoint: during 24 hours after surgery. Method of measurement: documented in medical record sheets by healthcare providers. INCLUSION CRITERIA: patients who candidate for hysterectomy with non malignant reason

(2023). "Effect of long snake moxibustion combined with pelvic floor muscle training on BND and PUVA in patients with stress urinary incontinence of kidney-yang deficiency type."
	INTERVENTION: Observation group:Long snake moxibustion combined with pelvic floor muscle training;Control group:Pelvic floor muscle training; CONDITION: Stress urinary incontinence PRIMARY OUTCOME: 1h urine pad test;incontinence impact questionnaire short form;Values of bladder neck mobility and posterior vesicourethral angle; INCLUSION CRITERIA: 1. Meet the diagnostic criteria of appeal; 2. Multiparous women aged 30‐60 years; 3. Mild to moderate stress urinary incontinence; 4. Voluntarily participate in the study and sign the informed consent form; 5. No treatment for the disease or take drugs affecting lower urinary tract function in the past 1 month.

(2023). "Effect of Marma Chikitsa on Udavarta Yoni Vyapad (Primary dysmenorrhea."
	INTERVENTION: CONDITION: Health Condition 1: N944‐ Primary dysmenorrhea Health Condition 2: N944‐ Primary dysmenorrhea PRIMARY OUTCOME: It is expected that at the end of study, scholar will be able to evaluate the effect of Marma Chikitsa in the management of Udavarta Yoni Vyapad ( Primary Dysmenorrhea). ; Spasmodic pain ; Cramping in the lower abdomen ; Pain radiate to lower back and medial aspect of thighs ; ; Timepoint: It is expected that at the end of 2 month, scholar will be able to evaluate the effect of Marma Chikitsa in the management of Udavarta Yoni Vyapad ( Primary Dysmenorrhea). ; Spasmodic pain ; Cramping in the lower abdomen ; Pain radiate to lower back and medial aspect of thighs ; ; SECONDARY OUTCOME: It is expected that at the end of study, scholar will be able to evaluate the effect of Marma Chikitsa in the management of Udavarta Yoni Vyapad ( Primary Dysmenorrhea).Timepoint: It is expected that at the end of 1 month and 1 month follow up, scholar will be able to evaluate the effect of Marma Chikitsa in the management of Udavarta Yoni Vyapad ( Primary Dysmenorrhea). INCLUSION CRITERIA: â?¢Patient between the age of 14‐30 years. â?¢Patient which fall under the diagnostic criteria. â?¢Patient with complaint of painful menstruation but without pelvic pathology. â?¢Pain along with scanty or average amount of blood flow. â?¢Patient willing to be registered for study with written consent.

(2023). "Effect of Palashudumbaradi Lepam followed by Kapikacchu mooldhavanam along with yogic practices in Pelvic Organ Prolapse."
	INTERVENTION: CONDITION: Health Condition 1: N812‐ Incomplete uterovaginal prolapse PRIMARY OUTCOME: To reposition the prolapsed uterus and vagina into its original positionTimepoint: 3 months SECONDARY OUTCOME: relief in associated features like difficulty in micturition,dyspareunia,backache,vaginal dischargesTimepoint: 3 months INCLUSION CRITERIA: 1.Patients having sign and symptoms of 1st and 2nd degree uterine prolapse 2.Patient having signs and symptoms of cystocele and rectocele 3.Patients with complaints of difficulty in micturition,incomplete emptying of bladder,dyspareunia 4.Patient having signs and symptoms of laxity of perineum

(2023). "The Effect of Symptom Management Program Based on Story Theory on Vasomotor Symptoms and Sleep Quality in Postmenopausal Women." ClinicalTrials.gov.
	Purpose: To investigate the effect of the Symptom Management Program Based on Story Theory on vasomotor symptoms and sleep quality in postmenopausal women. Design: The type of this research is mixed method (qualitative and quantitative research design together). It enables to strengthen the weaknesses of mixed method research, to increase the generalizability of the results, and to produce more reliable outputs regarding theory and practice. The quantitative research dimension is a randomized single-blind pretest-posttest experimental model with a control group. The qualitative research dimension is the descriptive phenomenological design. Method: The research will be carried out at Ömürevleri, Atakum, Mimar Sinan, Çobanlı and Yenimahalle Family Health Centers located in different regions of the Atakum District of Samsun. After informing the women who come to the Family Health Centers about the face-to-face research, the research will be conducted completely online (due to the COVID-19 pandemic) after the verbal consent of the women who volunteered to participate in the research and their contact numbers are obtained. The postmenopausal women who apply to the institutions where the research will be conducted and meet the inclusion criteria constitute the population of the research. When the sample size calculated with the G.Power program was taken as Pittsburgh Sleep Quality Index score mean and standard deviation value as 6.57±1.23, with 5% significance level, 80% test power, 0.700 effect size, there were at least 68 groups, 34 for the experimental group and 34 for the control group. identified as a person. Considering the sample loss in the experimental and control groups, with 10% more sampling, a total of 76 women will be included in the sample, with 38 women in each group. n the study, the data will be collected with the Personal Information Form, the Menopause Symptoms Assessment Scale, the Pittsburgh Sleep Quality Index and the Story Theory Based Semi-Structured Interview Form (for qualitative research) developed by the researchers in line with the literature. As a result of the study, the data will be evaluated separately as qualitative and quantitative.

(2023). "The effect of yoga training program on pelvic floor muscle strength, bladder neck descent,urinary control, urogenital hiatus diameter and urethral rotation angles in female athletes with stress urinary incontinence due to training intensity." https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20230113057119N1.
	INTERVENTION: Intervention 1: Intervention: Yoga exercises group. After checking the records and evaluation using the form to collect information such as age, sports history, pregnancy history, disease history and drug use, etc and the international form of urinary incontinence from the patients,10 people will be selected with stress urinary incontinence. Then these people will be invited by signing the consent form. until the pre‐test (quality of life questionnaire, two‐dimensional ultrasound of pelvic floor muscles and clinical assessment of vaginal touch) and after the implementation of yoga rehabilitation exercise program to strengthen pelvic floor muscles and core muscles and breathing exercises for eight weeks in three sessions An hour and a quarter per week and in each session, a post‐test (quality of life questionnaire, two‐dimensional ultrasound of the pelvic floor muscles and clinical assessment of vaginal palpation) is performed. Intervention 2: Intervention: Yoga exercises group. After checking the records and evaluation using the form to collect information such as age, sports history, pregnancy history, disease history and drug use, etc and the international form of urinary incontinence from the patients,10 people will be selected with stress urinary incontinence. Then these people will be invited by signing the consent form. until the pre‐test (quality of life questionnaire, two‐dimensional ultrasound of pelvic floor muscles and clinical assessment of vaginal touch) and in these four weeks he continued with his routine activities and finally a post‐test (quality of life questionnaire, two‐dimensional ultrasound of the pelvic floor muscles and clinical assessment of vaginal palpation) is performed. CONDITION: N39.3 Stress Urinary Incontinence (SUI). ; Stress incontinence (female) (male) PRIMARY OUTCOME: Urinary Incontinence. Timepoint: Before eight weeks of yoga and after eight weeks of yoga. Method of measurement: Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ‐UI SF). SECONDARY OUTCOME: Angles of rotation of the urethra. Timepoint: Before and after eight weeks of yoga. Method of measurement: Ultrasound. Bladder neck descent. Timepoint: Before and after eight weeks of yoga. Method of measurement: Ultrasound. Pelvic floor muscle strength. Timepoint: Before and after eight weeks of yoga. Method of measurement: Vaginal touch clinical test. The diameter of the urogenital hiatus. Timepoint: Before and after eight weeks of yoga. Method of measurement: Ultrasound. Urinary Incontinence Quality Of Life. Timepoint: Before and after eight weeks of yoga. Method of measurement: Incontinence Quality Of Life(IQOL). INCLUSION CRITERIA: be a woman Suffering from stress urinary incontinence Sports history Have not done yoga for at least si Xmonths

(2023). "Effectiveness of an EMDR Intervention for Perinatal Loss."
	Perinatal loss is a general term that refers to a loss from conception to one month postpartum. It is a grief that is still socially unauthorized, however, it is a situation with significant traumatic potential. However, there are no studies evaluating the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) for the prevention or treatment of perinatal loss. We propose an one‐site, open label, randomized controlled trial with the aim of assessing the effectiveness of EMDR recent traumatic episode (EMDR‐RTE) as a preventive intervention for PTSD symptoms after perinatal loss. A total of 40 women who have suffered a perinatal loss from the Maternal‐Fetal Medicine Service of a tertiary university hospital will be recruited. Women will be randomized to EMDR‐RTE or treatment as usual (TAU). Researchers will compare EMDR‐RTE and TAU to see if women receiving EMDR‐RTE treatment had lower levels of post‐traumatic and depressive symptoms.

(2023). "Effectiveness of platelet-rich plasma injection in treatment of stress urinary incontinence."
	INTERVENTION: Intervention 1: Intervention group: 24 patients undergoing pelvic floor muscle rehabilitation treatment as 35‐minute sessions, once a week, including 20 minutes of electrical stimulation with a vaginal probe with biphasic alternating current settings with a frequency of 5 Hz and a pulse width of 300 microseconds and current intensity from 1 to 100 The milliampere is adjusted to the level tolerated by the patient. Then 15 minutes of biofeedback with pelvic floor rehabilitation protocol will be performed for the patient in 4 weekly sessions (one session per week) for one month. In between sessions, the patient should perform Kegel exercises 6 times a day. In this group, after 4 sessions of pelvic rehabilitation, one shot of platelet‐rich plasma in the anterior 1/3 wall of the vagina is performed. Three shots of platelet‐rich plasma are performed at 4‐week intervals. Before performing the procedure, a full blood test will be performed for the patients for platelet count, prothrombin time and check liver enzymes to rule out liver diseases, and a complete urine test. Then the injection process will be explained to the patients and patients with the following abnormalities will be excluded from the trial: 1‐ Platelet disorders 2‐ Thrombocytopenia 3‐ Hypofibrinogenemia 4‐ Patients who are not hemodynamically stable 5‐ Acute/chronic infection 6‐ Chronic liver disease 7‐ Patients who use anticoagulants 8‐ Malignancy. Eligible patients will be referred to the pain and rehabilitation clinic, and after obtaining informed consent from the patients, two 10 ml samples of blood will be taken, and after centrifugation, two 5 ml samples of platelet‐rich plasma will be prepared for administration. Gel‐based Royagen kits will be used to prepare platelet‐rich plasma. The procedure is done w CONDITION: N39.3 Stress urinary incontinence. ; Stress incontinence (female) (male) PRIMARY OUTCOME: Stress urinary incontinence. Timepoint: The effectiveness of platelet‐rich plasma injection and pelvic floor biofeedback after 4 weekly sessions of biofeedback and 3 monthly sessions of PRP shots on women suffering from stress urinary incontinence. Method of measurement: International Consultation on Incontinence Questionnaire‐ Female Lower Urinary Tract Symptom (ICIQ‐FLUTS) long form and short form. SECONDARY OUTCOME: Quality of life. Timepoint: The effectiveness of platelet‐rich plasma injection and pelvic floor biofeedback after 4 weekly sessions of biofeedback and 3 monthly sessions of PRP shots on quality of life of women suffering from stress urinary incontinence. Method of measurement: International Consultation on Incontinence Questionnaire‐ Quality of Life (ICIQ‐QOL). Sexual Function. Timepoint: The effectiveness of platelet‐rich plasma injection and pelvic floor biofeedback after 4 weekly sessions of biofeedback and 3 monthly sessions of PRP shots on sexual function of women suffering from stress urinary incontinence. Method of measurement: Female Sexual Function Inde XPelvic incontinence Sexual Questionnaire‐12. INCLUSION CRITERIA: Women with clinical symptoms of urinary incontinence. Age 35‐55 patients opting for non‐surgical management.

(2023). "Effects of intermittent fasting on quality of life and toleance of chemotherapy in patients with gynaecological cancers: a randomized-controlled multi-center study."
	INTERVENTION: Group 1: Intermittent fasting (16:8h) over a period of three months during chemotherapie, has to be performed at at least 5 of 7 days per week, no food intake allowed on day of chemotherapy Group 2: Normal diet during chemotherapy (encouraged to follow a healthy, mediterranean diet CONDITION: ; C50 ; C56 ; C54.1 ; C53 C54.1 Endometrium Malignant neoplasm of breast Malignant neoplasm of cervi Xuteri Malignant neoplasm of ovary PRIMARY OUTCOME: Changes in fatigue measured by the FACIT‐FS questionnaire during 3 months of chemotherapy. The questionnaire will be assessed weekly to evaluate changes in fatigue during the chemotherapy cycle. SECONDARY OUTCOME: Secondary, explorative clinical endpoints: ; ‐ General Quality of Life: measured by the FACT‐G questionnaire and tumorspecific FACT questionnaires, as well as the general wellbeing questions of the EORTC QLQ C30 questionnaire; weekly recording of changes ; ‐ Sleep Quality: measured by the Pittsburgh Sleep Quality Index, recorded at baseline, 3 months and 6 months ; ‐ Pelvic floor function: measured by the German pelvic floor questionnaire, recorded at baseline, 3 months and 6 months ; ‐ Chemotherapy associated side effects: measured by CTCAE criteria, recorded at every cycle ; ‐ Weight changes: measured by body weight every cycle ; ‐ Laboratory changes (metabolic and organ function): measurment of different values at different time points, blood draws weekly ; ‐ Tumor response: tumormarker every 3 months, radiological tumor response measured by RECIST 1.1 every 3 months in metastasized patients, pathological tumor response post‐surgery in neoadjuvantly treated patients ; ; Secondary, explorative laboratory endpoints: ; ‐ Changes in immunological cells: Composition of peripheral blood mononuclear cells at baslien, 7 weeks and 13 weeks ; ‐ Peripheral cell damage: measured by yH2A Xintensity 3h after the start of chemotherapy at cylce 1, 6 weeks and 12 weeks ; INCLUSION CRITERIA: ‐ Gynaecological cancers (ovarian/endometrial/cervical/breast) ‐ BMI = 19 kg/m2 ‐ Baseline ECOG Status 0‐2 ‐ Life expactancy of over 6 months ‐ No i.v. chemotherapy in last 3 months ‐ Planned to recieve chemotherapy with at least one topoisomeraseinhibitor or alkylating agent over a period of three months ‐ Ability to understand the meaning and effects of the trial

(2023). "Effects of Muscle Energy Techniques Versus Core Stability Exercises in Pelvic Girdle Pain."
	Pelvic girdle pain (PGP) is known to be a musculoskeletal disorders which affects the pelvic bone. PGP is referred to as a specific form of LBP which occurs isolatedly as well as in combination with lumbar back pain. PGP localized to the anterior or posterior pelvis, most commonly located between the posterior iliac crest and gluteal folds especially around the SI joint. Pelvic girdle pain radiated to the posterior thigh. Moreover, it can also cause pain in the symphysis (1). Compared to lower back pain, PGP is substantially more painful and linked with functional limitations as standing, walking, sitting and changing positions are less tolerable in such patients (2). PGP is musculoskeletal in nature and is not caused by gynecological or urological conditions (3). Despite the fact that the cause of PGP is unknown, it is considered that it occurs due to many reasons such as trauma, arthritis, anatomical fault or it can be associated with pregnancy (4

(2023). "Effects of Pelvic Floor Muscle Training."
	INTERVENTION: Intervention 1: Intervention group: The protocol consisted of pelvic floor muscle strengthening exercises. Women were encouraged to perform three sets of ten slow contractions, holding each contraction for 6 to 8 seconds, followed by a rest period equal to the duration of the contraction. and finally three to four rapid contractions are performed in supine, sitting and standing positions for at least three times a day. Mothers do these exercises for 10 consecutive weeks (25 weeks of pregnancy to 35 weeks of pregnancy) and gradually the number of contractions increases. In each exercise, pay attention that the muscles of the pelvic floor are contracted and the muscles of other parts of the pelvis are relaxed. During the research, the examiner communicates with the mother two days a week through social networks and phone calls. Intervention 2: Control group: This group will be given the usual recommendations for care during this period and pelvic floor strengthening exercises in the form of pamphlets. CONDITION: N39.3 Urinary incontinence. ; Stress incontinence (female) (male) PRIMARY OUTCOME: Comparison of bladder base displacement with ultrasound to evaluate the strength of the pelvic floor muscles. Timepoint: Measuring of bladder base displacement at the beginning of the third trimester (28‐25 weeks), late third trimester (35‐32 weeks). Method of measurement: Measurement of bladder base displacement by ultrasound. SECONDARY OUTCOME: Measurement of quality of life. Timepoint: Early third trimester (25‐28 weeks), late third trimester (35‐32 weeks). Method of measurement: Measurement of quality of life with incontinence quality of life (I‐QOL) questionnaire. INCLUSION CRITERIA: First pregnancy Gestational age of 25 week Presence of urinary incontinence Gestational diabetes mellitus

(2023). "Efficacy and safety of remazolam in hysteroscopy."
	INTERVENTION: Remazolam group and propofol group:The induction dose of rimazolam was 0.2mg/kg/min, and MOAA/S score was performed every 20 seconds. When MOAA/S=1, the maintenance dose was adjusted by 1 mg/kg/h, and surgery was started.;propofol group :The induced dose of propofol is 2mg/kg/min, and the MOAA/S score is performed every 20 seconds. When the MOAA/S = 1 minute, the maintenance dose is adjusted to 2mg/kg/h, and the operation is started; CONDITION: Endometrial lesions PRIMARY OUTCOME: onset time;Awakening time;Departure time; SECONDARY OUTCOME: Drug dosage;Incidence rate of adverse events; INCLUSION CRITERIA: Patients aged 18‐65, ASA grade I‐II, body mass inde X(BMI)18‐30kg/m2, selected for hysteroscopy, volunteered to participate in the study and signed informed consent, willing to comply with the study requirements.

(2023). "efficacy of hyoscine on dilation of the cervix."
	INTERVENTION: Intervention 1: Intervention group: The intervention group is candidate to receive hyosine vaginal tablets. 2 hours before the hysteroscopy procedure, two hyoscine tablets (10 mg, manufactured by Porsina Pharmaceutical Company) are given to each patient intravaginally. Intervention 2: Control group: There is no intervention for the control group. CONDITION: Menopausal women. ; Unspecified menopausal and perimenopausal disorder N95.9 PRIMARY OUTCOME: Cervical dilation. Timepoint: 2 hours after medication. Method of measurement: bogie number 4. SECONDARY OUTCOME: Hyoscine side effect. Timepoint: after operation. Method of measurement: physician submission. INCLUSION CRITERIA: Patient's willing to participate in study Menopausal women who are planed for hysteroscopy and dilator number 4 does not pass from cervix Negative past cervical surgery Negative allergy history about Hyoscine Negative past medical history about cancers, obstructive bowel disease and cardiopulmonary disease

(2023). "efficacy of lignocaine in distension medium to reduce pain perceived during office hysteroscopy."
	INTERVENTION: Intervention1: diagnostic hysteroscopy: efficacy of lignocaine in distension medium in improving pain score‐ during office hysteroscopy Control Intervention1: comparing pain: efficacy of lignocaine in distension medium in improving pain score‐ during office hysteroscopy pain is assessed by VAS score taking case and control. CONDITION: Health Condition 1: N939‐ Abnormal uterine and vaginal bleeding, unspecified Health Condition 2: N00‐N99‐ Diseases of the genitourinary system Health Condition 3: N921‐ Excessive and frequent menstruation with irregular cycle Health Condition 4: N920‐ Excessive and frequent menstruation with regular cycle Health Condition 5: N972‐ Female infertility of uterine origin Health Condition 6: N979‐ Female infertility, unspecified Health Condition 7: N926‐ Irregular menstruation, unspecified Health Condition 8: N915‐ Oligomenorrhea, unspecified Health Condition 9: N950‐ Postmenopausal bleeding Health Condition 10: N96‐ Recurrent pregnancy loss Health Condition 11: N911‐ Secondary amenorrhea Health Condition 12: N959‐ Unspecified menopausal and perimenopausal disorder PRIMARY OUTCOME: efficacy of lignocaine in distension medium in improving pain score during office hysteroscopyTimepoint: 5 minutes prior procedure ; during procedure ; 5 minutes after procedure SECONDARY OUTCOME: efficacy of lignocaine in distension medium in improving pain score during office hysteroscopyTimepoint: 5 minutes prior procedure ; during procedure ; 5 minutes after procedure INCLUSION CRITERIA: 1.All women aged 20‐55 years undergoing office hysteroscopy(AUB, Infertility, Recurrent pregnancy loss etc.) 2.willing to participate and sign informed written consent 3.participants falling in ASA I&II

(2023). "Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain."
	After being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Participants who meet eligibility requirements will be randomized in a double blind manner (participant and investigator) to each treatment arm depending on their primary complaint. Participants with erectile dysfunction will be randomized 2:2:1 to either fSWT, rWT or sham therapy. Patients with chronic pelvic pain syndrome will be randomized 1:1 to either fSWT with pelvic floor physical therapy (PFPT) or PFPT with sham treatment.

(2023). "Efficacy of Percutaneous Electrical Neurostimulation(PENS) of the Auricle as an Opioid Sparing Postoperative Analgesic Technique in Cancer Endometrium and Cancer Cervix Patients."
	Efficient post operative pain relief is an essential part of comprehensive recovery of patients. Conventional method of pain management of laparotomy surgeries in CA endometrium and cervix patients involves invasive techniques like epidural or selective nerve block coupled with a varied choice of analgesics like opioids, NSAID or acetaminophen, wherein each drug is associated with its own set of contraindications and side effects. Despite advances in analgesic regimen including multimodal analgesic regimen, opioids have been observed to remain the mainstay postoperative analgesia in cancer patients despite its well‐established side effects. This double‐blinded prospective interventional study is conducted to explore the alternative of percutaneous electrical nerve stimulation (PENS) devices for effective pain relief with minimal to no side‐effects. The device will have tiny needles and a battery system that will be placed on and behind the patient's ear when they are under anesthesia. It acts by stimulating nerves around ear region by series of pain free impulse generation leading to centrally (brain) mediated response by altering certain chemical substances responsible for causing pain thereby providing relief for the patient.

(2023). "Efficacy of vasopressin for adhisionolysis of bowel DIE in laparoscopy."
	INTERVENTION: Intervention 1: Intervention group: In intervention group 50 patients will allocated and diluted injection vasopressin in 200 cc normal salin will injected in low posterior wall of uterus. Bleeding, ease of adhesion dissection, surgical complications will be recorded. Intervention 2: Control group: 5o patients randomly will assigned in control group who received injection of normal salin in the site of adhesion. Bleeding, ease of adhesion dissection, surgical complications will be recorded. CONDITION: Severe endometriosis. ; N97.8 PRIMARY OUTCOME: Time of surgery,Bleeding,bowel injury, ease of dissection. Timepoint: After surgery. Method of measurement: Questionnaire. SECONDARY OUTCOME: Dysmenorrhoea, dysparunia,chemical pregnancy, clinical pregnancy. Timepoint: 3‐6 months after surgery. Method of measurement: Questionnaire,bhcg test. INCLUSION CRITERIA: Age 20‐50 Stage 3‐4 endometriosis according to ASRM Severe adhesion in pelvis

(2023). "Electroacupuncture for chronic pelvic pain(CPP),sequela of pelvic inflammatory disease (PID)."
	INTERVENTION: Electroacupuncture group:Electroacupuncture treatment;Drug group:Take ibuprofen orally; CONDITION: chronic pelvic pain(CPP),sequela of pelvic inflammatory disease (PID) PRIMARY OUTCOME: Visual analog scale; SECONDARY OUTCOME: Self‐Rating Anxiety Scale;Self‐Rating Depression Scale; INCLUSION CRITERIA: Conform to the diagnostic criteria of chronic pelvic pain due to sequela of pelvic inflammatory disease; Women aged 20‐50 years with a history of sexual life, have relatively regular menstrual cycles; Visual analog scale (VAS) score of lower abdomen and lumbosacral pain = 3 points; Able to follow the test regulations and sign the informed consent form.

(2023). "empagliflozin effect in polycystic ovarian syndrom."
	INTERVENTION: Intervention 1: Intervention group: The people of this group are given empagliflozin 10 mg tablets (ABIDI company) once a day for three months. Intervention 2: Control group: The people of this group were given 1000 mg metformin tablets (Rahadaroo company) once a day for three months. CONDITION: E28.2 Polycystic ovarian syndrome. ; Polycystic ovarian syndrome INCLUSION CRITERIA: women between 15‐55 years old polycystic ovarian syndrom PRIMARY OUTCOME: 17‐oh progesterone. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: ELISA. Alanine transaminase(ALT). Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: ELISA. AST (aspartate aminotransferase). Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: ELISA. Body mass index. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: Meter and scale. C‐reactive protein (CRP). Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: ELISA. Dehydroepiandrosterone. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: ELISA. Fasting blood sugar. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: spectrophotometry. Fasting insulin. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: ELISA. Hba1c. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: HPLC. HDL (high‐density lipoprotein). Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: spectrophotometry. Insulin resistance. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: HOMA.IR. LDL (low‐density lipoprotein). Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: spectrophotometry. Total cholestrol. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: spectrophotometry. Total testestrone. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: ECLIA. Triglycerides. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: spectrophotometry. Waist circumfernce. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: Measuring tape. Weight. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: Digital scale.

(2023). "Erratum: effect of Zuranolone vs Placebo in Postpartum Depression: a Randomized Clinical Trial (JAMA Psychiatry (2021) 78: 9 (951-959) DOI: 10.1001/jamapsychiatry.2021.1559)." JAMA Psychiatry 80(2): 191.
	Error in Results: In the Original Investigation titled “Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial,”1 published in the September 2021 issue, there was an error in the Results section. The number of patients in the zuranolone and placebo groups who had new antidepressantmedication treatment initiatied by investigators were switched and should be 6 and 4, respectively. This article has been corrected online.

(2023). "Erratum: efficacy and safety of weekly paclitaxel plus vistusertib vs paclitaxel alone in patients with platinum-resistant ovarian high-grade serous carcinoma: the OCTOPUS multicenter, phase 2, randomized clinical trial (JAMA Oncol. (2023) 9: 5) (675-682) DOI: 10.1001/jamaoncol.2022.7966."  9(8): 1155.
	The Original Investigation titled "Efficacy and SafetyofWeeklyPaclitaxel Plus Vistusertib vsPaclitaxel Alone inPatients With Platinum‐Resistant Ovarian High‐Grade Serous Carcinoma: The OCTOPUS Multicenter, Phase 2, Randomized Clinical Trial,"1 published online March 16, 2023, in the May 2023 print issue, has changed license status to open access (CC‐BYNC‐ND license). This article has been updated online.

(2023). "Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms." https://clinicaltrials.gov/show/NCT05755958.
	Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non‐invasive ablative procedure using a high‐intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation. Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer. In this comparative, randomized, double blind study , the primary objective is to evaluate the efficacy of the HIFU treatment of rectal endometriosis with Focal One® HIFU device on the Acute Pelvic Pain 3 months after HIFU treatment, in comparison to a Sham group.

(2023). "Expression of concern: "Calcium plus vitamin D supplementation influences biomarkers of inflammation and oxidative stress in overweight and vitamin D-deficient women with polycystic ovary syndrome: a randomized double-blind placebo-controlled clinical trial"." Clinical Endocrinology 98(5): 746.
	
(2023). "Expression of concern: oral carnitine supplementation influences mental health parameters and biomarkers of oxidative stress in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial and The effects of coenzyme Q10 supplementation on gene expression related to insulin, lipid and inflammation in patients with polycystic ovary syndrome." Gynecological Endocrinology 39(1): 1841983.
	
(2023). "Fezolinetant (Veozah) for menopausal vasomotor symptoms." The Medical letter on drugs and therapeutics 65(1679): 97-99.
	
(2023). "ICI-Chemo New Standard for Endometrial Cancer." Cancer discovery 13(5): 1030-1031.
	The phase III RUBY and NRG-GY018 trials indicate that women with advanced endometrial cancer whose disease is newly diagnosed or has recurred for the first time benefit from the combination of a PD-1 inhibitor with standard chemotherapy. Adding either dostarlimab or pembrolizumab significantly prolonged progression-free survival, with overall survival also trending in the right direction. (©2023 American Association for Cancer Research.)

(2023). "In brief: A new endometrial cancer indication for dostarlimab (Jemperli)." The Medical letter on drugs and therapeutics 65(1683): e138.
	
(2023). "Incorrect Interquartile Ranges." JAMA 330(12): 1194.
	The Original Investigation titled "Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial,"1 published on April 11, 2023, was corrected to fix incorrect IQR values in Table 1. The median IQR for gravidity in the hysteroscopy and vacuum aspiration groups should have been reported as "2 (2‐4)."The median IQR for parity in the hysteroscopy and vacuum aspiration groups should have been reported as "1 (0‐2)."This article was corrected online.

(2023). "Management of Premenstrual Disorders: ACOG Clinical Practice Guideline No. 7." Obstetrics and Gynecology 142(6): 1516-1533.
	Purpose: To provide recommendations for the management of premenstrual syndrome and premenstrual dysphoric disorder, collectively referred to as premenstrual disorders, based on assessment of the evidence regarding the safety and efficacy of available treatment options. An overview of the epidemiology, pathophysiology, and diagnosis of premenstrual disorders also is included to provide readers with relevant background information and context for the clinical recommendations.; Target Population: Reproductive-aged adults and adolescents with premenstrual symptoms.; Methods: This guideline was developed using an a priori protocol in conjunction with a writing team consisting of two specialists in obstetrics and gynecology appointed by the ACOG Committee on Clinical Practice Guidelines-Gynecology and one external subject matter expert. ACOG medical librarians completed a comprehensive literature search for primary literature within Cochrane Library, Cochrane Collaboration Registry of Controlled Trials, EMBASE, PubMed, and MEDLINE. Studies that moved forward to the full-text screening stage were assessed by two authors from the writing team based on standardized inclusion and exclusion criteria. Included studies underwent quality assessment, and a modified GRADE (Grading of Recommendations Assessment, Development and Evaluations) evidence-to-decision framework was applied to interpret and translate the evidence into recommendation statements.; Recommendations: This Clinical Practice Guideline includes recommendations on the following evidence-based treatment options for premenstrual disorders, with an acknowledgement that many patients may benefit from a multimodal approach that combines several interventions: pharmacologic agents (hormonal and nonhormonal), psychological counseling, complementary and alternative treatments, exercise and nutritional therapies, patient education and self-help strategies, and surgical management. Recommendations are classified by strength and evidence quality. Ungraded Good Practice Points are included to provide guidance when a formal recommendation could not be made because of inadequate or nonexistent evidence. Based on review of extrapolated data from adult populations and expert consensus, it was determined that the recommendations also apply to adolescents, with a few exceptions that are noted in the Clinical Practice Guideline. (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

(2023). "Managing Outpatient Hysteroscopy-associated Pain." https://clinicaltrials.gov/show/NCT05801172.
	A prospective randomized trial (consent no.1072.6120.228.2021) includes women subjected to OH due to focal uterine lesion, abnormal uterine bleeding, or infertility. Women are randomly assigned to 3 arms ‐ A: NSAID (ketoprofen 100 mg intravenously), B: A+infiltration anesthesia (20 ml 1% lidocaine), C: A+paracervical block (20 ml 1% lidocaine). Karl Storz 5.0 mm Bettocchi® operative sheath with 2.9 mm 30 degree telescope and 5 Fr working channel was used. Intensity of pain in numeric rating scale (NRS), intensity of cervical bleeding, frequency of vaso‐vagal reaction, and frequency of abandoning/ limiting the procedure were compared.

(2023). "Maternal Well-being in the Postnatal Stage."
	The objective of this study is to design and validate an online intervention aimed at promoting well‐being in women with postpartum depression. For this, the design of a multicomponent protocol consisting of empirically validated positive interventions and comparing these with a group Cognitive Behavioral Therapy (CBT) is proposed, following the National Institute for Health and Care Excellence (NICE) recommendations for the treatment of depression. Participants will be screened for inclusion in the program if they meet clinical criteria. After that, they will be randomly assigned to a CBT group or a positive psychology intervention group.

(2023). "Online Brief CBT Intervention for Women With PCOS." https://clinicaltrials.gov/show/NCT05679362.
	The online brief CBT intervention is designed to address three problems that have often been reported in women with PCOS. Therefore, the program contains three themes: Psychoeducation about PCOS; traditional CBT and problem‐solving therapy. The brief CBT intervention consists of 5 online individual CBT sessions (60 minutes per session) or 5 group CBT sessions (60 minutes per session). Participants are randomized into one of three groups: 1. immediate individual treatment (A) 2. immediate group treatment (B) and 3. a wait‐list‐control group. The immediately treatment A and B begins for a total duration of 3 months: Week 1: Session 1 +homework assignments Week 3: Session 2 +homework assignments Week 5: Session 3 +homework assignments Week 8: Session 4 +homework assignments Week 12: Session 5 +homework assignments The wait‐list control group receives no treatment for the first three months, at which point they will cross over to one of the intervention arms (individual treatment A or group treatment B) and start with the intervention.

(2023). "Oral carnitine supplementation reduces body weight and insulin resistance in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial." Clinical Endocrinology 98(5): 745.
	
(2023). "Oral versus vaginal progestogens in women with recurrent miscarriages." https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20230117057148N1.
	INTERVENTION: Intervention 1: Interventional Group 1: This group will be given oral progestogens in a dose of 10mg twice a day in morning and evening after meals for 12 weeks. Efficacy will be measured by continuation of pregnancy beyond 12 weeks. All the data will be recorded in predesigned data. Transvaginal ultrasound will be performed at 7, 9 and 12 week of gestation. Ultrasonography will be looked for presence of fetal cardiac activity. This group will also serve as control as it is the standard routine route by which progestogens are given. Intervention 2: Intervention group 2: This group was prescribed vaginal progestogens in a dose of 200mg twice a day for 12 weeks. Efficacy was measured by continuation of pregnancy beyond 12 weeks. All the data will be recorded in predesigned data. Transvaginal ultrasound will performed at 7, 9 and 12 week of gestation. Ultrasonography will be looked for presence of fetal cardiac activity. CONDITION: recurrent miscarriages. ; Spontaneous abortion PRIMARY OUTCOME: Pregnancy. Timepoint: 12 weeks of gestation. Method of measurement: ultrasound. INCLUSION CRITERIA: Pregnancy Aged 16‐40 years, A history of at least three recurrent miscarriages At or less than 7 weeks of gestational age

(2023). "ovary cyst and exercises." https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2023/01/048652.
	INTERVENTION: Intervention1: Functional Resisted exercises,diet: Blood pressure and heart rate will be recorded at the beginning of each session, followed by 5‐minute warm up that consisted of marching in place, unilateral reaches(unweighted), and side‐step lunges (unweighted). The warm‐up will be followed by the exercise protocol. â?¢ The exercises which will be performed, in order, squats, wood chopping, side step squat, bent row, reverse lunge with rotation, triceps dip, deadlift, modified pushups and chest raises. GROUP A â?¢ Each of the exercises require subjects to begin in a standing position with feet approximately shoulder width apart, and each exercise will perform with a focus on accuracy and form.The resistance of 40 to 60% of 1RM will be chosen for training. â?¢ Subjects will be given 90 seconds of rest between each set. At the beginning of the study, each subject will perform 2 sets of 5‐8 repetitions. â?¢ From that point on, the volume (sets and repetitions) will increase for each exercise biweekly. â?¢ At week 3 subjects will be asked to perform exercises 3 sets of 7 repetitions; at week 5 subjects will be asked to perform 4 sets of 7 repetitions, and finally at week 6 subjects will be asked to perform 4 sets of 9‐10 repetitions. Control Intervention1: Aerobics&Diet: Blood pressure and heart rate will be recorded at the beginning of each session, followed by 5‐minute warm up that consisted of Jumping jacks(15 reps),High knees(15 reps),Butt kicks(15 reps),Lunges(15 reps) The warm‐up will be Followed by the exercise protocol. Moderate‐intensity continuous training (MICT): 40 min of walking/jogging on the treadmill at 70â??80% HR max Cool down by slowing down the speed of treadmill for 5 minutes CONDITION: Health Condition 1: E282‐ Polycystic ovarian syndrome PRIMARY OUTCOME: Fasting blood glucose levels ; 2.Fasting Insulin ; 3.HOMA IR index ; 4. The Polycystic Ovary Syndrome Quality of Life scaleTimepoint: ; one at the start of study and other after SECONDARY OUTCOME: The Polycystic Ovary Syndrome Quality of Life scaleTimepoint: one at the start of study and other after exercise intervention INCLUSION CRITERIA: 1. Diagnosed cases of PCOS 2. Age‐19‐35 years 3. BMI‐25‐35 kg/m2

(2023). "Palliative pharmacotherapy for cancer-related fatigue." https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20150302021307N6.
	INTERVENTION: Intervention 1: First intervention group: They will receive oral methylphenidate for 4 weeks. Methylphenidate is started at a dose of 5 mg per day in the first week. After that, the dose of 5 mg twice a day is continued in the second and third week. After that, in the fourth week, the dose returns to 5 mg per day. Intervention 2: Second intervention group: They will receive oral bupropion for 4 weeks. Bupropion is started at a dose of 150 mg per day in the first week. After that, the dose of 150 mg twice a day is continued in the second and third week. After that, in the fourth week, the dose returns to 150 mg per day. Intervention 3: Third intervention group: They will receive oral amantadine for 4 weeks. Amantadine is started at a dose of 100 mg per day in the first week. After that, the dose of 100 mg twice a day is continued in the second and third week. After that, in the fourth week, the dose returns to 100 mg per day. Intervention 4: Fourth intervention group: They will receive oral ginseng for 4 weeks. Ginseng is started at a dose of 500 mg per day in the first week. After that, the dose of 500 mg twice a day is continued in the second and third week. After that, in the fourth week, the dose returns to 500 mg per day. Intervention 5: Control group: They will receive oral placebo. Placebo will start one capsule daily in the first week. After that, two capsules per day will continue in the second and third week. After that, one capsule will be consumed again in the fourth week. CONDITION: Cancer‐related fatigue. ; Malaise and fatigue PRIMARY OUTCOME: Fatigue level over time, which will be measured by the functional assessment of chronic illness therapy‐fatigue scale. Timepoint: Fatigue level will be measured at baseline, weekly during the 4‐week intervention period, and sixth and eighth weeks as follow‐up. Totally, fatigue level will be measured for 7 times. Method of measurement: The functional assessment of chronic illness therapy‐fatigue scale. SECONDARY OUTCOME: To evaluate the safety, the secondary outcome is the adverse events, which will be assessed by the Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events. (Adverse events will be evaluated in 14 subgroups including oral, respiratory, neurological, sleep, sexual, cardio, visual, mood, cutaneous, gastrointestinal, attention, pain, genitourinary, and miscellaneous). Timepoint: Adverse events will be assessed at baseline, and weekly during the 4‐week intervention period. Method of measurement: The Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events. INCLUSION CRITERIA: Age over 18 years with advanced cancer diagnosis undergoing active anticancer treatment Participants with all types of cancer except patients with central nervous system tumor or hormone‐sensitive cancers or Pheochromocytoma Report of moderate to severe fatigue in the last week (score = 4 on a scale of 0 to 10) Diagnosis of cancer‐related fatigue based on International Classification of Diseases 10th edition (ICD‐10) criteria Hemoglobin level above 9 g/dL in 2 weeks before enrollment Ability to swallow and absorb medications Females who are likely to become pregnant should use contraceptive methods during treatment and up to 6 weeks after. Ability to read and write

(2023). "Pelvic Floor Physical Therapy vs Standard Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation."
	This was a randomized double‐blind study. Both subjects and the surgeon performing the surgery as well as the personnel administering questionnaires to patients postoperatively were blinded to the randomization. Recruitment, Enrollment and Randomization Patients scheduled to undergo vaginoplasty surgery at Cleveland Clinic Main campus were approached about voluntary participation in this study. This occurred over the phone approximately one to three months before their scheduled surgery. Patients who agreed to participate were sent a consent form via the mail and were asked to sign consent in person. Enrollment and randomization occurred following informed consent. All patients were given a copy of their signed and dated consent. Once enrolled, patients were randomized into one of two groups: ‐ Postoperative PFPT ‐ No Postoperative PFPT If patients were randomized into the Postoperative PFPT arm, they were further randomized into the following sub‐arms: ‐ Postoperative PFPT alone ‐ Preoperative and Postoperative PFPT Surgery: All patients underwent vaginoplasty surgery by a single surgeon in a standard fashion. The neovaginal cavity was created using the same technique across all patients. Postoperative care was routine and the same for all patients. Postoperative Pelvic Floor Physical Therapy: There was three possible PFPT regimens. All PT regimens were performed by the same two physical therapists, trained in the management of patients who have undergone vaginoplasty surgery. 1. No PFPT Patients were present to see the physical therapist 3 weeks postoperatively. The following interventions were performed: Subjective assessment of bowel and bladder function. Visual and external palpation and assessment of external pelvic floor region. Intravaginal pelvic floor assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. 2. Postoperative PFPT Only Patients presented to the physical therapist 3 weeks and 6 weeks postoperatively. The following interventions were performed: 3 weeks: ‐ Subjective assessment of bowel and bladder function ‐ Visual and external palpation and assessment of external pelvic floor region ‐ Intravaginal pelvic floor assessment ‐ Pelvic floor muscle dynamics and coordination assessment ‐ Instruction of pelvic floor coordination and lengthening ‐ Discussion of dilator program and progression ‐ Home program with instructions 6 weeks: ‐ External scar assessment and treatment if tissue healing allows ‐ Instruction to patient of scar mobilizations ‐ Intravaginal pelvic floor assessment and treatment if indicated ‐ Review of pelvic floor lengthening and coordination ‐ Review and progression of dilator program if appropriate ‐ Assessment of current bowel/bladder symptoms; home program and instructions to address these symptoms 3) Preoperative PFPT and Postoperative PFPT: Patients presented to see the physical therapist 3 weeks before surgery, 3 weeks and 6 weeks postoperatively. The following interventions were performed: Preoperative: ‐ Diaphragmatic breathing ‐ Discuss dilator positioning/introduce dilator program ‐ External pelvic floor assessment ‐ Teach pelvic floor coordination ‐ Assessment of current bowel/bladder symptoms; home program and instructions to address these symptoms 3 weeks: ‐ Subjective assessment of bowel and bladder function ‐ Visual and external palpation and assessment of external pelvic floor region ‐ Intravaginal pelvic floor assessment ‐ Pelvic floor muscle dynamics and coordination assessment ‐ Instruction of pelvic floor coordination and lengthening ‐ Discussion of dilator program and progression ‐ Home program with instructions 6 weeks: ‐ External scar assessment and treatment if tissue healing allows ‐ Instruction to patient of scar mobilizations ‐ Intravaginal pelvic floor assessment and treatment if indicated ‐ Review of pelvic floor lengthening and coordination ‐ Review and progression of dilator program if appropriate ‐ Assessment of curren bowel/bladder symptoms; home program and instructions to address these symptoms Study Questionnaires & Exams: All patients were administered questionnaires preoperatively and 12 weeks postoperatively. The following questionnaires were administered: Preoperatively: ‐ CRAD‐8 and UDI‐6 ‐ PFIQ‐7 Postoperatively 1 week (at the time of routine dilation teaching): • Vaginal length (routine exam) Postoperatively 12 weeks: ‐ CRAD‐8 and UDI‐6 ‐ PFIQ‐7 ‐ PGI‐I ‐ Ease of Passing Dilator (VAS 0‐10) ‐ Pain with Dilation (VAS 0‐10) ‐ Largest dilator size used ‐ Vaginal length (routine exam) Cross‐Over Treatment: Any patients in the No PFPT arm who were determined to have pelvic floor dysfunction or symptoms that may have benefitted from PFPT referral, were referred after the 12‐week mark. Any patient in one of the PFPT arms who was determined to still need PFPT for persistent pelvic floor dysfunction or symptoms were referred for continued care.

(2023). "Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery." https://clinicaltrials.gov/show/NCT05731284.
	Platelet rich plasma (PRP) is an autologous product with high levels of platelets which are concentrated with bioactive growth factors responsible for accelerating tissue healing by stimulating the number of reparative cells to create collagen production, angiogenesis and neurogenesis. The overarching goal is to evaluate the effectiveness and safety of the adjunct application of PRP in the fibromuscular connective tissue (the site of anterior tissue plication) at the time of anterior colporrhaphy (the site of highest recurrence risk) in women undergoing native tissue vaginal prolapse repair, to promote tissue healing and regeneration, thus to improve surgical outcomes.

(2023). "POSTCARE-O: SURVIVORSHIP CARE FOR WOMEN LIVING WITH OVARIAN CANCER." https://clinicaltrials.gov/show/NCT05752448.
	Study Design We will conduct a 2‐arm randomized controlled trial to evaluate the impact of a telehealth delivered survivorship transition care process. Ovarian cancer survivors (120) will be randomly allocated to receive survivorship care either using the POSTCare Process or standard of care. Study design and reporting will be in accordance with the Consolidated Standards of Reporting Trials (CONSORT) checklist. We will use quantitative and qualitative methodologies in a concurrent triangulation mixed methods design utilizing qualitative data to augment our interpretation of quantitative data. Outcomes will be collected at baseline, 12 weeks and 24 weeks, with the primary outcome being quality of life assessment at 12 weeks. Sample Size We will enroll 120 women completing primary treatment for Stage 2‐4 ovarian cancer from 3 urban gynecologic oncology clinics located in the Southern United States. Participants will have received some combination of surgery, chemotherapy, radiation therapy, and biologics. Continued maintenance therapy is not an exclusion factor. Aim 1 proposes to implement a randomized controlled trial (RCT) devised to compare QOL measures among ovarian cancer patient randomized to receive usual care versus the POSTCare survivorship care transition program. The Functional Assessment of Cancer Therapy‐Ovarian (FACT‐O) QOL survey will be collected at baseline as well as 12 and 24 weeks after the initial course of adjuvant chemotherapy. The primary endpoint will be the 12‐week survey. We expect to observe a mean 12‐week FACT‐O score of 116 with standard deviation of 20 for women receiving usual care. The sample size of N=120 patients provides at least 80% power to detect a 7% increase in the mean FACT‐O score for women randomized to the POSTCare survivorship care intervention. This is sufficient to ascertain a minimally important difference of 8 points. Recruitment and Setting We will recruit participants from Gynecologic Oncology practices at 3 clinic settings in Texas: One safety net practice located in Dallas, one safety net practice located in Houston, and one faculty group practice located in Houston. Cumulatively the sites serve approximately 120 eligible patients per year and ensure a diverse population can be recruited during the 24‐month recruitment period. 120 women will be recruited. Sixty participants will be randomly assigned to the intervention group and receive care using the POSTCare Process and 60 will be randomly assigned to the control group. It is anticipated that our study sample will reflect the ethnic and racial diversity of our clinical settings.

(2023). "Preliminary outcomes of modified posterior colporrhaphy." https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2300067337.
	INTERVENTION: Group 1:Modified posterior colporrhaphy;Group 2:None; CONDITION: Vaginal relaxation combined with urinary stress incontinence PRIMARY OUTCOME: Female sexual function index, FSFI;Vaginal laxity questionnaire, VLQ;Incontinence Quality of life Questionnaires, I‐QOL; INCLUSION CRITERIA: 1. Patients with urinary incontinence were confirmed to have loose vagina by gynecological examination before surgery; 2. Patients with indications for vaginoplasty; 3. Patients who signed the informed consent form before the operation; 4. Patients with complete clinical data preservation.

(2023). "A prospective randomized controlled study on the relationship between preserving/removing circumflex iliac lymph nodes and lower limb lymphedema following lymphadenectomy in gynecological malignancies."
	INTERVENTION: Group one:pelvic lymphadenectomy with circumfle Xiliac nodes distal to the external iliac node (CINDEIN) preservation;Group two:pelvic lymphadenectomy with circumfle Xiliac nodes distal to the external iliac node (CINDEIN) removal; CONDITION: gynecologic oncology PRIMARY OUTCOME: the incidence of Lower limb lymphedema; SECONDARY OUTCOME: the metastasis rate of circumfle Xiliac nodes; INCLUSION CRITERIA: (1) Stages ? b1 ? A2 cervical cancer, ? ? uterine malignant tumors, and various stages of ovarian malignant tumors undergoing satisfactory ovarian tumor cell reduction surgery with clear pathological diagnosis (FIGO 2009 staging); (2) Age 18‐75 years old; (3) Willing to undergo surgery without any contraindications; (4) All patient surgeries include pelvic lymph node dissection; (5) Enrolled patients must understand and voluntarily participate in the study, and sign an informed consent form.

(2023). "A randomized controlled study on acupuncture treatment of levator ani syndrome."
	INTERVENTION: Acupuncture group:After communicating with the patient, the patient was instructed to take the prone position and the local skin was routinely disinfected. The acupuncturist acupunctured the patient 's bilateral Zhongliao ( sacrum, right in the third sacral foramen ) and Xialiao ( sacrum, right in the fourth sacral foramen ). Operation : 3‐inch filiform needle ( 0.35 * 0.75mm ) was punctured into the posterior sacral foramen, obliquely punctured 75mm, the tip of the needle was in the direction of the inner side and the root of the thigh. The needle body was 30 o angle with the longitudinal axis of the human body and 60 o angle with the skin. After acupuncture, the needle was gently lifted, inserted and twisted to obtain qi. After obtaining qi, the needle sensation was radiated to the anus. Bilateral Zhongliao and Xialiao points were connected with electroacupuncture at a frequency of 2 / 15 Hz and a stimulation intensity of 1 5 mA, which was based on patient comfort. Retain the needle for 30 minutes, no needle during the needle retention process.;sham acupuncture group:After communicating with the patient, the patient was instructed to take the prone position and the local skin was routinely disinfected. The acupuncturist took the bilateral false Zhongliao point to open 20 mm outward at the bilateral Zhenzhongliao point, the bilateral false Xialiao point to open 20 mm outward at the bilateral Zhenxialiao point, and the shallow acupuncture was 3‐5 mm. The electroacupuncture electrode placement and parameter setting were the same as those in the acupuncture group. Acupuncture had no operation of deqi, and electroacupuncture had no output. Retain the needle for 30 minutes, no needle during the needle retention process.; CONDITION: levator ani syndrome PRIMARY OUTCOME: Clinical treatment efficiency; SECONDARY OUTCOME: Pain days per month;life quality evaluation;psychological assessment;anorectal manometry;Pelvic floor surface electromyography detection;tcm syndrome score; INCLUSION CRITERIA: Subjects must meet all the following requirements : ( 1 ) Patients who met the diagnostic criteria for levator ani syndrome ( functional gastrointestinal disease Rome IV ) ; ( 2 ) Patients with chronic or recurrent anorectal pain, each pain lasted at least 30 minutes, at least once a week, symptoms appear = 1 year, rectal examination : puborectalis traction pain ; ( 3 ) Age 20 to 70 years old, gender is not limited ; ( 4 ) Those who did not receive acupuncture treatment 3 months before enrollment ; ( 5 ) Participants voluntarily participated and signed informed consent

(2023). "Robotic-Assisted Hysterectomy for Endometrial Cancer in People With Obesity: A Health Technology Assessment." Ontario Health Technology Assessment Series 23(6): 1-70.
	Background: Robotic-assisted surgery has been used in Ontario hospitals for over a decade, but there is no public funding for the robotic systems or the disposables required to perform robotic-assisted surgeries ("robotics disposables"). We conducted a health technology assessment of robotic-assisted hysterectomy (RH) for the treatment of endometrial cancer in people with obesity. Our assessment included an evaluation of the effectiveness, safety, and cost-effectiveness of RH, as well as the 5-year budget impact for the Ontario Ministry of Health of publicly funding RH. It also looked at the experiences, preferences, and values of people with endometrial cancer and obesity, as well as those of health care professionals who provide surgical treatment for endometrial cancer.; Methods: We performed a systematic literature search of the clinical evidence to identify systematic reviews and randomized controlled trials relevant to our research question. We reported the risk of bias from the included systematic review. We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search. We also analyzed the 5-year budget impact of publicly funding RH (including total, partial, and radical procedures) for people with endometrial cancer and obesity in Ontario. To contextualize the potential value of RH for people with endometrial cancer and obesity, we spoke with people with lived experience of endometrial cancer and obesity who had undergone minimally invasive surgery (either laparoscopic hysterectomy [LH] or RH), and we spoke with gynecological cancer surgeons who perform hysterectomy.; Results: We included one systematic review in the clinical evidence review. An indirect comparison showed that conversion rates to open hysterectomy (OH) were similar for LH and RH in patients with a body mass index (BMI) ≥ 30 kg/m 2 (6.5% vs. 5.5%, respectively) (GRADE: Very low). An indirect comparison within a subset of patients with a body mass index (BMI) ≥ 40 kg/m 2 showed that a higher proportion of patients who underwent LH required conversion to OH compared with patients who underwent RH (7.0% vs. 3.8%, respectively) (GRADE: Very low). Rates of perioperative complications were similarly low for both LH and RH (≤ 3.5%) (GRADE: Very low). We identified two studies that met the inclusion criteria of our economic literature review. The included economic studies found RH to be more costly than OH or LH for endometrial cancer; however, because these studies were conducted in other countries, the results were not applicable to the Ontario context. Assuming a moderate increase in the volume of robotic-assisted surgeries, our reference case analysis showed that the 5-year budget impact of publicly funding RH for people with endometrial cancer and obesity would be $1.14 million. The budget impact analysis results were sensitive to surgical volume and the cost of robotics disposables. The people we spoke with who had lived experience of endometrial cancer and obesity, as well as gynecological cancer surgeons, spoke favourably of RH and its perceived benefits over OH and LH for people with endometrial cancer and obesity.; Conclusions: Compared with LH, RH is associated with fewer conversions to OH in patients with endometrial cancer and obesity (i.e., those with a BMI ≥ 40 kg/m 2 ). Rates of perioperative complications were similarly low for both LH and RH. The cost-effectiveness of RH for people with endometrial cancer and obesity is unknown. We estimate that the 5-year budget impact of publicly funding RH for people with endometrial cancer and obesity would be $1.14 million. People we spoke with who had lived experience of endometrial cancer and obesity reported favourably on their experiences with minimally invasive hysterectomy (either LH or RH) and emphasized the importance of the availability of safe surgical options for people with obesity. Gynecological surgeons perceived RH as a perior alternative to OH and LH for people with endometrial cancer and obesity. (Copyright © Queen's Printer for Ontario, 2023.)

(2023). "Study of ART0380 in Advanced/Metastatic Solid Tumors Patients."
	ART0380 is being developed as an oral anti‐cancer agent for the treatment of patients with cancers that have defects in deoxyribonucleic acid (DNA) repair. The study will recruit selected patients with advanced or metastatic solid tumors, specifically: ‐ Patients with persistent or recurrent endometrial cancer (EC) ‐ Patients with advanced or metastatic solid tumors of any histology Above patients will be randomized in a 1:1 ratio to one of two dose regimens of ART0380. Safety will be evaluated on a quarterly basis, at a minimum. Patients may continue to receive ART0380 as long as they are continuing to derive benefit from treatment or until disease progression, withdrawal of consent, or until they experience unacceptable drug‐related toxicity.

(2023). "The Study on the Therapeutic Effect and Mechanism of Transcutaneous Acupoint Electrical Stimulation in Female." https://clinicaltrials.gov/show/NCT05799924.
	Dysmenorrhea is a common female disease, with an incidence about 20‐40% in female, affecting the living quality of the patients. The treatment of dysmenorrhea usually includes hormone drugs to suppress ovulation, and oral non‐steroidal anti‐inflammatory drugs to relieve pain, but symptoms would relapse after drugs withdrawal. While long‐term use of these drugs may cause endocrine disorders, even affect the normal preparation of pregnancy. Recent studies have shown that dysmenorrhea is related to many factors such as immune and neuroendocrine changes. Transcutaneous electric acupoint stimulation (TEAS) is a new therapeutic method derived from traditional acupuncture therapy. In this method, the electrode placed on the surface of the skin of acupoints is used to guide the stimulating current into the body and stimulate the acupoints to achieve the goal of treatment, and can effectively relieve the pain of patients by replacing the traditional mechanical stimulation of hand‐twisting needles. The aim of this study is to treat dysmenorrhea in women with TEAS, and to observe the therapeutic effect of TEAS, at the same time, prostaglandins, pain‐related factors and immune‐related factors were detected in dysmenorrhea women before and after treatment to study the mechanism.

(2023). "Therapeutic Exercise and Education in Neurophysiology of Pain in the Quality of Life of Women With Endometriosis."
	A study will be carried out whose objective is to improve the quality of life in women with endometriosis through a program of therapeutic exercise and education in the neurophysiology of pain. Also as secondary variables will be observed: menstrual symptoms, sexual function, and abdominal wall thickness measured with ultrasound.

(2023). "THERAPEUTIC EXERCISE AND EDUCATION IN PAIN NEUROPHYSIOLOGY TO IMPROVE PAIN INTENSITY IN WOMEN WITH ENDOMETRIOSIS. CLINICAL TRIAL."
	A study will be carried out whose objective is to improve the intensity of pain in women with endometriosis through a program of therapeutic exercise and education in the neurophysiology of pain. Also as secondary variables will be observed: kinesiophobia, catastrophism and impression of global improvement with treatment.

(2023). "This is a Bioequivalence Study between formulations of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (50 mg/m2 dose) for treating Patients with Advanced Ovarian Cancer." https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2023/03/050946.
	INTERVENTION: Intervention1: Doxorubicin Hydrochloride Liposome Injection: Dose Formulation‐Liposomal formulation,Dosage Level(s) 50 mg/m2,Route of Administration ‐Intravenous Control Intervention1: Doxorubicin Hydrochloride Liposome Injection: Dose Formulation‐Liposomal formulation,Dosage Level(s) 50 mg/m2,Route of Administration ‐Intravenous CONDITION: Health Condition 1: C569‐ Malignant neoplasm of unspecifiedovary PRIMARY OUTCOME: To characterize the pharmacokinetic profile and to assess the bioequivalence of Doxorubicin‐Test relative to Doxorubicin‐Reference in participants with advanced ovarian cancer.Timepoint: Pre‐dose (0.000), 0.333, 0.667, 1.250, 1.500, 2.000, 2.500, 3.000, 5.000, 8.000, 12.000, 16.000, 24.000, 48.000, 72.000, 120.000, 168.000, 216.000, 264.000, 312.000 and 360.000 hours. SECONDARY OUTCOME: To further characterize the pharmacokinetic profile of Doxorubicin‐Test relative to Doxorubicin‐Reference in participants with advanced ovarian cancerTimepoint: Pre‐dose (0.000), 0.333, 0.667, 1.250, 1.500, 2.000, 2.500, 3.000, 5.000, 8.000, 12.000, 16.000, 24.000, 48.000, 72.000, 120.000, 168.000, 216.000, 264.000, 312.000 and 360.000 hours. INCLUSION CRITERIA: 1 Participant must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study as described in Appendi X10.1.3 and in this protocol and is willing to participate in the study.2 Female participant must be 18 to 75 years of age (both inclusive), at the time of signing the informed consent.3 Participant with documented advanced ovarian cancer whose disease has progressed or recurred after platinum‐based chemotherapy AND who are already receiving or scheduled to start the monotherapy.4 Life expectancy of more than or equal to 12 weeks at screening visit.5 An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 at screening visit.6 Participant should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator. Participants who are already receiving doxorubicin hydrochloride liposome injection at a dose of 50 mg/m2 should not require dose reduction(s) in next planned

(2023). ""To Assess The Improvement In Cases of Polycystic Ovarian Syndrome After Constitutional Homeopathic Treatment Through Homeopathic Medical Repertory."." https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2023/02/049369.
	INTERVENTION: Intervention1: Homoeopathic Constitutional Similimum: Potentised Homeopathic medicine in the form of pills. Dose:The final selected remedy based on the individual totality will be prescribed in appropriate (200 C) potency and doses based on the susceptibility of individual case. Route of Administration‐ Oral Control Intervention1: Placebo: Placebo is given in the form of pills. CONDITION: Health Condition 1: E282‐ Polycystic ovarian syndrome PRIMARY OUTCOME: To evaluate effectiveness of individualized Homeopathic medicines in treatment of cases of polycystic ovarian syndromeTimepoint: Clinical examination ie effect on BMI, Hirsutism, Acne and appropriate investigations such as Hormonal assay FSH LH ratio androgen levels,USG reports, Ferriman gallwey score, Acne global severity scale score after 12 months treatment SECONDARY OUTCOME: 1.To ascertain adequacy of specific rubrics related to Polycystic Ovarian Syndrome from Homeopathic Medical Repertory 2. To assess the improvement in health related quality of life (HRQoL) in women suffering with Polycystic Ovarian SyndromeTimepoint: PCOSQ score before and after treatment for period of 12 months INCLUSION CRITERIA: 1.Female cases diagnosed with PCOS using Rotterdam criteria 2. Womens age group 12‐40 years are included in my study 3. Patients giving written consent and voluntarily participate in study

(2023). "Trauma-informed Approach to Timely Detection and Management of Early Postpartum Hypertension."
	This study will compare two interventions with the standard of care. Given that this is a stepped‐wedge design, all sites will begin with recruitment for the standard of care. All study participants will be identified, recruited and enrolled during their postpartum hospital stay (i.e. prior to discharge) by research study staff. Once study participants are enrolled, they will receive a Omron blood pressure (BP) cuff and will be instructed on how to use it. General Design Description Overall study design. This project spans three states (Connecticut, Massachusetts, New York) and includes three hospitals (Yale New Haven Hospital, UMass Worcester, and Oishei in Buffalo, New York). This is a multisite intervention study that follows a sequential stepped‐wedge design with the 3 hospitals randomized to their start time for the first arm followed by the second and third arms. Yale will serve as the coordinating center and facilitate as well as oversee the planning and implementation activities across sites to ensure standardization. All study staff at all centers will undergo training sessions in blood pressure measurement and management following a standardized protocol as well as mental health screening and management and refresher training sessions, as needed, including any remedial training in specific areas targeted by quality control monitoring for a specific site. Yale New Haven Hospital will provide the appropriate assistance across clinical sites. This may include site visits, to ensure that the study enrollment and treatment follows proper study procedures. Community Advisory Boards (CABs) will be formed at each of the project sites to integrate community perspectives into project activities and ensure community engagement in the decision‐making process throughout the duration of the project. The Yale Griffin Prevention Research Center (PRC) and Cicatelli Associates, Inc. (CAI) will be deeply engaged advising on the establishment of the CABs across sites. Twice a year, the three CABs will convene virtually to receive an update about the overall project progress and share ideas about strengthening study design and implementation to ensure it reflects overall community needs and best interests. We will compensate members for their participation and transportation plus provide refreshments for in‐person meetings. During in‐person meetings of the individual site CABs, current COVID protocols recommended by the Centers for Disease Control will be followed to ensure meetings are safe and participants protected. This study will compare two interventions with the standard of care. Given that this is a stepped‐wedge design, all sites will begin with recruitment for the standard of care. All study participants will be identified, recruited and enrolled during their postpartum hospital stay (i.e. prior to discharge) by research study staff. Once study participants are enrolled, they will receive a Omron blood pressure (BP) cuff and will be instructed on how to use it. Participants in the first intervention RMM will be provided with an Omron blood pressure cuff and blood pressure data will be recorded. Participants will be contacted within 72 hours following discharge. Follow‐up telehealth visits will occur at least 1 time per week for the first 6 weeks and up to 12 weeks as needed. There may be a need for more visits for those with high blood pressure or elevated scores on validated mental health screeners, therefore advanced practice professionals (APPs) will coordinate with the individual site team Co‐Is to address and arrange for additional follow‐up visits with the appropriate providers as indicated. In addition to the RMM described above, the second intervention, the community health model (CHM), includes the incorporation of research community health workers(CHW)/doulas who will be identified at each site. The CHWs/doulas will receive extensive training to be able to provide postpartum hypertension support and how to engage individuals in mental health services using a strengths‐based trauma‐inf rmed approach. CHWs/doulas will be available to the families during the first 6 weeks (at least 1x per week) and then every other month or as needed. A hybrid approach will be used with CHWs/doulas visiting participants in‐person and virtual based on the participant's needs and preferences. All participants will complete assessments and a blood pressure at intake along with telephone follow‐up assessments at 6 weeks postpartum, 3 months and 6 months postpartum including a blood pressure check and mental health screen with EPDS and other study surveys at each time point. Electronic medical record data will be collected.

(2023). "Use of Fractional CO2 Laser Versus Erbium: YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors."
	The objective is to compare microablative fractional CO2 laser (CO2 laser) (SmartXide2 V2 LR, Monalisa Touch; DEKA, Florence, Italy) and non‐ablative photothermal Erbium:YAG laser (Er:YAG laser) (Fotona Smooth™ XS; Fotona, Ljubljana, Slovenia) ‐ with sham vaginal applications for treatment of vaginal dryness as the leading symptom in breast cancer patients with iatrogenic menopause and treated with an AI.

(2023). "Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial."
	Minimally invasive surgery is the recommended approach in endometrial cancer (EC) patients based on the results of two randomized controlled trials, given its advantages without compromised oncologic outcomes. The uterine manipulator is commonly used in benign and malignant pathologies to perform a laparoscopic or robotic hysterectomy. However, although regularly used, the uterine manipulator adoption in EC is a controversial technical aspect due to the raised concerns regarding the possible risk of disruption of the tumor mass, the spread of malignant cells, and seeding of the disease, particularly at the level of the vaginal cuff or spread of tumor cells, with increased risk of recurrence and death due to EC. On that basis, given that hysterectomy without a uterine manipulator is feasible, only a randomized controlled trial comparing oncologic outcomes in EC patients after use versus not use of the uterine manipulator will be able to provide high‐quality evidence to answer this critical question and allow or exclude the use of a uterine manipulator during minimally invasive hysterectomy for EC.

(2023). "Zuranolone shows rapid‐acting effects in women with postpartum depression." Brown University Psychopharmacology Update 34(11): 1-5.
	Zuranolone, at a dose of 50 mg/day, led to significant improvement in depressive symptoms relative to placebo at two weeks in women with postpartum depression, a Phase 3 trial has found. Study results were published online July 26, 2023, in the American Journal of Psychiatry. In early August, the Food and Drug Administration (FDA) approved zuranolone for the treatment of postpartum depression.

a s, S., et al. (2021). DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma.
	No Results Available Biological: DCVAC/OvCa|Biological: DCVAC/OvCa placebo Overall Survival(OS)|Progression-Free Survival (PFS)|Objective Response Rate|Time to Relapse|Duration of Response|Biological Progression-Free Survival|Safety Assessments: NCI CTCAE version 5.0 Female Phase 3 0 Industry|Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment SOV09|VITALIA/ ENGOT-ov53 August 16, 2021

Aarshageetha, P., et al. (2023). "Role of Alternate Therapies to Improve the Quality of Life in Menopausal Women: A Systematic Review." Journal of mid-life health 14(3): 153-158.
	Middle aged women in majority undergoing menopausal symptoms are unaware of the physiological changes happening in their body, necessary lifestyle changes and alternate therapies to overcome the symptoms. All major electronic sources of relevant information were systematically searched and collected data were pooled under specific subheadings. From the reviewed papers, the awareness on symptoms and related complications of menopause in the middle aged women were consolidated. Studies helped to identify alternative therapies replacing or in parallel with the Hormone Replacement Therapy to overcome the menopausal symptoms. Reduced oestrogen and progesterone level causes physiological, psychological, and genitourinary symptoms. Prolonged consequences cause libido, osteoporosis, and cardio vascular diseases. Hypo-estrogenic status is well managed with alternative therapies including dietary intervention, acupuncture, aromatherapy, exercise, and yoga. Dietary interventions involving foods like Fennel, Soy, Black Cohash, St. John Wort, Red Clover and Date Pollen were found to be managing vasomotor symptoms and sexual dysfunction. Non-Hormonal and Non-Pharmacological impact behind acupuncture treatment was well accepted. Various studies proved inhaling and massaging with Lavender, Neroli oil, Fennel, Rose, and Geranium essential oils balance cortisol hormone and reduce stress and anxiety. Impact of yoga therapy on neurohormonal pathways reduce both psychological and physiological symptoms. Reviews summarizes various symptoms and complications during menopausal transition and alternate ways of better management with dietary intervention, yoga, exercise, aromatherapy, and acupuncture to improve the quality of menopausal women's life.; Competing Interests: There are no conflicts of interest. (Copyright: © 2023 Journal of Mid-life Health.)

Abaoglu, H., et al. (2024). "Combined mind-body intervention for premenstrual dysphoric disorder: A randomized controlled trial." Health Care for Women International: 1-21.
	In this study, we aimed to examine the effectiveness of relaxation training in women with PMDD through a randomized controlled design. Sixty-three women were recruited and randomized to relaxation training or control groups. The outcome measurements, administered at baseline and post-training, included the Premenstrual Symptoms Screening Tool (PSST), Hospital Anxiety and Depression Scale (HADS), Nottingham Health Profile (NHP), and Sheehan Disability Scale (SDS). The intervention group received 12 sessions of relaxation training, including progressive muscle relaxation and guided imagination. While there were significant differences within the group in the relaxation training group, no significant differences were found in the control group. Relaxation training had a positive effect on reducing premenstrual symptoms, anxiety, depression and disability and improving quality of life in women with PMDD. More research is necessary to recommend relaxation training as a primary and long-term treatment and to understand how it should be included in a comprehensive treatment plan.

Abbara, A., et al. (2023). "Endocrine Responses to Triptorelin in Healthy Women, Women With Polycystic Ovary Syndrome, and Women With Hypothalamic Amenorrhea." The Journal of Clinical Endocrinology and Metabolism 108(7): 1666-1675.
	Context: Limited data exist regarding whether the endocrine response to the gonadotropin-releasing hormone receptor agonist (GnRHa) triptorelin differs in women with polycystic ovary syndrome (PCOS) compared with healthy women or those with hypothalamic amenorrhea (HA).; Objective: We compared the gonadotropin response to triptorelin in healthy women, women with PCOS, or those with HA without ovarian stimulation, and in women with or without polycystic ovaries undergoing oocyte donation cycles after ovarian stimulation.; Methods: The change in serum gonadotropin levels was determined in (1) a prospective single-blinded placebo-controlled study to determine the endocrine profile of triptorelin (0.2 mg) or saline-placebo in healthy women, women with PCOS, and those with HA, without ovarian stimulation; and (2) a retrospective analysis from a dose-finding randomized controlled trial of triptorelin (0.2-0.4 mg) in oocyte donation cycles after ovarian stimulation.; Results: In Study 1, triptorelin induced an increase in serum luteinizing hormone (LH) of similar amplitude in all women (mean peak LH: healthy, 52.3; PCOS, 46.2; HA, 41.3 IU/L). The AUC of change in serum follicle-stimulating hormone (FSH) was attenuated in women with PCOS compared with healthy women and women with HA (median AUC of change in serum FSH: PCOS, 127.2; healthy, 253.8; HA, 326.7 IU.h/L; P = 0.0005). In Study 2, FSH levels 4 hours after triptorelin were reduced in women with at least one polycystic morphology ovary (n = 60) vs normal morphology ovaries (n = 91) (34.0 vs 42.3 IU/L; P = 0.0003). Serum anti-Müllerian hormone (AMH) was negatively associated with the increase in FSH after triptorelin, both with and without ovarian stimulation.; Conclusion: FSH response to triptorelin was attenuated in women with polycystic ovaries, both with and without ovarian stimulation, and was negatively related to AMH levels. (© The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society.)

Abbara, A., et al. (2024). "Endocrine profile of the kisspeptin receptor agonist MVT-602 in healthy premenopausal women with and without ovarian stimulation: results from 2 randomized, placebo-controlled clinical tricals." Fertility and Sterility 121(1): 95-106.
	Background: Kisspeptin is an essential regulator of hypothalamic gonadotropin-releasing hormone release and is required for physiological ovulation. Native kisspeptin-54 can induce oocyte maturation during in vitro fertilization treatment, including in women who are at high risk of ovarian hyperstimulation syndrome. MVT-602 is a potent kisspeptin receptor agonist with prospective utility to treat anovulatory disorders by triggering oocyte maturation and ovulation during medically assisted reproduction (MAR). Currently, the endocrine profile of MVT-602 during ovarian stimulation is unreported. Objective(s): To determine the endocrine profile of MVT-602 in the follicular phase of healthy premenopausal women (phase-1 trial), and after minimal ovarian stimulation to more closely reflect the endocrine milieu encountered during MAR (phase-2a trial). Design(s): Two randomized, placebo-controlled, parallel-group, dose-finding trials. Setting(s): Clinical trials unit. Patient(s): Healthy women aged 18-35 years, either without (phase-1; n = 24), or with ovarian stimulation (phase-2a; n = 75). Intervention(s): Phase-1: single subcutaneous dose of MVT-602 (0.3, 1.0, or 3.0 mug) or placebo, (n = 6 per dose). Phase-2a: single subcutaneous dose of MVT-602 (0.1, 0.3, 1.0, or 3.0 mug; n = 16-17 per dose), triptorelin 0.2 mg (n = 5; active comparator), or placebo (n = 5). Main Outcome Measure(s): Phase-1: safety/tolerability; pharmacokinetics; and pharmacodynamics (luteinizing hormone [LH] and other reproductive hormones). Phase-2a: safety/tolerability; pharmacokinetics; pharmacodynamics (LH and other reproductive hormones); and time to ovulation assessed by transvaginal ultrasound. Result(s): In both the trials, MVT-602 was safe and well tolerated across the entire dose range. It was rapidly absorbed and eliminated, with a mean elimination half-life of 1.3-2.2 hours. In the phase-2a trial, LH concentrations increased dose dependently; mean maximum change from baseline of 82.4 IU/L at 24.8 hours was observed after administration of 3 mug MVT-602 and remained >15 IU/L for 33 hours. Time to ovulation after drug administration was 3.3-3.9 days (MVT-602), 3.4 days (triptorelin), and 5.5 days (placebo). Ovulation occurred within 5 days of administration in 100% (3 mug), 88% (1 mug), 82% (0.3 mug), and 75% (0.1 mug), of women after MVT-602, 100% after triptorelin and 60% after placebo. Conclusion(s): MVT-602 induces LH concentrations of similar amplitude and duration as the physiological midcycle LH surge with potential utility for induction of oocyte maturation and ovulation during MAR. Clinical Trial Registration Number: EUDRA-CT: 2017-003812-38, 2018-001379-20.Copyright © 2023 The Authors

Abbas Ahmed, M., et al. (2020). "Higher clinical pregnancy rate with in-vitro fertilization versus intracytoplasmic sperm injection in treatment of non-male factor infertility: Systematic review and meta-analysis." Journal of Gynecology Obstetrics and Human Reproduction 49(6): 101706.
	Objective: To evaluate the evidence about in-vitro fertilization (IVF) versus intracytoplasmic sperm injection (ICSI) for the treatment of non-male factor infertility.; Data Sources: Electronic databases searched using the following MeSH terms (Sperm Injection, Intracytoplasmic) AND (in Vitro Fertilisation) AND (Infertility).; Methods of Study Selection: All RCTs included infertile patients due to non-male factors underwent IVF or ICSI were considered for this meta-analysis. One-thousand twenty-two studies were identified of which 20 studies deemed eligible for this review.; Data Extraction: Three independent authors extracted the relevant data from included studies. The study outcomes were pooled in the form of relative risk (RR) and 95 % confidence interval (CI) using Mantel-Hansel method. The main outcome measures are the fertilization rate, the implantation rate, the clinical pregnancy rate (CPR), the total fertilization failure and the live birth rate.; Results: Regarding the fertilization rate, the pooled estimate did not favour either IVF or ICSI group (RR = 0.94; 95 %CI [0.82, 1.07]; p = 0.34). However, IVF significantly increased the CPR than ICSI (RR = 1.28, 95 %CI [1.11, 1.49]; p = 0.001). The overall effect estimate did not favor either of two groups regarding the implantation rate (RR = 1.25, 95 % CI [0.92, 1.68], p = 0.15). Similarly, no difference between both groups regarding the live birth rate (RR = 1.08, 95 % CI [0.79, 1.49]; p = 0.62).; Conclusions: No difference between ICSI and IVF regarding fertilization rate per oocytes, implantation rate and live birth rate in the treatment of non-male factor infertility, while IVF has significantly higher clinical pregnancy rate and higher risk of total fertilization failure.; Competing Interests: Declaration of Competing Interest The authors declare that they have no conflict of interest. (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Abbas Ahmed, M., et al. (2019). "Medications for pain relief in outpatient endometrial sampling or biopsy: a systematic review and network meta-analysis." Fertility and Sterility 112(1): 140.
	Objective: To determine the most effective analgesia for pain relief during the outpatient endometrial biopsy (OEB) or outpatient hysteroscopy with endometrial aspiration (EA).; Design: Systematic review and network meta-analysis of randomized controlled trials.; Setting: Not applicable.; Patient(s): Pre- or postmenopausal women undergoing OEB or outpatient hysteroscopy with EA for evaluation of uterine pathology.; Intervention(s): We conducted an electronic search of the following bibliographic databases: Medline via PubMed, SCOPUS, Web of Science, ClinicalTrials.gov, and Cochrane Central Register of Controlled Trials (CENTRAL).; Main Outcome Measure(s): The intensity of pain during, immediately after, and 10-30 minutes after procedure assessed by the 10-cm visual analog scale.; Result(s): Lidocaine spray was the most effective medication for reducing pain during OEB (P-score = 0.83) and immediately after OEB (P-score = 0.96). On the other hand, naproxen sodium was the most effective medication for reducing pain during outpatient hysteroscopy with EA (P-score = 1.00), followed by misoprostol plus lidocaine (P-score = 0.87).; Conclusion(s): Lidocaine spray, either alone or with topical application of lidocaine, is the most effective medication for reducing the pain during and after the OEB. Naproxen sodium is the most effective analgesic option during outpatient hysteroscopy with EA. (Copyright © 2019 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Abboud, M., et al. (2020). "The Health Effects of Vitamin D and Probiotic Co-Supplementation: A Systematic Review of Randomized Controlled Trials." Nutrients 13(1).
	Evidence of synergic health effects of co-supplementation with vitamin D and probiotics is emerging. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses PRISMA statement, scientific databases and the grey literature were searched, and a narrative review and risk of bias assessment were conducted. Seven randomized controlled trials were included, which had low risk of bias. Six studies were double-blind, and once single-blind, extended over 6-12 weeks, and included 50-105 participants. Conditions explored included schizophrenia, gestational diabetes, type 2 diabetes and coronary heart disease, polycystic ovarian syndrome, osteopenia, irritable bowel syndrome (IBS), and infantile colic. Supplementation frequency was daily or bi-monthly, with mainly vitamin D3, and Lactobacillus , Bifidobacterium , and Streptococcus . Comparators were placebo, vitamin D, lower vitamin D dose, and probiotics and lower vitamin D dose. The co-supplementation yielded greater health benefits than its comparators did in all studies except in one assessing IBS. Beneficial effects included decreased disease severity, improved mental health, metabolic parameters, mainly insulin sensitivity, dyslipidemia, inflammation, and antioxidative capacity, and lower use of healthcare. Co-supplementation of vitamin D and probiotics generated greater health benefits than its comparators did. More studies in other diseases and various populations are needed to confirm these findings and to elucidate the optimal form, composition, and frequency of this co-supplementation.

Abby, D., et al. (2021). "What are the emotional impacts of conservative management for women experiencing early miscarriage – a systematic review."
	
Abdalla Mohammed, A., et al. (2021). "The potential role of incretin-based therapies for polycystic ovary syndrome: a narrative review of the current evidence." Therapeutic Advances in Endocrinology and Metabolism 12: 2042018821989238.
	Introduction: Polycystic ovary syndrome (PCOS) is a common endocrine disorder that affects women of reproductive age. Metabolic consequences associated with PCOS include, but are not limited to, insulin resistance (IR), type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). This narrative review aims to provide a comprehensive overview of the potential therapeutic roles of the incretin-based therapies in the management of PCOS.; Methods: We performed a systematic search of databases including PubMed, MEDLINE and EMBASE up to 1 October 2020. We developed a search string of medical subject headings (MeSH) including the terms PCOS, incretin mimetics, glucagon-like peptide-1 (GLP-1), glucagon-like peptide-1 receptor antagonists (GLP-1 RAs), liraglutide, exenatide, semaglutide, dipeptidyl peptidase-4 (DPP-4) inhibitors, combined with IR, testosterone and sex hormone-binding globulin (SHBG).; Results: We identified 854 relevant articles and, after the initial screening, eight interventional animal studies, one observational animal study, 14 interventional human studies, two case-control studies and one systematic review were included. These studies showed the potential significant roles of GLP-1 RAs and DPP-4 inhibitors in the management of PCOS, with significant improvements in the metabolic parameters, including substantial weight reduction and improved insulin sensitivity. These agents also improved the hormonal parameters through decreased free androgen and increased SHBG. Moreover, they improved menstrual regularity, increased fertility with enhanced ovulation and pregnancy in obese women with PCOS.; Conclusion: GLP-1 RAs and DPP-4 inhibitors have a promising therapeutic role in PCOS; however, larger clinical trials are needed to establish the role of incretin-based therapies in the management of PCOS.; Competing Interests: Conflict of interest: The authors declare that there is no conflict of interest. (© The Author(s), 2021.)

Abdallah, K. S., et al. (2021). "Intrauterine injection of HCG before embryo transfer: a parallel, double-blind randomized trial." Reproductive Biomedicine Online 43(4): 663-669.
	RESEARCH QUESTION: Does intrauterine administration of HCG before embryo transfer improve live birth rate during IVF cycles? DESIGN: A parallel, randomized controlled trial conducted between July 2018 and February 2020. Infertile women (n = 181) scheduled for fresh or vitrified-warmed embryo transfer after IVF carried out for any indication were randomized in a 1:1 ratio to receive either HCG (500 IU in 0.1 ml of tissue culture media) or culture media (0.1 ml of tissue culture media) via intrauterine injection 4 min before embryo transfer. In both groups, an intrauterine insemination catheter was used for administering the medication. Primary outcome was live birth, with ongoing pregnancy and clinical pregnancy as secondary outcomes. Analysis was based on intention-to-treat principle. RESULTS: Baseline and cycle characteristics were comparable between the two groups. In the control group, one woman with a confirmed clinical pregnancy was lost to follow-up. Live birth rates were 24% (22/90) in the HCG group versus 19% (17/90) in the control group (RR 1.29, 95% CI 0.74 to 2.27). Clinical pregnancy and ongoing pregnancy rates were 34% versus 26% (RR 1.31, 95% CI 0.84 to 2.04) and 24% versus 19% (RR 1.29, 95% CI 0.74 to 2.27) in the HCG and the control groups, respectively. CONCLUSION: Intrauterine injection of HCG before embryo transfer did not improve live birth rates in women undergoing IVF. As the study was designed to detect a 20% difference between groups, a smaller, clinically important difference could not be ruled out. Treatment outcomes were lower than expected in the control group.

Abdelaziz, A., et al. (2021). "Transvaginal radiofrequency energy for the treatment of urinary stress incontinence: A comparison of monopolar and bipolar technologies in both pre- and post-menopausal patients." Neurourology and Urodynamics 40(7): 1804-1810.
	Aim: A study to compare the effect of two different radio frequency energy models (mono polar and bipolar) for the treatment of urinary stress incontinence.; Methods: Retrospective chart review, which was conducted at 2 sites, 69 patients received treatment with a bipolar radiofrequency device. Out of those 69 patients, 13 patients received bipolar in conjugation with CO 2 laser treatment, while 32 patients received monopolar frequency. The study protocol normally consists of three sessions of treatment. Each session was four weeks apart with a whole 6-month duration follow-up. Results were evaluated by urogenital distress inventory (UDI)-6 questionnaire before and after treatment.; Results: The bipolar group improved UDI-6 scores across time more so than did the monopolar group with some evidence suggesting that the bipolar radiofrequency treatment was more effective compared to the monopolar radiofrequency. Three months after treatment, the bipolar group UDI-6 values were lower than those of the monopolar group. Six months after treatment, the UDI-6 scores increased in both groups, suggesting decrease efficacy with time however, the bipolar group's UDI-6 scores were consistently lower than the monopolar group's scores.; Conclusion: This study shows benefit of both monopolar and bipolar radiofrequency device in patients with stress urinary incontinence and mixed UI, with bipolar RF more efficacious than monopolar RF. More randomized prospective studies are needed to confirm these findings. (© 2021 Wiley Periodicals LLC.)

Abdel-Fattah, M., et al. (2022). "Single-incision mini-slings for stress urinary incontinence in women." New England Journal of Medicine 386(13): 1230-1243.
	BACKGROUND Until recently, synthetic midurethral slings (made of mesh or tape) were the standard surgical treatment worldwide for female stress urinary incontinence, if conservative management failed. Data comparing the effectiveness and safety of newer single-incision mini-slings with those of standard midurethral slings are limited. METHODS We performed a pragmatic, noninferiority, randomized trial comparing mini-slings with midurethral slings among women at 21 U.K. hospitals during 36 months of follow-up. The primary outcome was patient-reported success (defined as a response of very much or much improved on the Patient Global Impression of Improvement questionnaire) at 15 months after randomization (approximately 1 year after surgery). The noninferiority margin was 10 percentage points. RESULTS A total of 298 women were assigned to receive mini-slings and 298 were assigned to receive midurethral slings. At 15 months, success was reported by 212 of 268 patients (79.1%) in the mini-sling group and by 189 of 250 patients (75.6%) in the midurethral-sling group (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<0.001 for noninferiority). At the 36-month follow-up, success was reported by 177 of 246 patients (72.0%) and by 157 of 235 patients (66.8%) in the respective groups (adjusted risk difference, 5.7 percentage points; 95% CI, -1.3 to 12.8). At 36 months, the percentage of patients with groin or thigh pain was 14.1% with mini-slings and 14.9% with midurethral slings. Over the 36-month follow-up period, the percentage of patients with tape or mesh exposure was 3.3% with mini-slings and 1.9% with midurethral slings, and the percentage who underwent further surgery for stress urinary incontinence was 2.5% and 1.1%, respectively. Outcomes with respect to quality of life and sexual function were similar in the two groups, with the exception of dyspareunia; among 290 women responding to a validated questionnaire, dyspareunia was reported by 11.7% in the mini-sling group and 4.8% in the midurethral-sling group. CONCLUSIONS Single-incision mini-slings were noninferior to standard midurethral slings with respect to patient-reported success at 15 months, and the percentage of patients reporting success remained similar in the two groups at the 36-month follow-up.Copyright © 2022 Massachusetts Medical Society.

Abdel-Fattah, M. S., et al. (2023). "Single-incision mini-slings versus standard mid-urethral slings in the surgical management of female stress urinary incontinence: An updated systematic review and meta-analysis." European Urology 83(Supplement 1): S1250.
	Introduction & Objectives: Stress urinary incontinence is a prevalent, burdensome condition commonly treated surgically using synthetic standard mid-urethral slings (SMUS). An updated systematic review and meta-analysis of RCTs comparing Single Incision Mini-Slings (SIMS) versus Standard Mid-Urethral Slings (SMUS) in the surgical management of female stress urinary incontinence (SUI). To evaluate the efficacy, safety and cost-effectiveness of SIMS compared to SMUS (retro-pubic and transobturator tension-free vaginal tapes) in the Surgical Management of Female SUI. Material(s) and Method(s): Literature search was performed for all RCTs and quasi RCTs comparing SIMS to either TO-TVT or RP-TVT. The literature search had no language restrictions and was conducted on 18th January 2021 and planning to be updated on February 2023 to include our SIMS trial results which was published in NEJM March 2022. The primary outcomes were patient-reported and objective cure rates and were segregated into: short (12-18 months), mid (19-59 months), and longer-term (>= 60 months) follow-up. Secondary outcomes included: quality of life and sexual function, pain scores, operative data, perioperative complications, and cumulative adverse event rates. The GRADE methodology was used to subjectively assess quality of included studies and certainty of outcomes. Data were analysed using Review Manager 5.4.1. Meta-analyses of TVTSecurTM vs. SMUS are presented separately having been withdrawn from clinical practice. Result(s): Meta-analysis demonstrated no significant difference between SIMS (excluding TVT-Secur) and SMUS for mid-term patient-reported success (risk ratio [RR]: 0.98; 95% confidence interval [CI], 0.95-1.02) and objective cure rate (RR: 0.97; 95% CI, 0.93-1.01). Long-term data were lacking. SIMS demonstrated higher reoperation rates (RR: 1.92; 95% CI, 1.18-3.12), but no significant difference for de-novo dyspareunia (RR: 1.26; 95% CI, 0.57-2.82), or mesh exposure (RR: 0.98; 95% CI, 0.44-2.20), compared to SMUS. Favourable surgical data and reduced postoperative pain was observed but remains questionable. Conclusion(s): Excluding TVT-Secur, SIMS there was no evidence of significant difference in patient-reported and objective cure between currently used SIMS and SMUS at mid-term follow-up. Results should be interpreted with caution due to the heterogeneity of the trials included.Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Abdelhafez, M. A., et al. (2023). "Psychiatric illness and pregnancy: A literature review." Heliyon 9(11): e20958.
	BACKGROUND: Women of reproductive age frequently suffer from psychiatric disorders. The risk of developing anxiety, bipolar, and depressive disorders is especially significant during the perinatal period. OBJECTIVES: This article aims to identify and discuss the different psychiatric conditions that might affect pregnant women and update the mother's carers about the recent and updated bidirectional relationship between psychiatric disease and adverse pregnancy outcomes, As well as the most updates in diagnostic and management strategies. METHODS: A thorough analysis of the literature was conducted using database searches in EMBASE, Science Direct, Google Scholar, Scopus, and PubMed to obtain the objectives and aim of the study. RESULTS: The presence of maternal mental illness during pregnancy has been linked to preterm delivery, newborn hypoglycemia, poor neurodevelopmental outcomes, and disturbed attachment. Placental anomalies, small-for-gestational-age foetuses, foetal discomfort, and stillbirth are among more undesirable perinatal outcomes. CONCLUSIONS: Pregnancy-related psychiatric disorders are frequent. The outcomes for pregnant women, infants, and women's health are all improved by proper diagnosis and treatment of psychiatric problems.

Abdelsalam, W. A., et al. (2021). "Predictive Factors of Para-Aortic Lymph Nodes Metastasis and Survival Advantages of Para-Aortic Lymphadenectomy in Early Stage Cervical Cancer." Journal of Gynecologic Surgery 37(3): 205‐213.
	Background: Performing dissection of para‐aortic lymph nodes (LNs) during radical hysterectomy is still optional and must be individualized. The clinical benefits of performing lymphadenectomy are not only for detection of occult metastases but it could positively affect the survival of patients. Aim of the Study: To assess the predictive clinical and pathologic parameters of occurrence of para‐aortic LNs metastasis in early stage cervical cancer patients (stages I and II) in addition to evaluate of the effect of the extent of lymphadenectomy on patients' survival. Patients and Methods: We included 60 patients with cancer cervix stages I‐II, we randomly divided them into the following: first group was managed by radical hysterectomy, dissection of both pelvic and para‐aortic LNs and second group underwent radical hysterectomy with dissection of only pelvic LNs. Results: We found that presence of deep stromal and uterine body invasion, ovarian spread, presence of pelvic LN metastasis, and presence of gross enlargement of para‐aortic LN were related to positive para‐aortic LNs (p < 0.001). Patients with para‐aortic LNs metastases have unfavorable disease‐free survival (DFS) and unfavorable overall survival (OS) rates (p < 0.001). DFS and OS rates were more favorable in patients who underwent para‐aortic lymphadenectomy than the other group who underwent only pelvic lymphadenectomy. Conclusions: Predictive factors for para‐aortic LNs metastases in patients with early stage cervical cancer are presence of lympovascular invasion and pelvic LNs spread. Additionally performing para‐aortic lymphadenectomy has survival benefits mainly in high‐risk patients with higher stage and widespread pelvic LNs metastases. Clinical Registration Number, NCT03361730. (J GYNECOL SURG 37:205)

Abdi, F., et al. (2021). "Impact of phytoestrogens on treatment of urogenital menopause symptoms: A systematic review of randomized clinical trials." European Journal of Obstetrics, Gynecology, and Reproductive Biology 261: 222-235.
	Objective: Menopause symptoms affect the various dimensions of women's lives and they can lead to reduction of their quality of life. Phytoestrogens can be used as an approach to diminish these symptoms. The aim of this systematic review was to investigate the effect of phytoestrogens on the treatment of urogenital menopause symptoms.; Study Design: PubMed, EMBASE, Web of Science, Cochrane library,Scopus and ProQuest were systematically searched from 2000-2020. All randomized clinical trials were included. The quality of the selected papers was evaluated by the CONSORT checklist.; Results: 33 eligible high-quality papers were reviewed. Various forms of phytoestrogens such as Pueraria Mirifica, fennel, Hop plant(Humuluslupulus L.), Glycine Max (L.) Merr, soy, red clover, black cohosh, ginsing, cimicifugaracemosa, genistein, diadzein, glycitein and isoflavone in the form of oral capsules and pill, food supplement, enriched powder, vaginal gel, cream and suppository could improve menopausal urogenital symptoms. The recovery rate in vaginal use of these phytoestrogens was greater than other consumptions.; Conclusions: After using a variety of phytoestrogens in different forms indicators of urogenital atrophy and urinary disorders improved and women's sexual function improved after treatment. The use of phytoestrogens as a safe, low-risk compared to hormone therapy and almost accessible method for women can relieve urogenital symptoms and promote the sexual satisfaction and quality of life.; Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2021 Elsevier B.V. All rights reserved.)

Abdnezhad, R. and M. Simbar (2020). "A review of the effective herbal medicines on hot flashes in menopausal women." Iranian Journal of Obstetrics, Gynecology and Infertility 23(8): 107-119.
	Introduction: Vasomotor symptoms occur in approximately 75% of menopausal women. Hot flash is the main reason of women's referring to receive menopausal care. Estrogen therapy is the most effective way to treat symptoms; given the known risks of hormone therapy, many women are interested to use herbal medicines for treatment of menopausal symptoms including hot flushes. Therefore, this study was performed with aim to evaluate the clinical trials conducted to evaluate the effectiveness of herbal medicines for treatment of hot flashes. Method(s): In this review study, to find the related articles, the databases of SID, Pubmed, Scopus and Web of Science were searched using the keywords of Menopause, Herbal medicine, medicine and Hot flash from 2002-2019. The articles which were performed as clinical trial were selected. Result(s): 31 randomized clinical trials were identified. These studies had investigated Vitagnus (2), soybean (4), Black cohosh (3), Ginkgo biloba (2), sage (4), Valerian (2), Flaxseed (2), red clover (5), Hypericum perforatum (1), evening primrose (2), fenugreek (1) and passion flower (1), and one study was also done as combination. It seems that phytoestrogens and lignans found in these plants can reduce the severity and duration of hot flashes with minimal side effects. Conclusion(s): Overall, the findings of this study showed that herbal medicine which belongs to phytoestrogens or lignans like as Vitagnus, licorice, soy, red clover, flax seeds, sage, passion flower, valerian, Hypericum and evening primrose can lead to improvement of hot flashes, but further studies in larger populations are needed.Copyright © 2020, Mashhad University of Medical Sciences. All rights reserved.

Abdolahian, S., et al. (2020). "Effect of lifestyle modifications on anthropometric, clinical, and biochemical parameters in adolescent girls with polycystic ovary syndrome: a systematic review and meta-analysis." BMC Endocrine Disorders 20(1): 71.
	Background: Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of childbearing age. This study aimed to compare the effects of lifestyle interventions on anthropometric, clinical, and biochemical parameters in adolescent girls with PCOS.; Methods: PubMed, Scopus, and Web of Science was systematically searched to retrieve studies investigating the effects of lifestyle modifications in adolescent girls with PCOS, which were published up to December 2019. The primary outcome was Body Mass Index (BMI) and secondary outcomes were all manifestations of PCOS, including clinical, metabolic, and hormonal parameters. Random effect meta-analysis was applied for significant results. Publication bias was assessed using the Egger test.; Results: This study showed significant improvements in luteinizing hormone (LH) (Pooled SMD = - 0.1.23; 95% CI, - 2.44 to - 0.03), and Free Androgen Index (FAI) levels (Pooled SMD = - 0.78 95% CI, - 0.1.42 to - 0.13) in adolescent girls receiving lifestyle intervention compared to baseline. This study also revealed that diet modifications alone were associated with a significant decrease in Body Mass Index (BMI) (Pooled SMD = - 0.45; 95% CI, - 0.76 to - 0.13), and FG score (Pooled SMD = - 0.81; 95% CI, - 1.33 to - 0.28). Exercise interventions were associated with significant changes in the menstrual cycles (Pooled SMD = 1.16; 95% CI, 0.72 to 1.61), Ferriman-Gallwey (FG) score (Pooled SMD = - 0.57; 95% CI, - 0.99 to - 0.15), LH (Pooled SMD = - 056; 95% CI, - 0.98 to - 0.14), Anti-Müllerian Hormone (AMH) (Pooled SMD = - 0.81; 95% CI, - 0.1.24 to - 0.38), and Triglyceride (TG) levels (Pooled SMD = - 0.32; 95% CI, - 0.62 to - 0.02).; Conclusion: This meta-analysis concluded lifestyle interventions, such as diet and exercise, can improve some clinical, metabolic, and hormonal parameters in adolescent girls with PCOS.

Abdulkhalikova, D., et al. (2022). "Reproductive Outcome After GnRH Agonist Triggering With Co-Administration of 1500 IU hCG on the Day of Oocyte Retrieval in High Responders: A Long-Term Retrospective Cohort Study." Frontiers in Endocrinology 13: 826411.
	While triggering oocyte maturation with GnRH agonist (GnRHa) seems to be safe and effective in terms of the risk of developing OHSS and the number of metaphase II oocytes, it nevertheless results in luteal phase deficiency. To date, strategies have been developed in order to rescue defective luteal phase of GnRHa triggered cycles. Our study aimed to assess the reproductive outcome of GnRHa triggered cycles combined with modified luteal support (1500 IU hCG at the day of oocyte retrieval) in women with high ovarian response and to compare the outcome with hCG triggered cycles in GnRH antagonist IVF-ICSI procedures. A retrospective cohort database review of the results of GnRH antagonist IVF-ICSI cycles was conducted at a tertiary-care IVF center in Ljubljana, Slovenia. A total of 6126 cycles, performed from January 1, 2014, to December 31, 2020, were included in the final analysis. Final oocyte maturation was performed with either 5000, 6500, or 10,000 IU hCG (women with normal ovarian response) or 0.6 mg GnRHa (buserelin), supplemented with 1500 IU hCG on the day of oocyte retrieval (in women with high ovarian response). In cases of excessive ovarian response and/or high risk of OHSS luteal support was not introduced and all good quality blastocysts were frozen. According to significant differences in patients' age and the number of oocytes in the two groups, matching by age and number of oocytes was performed. No significant differences were observed regarding pregnancy rate per embryo transfer, rate of early pregnancy loss, and livebirth rate per pregnancy between the GnRHa and hCG trigger groups, respectively. A significant difference in the number of developed embryos and blastocysts, as well as the number of frozen blastocysts, was seen in favor of the GnRHa trigger. However, the birth weight in the GnRHa trigger group was significantly lower.; Conclusion: The results of our study support the use of GnRHa for final oocyte maturation in GnRH antagonist IVF cycles in women with high ovarian response. Luteal phase rescue was performed by co-administration of 1500 IU hCG on the day of oocyte retrieval and estradiol and progesterone supplementation. In our experience, such an approach results in a comparable reproductive outcome with hCG trigger group.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Abdulkhalikova, Bokal, Stimpfel, Ciglar and Korosec.)

Abdul-Latif, M., et al. (2023). "Functional Magnetic Resonance Imaging in Cervical Cancer Diagnosis and Treatment." Clinical Oncology 35(9): 598-610.
	Cervical Cancer is the fourth most common cancer in women worldwide. Treatment with chemoradiotherapy followed by brachytherapy achieves high local control, but recurrence with metastatic disease impacts survival. This highlights the need for predictive and prognostic biomarkers identifying populations at risk of poorer treatment response and survival. Magnetic resonance imaging (MRI) is routinely used in cervical cancer and is a potential source for biomarkers. Functional MRI (fMRI) can characterise tumour beyond anatomical MRI, which is limited to the assessment of morphology. This review summarises fMRI techniques used in cervical cancer and examines the role of fMRI parameters as predictive or prognostic biomarkers. Different techniques characterise different tumour factors, which helps to explain the variation in patient outcomes. These can impact simultaneously on outcomes, making biomarker identification challenging. Most studies are small, focussing on single MRI techniques, which raises the need to investigate combined fMRI approaches for a more holistic characterisation of tumour.Copyright © 2023

Abe, M., et al. (2022). "Is a freeze-all strategy necessary for all embryo transfers : Fresh embryo transfer without progesterone elevation results in an equivalent pregnancy rate to cryopreserved embryo transfer." The journal of medical investigation : JMI 69(3.4): 224-229.
	Objectives : It has been suggested that the clinical outcomes of frozen-thawed embryo transfer (ET) are superior to those of fresh embryo transfer. We examined whether a freeze-all strategy is necessary for all embryo transfers, and, if not, to evaluate the conditions in which the pregnancy rates of fresh embryo transfer and frozen-thawed ET did not differ. Methods : Patients who underwent blastocyst transfer at Tokushima University Hospital between 2008 and 2019 were enrolled. The clinical outcomes and clinical characteristics of 1,022 patients that underwent fresh embryo transfer and 1,728 patients that underwent frozen-thawed ET were examined retrospectively. We considered the factors that influenced the pregnancy outcomes of fresh embryo transfer. Results : The frozen-thawed ET group exhibited significantly higher pregnancy, live-birth, and miscarriage rates than the fresh embryo transfer group. In the fresh embryo transfer group, a high progesterone level on the day of the human chorionic gonadotropin (hCG) trigger and lower grade embryos were risk factors for a low pregnancy rate. However, in the cases in which the progesterone level was < 1.0 ng / mL the pregnancy rate was equal to that of frozen-thawed ET. Conclusions : A freeze-all strategy is not necessary for embryo transfers, but should be employed in cases involving pre-ovulatory progesterone elevation. J. Med. Invest. 69 : 224-229, August, 2022.

Abe, S. K. and M. Inoue (2021). "Green tea and cancer and cardiometabolic diseases: a review of the current epidemiological evidence." European Journal of Clinical Nutrition 75(6): 865-876.
	Green tea is commonly consumed in China, Japan, and Korea and certain parts of North Africa and is gaining popularity in other parts of the world. The aim of this review was to objectively evaluate the existing evidence related to green tea consumption and various health outcomes, especially cancer, cardiovascular disease and diabetes. This review captured evidence from meta-analyses as well as expert reports and recent individual studies. For certain individual cancer sites: endometrial, lung, oral and ovarian cancer, and non-Hodgkins lymphoma the majority of meta-analyses observed an inverse association with green tea. Mixed findings were observed for breast, esophageal, gastric, liver and a mostly null association for colorectal, pancreatic, and prostate cancer. No studies reported adverse effects from green tea related to cancer although consuming hot tea has been found to possibly increase the risk of esophageal cancer and concerns of hepatotoxity were raised as a result of high doses of green tea. The literature overall supports an inverse association between green tea and cardiovascular disease-related health outcomes. The evidence for diabetes-related health outcomes is less convincing, while the included meta-analyses generally suggested an inverse association between green tea and BMI-related and blood pressure outcomes. Fewer studies investigated the association between green tea and other health outcomes such as cognitive outcomes, dental health, injuries and respiratory disease. This review concludes that green tea consumption overall may be considered beneficial for human health.Copyright © 2020, The Author(s), under exclusive licence to Springer Nature Limited.

Abenhaim, H. A., et al. (2022). "Progesterone for Prevention of Miscarriage & Preterm Birth in Women with First Trimester Bleeding: pREEMPT-Trial." American Journal of Obstetrics and Gynecology 226(1): S18.
	Objective: First trimester bleeding is associated with miscarriage and preterm birth for which progesterone has been suggested to improve outcomes. The objective of our study was to evaluate the effect of progesterone treatment throughout pregnancy on preventing miscarriage and preterm birth in pregnancies with first trimester bleeding. Study Design: Multicenter double‐blind placebo controlled randomized trial comparing vaginally administered Micronized Progesterone 200mg nightly from presentation until 34weeks of pregnancy with an identically appearing placebo. Subjects with vaginal bleeding and a live intrauterine pregnancy under 14weeks were offered study participation. Multifetal gestations, cervical insufficiency, recurrent pregnancy loss, or bleeding unrelated to placentation were excluded. Primary outcome was the occurrence of a live term pregnancy. Secondary outcomes included adverse maternal and newborn events and time to miscarriage / birth. Chi square analyses were used to compare proportions and Mann‐Whitney tests were used to compare time‐to‐event outcomes Results: 549 subjects were recruited and randomized of which 16 withdrew or were lost to follow‐up leaving 264 subjects in the progesterone group and 269 subjects in the placebo group. Baseline characteristics were comparable in both groups. As compared to subjects in the placebo group, the number of subjects having a live term birth among those in the progesterone group was 197 (74.6%) vs 190 (70.6%), p=0.30, respectively. As compared to subjects in the placebo group, those in the progesterone group had comparable risks of abortion under 20 weeks, 38 (14.4%) vs 43 (16.0%), p=0.94, preterm birth, 27 (10.2%) vs 33 (12.3%), p=0.46, and stillbirth 2 (0.9%) vs 3 (1.3%), p=0.65, respectively. There were no differences in adverse maternal or newborn outcomes, or in time‐to‐event for miscarriage or birth between the two groups. Conclusion: Progesterone prescribed throughout pregnancy is not effective in preventing miscarriage or prematurity in subjects presenting with first trimester vaginal bleeding in context of a live intrauterine pregnancy. [Formula presented]

Abitbol, J., et al. (2023). "Impact of robotic surgery on patient flow and resource use intensity in ovarian cancer." Journal of Robotic Surgery 17(2): 537-547.
	There is an emerging focus on the role of robotic surgery in ovarian cancer. To date, the operational and cost implications of the procedure remain unknown. The objective of the current study was to evaluate the impact of integrating minimally invasive robotic surgery on patient flow, resource utilization, and hospital costs associated with the treatment of ovarian cancer during the in-hospital and post-discharge processes. 261 patients operated for the primary treatment of ovarian cancer between January 2006 and November 2014 at a university-affiliated tertiary hospital were included in this study. Outcomes were compared by surgical approach (robotic vs. open surgery) as well as pre- and post-implementation of the robotics platform for use in ovarian cancer. The in-hospital patient flow and number of emergency room visits within 3 months of surgery were evaluated using multi-state Markov models and generalized linear regression models, respectively. Robotic surgery cases were associated with lower rates of postoperative complications, resulted in a more expedited postoperative patient flow (e.g., shorter time in the recovery room, ICU, and inpatient ward), and were between $10,376 and $7,421 less expensive than the average laparotomy, depending on whether or not depreciation and amortization of the robotic platform were included. After discharge, patients who underwent robotic surgery were less likely to return to the ER (IRR 0.42, p = 0.02, and IRR 0.47, p = 0.055, in the univariate and multivariable models, respectively). With appropriate use of the technology, the addition of robotics to the medical armamentarium for the management of ovarian cancer, when clinically feasible, can bring about operational efficiencies and entails cost savings.Copyright © 2022, The Author(s), under exclusive licence to Springer-Verlag London Ltd., part of Springer Nature.

Ablon, G. and S. Kogan (2021). "A Randomized, Double-Blind, Placebo-Controlled Study of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women With Thinning Hair." Journal of drugs in dermatology 20(1): 55‐61.
	Hair loss is a complex and multi‐factorial problem that is associated with significant psychological morbidity in women. Menopausal women represent a significant percentage of those affected, since the menopausal hormonal transition can be a contributing factor. A novel nutraceutical supplement has been specifically formulated with phytoactives to improve hair growth and quality in menopausal women (Nutrafol® Women’s Balance Capsules). The objective of this 6‐month, randomized, double‐blind, placebo‐controlled study was to assess the safety and efficacy of this oral supplement to promote hair growth in perimenopausal, menopausal, and postmenopausal women with self‐perceived thinning. Subjects were randomized to the study supplement (n=40) or placebo (n=30). The primary endpoint was a statistically significant increase in the number of terminal and vellus hairs based on phototrichogram analysis. Daily intake of the nutraceutical supplement resulted in progressive and significant increase in terminal and total hair counts on days 90 (P<0.01) and 180 (P<0.01) compared to placebo. The vellus hair counts significantly increased for the active treatment group (P<0.05) by day 180 while significantly decreasing for the placebo group subjects. Hair shedding progressively and significantly decreased for the active group compared to placebo, culminating in a reduction of 32.41% by day 180 (P<0.01). The study supplement was well‐tolerated. ClinicalTrials.gov Identifier: NCT04048031 J Drugs Dermatol. 2021;20(1):55‐61. doi:10.36849/JDD.5701 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Ablon, G., et al. (2022). "A Long-Term Study of the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women." Journal of drugs in dermatology : JDD 21(7): 783.
	The prevalence of female hair loss and hair thinning increases with advancing age and is most common among post-menopausal women. Recent statistics show that by age 60, an estimated 80% of women experience hair loss. A previous publication detailing the results of the 6-month randomized, double-blind, placebo-controlled phase of this study demonstrated the ability of a nutraceutical supplement to significantly improve hair growth and shedding compared to placebo. Here, we present results from a subsequent 6-month, open-label extension phase assessing the continued safety and efficacy of this nutraceutical for promoting and improving hair growth and evaluate potential long-term benefits on quality of life and menopausal symptoms. After a total of 12 months with the active nutraceutical, subjects had progressive improvements in hair growth, quality, and shedding. Quality of life measures and menopausal symptoms also improved over the duration of the study. When transitioned to daily intake of the supplement, subjects previously treated with placebo achieved significant increases in all hair counts, a significant decrease in shedding, and significant improvement in blinded investigator global hair growth and quality assessments. The results of this long-term study demonstrate that continued use of a novel nutraceutical provides significant incremental improvement over the beneficial effects achieved during the initial 6-month randomized, placebo-controlled phase. Continued use may provide ongoing improvements in hair growth and exert a positive effect on secondary symptoms of menopause, and quality of life in perimenopausal, menopausal, and postmenopausal women with selfperceived thinning hair (ClinicalTrials.gov Identifier: NCT04048031). J Drugs Dermatol. 2022;21(7):776-783. doi:10.36849/JDD.6912.

Aboshama Rehab, A., et al. (2022). "The effect of hyoscine-N-butylbromide on pain perception during and after hysterosalpingography in infertile women: a systematic review and meta-analysis of randomised controlled trials." Human fertility (Cambridge, England) 25(3): 422-429.
	This paper reports a systematic review and meta-analysis of the effectiveness of hyoscine-N-butylbromide (HBB) administration in hysterosalpingography (HSG). Four electronic databases were searched for randomised controlled trials (RCTs) that compared HBB versus placebo or no intervention in infertile women undergoing HSG. Pain during and after HSG and different adverse events including nausea, vomiting, and dizziness were evaluated. Three RCTs with 335 patients were included. The analysis showed HBB was significantly effective in reducing pain during and after HSG (MD = -0.76 mm, 95% CI [-1.35, -0.17], p = 0.01) and (MD = -0.81 mm, 95% CI [-1.07, -0.56], p < 0.001), respectively. There were no significant differences in adverse events between HBB and control groups. The methodological evidence quality was high as evaluated by GRADEpro. In conclusion, this review provides good evidence that prior administration of HBB is effective in reducing induced pain during and after HSG with tolerable side effects.

Aboualsoltani, F., et al. (2020). "Therapeutic effects of citrus aurantium components on psychological states: A systematic review." Crescent Journal of Medical and Biological Sciences 7(4): 443-450.
	Objectives: Citrus aurantium L., frequently known as the sour or bitter orange, is native to Asia and, nowadays, is widely cultivated in different regions such as the Mediterranean. Different parts of C. aurantium are consumed as an alternative medicine in some areas to treat some diseases, and various recent studies have proven the potential of this medicinal plant. This review examined the therapeutic effects of C. aurantium components. Method(s): Tactful and progressive search strategies were developed to determine the studies. To this end, a large number of databases were evaluated, including Cochrane Library, PubMed/MEDLINE, Scopus, and Google Scholar (2010 to April 2019). Finally, 12 clinical trial studies were selected for evaluation and analysis, and the JADAD scale was used to evaluate the quality of the papers. Result(s): Of 546 papers found in the preliminary search, 12 clinical trials (1132 participants), which were written in English, were selected for structured reviews. The researches consisted of those which evaluated the therapeutic role of the plants in anxiety, depression, sleep quality, premenstrual syndrome, and menopausal symptoms. Conclusion(s): The review of clinical trials brings some evidence that different components of C. aurantium, especially its flower have therapeutic effects on particularly psychological states like anxiety, depression, and insomnia and aromatherapy by the essential oil is considered as the most used method of prescription. Therefore, C. aurantium can confidently be used in various disorders which have these psychological aspects among their symptoms.Copyright © 2020 The Author(s)

Abraham, F., et al. (2022). "Safely and practice of Foley Catheter for second trimester surgical abortion: a protocol for a systematic review."
	
Abrao, M. S., et al. (2021). "Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients." BMC Women's Health 21(1): 246.
	Background: Elagolix is an oral, gonadotropin‐releasing hormone (GnRH) receptor antagonist, that significantly reduces dysmenorrhea and non‐menstrual pelvic pain (NMPP) in women with moderate to severe endometriosis‐associated pain. Methods: Data were pooled from two 6‐month, placebo‐controlled, phase 3 studies (Elaris Endometriosis [EM]‐I and II) in which 2 doses of elagolix were evaluated (150 mg once daily and 200 mg twice daily). Pooled data from > 1600 women, aged 18–49, were used to evaluate the efficacy of elagolix and health‐related quality of life (HRQoL) in prespecified subgroups of women with various baseline characteristics. Results: Of the 1686 women treated, 1285 (76.2%) completed the studies. The percentages of women with clinically meaningful reductions in dysmenorrhea and NMPP were generally consistent by subgroup. Significant treatment by subgroup interaction was demonstrated for dysmenorrhea response in baseline analgesic use (p < 0.01) and previous history of pregnancy (p < 0.05) subgroups, and for NMPP response in the baseline NMPP score (p < 0.05) and history of pregnancy (p < 0.05) subgroups. Patient‐reported reduction in pain at month 3 was significant across all subgroups taking elagolix 200 mg BID, and significant across most subgroups with elagolix 150 mg QD. Women across subgroups experienced improvement within each domain of the Endometriosis Health Profile‐30 (EHP‐30), although significant treatment by subgroup interactions were observed in several categories. Conclusions: Elagolix was effective in reducing dysmenorrhea and NMPP, and improving HRQoL, compared with placebo across numerous subgroups of women with various baseline characteristics, covering a broad segment of the endometriosis disease and patient types. Clinical trial registration: ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT01620528; https://www.clinicaltrials.gov/ct2/show/NCT01931670.

Abshirini, M., et al. (2021). "Effect of Greenshell TM mussel on osteoarthritis biomarkers and inflammation in healthy postmenopausal women: a study protocol for a randomized double-blind placebo-controlled trial." Trials 22(1): 498.
	Background: New Zealand Greenshell™ mussels (GSM; Perna canaliculus) have recently been shown to decrease cartilage degradation in a rat model of induced metabolic osteoarthritis (MetOA). However, this effect has not been investigated in human subjects. This study aims to determine the effect of GSM powder on biomarkers of cartilage metabolism, bone resorption, and inflammation in New Zealand healthy overweight/obese postmenopausal women who are at early stage or at high risk of OA.; Method: Fifty overweight or obese (BMI 25-35 kg/m 2 ) postmenopausal women (aged 55-75 years) will be recruited by advertisement. Participants will be randomized based on a double-blind randomization schedule and stratified randomization based on BMI and age distribution. The participant will be assigned with a 1:1 allocation ratio to receive 3 g/d whole meat GSM powder or placebo (sunflower seed protein) for 12 weeks. Data on socio-demographics, physical activity, and dietary intake will be collected for each subject. Cartilage turnover biomarkers [(C-telopeptide of type II collagen (CTX-II), C-propeptide of type II procollagen (CPII), Cartilage oligomeric matrix protein (COMP)], and bone resorption marker (CTX-I) will be measured in blood and urine samples. Inflammatory status (hs-CRP and cytokine panel) will be assessed and iron status will be measured. Body composition including fat mass (FM), lean mass (LM), and fat percentage will be measured using dual-energy X-ray absorptiometry (DXA). Joint pain and knee function will be assessed using a 100-mm visual analog scale (VAS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, respectively.; Discussion: This trial will be the first to explore the effects of whole meat GSM powder on cartilage turnover, bone resorption, and inflammation biomarkers in overweight/obese postmenopausal women. The results from this trial will provide evidence on the efficacy of GSM in the prevention of OA.; Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000413921p . Registration on 27 March 2020. (© 2021. The Author(s).)

Abshirini, M., et al. (2023). "Effect of green-lipped mussel ( Perna canaliculus ) supplementation on faecal microbiota, body composition and iron status markers in overweight and obese postmenopausal women: a randomised, double-blind, placebo-controlled trial." Journal of nutritional science 12: e58.
	The present study aimed to determine the effect of whole meat GSM powder on gut microbiota abundance, body composition and iron status markers in healthy overweight or obese postmenopausal women. This was a 3-months trial involving forty-nine healthy postmenopausal women with body mass index (BMI) between 25 and 35 kg/m 2 who were randomly assigned to receive 3 g/d of either GSM powder ( n 25) or placebo ( n 24). The gut microbe abundance, serum iron status markers and body composition were measured at the baseline and the end of the study. The between-group comparison at the baseline showed a lower abundance of Bacteroides and Clostridium XIVa in the GSM group compared with the placebo ( P = 0⋅04). At the baseline, the body fat (BF)% and gynoid fat% were higher in the GSM group compared with the placebo ( P < 0⋅05). No significant changes were found in any of the outcome measures, except for ferritin levels that showed a significant reduction over time (time effect P = 0⋅01). Some trend was observed in bacteria including Bacteroides and Bifidobacterium which tended to increase in the GSM group while their abundance decreased or remained at their baseline level in the control group. Supplementation with GSM powder did not result in any significant changes in gut microbe abundance, body composition and iron markers compared with placebo. However, some commensal bacteria such as Bacteroides and Bifidobacteria tended to increase following supplementation with GSM powder. Overall, these findings can expand the knowledge surrounding the effects of whole GSM powder on these outcome measures in healthy postmenopausal women. (© The Author(s) 2023.)

Abu-Zaid, A., et al. (2022). "Ascorbic Acid for Prevention of Intraoperative Blood Loss and Related Complications During Myomectomy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." Cureus 14(11): e31571.
	Leiomyomas are inherently well-vascularized neoplasms; thus, they are very vulnerable to bleeding-associated complications during myomectomy. Ascorbic acid has well-established functions in tissue healing and the prevention of bleeding tendencies. Several randomized controlled trials (RCTs) have explored the antihemorrhagic utility of ascorbic acid administration during myomectomy. This research aimed to systematically and meta-analytically summarize the clinical antihemorrhagic efficacy of ascorbic acid (i.e., the intervention arm) versus placebo/no treatment (i.e., the control arm) during myomectomy. We electronically searched six sources, i.e., PubMed, Scopus, Web of Science, Cochrane Central Register of Controlled Trials, and Google Scholar. Our search was from inception until October 2022. We used the Cochrane Risk of Bias Scale (version 2) to assess the quality of the included studies. We summarized the effect sizes as the mean difference (MD) or risk ratio (RR) with a 95% confidence interval (CI) in a fixed-effects or random-effects model. Overall, three RCTs met the inclusion criteria, comprising a total of 193 patients: 99 patients were allocated to the ascorbic acid arm, whereas 94 patients were allocated to the control arm. The overall study quality was "low" and "some concerns" risk of bias in two and one RCT(s), respectively. There was no significant difference between the ascorbic acid and control arms regarding the mean intraoperative blood loss (n=2 RCTs, MD = -190.29 ml, 95% CI [-626.62, 246.05], p=0.39) and mean change in hemoglobin level (n=3 RCTs, MD = -0.26 mg/dl, 95% CI [-0.56, 0.04], p=0.09), respectively. Conversely, the ascorbic acid arm had statistically significant reductions in the mean operative time (n=3 RCTs, MD = -24.10 min, 95% CI [-30.67, -17.53], p<0.001) and the rate of blood transfusion (n=3 RCTs, RR=0.36, 95% CI [0.15, 0.87], p=0.02) compared with the control arm. No serious adverse events related to ascorbic acid were identified. In conclusion, ascorbic acid administration was associated with several beneficial effects, including reductions in mean operative time and rate of blood transfusion, but without affecting the mean intraoperative blood loss and mean change in hemoglobin level. In view of the limitations of the present meta-analysis, the use of ascorbic acid as an antihemorrhagic additive among patients undergoing myomectomy is not strongly recommended.; Competing Interests: The authors have declared that no competing interests exist. (Copyright © 2022, Abu-Zaid et al.)

Abu-Zaid, A., et al. (2023). "Effect of selenium supplementation on cardiometabolic risk factors in polycystic ovary syndrome (PCOS) patients: A systematic review and meta-analysis of randomized clinical trials." PharmaNutrition 26: 100358.
	Background: Polycystic ovary syndrome (PCOS) has been shown to be associated with cardiometabolic risk factors. Selenium (Se) is a naturally occurring mineral trace element that constitutes an essential component of selenoproteins and plays a vital role in antioxidant defense. This systematic review and meta-analysis aims to assess the effects of selenium supplementation on cardiometabolic risk factors in patients with PCOS. Method(s): MEDLINE, Cochrane Central Register of Controlled Trials, Web of Science, and Scopus databases were searched up to March 2023 for randomized clinical trials that evaluated the effect of oral selenium supplementation on patients with PCOS. We employed a random-effects model to generate pooled estimates and 95% confidence intervals (CI). Result(s): Seven trials published between 2015 and 2022 were included. All the included studies were double blind, placebo-controlled trials. Selenium supplementation resulted in a significant decrease in VLDL (SMD = -0.35, 95% CI: -0.65; -0.05), MDA (SMD = -0.89, 95% CI: -1.21; -0.57) and hs-CRP (SMD = -0.38, 95% CI: -0.73; -0.03), as well as a significant increase in QUICKI (SMD = 0.78, 95% CI: 0.47; 1.09). The current meta-analysis did not find any significant changes in FPG, insulin, HOMA-IR, TC, TG, HDL, LDL, TAC, GSH, NO, SHBG, total testosterone, or mFG score for PCOS patients following selenium supplementation compared to placebo. Conclusion(s): Selenium supplementation may serve as a good adjunct therapy in patients with PCOS to decrease lipid peroxidation and inflammatory status. Moreover, selenium may improve insulin sensitivity in these patients. However, the overall effects of selenium on all cardiometabolic risk factors in PCOS patients still need to be evaluated through large population and long duration RCTs.Copyright © 2023 Elsevier B.V.

Achen, G., et al. (2021). "[Epithelial ovarian cancers and minimally invasive cytoreductive surgery after neoadjuvant chemotherapy: A systematic review]." Gynecologie, obstetrique, fertilite & senologie 49(10): 736-743.
	Introduction: Advanced epithelial ovarian cancer (EOC) is associated with high mortality and often managed first with neoadjuvant chemotherapy (NACT) followed by debulking surgery. Laparoscopic surgery with or without robotic assistance (Minimally Invasive Surgery (MIS)) may represent a beneficial option for these patients. The objective of this literature review is to clarify the place of MIS in the management of advanced EOC for selected patients.; Method: Pubmed, Cochrane and Clinicaltrials.gov online databases were used for this review, to select English or French published articles.; Results: We selected 11 original articles published between 2015 and 2020, 6 of which compared MIS and laparotomy. Among these 11 studies, 8 were retrospective cohorts, 2 were phase II trials, and one was a case-control study. In total, there were 3721 patients, of which 854 (23%) were treated with MIS. The robotic assistance was used with 224 patients (26%) of those MIS patients. Looking specifically at MIS patients, the laparoconversion rate was 9.5%, the rate of complete resection (CC-0) was 83.4%. Finally, the MIS complication rate was 1% intraoperatively and 12% postoperatively. The rate of complete resection, postoperative complication, as well as overall survival (OS) were comparable between patients treated with MIS or laparotomy. One study found an improved disease-free survival (DFS) in MIS versus laparotomy (18 months versus 12 months; P=0.027).; Conclusion: MIS seems feasible, effective, and reliable in comparison to laparotomy for the completion of cytoreductive surgery after NACT without compromising oncological safety. Prospective randomized controlled trials are needed to confirm the role of MIS in advanced EOC. (Copyright © 2021 Elsevier Masson SAS. All rights reserved.)

Acién, P., et al. (2021). "Long-term outcomes of transvaginal ultrasound-guided aspiration versus traditional conservative surgery as treatment for endometriomas: A retrospective study of cohorts." The Journal of Obstetrics and Gynaecology Research 47(4): 1462-1471.
	AIM: To evaluate if the long-term results (on fertility, need of hysterectomy and persistence of endometriosis) after a minimally invasive intervention (transvaginal ultrasound-guided puncture-aspiration [TUGPA]) for endometriomas are significantly different from performing the traditional conservative surgery (CS) by laparoscopy or laparotomy. METHODS: We performed a retrospective study of cohorts on patients undergoing surgery for ovarian endometriomas between January 1998 and April 2015. Cohort 1 consisted of 75 women whose first intervention for endometriomas had been TUGPA. For the cohort 2, we selected a randomized paired case in which the first operation for endometriomas had been CS by laparoscopic or laparotomy (another set of 75 patients). RESULTS: There were significantly more recurrences and the time to recurrence and repetition of operations were also significantly shorter in patients with TUGPA. However, there were no significant differences in overall pregnancy/delivery outcomes, in hysterectomy performances, or in endometriosis persistence at the last follow-up visit. There were no significant differences related to the symptoms or to analytical presurgical values but the application of multivariate analysis with binary logistic regression to each dependent variable adjusted for age, symptoms, and presurgical analyses showed a significant risk of recurrence and reoperation of TUGPA versus CS. CONCLUSIONS: Those patients with endometriomas who underwent TUGPA (with or without associated medications) had a significant increase in recurrence and the need for reoperation. However, in the long-term there were no significant differences in the results of pregnancy/childbirth, need for hysterectomy, or in the clinical or doubtful persistence of endometriosis.

Ackert Kathleen, E., et al. (2023). "Implementation of an enhanced recovery after surgery (ERAS) protocol for total abdominal hysterectomies in the division of gynecologic oncology: a network-wide quality improvement initiative." Journal of osteopathic medicine 123(10): 493-498.
	Context: Enhanced Recovery After Surgery (ERAS) protocols have been shown to decrease length of stay and postoperative opioid usage in colorectal and bariatric surgeries performed at large academic centers. Hysterectomies are the second most common surgical procedure among women in the United States. Hysterectomies performed in an open fashion, or total abdominal hysterectomies (TAHs), account for a large portion of procedures performed by gynecologic oncologists secondary to current oncology guidelines and surgical complexity. Implementation of an ERAS protocol for gynecologic oncology TAHs is one way in which patient outcomes may be improved.; Objectives: An ERAS protocol for gynecologic oncology surgeries performed in a community hospital was instituted with the goal to optimize patient outcomes preoperatively. The primary outcome of interest was to reduce patient opioid usage. Secondary outcomes included compliance with the ERAS protocol, length of stay, and cost. Thirdly, this study aimed to demonstrate the unique challenges of implementing a large-scale protocol across a community network.; Methods: An ERAS protocol was implemented in 2018, with multidisciplinary input from the Departments of Gynecologic Oncology, Anesthesia, Pharmacy, Nursing, Information Technology, and Quality Improvement to develop a comprehensive ERAS order set. This was implemented across a 12-site hospital system network that consisted of both urban and rural hospital settings. A retrospective review of patient charts was performed to assess measured outcomes. Parametric and nonparametric tests were utilized for statistical analysis with p<0.05 denoting statistical significance. If the p value was >0.05 and <0.09, this was considered a trend toward significant.; Results: A total of 124 patients underwent a TAH utilizing the ERAS protocol during 2018 and 2019. The control arm consisted of 59 patients who underwent a TAH prior to the ERAS protocol intervention, which was the standard of care in 2017. After 2 years of implementation of the ERAS protocol intervention, we found that 48 % of the ERAS patients had minimal opioid requirements after surgery (oral morphine equivalent [OME] range 0-40) with decreased postoperative opioid requirements in the ERAS group (p=0.03). Although not statistically significant, utilization of the ERAS protocol for gynecologic oncology TAHs trended toward shorter hospital length of stay from 5.18 to 4.17 days (p=0.07). The median total hospital costs per patient also showed a nonsignificant decrease in cost from $13,342.00 in the non-ERAS cohort and $13,703.00 in the ERAS cohort (p=0.8).; Conclusions: A large-scale quality improvement (QI) initiative is feasible utilizing a multidisciplinary team to implement an ERAS protocol for TAHs in the division of Gynecologic Oncology with promising results. This large-scale QI result was comparable to studies that conducted quality-improvement ERAS initiatives at single academic institutions and should be considered within community networks. (© 2023 the author(s), published by De Gruyter, Berlin/Boston.)

Acs, M., et al. (2022). "Prolonged Exposition with Hyperthermic Intraperitoneal Chemotherapy (HIPEC) May Provide Survival Benefit after Cytoreductive Surgery (CRS) in Advanced Primary Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer." Cancers 14(14).
	Background: The usage of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) for advanced gynecological cancers is increasing. Methods: Prospectively collected data of 85 advanced primary ovarian/fallopian tube cancer and peritoneal carcinoma patients of a single center were investigated. Results: A total 48, 37, 62, and 25 patients were enrolled into the HIPEC with/without neoadjuvant chemotherapy (upfront vs. interval) and into the 60 min and 90 min long HIPEC groups, respectively. Better overall survival (OS) was observed in the 90 min HIPEC group (p = 0.0330), compared to the 60 min HIPEC group. Neither OS (p = 0. 2410), disease-specific (p = 0. 3670), nor recurrence-free survival (p = 0.8240) differed between upfront and interval HIPEC. Higher peritoneal carcinomatosis index (PCI) values were associated with worse disease-specific survival (p = 0.0724). Age (p = 0.0416), body mass index (p = 0.0044), PCI (p < 0.0001), the type (p = 0.0016) and duration (p = 0.0012) of HIPEC, and increased perioperative morbidity (p < 0.0041) had the greatest impact on OS. Conclusions: Increasing data support the value of HIPEC in the treatment of advanced ovarian cancer. Ongoing prospective studies will definitively clarify the role and timing of this additional therapeutic approach.

Actrn (2021). "The effect of a paracervical block prior to total laparoscopic hysterectomy on patient's quality of recovery." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: The intervention group will receive 20mL of bupivacaine 0.5% with 1:200,000 adrenaline infiltrated via paracervical block, after induction of general anaesthesia and prior to the initial surgical incision. The intervention is TGA approved. Five millilitres of the solution will be injected at the 3, 5, 7, and 9 o’clock positions of the cervicovaginal junction at a depth of 10mm as described in the 7th edition of Te Linde’s Operative Gynecology. The injection will be prepared at the hospital pharmacy. The Study Coordinator will deliver this to the surgeon in theatre. A copy of the randomisation sheet documenting the drug administered will be filed in the patients medical records. The surgeon, patient and anaesthetist will not be aware of which preparation is used. CONDITION: Anaesthesiology ‐ Pain management Post operative pain;Hysterectomy; ; Post operative pain ; Hysterectomy Reproductive Health and Childbirth ‐ Other reproductive health and childbirth disorders Surgery ‐ Other surgery PRIMARY OUTCOME: Completion of Quality of recovery questionnaire (QoR‐15) to measure patient reported quality of recovery.[Measured 24‐36 hours post operatively] SECONDARY OUTCOME: Assessing Length of Hospitalisation by accessing patient medical records ; [At the time of hospital discharge ; ] Completion of Quality of recovery questionnaire (QoR‐15) to measure patient reported quality of recovery.[measured 7 days post surgery.] Composite opioid measured by accessing patient medical records[Measured up to 24 hours post surgery] Nausea and Vomiting[Assessed by requirement for anti‐emetics, which will be determined by accessing patient medical records. Antiemetic use will be documented for the first 24 hours post surgery.] Opioid use in Post Anesthesia Care Unit by accessing patient medical records. ; [Period whilst in Post Anesthesia Care Unit ; ] Pain score utilising visual analogue scale at rest [Measured at a single set timepoint between 24‐36 hours post surgery. ; ] Pain score utilising visual analogue scale at rest [Measured at day 7 post operatively] Pain score utilising visual analogue scale at time of mobilisation [Measured at a single timepoint between 24‐36 hours post surgery. ; ] Pain score utilising visual analogue scale at time of mobilisation [Measured at day 7 post operatively] Time in Post Anesthesia Care Unit by accessing patient medical records. ; [Timepoint: from surgery finish time to time returned to ward ; ] Time to mobilisation after surgery by accessing patient medical records. ; [Measured up to 36 hours post surgery ; ] INCLUSION CRITERIA: 1. Women undergoing a total laparoscopic hysterectomy (TLH) plus or mimus bilateral Salpingo‐oophorectomy (BSO) for any of the following conditions: a. Heavy menstrual bleeding/ abnormal uterine bleeding b. Stage 1 and 2 Endometriosis c. Adenomyosis d. Risk reduction surgery e.g. carriers of BRCA1/2 gene faults, Lynch Syndrome or women considered high risk due to family history e. Complex adnexal masses not suspicious for malignancy f. Early stage cervical cancer requiring simple hysterectomy 2. Patients aged 18 years of age and over 3. Fluent in English

Actrn (2021). "The effect of lignocaine on pain outcomes for women undergoing gynaecological surgery for chronic pelvic pain." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Double blind randomised controlled trial of the use of peri‐operative intravenous lignocaine compared to placebo matched control intravenous saline at the time of operative laparoscopy for chronic pelvic pain conditions. Description of drug intervention: Name ‐ Lignocaine, or Lidocaine (International Non‐proprietary Name) Dose, duration and mode of administration ‐ 1.5mg/kg intravenous bolus with induction of anaesthesia (max 200mg), followed by 2mg/kg/hour intravenous infusion during anaesthesia. Cease infusion prior to emergence from anaesthesia. CONDITION: Anaesthesiology ‐ Pain management Chronic pelvic pain; ; Chronic pelvic pain Renal and Urogenital ‐ Other renal and urogenital disorders Surgery ‐ Other surgery PRIMARY OUTCOME: Visual Analogue Scale (VAS) pain scores [Measured at 2, 4, 6 and 12‐24 hours postoperative] SECONDARY OUTCOME: Change in pain assessment on specifically designed questionnaire from preoperative to postoperative assessment at 3 months ‐ questionnaire designed specifically for this study ; [3 months postoperative] Change in Quality of life scores (12‐item short form survey [SF‐12], Fatigue survey score) from preoperative to postoperative assessment at 6 weeks and 3 months[6 weeks and 3 months] Length of hospital stay ‐ data collected from medical records[Postoperative period ‐ from immediately following the surgery to time of discharge under direct observation during inpatient stay, and reassessed again at 1 week via patient survey] Pain assessment 1‐week postoperative (daily VAS and analgesia use questionnaire for 3‐7 days) ‐ questionnaire designed specifically for this study[1 week post operative] Postoperative morphine equivalent dose rescue analgesia use ‐ data collected from medical records[In the first 24hours] Potential adverse effects of intravenous lignocaine ; ‐ Numbness around mouth/tongue ; ‐ Light‐headedness ; ‐ Ringing in ears ; ‐ Twitches ; ‐ Increased sedation ; ‐ Slurred speech ; ‐ Confusion ; ‐ Hallucinations ; ‐ Hypotension ; ‐ Bradycardia ; ‐ Other ; ; Data collected from medical records[Duration of the study ‐ for each participant follow up will continue until 3 months postoperatively] Psychological distress as measured by K10 score, Change from pre‐operative to 3 months postoperative[3 months post operative] Time to first breakthrough analgesic request ‐ data collected from medical records[24 hours postoperative] INCLUSION CRITERIA: ‐ Women requiring elective operative gynaecological laparoscopy for benign indication as determined and agreed by both the surgeon and the participant. ‐ Experience of pelvic pain on most days in the preceding 6 months ‐ Over 18years old and premenopausal at the time of the surgery. ‐ Participants who understand the conditions of the study and are willing to participate for the duration of study including all follow‐up. ‐ Participants who are capable of, and have given, informed consent to their participation in the study. ‐ English language or an available translator sufficient to complete the validated quality of life instruments. ‐ Surgery at Moorabbin Hospital under specialised Endosurgery unit

Actrn (2021). "Effect of Palmitoylethanolamide (PEA) and Resveratrol compared to a placebo on menstrual pain symptoms in an Adult Population – A double blind, randomised controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: PEA is a TGA approved ingredient for use in listed medicines in Australia (Brand name Levagen+). PEA + resveratrol (350 mg of Levagen+ (containing no less than 300 mg PEA) and 40 mg of Resveratrol) will be taken as a single capsule twice daily (one in the morning and one in the evening) with water from day 1 of first menstrual month until the end of the 3rd menstrual month. Participants will start to take trial product on day 1 of their next menstrual period following the baseline menstrual period. Once enrolled, participants will then undergo a health assessment including basic information, lifestyle, medication and medical history. Participants will document their use of any medication (including contraception use) including any use of medication during menses (i.e. pain medication, analgesics, NSAIDs) and complete a self‐reported Pittsburg Sleep Quality Index (PQSI) questionnaire. Following enrolment and health assessment, participants will be provided with their trial product, but instructed to only start supplementation at the required dose once they have recorded data for one full menstrual period. Participants will be provided with their supplements in an opaque bottle containing capsules according to their randomisation. Placebo capsules will appear identical to the active comparator. This study will consist of a total of 4 menstrual periods being recorded for each participant (1 without supplementation and 3 with supplementation). The first cycle will be recorded prior to any supplementation starting and will count as a baseline/control measure for each participant. Day 1 will be defined as the first day bleeding occurs. From day 1, participants will complete a visual analogue scale (VAS) and Menstrual Distress Questionnaire Form T (MDQ‐T) ass CONDITION: Alternative and Complementary Medicine ‐ Other alternative and complementary medicine Menstrual Pain; ; Menstrual Pain Reproductive Health and Childbirth ‐ Menstruation and menopause PRIMARY OUTCOME: Changes in monthly pain/severity as assessed by VAS for pain [Daily for the duration of each menstrual period ‐ Day 1 to end of menstrual cycle (Final day of 4th menstrual period primary endpoint)] INCLUSION CRITERIA: ‐ Women who experience mild to moderate menstruating pain ‐ Aged 18‐50 years old ‐ Otherwise healthy ‐ Able to provide informed consent ‐ Regular menstrual cycle (28 days ± 7 days) and period SECONDARY OUTCOME: Changes in menstrual symptoms (changes in pain) as measured by VAS scale. [Daily for the duration of each menstrual cycle ‐ Day 1 to end of menstrual cycle (Max 4 menstrual periods) ] Changes in menstrual symptoms as assessed by the MDQ‐T (change in menstrual symptom: bloating as assessed by the MDQ‐T) [Daily for the duration of each menstrual cycle ‐ Day 1 to end of menstrual cycle (Max 4 menstrual periods) ] Changes in premenstrual syndrome (PMS) severity as assessed by PMSIS [Day 1 of each menstrual cycle (4 menstrual periods) ] Changes in rescue medication use as assessed by self‐reported questions included in electronic capture of administered questionnaires (PMSIS, MDQ‐T). [Daily for the duration of each menstrual period ‐ Day 1 to end of menstrual cycle (Max 4 menstrual periods) ]

Actrn (2021). "Effect of Paracervical Block on Post-operative Pain Following Benign Laparoscopic Hysterectomy: objective Evaluation Of Parameters By Utilising A Single Centre Double Blind Randomized Controlled Trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Paracervical block with 0.5% Bupivacaine (with 1:200,000 Adrenaline) before benign laparoscopic hysterectomy The study will objectively evaluate pain by measuring opioid intake postoperatively and by determining the impact in patient reported pain beyond the first 24 hours postextubation. Subsequent impact on return to normal activity and quality of life score (QOL) will also be determined using the widely validated tool EQ‐5D 5L. Two‐arm single centre double blinded randomized placebo‐controlled trial. 1. Treatment arm: Paracervical injection of 0.5% bupivacaine with adrenaline 1:200,000 (20 mL) containing 100mg of anhydrous bupivacaine HCL and 100 micrograms of adrenaline. 2. Placebo arm: Paracervical injection of normal saline (20 mL) Cervical infiltration technique: Infiltration will be performed just prior the insertion of uterine manipulator by the primary surgeon. The content will be injected into the cervical stroma at the 3 and 9 o’clock positions with a depth of 2‐3 cm, with 10 mL injected at each side. Data will be routinely reviewed for completeness and accuracy as well as any evidence that may be indicative of participant risk. When the data are incomplete, attempts will be made to obtain the data whenever possible. Ensuring satisfactory response rate, data completeness and identifying missing data will remain responsibilities of the core research team. Every reasonable attempt will be made to determine the reason for a patient being lost to follow‐up. All participants will be given a standardised discharge prescription of twenty tablets of 5 mg Oxycodone for use as ‘PRN’. CONDITION: Anaesthesiology ‐ Pain management Pain; ; Pain Surgery ‐ Other surgery PRIMARY OUTCOME: ; a. Patient reported pain score at rest 60 minutes post‐extubation using Numeric Rate Scale (NRS) ; ; [1. 60 minutes post‐extubation ; ] SECONDARY OUTCOME: ; ; Patient reported pain score at rest and with coughing on the first post‐operative day using NRS ; ; ; [1. day 1: once, 24 hours post‐operation] Length of stay in hours (from the relevent electronic medical record)[From post extubation to discharge ] Opioid intake measurement by chart review: Use of oxycodone in day 1 and day 2[day 1 and day 2 post‐operation ] Opioid intake post‐discharge. This outcome will be assessed by conducting a phone interview on day 7 postoperative. Participants will be advised to keep a record of opioid intake at their discharge.[day 7 post‐operation ] Return to usual daily activity: Patient reported activity score on day 7 post‐op using EQ‐5D‐5L visual analogue scale [day 7 post‐operation] INCLUSION CRITERIA: 1. Age greater than or equal to 18 years 2. Undergoing a total laparoscopic hysterectomy for benign indications (elective) 3. Indication of prophylactic surgery for at‐risk patients can be included 4. With or without the following concurrent procedures: a. Unilateral or bilateral salpingo‐oophorectomy b. Excision of endometriosis (below pelvic brim)

Actrn (2021). "The effectiveness of a Mediterranean diet on hormonal, metabolic and body composition in overweight and obese women with Polycystic Ovary Syndrome." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Participants will be randomly allocated one of two prescribed and individualised 12‐week dietary interventions. The Mediterranean diet (MedDiet) group will be asked to consume a diet consistent with a traditional Mediterranean Diet including: 1–4 tablespoons of extra virgin olive oil/day 5–6 serves of vegetables/day 2–3 serves of fruit/day 4–6 serves of wholegrains/day up to 200ml red wine/day 3 serves of legumes/wk 3 serves of nuts/wk 3 serves of Greek yoghurt/wk 2‐3 servings of eggs/wk 2‐3 serves of fish and seafood/wk 1–3 servings of poultry/wk up to 1 serve of red meat/wk Participants will receive fortnightly face to face consultations with an Accredited Practising Dietitian at a consultation room at the University of the Sunshine Coast. Consultations will consist of: *Baseline lasting 60‐90mins to include assessment of outcome measures, counselling and education on the dietary protocol and a set of educational resources to facilitate dietary compliance *Five fortnightly consults at weeks 2, 4, 6, 8 and 10 lasting 30mins to include dietary counselling, education and monitoring of body mass. *Final lasting 60‐90mins to include assessment of outcomes. Participants will complete a daily dietary checklist consistent with the dietary protocol and return the checklist each fortnight. Participants will also complete a 4‐day food diary at baseline, week 6 and week 12. These will be used to facilitate discussion and education during the Dietetic consultations. In each of the five fortnightly consults, all participants (irrespective of the treatment allocation) will receive individual counselling and education by an Accredited Practising Dietitian. As such, part of this process will also involve the provisi CONDITION: Metabolic and Endocrine ‐ Other endocrine disorders Polycystic Ovary Syndrome; ; Polycystic Ovary Syndrome PRIMARY OUTCOME: Change in fasting blood glucose concentrations (12‐hour fasting blood test)[Baseline and post‐intervention (week 12)] Change in serum concentration of insulin (homeostatic model assessment (HOMA)) using 12‐hour fasting blood test.[Baseline and week 12 (post intervention)] Change in serum concentrations of total testosterone and sex hormone binding globulin (composite outcome) using 12‐hour fasting blood test.[Baseline and week 12 (post‐intervention)] INCLUSION CRITERIA: 1. Confirmed diagnosis of Polycystic Ovary Syndrome according to the Rotterdam criteria which is based on participants presenting with two of the three following criteria including: 1) menstrual irregularity (infrequent menstrual periods) and/or anovulation; 2) clinical and/or biochemical hyperandrogenism; 3) polycystic ovaries based on ultrasound examination. 2. Body mass index of 25kg/m2 or more SECONDARY OUTCOME: Adherence to a Mediterranean diet. This will will be assessed using the previously validated 14‐item MEDAS, used in the Prevención con Dieta Mediterránea (PREDIMED) study. The MEDAS determines adherence scores according to pre‐defined normative criterion cut‐off points for the habitual frequency of consumption or amount consumed (pre‐defined servings/day or servings/week) of 12 main dietary elements and two food habits related to a traditional MedDiet pattern. The 14 questions in the questionnaire will each be scored a 0 or 1, generating a maximum score of 14. Specifically, a MEDAS score greater than 10 suggests high adherence, scores between 6 and 9 indicate moderate adherence, and a score less than 5 is considered low adherence.[Baseline and post‐intervention (week 12)] Change in body mass (kg). A calibrated digital scale (AND Weighing; HW‐KGL, Melbourne, Australia) will be used to record body mass to the nearest 0.1 kg,[Change in body mass: Baseline, weeks 2, 4, 6, 8, 10, 12 (post intervention)] Change in waist circumference. This measure will be performed by trained research personnel and measured to the nearest 0.1 cm using a flexible steel tape measure (Lufkin Executive Thinline) at the point midway between the iliac crest and the lower cos l border (lower rib) according to standardized protocols. This will be measured on three separate occasions with the mean of the three measures used for final analyses.[Baseline and post‐intervention (week 12)] Dietary intake. this will be assessed using a 4‐day food record.Participants will be asked to record all food and beverage intake for a period of 4‐days (3 weekdays and 1 weekend day) using standard household utensils such as cup/teaspoon and tablespoon measures before sending the food record back to the investigators using the return paid envelope provided. All food records will be entered into Foodworks by a member of the research team for a comprehensive nutrient analysis assessment using food composition data derived from two Australian databases, AUSNUT 2007 and NUTTAB 2010. [Baseline, week 6 and week 12 (post intervention)] Feasibility to the MedDiet intervention. Participants randomized to the MedDiet intervention will complete an individual semi‐structured interview and complete a series of Likert scales to assess their opinion of the acceptability of the study resources and their confidence in their ability to follow a MedDiet. [Baseline and post‐intervention (week 12)] Physical activity status. This will be monitored using the short version of the International Physical Activity Questionnaire (IPAQ‐SF). IPA‐SF quantifies physical activity during the previous seven days and is divided into four categories: vigorous intensity, moderate intensity, walking and sedentary behaviour. Furthermore, intensity, frequency and duration of physical activity are also assessed.[Baseline and post‐intervention (week 12)]

Actrn (2021). "Efficacy and Demonstration of IntraVenous Iron for Anaemia in pregnancy (EDIVA)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: This will be a two‐arm (1:1) Phase III open‐label superiority individual‐randomised controlled trial assessing the effectiveness of the intravenous iron ferric carboxymaltose in reducing maternal anaemia, compared to the standard of care of oral iron supplementation. Women in their second or third trimester of pregnancy will be screened for anaemia and those found to be moderately‐severely anaemic (haemoglobin <10g/dL) will be randomized to receive the intervention or the control. Intervention: intravenous iron treatment course administered once during pregnancy. Intravenous ferric carboxymaltose (FCM) 1000 mg total dose for body weight of 50 kg or more, or 20 mg/kg for body weight less than 50 kg, will be given over 15 minutes by a skilled study physician/ medical technologist. For participants receiving the intravenous iron treatment course: the skin will be cleaned with ethanol following standard aseptic procedure, and a sterile cannula will be inserted into the forearm or hand by a skilled study physician/medical technologist, and the cannula will be fixed in place with a sterile Tegaderm or clinical tape. The participant will be monitored over the 15 minutes of the infusion for any adverse events and at 10 minutes into the infusion, she will be asked if she experiences any problems and everything will be recorded. If the participant develops any complications, these will be attended to promptly and treated according to standard clinical management guidelines. The participant will be observed for a further 45 minutes and similarly, any problems experienced will be recorded. CONDITION: Anaemia;Iron deficiency;Maternal depression;Low birthweight;Prematurity;small for gestational age; ; Anaemia ; Iron deficiency ; Maternal depression ; Low birthweight ; Prematurity ; small for gestational age Blood ‐ Anaemia Diet and Nutrition ‐ Other diet and nutrition disorders Mental Health ‐ Depression Reproductive Health and Childbirth ‐ Fetal medicine and complications of pregnancy PRIMARY OUTCOME: Maternal anaemia (haemoglobin <11g/dL), assessed by a finger prick test using a HemoCue301 portable haemolgobin analyzer[36 weeks gestation (this timepoint is after delivery of the intervention)] SECONDARY OUTCOME: Abortion (pregnancy loss before 28 weeks of gestation) as reported by participant, study staff or based on clinical records[<28 weeks gestation] Adverse perinatal events including postpartum haemorrhage, need for blood transfusion, intensive care admission or mortality, as reported by patient or based on clinical records, or as observed by study staff.[From recruitment to 28 days postpartum] Birthweight (as a continuous variable measured in grams) using infant scales[At delivery visit] Child neurodevelopment, assessed by neonatal behavioral assessment scale[At delivery and 42 days postnatal] Child neurodevelopment, assessed by the auditory brainstem response tool[42 days postnatal and 6 months postnatal] Child neurodevelopment, assessed by the Bayleys scales of infant development[6 months postnatal] Child physical growth (length and weight) as a composite outcome, measured using infant scales and measuring tape[42 days postnatal, 3 months postnatal and 6 months postnatal] Child physical growth (length, cm) measured with measuring tape[42 days postnatal, 3 months postnatal and 6 months postnatal] Gestational age at birth (weeks), based on calculated duration of gestation, using dating at baseline ultrasound examination to date of actual delivery.[At delivery visit] Infant adverse events including hospitalisation and clinic visits as reported by mother, study staff or based on clinical records[Throughout study from delivery through to 6 months old] Infant ferritin levels (continuous), assessed by enzyme‐linked immunosorbent assays (ELISAs) for serum ferritin.[42 days postnatal, 3 months postnatal and 6 months postnatal] Infant haemoglobin levels (as a continuous variable) assessed by a finger prick test using a HemoCue301 portable haemolgobin analyzer[42 days postnatal, 3 months postnatal n 6 months postnatal] Infusion related adverse events including allergic reactions as reported by study staff or based on clinical records[Time of administration of intervention, and any severe adverse events reported by study staff or based on clinical records up to two weeks post intervention] Low birth weight (as a categorical variable, birth weight <2500g) using infant scales[At delivery visit] Maternal anaemia (haemoglobin <11g/dL), assessed by a finger prick test using a HemoCue301 portable haemolgobin analyzer[4 weeks post intervention, 42 days postpartum, 3 months postpartum and 6 months postpartum] Maternal depression measured by the Edinburgh postnatal depression scale[4 weeks post intervention, 36 weeks gestation, and 3 months postpartum ] Maternal ferritin levels (as a continuous variable), assessed by enzyme‐linked immunosorbent assays (ELISAs) for serum ferritin.[4 weeks post intervention, 36 weeks gestation, 42 days postpartum, 3 months postpartum and 6 months postpartum] Maternal haemoglobin levels (as a continuous variable), assessed by a finger prick test using a HemoCue301 portable haemolgobin analyzer[4 weeks post intervention, 36 weeks gestation, 42 days postpartum, 3 months and 6 months postpartum] Maternal hypophosphatemia based on biochemical measurement of serum phosphate[4 weeks post intervention, 36 weeks gestation] Maternal inflammation, measured by enzyme‐linked immunosorbent assays (ELISAs) for C‐reactive protein[4 weeks post intervention, 36 weeks gestation, 42 days postpartum, 3 months postpartum and 6 months postpartum] Maternal iron deficiency (ferritin <15 mg/L), assessed by enzyme‐linked immunosorbent assays (ELISAs) for serum ferritin.[4 weeks post intervention, 36 weeks gestation, 42 days postpartum, 3 months postpartum, 6 months postpartum] Mother to infant bonding measured by the mother to infant bonding scale [3 months postpartum] Neonatal mortality as reported by participant, study staff or based on clinical records[Death of child within the first month of life] Premature birth (<37 weeks) Gestational age at birth (weeks), based on calculated duration of gestation, using dating at baseline ultrasound examination to date of actual delivery.[At delivery visit] Small for gestation age as a dichotomous variable (<10th centile), based on baseline ultrasound dating of pregnancy adjusted birth weight[At delivery visit] Stillbirth (birth of a baby showing no signs of life after 28 weeks gestation) as reported by participant, study staff or based on clinical records[> 28 weeks gestation] INCLUSION CRITERIA: ‐ In their second (13‐25 completed weeks) or third trimester (26‐32 completed weeks of gestation), dated by Last Menstrual Period. ‐ Moderate to severe anaemia (capillary Hb <10g/dL). ‐ Not known to have a multiple pregnancy. ‐ Expected to deliver the baby inside or within 30 minutes of road transport of the study catchment area. ‐ Have drinking water groundwater iron <1mg/L. ‐ Willing to provide written informed consent (if the pregnant woman is <18 years of age, consent will be collected from her guardian, while she will sign an assent form).

Actrn (2021). "ENDOTEXT: a text message supportive program for individuals with endometriosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: ENDOTEXT is a text messaged based intervention that provides supportive messages to individuals living with endometriosis. Messaging covers a range of domains including general endometriosis information, lifestyle tips and self‐care. Participants will receive four semi‐personalised text messages (e.g., to their preferred name) per week, free of charge, for a period of three months with messages selected from the ENDOTEXT message bank according to their user characteristics (e.g., smoker vs. non‐smoker). Each message is very brief ‐ a maximum of 50 characters and should take less than 1 minute to read. CONDITION: Endometriosis;Quality of Life; ; Endometriosis ; Quality of Life Reproductive Health and Childbirth ‐ Other reproductive health and childbirth disorders PRIMARY OUTCOME: Endometriosis‐specific quality of life assessed with the reliable and valid Endometriosis Health Profile Questionnaire‐30 (EHP‐30; Jones et al., 2006)[3 months post baseline] SECONDARY OUTCOME: Emotional health measured using the widely used and validated short‐version of the original DASS, the Depression, Anxiety and Stress Scales 21 item (DASS‐21; Lovibond & Lovibond[3 months post baseline] Self‐efficacy for managing endometriosis symptoms, daily activities, medication/treatment and social interactions, assessed by the reliable and valid PROMIS Self‐Efficacy for Managing Chronic Conditions Short‐Form 4‐item subscales (Cella et al., 2010; Lee et al., 2020). [3 months post baseline] The Perceived Consequences subscale of the valid and reliable Revised Illness Perception Questionnaire (IPQ‐R; Moss‐Morris et al., 2002) is a 6‐item measure which will be used to assess endometriosis severity[3 months post baseline] User acceptability (e.g., messages easy to understand) is assessed via a self‐report online survey using Likert‐type questions (i.e., along a scale from Not at all to Very Much so). These questions are derived from questions used in prior research by this team: ; Sherman KA, Shaw LK, Jørgensen L, Harcourt D, Cameron L, Boyages J, Elder E, Kirk J, Tucker K. Qualitatively understanding patients' and health professionals' experiences of the BRECONDA breast reconstruction decision aid. Psychooncology. 2017 Oct;26(10):1618‐1624. doi: 10.1002/pon.4346. Epub 2017 Jan 30. PMID: 27957772. ; and ; Singleton, A., Partridge, S., Raeside, R., Regimbal, M., Hyun, ; K., Chow, C., Sherman, K., Elder, E., Redfern, J. (2019). A text ; message intervention to support women's physical and mental ; health after breast cancer treatments (EMPOWER‐SMS): a ; randomised controlled trial protocol. BMC Cancer, 19(1), 1‐8. ; doi ="http://dx.doi.org/10.1186/s12885‐019‐5886‐8"[3 months post baseline] INCLUSION CRITERIA: Participants are eligible to participate if they are: over 18 years of age; clinically diagnosed with endometriosis; proficient in English; have access to the internet and a mobile phone; resident in Australia

Actrn (2021). "Enhancing treatment outcomes after gynaecological cancer (ACUMEN): using exercise to promote health after cancer therapy." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: The total study period is 24 weeks. It comprises of a 12‐week exercise training intervention and a 12‐week maintenance period. After participant screening and baseline assessment, participants will be randomised to either the intervention or control group. Participants allocated to the control group will receive standard care and will receive general advice about self‐managed exercise, a Fitbit, and the Exercise is Medicine guidelines for gynaecological cancer. Control participants will be asked to wear the Fitbit device to assess physical activity performed over the study period. Participants assigned to the intervention group will received one‐on‐one supervision by an Accredited Exercise Physiologists or Physiotherapists (AEPP). Goals will be prioritised and set with the participant and the prescription co‐designed with the participant, including strategies for relapse prevention and longer‐term maintenance. As part of this process, the 12‐week exercise training intervention will adhere to the following principles: 1. Participants will be screened for known disease and risk of adverse events due to exercise with the Adult Pre‐Exercise Screening System (APSS). 2. The goal is to enhance neuromuscular strength, endurance, balance, flexibility, cardiorespiratory fitness and cardiovascular function. The AEPP will individually tailor exercise to the functional capacity of each participant towards these goals, cognisant of potential restrictions caused by surgical scarring, pain, metastases, lymphoedema, obesity, incontinence or neuropathic problems. 3. Participants will aim for 3 x 60 minute exercise sessions per week, individually prescribed by an Accredited Exercise Physiologist or Physiotherapist (AEPP) based on APSS results and the participan CONDITION: Cancer ‐ Cervical (cervix) Cancer ‐ Other cancer types Cancer ‐ Ovarian and primary peritoneal Cancer ‐ Womb (Uterine or endometrial cancer) Gynaecological cancer; ; Gynaecological cancer PRIMARY OUTCOME: ; The mean difference on the mental component summary (MCS) scores of health‐related quality of life between intervention and control in this trial, as measured by the SF36.; [; Baseline (pre‐intervention), week 12 (primary time‐point, end of intervention) and week 24 (longer‐term maintenance).; ] The mean difference on the physical component summary (PCS) scores of health‐related quality of life between intervention and control in this trial, as measured by the Short Form‐36 (SF36).[Baseline (pre‐intervention), week 12 (primary time‐point, end of intervention) and week 24 (longer‐term maintenance)] SECONDARY OUTCOME: Balance (assessed via centre of pressure displacement techniques) ; ] Duration of physical activity levels as assessed by the Fitbit watch.[Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance).] Dynamic upper and lower body muscle strength (chest and leg press respectively using one repetition maximum).[Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance).] Exercise self‐efficacy as measured by the Exercise Self‐efficacy Scale (ESES). [Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance). 3. Resident in Australia. 4. Have access to the internet. 5. Own, or have access to, a computer or tablet device. 6. Willing and able to comply with all study requirements, including intervention, timing and nature of required assessments. 7. Able to speak and read in English to ensure consent is informed and documentation of participant‐reported outcome measures can be adhered to. 8. Can provide voluntary written informed consent. ; [Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance).] Blood markers for steroid hormone modulation ‐ follicle stimulating hormone[Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance).] Blood markers for steroid hormone modulation ‐ u einizing hormone[Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance).] Blood markers for steroid hormone modulation ‐ oestradiol[Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance).] Blood markers for steroid hormone modulation ‐ progesterone[Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance).] Blood markers of glycaemic modulation (assessed by HBA1c levels in blood). [Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance).] Blood markers of inflammatory modulation (assessed by the levels of TNF‐a, IL‐2, IL1ß, IL‐6 and IL‐8 in blood).[Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance).] Body composition measured via waist‐hip ratio with a measuring tape according to WHO STEPwise Approach to Surveillance (STEPS) protocol for consistent measurement. .[Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance).] Cardiorespiratory fitness (VO2peak and exercise capacity) assessed during a graded cycling test with breath‐by‐breath gas analysis [Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance). ; ] Frequency of physical activity levels as assessed by the Fitbit watch.[Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance).] Intensity of physical activity levels as assessed by the Fitbit watch.[Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance).] INCLUSION CRITERIA: 1. Women > 18 years diagnosed with cancer of the ovary, cervix, Fallopian tubes, placenta, endometrium, vagina or vulva in the previous 60 months, including early, recurrent, advanced or metastatic cancer. 2. > 1 month since end of intensive cancer treatment (including surgery, radiotherapy, chemotherapy). Supportive therapies such as bisphosphonate, pain medication and hormone replacement allowable.

Actrn (2021). "Evaluation of the "Living with Loss" program: an online perinatal bereavement program for psychological distress and emotional wellbeing of parents following perinatal loss." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: This study is a randomised controlled trial evaluating the efficacy and acceptability of a self‐guided internet‐based (i.e. online) perinatal bereavement program ‐ 'Living with Loss' ‐ compared to usual care in improving the psychosocial and emotional wellbeing of parents following perinatal loss. The 'Living with Loss' online program consists of six modules featuring interactive activities, information, and a comic‐style storyline. Modules will take approximately 30 minutes each to complete, and are designed to be completed in any order over a period of six‐to‐eight weeks (i.e. one module recommended to be completed per week with an additional two weeks for revision). Using the software reporting function, the research team will be able to view incomplete modules and encourage participants to finish via an automated email system. The total duration of the study period including follow‐up will be six (6) months. This online perinatal bereavement program aims to support parents through their grief experience and focuses on enhancing and building adaptive coping strategies to help parents identify, tolerate, and gain more control over the regulation of their emotional experiences. This online program includes skills and strategies from several psychotherapeutic modalities (i.e. Cognitive Behavioural Therapy, Complicated Grief Therapy, Mindfulness, and Compassion‐focused therapy) with content specifically addressing the most commonly reported psychosocial difficulties experienced by parents after the death of their baby (e.g. understanding styles of grieving, managing worry and intense emotions, facing difficult conversations, returning to work, relationships and communication, planning for the future etc). This online program has been co‐developed and d CONDITION: Mental Health ‐ Depression psychological distress;stillbirth;grief;depression;perinatal loss;neonatal death ;bereavement; ; psychological distress ; stillbirth ; grief ; depression ; perinatal loss ; neonatal death; ; bereavement Reproductive Health and Childbirth ‐ Complications of newborn Reproductive Health and Childbirth ‐ Fetal medicine and complications of pregnancy PRIMARY OUTCOME: Psychological distress severity: Changes in score from baseline on the Kessler Psychological Distress 10‐item Scale (K10)[The primary outcome will be assessed in the control group at two timepoints: Week 9 (primary timepoint) and week 21. ; ; The primary outcome will be assessed in the intervention group at the following timepoints: once weekly during the eight‐week active study period (weeks 1‐8); 1 week after program completion (week 9 post‐intervention commencement, primary timepoint); at the 3‐month follow‐up (week 21 post‐intervention commencement), and at the 6‐month follow up (week 33 post‐intervention commencement).] SECONDARY OUTCOME: Anxiety severity: Change in scores from baseline on the Generalized Anxiety Disorder 7‐item Scale (GAD‐7)[The secondary outcome will be assessed in the control group at two timepoints: Week 9 and week 21. ; ; The secondary outcome will be assessed in the intervention group at the following timepoints: 1 week after program completion (week 9 post‐intervention commencement); at the 3‐month follow up (week 21 post intervention assessment); and at the 6‐month follow up (week 33 post‐intervention commencement).] Brief Grief Questionnaire (BGQ)‐ 5 item self‐report assessment of grief symptomology[The secondary outcome will be assessed in the intervention group at the 6‐month follow up (week 33 post‐intervention commencement).] Extent of distress and remorse after a healthcare decision: Change in scores from baseline on the Decisional Regret 5‐item Scale (DRS)[The secondary outcome will be assessed in the control group at two timepoints: Week 9 and week 21. ; ; The secondary outcome will be assessed in the intervention group at the following timepoints: 1 week after program completion (week 9 post‐intervention commencement); at the 3‐month follow up (week 2 ost intervention assessment); and at the 6‐month follow up (week 33 post‐intervention commencement).] Grief intensity: Change in scores from baseline on the Perinatal Grief Scale ‐ 33‐item Short Form (PGS‐SF) ; [The secondary outcome will be assessed in the control group at two timepoints: Week 9 and week 21. ; ; The secondary outcome will be assessed in the intervention group at the following timepoints: 1 week after program completion (week 9 post‐intervention commencement); at the 3‐month follow up (week 21 post intervention assessment); and at the 6‐month follow up (week 33 post‐intervention commencement).] Health‐related quality of life: Change in scores from baseline on the Assessment of Quality of Life 35‐item Scale (AQoL‐8D) [The secondary outcome will be assessed in the control and intervention group at week 9 (9 weeks post intervention commencement) and at the 3‐month follow up (21 weeks post intervention commencement).] Participant health service utilisation on the Health Service Utilisation 23‐item Scale (HSUS)[The secondary outcome will be assessed in the control and intervention group at week 9 (9 weeks post intervention commencement) and at the 3‐month follow up (21 weeks post intervention commencement).] Participants satisfaction of the intervention program on the Module Satisfaction Scale (MSS)[Once weekly during the eight‐week active study period (Weeks 1‐8).] Participants satisfaction of the intervention program on the Program Satisfaction Questionnaire (PSQ)[Post‐intervention (Week 9 post intervention commencement).] Perinatal depression severity: Change in scores from baseline on the Edinburgh Postnatal Depression 10‐item Scale (EPDS)[The secondary outcome will be assessed in the control group at two timepoints: Week 9 and week 21. ; ; The secondary outcome will be assessed in the intervention group at the following timepoints: 1 week after program completion (week 9 post‐intervention commencement); at the 3‐month follow up (week 21 post intervention assessment); and at the 6‐month follow up (week 33 post‐intervention commencement).] INCLUSION CRITERIA: Parents who have experienced a stillbirth or neonatal death in the last 2 years, and: ‐ Aged 18 years or older; ‐ Experienced a stillbirth or neonatal death within the past two years; ‐ Reside in Australia; ‐ Oral and written fluency in English language; ‐ Reliable access to a computer with internet connection; ‐ Willing to provide informed consent online.

Actrn (2021). "Investigating the efficacy of a pulmonary recruitment maneuver and closed drainage in reducing shoulder tip pain in women undergoing a total laparoscopic hysterectomy." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Participants that meet the study exclusion inclusion criteria will be randomised into one of four study groups. Group A ‐ Participants will receive the combined treatment of closed drainage for 4 hours and the pulmonary recruitment maneuver. Group B ‐ Participants will receive the single treatment of closed drainage for 4 hours. Group C ‐ Participants will receive the single treatment of the pulmonary recruitment maneuver plus a sham drain. Group D ‐ Participants will receive the current standard of care (no treatment) plus a sham drain. The method of entry into the patient’s abdomen will be left to the discretion of the surgeon. The maximum number of ports allowed to complete the surgery will be four. Only one 10mm port will be allowed. Intraabdominal pressure during the surgical procedure should not exceed 15mmHg and the maximum flow rate should not exceed 40ml/min. Closed Drain method The drain will be administered by the surgeon. A 15cm Blakes drain will be inserted through one of the existing 5mm port sites at the end of the surgery if the patient is randomized to arm A or B of the study. The drain will be placed on low suction, sutured down at its proximal end and removed 4 hours later by the ward nurse. Patient’s randomized to arm C or D of the study will have a sham drain tube placed beneath a strip of sterile gauze taped to the skin, with no intraperitoneal or subcutaneous insertion and removed 4 hours later by the ward nurse. Documentation will be provided to ward staff to ensure awareness of the presence of the sham drain tube. Pulmonary recruitment maneuver The pulmonary recruitment maneuver will be administered by the anaesthetist. The pulmonary recruitment maneuver wi CONDITION: Musculoskeletal ‐ Other muscular and skeletal disorders Reproductive Health and Childbirth ‐ Other reproductive health and childbirth disorders Shoulder Tip Pain; ; Shoulder Tip Pain Surgery ‐ Other surgery PRIMARY OUTCOME: Shoulder tip pain will be measured using the numberical / visual analogue scale, 24‐36 hours after the patient has had a total laparoscopic hysterectomy .[Recorded 24‐36 hours after total laparoscopic hysterectomy.] SECONDARY OUTCOME: Incidence of hospital readmission will be ascertained from hospital records, consulting room records and at the final study visit. ; [42 days from the intervention.] Incidence of intraoperative complications graded according to the Clavien Dindo classification. ; ; [At time of surgery] Incidence of post‐operative complications to 42 days graded according to the Clavien Dindo classification ; [Post‐operative complications up to 42 days post surgery.] Length of hospital stay will be ascertained from hospital records. ; [Up to 42 days from the intervention.] The patient will complete a QoR‐15 questionnaire to measure patient‐reported quality of recovery, 24‐36 hours after surgery, and again at 6 weeks post surgery. ; [24‐36 hours post‐surgery and at 6 weeks post surgery ; ] INCLUSION CRITERIA: 1. All women aged 18 years and over undergoing total laparoscopic hysterectomy 2. American Society of Anesthesilogists (ASA) Score 1 or 2 3. Undergoing a total laparascopic hysterectomy for one of the following conditions:‐ 1. Abnormal uterine bleeding. 2.Early stage uterine cancer 3.Atypical hyperplasia 4. Uterine fibroids where the uterine size should not exceed 10cm. 5. Risk reducing surgery

Actrn (2021). "Program for Perinatal Mental Health Promotion and Work-Life Balance." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: The MAternal Mental Health in the WORKplace (MAMH@WORK) intervention will address maternal mental health and well‐being protection and promotion during late pregnancy, postpartum and return to work. More specifically, it will target women’s psychosocial adjustment and resilience during this life stage, while promoting several strategic skills: recognition of signals and symptoms of mental disorders; reduction of stigma against mental disorders; coping skills for stressful situations, with a special focus on e‐training of mindfulness; enhancement of help‐seeking efficacy; and strengthening of emotional and cognitive self‐regulation. Health education sessions will be conducted by trained psychologists and psychiatrists experienced in cognitive‐behavioural therapy‐based psychoeducation interventions, prevention and treatment of depression and anxiety disorders. The intervention will be either conducted on‐site (Instituto de Saúde Ambiental da Faculdade de Medicina da Universidade de Lisboa) or live streaming online. The format, setting and contents of the intervention will be fully defined after scoping literature reviews and Delphi technique, which will assure its adequacy as a short‐term and sustainable intervention. Still, the intervention is planned as follows (slight changes are anticipated as a consequence of the scoping literature reviews and Delphi technique for consensus‐building): ‐ Modules: mental health literacy, self‐ and perceived stigma towards mental illness, work‐life balance, early signs of mental disorders, mother‐child interaction and promotion of secure attachment, social support, information about biofeedback (including technical details about the wearable devices), and mindfulness concepts and exercises. ‐ Materials: a standard CONDITION: Anxiety;Postpartum depression;Postpartum blues;Child‐mother attachment;Child emotional self‐regulation;Child cognitive self‐control;Poor sleep;Postpartum bonding; ; Anxiety ; Postpartum depression ; Postpartum blues ; Child‐mother attachment ; Child emotional self‐regulation ; Child cognitive self‐control ; Poor sleep ; Postpartum bonding Mental Health ‐ Anxiety Mental Health ‐ Depression Mental Health ‐ Other mental health disorders Public Health ‐ Health promotion/education Reproductive Health and Childbirth ‐ Childbirth and postnatal care Reproductive Health and Childbirth ‐ Other reproductive health and childbirth disorders PRIMARY OUTCOME: Child attachment security assessed using the Strange Situation Procedure (Ainsworth & Bell, 1970).[12 months postpartum] Postnatal depression, assessed using the Edinburgh Postnatal Depression Scale (Cox et al., 1987) for the three arms.[2 weeks postpartum, 5 months postpartum and 12 months postpartum (primary endpoint)] Postpartum bonding, assessed using the Postpartum Bonding Questionnaire (Brockington et al., 2006) for the three arms.[2 weeks postpartum, 5 months postpartum and 12 months postpartum (primary endpoint)] INCLUSION CRITERIA: Native Portuguese speakers or women living in Portugal for at least 5 years; intended pregnancy; primiparous, singleton pregnant women at the gestational age of 28‐30 weeks; aged 18‐40 years; employed; with access to a smartphone; and have had understood and signed the project’s informed consent form. SECONDARY OUTCOME: Child development assessed using the Schedule of Growing Skills II (Bellman et al, 2012).[5 months postpartum and 12 months postpartum] Participants’ mental health literacy assessed using the Mental Health Literacy Scale (O'Connor & Casey, 2015) at the study close‐out.[Baseline (28‐30 weeks gestation) and 12 months postpartum.] Presenteeism assessed using the World Health Organization’s Heath and Work Performance Questionnaire (Kessler et al, 2003) for the three arms.[12 months postpartum] Resilience assessed using the Connor‐Davidson Resilience Scale (Connor & Davidson, 2003).[Baseline (28‐30 weeks gestation), 29‐31 weeks gestation, 2 weeks postpartum, 5 months postpartum and 12 o ths postpartum] Sleep quality determined using app data from a wearable device (sleep analyzer). [Baseline (28‐30 weeks gestation), 29‐31 weeks gestation, 2 weeks postpartum, 5 months postpartum and 12 months postpartum]

Actrn (2022). "Effect of Yoga and Theta Healing on Symptoms of Primary Dysmenorrhea." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Yoga will be applied to Group 1 and Theta Healing® to Group 2 for 6 months with a researcher. Based on researcher training in practitioner yoga and ThetaHealing for Group 1 yoga program designed by researcher, for Group 2 ThetaHealing program designed by researcher, Group 1 will do yoga 2 days a week 40‐45 minutes, live online group classes, low level of intensity designed for healthy people by a researcher. The program has been prepared based on simple pregnancy yoga practices so that everyone can easily apply it. After the program 3. months and 6. months participants will check by questionnaire and scales. Group 2 will do ThetaHealing 2 days a week 15‐30 minutes live online individual interviews. ThetaHealing is a meditation to remove negative emotions. Negative feelings are determined by talking to the participant. Determined negative emotions are tried to be reduced through meditation. After the program 3. months and 6. months participants will check by questionnaire and scales.The researcher will make the intervention. The yoga and ThetaHealing program will be done online 2 days a week for 6 months.[ Online live platform ( live online at participant’s home or any place where the participant can easily perform )] CONDITION: Alternative and Complementary Medicine ‐ Other alternative and complementary medicine Alternative and Complementary Medicine ‐ Spiritual care Primary Dysmenorrhea; ; Primary Dysmenorrhea Reproductive Health and Childbirth ‐ Menstruation and menopause PRIMARY OUTCOME: Primary outcome 1: Evaluation of change in dysmenorrhea with yoga (composite outcome). Dysmenorrhea Affectation Scale (DAC) and Negative Mood Regulation Expectancies Scale (NMR) will be used. [Timepoint: 3rd and 6th months (primary time point) after randomization ] Primary outcome 3: Evaluation of change in dysmenorrhea with ThetaHealing (composite outcome). Dysmenorrhea Affectation Scale (DAC) and Negative Mood Regulation Expectancies Scale (NMR) will be used.[Timepoint: 3rd and 6th months (primary time point) after randomization ] SECONDARY OUTCOME: Nil[Nil] INCLUSION CRITERIA: primary dysmenorrhoea problem among midwifery students at a university's faculty of health sciences

Actrn (2022). "Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention for maternal mental health in the peripartum: a randomised controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: A Mindfulness App will be available to the intervention group. The Mater Parent Lounge app is a perinatal mindfulness‐based app, co‐designed by women with a lived experience of perinatal mental illness, and clinicians with expertise in mindfulness. The content on the app will consist of 40 mindfulness podcasts, tailored to different stages in the pre‐ (second trimester) and post‐partum period (6 months after birth). Women will therefore take part in the study from 16 weeks gestation to 6 months postpartum (approximately 11 months in total, dependent on which gestation week participants' give birth). The content of the app has been co‐designed by a working group of clinicians, peer workers, and consumer advocates (women who have previous lived experiences of perinatal mental health issues). The podcasts brief (5‐10 minute) videos that take women through a range of mindfulness exercises, such as breathing exercises, visualisation, body scanning, guided interaction with baby, guided meditation and other grounding techniques. Acceptability of the content was determined by all members of the co‐design working group over a series of meetings. The app will notify women with suggestions of appropriate (pregnancy‐period specific) podcasts on a regular basis. Women may choose to watch the suggested podcasts, or search for other podcasts when they wish to utilise them. Women will be free to use these podcasts as often as they wish for the study period, and beyond. For the study period, they will be asked to utilise the app a minimum of once a week to determine its benefit. Click analytics will be used to measure the frequency of app use, and to determine which podcasts are the most used. Daily 'mood' data will also be collected from the app using a five point faces scal CONDITION: Mental Health ‐ Anxiety Mental Health ‐ Depression Mental Health ‐ Other mental health disorders Mental Health ‐ Psychosis and personality disorders Mental Health ‐ Schizophrenia Perinatal Mental Health; ; Perinatal Mental Health PRIMARY OUTCOME: Psychological distress (measured using the Edinburgh Postnatal Depression Scale).[Baseline (16 weeks gestation), Time 2 (28 weeks gestation), Time 3 (3 months postpartum), Time 4 (6 months postpartum ‐ primary endpoint).] INCLUSION CRITERIA: Women who are attending either the public or private maternity clinics at Mater Mothers Hospital in South Brisbane with English Proficiency SECONDARY OUTCOME: App satisfaction and feedback ; App satisfaction and participant feedback will be collected in focus group interviews. ; A portion of randomly selected intervention participants will be sent an invitation to participate in a focus group. Approximately 15 women will be recruited for focus group interviews, which will be conducted in groups of 6‐8. They will be facilitated by a member of the research team with experience in qualitative interviewing. ; The interviews will be conducted at the Mater hospital. Women will receive free parking and will be compensated with a $50 voucher for their time. ; Focus group interviews will be semi‐structured (based on an interview question guide), and will be approximately 45 ‐ 60 minutes in length. They will be audiotaped and then de‐identified and transcribed by a professional, third party transcription service. [Focus group interviews will be conducted at the conclusion of the study. ] App utilisation. Click analytics will be used to determine the frequency to which the app was used, and which podcasts were listed to most frequently. [This data will not be collected at a specific timepoint, but will be looked at periodically during the study period by researchers. ] Cost‐efficiency (cost benefits) of the intervention, assessed using Quality‐Adjusted Life Years (QALYs ‐ derived from the PROMIS Global‐10 quality of life survey).[Baseline (16 weeks gestation), Time 2 (28 weeks gestation), Time 3 (3 months postpartum), Time 4 (6 months postpartum).] Mother‐infant bonding (measured using the Mother‐to‐infant bonding sc e).[Time 3 (3 months postpartum), Time 4 (6 months postpartum).] Satisfaction with the mindfulness app, measured using a Satisfaction Survey. This is a study‐ survey developed specifically for the purposes of this research project.[Time 3 (3 months postpartum)]

Actrn (2022). "The Effects of Eurycoma Longifolia Water Extract (Physta®) on Well-Being of Peri and Postmenopausal Women." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: The study is a randomized, double‐blind, placebo‐controlled study 12 weeks study involving middle‐aged women from 45 to 55 years old. The study aim is to determine the effect of Tongkat Ali water extract (Physta®) on overall well‐being of peri and postmenopausal women. Eligible subjects will be selected and randomized into three study groups (A, B or C) to receive one supplement capsule daily, each containing either 50 mg or 100 mg of Tongkat Ali water extract (Physta®) or 280 mg of maltodextrin placebo respectively. Subjects will be required to attend 3 follow up visits (week 0 (baseline), week 6 and week 12) at the study site. Study compliance and adherence to protocol will be monitored by performing capsule counting and with reference to the daily dose diary filled up by the subjects (week 6 and week 12 visits). CONDITION: Alternative and Complementary Medicine ‐ Other alternative and complementary medicine Menopause ;Climacteric symptoms ; ; Menopause ; Climacteric symptoms Reproductive Health and Childbirth ‐ Menstruation and menopause PRIMARY OUTCOME: Energy measured using Chalder Fatigue Scale (CFQ) questionnaire ; [The trial is conducted for 12 weeks of oral administration of Tongkat Ali Physta supplement. ; At 4 timepoints the outcomes will be measured (Week 0 (Baseline), Week 2, Week 6 and Week 12).] Mood state by using Profile of Mood State (POMS) questionnaire; [The trial is conducted for 12 weeks of oral administration of Tongkat Ali Physta supplement. ; At 4 timepoints the outcomes will be measured (Week 0 (Baseline), Week 2, Week 6 and Week 12).] Quality of life by using Menopause‐Specific Quality of Life (MENQOL) questionnaire ; [The trial is conducted for 12 weeks of oral administration of Tongkat Ali Physta supplement. ; At 4 timepoints the outcomes will be measured (Week 0 (Baseline), Week 2, Week 6 and Week 12).] SECONDARY OUTCOME: Effects of the Eurycoma longifolia water extract (Physta®) on female reproductive hormones (estrogen, progesterone, Testosterone, luteinizing hormone (LH) and follicle‐stimulating hormone (FSH)). This is a composite secondary outcome. [For this secondary outcome measures, commercial blood tests will be performed at week 0, week 6 and week 12 to analyse the female reproductive hormones. ] Effects of the Eurycoma longifolia water extract (Physta®) on inflammatory biomarkers & oxidative stress biomarkers. Its a composite secondary outcome to measure the inflammatory biomarkers (iNOS, Cox2) and oxidative stress biomarkers (MDA, LPO). ; [For this secondary outcome measures, blood test will be done at week 0 and week 12. The plasma samples obtained from blood samples will be used to run the ELISA analysis to assess the respective inflammatory biomarkers (iNOS, Cox2) and oxidative stress biomarkers (MDA, LPO) of subjects. ] INCLUSION CRITERIA: a) Women aged 45‐55 years b) Scoring of MENQOL is more than or equal to 61 (higher score indicates the presence of climacteric symptoms) c) Experience aches at muscles, joints, back of the neck and head (Scores “YES” for MENQOL question number 12 or/and 15) d) Experience tiredness, worn out and lack of energy (Score “YES” for MENQOL question number 13 or/and 18) e) In a stable heterosexual relationship for at least 6 months f) BMI 20‐29.9 kg/m2

Actrn (2022). "Enhancing treatment outcomes after gynaecological cancer (ACUMEN For ALL): using telehealth exercise delivery to promote health after cancer therapy." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: The total study period is 24 weeks. It comprises of a 12‐week exercise training intervention and a 12‐week maintenance period. After participant screening and baseline assessment, participants will be randomised to either the intervention or waitlist‐control group. Participants in the delayed intervention control group will complete a 12‐week control period, they will then be eligible for the intervention and the same outcome assessments will be repeated. The telehealth intervention has two components, an exercise component underpinned by a behavioural component. Both will be delivered via video‐link by an accredited exercise physiologist or physiotherapist (AEPP) trained in cancer care. The exercise component is structured over 12 weeks and adheres to Exercise and Sports Science Australia recommendations, including Adult Pre‐Exercise Screening System (APPS form) for risk of adverse event due to exercise. Goals will be prioritised and set, and the prescription co‐designed with the participant, including strategies for longer‐term maintenance. The intervention will adhere to ESSA guidelines: 1. The goal is to enhance neuromuscular strength, endurance, balance, flexibility, and cardiorespiratory fitness. The AEPP will individually tailor exercise to the functional capacity of each participant towards these goals, cognisant of participant restrictions. 2. Up to 3 X60‐minute exercise sessions per week, individually prescribed by an AEPP. The session will aim for an aerobic component (up to 40 minutes moderate‐to‐vigorous intensity based on a percentage range of age‐predicted heart rate maximum) such as jogging ‐on‐the‐spot or fast walking and resistance component (2 X8‐12+ repetitions of major muscle group exercises at >6‐10 on the OMNI percei CONDITION: Cancer ‐ Cervical (cervix) Cancer ‐ Other cancer types Cancer ‐ Ovarian and primary peritoneal Cancer ‐ Womb (Uterine or endometrial cancer) Gynaecological cancer; ; Gynaecological cancer PRIMARY OUTCOME: Feasibility of the exercise intervention delivered via video technology will be assessed as a composite outcome determined by percentage of patients who register interest and are recruited into the study via audit of study screening and enrolment logs.; Attendance at the scheduled exercise sessions will be recorded by the AEPP via intervention session sheets, capturing the participant attendance for each of the 36 planned sessions. ; Adherence and compliance with the exercise prescription (measured by heart rate monitoring and perceived exertion) will be recorded by the AEPP via intervention session sheets, capturing the participant heart‐rate response, perceived exertion rating, load and repetitions of every exercise for each of the 36 planned sessions. [Cumulative data will be assessed at the conclusion of the study.; ] Safety will be measured by data collected on adverse events.; Number, type and severity of adverse events reported. Participants will be advised that they should report any spontaneous adverse events that may occur during the study, and will be provided with contact details for reporting. AEPP will monitor and report adverse events during the intervention period, and participants will be regularly contacted during trial for monitoring of adverse events.; [Any adverse events that occur throughout the 24 weeks of the study will be recorded in the study adverse event log for cumulative review at the conclusion of the study.] SECONDARY OUTCOME: Adherence will be measured as the percentage of the prescription completed during these sessions, divided into modalities. Adherence and compliance with the exercise session will also be assessed through remote heart rate monitoring via a fitbit device. The number of non‐supervised home‐based sessions completed will also be recorded. Reasons for non‐adherence will also be captured. [Cumulative data will be assessed at the conclusion of the study.] Aerobic fitness (6 minute walk test) will assess the participant’s exercise capacity.[Baseline, week 1 and week 24.] Attendance will be measured as the number of video‐supervised sessions attended. The number of video‐supervised sessions attended by will be recorded via intervention session sheets completed for each individual session.[Cumulative data will be assessed at the conclusion of the study.] Balance (assessed via centre of pressure displacement techniques).[Baseline, week 12, and week 24.] Body composition measured via waist‐hip ratio with a measuring tape according to WHO STEPwise Approach to Surveillance (STEPS) protocol for consistent measurement. [Baseline, week 12, and week 24.] Duration of physical activity levels as assessed by the Fitbit watch.[Baseline, week 12, and week 24.] Dynamic lower body muscle strength (timed repetition test).[Baseline, week 12, and week 24.] Dynamic upper body muscle strength (timed repetition test).[Baseline, week 12, and week 24.] Exercise self‐efficacy as measured by the Exercise Self‐efficacy Scale (ESES)[Baseline (pre‐intervention), week 12 (end of intervention) and week 24 (longer‐term maintenance).] Frequency of physical activity levels as assessed by the Fitbit watch.[Baseline, week 12, and week 24.] Intensity of physical activity levels as assessed by the Fitbit watch.[Baseline, week 12, and week 24.] Participants perceived benefits and barriers to exercise as measured by the Exercise Benefits / Barriers Scale (EBBS).[Baseline, week 12, and week 24.] The mean difference on the mental component summary (MCS) scores of health‐related quality of life between intervention and control in this trial, as measured by the SF36.[Baseline, week 12, and week 24.] The mean difference on the physical component summary (PCS) scores of health‐related quality of life between intervention and control in this trial, as measured by the Short Form‐36 (SF36).[Baseline, week 12, and week 24.] The telehealth intervention will be assessed for its acceptability, appropriateness, and feasibility as a composite to determine the implementation potential of telehealth video collected via Acceptability, Appropriateness and Feasibility of Intervention Measures (AFFIMs) questionnaire. The AAFIMs collectively assess the factors that indicate implementation potential to patients, clinicians and organisational decision‐makers. Each measure contains four items that assess the extent to which respondents consider an intervention or implementation strategy is acceptable, appropriate, and feasible. Higher scores indicate greater acceptability, appropriateness, and feasibility. As a suite, the measures have confirmed validity and reliability.[Completed by AEPP and participant at the conclusion of the final intervention session.] INCLUSION CRITERIA: 1. Women aged 18 years or older diagnosed with cancer of the ovary, cervix, Fallopian tubes, placenta, endometrium, vagina or vulva in the previous 60 months, including early, recurrent, advanced or metastatic cancer. 2. > 1 month since end of intensive cancer treatment (including surgery, radiotherapy, chemotherapy). Supportive therapies such as bisphosphonate, pain medication and hormone replacement allowable. 3. Resident in Australia. 4. Have access to the internet. 5. Own, or have access to, a computer or mobile device. 6. Willing and able to comply with all study requirements, including intervention, timing and nature of required assessments. 7. Able to speak and read in English to ensure consent is informed and documentation of participant‐reported outcome measures can be adhered to. 8. Can provide voluntary written informed consent. 9. Unable or unwilling to attend face‐to‐face exercise training and objective outcome assessment

Actrn (2022). "High-Intensity Functional Training for Polycystic Ovary Syndrome." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group 1 ‐ High‐intensity functional training (HIFT) The HIFT intervention will be supervised by a certified fitness professional. HIFT will include both “cardio” or “resistance” sessions. The cardio sessions include body weight and dynamic movements which target the aerobic and anaerobic energy systems. The resistance sessions use weighted functional movement patterns to target muscle mass, strength, and power. Both the cardio and resistance sessions last a total of 45 minutes. Participants will initially be prescribed one exercise session per week (aerobic session) in week 1, two exercise sessions per week (1 aerobic sessions and 1 resistance session) in week 2. From week 3, participants will be asked to attend three HIFT (2 aerobic sessions and 1 resistance session) classes per week. Location where intervention will be delivered: F45® Bulli or Corrimal, Mode of delivery: the exercise sessions will be delivered in groups of no more than 30 people per class. Duration of intervention: 12 weeks. Intensity of duration: participants will be asked to work out at an intensity equivalent to 13‐17 RPE during the active exercise period. Examples of exercises prescribed as part of the intervention: squats (bodyweight and weighted back squats), deadlift, push‐press, medicine ball throws, skipping (including double‐unders) and more. Adherence: Adherence will be monitored through session attendance checklists and HR will be recorded by a HR monitor. Group 2 ‐ Physical Activity Guidelines (PAG) Participants in PAG will be prescribed an exercise program that is consistent with current Australian physical activity guidelines for 12 weeks. This includes instruction to undertake 150 min of moderate‐intensity or 75 min of vigorous‐intensity aerobic exer CONDITION: Reproductive Health and Childbirth ‐ Other reproductive health and childbirth disorders Metabolic and Endocrine ‐ Other endocrine disorders Polycystic Ovary Syndrome; ; Polycystic Ovary Syndrome PRIMARY OUTCOME: Cardiorespiratory fitness assessed via graded exercise test and gas analysis.[Assessed at baseline and at 13 weeks post‐intervention commencement. ] Muscle endurance via maximal repetitions to failure at 70% 1RM for the bench press and back squat exercises.[Assessed at baseline and at 13 weeks post‐intervention commencement. ] Muscular strength assessed via one repetition maximum of chest press and leg press exercises.[Assessed at baseline and at 13 weeks post‐intervention commencement. ] INCLUSION CRITERIA: To participate in this study, participants must: • be between the ages of 18‐40 years; • have a diagnosis of polycystic ovary syndrome (PCOS) as per Rotterdam 2003 criteria; • be physically inactive (undertaking < 150 minutes of exercise per week or exercising < 3 days per week); • have overweight or obesity (BMI between 25 to 40 kg/m2); • able to attend three training sessions per week at F45® Bulli or Corrimal for 12 weeks; • ability to read and communicate in the English language. SECONDARY OUTCOME: Insulin sensitivity measured via homeostatic model of insulin resistance (HOMA‐IR) and oral glucose tolerance test.[Assessed at baseline and at 13 weeks post‐intervention commencement. ] Body composition (fat mass, lean mass, body fat %) will be assessed using dual x‐ray absorptiometry. [Assessed at baseline and at 13 weeks post‐intervention commencement. ] Anthropometry (body mass, height, waist circumference, hip circumference)[Assessed at baseline and at 13 weeks post‐intervention commencement. ] Arterial stiffness measured via pulse wave velocity assessment.[Assessed at baseline and at 13 weeks post‐intervention commencement. ] Blood biochemistry: serum glucose, insulin, lipids, inflammatory markers, and liver enzymes[Assessed at baseline and at 13 weeks post‐intervention commencement. ] Physical activity enjoyment scale (PACES Questionnaire) [Assessed at baseline and at 13 weeks post‐intervention commencement. ] Quality of life via 36‐Item Short Form Health Survey (SF36) and Mo fied Polycystic Ovary Syndrome Health‐Related Quality of Life Questionnaire (MPCOSQ)[Assessed at baseline and at 13 weeks post‐intervention commencement. ]

Actrn (2022). "The impact of electromyographic (EMG)-biofeedback assisted training on the function of the pelvic floor muscles in women after vaginal and cesarean delivery." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Before starting the research, all participants will be assessed: strength and endurance of the pelvic floor muscles with the help of palpation, EMG and perineometer, bladder diary, UDI‐6 and IIQ‐7 questionnaire, SES Self‐assessment scale, changes in KHQ quality of life indicators and Questionnaire of the Quality of Women's Sexual Life. Randomized controlled trials will be carried out on a group of not less than 100 patients aged 25‐35 years, after the first vaginal delivery or after the first caesarean section, which will be randomly divided into groups: Arm 1: Vaginal delivery Bebo® group A group of women after vaginal delivery underwent a 6‐week, each session according to the Bebo® concept runs for one hour . The training is conducted individually, by a qualified therapist, twice a week. We will monitor attendance using the attendance list. The Bebo® concept ‐ is based on five exercise groups, which are: awareness exercises, mobilization exercises, strengthening exercises, relaxation exercises, and the integration of pelvic floor muscles in everyday activities. Each group of exercises will last approximately 10 minutes. Arm 2: Vaginal delivery Bebo®+ EMG group A group of women after vaginal delivery underwent a 6‐week, each session according to the Bebo® concept runs for one hour , supported by a 10‐minute EMG‐biofeedback training. The training is conducted individually, by a qualified therapist, twice a week. The group, apart from exercises according to the Bebo® concept, will perform a 10‐minute EMG‐biofeedback training. Its aim will be to obtain conscious tension of the pelvic floor muscles with a strength corresponding to 20, 50, 80% of the previously measured maximum contraction and to maintain the tension at th CONDITION: Caesarean section;Urinary incontinence;Pelvic floor dysfunction; ; Caesarean section ; Urinary incontinence ; Pelvic floor dysfunction Reproductive Health and Childbirth ‐ Childbirth and postnatal care PRIMARY OUTCOME: A perineometer is a device used to measure the resting tension [cmH2O], the maximum voluntary force of contraction [cmH2O] and the strength of the pelvic floor muscles [s]. The examined person places the probe into the vagina to a depth of 3.5 cm. The subject is asked to perform 3 contractions and hold them for 5 seconds, the pause between each contraction was 30 seconds.[The procedure will be performed at the start of the tests and after 6 weeks.] EMG‐test. The EMG is used to assess the function of the pelvic floor muscles. The test will be carried out using surface and vaginal electrodes. The first electrode will be placed on the lower abdomen and the second will be mounted on the vaginal probe. The test will be performed according to a protocol consisting of 5 activities:; 1.60‐second rest (before starting the test ‐ divided into 3 intervals: I‐5s, II‐5s, III‐50s).; 2. Five 2‐second phase contractions (fast movements), with a 10‐second interval in between.; 3. Five 10‐second tonic contractions, with a 10‐second rest in between.; 4. One 60‐second strength contraction.; 5.60‐second rest (after exercise).[The procedure will be performed at the start of the tests and after 6 weeks.] Muscle strength assessed by palpation. The examination consists in inserting the index finger into the vagina, after disinfecting the hands, wearing disposable gloves and applying the gel, as well as observing the perineum area. The strength of the pelvic floor muscles during vaginal palpation will be assessed according to the PERFECT scheme.[The procedure will be performed at the start of the tests and after 6 weeks.] INCLUSION CRITERIA: primipara single pregnancy proper course of pregnancy 6‐8 weeks after vaginal delivery or cesarean delivery correct body weight consent to participate in free research SECONDARY OUTCOME: Self‐assessment of the respondents on the basis of the SES Self‐Evaluation Scale by M. Rosenberg. This tool evaluates your self‐esteem.[The procedure will be performed at the start of the tests and after weeks.] Assessment of toilet habits and fluid intake using the bladder diary. The bladder diary was designed specifically for this study.[The procedure will be performed at the start of the tests and after 6 weeks. ; Each patient will be asked to complete the diary for 3 days at the start of the study and after 6 weeks. ] Assessment of the impact of urinary incontinence on daily activity using the Incontinence Impact Questionnaire, Short Form (IIQ‐7) [The procedure will be performed at the start of the tests and after 6 weeks.] Symptoms of urinary incontinence using the Urinary Distress Inventory, Short Form (UDI‐6)[The procedure will be performed at the start of the tests and after 6 weeks.] The quality of sexual life based on the Sexual Quality of Life Questionnaire Female‐ (SQoL‐F)[The procedure will be performed at the start of the tests and after 6 weeks.] Quality of life using the King's Health Questionnaire (KHQ questionnaire)[The procedure will be performed at the start of the tests and after 6 weeks.] a medical certificate confirming that there are no contraindications to participate in the research

Actrn (2022). "Partner Cohort Treatment Study (PACT study) for bacterial vaginosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: The PACT study is a partner‐treatment study for monogamous couples who are in the LGBTQIA+ community, where one person has a vagina and is diagnosed with bacterial vaginosis (BV) and their partner, regardless of their genitals or their gender identity (excluding cisgender‐men). All couple will receive treatment, as outlined below. Initially, participants will be asked if they have any allergies or contraindications prior to determination of their treatment. Couples will be treated with the same regimen in most cases (with some exceptions, see below). If both partners have a vagina and can tolerate both first‐line medications: both will be randomised to one of two treatment groups: Group 1: Both receive oral metronidazole 400mg twice daily for 7 days Group 2: Both receive combination of oral metronidazole 400mg twice daily for 7 days AND clindamycin 2% cream intravaginally once a day at night for 7 nights If one or both partners cannot tolerate oral metronidazole or topical clindamycin cream, they will both receive treatment with the regimen that one/both can tolerate (i.e. both will receive oral metronidazole 400mg twice daily for 7 days, or both will receive topical clindamycin cream intravaginally once daily at night for 7 nights). Couples will be excluded from the primary analysis and not form part of the main evaluation group in the following circumstances: • Partner with a vagina who does not have BV and declines treatment; The couples will still be followed for 9 weeks and asked to self‐collect specimens and complete questionnaires. This sub‐group will be able to access treatment at a later time point if they request it. • Partner with a penis; The participant will receive oral metronidazole 400mg twice daily and t CONDITION: bacterial vaginosis; ; bacterial vaginosis Infection ‐ Other infectious diseases Renal and Urogenital ‐ Other renal and urogenital disorders Reproductive Health and Childbirth ‐ Other reproductive health and childbirth disorders PRIMARY OUTCOME: Establish the effect of both treatment strategies on the genital microbiota of couples using genomic sequencing of genital swabs.[This will be assessed at baseline, and day 8 as well as weekly for 9 weeks post‐treatment commencement. All specimens will be included.] The acceptability, tolerability and adherence to concurrent partner treatment (whole population) as a composite outcome.; Adherence and tolerability will be assessed by audit of participant questionnaire designed specifically for this study and to be filled‐out the day after treatment is expected to be completed (i.e. day 8). Acceptability will be assessed by audit of participation in the trial by partners of an index with bacterial vaginosis diagnosed ‐ i.e. proportion of index BV participants whose partners received treatment.; [Adherence tolerability and acceptability will be assessed at day 8 post‐intervention commencement] SECONDARY OUTCOME: 1) BV recurrence within 9 weeks of treatment in all study groups/populations. This will be assessed using vaginal smears provided each week by participants, which will undergo Nugent scoring by an experienced microscopist. Two sequential Nugent scores of 7‐10 will indicate BV. [Recurrence will be assessed weekly for 9 weeks post‐treatment commencement] 2) BV recurrence within 4 weeks of treatment in all study groups/populations. ; BV will be assessed using vaginal smears provided each week by participants, which will undergo Nugent scoring by an experienced microscopist. Two sequential Nugent scores of 7‐10 will indicate BV. [Recurrence will be assessed weekly for 4 weeks post‐treatment commencement] 3) BV recurrence within 9 weeks of treatment assessed separately (stratified) according to treatment regimen (Arm 1 and 2) ; BV will be assessed using vaginal smears provided each week by participants, which will undergo Nugent scoring by an experienced microscopist. Two sequential Nugent scores of 7‐10 will indicate BV. The two treatment arms will not be able to be directly compared but the fi ings will be used to generate recurrence rates and confidence intervals by treatment arm.[Recurrence will be assessed weekly for 9 weeks post‐treatment commencement] 4) The acceptability, tolerability and adherence will be assessed as a composite secondary outcome. The findings will be stratified by the two different treatment regimens in the principal study population (Arm 1 and 2). ; Adherence and tolerability will be assessed by audit of participant questionnaire administered the day after treatment is expected to be completed (i.e. day 8) ‐ this questionnaire has been designed for this study. ; ; Acceptability will be assessed by audit of participation in the trial by partners of an inde Xwith bacterial vaginosis diagnosed (e.g. proportion of inde XBV participants whose partners also received treatment). These data will be separately assessed according to treatment arm.[Adherence tolerability and acceptability will be assessed at day 8 post‐intervention commencement] 5) The effect of treatment on the genital microbiome of couples over 9 weeks, assessed by (stratified) the two different treatment regimens in the principal study population (Arm 1 and 2), using genomic sequencing of genital swabs. This outcome may not be statistically powered to directly compare the two arms, however the results will be separately analysed.[This will be assessed at baseline, and day 8 as well as weekly for 9 weeks post‐treatment commencement. All specimens will be included.] 6) The effect of concurrent partner treatment on the oral microbiome of couples over 9 weeks (including oral specimens from both the inde Xwith BV at enrolment and partner), using genomic sequencing of saliva samples. [This will be assessed at baseline, and day 8 as well as weekly for 9 weeks post‐treatment commencement. All oral specimens will be included.] 7) The effect of concurrent partner treatment on the gut microbiome of couples over 9 weeks (including specimens from both the inde Xwith BV at enrolment and partner), using genomic sequencing of rectal swabs. [This will be assessed at baseline, and day 8 as well as weekly for 9 weeks post‐treatment commencement. All rectal swab specimens will be included.] INCLUSION CRITERIA: Inde Xparticipants will be eligible if they are: i) Are diagnosed with BV ii) Aged 18 years to pre‐menopausal (i.e. not more than 12 consecutive months after the last menstrual period/menopause) iii) Have an partner who meets the study criteria iv) Sufficient English to understand study procedures v) Provide written informed consent and is willing to comply with study procedures vi) Able to complete study protocol requirements The partner will be eligible if they: i) Have an partner (the index) who has been diagnosed with BV (they do not need to have a BV diagnosis as well) ii) Are aged 18 years or older iii) For partners of an inde Xwho attended clinic: enrol within 3 business days of their partner being diagnosed with BV (or the inde Xagrees to waits before starting treatment so that couples are aligned with therapy) iv) For partners at home: return baseline procedures/screening packs to determine BV‐status if appli

Actrn (2022). "ROBOTIC PELVIC SURGERY (ROPES) I: robotic Extended Resection for Locally Advanced and Recurrent Pelvic Malignancy: an IDEAL 2B Prospective Study to Design a Phase III Randomised Controlled Trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: This IDEAL 2B observational study will assess the current use of robotic assisted extended resection for locally advanced and recurrent pelvic malignancies. Patients being considered for a robotic approach with locally advanced or recurrent pelvic malignancy will be included in the study. This study is observational and so it will not change which treatment the patient receives. INDICATION: Locally advanced or recurrent pelvic cancer requiring extended resection PRIMARY OBJECTIVES: To determine the current case volume and current patient selection criteria of robotic assisted surgery for locally advanced or recurrent pelvic malignancy in expert centres. SECONDARY OBJECTIVES: 1. To obtain pilot outcome data including clinical, pathological and patient reported outcome measures (PROMS). 2. To assess feasibility and plan a future prospective phase III randomised controlled trial of robotic versus non robotic extended resection in locally advanced or recurrent pelvic cancer. TRIAL DESIGN: Observational IDEAL 2B prospective study OBSERVATIONAL STUDY ARMS: Cases: Robotic extended resection for locally advanced or recurrent pelvic malignancy Controls: Non‐robotic extended resection for locally advanced or recurrent pelvic malignancy For participants there will be no change to their treatment. Their data will be collected from medical records. They will be invited to participate in PROMS questionnaires at: 1. 7 days post operatively 2. 3 months 3. 6 months 4. One year Measures used will take approximately 30 minutes at each time point: Generic Measures: • EORTC QLQC30‐ This is a questionnaire specifically designed to assess the QOL of cancer patients. • QOR15‐ Quality of Recovery ‐ T CONDITION: Cancer ‐ Bladder Cancer ‐ Bowel ‐ Anal Cancer ‐ Bowel ‐ Back passage (rectum) or large bowel (colon) Cancer ‐ Cervical (cervix) Cancer ‐ Neuroendocrine tumour (NET) Cancer ‐ Prostate Cancer ‐ Sarcoma (also see 'Bone') ‐ soft tissue Cancer ‐ Womb (Uterine or endometrial cancer) Locally advanced pelvic malignancy;Recurrent pelvic malignancy; ; Locally advanced pelvic malignancy ; Recurrent pelvic malignancy PRIMARY OUTCOME: ; ; To determine the current case volume of robotic assisted surgery for locally advanced or recurrent pelvic malignancy in expert centres. This will be assessed by a study specific questionnaire and data will be entered onto redcap at participating sites. [This primary timepoint will be at the time of selection for surgery, i.e. at initial enrolment into the study. ] To determine current patient selection criteria of robotic assisted surgery for locally advanced or recurrent pelvic malignancy in expert centres. ; ; The surgical team will enter data on redcap based on a patient selection for robotic surgery questionnaire designed specifically for the study. [for the primary end point, it will be assessed at time of selection for surgery; ] ; ] QOR15‐ Quality of Recovery[7 days, 3 months, 6 months and 1 year post operatively ] INCLUSION CRITERIA: 1. Patients with locally advanced or recurrent pelvic malignancy requiring extended resection 2. Patients in expert centres where a robotic approach is offered to selected cases with locally advanced or recurrent pelvic malignancy SECONDARY OUTCOME: Abdominal wall integrity assessed clinically and radiologically at one year at outpatient visit and reviewing routine postoperative surveillance CT's for evidence of hernia ‐ site and symptomatic status will be recorded [1 year ] clinical ‐ length of stay (days) using data linkage to medical records[Measured on discharge from hospital ] Clinical outcome‐ estimated blood loss ‐ measured in mls from operative note [This will be recorded on the day of surgery at the end of the case using the operative details proforma.] clinical‐ pain score ‐ verbal numeric rating scale [day 1 and day 7 post operatively ] complications‐ scored using Clavien dindo system [30 days post‐operatively ] Disease free survival ‐ survival and recurrence will be recorded at 1 year post oper ively using data linkage to medical records[1 year ] EORTC QRQC30 will be used as a disease specific quality of life metric and administered as a questionnaire to patients [day 7, 3 months, 6 months and one year post operatively ] European Quality of Life‐5 Dimensions Questionnaire‐ EQ5D will be used to assess quality of life ‐ this metric can be used for health economic analysis [7 days/ 3 months/6 months/ 1 year post operatively ] Pathological Factors ‐ R0 resection and nodes using data linkage to medical records reviewing the pathology report and the operative note [at 30 days postoperatively ] Patient reported outcome measures ‐ EORTC QLQC30[7 days post operatively, 3 months, 6 months and One year

Actrn (2022). "TELE-CONNECT: telehealth Exercise for Continence After Gynaecological Cancer Treatment." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Pelvic floor muscle training (PFMT) + home exercise program + non‐exercise components. Pelvic floor muscle training (PFMT) intervention: 'What' The intervention: 8 x 30‐60 minute telehealth sessions over 16 weeks (e.g. at 1, 2, 4, 6, 8, 10, 13 & 16 weeks). The initial consultation will be 60 minutes, consultations 2 ‐ 7 will be 30 minutes and consultation 8 will be 45 minutes in order to provide all elements of the intervention at the appropriate time. 'Who' The provider: Physiotherapist with postgraduate training in pelvic floor physiotherapy. Per‐protocol study training: detailed study manual and training in study processes and procedures, designed specifically for this study, including: pelvic floor muscle (PFM) assessment and exercise instruction processes; instructions for teaching use of the biofeedback device (device name: 'femfit®'); biofeedback data export; practice video‐consultations to practice video‐consultation skills. In the 8 weeks before the first participant is enrolled, physiotherapists will undergo protocol training, using live face to face and online training, supplemented by supply of all required resources and standard operating protocols. During the study: regular meetings with the research team to review per‐protocol procedures to ensure adherence to standardised training protocols. 'How' Group or individual: Individual telehealth‐delivered instruction in PFMT. The woman will receive the telehealth and home exercise program in her home. The femfit’s® pre‐determined, starting level and exercise program will be used. The starting level may be modified and additional tailoring to each woman may also be recommended by the treating study physiotherapist based on assessment findings. Supervision: Individually‐supervise CONDITION: Cancer ‐ Cervical (cervix) Urinary incontinence;gynaecological cancer;Faecal incontinence; ; Urinary incontinence ; gynaecological cancer ; Faecal incontinence Cancer ‐ Womb (Uterine or endometrial cancer) Cancer ‐ Ovarian and primary peritoneal PRIMARY OUTCOME: Impact of urinary incontinence: the International Consultation on Incontinence ‐ Urinary Incontinence Short Form (ICIQ‐UI SF)[Baseline, and 17 (primary end‐point) and 52 weeks post‐randomisation] ; To estimate costs of pad use for incontinence we will collect details of ; ‐ disposable pads including brand name, cost and average number used via Table 1 of the Dowell Bryant Incontinence Cost Patients Index (DBICI) ; ‐ reusable incontinence underwear including brand and cost.[Baseline, 17 and 52 weeks post‐randomisation] Laundry associated with incontinence ; Collected from participants using a modified version of Table 3 of the DBICI [Baseline, 17 and 52 weeks post‐randomisation] Cost of physiotherapist’s time (intervention group only) ; The cost of physiotherapy services provided to each participant will be calculated. [17 weeks post‐randomisation (intervention group only)] Work productivity ; Information about paid employment or self‐employed, leave and job performance will be collected from participants via a custom‐built questionnaire[Baseline, 17 and 52 weeks post‐randomisation.] Cost of resources (intervention group only). SECONDARY OUTCOME: Number of leakage episodes: collected by the participant in a custom‐developed 7‐day Accident Diary. [Baseline, 17 and 52 weeks post‐randomisation] Time spent (days, hours, minutes) on vigorous physical activities in the past 7 days: International Physical Activity Questionnaire Short form last 7 days Self‐Administered Format.[Baseline, 17 and 52 weeks post‐randomisation] Bother of pelvic floor symptoms including stress urinary incontinence, urinary urgency and frequency, urge incontinence, dysuria, pelvic organ prolapse, obstructed defecation, faecal incontinence, and dyspareunia: Pelvic Floor Bother Questionnaire (PFBQ)[Baseline, 17 and 52 weeks post‐randomisation] Impact of any type of urinary incontinence on quality of life: International Consultation on Incontinence Questionnaire Lower rinary Tract Symptoms Quality of Life (ICIQ‐LUTSqol)[Baseline, and 17 and 52 weeks post‐randomisation] Cost of pads for bladder leakage. ; The cost of intervention resources provided to each intervention group participant will be calculated by the research team. Resources include the biofeedback devices and package of participant resources.[17 weeks post‐randomisation (intervention group only) ; ] Acceptance and use of technology: self‐reported custom‐built questionnaire modified from the Unified theory of acceptance and use of technology (UTAUT‐II) model[Baseline and 17 weeks post‐randomisation] Number of continence pads used: collected by the participant in a custom‐developed 7‐day Accident Diary. [Baseline, 17 and 52 weeks post‐randomisation] Self‐reported health‐related quality of life: EQ‐5D‐5L[Baseline, 17 and 52 weeks post‐randomisation] Health service use related to urinary incontinence ; Health professional appointments, surgeries, investigations, and medications relating to urinary incontinence will be collected from participants using Section 2 of the DBICI [Baseline, 17 and 52 weeks post‐randomisation] Time spent (days, hours, minutes) on moderate activities in the past 7 days: International Physical Activity Questionnaire Short form last 7 days Self‐Administered Format.[Baseline, 17 and 52 weeks post‐randomisation] Patient Global Impression of Change (PGIC) Global Rating of Change Scale: self‐reported in response to “Compared to your first assessment in this study (when you completed your baseline information 17 weeks ago) overall, how would you rate your bladder control now?"[17 and 52 weeks post‐randomisation] Time spent (days, hours, minutes) walking in the past 7 days: International Physical Activity Questionnaire Short form last 7 days Self‐Administered Format.[Baseline, 17 and 52 weeks post‐randomisation] Time spent (days, hours, minutes) sitting in the past 7 days: International Physical Activity Questionnaire Short form last 7 days Self‐Administered Format.[Baseline, 17 and 52 weeks post‐randomisation] INCLUSION CRITERIA: Women aged 18 years or more; following cancer treatment (with or without radiotherapy) for Stage I, II or III uterine, cervical or ovarian cancer or borderline ovarian tumour; have the ability to speak and read English sufficiently for purposes of the study; have primary cancer treatment completed at least 6 months ago; have self‐reported urinary incontinence (at least 1 episode per week for last 4 weeks); have received no physiotherapy‐supervised pelvic floor treatment for urinary incontinence since commencing cancer treatment; and have a home internet connection and a smartphone.

Actrn (2023). "An anchor in the storm: the effectiveness of a flexible perspective-taking intervention in supporting the transition to motherhood." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Mothers in the intervention group will be given access to online resources specifically designed for use in this study: (i) a brief web‐based informational video (approx. 7 mins) that begins with a psychoeducation component on flexible perspective taking (self‐as‐context, a component of Acceptance and Commitment Therapy [ACT]) and relevance to mothers of infants (from birth to 23 months), drawing on ACT methaphors for enhancing a transcndent sense of self; (ii) an audio‐guided experiential exercise on flexible perspective taking tailored to pregnant and new mothers (approx. 9 mins), which women will be encouraged to listen to and use to guide their own meditation practice; and (iii) a simple tip sheet (designed specifically for this study) summarising key points that will be made available to participants to download and print. Resource use will be monitored using website analytics. Particpants will have access to the resources for the full duration of the study and extending to 12 months from the time of enrolment. CONDITION: Mental Health ‐ Anxiety Mental Health ‐ Depression Mental Health ‐ Other mental health disorders Mental health among mothers of infants;Alcohol use in pregnancy; ; Mental health among mothers of infants ; Alcohol use in pregnancy Reproductive Health and Childbirth ‐ Childbirth and postnatal care PRIMARY OUTCOME: Anxiety symptoms, as measured using the Depression Anxiety Stress Scales[6 weeks and 4 months post expected date of delivery] Depressive symptoms, as measured using the Depression Anxiety Stress Scales[6 weeks and 4 months post expected date of delivery] Post‐traumatic stress symptoms, as measured using the Impact of Event Scale ‐ Revised[6 weeks and 4 months post expected date of delivery] SECONDARY OUTCOME: Acceptability of the intervention, as indicated by a series of items (Likert scales, open‐ended questions) developed for use in this study[6 weeks post expected date of delivery] Alcohol consumption as assessed using the Alcohol Use and Disorders Identification Test (AUDIT‐C)[6 weeks and 4 months post expected date of delivery] Birth satisfaction, as measured using the Perception of Labour and Delivery Scale[6 weeks post expected date of delivery] Breastfeeding satisfaction, as measured using the Maternal Breastfeeding Evaluation Scale[6 weeks and 4 months post expected date of delivery] Emotional availability, as assessed on the Emotional Availability ‐ Self‐Report[4 months post expected date of delivery] Feasibility of the intervention, as indicated by rate of participant recruitment and particpant retention (assessed via data from participant tracking database)[At study completion] Psychological flexibility, as measured using the CompACT[6 weeks and 4 months post expected date of delivery] Self‐as‐context, as measured using the Self‐As‐Context Scale[6 weeks and 4 months post expected date of delivery] Stress symptoms, as measured using the Depression Anxiety Stress Scales[6 weeks and 4 months post expected date of delivery] INCLUSION CRITERIA: Participants will be women aged 18 years and over, who are currently at least 20 weeks pregnant, and living in Australia or New Zealand.

Actrn (2023). "The Bugs & Bumps study: the effect of a smartphone app on diet quality in pregnancy to support maternal and child mental health-related outcomes." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Starting from week 26 of pregnancy until birth, women in the intervention group will receive a 10‐week gut health‐focused, smartphone‐delivered, prenatal dietary program (Bugs & Bumps). The Bugs & Bumps dietary intervention app delivers eight simple dietary education topics, encompassing 120 short Instagram‐style videos, over a total of 57:53 minutes. Each video is very brief (< 1 minute) and can be stopped and started at any time. Women are asked to use the app from week 26 of pregnancy through to when their babies are born. Participants will watch the videos at their own pace, and set their first goal within the first week of the program. The eight topics are: 1. Introduction to the app, 2. Food Safety, 3. What you eat (what your diet is made up of), 4. Education about eating for health and wellbeing, 5. Education about what your gut bugs do, 6. Eating for your gut bugs ‐ dietary advice based on the Australian Dietary Guidelines (ADG), 7. Activities for how to plate up meals and supercharge them with specific ingredients, and 8. Goal setting. The dietary advice in topic 6 is focused on ‘eating for their gut bugs’, which involves adhering to the ADG and increasing intakes of prebiotic foods and common fermented foods. The program capitalises on app‐based features that deliver with behaviour setting techniques such as: ‐ Goal setting and monitoring; ‐ Links to question / answer style content to address barriers and enablers to change; ‐ Automated dietary monitoring (i.e., completing the Short Diet Questionnaire tool) and feedback. Feedback is based on the scores from the dietary questionnaire. to help improve their diet qualty, This feedback was designed by two Accredited Practicing Dietitians and the study investigator. ‐ Demonstrati CONDITION: Diet and Nutrition ‐ Other diet and nutrition disorders Inflammatory and Immune System ‐ Normal development and function of the immune system Mental Health ‐ Anxiety Mental Health ‐ Depression Mental Health ‐ Studies of normal psychology, cognitive function and behaviour Oral and Gastrointestinal ‐ Normal oral and gastrointestinal development and function Poor prenatal diet quality;Poorer prenatal mental wellbeing;Disturbances in the prenatal vaginal microbiome;Disturbances in the maternal gut microbiome;Elevated inflammatory markers in pregnancy;Elevated child emotional behaviour problems;Developmental trajectory of the infant gut microbiome;Elevated inflammatory markers in infancy;Poorer child neurocognition;Poorer child temperament;Elevated respiratory health problems;Elevated allergies;Poorer pregnancy outcomes;Poorer infant diet quality; ; Poor prenatal diet quality ; Poorer prenatal mental wellbeing ; Disturbances in the prenatal vaginal microbiome ; Disturbances in the maternal gut microbiome ; Elevated inflammatory markers in pregnancy ; Elevated child emotional behaviour problems ; Developmental trajectory of the infant gut microbiome ; Elevated inflammatory markers in infancy ; Poorer child neurocognition ; Poorer child temperament ; Elevated respiratory health problems ; Elevated allergies ; Poorer pregnancy outcomes ; Poorer infant diet quality Reproductive Health and Childbirth ‐ Normal pregnancy SECONDARY OUTCOME: Between‐group change from baseline in butyrate producing capacity of maternal stool samples measured using metagenomic sequencing.[ 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group change from baseline in Lachnospiraceae in maternal stool samples measured using metagenomic sequencing.[ 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group change from baseline in P. copri in maternal stool samples measured using metagenomic sequencing.[ 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group change from baseline in Ruminococcaceae in maternal stool samples measured using metagenomic sequencing.[ 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group change from baseline in the alpha diversity of maternal stool samples measured u ng metagenomic sequencing.[ 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group change from baseline in the beta diversity of maternal stool samples measured in stool using metagenomic sequencing.[ 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group change from baseline in the differentially abundant taxa of maternal stool samples measured using metagenomic sequencing.[ 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group change from baseline over time in maternal anxiety symptoms using scores on the Edinburgh Postnatal Depression Scale[ 5 weeks post‐intervention (31 weeks gestation) ; 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group change from baseline over time in maternal depression symptoms using scores on the Edinburgh Postnatal Depression Scale[ 5 weeks post‐intervention (31 weeks gestation) ; 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group change from baseline over time in maternal dietary intake of discretionary foods as measured using the SDQ‐gut dietary questionnaire[ 5 weeks post‐intervention (31 weeks gestation) ; 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group change from baseline over time in maternal dietary intake of fermented food intakes as measured using the SDQ‐gut dietary questionnaire[ 5 weeks post‐intervention (31 weeks gestation) ; 10‐weeks post‐intervention (36‐weeks gestation) ; ] Between‐group change from baseline over time in maternal dietary intake of prebiotic‐containing food intakes as measured using the SDQ‐gut dietary questionnaire[ 5 weeks post‐intervention (31 weeks gestation) ; 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group change from baseline over time in maternal dietary variety as measured using the SDQ‐gut dietary questionnaire[ 5 weeks post‐intervention (31 weeks gestation) ; 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group change sustained throughout the postnatal period in maternal anxiety symptoms using scores on the Edinburgh Depression Scale[ 1‐month post‐birth ; 9‐months post‐birth ; 12‐months post‐birth ; 18‐months post‐birth] Between‐group change sustained throughout the postnatal period in maternal depression symptoms using scores on the Edinburgh Depression Scale[ 1‐month post‐birth ; 9‐months post‐birth ; 12‐months post‐birth ; 18‐months post‐birth] Between‐group changes in maternal GlycA in measured in blood serum[ 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group difference over time in infant allergies as measured by the International Study of Asthma and Allergies in Childhood scale[ 18‐months of age] Between‐group difference over time in infant respiratory health as measured by the International Study of Asthma and Allergies in Childhood scale[ 18‐months of age] Between‐group difference over time in the alpha diversity of infant stool samples measured using metagenomic sequencing.[ 1‐week of age ; 4 weeks of age, ; 12 months of age] Between‐group difference over time in the beta diversity of infant stool samples measured using metagenomic sequencing.[ 1‐week of age] Between‐group difference over time in the differentially abundant taxa of infant stool samples measured using metagenomic sequencing.[ 1‐week of age] Between‐group difference over time in the functional pathways of infant stool samples measured using metagenomic sequencing.[ 1‐week of age] Between‐group difference over time in the microbiome maturation trajectory of infant stool samples measured using metagenomic sequencing.[ 1‐week of age] Between‐group differences in infant adaptive skills scores using the clinician assessed Bayley Scales of Infant and Toddler Development[ 18 months of age] Between‐group differences in infant cognitive scores using the clinician assessed Bayley Scales of Infant and Toddler Development[ 18 months of age] Between‐group differences in infant internalising and externalising behaviour pr lem scores as measured using the Child Behaviour Checklist[ 18 months of age] Between‐group differences in infant language scores using the clinician assessed Bayley Scales of Infant and Toddler Development[ 18 months of age] Between‐group differences in infant motor scores using the clinician assessed Bayley Scales of Infant and Toddler Development[ 18 months of age] Between‐group differences in infant social‐emotional scores using the clinician assessed Bayley Scales of Infant and Toddler Development[ 18 months of age] Between‐group differences in infant socio‐emotional behaviour scores as measured using the Brief Infant and Toddler Social Emotional Assessment at 12‐months[ 12 months of age] Between‐group differences in infant temperament scores as measured using the Revised Infant Temperament Questionnaire [ 9 months of age] Between‐group differences in maternal differential abundance in vaginal microbiome composition measured by metagenomic sequencing.[ 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group differences in maternal differential abundance in vaginal microbiome function measured by metagenomic sequencing.[ 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group differences in maternal urinary Hippurate measured by Nuclear Magnetic Resonance spectroscopy[ 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group differences in maternal urinary metabolites measured by Nuclear Magnetic Resonance spectroscopy[ 10‐weeks post‐intervention (36‐weeks gestation)] Between‐group differences of infant systemic inflammation measured as GlycA in Guthrie blood spots[ Birth] Caesarean section rates measured by self‐report during Birth and Infant Health questionnaire..[ Birth] Gestational diabetes measured by self‐report during eliciting of adverse events.[ Birth] Pre‐eclampsia measured by self‐report during eliciting of adverse events.[ Birth] Preterm birth measured by self‐report during Birth and Infant Health questionnaire.[ Birth] PRIMARY OUTCOME: Between‐group change from baseline over time in maternal diet quality as measured by the Simple Dietary Questionnaire ‐ Gut (SDQ‐gut) dietary questionnaire[ 10‐weeks post‐intervention start (36‐weeks gestation ‐ primary timepoint)] INCLUSION CRITERIA: • Are able to participate and attend the study visits on Ryrie St, Geelong • Are adults aged 18 years or older • Are currently pregnant and less than 26‐weeks’ gestation • Will be 26 weeks gestation by the 21st week of recruitment • Use a smartphone with internet access • Have capacity to provide informed consent and understand written and spoken English

Actrn (2023). "The effect of a single therapy of the temporomandibular joints on the pelvic floor muscles." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: In the experimental group, a one‐time therapy of the temporomandibular joints will be used. The therapy will consist of soft tissue mobilization techniques inside and outside the temporomandibular joints. External techniques will include 1‐minute compression on the trigger points, positional release and myofascial release within the temporal muscle and masseter muscle. Internal techniques will include coppression and relaxation of the pterygoid muscle and masseter muscle. The therapy will be performed by physiotherapist in the supine position of patient and will last approximately 15 minutes. The measurements will be performed before and after the therapy. CONDITION: Musculoskeletal ‐ Normal musculoskeletal and cartilage development and function Physical Medicine / Rehabilitation ‐ Physiotherapy urinary incontinence;temporomandibular joints dysfunction;pelvic floor muscles tone disorder; ; urinary incontinence ; temporomandibular joints dysfunction ; pelvic floor muscles tone disorder PRIMARY OUTCOME: Evaluation of the bioelectrical activity at rest and during volitional contractions of the pelvic floor muscles, using surface electromyography. Evaluation of the following muscles will be performed: pelvic floor muscles, masseter muscles, sternocleidomastoid muscles, trapezius dorsi descending and ascending parts. The results will be analyzed together, indicating muscle activity and the relationships between them.[In the experimental group: Baseline and after a 15‐minute therapy of the temporomandibular joints. ; In the control group: double measurement with a 15‐minute break between measurements, without intervention.] Pelvic floor muscle activity using transabdominal ultrasonography (USG).[In the experimental group: Baseline and after a 15‐minute therapy of the temporomandibular joints. ; In the control group: double measurement with a 15‐minute break between measurements, without intervention.] The composite outcome includingbody balance and load distribution using baropodometry platform during standing.[In the experimental group: Baseline and after a 15‐minute therapy of the temporomandibular joints. ; In the control group: double measurement with a 15‐minute break between measurements, without intervention.] SECONDARY OUTCOME: Assessment of the mobility of the cervical spine using a centimeter tape.[In the experimental group: Baseline and after a 15‐minute therapy of the temporomandibular joints. ; In the control group: double measurement with a 15‐minute break between measurements, without intervention.] Assessment of the mobility of the temporomandibular joints using a caliper.[In the experimental group: Baseline and after a 15‐minute therapy of the temporomandibular joints. ; In the control group: double measurement with a 15‐minute break between measurements, without intervention.] INCLUSION CRITERIA: ‐ nulliparous; ‐ no pregnancies or miscarriages; ‐ no reported dysfunctions in the genitourinary system; ‐ consent to participate in the study

Actrn (2023). "Examining the efficacy and acceptability of an internet-delivered pain management program for endometriosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: The Endometriosis Pain Course is an internet‐delivered self‐management program. It is a psychological treatment based on cognitive behaviour therapy (CBT) principles adapted to address the impacts of endometriosis‐associated symptoms and difficulties, such as chronic pain, on women's daily functioning and wellbeing. The course consists of: (a) Five lessons released via the eCentreClinic participant portal over an 8‐week period. Each lesson is delivered individually and covers a different topic and introduces 1‐2 core CBT skills designed to promote self‐management, psychological wellbeing and quality of life. Lesson 1 (released in week 1) provides an introduction and overview of the course, psychoeducation on chronic pain, the pain system, and emotional wellbeing. Participants are encouraged to identify their symptoms (e.g., unhelpful thinking styles, physical symptoms, unhelpful coping strategies) as a home‐based exercise. Lesson 2 (released in week 2) provides psychoeducation on unhelpful thinking, particularly as it relates to chronic pain and introduces cognitive challenging skills. Participants are encouraged to practise thought challenging in the following two weeks. Lesson 3 (released in week 4) covers behavioural activation and relaxation strategies to manage mood and anxiety symptoms, and participants are provided with the resources to undertake activity scheduling as a home‐based task. Lesson 4 (released in week 5) introduces activity pacing to manage symptoms such as pain and fatigue, and graded exposure to manage anxiety and avoidance. Participants are encouraged to attempt activity pacing and/or graded exposure tasks as a home‐based task. Lesson 5 (released in week 7) provides information and strategies relating to relapse prevention. Participants CONDITION: Depression;Anxiety;Chronic Pain;Endometriosis; ; Depression ; Anxiety ; Chronic Pain ; Endometriosis Mental Health ‐ Anxiety Mental Health ‐ Depression Reproductive Health and Childbirth ‐ Menstruation and menopause Reproductive Health and Childbirth ‐ Other reproductive health and childbirth disorders INCLUSION CRITERIA: (a) Diagnosis of endometriosis by a medical professional and experiencing endometriosis‐associated chronic pain (b) Chronic pain has been assessed and is being managed by a healthcare physician (c) Endometriosis‐related chronic pain/symptoms are affecting (self‐reported) psychological wellbeing, impacting functioning, or causing the individual problems at work, socially, or in another important way (d) Aged 18 or over (e) Access to the internet and an internet‐connected device. PRIMARY OUTCOME: Generalised Anxiety Disorder ‐ 7 (GAD‐7) which is a self‐report measure of anxiety symptomatology.[Application prior to enrolment, pre‐treatment, mid‐treatment (4 weeks post‐treatment commencement), post‐treatment (9 weeks post‐treatment commencement, primary endpoint), 3‐months post‐treatment commencement.] Pain Disability Index 7‐Item (PDI) which is a self‐report measure assessing the impact of chronic pain on different life domains.[Application prior to enrolment, pre‐treatment, mid‐treatment (4 weeks post‐treatment commencement), post‐treatment (9 weeks post‐treatment commencement, primary endpoint), 3‐months post‐treatment commencement.] Patient Health Questionnaire ‐ 9 (PHQ‐9) which is a self‐report measure of depressive symptomatology.[Application prior to enrolment, pre‐treatment, mid‐treatment (4 weeks post‐treatment commencement), post‐treatment (9 weeks post‐treatment commencement, primary endpoint), 3‐months post‐treatment commencement.] SECONDARY OUTCOME: Endometriosis Health Profile 5‐Item (EHP‐5) which is a 5‐item short form measuring the health‐related quality of life in women with endometriosis. [Pre‐treatment, post‐treatment (9 weeks post‐treatment commencement), 3‐months post‐treatment commencement.] Endometriosis Health Profile Modular Questionnaire 23‐Item (EHP‐23) which is a 23‐item adjunct o the Endometriosis Health Profile Questionnaire measuring impact of endometriosis on work, relationships, and interactions with the healthcare system. [Pre‐treatment, post‐treatment (9 weeks post‐treatment commencement), 3‐months post‐treatment commencement.] Fear of Pain Questionnaire 9‐Item (FOPQ‐9) which is an abbreviated version of the original 30‐item questionnaire that measures participants’ expected fearfulness towards a range painful experiences.[Pre‐treatment, post‐treatment (9 weeks post‐treatment commencement), 3‐months post‐treatment commencement.] Pain Acceptance 8‐Item (CPAQ‐8) which is an 8‐item measure designed to get a sense of peoples’ adjustment to living with pain. [Pre‐treatment, post‐treatment (9 weeks post‐treatment commencement), 3‐months post‐treatment commencement.] Pain Catastrophising Scale 4‐Item (PCS‐4) which is an abbreviated version of the original 13‐item measure that assesses a participants’ thoughts and feelings when in pain.[Pre‐treatment, post‐treatment (9 weeks post‐treatment commencement), 3‐months post‐treatment commencement.] Pain Self Efficacy Questionnaire 2‐Item (PSEQ‐2) which is an abbreviated version of the original 10‐item measure which rates participants’ confidence in performing various daily activities despite pain. [Pre‐treatment, post‐treatment (9 weeks post‐treatment commencement), 3‐months post‐treatment commencement.] Tampa Scale of Kinesiophobia 4‐Item (TSK) which is an abbreviated version of the original 17‐item scale assessing fear of movement and re‐injury.[Pre‐treatment, post‐treatment (9 weeks post‐treatment commencement), 3‐months post‐treatment commencement.] The Treatment Satisfaction Questionnaire (TSQ) which is a purpose‐built measure to assess the acceptability of online treatment Courses and to measure participants’ satisfaction with treatment. [Post‐treatment (9 weeks post‐treatment commencement).] Wisconsin Brief Pain Questionnaire 4‐Item (WBPQ‐4) which is a widely used questionnaire measuring the nature of participants’ pain including location, severity, and responsiveness to pain medications. [Application prior to enrolment, pre‐treatment, mid‐treatment (4 weeks post‐treatment commencement), post‐treatment (9 weeks post‐treatment commencement), 3‐months post‐treatment commencement.]

Actrn (2023). "Mate whenua: follow up after early medical abortion." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Self‐assessment method of follow up after early medical abortion ‐ using a low sensitivity urine pregnancy test at 3 weeks after taking medications (mifepristone). It takes 1‐2 minutes, can be performed at home, and will be followed up by telephone or text with health practitioner. CONDITION: early medical abortion; ; early medical abortion Reproductive Health and Childbirth ‐ Abortion PRIMARY OUTCOME: Lost to follow up, using audit of patient medical records[6 weeks after early medical abortion (EMA)] INCLUSION CRITERIA: Included are women having an early medical abortion at 10.0 weeks' pregnant or less, who provide informed consent. SECONDARY OUTCOME: Additional community prescription dispensed (categorised as antibiotics, painkillers, or other), audit of patient medical records ; [6 weeks after EMA] Additional health care visit (categorised as to abortion service, hospital emergency department or mental health service), audit of medical patient records ; [6 weeks after EMA] Additional investigations (categorised as blood test, pelvic ultrasound scan, or other), audit of patient medical records ; [6 weeks after EMA] Admission to intensive care unit or equivalent, audit of patient medical records[6 weeks after EMA] Contraception use, assessed by patient questionnaire, developed specifically for this study[12 months after EMA] Death[6 weeks after EMA] ectopic pregnancy (categorised as ruptured or not), audit of patient medical records[6 weeks after EMA] Gestational age in weeks at detection of ongoing pregnancy, audit of patient medical records[8 months after EMA] Haemorrhage, defined as estimated blood loss 500mL or more (categorised as requiring red blood cell transfusion or not), audit of patient medical records ; [6 weeks after EMA] Health care utilisation cost, using the dataset, and basing it on pharmaceutical, equipment and consumable costs, and health care utilisation cost ; [at end of trial] Hospitalisation, audit of patient medical records[6 weeks after EMA] Incomplete abortion/retained pregnancy tissue/retained products of conception, audit of patient medical records[6 weeks after EMA] Incremental cost effective ratio for lost to follow up (LFU) rate, using the dataset[at end of trial] length of stay in intensive care, audit of patient medical records[6 weeks after EMA] number of additional health care visits, audit of patient medical records [6 weeks after EMA] number of additional investigations, audit of medical patient records[6 weeks after EMA] number of additional prescriptions, audit of patient medical records [6 weeks after EMA] Ongoing viable (live) pregnancy, using audit of patient medical records ; [up to 8 months after EMA] outcome of ongoing pregnancy (categorised as live birth, stillbirth, miscarriage, ectopic pregnancy, surgical abortion, medical abortion), audit of patient medical records [8 months after EMA] Patient experience, assessed by questionnaire developed specifically for this study, based on published similar patient experience questionnaires[6 weeks after EMA] Pregnancy outcome (e.g. miscarriage, abortion, birth), assessed by patient questionnaire, developed specifically for this study[12 months after EMA] Pregnancy, assessed by patient questionnaire, developed specifically for this study[12 months after EMA] primary reason for admission to intensive care, audit of patient medical records[6 weeks after EMA] Seen the primary care health practitioner (if yes, main reason), assessed by patient questionnaire developed specifically for this study[12 months after EMA] Staff satisfaction, assessed by questionnaire developed specifically for this study, based on published similar staff satisfaction questionnaires[6 months into recruitment] Successful abortion, defined as termination of pregnancy without need for surgery, audit of patient medical records[6 weeks after EMA] Surgical intervention, audit of patient medical records ; [6 weeks after EMA] timing of follow up test, using audit of patient medical records[6 weeks after EMA] type of additional surgical inte ention, audit of medical patient records[6 weeks after EMA] Uterine infection, defined clinically as fever, tachycardia, tender on exam, or purulent vaginal discharge AND received broad spectrum intravenous antibiotics, audit of patient medical records[6 weeks after EMA] Uterine rupture, defined as clinically significant rupture involving the full thickness of the uterine wall and requiring surgical repair, audit of patient medical records[6 weeks after EMA]

Ádám, C., et al. (2023). "Comparison of robot-assisted versus conventional laparoscopy for the treatment of endometriosis: a systematic review and meta‑analysis."
	
Adam, C., et al. (2022). "Investigating the most effective medical treatments for endometriosis-related pain: a systematic review and network meta-analysis."
	
Adam, N., et al. (2021). "Pressurised Intraperitoneal Aerosolised Chemotherapy (PIPAC) for metastatic ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma: a systematic review by the UK PIPAC Collaborative."
	
Adam, P., et al. (2021). "High-frequency, high-intensity transcutaneous electrical nerve stimulation (TENS) for postoperative pain after gynaecological surgery: a systematic review and meta-analysis."
	
Adams, J. A. M., et al. (2023). "The First Large GWAS Meta-Analysis for Postpartum Depression." The American Journal of Psychiatry 180(12): 862-864.
	
Adamyan, L., et al. (2023). "Laser vaporization compared with other surgical techniques in women with ovarian endometrioma: a systematic review and meta-analysis." Archives of Gynecology and Obstetrics 308(2): 413-425.
	Objective: To compare outcomes after laparoscopic cystectomy versus laser vaporization in women of reproductive age with ovarian endometrioma.; Evidence Review: Our systematic review and meta-analysis was registered in PROSPERO (CRD42021281781) and was done according to the PRISMA 2020 checklist. Studies (published until October 2021) were identified by searching PubMed, Cochrane Library, Google Scholar, and ClinicalTrials.gov databases (key words "cystectomy", "laser vaporization", and "endometrioma"). The search was conducted independently by two investigators (L.P. and S.I.). Inclusion criteria were: women of reproductive age undergoing surgery for symptomatic endometriomas larger than 30 mm. The exclusion criteria were: women who undergo conservative treatment. Outcomes were: risk ratio for recurrence, ovarian reserve and pregnancy rates. The studies included were randomized clinical trials (RCTs) and nonrandomized clinical trials (prospective controlled, prospective cohort, retrospective studies, and other types of studies) that included a minimum of 10 patients and written in English. Tools recommended by the Cochrane Society achieved risk-of-bias assessment.; Results: Totally, 874 studies were found, 9 studies were included in qualitative synthesis (822 patients). All the authors compared the efficacy and safety of cystectomy or laser vaporization in reproductive-aged women with ovarian endometrioma. The overall risk of bias for the randomized trials was 80% 'some concerns' and 20% 'low', and for the cohort studies, 50% 'some concerns' and 50% 'low'. The primary meta-analysis focused on recurrence rates (4 studies included) with no statistically significant differences found between these two interventions (RR = 0.53, 95% CI 0.24 to 1.21, P = 0.13). The next meta-analysis estimated antral follicle count (3 studies) which was significantly lower in cystectomy group (RR = - 2.56, 95% CI - 3.71 to - 1.42, P < 0.0001). Pregnancy rates were analyzed in 3 studies with no statistically significant difference (RR = 0.96, 95% CI 0.81 to 1.14, P = 0.64).; Conclusions: There was no statistical difference in the recurrence rate and pregnancy rates, but the antral follicle count was higher in the laser vaporization group. However, we need more clinical trials to make stronger recommendations. (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Adel-Mehraban Mohammad, S., et al. (2022). "Effects of pomegranate supplement on menopausal symptoms and quality of life in menopausal women: A double-blind randomized placebo-controlled trial." Complementary Therapies in Clinical Practice 46: 101544.
	Background: Menopausal symptoms have negative effects on the aspects of quality of life and impose a high cost on the health system. In traditional Persian medicine, pomegranate is recommended to alleviate menopausal symptoms.; Material and Methods: A randomized double-blind placebo-controlled trial was performed among 78 healthy women. Participants were interviewed three times: Before receiving the supplement/placebo, after completing the treatment, and after 3 weeks with no intervention. They filled out the demographic information sheet, modified-Kupperman index, and Menopause-Specific Quality of Life (MENQOL) questionnaires.; Results: The mean scores of the modified-Kupperman index and MENQOL characteristics before and after the treatment and after the follow-up period were significantly different between pomegranate and placebo groups in both modified-Kupperman and MENQOL scores (p < 0.001).; Conclusion: This study demonstrated that 4 weeks' treatment with the pomegranate supplement significantly ameliorates the irritating symptoms of menopause and improves the quality of life in menopausal women even after 4 weeks' medicine deprivation. (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Adriana, G.-L., et al. (2023). "The impact of targeted endometriosis treatment on patients with central sensitization: a systematic review."
	
Adrianto, N., et al. (2024). "Perioperative vaginal misoprostol versus intraoperative pericervical hemostatic tourniquet outcome during abdominal myomectomy: A systematic review and meta-analysis." Journal of Endometriosis and Pelvic Pain Disorders.
	Background: Abdominal myomectomy is a commonly performed surgical procedure for removing fibroids. Various techniques and interventions have been explored to minimize blood loss during abdominal myomectomy. This study aims to assess and compare the efficacy of perioperative vaginal misoprostol and intraoperative pericervical hemostatic tourniquet in minimizing blood loss during abdominal myomectomy. Method(s): Eligible studies were identified using several databases. Analysis was conducted using RevMan version 5.3. This systematic review and meta-analysis were registered in PROSPERO on June 20, 2023, with registration number CRD42023434191. We included three studies with 88 participants. Result(s): Of the 73 records identified initially, 3 met the inclusion criteria-sample sizes of the included studies involving 88 participants. There was a significant mean difference in intraoperative blood loss (p = 0.022 (95% CI, 0.0706-0.901) and operative time (p = 0.015, 95% CI, 0.116-1.066) between groups. There was no significant mean difference in postoperative hematocrit (p = 0.053 (95% CI, -0.734 to 0.00411)) and intraoperative blood transfusion (OR = 1.60 (95% CI, 0.587-4.405), p = 0.355)) between group. Conclusion(s): Our studies indicate that using tourniquets lowered intraoperative bleeding and shortened operating time among the participants. Intraoperative vaginal misoprostol has no significant advantage over the tourniquet group in either intraoperative blood transfusion needs or postoperative hematocrit.Copyright © The Author(s) 2024.

Afandak, F., et al. (2023). "Effect of sumac powder on clinical symptoms, hyperandrogenism, inflammation, blood glucose, lipid profiles in women with polycystic ovary syndrome: A double-blind randomized clinical trial." Phytotherapy research : PTR 37(6): 2315-2325.
	Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders associated with a high risk of diabetes, atherosclerosis, and cardiovascular disease. The purpose of this study was to determine the effect of sumac powder on clinical symptoms and laboratory parameters in women with PCOS. The double-blind randomized controlled clinical trial was conducted on 88 women with PCOS randomly assigned to the intervention and control groups. The intervention group received three capsules each containing 1 g of sumac powder for 12 weeks. All data and serum levels of sex hormone, hs-CRP, glucose, and lipid profiles were measured at the baseline and at the end of the study. Data were analyzed using SPSS version 25 software. The ANCOVA test results showed that hs-CRP level was significantly reduced in the intervention group (p = .008). Blood glucose and lipid profiles in the intervention group were significantly reduced compared to the placebo group (p < .05). Insulin sensitivity and HDL levels were increased significantly in the Sumac group after the intervention (p < .05). Sumac powder can reduce the inflammatory effects, and glycemic status and lipid profile of polycystic ovaries in affected women, but has no significant effect on anthropometric parameters and sex hormones. (© 2023 John Wiley & Sons Ltd.)

Afghan, M., et al. (2022). "The Effect of Eight Weeks of Moderate-Intensity Continious Training on P- and QT Dispersion in ECG of Women with Polycystic Ovary Syndrome." Research in medicine: journal of research in medical sciences 46(4): 91‐98.
	
Aftan, R. M., et al. (2023). "A Comparison between the Effects of Evening Primrose Oil and Soybean Oil on Menopause Symptoms." Journal of Babol University of Medical Sciences 25(1): 305‐315.
	Background and Objective: More than 80% of women experience physical, vasomotor, sexual and psychological symptoms after menopause, and in 10‐20% of women, the severity of menopause symptoms affects their quality of life. Due to the complications of using chemical drugs, this study was conducted to compare the effectiveness of evening primrose oil and soybean oil in postmenopausal women. Methods: In this randomized controlled prospective study, 40 postmenopausal women were assigned into two groups of 20, 500 mg of evening primrose oil and 233 mg of soybean oil extract twice a day for 8 weeks. Measurement of serum hormones (follicle stimulating hormone, luteinizing hormone, estradiol), lipid profile, fasting blood glucose, and high sensitivity C‐reactive protein were performed. Moreover, menopausal symptoms were analyzed and compared based on the evaluation score of menopausal symptoms (range 0‐3). Findings: The mean age of women was (51.65±3.7) years. After 2 months of treatment with evening primrose oil, there was a decrease in follicle stimulating hormone, luteinizing hormone levels concurred with increase in estradiol levels (‐10.64%) (‐8.09%) (7.47%), respectively (p<0.05). Meanwhile, women receiving the soybean oil revealed increase in all the three hormones (5.77%) (12.73%) (13.39%), respectively (p<0.05). Total cholesterol and triglycerides decreased in both study groups after treatment (p<0.05), fasting blood glucose level decreased in group 1 only (‐1.39%), and high sensitivity C‐reactive protein decreased in group 2 only (‐22.33%) (p<0.05). In both groups, women presented with mild to moderate pre‐treatment menopausal symptoms (Menopause Symptom Assessment score ranging from 0.75 to 2.25) showed significant decrease in their score up to no symptoms in each study group after 2 months (less than 0.75) (p<0.01). Conclusion: The results of the study showed that both evening primrose oil and soybean oil supplements improve menopausal symptoms.

Agacayak, E., et al. (2022). "Comparison of long-term results of obliterative colpocleisis and reconstructive vaginal surgery including sacrospinous ligament fixation in patients with total genital prolapse." Nigerian journal of clinical practice 25(5): 597-604.
	Background: Treatment of total genital prolapse in elderly patients is still controversial in terms of postoperative objective and subjective results.; Aim: The present study aimed to compare the long-term objective and subjective cure rates of sacrospinous ligament fixation and Le Fort operation for treatment of total genital prolapse.; Patients and Methods: Patients over the age of 60 with stage 3 or 4 pelvic organ prolapse that presented to the Obstetrics and Gynaecology Clinic of the Faculty of Medicine of *** University. The study sample consisted of 17 patients that underwent Le Fort operation and 29 patients that underwent sacrospinous ligament fixation. Data on duration of operation, intraoperative complications, duration of hospital stay, and differences between preoperative and postoperative estimated blood loss, postoperative complications, and relapse in the long term were obtained. Questionnaires exploring quality of life, incontinence, and pelvic floor disorders were applied to the patients.; Results: As subjective cure rates, postoperative patient satisfaction (P = 0.001), regret rate (P = 0.038) and recommendation rate (P = 0.044), as well as postoperative questionnaire results, Pelvic Floor Impact Questionnaire and SF36 were found to be significantly better in the Le Fort group (respectively P = 0.039 and 0.042). As objective cure rates, there was no difference between the two groups in terms of postoperative cystocele, rectocele, and cystorectocele (P = 0.955) and postoperative recurrence of prolapse beyond the hymen (P: 0.893). Duration of operation and duration of hospital stay were found to be significantly shorter in the Le Fort group (respectively P = 0.032 and 0.012).; Conclusion: Le Fort operation could be the intervention of choice in sexually inactive elderly patients with stage 3 or 4 pelvic organ prolapse.; Competing Interests: None

Agarwal, D. and P. Chaudhary (2023). "Effect of Turmeric-Boswellia-Sesame Formulation in Menstrual Cramp Pain Associated with Primary Dysmenorrhea-A Double-Blind, Randomized, Placebo-Controlled Study." Journal of Clinical Medicine 12(12).
	Primary dysmenorrhea is a common menstrual disorder that significantly impacts women's quality of life, productivity, and healthcare utilization. In this randomized, double-blinded, placebo-controlled trial, sixty women with primary dysmenorrhea were randomly divided into two groups with thirty participants each, and were allocated either turmeric-boswellia-sesame formulation (treatment) or placebo. The participants were advised to take two softgels of 500 mg as a single dose of allocated study intervention (total dose 1000 mg) when their menstrual pain reached 5 or more on a numerical rating scale (NRS). Menstrual cramp pain intensity and relief were evaluated every 30 min post-dose until 6 h. Results indicated a promising role of turmeric-boswellia-sesame formulation for menstrual pain relief compared to the placebo. The mean total pain relief (TOTPAR) of the treatment group (18.9 ± 0.56) was found to be 12.6 times better than the placebo group (1.5 ± 0.39). The NRS analysis showed that there was a statistically significant difference in pain intensity between the treatment and placebo groups ( p < 0.001) at every timepoint. Additionally, the sum of pain intensity difference at 6 h (SPID6) of the treatment group (34.32 ± 1.41) showed a significant difference ( p < 0.0001) and was 20.19 times better when compared to placebo (1.7 ± 0.56). Based on the study results, the turmeric-boswellia-sesame formulation exhibited remarkable menstrual pain relief as compared to the placebo.

Agency British Columbia, C., et al. (2024). STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision.
	No Results Available Procedure: Re-excision Local Vulvar Disease Recurrence - Local vulvar disease recurrence rate (within 3 years) in HPV-I and HPV-A vulvar squamous cell carcinoma|Health Economic Impact of implementation of HPV and p53 stratified treatment algorithms - Measure the delta in surgical parameters (surgical take backs, longer hospital stay for more extensive surgery)|Patient Reported Outcome EORTC QLQ-C30 - Measures subject's physical, psychological and social functions.|Patient Reported Outcome EORTC QLQ-VU34 vulva-specific module - Measures symptoms or problems related to the genital area|Patient Decisional Conflict Scale - Change in level of patient decisional conflict is defined as the change in the Decisional Conflict Scale or subscale prior to and after treatment|Disease-specific survival is defined as the time from study enrolment to the time of death from vulvar cancer. Overall survival is defined as the time from study enrolment to the time of death from any cause.|Proportion of patients who had p16 IHC and in HPV-I VSCC who had p53 IHC performed on resection margin in an acceptable turnaround time ie >85% of patients tumours had this performed and reported within 21 days of surgery Female Not Applicable 249 Other Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment STRIVE December 2025

Agenus, I. (2021). "A Phase 2 Study of Balstilimab Independently or in Combination With Zalifrelimab in Cervical Cancer." ClinicalTrials.gov.
	This is a randomized, non‐comparative, two‐arm Phase 2 clinical trial to assess the efficacy ,safety and pharmacokinetics of Balstilimab (Treatment Arm 1 ‐ monotherapy) or in combination with Zalifrelimab (Treatment Arm 2‐ combination therapy) for treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first‐line platinum‐based chemotherapy.

Aghababaei, Z., et al. (2021). "Efficacy of Sesame (Sesamum indicum L.) in the Management of Incomplete Abortion: an Open-Label Randomized Controlled Clinical Trial." Complementary Medicine Research 28(6): 501‐507.
	BACKGROUND: Incomplete abortion is a common complication of pregnancy. Sesamum indicum L. is a widely used emmenagogue herb. OBJECTIVES: We designed a clinical trial to evaluate the efficacy of sesame for the removal of retained products of conception (RPOC). METHODS: In this randomized, open‐label, and controlled trial, 45 patients received sesame powder as an intervention group and 45 patients received expectant management as a control group for 5 days. The primary outcome measure was complete resolution of RPOC assessed by sonography. Secondary outcome measures were severity of patients' vaginal bleeding and pain. RESULTS: 84.1% had complete resolution of RPOC in the sesame group, while 26.2% had complete resolution of RPOC in the control group, which was statistically significant (p < 0.001). Moreover, patients in the sesame group showed a significantly more decreasing trend in pain and vaginal bleeding compared to the control group (p < 0.001). CONCLUSION: Sesame had a significant effect on the removal of RPOC and the reduction of pain and vaginal bleeding.

Aghajanian, C., et al. (2021). "Progression-free survival by investigator versus blinded independent central review in newly diagnosed patients with high-grade serous ovarian cancer: Analysis of the VELIA/GOG-3005 trial." Gynecologic Oncology 162(2): 375-381.
	OBJECTIVE: In the phase 3 VELIA/GOG-3005 trial, veliparib added to carboplatin-paclitaxel and continued as maintenance improved progression-free survival (PFS) compared to carboplatin-paclitaxel alone in patients with newly diagnosed ovarian carcinoma. Primary analysis of PFS was by investigator (INV) assessment, with a supplemental analysis of PFS by blinded independent central review (BICR). METHODS: Patients received veliparib or placebo with carboplatin-paclitaxel (6 cycles) and as maintenance (30 additional cycles). The primary analysis compared PFS in the veliparib-throughout arm to the carboplatin-paclitaxel only arm in the BRCA mutation (BRCAm), homologous recombination deficiency (HRD), and intention-to-treat (ITT) populations. Exploratory analyses of PFS in BRCA wildtype (BRCAwt), homologous recombination proficient (HRP), and HRD + BRCAwt populations were also performed. PFS per BICR and overall concordance rates between INV and BICR assessments were analyzed. RESULTS: Hazard ratios for PFS by INV and BICR were consistent in each of the primary analysis and exploratory populations. In the ITT population, median PFS per INV was 23.5 months in the veliparib-throughout arm versus 17.3 months in the control arm (hazard ratio [HR] 0.683, 95% confidence interval [CI] 0.562-0.831; P < 0.001). Median PFS by BICR was 29.3 months versus 19.2 months (HR 0.687, 95% CI 0.504-0.806). In the ITT population, the overall concordance rates between INV and BICR were 78% and 75% for the veliparib-throughout and control arms, respectively. CONCLUSIONS: Hazard ratios for PFS per BICR and per INV were consistent, with no suggestion of investigator bias. These findings support the reliability of PFS by INV in ovarian cancer trials.

Aghajanian, C., et al. (2022). "Impact of veliparib, paclitaxel dosing regimen, and germline BRCA status on the primary treatment of serous ovarian cancer - an ancillary data analysis of the VELIA trial." Gynecologic Oncology 164(2): 278-287.
	Objective: In the Phase 3 VELIA trial (NCT02470585), veliparib added to carboplatin plus paclitaxel concomitantly and as maintenance for women with newly-diagnosed advanced ovarian cancer significantly improved progression-free survival (PFS) versus chemotherapy alone. Here we present exploratory analyses by paclitaxel dosing schedule and germline BRCA (gBRCA) status.; Methods: Women with untreated ovarian carcinoma were randomized (1:1:1) to: veliparib during chemotherapy and maintenance (veliparib-throughout), veliparib during chemotherapy followed by placebo maintenance (veliparib-combination only), or placebo during chemotherapy and maintenance (control). Chemotherapy included carboplatin plus dose-dense (DD; weekly) or every-3-week (Q3W) paclitaxel (a stratification factor at randomization), selected at the investigator's discretion pre-randomization. PFS was assessed by paclitaxel dosing schedule using a Cox proportional hazard model adjusted by treatment arm and stratification factors; safety was analyzed based on paclitaxel dosing schedule and gBRCA status.; Results: 1132 patients were analyzed by paclitaxel schedule. Pooled treatment arms demonstrated longer median PFS with DD (n = 586) versus Q3W (n = 546) paclitaxel (ITT: 20.5 vs 15.7 months, hazard ratio [HR] 0.77; homologous recombination proficient cancer: 15.1 vs 11.8 months, HR 0.64; BRCAwt: 18.0 vs 12.9 months, HR 0.70). Comparison between arms favored veliparib-throughout versus control in both DD (PFS, 24.2 vs 18.3 months, hazard ratio 0.67) and Q3W (19.3 vs 14.6, hazard ratio 0.69) subgroups. DD paclitaxel was associated with higher incidence of Grade 3/4 neutropenia, fatigue, and anemia versus Q3W. There were no differences in toxicity between gBRCAm (n = 211) and gBRCAwt (n = 902) subgroups.; Conclusions: DD paclitaxel was tolerable and associated with longer PFS in the HR proficient and gBRCAwt groups, versus Q3W. gBRCA status did not impact safety.; Competing Interests: Declaration of competing interest None. (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Aghajanova, L., et al. (2021). "Autologous platelet-rich plasma treatment for moderate-severe Asherman syndrome: the first experience." Journal of Assisted Reproduction and Genetics 38(11): 2955-2963.
	PURPOSE: Treatment of Asherman syndrome (AS) presents a significant clinical challenge. Based on our in vitro data showing that PRP could activate endometrial cell proliferation and migration, we hypothesized that intrauterine infusion of autologous platelet-rich plasma (PRP) may improve endometrial regeneration and fertility outcomes in patients with moderate-severe AS. MATERIALS AND METHODS: Subjects with moderate-severe AS were randomized to PRP or saline control administered following hysteroscopic adhesiolysis. Due to relative inability to randomize patients to the control group, after initial randomization of 10 subjects (6 in PRP and 4 in control groups), the remainder were prospectively enrolled in PRP group (n = 9), with 11 historic controls added to control group, for a total of 30 subjects (PRP n = 15; saline control n = 15). Right after hysteroscopy, 0.5-1 mL of PRP or saline was infused into the uterus via a Wallace catheter, followed by estrogen therapy. The primary outcomes were changes in endometrial thickness (EMT, checked in 3 weeks) and in menstrual flow; secondary outcomes were pregnancy and live birth rates. EMT and menstrual bleeding pattern were assessed before and after the intervention. Pregnancy was assessed over a 6-month period. RESULTS: There were no statistically significant differences in age, gravidity/parity, cause of AS, preoperative menses assessment, AS hysteroscopy score, and intrauterine balloon placement between the groups. There was no statistically significant difference (p = 0.79) in EMT pre-PRP infusion for control (5.7 mm, 4.0-6.0) and study arm (5.3 mm, 4.9-6.0). There was no statistically significant change (p = 0.78) in EMT after PRP infusion (1.4 mm, - 0.5-2.4) vs saline (1.0 mm, 0.0-2.5). Patients tolerated the procedure well, with no adverse effects. There was no difference in the predicted likelihood of pregnancy (p = 0.45) between the control (0.67, 0.41-0.85) and study arm (0.53, 0.29-0.76). CONCLUSIONS: PRP was well accepted and tolerated in AS patients. However, we did not observe any significant EMT increase or improved pregnancy rates after adding PRP infusion, compared to standard treatment only. The use of intrauterine PRP infusion may be a feasible option, and its potential use must be tested on a larger sample size of AS patients.

Aghajanpour, S., et al. (2021). "Endometrial scratching affects gene expression of NLRP3 in patients with unexplained repeated implantation failure: a randomized control trial." International Journal of Reproductive Biomedicine 19(5 SUPPL 1): 68.
	Background: Alternative strategies have been used to augment success rate of implantation in IVF/ICSI cycles in unexplained repeated implantation failure patients. Endometrial scratching is one of these procedures. It seems scratching can affect NLRP3 gene expression which has an important role on receptivity of endometrium. NLRP3 is an intracellular sensor that detects a broad range of harmful sterile or infectious stimuli, resulting in the formation and activation of the NLRP3 inflammasome Objective: In the present study, we investigated whether gene expression of NLRP3 (NOD‐, LRR‐ and pyrin domain‐containing protein 3) is affected by endometrial injury during proliferative phase of menstrual cycle before embryo transfer. Materials and Methods: Twenty women with unexplained repeated implantation failure who failed to conceive during three or more IVF/ICSI cycles and embryo transfer were selected. The patients randomly classified into two study groups (N = 10 in each group). In the intervention group (not in the control group), endometrial scratching was done on day 9‐13 in the proliferative phase of the preceding menstrual cycle. Then, endometrial biopsies of the intervention and control groups were performed in the luteal phase (on 19‐21 day). The RNA of all samples was extracted and cDNA synthesis was performed. The expression of NLRP3 was quantified by quantitative real‐time PCR. Results:NLRP3 gene expression from all samples was investigated. Relative expression of NLRP3 was lower in the intervention samples compared to the controls. Conclusion: The inflammasome components are suggested as a novel family of endometrial biomarkers. This result is in consistent with other studies that showed dysregulated inflammasome activation has involved in the disruption of maternal‐fetal immune‐tolerance and in pregnancy complications.

Aghajanpour, S., et al. (2022). "Endometrial scratching: A strategy to stimulate the angiogenesis aspect of implantation in unexplained, repeated implantation failure." Human Reproduction 37(Supplement 1): i370.
	Study question: Does endometrial scratching serve as an angiogenic stimulator during implantation in unexplained, repeated implantation failure (uRIF) patients? Summary answer: Endometrial scratching can reimburse and regulate genes involved in both endometrial angiogenesis and receptivity. What is known already: The vascular endothelial growth factor (VEGF), as an angiogenic factor, is well-known for its function in a variety of physiological and pathological aspects of female reproduction. Following the embryo transfer in the In-Vitro Fertilization cycles, the most challenging clinical obstacle to overcome is RIF. Endometrial scratching is a technique considered as an option for enhancing the embryo implantation of uRIF patients by modulating the different cellular and molecular components regulating endometrial receptivity before and during implantation. Study design, size, duration: Twenty uRIF patients were enrolled based on a randomized controlled trial (RCT) to study the expression of genes involved in endometrial angiogenesis and receptivity functions (VEGFR1, VEGFR2, COL18A1, E-cadherin, FGF1) following ES. Ten uRIF patients were randomly assigned to the intervention group (twice endometrial sampling in the follicular and luteal phases) and ten in the control group (only luteal phase sampling) prior to the ovarian stimulation cycle. Participants/materials, setting, methods: Women who failed to conceive following three or more IVF/ICSI cycles, high-quality embryo transfer, and at least one blastocyst embryo transfer cycle met the inclusion criteria. Post-biopsy endometrial samples were divided evenly. One component was placed in 10% formalin for histology dating and another in RNALater for genomic analysis and preserved at -80 degreeC for RNA extraction. Main results and the role of chance: The expression levels of VEGFR1 and VEGFR2 (both as the receptors of VEGF) were significantly increased after ES (P<0.05). The mRNA expression level of COL18A1 was significantly decreased after ES. COL18A1 is an inhibitor of VEGF which can impede VEGF-mediated signaling and endothelial cell proliferation, via blocking of its receptor specifically VEGFR2. The E-cadherin expression level was significantly decreased (P<0.05) in the endometrium of the intervention group after scratching. E-cadherin is a cell-cell adhesion molecule that has a pivotal role in maintaining normal epithelial architecture, establishing cell polarity, glandular differentiation, and morphogenesis. Data showed that Fibroblast Growth Factor1 (FGF1) expression level was significantly increased in the intervention group (P<0.05). FGF1 promotes the formation of blood vessels which improves endometrial trophoblastic interaction and affects embryo implantation. Limitations, reasons for caution: To further understand the function of these changes, it is preferable to compare the data with endometrium from a fertile group, which is ongoing. Wider implications of the findings: On the timeline of embryo implantation, angiogenic factors (e.g., VEGFR1 and VEGFR2), their inhibitors (e.g., E-cadherin and COL18A1), and activators (e.g., FGF1) work together to establish a dynamic environment responsible for endometrial receptivity, which has been compromised in the endometrium of RIF patients.ES can reimburse and regulate these angiogenesis processes.

Aghbash, P. S., et al. (2022). "Monoclonal antibodies in cervical malignancy-related HPV." Frontiers in Oncology 12: 904790.
	Despite many efforts to treat HPV infection, cervical cancer survival is still poor for several reasons, including resistance to chemotherapy and relapse. Numerous treatments such as surgery, radiation therapy, immune cell-based therapies, siRNA combined with various drugs, and immunotherapy are being studied and performed to provide the best treatment. Depending on the stage and size of the tumor, methods such as radical hysterectomy, pelvic lymphadenectomy, or chemotherapy can be utilized to treat cervical cancer. While accepted, these treatments lead to interruptions in cellular pathways and immune system homeostasis. In addition to a low survival rate, cervical neoplasm incidence has been rising significantly. However, new strategies have been proposed to increase patient survival while reducing the toxicity of chemotherapy, including targeted therapy and monoclonal antibodies. In this article, we discuss the types and potential therapeutic roles of monoclonal antibodies in cervical cancer.Copyright © 2022 Aghbash, Hemmat, Fathi and Baghi.

Agholme, F., et al. (2023). "POWER: an open, single-arm, post-market clinical trial using the TENA SmartCare Change Indicator in a home environment." Archives of Medical Science 19(1): 270-273.
	Introduction: This clinical trial tested the use of the TENA SmartCare Change Indicator in a homecare environment. Method(s): The trial included 35 elderly subjects with urinary incontinence. The trial lasted for 3 weeks. The primary outcome was the reduction in manual absorbing product checks between the baseline (first) and the investigational (third) week. Result(s): The numbers of checks and leakages were significantly reduced by 16% (p = 0.001) and 40% (p = 0.0051). Conclusion(s): Use of the device led to a reduction in the numbers of manual checks and leakages. The device appears to be safe, well tolerated and easy to use.Copyright © 2023 Termedia & Banach.

Agnes, A., et al. (2021). "ORAL ADMINISTRATION OF SODIUM TUNGSTATE IN HEALTHY WOMEN OF CHILDBEARING AGE IS SAFE AND WELL-TOLERATED. Results OF TWO PHASE I STUDIES OF A DRUG IN DEVELOPMENT TO TREAT FEMALE INFERTILITY." Fertility and Sterility 116(3): e422.
	Objective: To assess the safety, tolerability, and pharmacokinetic profile of sodium tungstate (ST), a drug in development to treat female infertility. Materials and Methods: Two phase I, randomized, double‐blind, placebo‐controlled clinical trials were conducted, both administering ST or placebo, oral and daily, during a menstrual cycle. The doses tested were 100mg (n=7), 200mg (n=7), 300mg (n=8) and placebo (n=8) in the first study, and 500mg (n=8) vs placebo (n=2) in the second one. Safety and tolerability were evaluated by the incidence of adverse events (AEs), physical and gynecologic evaluation also with TVUS, records of vital signs and clinical laboratory results, before and during the treatment, and after a 28‐day follow‐up period. Individual blood samples were obtained at baseline,+1h, +2h,+3h,+3.33h,+3.66h, +4h, +4.33h, +4.66h, +5h, +6h, +8h, +12h, +16h, +20h, +24h, +48h, +72h, +144h, D14, D21, D28 and D28+72h. Pharmacokinetic analysis were performed using a non‐compartimental analysis approach, a PK/PD data management and modeling software package. Descriptive statistics were provided for all safety variables. The studies were authorized by the Spanish Health Agency and Ethics Committee. Results: Results showed that ST was safe and well‐tolerated at all doses, up to 500mg/day. No relevant changes were observed for gynecologic and physical evaluation, vital signs and laboratory tests. Few individual laboratory results out of the normal ranges were observed and had no clinical relevance. Few related AEs were observed and were qualified as mild or moderate. The AEs were distributed in the placebo and the treated groups with similar frequency, except for nausea (10% vs 17%). The most frequent (>5% frequency) AEs observed with ST were headache (17%), nausea (17%), somnolence (7%) and nasopharyngitis (7%). No dose relationship seemed to exist in reported AEs. ST pharmacokinetic curves were similar at all doses tested (100‐500 mg/day), with a fast peak absorption, mean Tmax between 4 and 5 hours. No accumulation was observed in any of the doses studied, since the Cmax values on day 28 were similar to those on day 1. Cmax and AUC increased with increasing dose; however, the linearity observed within the range of 100 to 300 mg/day disappeared with 500 mg/day. Conclusions: Oral treatment with ST is safe, well‐tolerated, and has a well‐characterized pharmacokinetic profile in healthy women of childbearing age at doses of up to 500mg/day. Future phase II studies are well‐supported by the available evidence. Impact Statement: These phase I studies in women of childbearing age confirm that sodium tungstate has the necessary wide safety margin and non‐complex kinetics to further investigate its therapeutic use in women's health.

Agostinis, C., et al. (2020). "Immunological Basis of the Endometriosis: The Complement System as a Potential Therapeutic Target." Frontiers in Immunology 11: 599117.
	Endometriosis (EM) is a chronic disease characterized by the presence and proliferation of functional endometrial glands and stroma outside the uterine cavity. Ovaries and pelvic peritoneum are the most common locations for endometrial ectopic tissue, followed by deep infiltrating EM sites. The cyclic and recurrent bleeding, the progressive fibrosis and the peritoneal adhesions of ectopic endometrial glands, may cause different symptoms depending on the origin involved. EM is a frequent clinical condition affecting around 10% of women of mainly reproductive age, as well as in post-menopausal women and adolescents, especially with uterine anomalies. The risk of developing EM depends on a complex interaction between genetic, immunological, hormonal, and environmental factors. It is largely considered to arise due to a dysfunction of immunological surveillance. In fact, women with EM exhibit altered functions of peritoneal macrophages, lymphocytes and natural killer cells, as well as levels of inflammatory mediators and growth factors in the peritoneal fluid. In EM patients, peritoneal macrophages are preponderant and highly active compared to healthy women. Peritoneal macrophages are able to regulate the events that determine the production of cytokines, prostaglandins, growth factors and complement components. Several studies have shown alteration in the regulation of the complement activation, leading to chronic inflammation characteristic of EM. Aberrant regulation/activation of the complement system has been observed in the peritoneal cavity of women affected by EM. Thus, complement inhibition may represent a new approach for the treatment of EM, given that a number of complement inhibitors are under pre-clinical and clinical development. Such an intervention may provide a broader therapeutic control of complement-mediated inflammatory damage in EM patients. This review will focus on our current understanding of the role of complement activation in EM and possible modalities available for complement-based therapy.© Copyright © 2021 Agostinis, Balduit, Mangogna, Zito, Romano, Ricci, Kishore and Bulla.

Aguaviva, B., et al. (2024). "Dietary interventions in the treatment of polycystic ovary syndrome: A bibliographic review." Clinica e Investigacion en Ginecologia y Obstetricia 51(1): 100911.
	Polycystic ovary syndrome (PCOS) is a female endocrinopathy recognized as a heterogeneous disorder characterized by hyperandrogenism and ovulatory dysfunction that leads to fertility problems. In addition, patients usually present with associated symptoms such as insulin resistance, glucose intolerance, central obesity and/or metabolic syndrome that can induce an increased risk of cardiovascular disease. Since one of the main goals of PCOS is to reduce the metabolic consequences related to obesity, insulin resistance, and the metabolic syndrome, targeted dietary interventions may be effective in treating PCOS. A bibliographic search has been carried out in different databases such as Web of Science, Pubmed and Google Scholar, establishing previously defined search criteria. Eleven have been chosen for full review and critical analysis. Among the different interventions that have been used, dietary strategies have been followed such as the dietary approaches to stop hypertension (DASH), modifications in carbohydrates, the inclusion of a certain food in the usual dietary pattern and/or lifestyle modifications. Of the results obtained, we highlight the improvements in body markers with a DASH diet, the benefits promoted by diets with modifications in carbohydrates, in insulin resistance and hormonal markers and favorable effects on clinical manifestations related to hyperandrogenism, fostered by soy consumption and lifestyle modifications., El sindrome del ovario poliquistico (SOP), es una endocrinopatia femenina reconocida como un trastorno heterogeneo caracterizado por un hiperandrogenismo y una disfuncion ovulatoria que conlleva problemas de fertilidad. Ademas, las pacientes suelen presentar una sintomatologia asociada como la resistencia a la insulina, la intolerancia a la glucosa, la obesidad central y/o el sindrome metabolico que pueden inducir a un aumento del riesgo de enfermedad cardiovascular. Dado que uno de los principales objetivos del tratamiento del SOP es reducir las consecuencias metabolicas relacionadas con la obesidad, la resistencia a la insulina y el sindrome metabolico, las intervenciones dieteticas dirigidas a este proposito pueden resultar eficaces en el tratamiento de este padecimiento. Se ha llevado a cabo una busqueda bibliografica en diferentes bases de datos como Web of Science (WOS), PubMed y Google Academico estableciendo unos criterios de busqueda previamente definidos. Se han elegido 11 trabajos para su revision completa y analisis critico. Entre las diferentes intervenciones que se han utilizado, se han seguido estrategias dieteticas como la Dietary Approaches to Stop Hypertension (DASH), modificaciones en los hidratos de carbono (HC), la inclusion de algun alimento determinado en el patron dietetico habitual y/o los cambios en el estilo de vida. De los resultados obtenidos, destacan las mejoras propiciadas en los marcadores corporales con un regimen DASH, los beneficios promovidos por dietas con modificaciones en los HC, en la resistencia insulinica (IR) y los marcadores hormonales, asi como los efectos favorables en las manifestaciones clinicas relacionadas con el hiperandrogenismo, fomentados por el consumo de soja y las modificaciones en el estilo de vida (LSM).Copyright © 2023 The Authors

Agur, W., et al. (2021). "Treating Women with Recurrent Stress Urinary Incontinence: a Hornet's Nest Still Needing Proper Clinical Evidence." European Urology 79(1): 6‐7.
	Evidence is lacking on the best treatment for women presenting with recurrent stress urinary incontinence. PURSUIT is a randomised trial of urethral bulking agent injection versus surgical intervention. It will provide high‐quality evidence to aid counselling and inform choice. https://research-information.bris.ac.uk/ws/portalfiles/portal/256087477/PURSUIT_Editorial_280920_COI.pdf

Ahangari, F., et al. (2023). "The Efficacy of Salvia officinalis on the Prevention of Recurrent Vulvo-vaginal Candidiasis: A Randomized, Controlled Clinical Trial." Current Women's Health Reviews 19(4): e081222211757.
	Background: In addition to physical discomfort, recurrent vulvovaginal candidiasis impos-es a significant financial and psychosocial burden, such as lower levels of self-esteem, a higher level of stress, clinical depression, and less satisfaction with their life. Recurrent vulvovaginal candidiasis interferes with emotional and sexual relationships. Objective(s): This study aimed to compare the effect of vaginal Salvia officinalis, clotrimazole, and their combination on the prevention of recurrent vulvovaginal candidiasis. Method(s): This randomized triple-blinded trial was conducted on 111 women aged 18-49 years with vulvovaginal candidiasis. Participants were randomly assigned into one of the three groups of vaginal tablets of Salvia officinalis 400 mg and placebo of clotrimazole 100 mg, clotrimazole 100 mg and placebo of Salvia officinalis 400 mg, or Salvia officinalis and clotrimazole that were applied every night for 7 consecutive days. A recurrence rate of vulvovaginal candidiasis was evaluated by WET test and vaginitis symptoms examination after 12 weeks. In the case of positive evaluation, the culture of vaginal discharge was performed. Result(s): Totally, 29 patients (80.6%) in group clotrimazole, 33 patients (94.3%) in group Salvia offic-inalis and 35 patients (97.2%) in group Salvia officinalis-clotrimazole were treated (P = 0.43). Out of cured patients, 4 (13.8%) patients in the group clotrimazole, 1 patient (3%) in group Salvia officinalis, and no case in group Salvia officinalis-clotrimazole experienced the recurrence of infection. There was a significant difference among the 3 groups in terms of recurrence (P = 0.023). Moreover, no adverse event during the 12 weeks after treatment was observed. Conclusion(s): Adjuvant therapy of Salvia officinalis alongside routine vaginal clotrimazole could suc-cessfully prevent recurrent vulvovaginal candidiasis after three months. Clinical Trial Registration Number: IRCT2017020227311N4.Copyright © 2023 Bentham Science Publishers.

Ahc, M. (2021). "Management of Heavy Menstrual Bleeding: levonorgestrel-Releasing Intrauterine System vs. Endometrial Ablation." OB/GYN clinical alert 38(3): 1‐3.
	"SYNOPSIS: In this multicenter, randomized, noninferiority trial among patients aged 34 years and older with heavy menstrual bleeding, the levonorgestrel-releasing intrauterine system did not meet the noninferiority threshold when compared to endometrial ablation for mean blood loss at 24 months following intervention. Both interventions did lead to large decreases in blood loss and comparable satisfaction and quality-of-life scores." A synopsis of this paper: SOURCE: Beelen P, van den Brink MJ, Herman MC, et al. Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding. Am J Obstet Gynecol 2021;224:187.e1-187.e10.

Ahdi Derav, B., et al. (2023). "Effectiveness of Group Cognitive-Behavioral Therapy for Managing Anxiety and Depression in Women Following Hysterectomy for Uterine Cancer." Asian Pacific journal of cancer prevention : APJCP 24(12): 4237-4242.
	Objective: Hysterectomy as well as uterine cancer could be associated with a long-term risk of mental disorders. The purpose of this study is to investigate the effectiveness of group cognitive-behavioral therapy (GCBT) in reducing anxiety and depression in women who have undergone hysterectomy for uterine cancer.; Method: This experimental, pretest-post-test study was conducted in an academic hospital. 26 women with uterine cancer who underwent hysterectomy were recruited and randomly divided into two equal groups as the experimental and control groups. The experimental group was treated by GCBT for eight 1-hour sessions (by a senior psychology expert) every week until 8 weeks. Otherwise, no intervention was performed for the control group. The anxiety and depression scores of all participants were assessed and compared before and after the therapy sessions by Beck Anxiety (BAI) and Beck Depression-second version (BDI-II) questionnaires.; Results: The mean±SD age of the participants was 33.6±4.1. Our result found significant different after GCBT in both anxiety (p=0.000) and depression (p=0.000) scores in the experimental group. However, no differences between pre and post-test scores in the control group were observed. Compared to the control group the rate of depression (p=0.000) and anxiety (p=0.000) in the case group was significantly decreased after therapy.; Conclusion: GCBT is effective in reducing anxiety and depression in women after hysterectomy. The use of GCBT in oncology centers along with medical treatments to reduce mental distress, improve mental health, and accelerate the recovery process of patients with uterine cancer and other cancers seems necessary.

Ahmad, G., et al. (2020). "Barrier agents for adhesion prevention after gynaecological surgery." The Cochrane Database of Systematic Reviews 3: CD000475.
	Background: Pelvic adhesions can form secondary to inflammation, endometriosis, or surgical trauma. Strategies to reduce pelvic adhesion formation include placing barrier agents such as oxidised regenerated cellulose, polytetrafluoroethylene, and fibrin or collagen sheets between pelvic structures.; Objectives: To evaluate the effects of barrier agents used during pelvic surgery on rates of pain, live birth, and postoperative adhesions in women of reproductive age.; Search Methods: We searched the following databases in August 2019: the Cochrane Gynaecology and Fertility (CGF) Specialised Register of Controlled Trials, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the Cochrane Central Register of Controlled Trials (CENTRAL), Epistemonikos, and trial registries. We searched reference lists of relevant papers, conference proceedings, and grey literature sources. We contacted pharmaceutical companies for information and handsearched relevant journals and conference abstracts.; Selection Criteria: Randomised controlled trials (RCTs) on the use of barrier agents compared with other barrier agents, placebo, or no treatment for prevention of adhesions in women undergoing gynaecological surgery.; Data Collection and Analysis: Three review authors independently assessed trials for eligibility and risk of bias and extracted data. We calculated odds ratios (ORs) or mean differences (MDs) with 95% confidence intervals (CIs) using a fixed-effect model. We assessed the overall quality of the evidence using GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methods.; Main Results: We included 19 RCTs (1316 women). Seven RCTs randomised women; the remainder randomised pelvic organs. Laparoscopy (eight RCTs) and laparotomy (11 RCTs) were the primary surgical techniques. Indications for surgery included myomectomy (seven RCTs), ovarian surgery (five RCTs), pelvic adhesions (five RCTs), endometriosis (one RCT), and mixed gynaecological surgery (one RCT). The sole indication for surgery in three of the RCTs was infertility. Thirteen RCTs reported commercial funding; the rest did not state their source of funding. No studies reported our primary outcomes of pelvic pain and live birth rate. Oxidised regenerated cellulose versus no treatment at laparoscopy or laparotomy (13 RCTs) At second-look laparoscopy, we are uncertain whether oxidised regenerated cellulose at laparoscopy reduced the incidence of de novo adhesions (OR 0.50, 95% CI 0.30 to 0.83, 3 RCTs, 360 participants; I² = 75%; very low-quality evidence) or of re-formed adhesions (OR 0.17, 95% CI 0.07 to 0.41, 3 RCTs, 100 participants; I² = 36%; very low-quality evidence). At second-look laparoscopy, we are uncertain whether oxidised regenerated cellulose affected the incidence of de novo adhesions after laparotomy (OR 0.72, 95% CI 0.42 to 1.25, 1 RCT, 271 participants; very low-quality evidence). However, the incidence of re-formed adhesions may have been reduced in the intervention group (OR 0.38, 95% CI 0.27 to 0.55, 6 RCTs, 554 participants; I² = 41%; low-quality evidence). No studies reported results on pelvic pain, live birth rate, adhesion score, or clinical pregnancy rate. Expanded polytetrafluoroethylene versus oxidised regenerated cellulose at gynaecological surgery (two RCTs) We are uncertain whether expanded polytetrafluoroethylene reduced the incidence of de novo adhesions at second-look laparoscopy (OR 0.93, 95% CI 0.26 to 3.41, 38 participants; very low-quality evidence). We are also uncertain whether expanded polytetrafluoroethylene resulted in a lower adhesion score (out of 11) (MD -3.79, 95% CI -5.12 to -2.46, 62 participants; very low-quality evidence) or a lower risk of re-formed adhesions (OR 0.13, 95% CI 0.02 to 0.80, 23 participants; very low-quality evidence) when compared with oxidised regenerated cellulose. No studies reported results regarding pelvic pain, live birth rate, or clinical pregnancy rate. Collagen membrane with polyethylene glycol and glycerol versus no treatment at naecological surgery (one RCT) Evidence suggests that collagen membrane with polyethylene glycol and glycerol may reduce the incidence of adhesions at second-look laparoscopy (OR 0.04, 95% CI 0.00 to 0.77, 47 participants; low-quality evidence). We are uncertain whether collagen membrane with polyethylene glycol and glycerol improved clinical pregnancy rate (OR 5.69, 95% CI 1.38 to 23.48, 39 participants; very low-quality evidence). One study reported adhesion scores but reported them as median scores rather than mean scores (median score 0.8 in the treatment group vs median score 1.2 in the control group) and therefore could not be included in the meta-analysis. The reported P value was 0.230, and no evidence suggests a difference between treatment and control groups. No studies reported results regarding pelvic pain or live birth rate. In total, 15 of the 19 RCTs included in this review reported adverse events. No events directly attributed to adhesion agents were reported.; Authors' Conclusions: We found no evidence on the effects of barrier agents used during pelvic surgery on pelvic pain or live birth rate in women of reproductive age because no trial reported these outcomes. It is difficult to draw credible conclusions due to lack of evidence and the low quality of included studies. Given this caveat, low-quality evidence suggests that collagen membrane with polyethylene glycol plus glycerol may be more effective than no treatment in reducing the incidence of adhesion formation following pelvic surgery. Low-quality evidence also shows that oxidised regenerated cellulose may reduce the incidence of re-formation of adhesions when compared with no treatment at laparotomy. It is not possible to draw conclusions on the relative effectiveness of these interventions due to lack of evidence. No adverse events directly attributed to the adhesion agents were reported. The quality of the evidence ranged from very low to moderate. Common limitations were imprecision and poor reporting of study methods. Most studies were commercially funded, and publication bias could not be ruled out. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Ahmad, G., et al. (2020). "Fluid and pharmacological agents for adhesion prevention after gynaecological surgery." The Cochrane Database of Systematic Reviews 7: CD001298.
	Background: Adhesions are fibrin bands that are a common consequence of gynaecological surgery. They are caused by conditions that include pelvic inflammatory disease and endometriosis. Adhesions are associated with comorbidities, including pelvic pain, subfertility, and small bowel obstruction. Adhesions also increase the likelihood of further surgery, causing distress and unnecessary expenses. Strategies to prevent adhesion formation include the use of fluid (also called hydroflotation) and gel agents, which aim to prevent healing tissues from touching one another, or drugs, aimed to change an aspect of the healing process, to make adhesions less likely to form.; Objectives: To evaluate the effectiveness and safety of fluid and pharmacological agents on rates of pain, live births, and adhesion prevention in women undergoing gynaecological surgery.; Search Methods: We searched: the Cochrane Gynaecology and Fertility Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, and Epistemonikos to 22 August 2019. We also checked the reference lists of relevant papers and contacted experts in the field.; Selection Criteria: Randomised controlled trials investigating the use of fluid (including gel) and pharmacological agents to prevent adhesions after gynaecological surgery.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. We assessed the overall quality of the evidence using GRADE methods. Outcomes of interest were pelvic pain; live birth rates; incidence of, mean, and changes in adhesion scores at second look-laparoscopy (SLL); clinical pregnancy, miscarriage, and ectopic pregnancy rates; quality of life at SLL; and adverse events.; Main Results: We included 32 trials (3492 women), and excluded 11. We were unable to include data from nine studies in the statistical analyses, but the findings of these studies were broadly in keeping with the findings of the meta-analyses. Hydroflotation agents versus no hydroflotation agents (10 RCTs) We are uncertain whether hydroflotation agents affected pelvic pain (odds ratio (OR) 1.05, 95% confidence interval (CI) 0.52 to 2.09; one study, 226 women; very low-quality evidence). It is unclear whether hydroflotation agents affected live birth rates (OR 0.67, 95% CI 0.29 to 1.58; two studies, 208 women; low-quality evidence) compared with no treatment. Hydroflotation agents reduced the incidence of adhesions at SLL when compared with no treatment (OR 0.34, 95% CI 0.22 to 0.55, four studies, 566 women; high-quality evidence). The evidence suggests that in women with an 84% chance of having adhesions at SLL with no treatment, using hydroflotation agents would result in 54% to 75% having adhesions. Hydroflotation agents probably made little or no difference to mean adhesion score at SLL (standardised mean difference (SMD) -0.06, 95% CI -0.20 to 0.09; four studies, 722 women; moderate-quality evidence). It is unclear whether hydroflotation agents affected clinical pregnancy rate (OR 0.64, 95% CI 0.36 to 1.14; three studies, 310 women; moderate-quality evidence) compared with no treatment. This suggests that in women with a 26% chance of clinical pregnancy with no treatment, using hydroflotation agents would result in a clinical pregnancy rate of 11% to 28%. No studies reported any adverse events attributable to the intervention. Gel agents versus no treatment (12 RCTs) No studies in this comparison reported pelvic pain or live birth rate. Gel agents reduced the incidence of adhesions at SLL compared with no treatment (OR 0.26, 95% CI 0.12 to 0.57; five studies, 147 women; high-quality evidence). This suggests that in women with an 84% chance of having adhesions at SLL with no treatment, the use of gel agents would result in 39% to 75% having adhesions. It is unclear whether gel agents affected mean adhesion scores at SLL (SMD -0.50, 95% CI -1.09 to 0.09; four studies, 159 women; moderate-quality evidence), or clinical pregnancy rate (OR 0.20, 95% CI 0.02 to 2.02; one study, 30 women; low-quality evidence). No studies in this comparison re orted on adverse events attributable to the intervention. Gel agents versus hydroflotation agents when used as an instillant (3 RCTs) No studies in this comparison reported pelvic pain, live birth rate or clinical pregnancy rate. Gel agents probably reduce the incidence of adhesions at SLL when compared with hydroflotation agents (OR 0.50, 95% CI 0.31 to 0.83; three studies, 538 women; moderate-quality evidence). This suggests that in women with a 46% chance of having adhesions at SLL with a hydroflotation agent, the use of gel agents would result in 21% to 41% having adhesions. We are uncertain whether gel agents improved mean adhesion scores at SLL when compared with hydroflotation agents (MD -0.79, 95% CI -0.82 to -0.76; one study, 77 women; very low-quality evidence). No studies in this comparison reported on adverse events attributable to the intervention. Steroids (any route) versus no steroids (4 RCTs) No studies in this comparison reported pelvic pain, incidence of adhesions at SLL or mean adhesion score at SLL. It is unclear whether steroids affected live birth rates compared with no steroids (OR 0.65, 95% CI 0.26 to 1.62; two studies, 223 women; low-quality evidence), or clinical pregnancy rates (OR 1.01, 95% CI 0.66 to 1.55; three studies, 410 women; low-quality evidence). No studies in this comparison reported on adverse events attributable to the intervention.; Authors' Conclusions: Gels and hydroflotation agents appear to be effective adhesion prevention agents for use during gynaecological surgery, but we found no evidence indicating that they improve fertility outcomes or pelvic pain, and further research is required in this area. It is also worth noting that for some comparisons, wide confidence intervals crossing the line of no effect meant that clinical harm as a result of interventions could not be excluded. Future studies should measure outcomes in a uniform manner, using the modified American Fertility Society score. Statistical findings should be reported in full. No studies reported any adverse events attributable to intervention. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Ahmad, M. F. (2020). "Ganoderma lucidum: A rational pharmacological approach to surmount cancer." Journal of Ethnopharmacology 260: 113047.
	Ethnopharmacological relevance: Ganoderma lucidum (G. lucidum) has been broadly used for health endorsement as well as longevity for over 2000 years in Asian countries. It is an example of an ancient remedy and known as immortality mushroom. It has been employed as a health promoting agent owing to its broad pharmacological and therapeutical approaches. It has been confirmed that G. lucidum exhibits significant potency to prevent and treat different types of cancers such as breast, prostate, colon, lung and cervical. Aim of the study: To explore anticancer effects of various pharmacologically active compounds obtained from G. lucidum and their possible mechanism of action. Material(s) and Method(s): A literature search was conducted using PubMed, Goggle Scholar, Saudi Digital Library and Cochrane Library until October 11, 2019. Search was made by using keywords such as anticancer evidence, mechanism of action, pharmacology, antioxidant, toxicity, chemotherapy, triterpenoids and polysaccharides of G. lucidum. Result(s): Various chemical compounds from G. lucidum exhibit anticancer properties mainly through diverse mechanism such as cytotoxic properties, host immunomodulators, metabolizing enzymes induction, prohibit the expression of urokinase plasminogen activator (uPA) and urokinase plasminogen activator receptor (uPAR) in cancer cells. Among the various compounds of G. lucidum triterpenoids and polysaccharides are under the major consideration of studies due to their several evidence of preclinical and clinical studies against cancer. Conclusion(s): Natural alternatives associated with mild side effects are the basic human need of present therapy to eradicate the new emerging disorders. This review is an attempt to compile pharmacologically active compounds of G. lucidum those exhibit anti cancer effects either alone or along with chemotherapy and anticancer mechanisms against various cancer cells, clinical trials, chemotherapy induced toxicity challenges with limitations. It acts as a possible substitute to combat cancer growth with advance and conventional combination therapies as natural alternatives.Copyright © 2020 Elsevier B.V.

Ahmadian, S., et al. (2020). "Effectiveness of Stem Cell Therapy in the Treatment of Ovarian Disorders and Female Infertility: A Systematic Review." Current stem cell research & therapy 15(2): 173-186.
	Background: Infertility is a major problem worldwide. Various strategies are being used to develop better treatments for infertility and The most trending strategy is the stem cell therapy. In this study, the literature on stem cell therapy for ovarian disorders is summarized with analysis of current developments.; Objective: Different published studies on stem cell-based therapy for the treatment of various types of ovarian insufficiency and disorders such as Premature Ovarian Insufficiency (POI) in the affected female population in animal or human clinical studies are systematically reviewed.; Methods: We monitored five databases, including PubMed, Cochrane, Embase, Scopus, and ProQuest. A comprehensive online search was done using the criteria targeting the application of stem cells in animal models for menopause. Two independent reviewers carefully evaluated titles and abstracts of studies. The stem cell type, source, dosage, route of administration were highlighted in various POI animals models. Non-relevant and review articles were excluded.; Outcomes: 648 published studies were identified during the initial comprehensive search process from which 41 were selected according to designed criteria. Based on our analysis, stem cells could accelerate ovarian tissues rejuvenation, regulate systemic sex-related hormones levels and eventually increase fertility rate.; Conclusion: The evidence suggests that stem cell-based therapies could be considered as an alternative modality to deal with women undergoing POI. (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Ahmadian, S., et al. (2019). "Effectiveness of Stem Cell Therapy in Treatment of Ovarian Disorders and Female Infertility: A Systematic Review." Current stem cell research & therapy.
	BACKGROUND: Infertility is a major problem worldwide. Various strategies are being used to develop better treatments for infertility. On trending, the strategy is stem cell therapy. In this study, the literature on stem cell therapy for ovarian disorders is summarized with analysis of current developments. OBJECTIVE: Different published studies on stem cell-based therapy for the treatment of various types of ovarian insufficiency and disorders such as Premature Ovarian Insufficiency (POI) in the affected female population in animal or human clinical studies systematically reviewed. METHOD: We monitored five databases, including PubMed, Cochrane, Embase, Scopus, and ProQuest. A comprehensive online search was done using including criteria targeting application of stem cells in animal models for menopause. Two independent reviewers carefully evaluated titles and abstracts of studies. The stem cell type, source, dosage, route of administration were highlighted in various POI animals models. Non-relevant and review articles were excluded. OUTCOMES: 648 published studies were identified during the initial comprehensive search process from which 41 were selected according to designed criteria. Based on our analysis, stem cells could accelerate ovarian tissues rejuvenation, regulate systemic sex-related hormones levels and eventually increase fertility rate. CONCLUSION: The evidence suggests that stem cell-based therapies could be considered as an alternative modality to deal with women undergoing POI.

Ahmed, A.-Z., et al. (2021). "A systematic review and meta-analysis of the selenium supplementation effects on cardiometabolic and hormonal parameters of PCOS patients."
	
Ahmed, M. and E.-M. Akmal (2022). "Intrauterine infusion of autologous platelet-rich plasma in women with recurrent implantation failure." PROSPERO International prospective register of systematic reviews.
	
Ahmed, M., et al. (2024). "Is high-intensity focused ultrasound a magical solution to endometriosis? A systematic review."
	
Ahmed, N., et al. (2022). "Bioactive Yoghurt Containing Curcumin and Chlorogenic Acid Reduces Inflammation in Postmenopausal Women." Nutrients 14(21).
	Menopause is marked by a gradual and permanent decrease of estrogen from the ovaries, leading to metabolic and physiological changes in the body. Combined with increased body mass index, postmenopausal women have elevated systemic inflammation and metabolic disturbances leading to increased risk of developing chronic diseases. A bioactive coconut yoghurt containing curcumin and chlorogenic acid was developed with the potential to target inflammatory processes. In this randomized crossover study, healthy postmenopausal women with a BMI of 25-40 were recruited to consume 125 g of either the bioactive or placebo yoghurt. Blood samples were collected at baseline, 30 min, and 1, 2, 3 and 4 h postprandially. Plasma inflammatory markers (TNFα and IL6) and metabolic markers (triglycerides, insulin and glucose) were measured. Participants had significantly lower plasma TNFα C max after consumption of the bioactive yoghurt compared to placebo (mean difference = 0.3 pg/mL; p = 0.04). Additionally, plasma TNFα was significantly lower postprandially compared to baseline after consumption of the bioactive yogurt but not the placebo. No differences were observed in the metabolic markers measured. Conclusions: The bioactive yoghurt fortified with curcumin and chlorogenic acid has the potential to reduce inflammatory mediators; however, a larger and longer-term study is required to confirm these findings.

Ahmed, R. J., et al. (2021). "The cost implications of continuous glucose monitoring in pregnant women with type 1 diabetes in 3 Canadian provinces: a posthoc cost analysis of the CONCEPTT trial." CMAJ open 9(2): E627‐E634.
	BACKGROUND: The Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial (CONCEPTT) found improved health outcomes for mothers and their infants among those randomized to self‐monitoring of blood glucose (SMBG) with continuous glucose monitoring (CGM) compared with SMBG alone. In this study, we evaluated whether CGM or standard SMBG was more or less costly from the perspective of a third‐party payer. METHODS: We conducted a posthoc analysis of data from the CONCEPTT trial (Mar. 25, 2013, to Mar. 22, 2016). Health care resource data from 215 pregnant women, randomized to CGM or SMBG, were collected from 31 hospitals in 7 countries. We determined resource costs posthoc based on prices from hospitals in 3 Canadian provinces (Ontario, British Columbia, Alberta). The primary outcome was the difference between groups in the mean total cost of care for mother and infant dyads, paid by each government (i.e., the third‐party payer) from randomization to hospital discharge (time horizon). The secondary outcome included CGM and SMBG costs not paid by governments (e.g., glucose monitoring devices and supplies). RESULTS: The mean total cost of care was lower in the CGM group compared with the SMBG group in each province (Ontario: $13 270.25 v. $18 465.21, difference in mean total cost [DMT] ‐$5194.96, 95% confidence interval [CI] ‐$9841 to ‐$1395; BC: $13 480.57 v. $18 762.17, DMT ‐$5281.60, 95% CI ‐$9964 to ‐$1382; Alberta: $13 294.39 v. $18 674.45, DMT ‐$5380.06, 95% CI ‐$10 216 to ‐$1490). There was no difference in the secondary outcome. INTERPRETATION: Government health care costs are lower when CGM is paid by the patient, driven by lower costs from reduced use of the neonatal intensive care unit in the CGM group; however, when governments pay for CGM equipment, there is no overall cost difference between CGM and SMBG. Governments should consider paying for CGM, as it results in improved maternal and neonatal outcomes with no added overall cost. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT01788527.

Ahmed, s., et al. (2022). "trans-vaginal hydro-laparoscope and hysterosalpingography in the infertility assessment."
	
Ahmed, S., et al. (2022). "Efficacy of Intrauterine Infusion of Autologous Platelet-Rich Plasma for Women with Repeated Embryo Implantation Failure: A Systematic Review and Meta‐Analysis of Randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Ahmed, S. I., et al. (2022). "Prophylactic antibiotics for uterine evacuation procedures to treat miscarriage." Cochrane Database of Systematic Reviews 2022(1): CD014844.
	Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. The objective of this review is to evaluate the effectiveness of routine antibiotic prophylaxis to women undergoing uterine evacuation procedures to treat miscarriage.Copyright © The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Ahn Eugene, R., et al. (2023). "Pertuzumab Plus Trastuzumab in Patients With Endometrial Cancer With ERBB2/3 Amplification, Overexpression, or Mutation: Results From the TAPUR Study." JCO precision oncology 7: e2200609.
	Purpose: The TAPUR Study is a pragmatic basket trial evaluating antitumor activity of commercially available targeted agents in patients with advanced cancers harboring potentially actionable genomic alterations. Data from a cohort of patients with endometrial cancer (EC) with ERBB2 or ERBB3 (ERBB2/3) amplification, overexpression, or mutation treated with pertuzumab plus trastuzumab (P + T) are reported.; Methods: Eligible patients had advanced EC, no standard treatment options, measurable disease (RECIST v1.1), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and tumors with ERBB2/3 amplification, overexpression, or mutation. Simon's two-stage design was used with a primary end point of disease control (DC), defined as objective response (OR) or stable disease (SD) of at least 16 weeks (SD16+) duration. Secondary end points include safety, duration of response, duration of SD, progression-free survival (PFS), and overall survival (OS).; Results: Twenty-eight patients were enrolled from March 2017 to November 2019; all patients were evaluable for efficacy and toxicity. Seventeen patients had tumors with ERBB2/3 amplification and/or overexpression, eight with both ERBB2 amplification and ERBB2/3 mutations, and three with only ERBB2 mutations. Ten patients had DC (two partial response and eight SD16+); all 10 had ERBB2 amplification, and 6 of the 10 patients with DC had >1 ERBB2/3 alteration. DC and OR rates were 37% (95% CI, 21 to 50) and 7% (95% CI, 1 to 24), respectively; the median PFS and median OS were 16 weeks (95% CI, 10-28) and 61 weeks (95% CI, 24-105), respectively. One patient experienced a grade 3 serious adverse event (muscle weakness) at least possibly related to P + T.; Conclusion: P + T has antitumor activity in heavily pretreated patients with EC with ERBB2 amplification and warrants additional study.

Ahnert, J. R., et al. (2023). "Phase 2, multicenter open-label basket trial of nab-sirolimus for patients with inactivating alterations in TSC1 or TSC2 (PRECISION I)." Cancer Research 83(8 Supplement).
	nab-Sirolimus is a novel albumin-bound mTOR inhibitor (mTORi) approved in the US for adult patients with malignant PEComa. In an exploratory analysis of the pivotal AMPECT trial of nabsirolimus in advanced malignant PEComa (NCT02494570), 8/9 (89%) and 1/5 (20%) patients with inactivating alterations in TSC1 and TSC2, respectively, had confirmed response (Wagner, J Clin Oncol, 2021). TSC1 and TSC2 alterations have been observed in patients with a broad variety of cancers. Most treatment-related adverse events in AMPECT were grade 1/2 (none were grade >=4) and were consistent with long-term treatment of nab-sirolimus. PRECISION I (NCT05103358) will evaluate efficacy and safety of nab-sirolimus in patients with TSC1 (Arm A) and TSC2 (Arm B) alterations. Eligible patients are >=12 years old and mTORi-naive, possess malignant solid tumors with TSC1 or TSC2 inactivating alterations (confirmed by central review of sequencing reports), and have received appropriate standard treatments, as determined by the investigator. nab-Sirolimus 100 mg/m2 will be given weekly intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle. The primary endpoint is overall response rate per independent radiographic review (IRR) using RECIST v1.1. Other endpoints include duration of response, time to response, progressionfree survival by IRR, overall survival, patient-reported quality of life, and safety. Enrollment began March 2022. Collaboration with leading next-generation sequencing vendors will expedite the identification of patients with qualifying TSC1 or TSC2 mutations; study access will be facilitated through a "just-in-time" approach to trial location activation. Based on the prevalence of TSC1 or TSC2 inactivating alterations, the most frequent tumor types expected are bladder, hepatobiliary, endometrial, soft tissue sarcoma, ovarian, and esophagogastric (Table). .

Ahren, I. L., et al. (2023). "Decreasing the Adverse Effects in Pelvic Radiation Therapy: A Randomized Controlled Trial Evaluating the Use of Probiotics." Advances in Radiation Oncology 8(1): 101089.
	Purpose: The aim of this randomized controlled trial was to evaluate the potential benefit from 2 probiotic bacteria of the species Lactiplantibacillus plantarum against radiation therapy-induced comorbidities. Methods and Materials: Women (>18 years of age) scheduled for radiation therapy because of gynecologic cancer were randomly allocated to consume placebo or either low-dose probiotics (1 x 1010 colony-forming unit/capsule twice daily) or high-dose probiotics (5 x 1010 colony-forming unit/capsule twice daily). The intervention started approximately 1 week before the onset of radiation therapy and continued until 2 weeks after completion. During this period the participants were daily filling in a study diary documenting the incidence and severity of symptoms, intake of concomitant medication, and stool consistency. The primary endpoint was the probiotic effect on the mean number of loose stools during radiation therapy. Result(s): Of the 97 randomized women, 75 provided data for the analysis of the results. The mean number of loose stools (sum of Bristol stool type 6 and 7) was not significantly reduced in the probiotic groups, but there was a significant reduction in the mean number of days with >1 loose stool with 15.04 +/- 8.92 days in the placebo and 8.65 +/- 5.93 days in the high-dose probiotics group (P = .014). The benefit was even more pronounced in the 2 weeks following the end of radiation therapy (P = .005). Moreover, intake of the probiotics resulted in a reduced severity of the symptoms grinding abdominal pain (P = .041) and defecation urgency (P = .08) and a reduced percentage of days with these symptoms (P = .023 and P = .042, respectively), compared with placebo. There were no differences regarding reported adverse events. Conclusion(s): Intake of the 2 probiotic bacteria was beneficial and reduced many measures or symptoms of the radiation-induced toxicity in women treated for gynecologic cancer.Copyright © 2022 The Authors

Ahsen DemİRhan, K. and İ. Kevser (2023). "The effect of telemedicine interventions on patient outcomes in gynecological surgery: A systematic review and meta-analysis study."
	
Ai, F., et al. (2022). "Effect of estrogen on vaginal complications of pessary use: a systematic review and meta-analysis." Climacteric 25(6): 533-542.
	Objective: We aimed to systematically review the impact of local estrogen use in combination with a pessary on vaginal complications in postmenopausal women with pelvic organ prolapse (POP). Method(s): We searched databases including Medline, Embase, PubMed, Clinical Trials and the Cochrane Central Register of Controlled Trials for relevant literature published in English from inception to 31 May 2021. Only randomized controlled trials (RCTs) and cohort studies were included. Result(s): In total, five studies were included (three RCTs, one prospective study and one retrospective cohort study). The meta-analysis was performed with subgroups. Our results indicated a significantly lower incidence of bacterial vaginosis (BV) among postmenopausal women who used estrogen than among controls, with a total pooled odds ratio (OR) of 0.29 (95% confidence interval [CI]: 0.11-0.72; I 2 = 38%; p = 0.008). The summary ORs of the estrogen use group were 0.98 (95% CI: 0.59-1.63; I 2 = 41%; p = 0.95) for vaginal ulceration, 0.80 (95% CI: 0.42-1.54; I 2 = 29%; p = 0.50) for vaginal bleeding and 0.74 (95% CI: 0.35-1.58; I 2 = 35%; p = 0.44) for vaginal discharge. Conclusion(s): Local estrogen in combination with a pessary could decrease the BV rate among postmenopausal women with POP. However, consensus regarding the value of estrogen use for decreasing other pessary complications has not yet been reached. Additional multicenter RCTs with large sample sizes should be conducted to better understand the effect of estrogen use on reducing pessary-related complications.Copyright © 2022 International Menopause Society.

Aitbayeva, B., et al. (2023). "Effects of unilateral apical sling and laparoscopic sacrocolpopexy on the outcome in women with apical prolapse: randomised trial." Ginekologia polska.
	OBJECTIVES: The purpose of this study was to compare the use of unilateral apical sling versus laparoscopic sacrocolpopexy in the treatment of the apical form of pelvic organ prolapse in women. M: aterial and methods:A prospective, single-center randomized trial included 100 patients who were alternately assigned to treatment. Each patient had a >= III stage of apical or anterior-apical prolapse determined by the POP-Q system. 45 accepted for unilateral apical sling (UAS)and 55 accepted for laparoscopic sacrocolpopexy (LS). Data were compared by the One-way ANOVA test using IBM SPSS stats 19. RESULT(S): Mean operating time was significantly greater in the LS group versus UAS group, 194.6 vs 42.4 minutes, respectively (p < 0.05). The amount of intraoperative bleeding was significantly higher in the UAS group, compared to the LS group (p = 0.01). Within the follow-up period, 2 patients in UAS group and 3 patients in LS group (4.4% vs 5.4%, respectively; p = 0.9) had recurrent cystocoele. HRQoL and sexual outcomes did not differ significantly between the two treatment groups. CONCLUSION(S): s:Our data demonstrate the non-superiority one on each other of the two different approaches, except in terms of shorter operating time and higher intraoperative bleeding when UAS used. These findings raise questions about the need for long-term results of quality of life outcomes for women with genital prolapse, especially in resource-limited settings similar to Kazakhstan.

Akansha, et al. (2023). "Low Dose-Extended Letrozole versus Double Dose-Short Letrozole Protocol for Induction of Ovulation in Women with Polycystic Ovary Syndrome." International Journal of Pharmaceutical and Clinical Research 15(2): 915-923.
	Background and Aim: The major factor for anovulatory infertility is polycystic ovarian syndrome (PCOS). As a new therapeutic option, letrozole and other aromatase inhibitors (AIs) may compete with clomiphene citrate (CC) to induce ovulation in this population. The purpose of the current study was to compare the effectiveness of the low dose-extended or long letrozole protocol and the double dose-short letrozole strategy in ovulation induction in individuals with polycystic ovarian syndrome. Material(s) and Method(s): This study was done on the diagnosed cases of PCOS patients with subfertility in the department of obstetrics and gynecology for the period of 1 year. Letrozole 2.5 mg tablets were given daily for 10 days to the low dose-extended letrozole group or experimental group and tabs were given to the double dose-short letrozole group or control group. Starting on the second day of menstruation or the first day of withdrawal bleeding, take letrozole 5 mg once day for 5 days. On day 12 of the menstrual cycle, transvaginal sonography was used to quantify the endometrial thickness and count of developing follicles using a technique called folliculometry. On days 21 through 23, mid-luteal serum progesterone was tested to confirm ovulation. Result(s): The mean LH levels of the two groups did not significantly differ from one another. In the third cycle, patients in the extended letrozole group (54.28%) and the short letrozole group (18.75%), respectively, achieved multifollicular development, bearing statistically significant differences. In the first cycle, group II had more patients grow dominant follicles (18 mm) than group I, however in the second and third cycles, group I patients had more patients generate dominant follicles (18 mm). While there was a higher percentage of ovulating patients in the low dose prolonged letrozole group (76.5% versus 71.9%), there was no statistically significant difference. Conclusion(s): Low dose-extended letrozole protocol can be a better alternative to double dose-short letrozole protocol in respect to significant increase in the number of growing follicles with a higher trend to raise the ovulation rate and pregnancy rate though there were no significant differences in dominant follicle size, endometrial thickness, ovulation rate and pregnancy rate between two groups.Copyright © 2023, Dr Yashwant Research Labs Pvt Ltd. All rights reserved.

Akbari, A., et al. (2023). "Effect of intramuscular injection of human chorionic gonadotropin on endometrium preparation in frozen-thawed embryo transfer cycle: A randomized clinical trial." Caspian journal of internal medicine 14(2): 185-191.
	Background: Assisted reproductive therapy (ART) has been developed remarkably in these decades; however, the rate of unsuccessful embryo implantation especially in the frozen-thawed embryo transfer (FET) cycles remains high and is reported up to 70%. The current study was designed to compare the effect of intramuscular injection of hCG on endometrium preparation and embryo implantation, in women undergoing FET compared to the control group.; Methods: This clinical trial was done on 140 infertile women that underwent FET. The study sample was randomly allocated to the intervention group (two 5000 unit ampoules of hCG were injected intramuscularly before the first dose of progesterone administration) and the control group (without hCG injection). In both groups, 4 days after progesterone administration, the cleavage stage embryos were transferred. The study outcomes were biochemical pregnancy, clinical pregnancy and abortion rate.; Results: The average age of intervention and control group was 32.65±6.05 and 33.11±5.36 years, respectively. The basic information between two study groups did not differ significantly. The chemical (30% vs. 17.1%, P=0.073, relative risk (RR)=0.57) and clinical (28.6% vs. 14.3%, P=0.039, RR=0.50) pregnancy rates were higher in the intervention group compared to the control group; these higher ratios were only significant in clinical pregnancy rate. Abortion rate was not significantly (P=0.620) different between the intervention and control groups (4.3% vs. 1.4%, respectively).; Conclusion: This study showed that intramuscular injection of 10000 IU hCG before the endometrial secretory transformation phase in cleavage-stage embryo, improves IVF cycle outcomes.; Competing Interests: The authors declare no conflict of interest.

Akbaribazm, M., et al. (2021). "Female infertility and herbal medicine: An overview of the new findings." Food science & nutrition 9(10): 5869-5882.
	Infertility is defined as the failure to achieve a successful pregnancy after 12 months' sexual activity that affects 15%-17% of couples in the world and about 50% of them are related to female infertility factors. In this study, using the PRISMA checklist and MeSH keywords, 128 articles were extracted from various databases (PubMed, Cochrane library, WHO, Iranmedex, Science Direct, SID, and Google Scholar search engine) without language and time restrictions, and 128 articles were selected after eliminating duplicate studies. In this review, we present some solid evidence for role of herbal medicine in the treatment of female infertility. The results of this study showed that different parts of some plants are rich in polyphenolic compounds (isoflavones and flavonoids) and other compounds which are beneficial to in reproductive health in women. The compounds in these plants, along with regulating the female endocrine pathways, and improving symptoms of menopause, treat female reproductive disorders such as polycystic ovary syndrome (PCOS), premature ovarian failure (POF), endometriosis, hyperprolactinemia, and hypothalamic dysfunction; moreover, because of their anticancer, antioxidant, and antidepressant properties, they can be used in traditional medicine or in the pharmaceutical industry as safe compounds in women's health.

Akbari-Sene, A., et al. (2023). "Intravenous Versus Intraperitoneal Dexamethasone Effects on Postoperative Nausea, Vomiting, and Pain After Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial." Journal of Gynecologic Surgery 39(5): 213-219.
	Objective: This study compared the effects of intraperitoneal (i.p.) versus intravenous (i.v.) dexamethasone injection on reducing postoperative nausea and vomiting (PONV) as well as pain after gynecologic laparoscopic surgery. Material(s) and Method(s): In this randomized, triple-blinded clinical trial, 90 women who underwent laparoscopic surgery for gynecologic indications were divided randomly into 3 groups: (1) Group IV-D, single 8-mg dose of i.v. dexamethasone intraoperatively with i.p. placebo; (2) IP-D, single 8-mg dose of i.p. dexamethasone with i.v. placebo; and (3) placebo, i.v. and i.p. distilled water. PONV and pain intensity were measured every 6 hours postoperatively in the first 24 hours with a visual analogue scale (VAS). Result(s): Ninety patients were in the 3 groups, with 30 patients in each group. The mean - standard deviation age of participants was 29.38 - 4.66 years. There was a significant difference in VAS pain at 6, 12, 18, and 24 hours after surgery between groups IV-D and IP-D (p < 0.001), groups IP-D and placebo (p < 0.001), and groups IV-D and placebo (p < 0.001). PONV VAS at 6, 12, 18 and 24 hours were significantly different between groups IV-D and IP-D (p < 0.001), groups IP-D and placebo (p < 0.001), and groups IV-D and placebo (p < 0.001). Conclusion(s): Dexamethasone significantly reduced incidence and severity of PONV and pain in patients after laparoscopic gynecologic surgery, more so when using i.p. injection. Dexamethasone reduced the need for opioid analgesics.Copyright © Mary Ann Liebert, Inc.

Akdemir, A., et al. (2023). "Comparison of laparoscopic enclosed electromechanical morcellation and vaginal enclosed scalpel morcellation at laparoscopic myomectomy: A prospective randomized trial." The Journal of Obstetrics and Gynaecology Research 49(2): 691-700.
	Aim: This study aimed to compare the laparoscopic-enclosed electromechanical morcellation (LEM) with vaginal-enclosed scalpel morcellation (VSM) in laparoscopic myomectomy procedures.; Methods: One hundred eighteen patients who underwent laparoscopic myomectomy were enrolled the prospective randomized interventional clinical study in tertiary university hospital. After myomectomy, tissue removal was accomplished via either LEM using the in-glove morcellation technique or VSM.; Results: The median tissue removal time was longer in the LEM group (25 min [range: 14-55]) than the VSM group (20 min [range: 6-38] [p = 0.001]). Rescue analgesia requirement was significantly higher in the LEM group than the VSM group (mean rank: 56.92 vs. 40.92 doses, respectively; p < 0.001). There was no significant difference between preoperative and postoperative third month total scores of female sexual function index (FSFI) and subdomains in the LEM group. Conversely, all subdomains and total scores of FSFI (26.5 [16.7-34.8] vs. 22.7 [15.2-28.7]) except pain significantly worsened 3 months after operation in the VSM group.; Conclusions: LEM was associated with a longer tissue removal time and increased postoperative analgesic requirement. On the other hand, VSM was associated with worsened postoperative sexual function from baseline. (© 2022 Japan Society of Obstetrics and Gynecology.)

Aker Menekşe, N. and F. Özdemir (2023). "The effect of the approach based on the Neuman Systems Model on stress and coping in women receiving intrauterine insemination treatment: A randomized controlled trial." Health Care for Women International 44(4): 457-472.
	This randomized controlled study was conducted to determine the effect of the approach based on the Neuman Systems Model (NSM) on stress and coping in women receiving intrauterine insemination (IUI) treatment. The study participants consisted of 62 women. Data was collected using a personal information form, the COMPI Fertility Problem Stress Scale, and the COMPI Coping Strategy Scale. Women in the intervention group had lower stress levels in their personal and marital domain post-test median scores than those in the control group. Women in the intervention group also had lower active-avoidance coping method and higher meaning-based coping method post-test mean scores. The NSM-based approach is beneficial in decreasing stress and positively affects women to cope with stress. Both infertility and its treatments are stressful. Health care professionals have important responsibilities for reducing the stress of infertile women and strengthening infertile women's ability to cope. The NSM-based approach is considered to have positive effects on stress and the ability of women to cope who receive IUI treatments. In addition, IUI is a widely applied method which is used before switching to assisted reproductive techniques. If this treatment fails, the stress coping techniques learned during this treatment can be used in later treatment processes. We conducted this study to investigate the effects of the NSM-based approach on stress and coping strategies in women receiving IUI treatment.

Akhatova, A., et al. (2023). "Reproductive and Obstetric Outcomes after UAE, HIFU, and TFA of Uterine Fibroids: Systematic Review and Meta-Analysis." International Journal of Environmental Research and Public Health 20(5).
	Novel treatment options for uterine fibroids, such as uterine artery embolization (UAE), ultrasound-guided and magnetic resonance-guided high-intensity focused ultrasound (USgHIFU and MRgHIFU), and transcervical radiofrequency ablation (TFA) methods, are widely used in clinical practice. This systematic review and meta-analysis (CRD42022297312) aims to assess and compare reproductive and obstetric outcomes in women who underwent these minimally invasive approaches for uterine fibroids. The search was performed in PubMed, Google Scholar, ScienceDirect, Cochrane Library, Scopus, Web of Science and Embase. Risk of bias was assessed using the Newcastle-Ottawa Scale (NOS) and Cochrane guidelines. The articles were selected to meet the following eligibility criteria: (1) research article, (2) human subject research, and (3) the study of pregnancy outcomes after the treatment of uterine fibroids by either one of three methods-UAE, HIFU, and TFA. The analysis of 25 eligible original articles shows a similar rate of live births for UAE, USgHIFU, MRgHIFU, and TFA (70.8%, 73.5%, 70%, and 75%, respectively). The number of pregnancies varied considerably among these studies, as well as the mean age of pregnant women. However, the results of pregnancy outcomes for TFA are insufficient to draw firm conclusions, since only 24 women became pregnant in these studies, resulting in three live births. The miscarriage rate was highest in the UAE group (19.2%). USgHIFU was associated with a higher rate of placental abnormalities compared to UAE (2.8% vs. 1.6%). The pooled estimate of pregnancies was 17.31% to 44.52% after UAE, 18.69% to 78.53% after HIFU, and 2.09% to 7.63% after TFA. The available evidence confirmed that these minimally invasive uterine-sparing treatment options for uterine fibroids are a good approach for patients wishing to preserve their fertility, with comparable reproductive and obstetric outcomes among the different techniques.

Akhtar, M. A., et al. (2019). "Thyroxine replacement for subfertile women with euthyroid autoimmune thyroid disease or subclinical hypothyroidism." The Cochrane Database of Systematic Reviews 6: CD011009.
	Background: Thyroid disease is the second most common endocrine disorder affecting women of reproductive age. Subclinical hypothyroidism is diagnosed by an elevated thyroid-stimulating hormone concentration with a normal concentration of free thyroxine hormone. Autoimmune thyroid disease (ATD) is diagnosed by the presence of thyroid autoantibodies, regardless of thyroid hormone levels. Thyroxine may be a useful treatment for subfertile women with these two specific types of thyroid disease for improving pregnancy outcomes during assisted reproduction.; Objectives: To evaluate the efficacy and harms of levothyroxine replacement in subfertile women with subclinical hypothyroidism or with normal thyroid function and thyroid autoimmunity (euthyroid autoimmune thyroid disease, or euthyroid ATD) undergoing assisted reproduction.; Search Methods: We searched the Cochrane Gynaecology and Fertility (CGF) Group specialised register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and two trials registers together with reference checking and contact with study authors and experts in the field to identify studies. We searched for all published and unpublished randomised controlled trials (RCTs) comparing thyroxine with no treatment or placebo, without language restrictions, from inception to 8 April 2019, and in consultation with the Cochrane CGF Information Specialist.; Selection Criteria: We included women undergoing assisted reproduction treatment, meaning both in vitro fertilisation and intracytoplasmic sperm injection, with a history of subfertility and with subclinical hypothyroidism or with euthyroid ATD. We excluded women with a previously known clinical hypothyroidism or already taking thyroxine or tri-iodothyronine. RCTs compared thyroxine (levothyroxine) with either placebo or no treatment.; Data Collection and Analysis: We used standard methodological procedures expected by Cochrane. Our primary review outcomes were live birth and adverse events of thyroxine; our secondary outcomes were clinical pregnancy, multiple pregnancy and miscarriage.; Main Results: The review included four studies with 820 women. The included studies were of overall low risk of bias. Using GRADE methodology, we assessed the quality of evidence for the primary outcomes of this review to be very low- to low-quality evidence. Evidence was downgraded for imprecision as it was based on single, small trials with wide confidence intervals (CI). We were able to include data from three of the four included studies.In one study of women with both subclinical hypothyroidism and positive or negative anti-TPO antibodies (autoimmune disease), the evidence suggested that thyroxine replacement may have improved live birth rate (RR 2.13, 95% CI 1.07 to 4.21; 1 RCT, n = 64; low-quality evidence) and it may have led to similar miscarriage rates (RR 0.11, 95% CI 0.01 to 1.98; 1 RCT, n = 64; low-quality evidence). The evidence suggested that women with both subclinical hypothyroidism and positive or negative anti-TPO antibodies would have a 25% chance of a live birth with placebo or no treatment, and that the chance of a live birth in these women using thyroxine would be between 27% and 100%.In women with normal thyroid function and thyroid autoimmunity (euthyroid ATD), treatment with thyroxine replacement compared with placebo or no treatment may have led to similar live birth rates (risk ratio (RR) 1.04, 95% CI 0.83 to 1.29; 2 RCTs, number of participants (n) = 686; I 2 = 46%; low-quality evidence) and miscarriage rates (RR 0.83, 95% CI 0.47 to 1.46, 2 RCTs, n = 686, I 2 = 0%; low-quality evidence). The evidence suggested that women with normal thyroid function and thyroid autoimmunity would have a 31% chance of a live birth with placebo or no treatment, and that the chance of a live birth in these women using thyroxine would be between 26% and 40%.Adverse events were rarely reported. One RCT reported 0/32 in the thyroxine replacement group and 1/32 preterm births in the control group in women diagnosed with subclinical hypothyroidism and positive or negative anti TPO antibodies. One RCT reported 21/300 preterm births in the thyroxine replacement group and 19/300 preterm births in the control group in women diagnosed with positive anti-TPO antibodies. None of the RCTs reported on other maternal pregnancy complications, foetal complications or adverse effects of thyroxine.; Authors' Conclusions: We could draw no clear conclusions in this systematic review due to the very low to low quality of the evidence reported.

Akmansu, M., et al. (2023). "Probiotic-prebiotic usage effects on acute inflammation parameters receiving pelvic radiotherapy patients : A prospective multicentric study." Clinical Nutrition ESPEN 58: 446.
	Rationale: Patients using prebiotics or probiotics+probiotics while receiving pelvic radiotherapy were compared with the control group, and their side effects and acute inflammatory responses were examined. Method(s): The study started after the approval of the ethics committee.76 consecutive patients from 2 centers participated in the study.The patients were divided into 3 groups.The first group used a conventional diet,the second group used a conventional diet+prebiotic, and the third group used a conventional diet+a prebiotic and probiotic-containing product.16 of them were in the control group,22 of them were in the prebiotic group and 38 of them were in the probiotic+prebiotic group.Their side effects were calculated with EORTC-QLQ-CR-29 and Bristol stool scale.Inflammatory response assessment was done with TNF-alpha and IL-6. All patients underwent both a blood examination and the aforementioned tests at 1st week and at the 5th week of radiotherapy. Result(s): In patients in the control group who underwent pelvic RT without probiotic-prebiotic use such as TNF-alpha and IL-6 at 5th week, there was increase trend in acute phase reactant mean values. There was a significant increase in IL-6 in the prebiotic group,but not in TNF-alpha.There was no significant increase in TNF-alpha or IL-6 in the prebiotic+probiotic group. In prebiotic+probiotic group,there was no increase in GIS side effect parameters in EORTC-QLQ-CR-29 and bristol stool scores. Conclusion(s): This is the first prospective clinical study to evaluate the acute inflammatory effects of radiotherapy with acute phase reactants comparing it with the probiotic+prebiotic or prebiotic-only group and the control group.Absence of an increase in TNF-alpha and IL-6 in the group using prebiotic+probiotic while applying pelvic radiotherapy indicates the effectiveness of prebiotic+probiotic usage against GIS side effects Disclosure of Interest: None declaredCopyright © 2023

Aktaş, H. Ş., et al. (2022). "The effects of high intensity-interval training on vaspin, adiponectin and leptin levels in women with polycystic ovary syndrome." Archives of physiology and biochemistry 128(1): 37-42.
	Aim: We aimed to investigate the metabolic effects of HIIT exercise on PCOS patients and how it affects adiponectin, vaspin and leptin.; Material and Methods: Twenty women with PCOS were included in the study and were divided into two groups. HIIT program was applied for 10 PCOS and Medium Intensity Continuous Training (MICT) program was applied for other 10 PCOS. At the beginning and at the end of the study, total cholesterol, low-density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), triglyceride(TG), insulin, Adiponectin, Leptin, Vaspin levels of both PCOS groups were evaluated.; Results: When PCOS patients by performed HIIT exercise for 12 weeks, we found that the levels of leptin and vaspin did not change while adiponectin levels increased. Moreover serum levels of insulin, TG, total cholesterol, LDL-C decreased but levels of HDL-C increased.; Conclusion: HIIT increased in the adiponectin levels in women with PCOS and provided more weight loss.

Akter, S., et al. (2023). "Melatonin enhances ovarian response in infertile women with polycystic ovary syndrome: A randomized controlled trial." Bangladesh Journal of Medical Science 22(4): 850-858.
	Background: Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age. Anovulation, decreased Oocyte quality and low endometrial receptivity are the cause of infertility in women with PCOS. Anovulation is the consequence of hyperandrogenism, insulin resistance. Furthermore, the reactive oxygen species (ROS) induce oxidative stress which may be responsible for poor Oocyte quality. Melatonin is a documented powerful free radical scavenger and broad-spectrum antioxidant. Current evidence suggests that melatonin involves in ovarian physiology including follicular development, ovulation, and oocyte maturation. Present study was tried to evaluate the effects of melatonin on biochemical parameters as well as outcomes of ovulation induction by letrozole in infertile women with polycystic ovary syndrome. Method(s): This is a randomized controlled trial including 74 women of Polycystic Ovary Syndrome (PCOS) with infertility. Intervention group received melatonin 3 mg at bed time for 8 weeks as pretreatment. Serum luteinizing hormone (LH), testosterone, anti mullerian hormone (AMH), fasting insulin, oral glucose tolerance test (OGTT) were measured at baseline and after 8 weeks. Both intervention and controlled group were received ovulation induction for 3 cycles by Letrozole (5 mg from cycle days 2 to 6). Intervention group continued melatonin until mature follicle achieved. The primary outcomes were biochemical changes by serum luteinizing hormone (LH), testosterone, anti mullerian hormone (AMH), fasting insulin, oral glucose tolerance test (OGTT) and ovarian responses by number of mature follicles, endometrial thickness and ovulation rate. Secondary outcome was pregnancy rate. Result(s): Melatonin treatment for 8 weeks significantly decreased testosterone (P <0.01) serum luteinizing hormone (<P.001), HOMA IR (P<0.01) and glucose tolerance (P<0.01). The change of anti mullerian hormone was not significant (>0.05). There was significant difference in number of mature follicles (< 0.01), mean endometrial thickness (P<0.01). The risk ratio (RR) of ovulation rate was 1.34(0.09-1.68) and pregnancy rate was 2.55 (.37-3.51). The risk ratio (RR) of pregnancy rate in relation to AMH level was 1.12(0.05-1.79) in <=8ng/ ml group and 8.65(0.25-9.59) in >=8ng/ml group which was significant. Conclusion(s): After 8 weeks pretreatment and 3 cycle's co treatment with ovulation induction by letrozole, melatonin seems to provide improved biochemical and ovarian response. Based on these results, melatonin could be considered as a potential therapeutic agent for infertile women with polycystic ovary syndrome.Copyright © 2023, Ibn Sina Trust. All rights reserved.

Al Qurashi, A. A., et al. (2022). "The effects of bariatric surgery on male and female fertility: A systematic review and meta-analysis." Annals of Medicine and Surgery 80: 103881.
	
Ala, S., et al. (2022). "Efficacy of Omega-3, -6, and -9 Fatty Acids, Alone or in Combination With Low Dose Aspirin, in Improvement of Uterine Blood Flow in Women With History of Recurrent Miscarriage: A Prospective, Randomized, Clinical Trial." Pharmaceutical and Biomedical Research 8(1): 43-52.
	Background: Much evidence suggests that increased uterine blood flow resistance (reduced uterine perfusion) raises the risk of Recurrent Miscarriage (RM). Objective(s): This study aimed at evaluating the efficacy of omega-3, -6, and -9 fatty acids, alone or in combination with aspirin, in reducing uterine blood flow resistance in women with a history of RM. Method(s): A total of 45 women with a history of two or more miscarriages and increased uterine artery blood flow resistance were included in this randomized clinical trial. They were randomly assigned to aspirin (80 mg/d) (group A, n=15), omega-3, -6, and -9 fatty acids (4800 mg/d) (group O, n=15), or combination therapy (group AO, n=15). The patients were visited after two months, and the uterine artery blood flow resistance was measured by Doppler sonography. Result(s): The Mean+/-SD age of participants was 32+/-3.5 years in group A, 32+/-3 years in group O, and 32.4+/-3 years in group AO. There was no significant difference between three groups in age (P=0.7), duration of marriage (P=0.55), duration of infertility (P=0.43) and number of previous miscarriages (P= 0.51). In all three groups, after two months of treatment, the average uterine artery blood flow resistance reduced considerably compared with the beginning of the trial (P=0.0001); however, there was no significant difference between the three groups (P=0.56). Conclusion(s): According to the study results, omega-3, -6, and -9 fatty acids can reduce uterine artery blood flow resistance and improve the uterine blood flow in women with RM, with equal efficacy to aspirin. Also, combination therapy offers no advantages over monotherapy.Copyright © 2020, The Authors.

Alabiad, M. A., et al. (2022). "Evaluation of Different Doses of the Aromatase Inhibitor Letrozole for the Treatment of Ectopic Pregnancy and Its Effect on Villous Trophoblastic Tissue." Reproductive Sciences 29(10): 2983-2994.
	Letrozole, an aromatase inhibitor, has recently been introduced as a favorable medical treatment for ectopic pregnancy. We aimed at evaluating the effects of different doses of letrozole for termination of ectopic pregnancy and study their effects on villous trophoblastic tissue. Sixty patients with undisturbed ectopic pregnancy were classified into three equal groups. Group I: the control group that contained women who underwent laparoscopic salpingectomy, Group II: patients who received letrozole (5 mg day-1) for 10 days, and Group III: patients who received letrozole (10 mg day-1) for 10 days. Subsequently, the beta-hCG levels were determined on the first day and after 11 days of treatment. Group IV consisted of patients of GII and GIII; their beta-hCG did not drop below 100 mIU/ml within 11 days, and underwent salpingectomy. Placental tissues from patients undergoing salpingectomy either from the control group or GIV were processed for the evaluation of estrogen (ER) and progesterone (PR) receptors, vascular endothelial growth factor (VEGF), and cleaved caspase 3 (CC-3) expression. Cases exposed to high dose letrozole 10 mg day-1 resulted in a higher ectopic pregnancy resolution rate of 85% (17/20), while the resolution rate of the low dose letrozole-treated group (5 mg day-1) was 65% (13/20), and also showed a significant reduction in beta-hCG levels on the 11th day, 25.63 +/- 4.29 compared to the low dose letrozole group 37.91 +/- 7.18 (P < 0.001), Meanwhile, the letrozole-treated group GIV showed markedly reduced expression of ER, PR, and VEGF and a significant increase in the apoptotic index cleaved caspase-3 compared to the control group (P < 0.001). The utilization of letrozole at a dose of 10 mg day-1 for medical treatment of ectopic pregnancy results in a high-successful rate without any severe side effects. Letrozole depriving the placenta of estrogen that had vascular supporting signals resulted in destroying the vascular network with marked apoptosis. Graphical abstract: [Figure not available: see fulltext.]Copyright © 2022, The Author(s).

Alamolhoda, S. H., et al. (2022). "The Effect of Herbal Medicines on Treatment of Hot Flashes in Postmenopausal Women: A Systematic Review and Meta-Analysis." Iranian Journal of Obstetrics, Gynecology and Infertility 25(10): 81-93.
	Introduction: Vasomotor symptoms during menopause occur on average in 75% of women. Hot flashes are the most common of these symptoms. Hormonal drugs are the most effective method of treatment. Due to the known risks of hormone therapy, many researchers have investigated the effect of herbal medicines to improve vasomotor symptoms, especially hot flashes. This study was performed with aim to investigate the clinical trial studies conducted on the effectiveness of various herbal medicines on hot flashes. Method(s): In this study, to find the related articles, databases of Google scholar, Scopus, PubMed, Web of science, Science direct and national databases such as (MagIran), (SID), (IranDoc) and (IranMedex) were searched from the beginning of January 2005 to January 2020. Data were combined using STATA software (version 12.2) and using meta-analysis method, random effects model. Result(s): In the present study, 11 clinical trials were included in the meta-analysis according to the inclusion criteria.In the medicinal plants group, mean reduction in the number of hot flushes was 2.41 times (95% CI: -1.56 to -3.27%) less than the control group, which was statistically significant (p<0.05).In addition, in the medicinal plants group, the intensity of hot flashes was 20.28 degrees (95% CI: -71.70 to -22.87) compared to the control group, and this difference was statistically significant (p<0.05). Conclusion(s): Medicinal plants containing phytoestrogens have good effects on reducing the frequency and intensity of hot flashes in menopausal women and can be a suitable treatment for hot flashes in menopausal women.Copyright © 2022, Mashhad University of Medical Sciences. All rights reserved.

Alan, U., et al. (2022). "Pharmacy role in the promotion of continence: a systematic review."
	
Alanwar, A. M., et al. (2022). "Maternal and Fetal Outcomes after Use of Lactoferrin in Prevention of Recurrent Bacterial Vaginosis in Pregnancy." NeuroQuantology 20(15): 7809-7815.
	Background: The most prevalent cause of vaginal discomfort in women is bacterial vaginosis (BV). It is characterised by an aberrant vaginal microbiota, which is predominately Gardnerellavaginalis and Atopobiumvaginae with a depletion of lactobacilli. Antibiotics are a short-term therapeutic approach that works well, but recurrent infections continue to be a severe issue that worsens maternal and foetal outcomes. Using probiotics effectively for the management of BV with better results is now supported by data. Aim of Study: To assess the maternal and fetal outcome after treatment with lactoferrin in patients with recurrent bacterial vaginosis in third trimester singleton pregnancy. Patients and method: This study was Randomized controlled clinical trial conducted at Obstetrics and Gynecology department, Zagazig University,outpatient clinic, included 66 cases with history of receurent bacterial vaginosis divided into two groups; study group: Lactoferrin (two capsules per day for five days, then one capsule per day for ten days) was administered orally. (pravotinR). Lactoferrin was not given to the control group. Throughout the follow-up phase, all women took 1 capsule of lactoferrin or placebo each day for 10 days per month. Result(s): Low APGAR1, preterm, CS delivery type, LBW and PROM were significantly higher with control group. Conclusion(s):In patients with bacterial vaginosis, repeated rounds of probiotics taken by mouth in conjunction with lactoferrin improved maternal and foetal outcomes.Copyright © 2022, Anka Publishers. All rights reserved.

Alba, M., et al. (2021). "Pelvic floor strengthening in non-specific lumbopelvic pain. Systematic review and meta-analysis."
	
Albahlol, I. A. (2021). "Cervical pregnancy management: An updated stepwise approach and algorithm." Journal of Obstetrics and Gynaecology Research 47(2): 469-475.
	The aim of this short review was to present and categorizes most of updated successful interventions for cervical pregnancy (CP) management in a simple designed easily recognized diagram together with a proposed algorithm of these interventions beside author clinical experience. A comprehensive literature search was carried out in the following electronic databases, PubMed, Scopus, Embase, Google Scholar, Directory of Open Access Journals and Cochrane electronic databases. Keywords including cervical ectopic pregnancy, medical treatment, conservative management, successful interventions, uterine artery embolization and hysteroscopy were used to search these various databases. There are different successful CP management interventions reported in the literature varied from simple to complex regimens according to the patient situation, obstetrician experience and availability of health services. These approaches were categorized in a stepwise diagram and a proposed algorithm. Up till now, there is no consensus regarding the optimal CP management. To the best of knowledge, this review was unprecedented in organizing and categorizing the different successful CP management interventions. The proposed currently undertaken stepwise approach diagram and algorithm highlights the rapidly changing management of CP and open the door for further meta-analysis.Copyright © 2020 Japan Society of Obstetrics and Gynecology

Albaladejo-Belmonte, M., et al. (2023). "Changes in pelvic floor electrical activity and vulvar pain after botulinum toxin treatment of vestibulodynia: are clinical and electrophysiological outcomes related?" Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference 2023: 1-4.
	Vestibulodynia is a gynecological condition with different treatment options available, including botulinum neurotoxin type A (BoNT/A) injections into the vulvar vestibule. Unlike other treatments, no studies have assessed changes in the myoelectrical activity of the pelvic floor muscles (PFM) after BoNT/A treatment. The aim of this study was thus to evaluate these changes and to correlate them with changes in vulvar pain sensitivity. To do this, 35 patients with vestibulodynia were recruited, the myoelectrical activity of their left and right PFM was recorded with surface electromyography (sEMG), and their vulvar pain sensitivity was monitored according to Visual Analogue Scale (VAS) and an algometer, both before and after BoNT/A treatment. According to our results, patients' signals during PFM relaxation showed a significantly higher power than those of healthy women at baseline, as shown by their root mean square values (RMS), but became similar at follow-up. Patients' mean vulvar pain VAS scores significantly decreased after treatment. Furthermore, baseline-to-follow-up differences of RMS at PFM rest vs. mean VAS were significantly correlated (CC=0.48, p<0.01) so that higher reductions in the PFM activity power were associated with higher decreases in vulvar pain.Clinical Relevance- Altered PFM electrophysiological condition of patients with vestibulodynia becomes similar to healthy women's after BoNT/A treatment. This study also points to a relationship between the evolution of clinical and PFM electrophysiological conditions.

Al-Bayyari, N., et al. (2021). "Androgens and hirsutism score of overweight women with polycystic ovary syndrome improved after vitamin D treatment: A randomized placebo controlled clinical trial." Clinical nutrition (Edinburgh, Scotland) 40(3): 870-878.
	BACKGROUND & AIM: The objective of this study was to investigate the effect of vitamin D treatment on androgen levels and hirsutism scores in overweight women with PCOS. METHODS: A prospective, randomized, double-blind, placebo-controlled clinical study was conducted at King Abdullah University Hospital in Irbid, Jordan. Overweight Jordanian females aged 18-49 years with vitamin D deficiency and PCOS (n = 60) were assigned to two groups: the treatment group (n = 30) who received 50,000 IU per week of vitamin D3 and the control group (n = 30) who received a placebo. RESULTS: After receiving the treatment for 12 consecutive weeks, the levels of total testosterone, parathyroid hormone, free androgen index, and hirsutism score were significantly decreased (P < 0.001), and the levels of 25-hydroxyvitamin D (25(OH)D), sex hormone binding globulin, and phosphorus were significantly increased (P < 0.05). Furthermore, significant changes were observed in ovarian volume and follicle numbers and size ultrasonography, and in the regularity of the menstrual cycle (P < 0.001). In the placebo group, no significant changes were observed in either androgen levels, hirsutism score, or menstrual regularity. CONCLUSION: Vitamin D3 at a treatment dose of 50,000 IU per week improved 25(OH)D levels and decreased the hirsutism scores and androgen levels of overweight women with PCOS. These results could mean increased fertility and better reproductive health for overweight women with PCOS; the use of vitamin D3 as a treatment for these patients should be further investigated. CLINICALTRIALS. GOV REGESTRATION NUMBER: NCT02328404.

Alberta University, o. (2024). Mindfulness in High Risk Pregnancies.
	No Results Available Behavioral: Mindfulness Change in stress symptoms|Change in anxiety symptoms|Change in depression symptoms|Change in mindful awareness|Mindfulness practice|Gestational age Female Not Applicable 60 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care Pro00102522 June 2025

Alboni, C., et al. (2023). "Robotic Surgery and Deep Infiltrating Endometriosis Treatment: The State of Art." Clinical and Experimental Obstetrics and Gynecology 50(1): 13.
	Objective: Surgical treatment of endometriosis, when indicated, has demonstrated to be effective in reducing painful symptoms and improve quality of life of patients affected with endometriosis. The minimally invasive approach via laparoscopy is the preferred method when compared with laparotomy but in the last two decades another minimally invasive approach has become available, the robotically assisted laparoscopic surgery. Robotic technology is widely used in different surgical branches, such as general surgery and urology. Moreover, the use of robotic surgery is already accepted for different gynecological procedures either for benign and for oncological diseases. The advantages of robotic surgery such as improve dexterity of movements, avoided tremor, increased magnification of 3-dimensional vision seem strategic in the context of a complex surgery as is deep endometriosis eradication. However, to date there is no unanimous consensus on whether robotically assisted procedures are a valid and safe alternative to laparoscopy in the treatment of endometriosis. Mechanism: In this narrative review we analyze the available literature assessesing the robotic treatment of all types of endometriosis and specifically deep infiltrating endometriosis, compared to the outcomes of conventional laparoscopy. Findings in Brief: Indeed, the evidence of safety and effectiveness of robotically assisted laparoscopy in endometriosis treatment is strong and almost unanimous. There is no clear superiority of one approach to the other but robotic-related advantages and future prospective are promising to be able to improve operative outcomes, reduce surgeon's fatigue and provide a technology easy to implement with a fast learning curve. Conclusion(s): Robotic technology applied to laparoscopy in the treatment of endometriosis could be seen as an effective and safe alternative to the conventional laparoscopic treatment.Copyright © 2023 The Author(s). Published by IMR Press.

Alborov, D. K., et al. (2023). "Therapeutic physical factors in chronic inflammatory diseases of the pelvic organs. (A wounded home-controlled study)." Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury 100(6): 52-58.
	
Alborzi, S., et al. (2023). "Approach to ureteral endometriosis: A single-center experience and meta-analysis of the literature." The Journal of Obstetrics and Gynaecology Research 49(1): 75-89.
	Aim: To report single-center outcomes of laparoscopic management of patients with ureteral endometriosis and perform a meta-analysis in order to select the best approach for these patients.; Methods: The cross-sectional study was conducted during a 6-year period (2015-2021) in the referral endometriosis center on 353 patients with ureteral endometriosis. For the meta-analysis, 10 articles, including 505 patients, were found to be eligible. In our meta-analysis, as well as our study, all endometriosis-related pain symptoms and complications of surgery were evaluated, analyzed, and reported.; Results: Of the 326 patients whose ureteral involvement was confirmed in pathology, hydronephrosis and intrinsic ureteral lesions were detected in only 10.76% and 3.1% of the patients. Mean operating time and hospitalization were 3.25 ± 1.83 h and 86 ± 2.58 days, respectively. The most common site of concomitant involvement with endometriosis was uterosacral ligament (92.9%) and rectosigmoid (70.53%). Type II and III of Cliven-Dindo complications were seen in 5.66% and 1.13% of patients, respectively. During a follow-up period, no evidence of bladder or ureteral re-involvement was observed. Similar to our meta-analysis, all endometriosis-related pain decreased significantly following operation (p ≤ 0.001). In our meta-analysis, the rate of ureteral endometriosis recurrence, stenosis/stricture, bladder atonia, urinary tract infection, hematuria, and fistula formation after surgery were: 2.0% (I 2 : 50.42%), 15.0% (I 2 : 0.00%), 14.0% (I 2 : 8.76%), 6.0% (I 2 : 0.00%), 7.0% (I 2 : 79.28%), and 2.0% (I 2 : 0.0%), respectively.; Conclusion: The laparoscopic resection of the UE could be suggested as a feasible and safe method associated with favorable functional outcomes. (© 2022 Japan Society of Obstetrics and Gynecology.)

Alborzi, S., et al. (2022). "The effect of vasopressin injection on ovarian reserve in patients with ovarian endometrioma: a randomized controlled trial." Reproductive Biomedicine Online 44(4): 651-658.
	Research Question: Does injecting vasopressin into the mesovarium during endometrioma cystectomy further preserve postoperative ovarian reserve by reducing intraoperative bleeding and electrocoagulation points?; Design: Randomized controlled trial conducted between March 2016 and March 2020. One hundred and twenty patients with unilateral and unilobulated endometrioma were included and divided into two groups: group 1 (n = 60) comprised all patients with ovarian cystectomy after vasopressin injection in the mesovarium space; group 2 included the controls. In both groups, the anti-Müllerian hormone (AMH) concentration was examined before surgery and 3, 6 and 12 months after surgery. In both groups, the number of bipolar cauterization points and the amount of bleeding during cystectomy as well as the pain symptoms related to endometriosis and pregnancy rate were further assessed and compared.; Results: Compared with the vassopressin group, the controls had significantly higher haemostasis points and bleeding (P = 0.0001). No significant difference was found between the two groups in serum AMH concentration at 3, 6 and 12 months after surgery. A significant reduction in pain symptoms was reported in both groups 6 months after surgery (P = 0.0001). No significant difference was found between the two groups in spontaneous pregnancy, miscarriage rate and pregnancy time after surgery.; Conclusion: Despite the reduction in the amount of bleeding and electrocoagulation points in the vasopressin group, ovarian reserve had a similar downward trend in both groups, which is attributed to the nature of these cysts. (Copyright © 2021 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Alborzi, S., et al. (2019). "The success of various endometrioma treatments in infertility: A systematic review and meta-analysis of prospective studies." Reproductive Medicine and Biology 18(4): 312-322.
	Background: Endometriosis is seen in 0.5%-5% of fertile and 25%-40% of infertile women. To investigate this conflict between gynecologists that ovarian endometriomas should be removed or not before making any decision about pregnancy among infertile women, the authors decided to carry out a systematic review and meta-analysis to compare the effect of various available therapeutic methods and notice the impact of these options on women's pregnancy rate.; Methods: This review is based on PRISMA recommendations with an electronic search using the following databases: PubMed, Scopus, Google scholar, etc, from 2000 to 2018, in the English language. The studies compare pregnancy rate based on four different treatment types of OMAs between infertile women: (surgery + ART, surgery + spontaneous pregnancy, aspiration ± sclerotherapy + ART, and ART alone).; Main Findings: At least eight prospective studies were included, in which 553 infertile women were compared in terms of treatment methods of OMAs before trying to become pregnant.; Conclusion: Treatments are usually based on the patient's clinical condition and must be individual, with the purpose of relieving pain, improving fertility, or both. The authors do not have not any significant difference between our four groups of study; however, the success of surgical procedure compared to other methods was higher and the success of ART alone was the least.; Competing Interests: Conflict of interest: Saeed Alborzi, Ziba Zahiri Sorouri, Elham Askari, Tahereh Poordast, and Kefayat Chamanara declare that they have no conflict of interest. Human/animal rights statements and informed consent: This article does not contain any studies with human and animal patients performed by any of the authors. (© 2019 The Authors. Reproductive Medicine and Biology published by John Wiley & Sons Australia, Ltd on behalf of Japan Society for Reproductive Medicine.)

Albright, B. B., et al. (2023). "Treatments and outcomes in high-risk gestational trophoblastic neoplasia: A systematic review and meta-analysis." BJOG: An International Journal of Obstetrics and Gynaecology 130(5): 443-453.
	Background: High-risk gestational trophoblastic neoplasia (GTN) is rare and treated with diverse approaches. Limited published institutional data has yet to be systematically reviewed. Objective(s): To compile global high-risk GTN (prognostic score >=7) cohorts to summarise treatments and outcomes by disease characteristics and primary chemotherapy. Search Strategy: MEDLINE, Embase, Scopus, ClinicalTrials.gov and Cochrane were searched through March 2021. Selection Criteria: Full-text manuscripts reporting mortality among >=10 high-risk GTN patients. Data Collection and Analysis: Binomial proportions were summed, and random-effects meta-analyses performed. Main Result(s): From 1137 records, we included 35 studies, representing 20 countries. Among 2276 unique high-risk GTN patients, 99.7% received chemotherapy, 35.8% surgery and 4.9% radiation. Mortality was 10.9% (243/2236; meta-analysis: 10%, 95% confidence interval [CI] 7-12%) and likelihood of complete response to primary chemotherapy was 79.7% (1506/1890; meta-analysis: 78%, 95% CI: 74-83%). Across 24 reporting studies, modern preferred chemotherapy (EMA/CO or EMA/EP) was associated with lower mortality (overall: 8.8 versus 9.5%; comparative meta-analysis: 8.1 versus 12.4%, OR 0.42, 95% CI: 0.20-0.90%, 14 studies) and higher likelihood of complete response (overall: 76.6 versus 72.8%; comparative meta-analysis: 75.9 versus 60.7%, OR 2.98, 95% CI: 1.06-8.35%, 14 studies), though studies focused on non-preferred regimens reported comparable outcomes. Mortality was increased for ultra-high-risk disease (30 versus 7.5% high-risk; meta-analysis OR 7.44, 95% CI: 4.29-12.9%) and disease following term delivery (20.8 versus 7.3% following molar pregnancy; meta-analysis OR 2.64, 95% CI: 1.10-6.31%). Relapse rate estimates ranged from 3 to 6%. Conclusion(s): High-risk GTN is responsive to several chemotherapy regimens, with EMA/CO or EMA/EP associated with improved outcomes. Mortality is increased in patients with ultra-high-risk, relapsed and post-term pregnancy disease.Copyright © 2023 John Wiley & Sons Ltd.

Albright Benjamin, B., et al. (2021). "Primary cytoreductive surgery for advanced stage endometrial cancer: a systematic review and meta-analysis." American Journal of Obstetrics and Gynecology 225(3): 237.e231-237.e224.
	Objective: Endometrial cancer uncommonly presents at an advanced stage and little prospective evidence exists to guide the management thereof. We aimed to summarize the evidence about primary cytoreductive surgery in the treatment of advanced stage endometrial cancer.; Data Sources: MEDLINE, Embase, and Scopus databases were searched from inception to September 11, 2020, using search terms representing the themes "endometrial cancer," "advanced stage," and "primary cytoreductive surgery."; Study Eligibility Criteria: We included full-text, English reports that included ≥10 patients undergoing primary cytoreductive surgery for advanced stage endometrial cancer and that reported on the outcomes of primary cytoreductive surgery and survival rates based on the residual disease burden.; Methods: Two reviewers independently screened the studies and with disagreements between the reviewers resolved by a third reviewer. Data were extracted using a standardized form. The percentage of cases reaching maximal (no gross residual disease) and optimal (<1 cm or <2 cm residual disease) cytoreduction were assessed by summing binomials proportions, and the association with survival was assessed using an inverse variance-weighted meta-analysis of logarithmic hazard ratios.; Results: From 1219 unique records identified, 34 studies were selected for inclusion. Studies consisted of single or multi-institutional cohorts of patients collected over a period of 6 to 24 years and included various mixes of histologies (endometrioid, serous, clear cell, and carcinosarcoma) and disease stages (III or IV). In a meta-analysis of the extent of residual disease after primary cytoreductive surgery, we found that 52.1% of cases reached no gross residual disease status (n=18 studies; 1329 patients) and 75% reached <1 cm residual disease status (n=27 studies; 2343 patients). The proportion of cytoreduction for both thresholds was lower for studies of stage IV vs stage III to IV disease (41.4% vs 69.8% for no gross residual disease; 63.2% vs 82.2% for <1 cm residual disease) but did not vary notably by histology. In a meta-analysis of the reported hazard ratios, submaximal (any gross residual disease vs no gross residual disease) and suboptimal (≥1 cm vs <1 cm) cytoreduction thresholds were associated with worse progression-free survival (submaximal hazard ratio, 2.16; 95% confidence interval, 1.45-3.21; I 2 =68%; suboptimal hazard ratio, 2.55; 95% confidence interval, 1.93-3.37; I 2 =63%) and overall survival rates (submaximal hazard ratio, 2.57; 95% confidence interval, 2.13-3.10; I 2 =1%; suboptimal hazard ratio, 2.62; 95% confidence interval, 2.20-3.11; I 2 =15%). Sensitivity analyses limited to high-quality studies demonstrated consistent results.; Conclusion: Among cases of advanced stage endometrial cancer undergoing primary cytoreductive surgery, a significant proportion of patients are left with residual disease, which is associated with worse survival outcomes. Further investigations about the roles of neoadjuvant chemotherapy and primary cytoreductive surgery in prospective trials is warranted in this population. (Copyright © 2021 Elsevier Inc. All rights reserved.)

Alcala University, o. (2021). Lumbar Spine Manipulation Versus Pharmacological Therapy in Young Women With Primary Dysmenorrhea.
	No Results Available Other: Lumbar spine manipulation|Drug: Hyoscine and Ibuprofen Pain intensity|Pressure pain threshold measured in tibialis malleolus|Pressure pain threshold measured in peroneal malleolus|Low-back related disability|Anxiety and depression Female Not Applicable 42 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 2111730 November 10, 2022

Alcala University, o. (2023). Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis.
	No Results Available Other: TeleRehab Group|Other: Advices Group Health Status Questionnaire (SF-12)|Visual Numeric Scale (VNS)|Endometriosis Health Profile (EHP-30)|Index of Sexual Function (IFSF)|Tampa Scale of Kinesiophobia (TSK)|Pain Catastrophizing Scale (PCS)|Hospital Anxiety and Depression Scale (HADS)|International Physical Activity Questionnaire (IPAQ)|Pittsburg Sleep Quality Index (PSQI)|Perceived Stress Scale (PSS)|Patient's adherence will be evaluated|Patient global impression of change (PGI-I) Female Not Applicable 66 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Investigator, Outcomes Assessor)|Primary Purpose: Treatment CEID/2023/6/106 January 17, 2027

Alcantarilla, L., et al. (2023). "Risk factors for relapse or recurrence in women with bipolar disorder and recurrent major depressive disorder in the perinatal period: a systematic review." Archives of Women's Mental Health 26(6): 737-754.
	It is well known that the perinatal period supposes a considerable risk of relapse for women with bipolar disorder (BD) and recurrent major depressive disorder (rMDD), with the consequences that this entails. Therefore, the authors sought to provide a critical appraisal of the evidence related to specific risk factors for this population with the aim of improving the prevention of relapses during pregnancy and postpartum. The authors conducted a systematic review assessing 18 original studies that provided data on risk factors for relapse or recurrence of BD and/or rMDD in the perinatal period (pregnancy and postpartum). Recurrences of BD and rMDD are more frequent in the postpartum period than in pregnancy, with the first 4-6 weeks postpartum being especially complicated. In addition, women with BD type I are at higher risk than those with BD type II and rMDD, and the most frequent presentation of perinatal episodes of both disorders is a major depressive episode. Other risk factors consistently repeated were early age of onset of illnesses, severity criteria, primiparity, abrupt discontinuation of treatment, and personal or family history of perinatal affective episodes. This review shows that there are common and different risk factors according to the type of disorder and to perinatal timing (pregnancy or postpartum) that should be known for an adequate prevention of relapses.Copyright © 2023, The Author(s), under exclusive licence to Springer-Verlag GmbH Austria, part of Springer Nature.

Aldrich, E. R., et al. (2022). "Impact of intrarectal diazepam on early postoperative pain following pelvic reconstructive surgery: a double-blind, randomized placebo-controlled trial." American Journal of Obstetrics and Gynecology 226(3 Supplement): S1277-S1278.
	Objectives: To evaluate the effect of diazepam rectal suppositories on early postoperative pain following hysterectomy and vaginal reconstruction for pelvic organ prolapse. Material(s) and Method(s): In this institutional review board approved, double-blind, randomized placebo-controlled trial, eligible patients were those scheduled to undergo a total vaginal hysterectomy with reconstructive surgery for prolapse. Consented patients were randomized to receive either a 10mg diazepam rectal suppository or an identical appearing placebo intraoperatively at the completion of surgery. Our primary outcome was vaginal pain 3.5-6 hours postoperatively utilizing the 100mm visual analog scale (VAS). Participants also completed surveys regarding pain at baseline, the morning of postoperative day (POD) one, and two-weeks postoperatively. Secondary outcomes included total morphine equivalents following surgery, patient satisfaction with pain control, and overall satisfaction. Chi-squared test, Fisher's exact test, and Mann-Whitney test were utilized. Our sample size calculation demonstrated that 55 patients per arm were required to detect a difference in our primary outcome. Result(s): From February 2020 to August 2021, 130 subjects were randomized. Seven patients withdrew, 113 have been analyzed to date; 57 in the diazepam group, 56 in placebo. The median age was 65 (IQR 27, 80), median BMI was 27.9 (IQR 18.70, 45.90), and 96.5% (n=109) of participants were white. There were no differences in baseline characteristics, prolapse stage, or types of procedures performed between groups. Ninety-nine percent (n=112) of participants had concurrent uterosacral ligament suspension, anterior and posterior repairs. Forty-one percent (n=46) had midurethral slings. Forty-five percent (n=51) had same-day discharge. There were no differences in the amount of intraoperative lidocaine injected (30.84 vs 30.16mL, p=0.679) or amount of rescue narcotics used in the immediate postoperative period (22.5 vs 16 morphine equivalents, p=0.286). There was also no difference in the primary outcome of VAS score for vaginal pain 3.5-6 hours postoperatively (24 vs 21mm, p=0.417). At their 2-week survey, patients in the placebo group reported higher satisfaction with pain control in the hospital (31 vs 41mm, p=0.012) and pain control at home (31 vs 40mm, p=0.043). No differences were noted among patients discharged on POD0 compared to those admitted overnight. Conclusion(s): In our population, placement of a 10mg Diazepam rectal suppository immediately following pelvic reconstructive surgery did not improve pain or narcotic usage in the early postoperative period. Although the placebo group reported slightly higher satisfaction with pain control two-weeks following surgery, overall pain levels were low. Therefore, we do not feel the addition of diazepam to the post-operative regimen is warranted.Copyright © 2022

Aleixo, G. F., et al. (2018). "Pelvic floor symptoms 5 to 14 years after total versus subtotal hysterectomy for benign conditions: a systematic review and meta-analysis." International Urogynecology Journal 30(2): 181-191.
	Introduction and hypothesis: We aim to compare total versus subtotal abdominal hysterectomy regarding urinary and bowel symptoms and pelvic organ prolapse at long-term follow-up. Method(s): A systematic literature search was performed on the MEDLINE, LILACS, Cochrane CENTRAL and SCOPUS databases and conference abstracts (AAGL, AUGS, ICS) from inception up to November 2017. We included randomized trials comparing total versus subtotal hysterectomy for benign conditions that evaluated pelvic floor symptoms over 5 years of follow-up. Risk of bias and GRADE assessment for quality of evidence were performed. Result(s): We included four studies involving 566 participants with follow-up ranging from 5 to 14 years. Women who underwent total hysterectomy presented lower risk of reported urinary incontinence [RR 0.74 (CI = 0.58, 0.94) i2 0%; p = 0.02] and stress urinary incontinence [RR 0.84 (CI = 0.71, 0.99) i2 0%; p = 0.04] than those who had subtotal hysterectomy. The events urinary frequency, urge incontinence, incomplete bladder emptying, pelvic organ prolapse, incontinence of stool and constipation did not favor one procedure over another in the long term (P > 0.05). Conclusion(s): Patient-reported urinary incontinence and stress urinary incontinence events favored total hysterectomy over subtotal hysterectomy up to 14-year long-term follow-up.Copyright © 2018, The International Urogynecological Association.

Alenzi, E. O. (2023). "Impact of Vitamin D Supplementation on Menstrual Cycle Irregularities among Women with Polycystic Ovary Syndrome who were Treated with Metformin: A Systematic Review with Meta-Analysis." Current Women's Health Reviews 19(4): 147-154.
	Background: There is inconsistency in the evidence about the effect of adding vitamin D supplements to metformin therapy among women with polycystic ovary syndrome (PCOS). Objective(s): In this systematic review, we described the differences in menstrual cycle irregularities between women who received vitamin D supplementation and those who didn't receive vitamin D among women who diagnosed with PCOS and received metformin. Method(s): We reviewed previous literature to identify all relevant studies. The included studies' quality and risk of bias were assessed using the Consolidated Standards of Reporting Trials (CONSORT) and the Reporting of Observational Studies in Epidemiology (STROBE) instrument. Cochrane's Q-test and I2 statistic were used to assess the heterogeneity across included studies. The fixed-effect model was used to calculate the total effect size. Result(s): Six studies were included, involving 633 women diagnosed with PCOS. Supplementation of vitamin D with metformin could have a significant impact on the improvement of menstrual cycles compared to receiving metformin alone (OR = 2.11, 95% CI, 1.40-3.19). There was no evidence of heterogeneity across included studies. Subgroup analysis showed that the magnitude of the association increased when only infertile women with PCOS were included (OR = 2.37, 95% CI, 1.52-3.72). Conclusion(s): This evidence suggests the possible benefit of adding vitamin D to metformin in regulating the menstrual cycle among women with PCOS, especially infertile women.Copyright © 2023 Bentham Science Publishers.

Alesi, S., et al. (2022). "Nutritional Supplements and Complementary Therapies in Polycystic Ovary Syndrome." Advances in nutrition (Bethesda, Md.) 13(4): 1243-1266.
	Polycystic ovary syndrome (PCOS) affects 1 in 5 women of reproductive age, and is characterized by menstrual irregularities, clinical or biochemical hyperandrogenism, and the presence of polycystic ovary morphology. One of the recommended treatment strategies in the international evidence-based guidelines is lifestyle modification, which includes diet and exercise, with the aim of improving a range of health outcomes. The incurable nature of PCOS reinforces the importance of developing novel and innovative symptomatic relief strategies, which are currently the only available approaches for improving quality of life for these women. Women with PCOS tend to be nutrient deficient in many common vitamins and minerals, thought to be associated with the psychological (depression, anxiety, etc.) and physiological (insulin resistance, diabetes, infertility, etc.) sequelae of the condition. Nutrient supplementation and the integration of complementary medicine as adjuncts to traditional lifestyle-based therapies in PCOS could therefore provide additional benefits to these women. In this review, we synthesize the evidence regarding nutrient supplementation and complementary therapies in PCOS, predominantly from randomized controlled trials, systematic reviews, and meta-analyses, to provide an overview of the state of knowledge in this field. The evidence to date suggests that specific vitamins (B-12, inositols, folate, vitamins D, E, and K), vitamin-like nutrients (bioflavonoids and α-lipoic acid), minerals (calcium, zinc, selenium, and chromium picolinate), and other formulations (melatonin, ω-3 fatty acids, probiotics, and cinnamon), as well as some complementary approaches such as acupuncture and yoga may be beneficial in PCOS. However, there remain areas of uncertainty and key limitations in the literature that must be overcome before these therapies can be integrated into routine clinical practice. (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Society for Nutrition.)

Alesi, S., et al. (2023). "Efficacy and safety of anti-androgens in the management of polycystic ovary syndrome: a systematic review and meta-analysis of randomised controlled trials." EClinicalMedicine 63: 102162.
	Background: Anti-androgens and combined oral contraceptive pills (COCPs) may mitigate hyperandrogenism-related symptoms of polycystic ovary syndrome (PCOS). However, their efficacy and safety in PCOS remain unclear as previous reviews have focused on non-PCOS populations. To inform the 2023 International Evidence-based Guideline in PCOS, we conducted the first systematic review and meta-analysis investigating the efficacy and safety of anti-androgens in the management of hormonal and clinical features of PCOS.; Methods: We systematically searched MEDLINE, Embase, PsycInfo, All EBM reviews, and CINAHL up to 28th June 2023 for randomised controlled trials (RCTs) examining oral anti-androgen use, alone or in combination with metformin, COCPs, lifestyle, or other interventions, in women of any age, with PCOS diagnosed by Rotterdam, National Institutes of Health or Androgen Excess & PCOS Society criteria, and using a form of contraception. Non-English studies and studies of less than 6 months duration or which used the same anti-androgen regimen in both/all groups were excluded in order to establish efficacy for the clinical outcomes of interest. Three authors screened articles against selection criteria and assessed risk of bias and quality using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework. Critical outcomes (prioritised during guideline development for GRADE purposes) included weight, body mass index (BMI), irregular cycles, hirsutism, liver function, and quality of life. Random effects meta-analyses were conducted where appropriate. This study is registered with PROSPERO, CRD42022345640.; Findings: From 1660 studies identified in the search, 27 articles comprising 20 unique studies were included. Of these, 13 studies (n = 961) were pooled in meta-analysis. Seven studies had a high risk of bias, nine moderate and four low. Anti-androgens included finasteride, flutamide, spironolactone, or bicalutamide. In meta-analysis, anti-androgens + lifestyle were superior to metformin + lifestyle for hirsutism (weighted mean difference [WMD] [95% CI]: -1.59 [-3.06, -0.12], p = 0.03; I 2 = 74%), SHBG (7.70 nmol/l [0.75, 14.66], p = 0.03; I 2 = 0%), fasting insulin and fasting insulin: glucose ratio (-2.11 μU/ml [-3.97, -0.26], p = 0.03; I 2 = 0% and -1.12 [-1.44, -0.79], p < 0.0001, I 2 = 0%, respectively), but were not superior to placebo + lifestyle for hirsutism (-0.93, [-3.37, 1.51], p = 0.45; I 2 = 76%) or SHBG (9.72 nmol/l [-0.71, 20.14], p = 0.07; I 2 = 31%). Daily use was more effective for hirsutism than use every three days (-3.48 [-4.58, -2.39], p < 0.0001, I 2 = 1%), and resulted in lower androstenedione levels (-0.30 ng/ml [-0.50, -0.10], p = 0.004; I 2 = 0%). Combination treatment with anti-androgens + metformin + lifestyle resulted in lower testosterone compared with metformin + lifestyle (-0.29 nmol/l [-0.52, -0.06], p = 0.01; I 2 = 61%), but there were no differences in hirsutism when anti-androgens + metformin + lifestyle were compared with either anti-androgens + lifestyle or metformin + lifestyle. In limited meta-analyses (n = 2 trials), combining anti-androgens with COCP resulted in poorer lipid profiles compared with COCP ± placebo, with no differences in other outcomes.; Interpretation: Current evidence does not support the use of anti-androgens preferentially to COCPs to treat hyperandrogenism in PCOS. Anti-androgens could be considered to treat hirsutism in PCOS, where COCPs are contraindicated, poorly tolerated, or present a sub-optimal response after a minimum 6-month period, with consideration of clinical context and individual risk factors and characteristics.; Funding: National Health and Medical Research Council (NH RC) of Australia Monash University.; Competing Interests: All authors declare no competing interests. JM received funding from the Orion Research Foundation and the Medical Society of Finland. MF received funding from the Gothenburg Medical Association, Sahlgrenska University H spital, the Iris Foundation and the Hjalmar Svensson Foundation, as well as honoraria from Gedeon Richter. HT received funding from the National Health and Medical Research Council (NHMRC) through the Centre for Research Excellence for Women's Health in Reproductive Life (CRE-WHiRL). SFW received support from the NHMRC-funded guideline to attend the guideline meeting and is a member of the board of directors for the Paediatric Endocrine Society. CTT is supported by CRE- WHiRL and chairs the Androgen Excess and Polycystic Ovary Syndrome Society Early Career Special Interest Group. None of these funding organisations had any role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. All other authors declare no competing interests. (© 2023 The Author(s).)

Alessandro, C., et al. (2022). "Intrauterine strategy to improve IVF outcome: a systematic review and meta-analysis."
	
Alessandro, C., et al. (2021). "Opening the black box: why do euploid blastocysts fail to implant? A systematic review and meta-analysis."
	
Alexander, A. T., et al. (2023). "Uterine artery embolisation versus myomectomy for the management of women with uterine leiomyomas."
	
Alexander, J., et al. (2022). "Carbon dioxide surgical laser for treatment of stress urinary incontinence in women: A randomized controlled trial." International Urogynecology Journal 33(Supplement 1): S64.
	Introduction: Stress urinary incontinence (SUI) is common with prevalence in most studies reported between 10-39%[1]. Bothersome SUI can be treated conservatively or surgically but there is a desire to develop effective non-surgical treatment options. Some studies have suggested laser therapy may improve or cure SUI[2]. The rationale for the use of CO2 laser for SUI is to trigger tissue remodelling and regeneration to improve urethral support and improve continence[3]. Objective(s): To evaluate CO2 laser versus shamfor the treatment of SUI in a RCT. Method(s): This was a multi-centre, prospective, single-blinded, shamcontrolled RCT. Participants were treated in the outpatient setting. Participants were aged 18-80 with symptomatic and objective SUI. Objective SUI was demonstrated with a positive cough stress test, urodynamic stress incontinence, or 24-hour pad weigh test (>4g). Participants had undertaken or declined supervised pelvic floor exercises. Intervention was performed using a CO2 fractionated vaginal laser to provide treatment. 7.5-12.5mJ with a 10-15% density, and a penetration depth of 600nm was delivered from the proximal vagina to 5mm from the introitus. Energy was delivered circumferentially to the entire vagina with one pass. An additional pass was performed at 10 o'clock and two o'clock. An additional two passes were performed at 12 o'clock. Participants underwent three treatments, 4 weeks apart, with increasing energy and density settings. The primary outcome was to assess the subjective cure rate (ICIQ-UI question 6c or 6e) of the CO2 surgical laser against sham 3 months after the completion of laser treatment. Secondary outcomes were to assess safety, subject discomfort, patient reported outcomes (PRO), quality of life (QOL) questionnaires (PGII, IIQ, PISQ, ICIQ OAB, ICIQ UI SF) and subject satisfaction 1 and 3 months after the last treatment. Based on previous data[4] we estimated a dry rate (ICIQ-UI SF=0) of 22% and 3% in laser and sham participants, respectively. - A sample size of 101 (including attrition) was calculated to provide 80% power (alpha=.05) to detect a difference between groups. Outcomes were compared using the chi-squared test for categorical data and student t test for continuous data. Differences in pre- and posttreatment changes between groups were assessed using analysis of covariance (ANCOVA). Result(s): 99 of 101 participants participated throughout the trial which commenced in April 2017 with the last treatment occurring in July 2020. Two further cases were excluded due to a delay in presentation posttreatment. Mean age was 53 years (34-79). Mean BMI was 26.1 (18.1- 49.6). 90% were vaginally parous. Baseline characteristics of the two groups are presented in table 1. 3 months post treatment, 48 (98%) participants in the laser arm, and 46 (96%) participants in the sham arm reported leak with cough, sneeze, or laughter (table 2), representing no difference. PRO and QOL outcomes were similar. Outcomes are presented in tables 2 and 3. There was no difference in mean pain VAS scores during treatment (1.6(laser) vs 1.1(sham), p=.26). There were no major complications confirmed during the trial Conclusion(s): CO2 vaginal laser therapy does not improve SUI compared to sham treatment in our population.

Alexander, J. W., et al. (2023). "CO2Surgical Laser for Treatment of Stress Urinary Incontinence in Women: A Randomized Controlled Trial." Obstetrical and Gynecological Survey 78(2): 101-103.
	
Alexandri, C., et al. (2020). "The role of microRNAs in ovarian function and the transition toward novel therapeutic strategies in fertility preservation: from bench to future clinical application." Human Reproduction Update 26(2): 174-196.
	Background: New therapeutic approaches in oncology have converted cancer from a certain death sentence to a chronic disease. However, there are still challenges to be overcome regarding the off-target toxicity of many of these treatments. Oncological therapies can lead to future infertility in women. Given this negative impact on long-term quality of life, fertility preservation is highly recommended. While gamete and ovarian tissue cryopreservation are the usual methods offered, new pharmacological-based options aiming to reduce ovarian damage during oncological treatment are very attractive. In this vein, advances in the field of transcriptomics and epigenomics have brought small noncoding RNAs, called microRNAs (miRNAs), into the spotlight in oncology. MicroRNAs also play a key role in follicle development as regulators of follicular growth, atresia and steroidogenesis. They are also involved in DNA damage repair responses and they can themselves be modulated during chemotherapy. For these reasons, miRNAs may be an interesting target to develop new protective therapies during oncological treatment. This review summarizes the physiological role of miRNAs in reproduction. Considering recently developed strategies based on miRNA therapy in oncology, we highlight their potential interest as a target in fertility preservation and propose future strategies to make the transition from bench to clinic.; Objective and Rationale: How can miRNA therapeutic approaches be used to develop new adjuvant protective therapies to reduce the ovarian damage caused by cytotoxic oncological treatments?; Search Methods: A systematic search of English language literature using PubMed and Google Scholar databases was performed through to 2019 describing the role of miRNAs in the ovary and their use for diagnosis and targeted therapy in oncology. Personal data illustrate miRNA therapeutic strategies to target the gonads and reduce chemotherapy-induced follicular damage.; Outcomes: This review outlines the importance of miRNAs as gene regulators and emphasizes the fact that insights in oncology can inspire new adjuvant strategies in the field of onco-fertility. Recent improvements in nanotechnology offer the opportunity for drug development using next-generation miRNA-nanocarriers.; Wider Implications: Although there are still some barriers regarding the immunogenicity and toxicity of these treatments and there is still room for improvement concerning the specific delivery of miRNAs into the ovaries, we believe that, in the future, miRNAs can be developed as powerful and non-invasive tools for fertility preservation. (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permission@oup.com.)

Alexey, R., et al. (2022). "Platinum vs non-platinum chemotherapy for platinum-resistant ovarian cancer: a systematic review and meta-analysis." MedRxiv.
	Background: recurrent ovarian cancer (OC) patients with platinum-free interval (PFI) <6 mo. are usually considered platinum-resistant and treated with non-platinum based chemotherapy. However, this was never confirmed in proper-conducted randomized trials. Method(s): we queried the PubMed database for all full-text articles and abstracts on the treatment of patients with platinum-resistant ovarian cancer (PROC) in 01/01/2000-01/06/2019 timeframe. The PRISMA tool was used to ensure transparent reporting of the results. Inclusion criteria were: 1) morphologically confirmed epithelial ovarian cancer; 2) recurrent disease within 6 months after completion of platinum-based chemotherapy; 3) treatment with platinum- or non-platinum chemotherapy with agents that are routinely used for OC; 4) no concomitant therapy with targeted or investigational agents or non-platinum doublets; 5) defined response rate (RR) and assessment criteria. Proportion meta-analysis (random-effect model) and beta-regression were conducted to assess the impact of platinum agents on response rate as well as significance of other variables. In the beta-regression model response rate was a dependent variable, while platinum agents (yes or no), used non-platinum drugs and method of response assessment were independent variables. Statistical analysis was dose with meta, metafor and betareg packages of R software. Result(s): we identified 7156 articles and screened them for title and abstract, 157 studies for further analysis. Overall, 6327 patients were included in the analysis, efficacy of non-platinum- and platinum-based therapy was assessed in 113 (n = 5272) and 44 (n = 1055) trials respectively. In meta-proportion random-effect model RR among patients treated with platinum-based and non-platinum chemotherapy RR was 36% (95% CI 30-41; I2 = 62%) and 16% (95% CI 14-19; I2=70%) respectively. For sensitivity analysis various regression models were made with different subsets of the trials and additional variables (including year of the trial, percentage of serous subtype of OC and median of prior therapy lines). Platinum was the strongest predictor of response in every developed model. Conclusion(s): this meta-analysis shows that patients with 'platinum-resistant' ovarian carcinoma may derive significant benefit from reintroduction of platinum agents. These results support recent ESMO-ESGO consensus on treatment of recurrent ovarian cancer .Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-ND 4.0 International license.

Alfahmy, A., et al. (2021). "Abdominal and vaginal pelvic support with concomitant hysterectomy for uterovaginal pelvic prolapse: a comparative systematic review and meta-analysis." International Urogynecology Journal 32(8): 2021-2031.
	Introduction and Hypothesis: While approximately 225,000 pelvic organ prolapse (POP) surgeries are performed annually in the US, there is no consensus on the optimal route for pelvic support for the initial treatment of uterovaginal prolapse (UVP). Our objective is to compare the outcomes of abdominal sacrocolpopexy (ASC) to vaginal pelvic support (VPS) with either uterosacral ligament suspension (USLS) or sacrospinous ligament fixation (SSF) in combination with hysterectomy for treating apical prolapse.; Methods: A systematic search was performed through March 2021. Studies comparing ASC with VPS for treatment of UVP were included in the review. The primary outcome was the rate of overall anatomic prolapse failure per studies' definition. Secondary outcomes included evaluating isolated recurrent vaginal wall prolapse, postoperative POP-Q points, total vaginal length (TVL), and Pelvic Floor Distress Inventory (PFDI-20) scores. Random effect analyses were generated utilizing R 4.0.2.; Results: Out of 4225 total studies, 4 met our inclusion criteria, including 226 patients in the ASC group and 199 patients in the VPS group. ASC was not found to be associated with a higher rate of vaginal wall prolapse recurrence (OR = 0.6; 95% CI = 0.2-2.4; P = 0.33). There was no significant difference between groups for anterior or apical vaginal wall prolapse recurrence (P = 0.58 and P = 0.97, respectively). ASC was associated with significantly longer TVL (mean difference [MD]: 1.01; 95% CI = 0.33-1.70; P = 0.02) and better POP-Q Ba scores [MD = -0.23; 95% CI = -0.37; -0.10; P = 0.01].; Conclusions: ASC and vaginal pelvic support (either USLS or SSF) have comparable anatomical outcomes. However, weak evidence of a difference in TVL and Ba was found. The strength of the evidence in this study is based on the small number of observational studies. A large, randomized trial is highly warranted. (© 2021. The International Urogynecological Association.)

Alfayumi-Zeadna, S., et al. (2022). "A Non-Randomized Controlled Trial for Reducing Postpartum Depression in Low-Income Minority Women at Community-Based Women's Health Clinics." Maternal and Child Health Journal 26(8): 1689-1700.
	Objective: To analyze an intervention that delivered tailored clinic staff training on postpartum depression (PPD) followed by awareness raising and social support aimed at lowering PPD among low-income Bedouin women in southern Israel.; Methods: We conducted a non-randomized controlled trial at two women's health clinics. The study included 332 of the 384 eligible women recruited at baseline (intervention = 169, control = 163), who completed two face-to-face interviews, one at 26-38 weeks of pregnancy (Time 1) and one 2-4 months postpartum (Time 2). PPD was measured by the Edinburgh Postnatal Depression Scale (EPDS) and dichotomized using a ≥ 10 score cutoff. We calculated EPDS change (rate difference of dichotomous EPDS from Time 1 to Time 2) (no change, positive change, or negative change), and compared EPDS changes in a control clinic vs. an intervention clinic.; Results: The intervention group showed a greater decrease in dichotomous EPDS ≥ 10 between times 1 and 2 (38.5% to 17.2%) than the control group (31.9% to 29.4%, PV = 0.008). Multinomial logistic regression showed that high PPD awareness significantly contributed to positive EPDS change in the intervention group (PV = 0.003) and high social support significantly protected against negative EPDS change in both groups, intervention (PV = 0.001) and control (PV = 0.003).; Conclusions: In low-income women, an intervention focusing on increasing PPD awareness and social support following staff training was associated with reduced EPDS and positive EPDS change following the intervention. Similar interventions should be implemented in women's clinics during pregnancy.; Clinical Trial Registry: ClinicalTrials.gov NCT02862444. (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Alfrink, J., et al. (2024). "Radiochemotherapy and interstitial brachytherapy for cervical cancer: clinical results and patient-reported outcome measures." Strahlentherapie und Onkologie.
	Objective: To evaluate clinical results and long-term patient-reported outcome measures (PROMs) on quality of life in cervical cancer patients following radiochemotherapy (RCT) and brachytherapy (BT) as definitive treatment. Material(s) and Method(s): Between 2003 and 2023, a total of 132 patients with advanced cervical cancer were evaluated for possible treatment. Patients treated by postoperative RCT, palliative radiotherapy, and those treated for recurrent disease were excluded. Thus, 46 patients receiving standard RCT and BT as their curative treatment were included in this study. PROMs were assessed prospectively by patients' self-completion of the EORTC-QLQ-C30 and EORTC-QLQ-CX24 questionnaires. Result(s): Five-year overall survival (OS), distant metastases-free survival (DMFS), and pelvic tumor-free survival rates (PTFS) were 53%, 54%, and 83%, respectively. A significant impact on OS was seen for FIGO (International Federation of Gynecologic Oncology) stage (IIB-IIIA: 79% vs. IIIB-IVA: 33%, p= 0.015), for overall treatment time (OTT; 50-65 d: 64% vs. >65 d: 38%, p= 0.004), and for rectal D2cc (<=73Gy: 50% vs. >73Gy: 38%, p= 0.046). The identical parameters were significantly associated with DMFS (FIGO stage: p= 0.012, OTT: p= 0.008, D2cc: p= 0.024). No parameters with a significant influence on PTFS were seen. In multivariate analysis, an impact of FIGO stage on OS (p= 0.05) and DMFS (p= 0.014) was detected, and of rectal D2cc on DMFS (p= 0.031). The overall QoL score was 63/100. Cognitive function was the least impaired (84/100), while role functioning was the worst (67/100). On the symptom scale, insomnia (46/100), fatigue (41/100), dyspnea (32/100), pain (26/100), and financial difficulties (25/100) were scored the worst. According to EORTC-QLQ-CX24, peripheral neuropathy (36/100) and lymphedema (32/100) occurred most frequently. Impaired sexual/vaginal functioning (32/100) and body image (22/100) were also frequently recorded. Conclusion(s): In patients with advanced cervical cancer, a combination of RCT and BT remains an excellent treatment option. In terms of patient-reported long-term quality of life, specific support is needed to alleviate symptoms including lymphedema, peripheral neuropathy, and impaired sexual activity.Copyright © 2024, The Author(s).

Algera, M. D., et al. (2022). "Surgical treatment for clinical early-stage expansile and infiltrative mucinous ovarian cancer: Can staging surgeries safely be omitted?" Current Opinion in Oncology 34(5): 497-503.
	Purpose of reviewMucinous ovarian cancers (MOCs) are categorized into infiltrative and expansile subtypes. These subtypes have different characteristics and prognoses. Patients with clinical early-stage disease of both subtypes currently undergo surgical staging (peritoneal washing, biopsies, omentectomy). Peritoneal and lymph node metastases of expansile MOC are rare, but whereas lymph node sampling (LNS) is omitted in these patients, peritoneal staging is not. Therefore, we collected all available MOC data to determine whether staging surgeries could safely be omitted in clinical early-stage expansile and infiltrative MOC.Recent findingsCurrent literature confirms that peritoneal metastases are rare in expansile MOC: more than 90% of patients have early-stage disease. Only 3.4% of the patients with clinical early-stage expansile MOC had positive peritoneal washings at surgical staging. Patients with infiltrative MOC were diagnosed more frequently with advanced-stage disease (21-54%). Moreover, upstaging clinical early-stage infiltrative MOC based on positive cytology, peritoneum and omentum metastases occurred in 10.3% of the patients. Therefore, we recommend that patients with early-stage infiltrative MOC undergo peritoneal staging and LNS. However, in addition to omitting LNS, we can also safely recommend omitting peritoneal staging in patients with clinical early stage expansile MOC.SummaryPeritoneal metastases are rare in clinical early-stage expansile MOC and peritoneal staging can therefore safely be omitted.Copyright © 2022 Lippincott Williams and Wilkins. All rights reserved.

Al-Hendy, A., et al. (2021). "ASSESSMENT OF COMMON ADVERSE EVENTS OF RELUGOLIX COMBINATION THERAPY IN PREMENOPAUSAL WOMEN TREATED FOR SYMPTOMATIC ESTROGEN-DRIVEN CONDITIONS: LIBERTY AND SPIRIT STUDIES." Fertility and Sterility 116(3): e11.
	Objective: Relugolix is a once‐daily, oral nonpeptide gonadotropin‐releasing hormone receptor antagonist being developed in combination with estradiol (E2) and norethindrone acetate (NETA) to treat heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) and moderate‐to‐severe pain associated with endometriosis (EM). In the Phase 3 LIBERTY 1/2 trials for UF (n=770), relugolix combination therapy (Rel‐CT [once‐daily relugolix 40 mg, E2 1 mg, NETA 0.5 mg]) reduced HMB vs placebo. In the SPIRIT 1/2 trials for EM (n=1251), Rel‐CT reduced dysmenorrhea, non‐menstrual pelvic pain and dyspareunia vs placebo. A pooled population assessment was undertaken to define an adverse event profile of Rel‐CT in premenopausal women. Materials and Methods: The common adverse event profile of Rel‐CT was assessed based on adverse events (AEs) observed at a frequency of ≥ 2% for Rel‐CT and higher than in placebo reported over 24 weeks in the pivotal studies. All AEs included were coded to preferred term (PT) and system organ class (SOC) using the global Medical Dictionary for Regulatory Activities (MedDRA) version 22.0 or higher. Results: There were 1344 patients in the pooled assessment from the 24‐week LIBERTY and SPIRIT studies. The most common AEs with Rel‐CT were headache (24.3%) and hot flush (10.6%) vs placebo (21.4% and 6.4%, respectively). Other AEs consistently observed in both populations included relevant terms of the reproductive tract, libido decrease and vasomotor symptoms (Table). Specifically for the UF population, AEs reported in at least 2% of women in the Rel‐CT group and at greater incidence than placebo included alopecia, irritability, dyspepsia, and breast cyst. Those reported for the EM population included nausea, back pain, arthralgia and vulvovaginal dryness. [Formula presented] a Includes menorrhagia, metrorrhagia, uterine hemorrhage, genital hemorrhage, and vaginal hemorrhage. SOC – System Organ Class, PT – Preferred Term Conclusions: In premenopausal women with UF or EM, Rel‐CT was well tolerated with a common adverse event profile representative of both populations. Impact Statement: An integrated adverse event profile for women with UF and EM may allow better understanding of the consistent risk profile of Rel‐CT in premenopausal women, for physicians and patients.

Al-Hendy, A., et al. (2022). "Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas." Obstetrics and Gynecology 140(6): 920-930.
	Objective: In the LIBERTY 1 and LIBERTY 2 placebo-controlled trials, once-daily relugolix combination therapy reduced menstrual blood loss volume and pain in women with heavy menstrual bleeding associated with uterine leiomyomas and was well tolerated, with preservation of bone mineral density (BMD) through 24 weeks. Here we report the long-term efficacy and safety of relugolix combination therapy treatment for up to 52 weeks.; Methods: Women with uterine leiomyoma-associated heavy menstrual bleeding who completed any treatment arm in either the LIBERTY 1 or LIBERTY 2 trial were eligible to enroll in a 28-week long-term extension study. All participants received once-daily relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) in the extension study. The primary efficacy endpoint was the proportion of women who achieved or maintained a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction in menstrual blood loss volume from LIBERTY study baseline to the last 35 days of treatment (defined as responders ). Analyses were conducted for all three randomized treatment groups from pivotal studies.; Results: Overall, 477 women enrolled, 476 were treated, and 363 (76.1%) completed 52 weeks. Among patients treated with relugolix combination therapy through 52 weeks (n=163), sustained improvement in heavy menstrual bleeding was observed in 87.7% (responders). The least squares mean menstrual blood loss volume reduction was 89.9%, with 70.6% of patients achieving amenorrhea. At week 52, 59.0% of patients with anemia at baseline had improvements in hemoglobin concentration of greater than 2 g/dL. Distress due to uterine leiomyoma-associated symptoms measured by the BPD (Bleeding and Pelvic Discomfort) scale score was reduced by 51.3 points. Sustained reductions in uterine and uterine leiomyoma volume were observed. Bone mineral density was preserved through week 52.; Conclusion: Improvements in heavy menstrual bleeding and anemia and reduction of uterine leiomyoma-associated symptom burden were sustained through up to 52 weeks of treatment with relugolix combination therapy in women with uterine leiomyomas. No new safety concerns were identified, and BMD was maintained.; Clinical Trial Registration: ClinicalTrials.gov , NCT03049735; NCT03103087; NCT03412890.; Funding Source: Myovant Sciences GmbH.; Competing Interests: Financial Disclosure Ayman Al-Hendy has been a Consultant for AbbVie, Bayer, Myovant Sciences, and ObsEva. They have received Research Support from the National Institutes of Health (R01 ES 028615–01, R01HD 087417, R01 HD 094378, R01 HD 094380, R01 HD 10036701, U54 MD 007602) and hold a patent for methods for novel diagnostics and therapeutics for uterine sarcoma (US Pat No. 9,790,562 B2). Andrea Lukes received research support from AbbVie, Astellas, Bayer, Ferring, Merck, Mithra, Mylan, Myovant Sciences, Organon. They have been a consultant for AbbVie and Myovant Sciences and served on the Speaker Bureau for AbbVie. Served on the advisory board for BCD Meetings & Events (December 10, 2021).Roberta Venturella has been a consultant for IBSA Pharmaceuticals and Myovant Sciences Inc. Elizabeth Stewart has been a consultant for AbbVie, Bayer, Myovant Sciences, and ObsEva. She received Research Support from the National Institutes of Health (R01 HD105714) and AHRQ and PCORI (P50 HS023418). She holds a patent for Methods and Compounds for Treatment of Abnormal Uterine Bleeding (US 6440445), which has no commercial activity. She has received royalties from UpToDate and payments for the development of educational content from the Med Learning Group, PER, Massachusetts Medical Society, and Peer View. Laura McKain is a former Myovant Sciences, Inc. employee. She served on the speaker's bureau and recently as consultant. She received payment from Evofem Biosciences (consultant role) and Cooper Surgical (consultant role). She is a Myovant Sciences shareholder. Rachel Wagman and Li are current employees of Myovant Sciences, Inc. Alfred Poindexter and Claudio Vil arroel did not report any potential conflicts of interest. (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Al-Hendy, A., et al. (2023). "A plain language summary of the long-term relugolix combination therapy study for uterine fibroids." Journal of comparative effectiveness research 12(8): e230069.
	What is this summary about? This is a summary of a research study (known as a clinical trial) called the LIBERTY extension study. The LIBERTY extension study is a long-term study looking at how well a medicine called relugolix combination therapy worked in reducing blood loss during menstrual periods in women with uterine fibroids with heavy menstrual periods. Women were included in the extension study if they finished the 24-week LIBERTY 1 or LIBERTY 2 studies. Heavy menstrual periods were considered to be menstrual blood loss of about one-third of a cup of blood (80 ml) per cycle for two cycles or about two-thirds of a cup of blood (160 ml) during one cycle. The LIBERTY extension study also looked at whether relugolix combination therapy was safe to take for up to 1 year. What were the results? Out of 770 total women with uterine fibroids with heavy menstrual bleeding who took part in the LIBERTY 1 and LIBERTY 2 studies, 476 took part in the LIBERTY extension study. From the start of the LIBERTY 1 and LIBERTY 2 studies through the end of the LIBERTY extension: 163 women took relugolix combination therapy for 52 weeks 149 women took relugolix alone for 12 weeks followed by relugolix combination therapy for 40 weeks 164 women took placebo for 24 weeks followed by relugolix combination therapy for 28 weeks The LIBERTY extension study showed that most women in all three treatment groups responded to relugolix combination therapy by having less bleeding during their menstrual periods, having improved anemia symptoms, and having stable bone mineral loss. Side effects were similar across treatment groups, and the most common side effects were headaches and hot flushes. What do the results mean? Women with uterine fibroids with heavy menstrual bleeding taking relugolix combination therapy may have fewer uterine fibroid bleeding symptoms for up to 1 year of treatment. Clinical Trial Registration: NCT03049735 (ClinicalTrials.gov) (LIBERTY 1) Clinical Trial Registration: NCT03103087 (ClinicalTrials.gov) (LIBERTY 2) Clinical Trial Registration: NCT03412890 (ClinicalTrials.gov) (LIBERTY extension study).

Al-Hendy, A., et al. (2024). "Fibroids and unexplained infertility treatment with epigallocatechin gallate: A natural compound in green tea (FRIEND) - Protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids." BMJ Open 14(1): e078989.
	Introduction Uterine fibroids affect 30%-77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications such as adhesions negatively impacting fertility. Existing medical therapies, such as oral contraceptives, gonadotropin hormone-releasing hormone (GnRH) analogues and GnRH antagonists, can manage fibroid symptoms but are not fertility friendly. This study addresses the pressing need for non-hormonal, non-surgical treatment options for women with fibroids desiring pregnancy. Previous preclinical and clinical studies have shown that epigallocatechin gallate (EGCG) effectively reduces uterine fibroid size. We hypothesise that EGCG from green tea extract will shrink fibroids, enhance endometrial quality and increase pregnancy likelihood. To investigate this hypothesis, we initiated a National Institute of Child Health and Human Development Confirm-funded trial to assess EGCG's efficacy in treating women with fibroids and unexplained infertility. Methods and analysis This multicentre, prospective, interventional, randomised, double-blinded clinical trial aims to enrol 200 participants with fibroids and unexplained infertility undergoing intrauterine insemination (IUI). Participants will be randomly assigned in a 3:1 ratio to two groups: green tea extract (1650 mg daily) or a matched placebo, combined with clomiphene citrate-induced ovarian stimulation and timed IUI for up to four cycles. EGCG constitutes approximately 45% of the green tea extract. The primary outcome is the cumulative live birth rate, with secondary outcomes including conception rate, time to conception, miscarriage rate, change in fibroid volume and symptom severity scores and health-related quality of life questionnaire scores. Ethics and dissemination The FRIEND trial received approval from the Food and Drug adminstration (FDA) (investigational new drug number 150951), the central Institutional Review Board (IRB) at Johns Hopkins University and FRIEND-collaborative site local IRBs. The data will be disseminated at major conferences, published in peer-reviewed journals and support a large-scale clinical trial. Trial registration number NCT05364008.Copyright © 2024 Author(s). Published by BMJ.

Al-Hendy, A., et al. (2022). "Incidence of Alopecia in Treatment of Women With Uterine Fibroids: Results of Two Phase 3 Trials of Linzagolix." Obstetrics and Gynecology 139(SUPPL 1): 30S.
	INTRODUCTION: Although hair loss (alopecia) is a benign disorder, it can negatively affect patient's self-esteem, self-image, and overall quality of life. Linzagolix is an oral GnRH antagonist being developed at full and partial suppression doses with and without hormonal addback therapy (ABT) for treatment of uterine fibroid-related symptoms. Alopecia was previously reported with other GnRH antagonists. METHOD(S): PRIMROSE 1 and 2 are two randomized, double-blind, placebo-controlled phase 3 trials investigating the efficacy and safety of linzagolix 100 mg and 200 mg once daily, +/- ABT in the treatment of uterine fibroids for 52 weeks. RESULT(S): Up to week 24, alopecia was reported in total of five subjects (0.5%) in the pooled safety analysis set (N=1037). There was a similar incidence in the placebo (two subjects; 1.0%), 100 mg (one subject; 0.5%), and 200 mg+ABT groups (two subjects; 1.0%), and no reports in the 100 mg+ABT or 200 mg groups. Four of the cases resolved. For one subject (200 mg+ABT group) mild alopecia had not resolved. For this subject, the study drug was continued, and no concomitant therapy was administered for the alopecia. Up to week 52, one (0.1%) subject in the 200 mg+ABT group reported alopecia, which resolved. None of the cases led to treatment discontinuation. No subjects reported alopecia during the post-treatment follow-up. CONCLUSION(S): Hair loss (alopecia) was rarely observed in the PRIMROSE trials of linzagolix in the treatment of uterine fibroids.

Al-Hendy, A., et al. (2021). "LIBERTY RANDOMIZED WITHDRAWAL STUDY: 2-YEAR EFFICACY AND SAFETY OF RELUGOLIX COMBINATION THERAPY IN WOMEN WITH HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE FIBROIDS." Fertility and Sterility 116(3): e2.
	Objective: In the pivotal LIBERTY 1 and 2 trials and Long‐Term Extension (LTE) study, once‐daily relugolix combination therapy (Rel‐CT: relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) reduced menstrual blood loss (MBL) volume and pain in women with uterine fibroids (UF). Rel‐CT was well tolerated, with preservation of bone mineral density (BMD) through 52 weeks. Here we report results of the Phase 3 LIBERTY randomized withdrawal study (RWS), designed to evaluate the efficacy and safety of Rel‐CT for up to 2 years. Materials and Methods: Women with UF‐associated heavy menstrual bleeding (HMB) who completed the 24‐week LIBERTY 1 or 2 trials and the 28‐week LTE study, and who met responder criteria (MBL <80 mL and ≥50% reduction from pivotal study baseline at Week 48 in the LTE study) were randomized 1:1 to blinded treatment with Rel‐CT or placebo for up to 52 weeks (total treatment period: 104 weeks). For women who had a relapse of HMB during the study (MBL volume ≥80 mL), treatment with open‐label Rel‐CT was provided. Primary endpoint was the proportion of women who maintained MBL volume <80 mL at Week 76. Key secondary endpoints included time to MBL volume ≥80 mL, proportion of women who maintained a MBL volume of <80 mL through Week 104 (over the 52‐week randomized treatment period), and the proportion of women achieving or maintaining amenorrhea at Week 76/end of treatment. Results: Of the 229 randomized women (Rel‐CT: 115, placebo: 114), 228 were treated and 89 (77.4%) and 86 (75.4%) completed the RWS. At Week 76, 78.4% of women on Rel‐CT maintained MBL <80 mL vs 15.1% in the placebo group (p<0.0001). Through Week 104, 88.3% of women randomized to placebo at Week 52 relapsed with HMB, with a median time to relapse of 5.9 weeks. Among the 89 women in the placebo group who relapsed and received open‐label rescue treatment, 87 women responded to Rel‐CT, with an MBL <80 mL. At Week 104, 69.8% of women on Rel‐CT maintained MBL <80 mL vs 11.8% in the placebo group (p<0.0001). The proportion of women who achieved or maintained amenorrhea was 57.4% vs 13.3% at Week 76 and 58.3% vs 10.6% at Week 104 for Rel‐CT vs the placebo group, respectively (both p<0.0001). Rel‐CT was generally well tolerated; no new safety signals were detected, and the adverse event profile was consistent with that reported through 1 year of treatment. BMD remained stable in women who received Rel‐CT from Week 52 to Week 104, and cumulative assessment showed that BMD was maintained through 2 years of treatment. Conclusions: After 2 years of treatment with Rel‐CT, there was evidence of durability of effect in maintaining low MBL volume in women with symptomatic UF. There was evidence of return of HMB in most women after treatment cessation, which improved upon re‐treatment with Rel‐CT. Impact Statement: Long‐term treatment with Rel‐CT was efficacious and generally well tolerated in women with UF.

Al-Hendy, A., et al. (2023). "Efficacy and safety of vilaprisan in women with uterine fibroids: data from the ASTEROID 3 randomized controlled trial." F&S science 4(4): 317-326.
	Objective: Vilaprisan is a highly potent selective progesterone receptor modulator shown to reduce heavy menstrual bleeding, induce amenorrhea, and diminish uterine fibroid volume in phase 2 studies. The objective of ASTEROID 3 was to demonstrate the superiority of vilaprisan compared with placebo in the treatment of heavy menstrual bleeding in women with uterine fibroids.; Design: Randomized, double-blind, placebo-controlled, multicenter phase 3 study.; Setting: Hospitals and medical centers.; Patient(s): Women with ≥1 uterine fibroid of ≥3 cm and heavy menstrual bleeding of >80 mL/cycle.; Intervention(s): Women were randomly assigned to 1 of 4 treatment arms, which were planned to comprise 2 treatment periods of 12 weeks, each with vilaprisan (2 mg/d) or placebo that were continuous or separated by a break of one bleed.; Main Outcome Measure(s): Amenorrhea (primary end point; <2 mL in the last 28 days of treatment) and heavy menstrual bleeding response (key secondary end point; <80 mL/cycle and >50% reduction in bleeding from baseline) were measured with the alkaline hematin method. Change in volume of the 3 largest fibroids from baseline to end of treatment was assessed by ultrasound. Safety was monitored throughout the study.; Result(s): Overall, 75 women completed the first 12 weeks of treatment. Statistically significant and clinically meaningful differences were observed between the vilaprisan- and placebo-treated groups in both the full analysis and per-protocol sets. In the per-protocol set (n = 36 and n = 12 for the vilaprisan and placebo groups, respectively), amenorrhea was observed more frequently in women treated with vilaprisan than in those who received placebo (83.3% vs. 0%, P<.0001), with a median time to onset of 3 days in the vilaprisan group. Similarly, more vilaprisan- than placebo-treated women achieved a response in heavy menstrual bleeding (91.7% vs. 25.0%, P<.0001). Serious adverse events were reported for 22 (27.8%) of 79 women and were evenly distributed among the 4 groups receiving vilaprisan and/or placebo. None of these events led to study discontinuation or were related to the liver, and no new safety findings were identified compared with the earlier phase 2 ASTEROID studies.; Conclusion(s): Vilaprisan is efficacious and well tolerated over 12 weeks in the treatment of heavy menstrual bleeding associated with uterine fibroids. Further investigations of the long-term efficacy and safety of vilaprisan are warranted.; Clinical Trial Registration Number: NCT03400943 (ClinicalTrials.gov).; Competing Interests: Declaration of interest A.A-H. reports funding from National Institutes of Health; consulting fees from AbbVie, Bayer, ObsEva, and Myovant Sciences; and a patent for novel diagnostics and therapeutics for uterine sarcoma (US Patent No. 9,790,562 B2) outside the submitted work. Y.F.Z. has nothing to report. E.G-W., S.P., and C.S. are employees of Bayer AG; T.F. is a former employee of Bayer AG. K.L. is an employee of Bayer Nordic SE. (Copyright © 2023 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Alhusen, J. L., et al. (2021). "A pilot study of a group-based perinatal depression intervention on reducing depressive symptoms and improving maternal-fetal attachment and maternal sensitivity." Archives of Women's Mental Health 24(1): 145-154.
	To conduct a pilot study of a group-based perinatal depression intervention, the Mothers and Babies Course, on depressive symptomatology, maternal-fetal attachment, and maternal sensitivity, 60 pregnant women with moderate to severe depressive symptomatology were randomized to a 6-week intervention or usual care group at their initial prenatal care visit. Measures of depressive symptomatology and maternal-fetal attachment were collected at baseline and 36 weeks gestation. At 12 weeks postpartum, participants completed a measure of depressive symptomatology, and an objective measure of maternal sensitivity was collected. Participants randomized to the intervention group completed an average of 5.2 sessions, and 70% of women completed all six sessions. Exploratory analyses showed that at 12 weeks postpartum, participants randomized to the intervention group had an 8.32-point decrease from baseline on the Edinburgh Postnatal Depression Scale (EPDS) as compared to a 4.59-point decrease among participants randomized to usual care. Participants randomized to the intervention group had a mean change score of 12.60 in maternal-fetal attachment via the Maternal Fetal Attachment Scale (MFAS) as compared to 4.60 among participants in usual care. Maternal sensitivity scores, assessed via the Nursing Child Assessment Satellite Training-Feeding Scale (NCAST-Feeding), were higher at 12 weeks postpartum for women in the intervention group as compared to women in usual care (59.2 and 51.8, respectively). Our pilot study findings provide preliminary support for the benefits of a perinatal depression intervention, delivered in a group setting, on reducing depressive symptomatology, and improving maternal-fetal attachment and maternal sensitivity. Further research, conducted with larger samples, is necessary to determine the effect of this intervention on indicators of maternal attachment.

Ali, A., et al. (2021). "Complications and Efficacy of Uterine Preserving Surgeries for the Repair of Pelvic Organ Prolapse versus Procedures Including Hysterectomy, A Systematic Review."
	
Ali, A., et al. (2023). "The Utilization of Bee Products as a Holistic Approach to Managing Polycystic Ovarian Syndrome-Related Infertility." Nutrients 15(5).
	Bee products, including honey, have been utilized since ancient times for nutritional and therapeutic purposes. Recently, other bee products such as bee pollen, royal jelly, and propolis have caught a lot of attention. Being high in antioxidants and bioactive compounds, these products have established their applications in the pharmaceutical field as supplementary or alternative medicines. This review focuses on their use against polycystic ovarian syndrome (PCOS)-related infertility. A systematic search of electronic databases including PubMed, Web of Science ScienceDirect, and Google Scholar was conducted from their inceptions up to November 2022. Studies with a small sample size, studies with inconclusive data, and pre-prints have been excluded. A narrative synthesis was performed during draft preparation after the authors independently performed a literature search. A total of 47 studies were finalized for the review. It can be observed that in vivo data on the use of bee products in treating PCOS mostly deals with their use in synergism with the PCOS medicines to enhance their effect and/or curb their side effects; however, clinical trials for the same are limited. With the amount of data being limited, it is difficult to map out the mechanism by which these products act in managing PCOS inside the human body. The review gives detailed insights into the reversal and restorative properties of bee products against the aberrations in reproductive health caused by PCOS.

Ali, E., et al. (2023). "Single-incision needleless mini-sling technique for female stress urinary incontinence: A comparative study with standard transobturator inside-out technique." Archivio Italiano di Urologia e Andrologia 95(2): 78-84.
	To evaluate the safety and efficacy of surgeon-tailored polypropylene mesh (STM) through a needle-less single incision mini-slings (SIMS) vs. standard trans-obturator tape (TOT) in the treatment of female stress urinary incontinence (SUI). Method(s): We conducted an open-label randomized controlled trial that included women with SUI. Eligible women were randomized in a 1:1 ratio to receive either standard TOT or SIMS techniques. All procedures were performed using a surgeon-tailored polypropylene mesh and monofilament tape. Result(s): A total of 60 women were included. The mean operative time was significantly longer in the standard TOT group. The mean bleeding rate was significantly higher in the standard TOT group (87.6 +/- 10.6 cc) compared to the SIMS group (60.0 +/- 8.1 cc). There was no urethral injury in both groups. Transient thigh pain occurs in 12 cases (40 %) of the standard TOT and no cases in the SIMS group (p < 0.001). After three months, there was no significant statistical difference between the result of the two groups as regard to cure or improvement rate. No failed cases were reported in both groups (p = 0.64). Likewise, there was no significant difference between the two groups regarding patients' satisfaction rate. Conclusion(s): SIMS was not inferior to standard TOT. STM SIMS is a mini-invasive, relatively safe, reproducible, easy to perform in a short time, with excellent patient tolerability and minimal pain, allowing early return to work and economically effective surgical procedure for the treatment of female stress urinary incontinence.Copyright © 2023 Edizioni Scripta Manent s.n.c.. All rights reserved.

Ali, H. M. H. H., et al. (2022). "Unilateral versus Bilateral Femoral Arterial Access for Uterine Artery Embolization." Open Access Macedonian Journal of Medical Sciences 10: 1432-1439.
	BACKGROUND: Uterine fibroids are the most common benign tumors in women. Their clinical presentation includes menorrhagia, metrorrhagia, lower abdominal pain, and infertility. Treatment of uterine fibroids includes medical management, surgical resection known as myomectomy, as well as minimally invasive options like uterine artery embolization. Uterine artery embolization can be done through unilateral or bilateral femoral arterial access. AIM: We aim to define the differences between unilateral and bilateral femoral access in concern to radiation dose, procedure time, fluoroscopy time, as well as the number of angiographic images. METHOD(S): A total of 48 patients were divided into two groups equally; one with a unilateral femoral access and the other group with a bilateral femoral arterial access. RESULT(S): The age of the patients ranged between 25 and 40 years, embolization was done with calibrated spheres. Bilateral procedures compared to the unilateral ones had less fluoroscopy times (8.6 min vs. 24.3 min), less total procedure time (28.4 min vs. 54.4 min), and less dose area product (155 Gy cm2 vs. 340.5 Gy cm2) as well as less mean number of angiographic images (93.8 vs. 176.5) with no significant difference in puncture site complications. CONCLUSION(S): Fluoroscopy times, procedure times, number of angiographic images, as well as radiation dose were significantly lower in the bilateral approach with no significant difference in the rates of puncture site complications between the two approaches.Copyright © 2022 Hossam Mohsen Hassan Hussein Ali, Sameh Mohamed Abdel-Wahab, Amr Mahmoud Abdel-Samad, Ahmed El-Shimy.

Ali, H. T. O., et al. (2022). "Urinary Complications among Women with Cystoceles: A Systematic Review." International Journal of Pharmaceutical Research and Allied Sciences 11(1): 121-128.
	Cystoceles result from a pelvic-floor support system that is not strong enough. This systematic review aims to study the urinary complications in women with cystoceles, especially SUI, and the complication following surgical repair. PubMed, Web of Science, Science Direct, EBSCO, and Scopus were searched. Study articles were screened by title and abstract using Rayyan QCRI then a full-text assessment was implemented. Thirteen studies were included, with a total of 1043 women with cystoceles and urinary complications. The follow-up duration ranged from 1.4 months to 53 months. Most of the included studies had SUI as a complication of cystoceles. The other complication included urge incontinence, mixed incontinence, frequency, incomplete voiding, and voiding difficulties. Incontinence recurrence and voiding dysfunction were reported only in one investigation. The majority of cystoceles cases had SUI. Frequency, incomplete voiding, urge incontinence, mixed incontinence, and voiding issues were among the other complications. The most frequent surgical complications were pyelonephritis, cystitis, and UTIs.Copyright © 2022 International Journal of Pharmaceutical Research and Allied Sciences. All rights reserved.

Ali, I., et al. (2022). "Effect of Benson's relaxation therapy alone or combined with aerobic exercise on cortisol, sleeping quality, estrogen, and severity of dyspeptic symptoms in perimenopausal women with functional dyspepsia." European Review for Medical and Pharmacological Sciences 26(22): 8342-8350.
	Objective: Besides repeated stress exposure, a sedentary lifestyle and low estrogen levels are risk factors for the development of functional dyspepsia (FD). The aim of this study was to find out the effect of adding aerobic exercise (5 sessions per week) to the daily application of a 40-minute Benson's relaxation therapy (BRT) (diaphragmatic breathing and progressive muscle relaxation applied for 20 minutes in the morning and evening) on Glasgow dyspepsia severity score (GDSS), cortisol, visual analogue scale (VAS) (for abdominal symptoms), estradiol (one of the endogenous estrogens), Pittsburgh sleep quality index (PSQI), and 42-item depression, anxiety, and stress scales (DASS-42) in 60 perimenopausal women with FD.; Patients and Methods: Women who consumed a daily dose of pantoprazole (40 mg tablet administered as a proton pump inhibitor drug) were randomly assigned to an 8-week study group (this group received aerobic exercise plus BRT, N=30) or an 8-week control group (this group received BRT only, N=30).; Results: Significant improvements were reported in all measured variables within women groups (except estradiol of the control group). Compared to the control group, the reported within-group significant improvements in GDSS, cortisol, VAS, PSQI, and DASS-42 were higher in the study group.; Conclusions: Significant improvements in GDSS, cortisol, VAS, PSQI, and DASS-42 could be achieved after adding adjunctive therapies - aerobic exercise and BRT - to the medications of FD in perimenopausal women. Compared to BRT alone, physical exercise plus BRT significantly increases the levels of estradiol in perimenopausal women with FD.

Ali, M., et al. (2021). "Safety and efficacy of elagolix (with and without add-back therapy) for the treatment of heavy menstrual bleeding associated with uterine leiomyomas: a systematic review and meta-analysis." Middle East Fertility Society Journal 26(1): 20.
	Background: Heavy menstrual bleeding (HMB) is a common clinical finding in patients with uterine leiomyomas that can negatively impact their quality of life. Recently, a novel oral GnRH-antagonist (elagolix) has emerged as a possible therapeutic agent for this ailment. Herein data was pooled from clinical trials assessing the safety and efficacy of elagolix with and without add-back therapy. Main text: PubMed and Cochrane library were systematically searched for RCTs that measured the efficacy and safety of elagolix for the treatment of uterine fibroid-associated HMB. All safety and efficacy endpoints were compared between elagolix-alone, elagolix w/add-back therapy, and placebo. The primary efficacy endpoint was defined as the number of women who achieved menstrual blood loss (MBL) < 80 ml and a reduction in MBL from baseline of > 50% at the end of treatment. Secondary outcomes assessed included change in hemoglobin levels, incidence suppression of bleeding and amenorrhea, and the incidence of adverse events. The random effects model was used to pool data, and heterogeneity was assessed using I2. Our search identified 4 clinical trials meeting our PICO criteria, with a total of 916 patients. Analysis of the primary outcome revealed that elagolix-alone was the most effective treatment compared to both placebo (LOR = 3.47, CI = 3.03-3.91, p = 0.000, I2 = 0.0%) and add-back therapy (LOR = 0.64, CI = 0.12-1.16, p = 0.016, I2 = 43.1%). Furthermore, both elagolix groups (irrespective of add-back therapy) observed a significant improvement in post-treatment hemoglobin levels as compared to the placebo group (elagolix-alone vs PBO: LOR = 1.44, CI = 0.66-2.22, I2 = 66.0%, p = 0.000; elagolix-w/add-back therapy vs PBO: LOR = 1.22, CI = 0.78-1.66, I2 = 0.0%, p = 0.000). Concerning safety, while elagolix without add-back therapy had the highest overall incidence of adverse effects (elagolix-alone vs placebo LOR = 0.84, CI = 0.48-1.20, I2 = 7.8%, p = 0.000; elagolix-alone vs elagolix-w/add-back LOR = 0.68, CI = 0.09-1.26, p = 0.024, I2 = 64.6%), the incidence of serious (life threatening) adverse events between all 3 treatment groups was not statistically different. The inclusion of add-back therapy with elagolix made the treatment noticeably safer (elagolix-w/add-back vs placebo: LOR = 0.19, CI = - 0.10 to 0.48, I2 = 0.0%, p = 0.194) without seriously compromising its efficacy. Conclusion(s): High-quality evidence from 4 trials suggests that elagolix is an effective treatment for leiomyoma-associated HMB, with a marked improvement in all efficacy endpoints. Furthermore, the inclusion of add-back therapy in the treatment regimen should be considered as it mitigates the hypoestrogenic effects of elagolix.Copyright © 2021, The Author(s).

Ali, S., et al. (2021). "Cytokine imbalance at materno-embryonic interface as a potential immune mechanism for recurrent pregnancy loss." International immunopharmacology 90: 107118.
	Recurrent pregnancy loss (RPL) is a prominent reproductive disease that distresses about 2%-5% of couples. RPL is the loss of two or more successive spontaneous pregnancies prior to the 20th week of embryo development. The commencement of pregnancy necessitates implantation of the embryo into responsive maternal decidua synchronized with the process of placentation, decidual and myometrial trophoblast incursion as well as refashioning of spiral blood arteries of uterus. The collapse of any of the processes fundamental for pregnancy success may result into an array of pregnancy problems including spontaneous pregnancy loss. Endometrium of human female manufactures an extensive range of cytokines during the proliferative and secretory stage of the menstrual cycle. These endometrial cytokines are thought as major players for making the uterus ready for embryo implantation and placental development during pregnancy. Decidual cytokines regulate the invasion of trophoblast and remodeling of spiral arteries as well as take part in immune suppression to accomplish the pregnancy. Deterrence of maternal rejection of embryo needs a regulated milieu, which takes place essentially at the embryo-maternal interface and the tissues of the uterus. The reasons of RPL remain anonymous in a large number of cases that lead to difficulties in management and severe trauma in couples. Cytokine modulatory therapies have been shown promising for preventing RPL. Further study of novel factors is wanted to establish more effective RPL treatment protocols. The present study aims to review the outcome of cytokine breach at materno-embryonic interface and the efficacy of cytokine modulatory therapies in RPL. (Copyright © 2020 Elsevier B.V. All rights reserved.)

Ali, S., et al. (2022). "The effect of antioxidant supplementation on endometriosis-related pelvic pain, a systematic review, and meta-analysis of clinical trials."
	
Aliakbari, F., et al. (2022). "Effects of Combination Therapy with Bunium persicum and Foeniculum vulgare Extracts on Patients with Polycystic Ovary Syndrome." Advanced biomedical research 11: 74.
	Background: Considering the side effects of common drugs used to treat polycystic ovary syndrome (PCOS), researchers have turned their attention to natural compounds, including medicinal plants. Foeniculum vulgare has estrogenic properties and has been traditionally used to treat gynecological disorders. Bunium persicum has medical aspects that have not yet been evaluated, so the aim of this study was to evaluate the effects of combination therapy with these extracts on clinical symptoms of women with PCOS.; Materials and Methods: In this double-blind clinical trial study, 70 women with PCOS referred to infertility clinics, were selected and randomly divided into two groups. The intervention group received B. persicum capsule 60 mg plus F. vulgare capsule 25 mg) twice daily for 4 months and the control groups received routine intervention. Before and after the intervention, levels of luteinizing hormone (LH), follicle-stimulating hormone, progesterone, prolactin, testosterone and dehydroepiandrosterone sulfate (DHEAS) levels, hirsutism score, and menstrual pattern were recorded and endometrial thickness and follicle count were determined by ultrasound. Data were analyzed by the SPSS21 software.; Results: Treatment with B. persicum and F. vulgare extracts significantly decreased LH and DHEAS levels, hirsutism score, and significantly increased menstrual duration compared to the control group. Before the intervention, 5.7% of the intervention and control groups had the normal menstrual pattern, while after the intervention 31.4% of the intervention group and 25.7% of the control group had the normal pattern.; Conclusion: Regarding the effect of these extracts combination and because they have no side-effects, which is a great advantage over chemical drugs, using of these plants recommend.; Competing Interests: There are no conflicts of interest. (Copyright: © 2022 Advanced Biomedical Research.)

Alibhai, K., et al. (2022). "The impact of bariatric surgery on assisted reproductive technology outcomes: a systematic review protocol." Systematic Reviews 11(1): 1.
	BACKGROUND: Individuals with obesity are at higher risk of experiencing complications during their pregnancy and may also experience infertility, requiring assisted reproductive technologies (ART) to conceive. The current body of literature demonstrates that bariatric surgery decreases an individual's risk of developing a variety of obesity-related obstetrical conditions during and after pregnancy. However, the effects of bariatric surgery on ART outcomes are not well understood. Therefore, the paucity in the literature warrants a need to determine these effects. METHODS: We will search electronic databases, including MEDLINE, Embase, Scopus, and Cochrane Central Register of Controlled Trials (CENTRAL), as well as the gray literature and the reference lists of included articles. We will screen all studies published between January 1978 and the present day that explore the impact of bariatric surgery on ART outcomes for women and men. We will include observational studies. Two independent reviewers will assess the studies for inclusion and extract data for each article. The main outcome that will be analyzed is live birth rate. Secondary outcomes such as time to conception, number of rounds of ART, type of bariatric surgery, and length of time between bariatric surgery and initiation of ART will also be recorded. Risk of bias will be conducted using the National Institutes of Health Study Quality Assessment Tools. A random effects model will be used to account for statistical analysis and results will be pooled with forest plots. In the event of statistical and reporting heterogeneity, we will provide a qualitative synthesis and narrative review of the results. DISCUSSION: This review will provide information on the outcomes of ART following bariatric surgery and may help healthcare professionals make informed decisions about the length of time between bariatric surgery and initiation of ART. The study findings may be of interest to various stakeholders including patients, bariatric surgeons, obstetricians, and gynecologists, and those who specialize in obesity medicine and reproductive endocrinology and infertility. We plan to disseminate our findings through presentations, publications, and social media releases to individuals who are navigating infertility and are interested in undergoing or have undergone bariatric surgery, healthcare professionals, policymakers, and researchers. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021252561.

Alikamali, M., et al. (2022). "The effects of vitamin E on the intensity of primary dysmenorrhea: A systematic review and meta-analysis." Clinical Nutrition ESPEN 52: 50-59.
	Background & Aims: Primary dysmenorrhea (PD) refers to the presence of painful menstrual cramps due to increased synthesis of prostaglandins. Vitamin E inhibits the release of arachidonic acid and its conversion to prostaglandins through its antioxidant properties. This study sought to examine the effects of oral vitamin E supplementation on PD intensity (primary outcome) and its side effects (secondary outcomes).; Methods: In this systematic review and meta-analysis, databases in English and Persian, including PubMed, Cochrane Library, Google Scholar, Scopus, Web of Science, SID, and Magiran, were systematically searched until August 30, 2021. The study included all randomized, controlled clinical trials comparing oral vitamin E to placebo in healthy women with PD and measuring PD severity as a primary or secondary outcome. The quality of the included articles was assessed using the Cochrane Handbook, and the meta-analysis was performed using RevMan software. Given the continuous nature of the data and the utilization of different tools in the extracted articles, the meta-analysis results were reported using standardized mean difference (SDM) and 95% confidence interval (95% CI). A subgroup analysis was performed in low-dose (100 units), moderate-dose (200 units), and high-dose (400 units) categories. The quality of evidence was examined according to the GRADE approach.; Results: Eight articles with a sample size of 1002 people were entered into this systematic review. The results of meta-analysis revealed that vitamin E consumption significantly reduced PD mean intensity in the first month (n = 7 records; SDM = -1.16; 95%CI: -2.16 to -0.17; I 2 = 31.9%; P = 0.02) and the second month (n = 8 records; SDM = -1.83; 95%CI: -2.90 to -0.77; I 2 = 76.3.9%; P < 0.0001) compared with placebo. Serious side effects were not reported in vitamin E recipients.; Conclusion: Vitamin E could be an adjunctive treatment for women with PD. However, higher-quality clinical trials with larger sample sizes are recommended for a more definite conclusion.; Prospero Id: CRD42021276609.; Competing Interests: Declaration of competing interest The authors declare that they have no competing interests. (Copyright © 2022 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.)

Alimoradi, Z., et al. (2023). "Therapeutic applications of lemon balm (Melissa officinalis) for obstetrics and gynecological health issues: A systematic review." Journal of Herbal Medicine 42: 100751.
	Introduction: Melissa officinalis (lemon balm) is a medicinal herb with several proposed therapeutic uses. The present paper systematically reviewed relevant evidence regarding the applications of M. officinalis for obstetrics and gynecological health issues. Method(s): Utilizing a systematic approach, academic electronic databases including PubMed, Scopus, ProQuest, Web of Science, and the Cochrane Library were searched up to September 21, 2022. The Cochrane Risk of Bias Assessment Toolkit was used to assess the methodological quality of the included studies. Due to methodological heterogeneity among a small number of retrieved studies, evidence was pooled utilizing a narrative synthesis. Result(s): In total, 15 studies were included. M. officinalis appears to be useful in pain reduction (childbirth after pain and primary dysmenorrhea), improving premenstrual symptoms, and postpartum blues. However, no effect was seen on the intensity of menstrual bleeding, and effectiveness was mixed in relation to sexual functioning and menopausal-related symptoms. Due to selection bias in almost all studies, the evidence level of the included studies was considered a high risk of bias. In most studies, no side effects were reported among the intervention groups. When reported they were minor (eg, diarrhea, constipation, flatulence, stomach pain, and sleep disturbance). Discussion/Conclusions: This intervention might have benefits for gynecological conditions but it is not strongly supported by the available evidence. Consequently, further studies are needed with (1) larger sample sizes, (2) more rigorous methodologies using Melissa officinalis alone to avoid synergistic or antagonistic effects, (3) adjustment for potential covariates, (4) toxicity assessment to establish optimal doses, and (5) the most effective forms of preparation.Copyright © 2023 Elsevier GmbH

Alirezaei, S., et al. (2022). "The effect of infertility counseling interventions on marital and sexual satisfaction of infertile couples: A systematic review and meta-analysis." International Journal of Reproductive Biomedicine 20(10): 795-806.
	BACKGROUND: Psychological consequences of infertility could have a negative effect on marital and sexual satisfaction. Numerous medical associations have strongly recommended psychological interventions, including counseling, to help infertile couples. OBJECTIVE: This study reviewed the effectiveness of counseling interventions on marital and sexual satisfaction in infertile couples. MATERIALS AND METHODS: This systematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist Databases including PubMed, Web of Science, Psych Info, Cochran Library, Scopus, and Embase were searched for relevant articles published up to March 2020. All randomized clinical trials assessing the impact of psychological interventions on marital and sexual satisfaction in infertile couples were included in the review. The outcome measures were marital and sexual satisfaction, and the pooled estimate of the effects was calculated using a random-effects model. The risk of bias was measured using the Cochrane risk of bias tool, and the summary measures were reported as 95% confidence interval and percentage of heterogeneity. RESULTS: Out of the 309 studies found through the search, 13 randomized clinical trials including 230 infertile women and 512 infertile couples were systematically reviewed and included in the meta-analysis. It was found that counseling interventions improve marital and sexual satisfaction. CONCLUSION: As counseling and psychological interventions increase the marital and sexual satisfaction of infertile couples, those are highly recommended for the psychological management of infertile couples.

Alkatout, I., et al. (2023). "Total or Subtotal Hysterectomy for the Treatment of Endometriosis: A Review." Journal of Clinical Medicine 12(11).
	Objective: The purpose of the review was to evaluate and compare outcomes after total or subtotal hysterectomy in women with endometriosis or adenomyosis.; Methods: We searched four electronic databases: Medline (PubMed), Scopus, Embase, and Web of Science (WoS). The first aim of the study was to compare outcomes after total and subtotal hysterectomy in women with endometriosis, and the second aim was to compare the two procedures in women with adenomyosis. Publications that reported short- and long-term outcomes after total and subtotal hysterectomy were included in the review. The search was not subject to any limitation in terms of time or method.; Results: After screening 4948 records, we included 35 studies published from 1988 to 2021; the studies were based on various methodologies. With regard to the first aim of the review, we found 32 eligible studies and divided these into the following four categories: postoperative short- and long-term outcomes, recurrence of endometriosis, quality of life and sexual function, and patient satisfaction after total or subtotal hysterectomy in women with endometriosis. Five investigations were deemed eligible for the second aim of the review. No differences were seen in terms of postoperative short- and long-term outcomes after subtotal or total hysterectomy in women with endometriosis or adenomyosis.; Conclusions: Preservation or removal of the cervix in women with endometriosis or adenomyosis appears to have no effect on short- or long-term outcomes, recurrence of endometriosis, quality of life and sexual function, or patient satisfaction. Nevertheless, we lack randomized blinded controlled trials on these aspects. Such trials will be needed to enhance our comprehension of both surgical approaches.

Alkermes, I., et al. (2022). Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7).
	No Results Available Biological: Nemvaleukin and Pembrolizumab Combination|Biological: Pembrolizumab|Biological: Nemvaleukin|Drug: Pegylated Liposomal Doxorubicin (PLD)|Drug: Paclitaxel|Drug: Topotecan|Drug: Gemcitabine Progression-free survival (PFS) as assessed by Investigator|Objective response rate as assessed by Investigator|Overall Survival Rate|Disease Control Rate (DCR) as assessed by Investigator|Duration of Response (DOR) as assessed by Investigator|Time to Response (TTR) as assessed by Investigator|Cancer antigen (CA)-125 response as defined by the Gynecologic Cancer InterGroup (GCIG)|Incidence of treatment-emergent adverse events (TEAEs) Female Phase 3 376 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment ALKS 4230-007|GOG-3063|ENGOT-OV68|KEYNOTE-C71 December 2026

Alkis, O., et al. (2022). "How effectively do we apply first-line treatment in overactive bladder?" International Urogynecology Journal 33(8): 2299-2306.
	INTRODUCTION AND HYPOTHESIS: We aimed to reveal the effectiveness of the combination of behavioral therapy (BT), drug therapy, and pelvic floor muscle training (PFMT) in patients with the diagnosis of overactive bladder (OAB) who did not respond to drug therapy. METHODS: Seventy female patients aged between 18 and 65 years diagnosed with wet-type OAB, who did not respond to drug therapy, were included in our study, which was planned as a prospective randomized controlled trial. The patients were randomly assigned to one of two groups. BT and a combination of anticholinergic + beta3-agonist was implemented in the control group for 12 weeks. BT and PFMT were applied with a combination of anticholinergic + beta3-agonist in the active therapy group for 12 weeks. Post-treatment changes in OAB, ICIQ-SF scores, and frequency and nocturia were compared. RESULTS: The age and BMI averages of the groups were similar (p>0.01). After the treatment, no significant decrease was observed in OAB scores in the control group (p = 0.06), but a significant decrease was observed in the active therapy group (p<0.01). The mean ICIQ-SF scores and the number of nocturia were found to decrease in both groups after 12 weeks of treatment (p<0.01). There was no significant decrease in frequency in the control group (p = 0.054). It regressed significantly in the active therapy group (p<0.01). After the treatment, 3 of 30 the patients in control group (10%) and 11 of the 32 patients in the active therapy group (34.3%) said that their complaints had regressed and that they were pleased with their current situation. Although after the treatment, 4 patients in the control group were dry (13.3%), 10 patients in the active therapy group were dry (31.25%). CONCLUSIONS: We demonstrated that drug therapy, BT, and PFMT, which are recommended in the first-line treatment of OAB reduce the need for invasive treatments when they are well explained to the patients and combined.

Allahqoli, L., et al. (2023). "Appendiceal Endometriosis: A Comprehensive Review of the Literature." Diagnostics 13(11): 1827.
	Objective: the purpose of this review was to evaluate the prevalence of appendiceal endometriosis and the safety of concomitant appendectomy in women with endometriosis or pelvic pain. Material(s) and Method(s): We searched the electronic databases Medline (PubMed), Scopus, Embase, and Web of Science (WOS). The search was not subject to any limitation in terms of time or method. The primary research question was: what is the prevalence of appendiceal endometriosis? The secondary research question was: is it safe to perform appendectomy during surgery for endometriosis? Publications that reported data about appendiceal endometriosis or appendectomy in women with endometriosis were reviewed regarding the inclusion criteria. Result(s): We found 1418 records. After review and screening, we included 75 studies published between 1975 and 2021. With regard to the first question of the review, we found 65 eligible studies and divided these into the following two categories: (a) endometriosis of the appendix presenting as acute appendicitis, and (b) endometriosis of the appendix as an incidental finding in gynecological surgery. Forty-four case reports described appendiceal endometriosis in women who were admitted for the treatment of pain in the right-sided lower abdomen. Endometriosis of the appendix was observed in 2.67% (range, 0.36-23%) of women who were admitted due to acute appendicitis. In addition, appendiceal endometriosis was an incidental finding during gynecological surgery in 7.23% of cases (range, 1-44.3%). With regard to the second question of the review, which was the safety of appendectomy in women with endometriosis or pelvic pain, we found 11 eligible studies. Reviewed cases had no significant intraoperative or follow-up complications during the 12 weeks. Conclusion(s): Based on the reviewed studies, coincidental appendectomy appears reasonably safe and was associated with no complications in the cases reviewed for the present report.Copyright © 2023 by the authors.

Allen, L. A., et al. (2022). "Long-term health outcomes in young women with polycystic ovary syndrome: A narrative review." Clinical Endocrinology 97(2): 187-198.
	Polycystic ovary syndrome (PCOS) has long been recognized as a common disorder in young women leading to reproductive and cutaneous sequelae. However, the associated health risks are now known to extend beyond these familiar manifestations to a range of longer-term comorbidities. Here we review the evidence for an association of PCOS with adverse long-term health outcomes, discussing the pathophysiological mechanisms involved in addition to opportunities for therapeutic intervention. Cross-sectional and longitudinal studies point to an increased risk of type 2 diabetes, hypertension and dyslipidaemia, with recent data confirming that these translate to an increased risk of cardiovascular events independently of obesity. Obstructive sleep apnoea, nonalcoholic fatty liver disease and endometrial cancer are also more prevalent, while mental health disorders, notably anxiety and depression, are common but under-appreciated associations. Uncertainties remain as to whether these risks are apparent in all patients with PCOS or are confined to particular subtypes, whether risks persist post-menopausally and how risk may be affected by ethnicity. Further work is also needed in establishing if systematic screening and targeted intervention can lead to improved outcomes. Until such data are available, clinicians managing women with PCOS should counsel patients on long-term health risks and invest in strategies that limit progression to metabolic and non-metabolic morbidities.Copyright © 2021 John Wiley & Sons Ltd.

Allenby, T. H., et al. (2020). "A systematic review of home-based dietary interventions during radiation therapy for cancer." Technical Innovations and Patient Support in Radiation Oncology 16: 10-16.
	Purpose: Our objectives are to assess (1) the acceptability and feasibility of dietary interventions for patients undergoing radiation therapy (RT), and (2) the impact of dietary interventions on patient reported outcomes, toxicities, and survival. Method(s): A PICOS/PRISMA/MOOSE selection protocol was used to include articles that evaluate adding dietary interventions to patients receiving RT. Acceptability was defined as (# accepting/# approached); feasibility was (# completing/# approached). Patient-reported outcomes were reported based on questionnaires used in each study and survival was measured from the date of diagnosis until death in each study. Level of evidence was assessed with Center for Evidence-Based Medicine (CEBM) criteria. Result(s): Sixteen articles were included; among these, 2027 patients were approached regarding the intervention, and 1661 accepted (81.9%); of these, 1543 (92.9%) completed the prescribed diet + RT course. The most common cancers included were gynecological, head and neck, and gastrointestinal. For patients with pelvic cancers, a high fiber diet may improve diarrhea (CEBM level 1b). Enteral nutrition formula, including formulas with proteins such as L-arginine, lipids such as eicosapentaenoic acids, glucids, and ribonucleotides, may help prevent of malnutrition in head and neck cancer patients undergoing RT (level 2b). Vitamin C and beta-carotene may reduce of xerostomia in head and neck cancer patients; however, the studies evaluating these vitamins included vitamin E, which increases all-cause mortality (level 2b). No dietary intervention for cancer patients receiving RT has been shown to improve survival. Conclusion(s): There are limited data to support safe and efficacious use of dietary interventions during RT.Copyright © 2020 The Authors

Alliance Foundation, T., et al. (2021). A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer.
	No Results Available Drug: Atezolizumab - 28 Day Cycle|Drug: Bevacizumab|Drug: Ipatasertib|Drug: Talazoparib|Drug: Trastuzumab emtansine|Drug: Tiragolumab|Drug: Atezolizumab - 21 Day Cycle|Drug: Inavolisib|Drug: Letrozole|Drug: Giredestrant|Drug: Abemaciclib Investigator-assessed overall response rate (ORR) of each biomarker cohort|The proportion of participants in each biomarker cohort who remain alive and progression-free for at least 6 months|Relative proportion of participants in each biomarker cohort who remain progression-free for at least 6 months compared to that from historical control studies|Investigator assessed disease-control rate of each biomarker cohort|Duration of response for participants in each biomarker cohort who achieve a complete or partial response.|Overall survival (OS) rates of participants in each biomarker cohort after 24 months|Duration of response for participants in each biomarker cohort who achieve a confirmed response (complete or partial)|Overall survival rates of participants in each biomarker cohort Female Phase 1|Phase 2 148 Other|Industry Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment AFT-50 October 2026

Almohammadi, A., et al. (2023). "The optimal route of progesterone administration for luteal phase support in a frozen embryo transfer: a systematic review." Archives of Gynecology and Obstetrics 308(2): 341-350.
	Objective: To investigate the optimal route of progesterone administration for luteal phase support in a frozen embryo transfer.; Design: Systematic review.; Patients: Women undergoing frozen embryo transfer (FET).; Interventions: We conducted an extensive database search of Medline (PubMed), Embase, Web of Science, and Cochrane Trials Register using relevant keywords and their combinations to find randomized controlled trials (RCTs) comparing the routes (i.e., oral, vaginal, intramuscular) of progesterone administration for luteal phase support (LPS) in artificial FET.; Main Outcome Measures: Clinical pregnancy, live birth, miscarriage.; Results: Four RCTs with 3245 participants undergoing artificial endometrial preparation (EP) cycles during FET were found to be eligible. Four trials compared vaginal progesterone with intramuscular progesterone and two trials compared vaginal progesterone with oral progesterone. One study favored of vaginal versus oral progesterone for clinical pregnancy rates (RR 0.45, 95% CI 0.22-0.92) and other study favored intramuscular versus vaginal progesterone for clinical pregnancy rates (RR 1.46, 95% CI 1.21-1.76) and live birth rates (RR 1.62, 95% CI 1.28-2.05). Tabulation of overall evidence strength assessment showed low-quality evidence on the basis that for each outcome-comparison pair, there were deficiencies in either directness of outcome measurement or study quality.; Conclusion: There was little consensus and evidence was heterogeneous on the optimal route of administration of progesterone for LPS during FET in artificial EP cycles. This warrants more trials, indirect comparisons, and network meta-analyses.; Propero No: CRD42021251017. (© 2022. The Author(s).)

Almuslim, H. and S. AlDossary (2022). "Models of incorporating telehealth into obstetric care during the COVID-19 pandemic, its benefits and barriers: A scoping review." Telemedicine and e-Health 28(1): 24-38.
	Introduction: Coronavirus disease 2019 (COVID-19) is a highly contagious viral infection. Hospitals worldwide have decreased face-to-face visits to reduce the exposure to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Prenatal and postpartum care are essential for the health of women and their fetuses. Therefore, many hospitals have incorporated telehealth into their protocols. Objectives: The aim of this review was to determine how health care organizations are responding to the COVID-19 pandemic by incorporating telehealth visits into their protocols for obstetrics care, what services were converted to telehealth, and its benefits and barriers. Method: A computerized literature search was performed using PubMed and Cumulative Index of Nursing and Allied Health Literature (CINAHL) databases using terms, including "telehealth," "virtual visits," "obstetric," "pregnancy," "postpartum," and "COVID-19" for articles published before October 2020. Peer reviewed articles and guidelines were included in this review. Results: A total of 25 articles were identified. Fifteen articles reported protocols. During this pandemic, protocols developed replaced some in-person visits with telehealth visits, when no testing or vaccinations are required. The main reported benefits were minimizing exposure to SARS-CoV-2 and the continuity to provide high-quality and safe care. Lack of access to high-speed internet and hardware and inaccessibility to patients were the most reported barriers. Conclusion: Telehealth provided the opportunity for reducing in-person visits during the COVID-19 pandemic. Some prenatal services could be completely provided through telehealth and others require medical equipment to be delivered. Health care organizations recognized that using telehealth could be continued beyond this pandemic, as they provided many benefits for patients, medical staff, and the organizations themselves. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Alomar, O., et al. (2022). "Prophylactic vasopressin to reduce intraoperative blood loss and associated morbidities during myomectomy: A systematic review and meta-analysis of 11 controlled trials." Journal of Gynecology Obstetrics and Human Reproduction 51(10): 102485.
	Objective: To collate evidence from randomized controlled trials (RCTs) and nonrandomized controlled trials (NCTs) on the efficacy and safety of vasopressin versus passive control (placebo/no treatment) during myomectomy.; Methods: Six information sources were screened until 25-June-2022. The Cochrane Collaboration tool and Newcastle-Ottawa Scale were used to evaluate the risk of bias. Data were summarized as mean difference or risk ratio with 95% confidence interval in a random-effects model.; Results: Eleven studies, comprising 1067 patients (vasopressin=567 and control=500) were analyzed. For RCTs (n = 8), the overall quality included 'high risk' (n = 4), 'low risk' (n = 2), and 'some concerns' (n = 2). For NCTs (n = 3), the overall quality included 'good' (n = 2) and 'fair' (n = 1). The mean intraoperative blood loss, mean difference in hemoglobin level, mean difference in hematocrit level, rate of perioperative blood transfusion, and mean operative time were significantly reduced in favor of the vasopressin group compared with the control group. However, there was no significant difference between both groups regarding the mean hospital stay. Pertaining to safety endpoints, after omission of an outlier study, the rate of drug-related cardiovascular adverse events did not significantly differ between both groups. There was no quantitative evidence of publication bias for the endpoint of intraoperative blood loss.; Conclusion: Among patients undergoing myomectomy, prophylactic administration of vasopressin was largely safe and correlated with significant reductions in intraoperative blood loss and associated morbidities compared with a passive control intervention. Nonetheless, the conclusions should be cautiously interpreted owing to the low-evidence quality and the used doses varied greatly between studies.; Competing Interests: Declaration of Competing Interest The authors report no conflict of interest. (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

Alomran, S. and E. D. Estrella (2023). "Effect of Dietary Regimen on the Development of Polycystic Ovary Syndrome: A Narrative Review." Cureus 15(10): e47569.
	BACKGROUND: Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting 4%-20% of women worldwide. The pathogenesis of PCOS is still unconfirmed. Some risk factors for the disease are obesity, insulin resistance, genetic factors, and diet. AIM: Our aim is to review studies investigating the role of diet in the development of PCOS. METHOD: We looked into studies published in different databases, such as PubMed, Scopus, Google Scholar, and Web of Science, using specific keywords as per our study topic. RESULTS: High-carbohydrate, high-fat diets, low-fiber diets, high glycemic index and glycemic load, and Western diets were associated with a higher risk of PCOS. Some vitamins, such as Vitamin D and B9, the Dietary Approaches to Stop Hypertension (DASH) diet, fruits, nuts, and seeds, such as pumpkin and sunflower, are associated with a lower risk of PCOS. The Alternate Healthy Eating Index-2010 (AHEI-2010) diet reduces the risk of hyperandrogenic or oligoanovulatory phenotypes. The review revealed that unhealthy diets encompass high levels of carbohydrates, animal proteins, fats, and processed foods. Despite inconsistent results from certain studies claiming no disparity in the dietary patterns between PCOS patients and healthy controls, the majority of researchers have amassed sufficient evidence linking nutrition to the incidence of PCOS. The review also underscores the significance of the interplay between genes and the environment in the prevalence of PCOS. Individuals possess a genetic predisposition to the condition from birth, and subsequent exposure to detrimental environmental factors, particularly diet and inactivity, trigger epigenetic changes that contribute to the development of the disorder. This study further illuminated the existence of the "lean PCOS" phenomenon, wherein roughly 20% of global PCOS cases exhibit clinical manifestations of the syndrome but maintain a normal or below-average weight. CONCLUSION: To sum up, the collective body of assessed research indicates that women with PCOS tend to share similar dietary habits, characterized by the consumption of numerous unhealthy foods such as processed foods, animal proteins, carbohydrates, and fats. While some studies present conflicting findings, these contradictions underscore the necessity for further investigation employing extensive cohorts.

Alonso, D., et al. (2023). "Digestive toxicity in cancer treatments. Bibliographic review. Influence on nutritional status." Endocrinologia, diabetes y nutricion 70(2): 136-150.
	Introduction: The cause of death can be attributed to malnutrition in 10-20% of cancer patients. Patients with sarcopenia present more chemotherapy toxicity, less progression-free time, less functional capacity and more surgical complications. Antineoplastic treatments have a high prevalence of adverse effects that compromise nutritional status. The new chemotherapy agents present direct toxicity on the digestive tract (nausea, vomiting, diarrhoea and/or mucositis). We present the frequency of adverse effects with nutritional impact of the most frequent chemotherapy agents used in the treatment of solid tumours, as well as strategies for early diagnosis and nutritional treatment.; Material and Methods: Review of commonly used cancer treatments (cytotoxic agents, immunotherapy, targeted therapies) in colorectal, liver, pancreatic; lung, melanoma, bladder, ovary, prostate and kidney cancer. The frequency (%) of gastrointestinal effects, and those of grade ≥3 are recorded. A systematic bibliographic search was carried out in PubMed, Embase, UpToDate, international guides and technical data sheets.; Results: They are shown in the form of tables in which the drugs appear together with the probability that they present any digestive adverse effect and the percentage of serious adverse effects (Grade ≥ 3).; Discussion: Antineoplastic drugs are associated with a high frequency of digestive complications with nutritional repercussions, which can reduce QoL and cause death as a result of malnutrition or due to the limiting effect of suboptimal treatments, closing the malnutrition-toxicity loop. It is necessary to inform the patient about the risks and establish local protocols regarding the use of antidiarrheal drugs, antiemetics and adjuvants in the management of mucositis. We propose action algorithms and dietary advice that can be used directly in clinical practice, to prevent the negative consequences of malnutrition. (Copyright © 2023. Published by Elsevier España, S.L.U.)

Alouini, S., et al. (2022). "Pelvic Floor Muscle Training for Urinary Incontinence with or without Biofeedback or Electrostimulation in Women: A Systematic Review." International Journal of Environmental Research and Public Health 19(5).
	To determine the effectiveness of pelvic floor muscle training (PFMT) with or without biofeedback or electrostimulation in reducing urinary incontinence and pelvic floor muscle con-traction in non-pregnant women with urinary incontinence.; Methods: The following electronic databases were searched: PubMed, Cochrane Central, ClinicalTrials.gov, EU Clinical Trials Register, and sources from NICE, FDA, EMA, and SMC (articles only in English, 2000-2021). Search terms were: urinary incontinence, pelvic floor muscle training or exercises, biofeedback, electrostimulation. We used the PRISMA statement (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) for this systematic review. Relevant articles were selected, data were extracted, and quality was assessed. Data were extracted in predesigned form, followed by narrative synthesis.; Results: Following the search, 15 RCTs were retrieved using the strict inclusion and exclusion criteria, assessing 2441 non-pregnant women with urinary incontinence. Of the 15 studies, 7 were low risk, 5 were medium risk, and 3 were high-risk studies. Of the 2441 patients, 970 were in PFMT, 69 were in extracorporeal magnetic innervation (ExMi) or with PFMT + BF, 30 were in electrostimulation (ES), 21 were in whole body vibration training (WBVT), 23 were in pelvic floor muscle + abdominal muscle therapy (PFM + AMT), 326 were in PFMT + biofeedback, 93 were in vaginal cones (VC), 362 were in PFMT + education, 318 were in education, and 229 were in control groups. The most often measures employed were pad tests, bladder diary, and questionnaire on the quality of life. Stress, urge and mixed urinary incontinence were studied. In all RCT, PFMT significantly reduced urinary incontinence, essentially SIU and MUI, when compared with the control group before and after treatment. Overall, out of 997 PFMT or PFMT + education patients, 504 patients (50.5%) showed improvement in urinary incontinence, and 218 became continent (21.8%) (negative pad test). In total, 62% of patients significantly reduced their urinary incontinence or cured it and improved their pelvic floor muscle contraction. All other physiotherapist techniques also significantly reduced urinary leakages, e.g., vaginal cones, biofeedback, ExMI, and WBVT when compared with the control group. There were no significant differences between these methods in reducing the severity of urinary incontinence.; Conclusion: PFMT alone or with bio-feedback or electrostimulation was effective in reducing urinary incontinence and improving pelvic floor muscle contraction. PFMT when compared with other interventions such as bio-feedback, VC, and WBVT did not show significant differences but was superior to the control group. RCT studies with similar parameters used for measuring the outcomes need to be included.

Alrawashdh, N., et al. (2022). "Meta-Analysis of Same-Day Pegfilgrastim Administration Stratified by Myelotoxic Febrile Neutropenia Risk and Tumor Type." Journal of the advanced practitioner in oncology 13(8): 796-811.
	BACKGROUND: Pegfilgrastim is recommended to be administered at least 24 hours following the completion of chemotherapy, yet some clinicians use a same-day administration protocol. In this meta-analysis, we compared the incidence of chemotherapy-induced (febrile) neutropenia (CIN/FN) as well as CIN/FN-related chemotherapy disruptions in cancer patients provided with pegfilgrastim same-day vs. next-day. METHODS: Six databases were searched for comparative studies of same-day vs. next-day pegfilgrastim administration. Fixed or random-effects meta-analyses were conducted to estimate pooled odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Thirteen studies were included in this meta-analysis. The FN OR for same-day vs. next-day administration was 1.48 (95% CI = 1.06-2.08) across all cycles, attributable mainly to studies of high FN risk (OR = 2.46, 95% CI = 1.04-5.83) vs. intermediate FN risk regimens (OR = 1.41, 95% CI = 0.95-2.10), and breast cancer (OR = 3.15, 95% CI = 1.24-8.01) vs. non-Hodgkin lymphoma (NHL; OR = 1.48, 95% CI = 0.98-2.23) and gynecologic cancers (OR = 0.64, 95% CI = 0.11-3.85). Where available, ORs for first cycle of chemotherapy, grades 3 and/or 4 CIN, and chemotherapy dose delays or reductions were in line with these findings. CONCLUSION: In this independent study, same-day pegfilgrastim administration may or may not increase the likelihood of FN, grades 3 and/or 4 CIN, and chemotherapy dose reductions or delays; and this may be a function of the myelotoxicity of the regimens (elevated in high-risk but not intermediate-risk regimens) and tumor type (elevated in breast but not in NHL or gynecologic cancers). With due caution, same-day pegfilgrastim administration may be safe and beneficial in intermediate-risk regimens and selected tumor types.

Alrhmoun, S. and S. Sennikov (2022). "The Role of Tumor-Associated Antigen HER2/neu in Tumor Development and the Different Approaches for Using It in Treatment: Many Choices and Future Directions." Cancers 14(24): 6173.
	The treatment of HER2-positive cancers has changed significantly over the past ten years thanks to a significant number of promising new approaches that have been added to our arsenal in the fight against cancer, including monoclonal antibodies, inhibitors of tyrosine kinase, antibody-drug conjugates, vaccination, and particularly, adoptive-T-cell therapy after its great success in hematological malignancies. Equally important is the new methodology for determining patients eligible for targeted HER2 therapy, which has doubled the number of patients who can benefit from these treatments. However, despite the initial enthusiasm, there are still several problems in this field represented by drug resistance and tumor recurrence that require the further development of new more efficient drugs. In this review, we discuss various approaches for targeting the HER2 molecule in cancer treatment, highlighting their benefits and drawbacks, along with the different mechanisms responsible for resistance to HER2-targeted therapies and how to overcome them.Copyright © 2022 by the authors.

Al-Samkari, H., et al. (2022). "Avatrombopag for chemotherapy-induced thrombocytopenia in patients with non-haematological malignancies: an international, randomised, double-blind, placebo-controlled, phase 3 trial." The Lancet. Haematology 9(3): e179-e189.
	Background: Chemotherapy-induced thrombocytopenia is common and causes chemotherapy dose reductions or treatment delays, bleeding, and suboptimal oncological outcomes. We aimed to evaluate avatrombopag, a thrombopoietin receptor agonist that increases platelet counts, in patients with non-haematological cancer and platelet counts lower than 50 ×10 9 cells per L.; Methods: In this randomised, double-blind, placebo-controlled, phase 3 study, patients aged 18 years or older at 71 hospitals or cancer treatment centres in China, Hungary, Poland, Russia, Serbia, Ukraine, and the USA and with ovarian, bladder, or lung cancer receiving chemotherapy who had severe thrombocytopenia were randomly assigned (2:1) to oral avatrombopag 60 mg or oral placebo once daily given 5 days before and after chemotherapy, with randomisation stratified by number of chemotherapy drugs used. Patients, investigators, and data collectors were masked to group allocation. Eligibility required two previous lines of chemotherapy or fewer, an ECOG performance status of 2 or less, and no previous history of chemotherapy-induced thrombocytopenia. The composite primary endpoint was the proportion of responders not requiring platelet transfusion or either a 15% or more chemotherapy dose reduction or a 4-day or more chemotherapy delay due to thrombocytopenia following study treatment until the start of the subsequent cycle. Analyses were done on the intention-to-treat and per protocol populations. Safety was analysed in all patients who received at least one dose of avatrombopag. The trial is registered with ClinicalTrials.gov, NCT03471078, and has been completed.; Findings: Between Oct 12, 2018, and June 28, 2020, 122 patients were enrolled and randomly assigned to receive avatrombopag (n=82) or placebo (n=40). Median follow-up was 31 days (IQR 22-61). Similar proportions of patients reached the primary endpoint in the avatrombopag and placebo groups (intention-to-treat: 57 [70%, 95% CI 58-79] of 82 vs 29 [73%, 95% CI 56-85] of 40; difference -3·0% (95% CI -21·6 to 15·6); p=0·72; per protocol: 51 [85%, 95% CI 73-93] of 60 vs 27 [84%, 95% CI 67-95] of 32; 0·6% (95% CI -20·8 to 22·1); p=0·96). 15 (18%) of 82 patients had serious adverse events in the avatrombopag group and eight (20%) of 40 in the placebo group, of which thrombocytopenia was most common (4 [5%] of 82 and 4 [10%] of 40 patients). Common grade 3-4 treatment-emergent adverse events were neutropenia (22 [27%] of 82 and 16 [40%] of 40 patients), leukopenia (19 [23%] of 82 and 5 [13%] of 40), anaemia (16 [20%] of 82 and 9 [23%] of 40), and thrombocytopenia (16 [20%] of 82 and 14 [35%] of 40). Most adverse events were considered unrelated to study drug. No treatment-related deaths were reported.; Interpretation: In this population of patients with non-haematological malignancies who are relatively chemotherapy naive, chemotherapy-induced thrombocytopenia treatment outcomes were similar between the avatrombopag and placebo groups. Given its safety and ability to augment platelet counts in patients with chemotherapy-induced thrombocytopenia, evaluation of avatrombopag in populations with more persistent chemotherapy-induced thrombocytopenia is warranted.; Funding: Dova Pharmaceuticals, a Sobi company.; Competing Interests: Declaration of interests HA-S reports grants, personal fees, and consultancy fees from Dova Pharmaceuticals (a Sobi company), during the conduct of the study; personal fees from Agios, Argenx, Rigel, Novartis, Moderna, and Forma; and grants from Agios and Amgen, outside the submitted work. XX and BDJ are employees of Dova Pharmaceuticals. JK-S and SZS declare no competing interests. (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Alsbjerg, B., et al. (2023). "Rectal progesterone administration secures a high ongoing pregnancy rate in a personalized Hormone Replacement Therapy Frozen Embryo Transfer (HRT-FET) protocol: a prospective interventional study." Human reproduction (Oxford, England) 38(11): 2221-2229.
	Study Question: Can supplementation with rectal administration of progesterone secure high ongoing pregnancy rates (OPRs) in patients with low serum progesterone (P4) on the day of blastocyst transfer (ET)?; Summary Answer: Rectally administered progesterone commencing on the ET day secures high OPRs in patients with serum P4 levels below 35 nmol/l (11 ng/ml).; What Is Known Already: Low serum P4 levels at peri-implantation in Hormone Replacement Therapy Frozen Embryo Transfer (HRT-FET) cycles impact reproductive outcomes negatively. However, studies have shown that patients with low P4 after a standard vaginal progesterone treatment can obtain live birth rates (LBRs) comparable to patients with optimal P4 levels if they receive additionalsubcutaneous progesterone, starting around the day of blastocyst transfer. In contrast, increasing vaginal progesterone supplementation in low serum P4 patients does not increase LBR. Another route of administration rarely used in ART is the rectal route, despite the fact that progesterone is well absorbed and serum P4 levels reach a maximum level after ∼2 h.; Study Design, Size, Duration: This prospective interventional study included a cohort of 488 HRT-FET cycles, in which a total of 374 patients had serum P4 levels ≥35 nmol/l (11 ng/ml) at ET, and 114 patients had serum P4 levels <35 nmol/l (11 ng/ml). The study was conducted from January 2020 to November 2022.; Participants/materials, Setting, Methods: Patients underwent HRT-FET in a public Fertility Clinic, and endometrial preparation included oral oestradiol (6 mg/24 h), followed by vaginal micronized progesterone, 400 mg/12 h. Blastocyst transfer and P4 measurements were performed on the sixth day of progesterone administration. In patients with serum P4 <35 nmol/l (11 ng/ml), 'rescue' was performed by rectal administration of progesterone (400 mg/12 h) starting that same day. In pregnant patients, rectal administration continued until Week 8 of gestation, and oestradiol and vaginal progesterone treatment continued until Week 10 of gestation.; Main Results and the Role of Chance: Among 488 HRT-FET single blastocyst transfers, the mean age of the patients at oocyte retrieval (OR) was 30.9 ± 4.6 years and the mean BMI at ET 25.1 ± 3.5 kg/m2. The mean serum P4 level after vaginal progesterone administration on the day of ET was 48.9 ± 21.0 nmol/l (15.4 ± 6.6 ng/ml), and a total of 23% (114/488) of the patients had a serum P4 level lower than 35 nmol/l (11 ng/ml). The overall, positive hCG rate, clinical pregnancy rate, OPR week 12, and total pregnancy loss rate were 66% (320/488), 54% (265/488), 45% (221/488), and 31% (99/320), respectively. There was no significant difference in either OPR week 12 or total pregnancy loss rate between patients with P4 ≥35 nmol/l (11 ng/ml) and patients with P4 <35 nmol/l, who received rescue in terms of rectally administered progesterone, 45% versus 46%, P = 0.77 and 30% versus 34%, P = 0.53, respectively. OPR did not differ whether patients had initially low P4 and rectal rescue or were above the P4 cut-off. Logistic regression analysis showed that only age at OR and blastocyst scoring correlated with OPR week 12, independently of other factors like BMI and vitrification day of blastocysts (Day 5 or 6).; Limitations, Reasons for Caution: In this study, vaginal micronized progesterone pessaries, a solid pessary with progesterone suspended in vegetable hard fat, were used vaginally as well as rectally. It is unknown whether other vaginal progesterone products, such as capsules, gel, or tablet, could be used rectally with the same rescue effect.; Wider Implications of the Findings: A substantial part of HRT-FET patients receiving vaginal progesterone treatment has lowserum P4. Adding rectally administered progesterone in these patients increases the reproductive outcome. Importantly, rectal progesterone administration is considered convenient, and progesterone pessaries are easy to administer rectally and of low c st.; Study Funding/competing Interest(s): Gedeon Richter Nordic supported the study with an unrestricted grant as well as study medication. B.A. has received unrestricted grant from Gedeon Richter Nordic and Merck and honoraria for lectures from Gedeon Richter, Merck, IBSA and Marckyrl Pharma. P.H. has received honoraria for lectures from Gedeon Richter, Merck, IBSA and U.S.K. has received grant from Gedeon Richter Nordic, IBSA and Merck for studies outside this work and honoraria for teaching from Merck and Thillotts Pharma AB and conference expenses covered by Merck. The other co-authors have no conflict of interest to declare.; Trial Registration Number (25): EudraCT no.: 2019-001539-29. (© The Author(s) 2023. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Alsbjerg, B., et al. (2022). "GnRH agonist supplementation in hormone replacement therapy-frozen embryo transfer cycles: a randomized controlled trial." Reproductive Biomedicine Online 44(2): 261-270.
	Research Question: Will two boluses of gonadotrophin-releasing hormone agonist (GnRHa) during hormone replacement therapy-frozen embryo transfer (HRT-FET) cycles reduce the total pregnancy loss rate?; Design: Randomized controlled trial including a total of 287 HRT-FET cycles performed between 2013 and 2019. After randomization participants allocated to the GnRHa group (n = 144) underwent a standard HRT protocol, supplemented with a total of two boluses of triptorelin 0.1 mg; one bolus 2 days before starting vaginal progesterone and one bolus on the 7th day of progesterone. The control group (n = 143) underwent a standard HRT-FET protocol only.; Results: The intention-to-treat analysis showed no significant difference in total pregnancy loss between the GnRHa group and the control group (21% versus 33%; relative risk [RR] 0.63, 95% confidence interval [CI] 0.35-1.11), nor was the biochemical pregnancy loss per positive human chorionic gonadotrophin (HCG) significantly lower in the GnRHa group (12%, 8/67) compared with the control group (25%, 18/72) (RR 0.48, 95% CI 0.22-1.02). Participants with a live birth had a significantly higher mean progesterone concentration compared with participants without a live birth (25.0 ± 12.2 versus 23.8 ± 8.9 nmol/l; P = 0.001). Furthermore, a trend for a higher live birth rate (LBR) correlated with the highest oestradiol quartile concentration (oestradiol >0.957 nmol/l).; Conclusions: Although a difference of 14% in biochemical loss and 12% in total pregnancy loss in favour of GnRHa supplementation was seen this did not reach statistical difference. Luteal progesterone and oestradiol concentrations correlate with LBR in the HRT-FET cycle, emphasizing the importance of luteal serum progesterone and oestradiol monitoring. (Copyright © 2021 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Alshammari, E. (2021). "The efficacy of zinc supplementation in postpartum depression: A review of studies on pregnancy and postdelivery care." International Journal of Pharmaceutical Research 13(1): 3162-3165.
	Depression is a major public health issue concerning many women during and after pregnancy. Most research studies indicate a prospective role of zinc in decreasing or inhibiting such depressive indications. Several investigations have evaluated the link between low zinc levels and depression. However, there are limited clinical trials examining zinc supplementation in depressed women before and after pregnancy. As a result, the review put together findings from some of the published studies on the effectiveness of zinc supplementation in the reduction or deterrence of depressive symptoms. Studies discussed in this paper were searched on Pubmed. In some of the studies, support for the effectiveness of zinc supplements on depressive indications was noted. However, in most of the studies, zinc supplementation was used as an adjunct of antidepressants drug treatment and was found to lower depressive symptoms significantly. The current study is limited in various ways. Currently, there are only a few trials investigating the impact of women taking zinc supplements to alleviate depressive symptoms before and after pregnancy. It is not possible to upgrade this review into a systematic review since a general pooled estimation of effect cannot be determined. In summary, it was evident from this review that zinc supplementation has potential benefits for depression, either as an independent intervention or as an addition to traditional antidepressant drug therapy. Even so, existing studies have several methodological challenges and there is need for additional well-designed studies evaluating zinc supplementation during pregnancy and post-delivery care to prevent postpartum depression.Copyright © 2021, Advanced Scientific Research. All rights reserved.

Alshammari, E. (2021). "Magnesium supplementation for premenstrual syndrome and premenstrual dysphoric disorder." International Journal of Pharmaceutical Research 13(1): 486-490.
	Premenstrual syndrome and premenstrual dysphoric disorder have been linked with low dietary intake of some vitamins and minerals, one of them being magnesium. In this regard, a suitable treatment plan should include supplementation of magnesium to achieve optimal status. However, it is necessary to verify if magnesium is effective and safe to manage PMS symptoms. The purpose of this review was to explore more recent studies examining magnesium supplementation for PMS and PMDD. Some studies identified magnesium supplementation as one of the options useful in the management of PMS in a nonpharmacological way. It is clear from the review that most women diagnosed with PMS show compromised levels of magnesium. These showed the significance of paying close attention to the nutritional status of females experiencing PMS to alleviate associated symptoms. In some cases, magnesium was used in combination with vitamin B6. The findings showed that magnesium combined with vitamin B6 had the biggest effect on PMS symptoms. Magnesium was more effective in controlling symptoms associated with water retention, craving, and anxiety. This mineral was also found to be valuable, low cost, and an effective treatment for PMS symptoms. In sum, evidence from most of the studies showed that magnesium could confer benefits to women who complain of premenstrual symptoms. The quality of some of the reviewed studies was questionable and it is necessary that well-designed randomized controlled trials are carried out to determine the effect of magnesium supplementation among women with PMS and PMDD. Hence, further investigations need to be carried out before encouraging the prescription of magnesium supplements for PMS and PMDD.Copyright © 2020, Advanced Scientific Research. All rights reserved.

Alsharif, S. A., et al. (2024). "Effect of Oral Consumption of Vitamin D on Uterine Fibroids: A Systematic Review and Meta-Analysis of Randomized Clinical Trials." Nutrition and Cancer 76(3): 226-235.
	Impaired vitamin D status is highly prevalent among women with UFs. The objective of this first-ever systematic review and meta-analysis was to summarize the effect of vitamin D supplementation on the size of uterine fibroids (UFs). We performed a comprehensive literature search for published randomized controlled trials (RCTs) in Medline, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials from inception to September 2022. Five trials including 511 participants (256 cases and 255 controls) were included. Pooling results from five trials, which compared size of UFs between experimental and placebo groups, revealed that vitamin D supplementation could significantly decrease the size of UFs (standardized mean difference [SMD]: -0.48, 95% confidence interval [CI]: -0.66, -0.31) and cause improvement in serum level of vitamin D compared to placebo group (SMD: 3.1, 95% CI: 0.66, 5.55). A significant effect was observed in the subset of trials administering vitamin D supplementation for >8 wk (SMD: -0.62, 95% CI: -0.88, -0.37). In conclusion, vitamin D supplementation significantly increases serum levels of vitamin D and reduces the size of UFs. However, larger, well-designed RCTs are still needed to determine the effect of vitamin D on other parameters of UFs.Copyright © 2024 Taylor & Francis Group, LLC.

Alsulihem, A. and J. Corcos (2021). "The use of vaginal lasers in the treatment of urinary incontinence and overactive bladder, systematic review." International Urogynecology Journal 32(3): 553-572.
	Objectives: To evaluate the available literature to assess the safety, efficacy, and outcomes of lasers in the treatment of female stress urinary incontinence (SUI) and overactive bladder (OAB). Method(s): Pubmed search was conducted up to May 2020, including observational and investigational human studies that documented the effects on laser treatment in SUI and OAB. Result(s): A total of 27 studies, recording subjective or objective measures in SUI or OAB were included. Lasers used included Er:YAG and Fractional CO2 lasers. The overall quality of studies was poor, and 23/27 studies were case series (LOE:4). Er:YAG laser showed a modest reduction in mild SUI cases, with benefits lasting a maximum of 13-16 months. Er:YAG laser for OAB showed conflicting results, with a trend to improve OAB symptoms for up to 12 months. Fractional CO2 laser showed an improvement of mild SUI in few studies; however, no long-term data are available. For OAB symptoms, studies showed minimal improvement that was evaluated in short term studies. When reported, adverse events were insignificant, however, they were not reported systematically. Several limitations have been noticed in the current literature of vaginal lasers, including large variation in laser settings and protocols, short term follow up, lack of urodynamic evaluation, and appropriate objective measures. Conclusion(s): Based on the available literature, lasers cannot be recommended as a treatment option at this time. Future better-quality studies are needed to document the exact mechanism of action, longevity, safety and its eventual place into the current treatment algorithms of SUI and OAB.Copyright © 2020, The International Urogynecological Association.

Al-Taie, M. J. M., et al. (2021). "Medical induction of first trimester abortion by misoprostol or misoprostol with letrozole." Indian journal of forensic medicine and toxicology 15(1): 2712‐2717.
	Background: Managing of abortion is an important subject in gynecology. Millions of patients had suffered from spontaneous abortions that occur per year. Objective(s): The aim of this study was to compare the effect of misoprostol alone and misoprostol with letrozole in the induction of abortion in the first trimester of pregnancy. Patients and Methods: In a single ‐blind clinical trial,128 female applicants for legal abortion within the first trimester of pregnancy that referred to AL‐Batool hospital, were divided in to two groups: intervention (misoprostol with letrozole) and control groups (misoprostol alone). The complete abortion, drug‐induced side effects of misoprostol and letrozole were noted and evaluated. Result(s): The complete abortion rate was93.2% in intervention group and in68.7% in the control group (misoprostol) only, which was significantly higher in intervention group (p = 0.001). Abdominal pain in the intervention group is also significantly lower than that of the control group (p = 0.013). Intervention group also had significantly lower duration of bleeding rather than control group (p = 0.006). Conclusion(s): Based on our results, pretreatment with letrozole plus Misoprostol was more effective for prompting abortion in the first trimester of pregnancy without increasing side effect compared to misoprostol alone. Copyright © 2021, Institute of Medico‐Legal Publications. All rights reserved.

Alteri, A., et al. (2024). "ESHRE guideline: number of embryos to transfer during IVF/ICSI+." Human reproduction (Oxford, England).
	STUDY QUESTION: Which clinical and embryological factors should be considered to apply double embryo transfer (DET) instead of elective single embryo transfer (eSET)? SUMMARY ANSWER: No clinical or embryological factor per se justifies a recommendation of DET instead of eSET in IVF/ICSI. WHAT IS KNOWN ALREADY: DET is correlated with a higher rate of multiple pregnancy, leading to a subsequent increase in complications for both mother and babies. These complications include preterm birth, low birthweight, and other perinatal adverse outcomes. To mitigate the risks associated with multiple pregnancy, eSET is recommended by international and national professional organizations as the preferred approach in ART. STUDY DESIGN, SIZE, DURATION: The guideline was developed according to the structured methodology for development and update of ESHRE guidelines. Literature searches were performed in PUBMED/MEDLINE and Cochrane databases, and relevant papers published up to May 2023, written in English, were included. Live birth rate, cumulative live birth rate, and multiple pregnancy rate were considered as critical outcomes. PARTICIPANTS/MATERIALS, SETTING, METHODS: Based on the collected evidence, recommendations were discussed until a consensus was reached within the Guideline Development Group (GDG). A stakeholder review was organized after the guideline draft was finalized. The final version was approved by the GDG and the ESHRE Executive Committee. MAIN RESULTS AND THE ROLE OF CHANCE: The guideline provides 35 recommendations on the medical and non-medical risks associated with multiple pregnancies and on the clinical and embryological factors to be considered when deciding on the number of embryos to transfer. These recommendations include 25 evidence-based recommendations, of which 24 were formulated as strong recommendations and one as conditional, and 10 good practice points. Of the evidence-based recommendations, seven (28%) were supported by moderate-quality evidence. The remaining recommendations were supported by low (three recommendations; 12%), or very low-quality evidence (15 recommendations; 60%). Owing to the lack of evidence-based research, the guideline also clearly mentions recommendations for future studies. LIMITATIONS, REASONS FOR CAUTION: The guideline assessed different factors one by one based on existing evidence. However, in real life, clinicians' decisions are based on several prognostic factors related to each patient's case. Furthermore, the evidence from randomized controlled trials is too scarce to formulate high-quality evidence-based recommendations. WIDER IMPLICATIONS OF THE FINDINGS: The guideline provides health professionals with clear advice on best practice in the decision-making process during IVF/ICSI, based on the best evidence currently available, and recommendations on relevant information that should be communicated to patients. In addition, a list of research recommendations is provided to stimulate further studies in the field. STUDY FUNDING/COMPETING INTEREST(S): The guideline was developed and funded by ESHRE, covering expenses associated with the guideline meetings, the literature searches, and the dissemination of the guideline. The guideline group members did not receive payment. DPB declared receiving honoraria for lectures from Merck, Ferring, and Gedeon Richter. She is a member of ESHRE EXCO, and the Mediterranean Society for reproductive medicine and the president of the Croatian Society for Gynaecological Endocrinology and Reproductive Medicine. CDG is the past Chair of the ESHRE EIM Consortium and a paid deputy member of the Editorial board of Human Reproduction. IR declared receiving reimbursement from ESHRE and EDCD for attending meetings. She holds an unpaid leadership role in OBBCSSR, ECDC Sohonet, and AER. KAR-W declared receiving grants for clinical researchers and funding provision to the institution from the Swedish Cancer Society (200170F), the Senior Clinical Investigator Award, Radiumhemmets Forskningsfonder (Dnr: 201313), Stockholm County Council FoU (Fo I-953912) and Karolinska Institutet (Dnr 2020-01963), NovoNordisk, Merck and Ferring Pharmaceuticals. She received consulting fees from the Swedish Ministry of Health and Welfare. She received honoraria from Roche, Pfizer, and Organon for chairmanship and lectures. She received support from Organon for attending meetings. She participated in advisory boards for Merck, Nordic countries, and Ferring. She declared receiving time-lapse equipment and grants with payment to institution for pre-clinical research from Merck pharmaceuticals and from Ferring. SS-R received research funding from Roche Diagnostics, Organon/MSD, Theramex, and Gedeo-Richter. He received consulting fees from Organon/MSD, Ferring Pharmaceuticals, and Merck Serono. He declared receiving honoraria for lectures from Ferring Pharmaceuticals, Besins, Organon/MSD, Theramex, and Gedeon Richter. He received support for attending Gedeon Richter meetings and participated in the Data Safety Monitoring Board of the T-TRANSPORT trial. He is the Deputy of ESHRE SQART special interest group. He holds stock options in IVI Lisboa and received equipment and other services from Roche Diagnostics and Ferring Pharmaceuticals. KT declared receiving payment for honoraria for giving lectures from Merck Serono and Organon. She is member of the safety advisory board of EDQM. She holds a leadership role in the ICCBBA board of directors. ZV received reimbursement from ESHRE for attending meetings. She also received research grants from ESHRE and Juhani Aaltonen Foundation. She is the coordinator of EHSRE SQART special interest group. The other authors have no conflicts of interest to declare. DISCLAIMER: This guideline represents the views of ESHRE, which were achieved after careful consideration of the scientific evidence available at the time of preparation. In the absence of scientific evidence on certain aspects, a consensus between the relevant ESHRE stakeholders has been obtained. Adherence to these clinical practice guidelines does not guarantee a successful or specific outcome, nor does it establish a standard of care. Clinical practice guidelines do not replace the need for application of clinical judgement to each individual presentation, nor variations based on locality and facility type. ESHRE makes no warranty, express or implied, regarding the clinical practice guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose (full disclaimer available at https://www.eshre.eu/Guidelines-and-Legal).Copyright © The Author(s) 2024. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.

Alteri, A., et al. (2020). "ALADDIN study: does assisted hatching of vitrified/warmed blastocysts improve live birth rate? Protocol for a multicentric randomised controlled trial." BMJ Open 10(7): e031544.
	Introduction: Recent data suggest a higher clinical pregnancy rate performing assisted hatching (AH) on previously cryopreserved embryos but fail to demonstrate significant effects on live birth rate. However, current evidence is based on studies with a small sample size and may hide a type II error. Moreover, poor attention has been given to the specific effect of AH on frozen/thawed blastocysts. To shed light on this topic, we developed the present protocol for a randomised trial to investigate the benefits of the laser-mediated partial removal of the zona pellucida in vitrified/warmed blastocysts.; Methods and Analysis: The pArtiaL zonA pelluciDa removal by assisteD hatchINg of blastocysts (ALADDIN) study is a multicentric prospective comparative study with a parallel randomised controlled design aiming to investigate whether AH performed on warmed blastocysts before embryo transfer can improve live birth rate. Women allocated to the control group will undergo embryo transfer of blastocysts not previously subjected to AH. Two infertility units will be involved in the study. Enrolment of patients will last 18 months with quarterly monitoring and the entire study is foreseen to be closed in 36 months. Secondary outcomes include: proportion of transferred blastocysts/thawed blastocyst, morphological features of blastocysts before embryo transfer, implantation, biochemical pregnancy, clinical pregnancy (ultrasound visible gestational sac), miscarriage, multiple pregnancy, preterm birth (<37 weeks of gestation), obstetrical and neonatal complications and congenital anomaly rates.; Ethics and Dissemination: This protocol received a favourable ethical opinion from the Ethical Committee of IRCCS San Raffaele Scientific Institute and the Ethical Committee Area 2 Milan. Each participant will provide written consent to participate and remain encoded during the study. The trial results will be published in peer-reviewed journals and presented at conferences.; Trial Registration Number: NCT03623659; Pre-results.; Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Alteri, A., et al. (2024). "The effect of laser-assisted hatching on vitrified/warmed blastocysts: the ALADDIN randomized controlled trial." Fertility and Sterility.
	Objective: To evaluate whether laser-mediated assisted hatching (AH) performed on vitrified/warmed blastocysts before embryo transfer can improve live birth rate.; Design: The "pArtiaL zonA pelluciDa removal by assisteD hatchINg of blastocysts (ALADDIN)" is a 2-center comparative study with a parallel randomized controlled design.; Setting: University hospital.; Patients: Participants were recruited between September 2018 and November 2021. They were aged 18-39 years, underwent nondonor in vitro fertilization cycles, and were scheduled for elective single embryo transfer with vitrified/warmed blastocysts. Those with uterine abnormalities, body mass index of >35 kg/m 2 , severe male factor infertility, or performing preimplantation genetic testing were excluded.; Intervention: Assisted hatching was performed using a 1,480 nm diode laser, removing approximately one-third of the zona pellucida with continuous 0.2 ms pulses applied from the 1-5 o'clock positions.; Main Outcome Measures: The primary outcome was the live birth rate. Secondary end points included clinical pregnancy, miscarriage, multiple pregnancies, preterm births, obstetric and neonatal complications, and congenital anomalies.; Results: Overall, 698 participants met the inclusion criteria and were randomized: 352 patients were assigned to the AH arm and 346 to the control arm. Of the participants, 105 (29.8%) and 101 (29.2%), respectively, achieved a live birth after treatment. The relative risk of live birth in patients with vitrified/warmed blastocysts treated with AH was 1.02 (95% confidence interval, 0.86-1.19). Exploratory subgroup analyses for women's age, recruiting centers, indications for in vitro fertilization, method of insemination, blastocyst quality, and days of blastocyst development failed to highlight any clinical situation that could benefit from AH in thawed blastocysts.; Conclusion: In patients undergoing frozen embryo transfer with vitrified/warmed blastocysts, laser AH does not improve the live birth rate. Further studies are required to rule out milder but potentially interesting benefits in specific subgroups of patients.; Trial Registration: ClinicalTrials.gov: NCT03623659.; Competing Interests: Declaration of Interests E.P. reported grants and personal fees from MSD, grants from Ferring, IBSA, TEVA, and Gedeon Richter, grants and personal fees from Merck. P.V. received honoraria for editorial engagements. E.S. received honoraria for presentations at meetings from IBSA and Gedeon Richter, and also is handling 2 research grants from Ferring and IBSA. A.A. has nothing to disclose. M.R. has nothing to disclose. C.G. has nothing to disclose. V.B. has nothing to disclose. G.B. has nothing to disclose. M.P. has nothing to disclose. E.R. has nothing to disclose. S.F. has nothing to disclose. A.P. has nothing to disclose. (Copyright © 2024 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Althanoon, Z. A. (2021). "Metabolic and hormonal effects of rosiglitazone in overweight women with PCOS." Turkish journal of physiotherapy and rehabilitation 32(3): 10963‐10968.
	Objective: Polycystic ovary syndrome(PCOS) is the most common hormonal disorder which mostly affects women of childbearing ages. Almost,women with this syndrome, insulin sensitizing drugs can have both beneficial hormonal and biochemical effects. Hence, the objective of this research was to assess and compare the effects of insulin sensitizing drug, rosiglitazone, on hormonal and biochemical profiles in patients with PCOS. Methods: In this simple randomization study, approximately, one hundred and twenty subjects were enrolled in this study, they were divided into two groups of 60 subjects each. The patients' group were received rosiglitazone treatment for three months (4‐5mg/day) and the other 60 were the control group which included apparently healthy volunteers. Hormonal profiles (serum testosterone, serum insulin, HOMA‐IR and serum resistin) and biochemical profiles (fasting serum glucose and lipid profile), in addition to body weight, height, body mass index, and even blood pressure were evaluated before and after treatment for both the patient and control groups. Results:The current study found a that there was a significant increase in the mean of body mass index (BMI), serum levels of glucose, insulin, testosterone, resistin, lipid profile (TC, HDL, LDL, TG) in addition to systolic and diastolic blood pressure in women with PCOS prior to rosiglitazone in comparison to controls. Whereas after drug therapy the patient experienced a significant decrease in all of the studied parameters associated with insulin resistance improvement, as well as a nonsignificant decrease in serum testosterone level. Conclusion: This study found that treating women with PCOS with rosiglitazone resulted in a decrease in hormonal profiles of serum insulin and serum testosterone, as well as an improvement in metabolic profiles, indicating the potential benefit of this drug in the treatment of PCOS patients.

Alur-Gupta, S., et al. (2019). "Two-Dose Versus Single-Dose Methotrexate for Treatment of Ectopic Pregnancy: A Meta-analysis." Obstetrical and Gynecological Survey 74(12): 716-717.
	
Alvisi, S., et al. (2022). "Short-Term Efficacy and Safety of Non-Ablative Laser Treatment Alone or with Estriol or Moisturizers in Postmenopausal Women with Vulvovaginal Atrophy." The Journal of Sexual Medicine 19(5): 761-770.
	Background: Among treatments for vulvo-vaginal atrophy (VVA), there is a new kind of energy-based device, the non-ablative CO 2 laser.; Aim: This study aimed to assess the efficacy and safety of the non-ablative CO 2 laser in menopausal women with VVA as a monotherapy or in association with vaginal estriol or moisturizer.; Methods: Seventy-five women with VVA received laser treatment (Laser group), laser plus estriol gel (Laser+E) or laser plus moisturizers (Laser+M). The study protocol consisted of 3 monthly laser sessions (t0, t1, t2) and a gynecological examination at baseline and 1 month after last laser treatment (t3). Objective measures included VHI (Vaginal Health Index) and VuHI (Vulvar Health Index); subjective symptoms of VVA (Dryness, Burning, Itching, Dysuria) evaluated via visual analog scales, sexual function evaluated by FSFI (Female Sexual Function Index), FSDS (Female Sexual Distress Score) and MENQOL (Mopause-specific Quality Of Life). Adverse events and discomfort encountered during the procedure were also assessed.; Outcomes: Primary outcomes were the evaluation of VHI and VuHI and secondary outcomes were changes in VVA symptoms (VAS), sexual function (MENQOL, FSFI, FSDS) and discomfort during the procedure.; Results: Seventy-five women (25 in Laser, 25 in Laser+E and 25 in Laser+M group) completed the study. At t3, mean VHI, VuHI, dryness, burning and itching VAS scores improved significantly with no differences between the groups. The lubrication domain of FSFI improved significantly only in the Laser+M group, while the pain domain improved significantly in all women with no differences between the groups. FSFI and FSDS overall scores and MENQOL sexual domain improved in all women with no significant difference between the groups. The mean score of the pain during the procedure was low at t0 and did not change throughout the study.; Clinical Implications: This study extends knowledge concerning the effectiveness of a new non-ablative CO 2 laser in post-menopausal women with VVA.; Strengths & Limitations: This is one of the first studies on this kind of laser and is the first to compare the effectiveness of laser treatment alone or in combination with vaginal estriol or moisturizers. Parameters of VVA and sexual function were evaluated using validated tools. Study limitations include short follow-up time, the limited number of participants and the absence of a sham-controlled group.; Conclusion: Non-ablative CO 2 laser seems to be an effective treatment for VVA in menopausal women. Our preliminary data shows that it can be effective as monotherapy or with adjuvant treatments. Alvisi S, Lami A, Baldassarre M, et al. Short-Term Efficacy and Safety of Non-Ablative Laser Treatment Alone or with Estriol or Moisturizers in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med 2022;19:761-770. (Copyright © 2022 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Alyami, M., et al. (2019). "Pressurised intraperitoneal aerosol chemotherapy: rationale, evidence, and potential indications." The Lancet. Oncology 20(7): e368-e377.
	Pressurised intraperitoneal aerosol chemotherapy (PIPAC) was introduced as a new treatment for patients with peritoneal metastases in November, 2011. Reports of its feasibility, tolerance, and efficacy have encouraged centres worldwide to adopt PIPAC as a novel drug delivery technique. In this Review, we detail the technique and rationale of PIPAC and critically assess its evidence and potential indications. A systematic search was done to identify all relevant literature on PIPAC published between Jan 1, 2011, and Jan 31, 2019. A total of 106 articles or reports on PIPAC were identified, and 45 clinical studies on 1810 PIPAC procedures in 838 patients were included for analysis. Repeated PIPAC delivery was feasible in 64% of patients with few intraoperative and postoperative surgical complications (3% for each in prospective studies). Adverse events (Common Terminology Criteria for Adverse Events greater than grade 2) occurred after 12-15% of procedures, and commonly included bowel obstruction, bleeding, and abdominal pain. Repeated PIPAC did not have a negative effect on quality of life. Using PIPAC, an objective clinical response of 62-88% was reported for patients with ovarian cancer (median survival of 11-14 months), 50-91% for gastric cancer (median survival of 8-15 months), 71-86% for colorectal cancer (median survival of 16 months), and 67-75% (median survival of 27 months) for peritoneal mesothelioma. From our findings, PIPAC has been shown to be feasible and safe. Data on objective response and quality of life were encouraging. Therefore, PIPAC can be considered as a treatment option for refractory, isolated peritoneal metastasis of various origins. However, its use in further indications needs to be validated by prospective studies. (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Alyanak, A., et al. (2022). "Comparison of botulinum toxin (BoNT) injection and lateral internal sphincterotomy (redo-LIS) for recurrent anal fissure treatment." Frontiers in surgery 9: 988082.
	Objective: Today's gold standard for treating chronic anal fissure is the Lateral Internal Sphincterotomy (LIS). Botulinum Toxin (BoNT) injection is, on the other hand, an alternative treatment for patients who do not want to have surgical treatment, patients undergoing chemotherapy, patients of high risk for surgery, and those who have the risk of anal incontinence (e.g., elderly, past anorectal surgery, vaginal multiple births, etc.). The aim of this study is to compare the effectiveness of BoNT and redo-LIS for treatment of post-LIS recurrent chronic anal fissure, and reveal differences if any.This study aims to compare redo-LIS and BoNT injection for treating post-LIS recurrent anal fissure.; Material and Method: Nineteen patients who received LIS treatment and then redo-LIS or BoNT injection due to recurrence in the follow-up were included in this study. Group I (redo-LIS group) include 11 patients and group 2 (BoNT group) includes 8 patients. Their data on age, sex, anal incontinence scores and pain (VAS score) score as well.; Results: During the 3-month post-surgery follow-up period, there was statistically significant difference ( p < 0.01) between groups by pain. No deterioration in the incontinence scores of patients in the group during the 6-month post-surgery period.; Conclusion: This study demonstrates that redo lateral internal sphincterotomy (LIS) is a reliable method for patients who received LIS but developed recurrent chronic anal fissure, and achieves successful results in terms of recurrence and relief of pain.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (© 2022 Alyanak, Gulen and Ege.)

Amani, B., et al. (2024). "Public health nurse-delivered cognitive behavioral therapy for postpartum depression: Assessing the effects of maternal treatment on infant emotion regulation." Development and psychopathology: 1-9.
	The effects of maternal postpartum depression (PPD) on offspring emotion regulation (ER) are particularly deleterious as difficulties with ER predict an increased risk of psychopathology. This study examined the impact of maternal participation in a public health nurse (PHN)-delivered group cognitive behavioral therapy (CBT) intervention on infant ER. Mothers/birthing parents were >= 18 years old with an Edinburgh Postnatal Depression Scale (EPDS) score >= 10, and infants were < 12 months. Between 2017 and 2020, 141 mother-infant dyads were randomized to experimental or control groups. Infant ER was measured at baseline (T1) and nine weeks later (T2) using two neurophysiological measures (frontal alpha asymmetry (FAA) and high-frequency heart rate variability (HF-HRV)), and informant-report of infant temperament. Mothers were a mean of 30.8 years old (SD = 4.7), 92.3% were married/ common-law, and infants were a mean of 5.4 months old (SD = 2.9) and 52.1% were male. A statistically significant group-by-time interaction was found to predict change in HF-HRV between T1 and T2 (F(1,68.3) = 4.04, p = .04), but no significant interaction predicted change in FAA or temperament. Results suggest that PHN-delivered group CBT for PPD may lead to adaptive changes in a neurophysiological marker of infant ER, highlighting the importance of early maternal intervention.

Amani, B., et al. (2022). "Peer-Delivered Cognitive-Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial." Journal of Clinical Psychiatry 83(1): 21m13928.
	Objective: To determine if a 9-week group cognitive-behavioral therapy (CBT) intervention delivered by women who have recovered from postpartum depression (peers) can effectively reduce symptoms of postpartum depression (PPD) and anxiety and improve social support and the mother-infant relationship. Method(s): A sample of 73 mothers living in Ontario, Canada, were randomized into experimental and waitlist control groups between March 2018 and February 2020. Participants were >= 18 years of age, had an infant < 12 months old, were fluent in English, and scored >= 10 on the Edinburgh Postnatal Depression Scale. The experimental group completed the 9-week group CBT intervention immediately after study enrollment, while the control group did so after a 9-week waiting period. All outcomes were assessed at enrollment (n = 54) and 9 weeks later (n = 38). Outcomes were assessed in the experimental group at 6 months to assess treatment stability. Result(s): Peer-delivered group CBT for PPD led to clinically and statistically significant improvements in symptoms of depression (F1,47 = 22.52, P< .01) and anxiety (F1,45 = 20.56, P< .05) in the experimental group, and these improvements were stable at the 6-month follow-up. Perceptions of impaired mother-infant bonding (t15 = 3.72, P< .01) and rejection and pathological anger (t15 = 3.01, P< .01) also decreased at the 6-month follow-up in the experimental group. Conclusion(s): Peer-delivered group CBT for PPD effectively treats symptoms of PPD and anxiety and may lead to improvements in the mother-infant relationship. This intervention is an effective and potentially scalable means by which access to a treatment that meets the needs and wants of mothers with PPD can be increased.© Copyright 2021 Physicians Postgraduate Press, Inc.

Amaya, S. and J. Shorter (2023). "Early Pregnancy Assessment Clinics: Expanding Patient-Centered and Equitable Early Pregnancy Care." Current Obstetrics and Gynecology Reports 12(2): 96-102.
	Purpose of Review: This review provides an overview of how early pregnancy assessment clinics (EPACs) provide patient-centered and evidence-based early pregnancy care, increase access to abortion care, and reduce health disparities. Recent Findings: There is growing evidence that early pregnancy care provided in an EPAC is cost-effective, patient centered, and highly valued by patients. Summary: Patients in the USA who have clinical needs in early pregnancy often do not have a standard location to seek care. EPACs have been shown to provide early pregnancy care that is efficient and compassionate while also promoting patient autonomy and increasing access to standardized early pregnancy loss and abortion care. EPACs, while underutilized in the USA, should be integrated into the health system to expand the availability of quality early pregnancy care.Copyright © 2023, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Ambacher, K., et al. (2022). "The use of progestin subdermal implants in the management of endometriosis-related pain symptoms and quality of life: a systematic review." Current medical research and opinion 38(3): 479-486.
	Objective: The purpose of this systematic review is to evaluate the evidence for the use of progestin subdermal implants for the treatment of endometriosis-related pain symptoms and quality of life.; Methods: A literature search of PubMed, Ovid (MEDLINE and EMBASE), and Web of Science was performed from inception to December 2020. In addition, a targeted search of cited references was also performed. Our search identified 330 articles of which 17 were deemed eligible for full-text review. Eligible studies included randomized control trials, observational studies, and case series with at least 5 cases, investigating the effect of progestin subdermal implants on endometriosis-related pain scores in women of reproductive age with a clinical, radiologic, or surgical diagnosis of endometriosis. Six articles were excluded after the full-text screen.; Results: Eleven articles describing a total of 335 patients were eligible for inclusion. Across all studies, etonogestrel- and segesterone-releasing progestin subdermal implants improved VAS pain scores for cyclic pelvic pain/dysmenorrhea (VAS at baseline ranged from 6.1 to 7.5 cm and after treatment from 1.7 to 4.9 cm, n = 121), non-cyclic pelvic pain (baseline VAS 7.2-7.6 cm and after treatment 2.0-3.7 cm, n = 96) and dyspareunia (baseline VAS 1.61-8.3 cm and after treatment 1.0-7.1 cm, n = 87). Symptom improvement with the progestin subdermal implant was equivalent to treatment with depot medroxyprogesterone acetate (DMPA; average baseline VAS 6.5 and after DMPA treatment 3.0, compared to 2.0 after treatment with the implant) or the 52 mg levonorgestrel-releasing intrauterine system (LNG-IUS; baseline cyclic and non-cyclic pain scores 7.3 and 7.4 respectively decreased to 1.9 and 1.9 after LNG-IUS treatment). Improvements were also demonstrated in quality-of-life scores (average improvement of 36% in all domains of the Endometriosis Health Profile-30 and significant improvements in social functioning, general health, bodily pain, vitality and mental health domains on the Short Form-36 questionnaire) and sexual function (total sexual function score improved from 24 to 25.35 and 26.25 at 6 and 12 months).; Conclusion: Etonogestrel- and segesterone-releasing progestin subdermal implants appear to improve endometriosis-related pain symptoms and quality of life and may provide an additional component in the management of endometriosis. However, this systematic review is limited by the small sample size and heterogeneity in the data. As such, larger prospective randomized trials are needed to guide further management.; Prospero Registration: CRD42021225665.

Ambrogio, P. L. and C. Angelo (2023). "Hormonal Therapy in Post-menopausal Women and the Effect of Progestins on Depression, Mood, Anxiety, and Quality of Life."
	
Amerigo, V., et al. (2023). "Does recipients endometriosis influences the live birth rate in oocyte donation cycles: a systematic review and meta-analysis."
	
Amin, H. L., et al. (2022). "The effects of ketogenic diet on the outcomes of polycystic ovary syndrome: A systematic review on clinical trials." Iranian Journal of Obstetrics, Gynecology and Infertility 25(7): 128-138.
	Introduction: Polycystic ovary syndrome is a major cause of anovulation and infertility in women that is associated with chronic diseases such as obesity, insulin resistance, diabetes, cardiovascular disease, and fatty liver disease. This systematic review was performed aimed to determine the effects of ketogenic diet on the outcomes of polycystic ovary syndrome. Method(s): In this systematic review, the keywords of "polycystic ovary syndrome", "ketogenic diet", "low carbohydrate diet", and "clinical trials" were searched in databases of Medline, PubMed, Science Direct, Magiran, ISD, ISC and Cochrane in English and Persian language without time restrictions. Then, the articles relevant to the study's aim were reviewed. Result(s): In this research, 4 studies were examined. The results showed that following a ketogenic diet in patients with polycystic ovary syndrome may reduce the risk of cardiovascular diseases in these patients by lowering weight and body mass index, blood pressure, serum total cholesterol, and triglycerides. Conclusion(s): Long-term adherence to a ketogenic diet may result in weight loss, improved insulin resistance, and serum lipid profile disorders in patients with polycystic ovary syndrome. Clinical trials are suggested to evaluate the effects of ketogenic diet on these metabolic and endocrine factors in PCOS women.Copyright © 2022, Mashhad University of Medical Sciences. All rights reserved.

Amin, M., et al. (2021). "Phase I Study of Docetaxel and Temsirolimus in Refractory Solid Tumors." American Journal of Clinical Oncology 44(9): 443-448.
	INTRODUCTION: The mammalian target of rapamycin (mTOR) is a downstream mediator in the phosphatidylinositol 3-kinase/Akt signaling pathway, and plays a central role in cell proliferation, growth, differentiation, migration, and survival. Temsirolimus (CCI-779), a selective inhibitor of the mTOR, is an ester analog of rapamycin (sirolimus) with improved aqueous solubility and pharmacokinetic (PK) properties. Preclinical studies have confirmed additive and synergistic antitumor activity in cancer cell lines (breast, prostate cancer) with combinations of taxanes and mTOR inhibitors. We conducted a phase I open-label, dose-escalation study to determine the maximal tolerated dose (MTD) of docetaxel in combination with temsirolimus in patients with refractory solid tumors. PATIENTS AND METHODS: Eligible patients had a diagnosis of a refractory solid malignancy, measurable disease, and adequate organ function. Patients were sequentially enrolled in 4 dose level intravenous combinations of docetaxel and temsirolimus. Temsirolimus was administered weekly with docetaxel administered every 3 weeks. Laboratory data for tumor markers and radiologic imaging were conducted prestudy and then after every 2 cycles of the treatment. Radiologic response was assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Blood samples for PK and pharmacodynamic analysis were planned to be drawn at MTD. Apart from the traditional 3+3 design, we also implemented Bayesian Optimal Interval design which uses isotonic regression method to select MTD. We proceeded with isotonic regression analysis by using 20% dose-limiting toxicity (DLT) rate as target. RESULTS: Twenty-six patients were treated in this study in 4 cohorts and dose levels. Fourteen males and 12 females were enrolled with a median age of 50 years (range of 27 to 72 y) and median Eastern Cooperative Oncology Group performance score of 1. Tumor histologies included pancreas (6), colon (5), rectum (3), gallbladder (2), non-small cell lung (2), endometrium (1), neuroendocrine (1), esophagus (1), stomach (1), pharynx (1), small intestine (1), and duodenum (1). Stable disease was observed in 2/4 (50%), 3/7 (43%), 4/10 (40%), and 3/5 (60%) patients in cohorts 1, 2, 3, and 4, respectively. Dose escalation in cohorts 2, 3, and 4 was complicated by DLTs such as grade 4 neutropenia and grade 3 diarrhea and an inability for patients to tolerate treatments during and beyond cycle 1 without dose reductions. Therefore, we could not determine an MTD or recommended phase II dose using the traditional 3+3 study analysis. Blood samples for PK and pharmacodynamic analysis were not collected since MTD was not determined. By using 20% DLT rate closest to the target, isotonic regression analysis showed identical estimated DLT rates in dose -1 (docetaxel 50 mg/m2 and temsirolimus 15 mg/m2) and dose level 1 (docetaxel 60mg/m2 and temsirolimus 15 mg/m2). CONCLUSIONS: Dose escalation of docetaxel and temsirolimus was limited by severe myelosuppressive toxicity in this phase I study. Most of the DLTs occurred after cycle 1 of therapy hence, we were unable to determine MTD or collect blood samples for PK and pharmacodynamic analysis. Our trial did not meet its objectives due to significant DLTs with this chemotherapy combination. Although our novel use of Bayesian Optimal Interval design using isotonic regression method to select MTD showed identical estimated DLT rates in dose levels 1 and -1, clinically our patients were not able to complete 2 cycles of this regimen without dose reductions due to myelosuppressive toxicity in either of these dose levels, and hence, escaped clinical validity. This combination regimen should not be studied further at the dose levels and schedules tested in our study.

Amini, S., et al. (2022). "The effect of vitamin D and calcium supplementation on inflammatory biomarkers, estradiol levels and severity of symptoms in women with postpartum depression: a randomized double-blind clinical trial." Nutritional neuroscience 25(1): 22-32.
	Objectives: Postpartum depression (PPD) is a major depressive disorder. Vitamin D deficiency may play a role in PPD pathogenesis. This study was designed to determine the effect of vitamin D and calcium supplementation on the severity of symptoms and some related inflammatory biomarkers in women with PPD. Materials and Methods: Eighty-one women with a PPD score >12 participated in this study. A total of 27 patients were randomly assigned into three groups (1:1:1 ratio) to receive either 50,000 IU vitamin D3 fortnightly + 500 mg calcium carbonate daily; or 50,000 IU vitamin D3 fortnightly + placebo of calcium carbonate daily, or placebo of vitamin D3 fortnightly + placebo of calcium carbonate daily (placebo group) for 8 weeks. At the baseline and end of the study, the severity score of PPD, levels of 25-hydroxy vitamin D, calcium, tumor necrosis factor-alpha (TNFα), interleukin 6 (IL6) and estradiol were measured. Results: The PPD score had more reduction in the vitamin D + calcium and vitamin D + calcium placebo groups than that of the placebo group (-1.7 ± 3.44, -4.16 ± 5.90 and 0.25 ± 2.81, respectively; p = 0.008). The effect of vitamin D on the PPD score was larger when vitamin D was given alone than given together with calcium ( p = 0.042 and p = 0.004, respectively). No significant differences in estradiol, IL6 and TNFα were observed between the three groups. Discussion: Vitamin D may be effective in improving the clinical symptoms of PPD; however, the mechanism of the effect might not entirely operate through inflammatory and/or hormonal changes.

Amini, S., et al. (2019). "Postpartum depression and vitamin D: A systematic review." Critical reviews in food science and nutrition 59(9): 1514-1520.
	Postpartum depression (PPD) is a prevalent mood disorder estimated to affect 20%-40% of women worldwide after childbirth. In recent studies, the effect of vitamin D on prevention of mood disorders and depression has been investigated, but it is still unclear how vitamin D may affect PPD. The evidence on the relevance between vitamin D deficiency and PPD is inconsistent, and assessment of the recent literature has not previously been carried out. Moreover, there are few clinical studies on PPD and vitamin D supplementation. Five studies have so far assessed the relationship between the levels of vitamin D and PPD. Findings from cohort studies suggest that vitamin-D deficiency is related to the incidence of PPD and vitamin D may play a significant role in the recovery of women with PPD, but it is uncertain whether these actions are the effect of vitamin D on the function of hypothalamic-pituitary-adrenal (HPA) axis, the levels of estradiol, serotonin, pro-inflammatory cytokines, and/or of other mechanisms involved in PPD.

amira, n., et al. (2022). "Manual therapy for myofascial pelvic pain syndrome:a systematic review."
	
Amiri, M., et al. (2022). "Whole-diet interventions and cardiovascular risk factors in postmenopausal women: A systematic review of controlled clinical trials." Maturitas 155: 40-53.
	Objectives: Menopause is accompanied by many metabolic changes, increasing the risk of cardiometabolic diseases. The impact of diet, as a modifiable lifestyle factor, on cardiovascular health in general populations has been well established. The purpose of this systematic review is to summarize the evidence on the effects of whole diet on lipid profile, glycemic indices, and blood pressure in postmenopausal women.; Methods: Embase, Medline, Cochrane Central Register of Controlled Trials, and Google Scholar were searched from inception to February 2021. We included controlled clinical trials in postmenopausal women that assessed the effect of a whole-diet intervention on lipid profile, glycemic indices, and/or blood pressure. The risk of bias in individual studies was assessed using RoB 2 and ROBINS-I tools.; Summary of Evidence: Among 2,134 references, 21 trials met all eligibility criteria. Overall, results were heterogenuous and inconsistent. Compared to control diets, some studies showed that participants experienced improvements in total cholesterol (TC), low-density lipoprotein cholesterol (LDL), systolic blood pressure (SBP), fasting blood sugar (FBS), and apolipoprotein A (Apo-A) after following fat-modified diets, but some adverse effects on triglycerides (TG), very low-density lipoprotein cholesterol (VLDL), lipoprotein(a) (Lp(a)), and high-density lipoprotein cholesterol (HDL) concentrations were also observed. A limited number of trials found some effects of the Paleolithic, weight-loss, plant-based, or energy-restricted diets, or of following American Heart Association recommendations on TG, TC, HDL, insulin, FBS, or insulin resistance.; Conclusion: Current evidence suggests that diet may affect levels of some lipid profile markers, glycemic indices, and blood pressure among postmenopausal women. However, due to the large heterogeneity in intervention diets, comparison groups, intervention durations, and population characteristics, findings are inconclusive. Further well-designed clinical trials are needed on dietary interventions to reduce cardiovascular risk in postmenopausal women. (Copyright © 2021. Published by Elsevier B.V.)

Amiri, M. and T. Ramezani (2020). "Comparison of the effects of combined oral contraceptives containing progestins with low androgenic and antiandrogenic activities on the clinical, androgenic, and metabolic manifestations of polycystic ovary syndrome." Iranian Journal of Endocrinology and Metabolism 22(1): 83-91.
	Introduction: Combined oral contraceptives (COCs) are commonly considered as the first-line treatment for polycystic ovary syndrome (PCOS). This study aimed to compare the effects of COCs with respect to their progestin component on the clinical, hormonal, and metabolic outcomes of women with PCOS. Data were extracted by searching PubMed, Scopus, EMBASE, and Google Scholar, without any time limitations (until 2020). All studies assessing the effects of COCs on PCOS patients of childbearing age were reviewed and discussed. Based on the findings, different types of COCs can improve hyperandrogenism and regulate the menstrual cycle by suppressing gonadotropins and increasing sex hormone-binding globulin. Compared to COCs containing androgenic progestins (e.g., desogestrel and levonorgestrel), COCs containing anti-androgenic progestins (e.g., cyproterone acetate and drospirenone) could reduce androgen deprivation through specific mechanisms. However, the available evidence does not support the superiority of these anti-androgenic compounds in improving the clinical manifestations of hyperandrogenism. While all COCs may be associated with lipid disorders, drospirenone-containing compounds seem to be associated with the fewest disorders. Also, as COCs may result in metabolic disorders, especially dyslipidemia, it is necessary to periodically measure metabolic parameters in COC-consuming patients.Copyright © 2020, Research Institute for Endocrine Sciences. All rights reserved.

Amiri, P., et al. (2019). "Application of distraction techniques in obstetrics and gynaecology: A systematic review." Journal of Clinical and Diagnostic Research 13(4): QE01-QE08.
	Introduction: International institutions have emphasised the role of midwives in ensuring women health, which guarantees family health and its physical, psychological, social, and spiritual aspects. The integration of midwifery knowledge with psychology is a good opportunity for the patients and healthcare providers. Distraction technique is a psychological approach, which has interested the field of medicine. Aim(s): To review the effectiveness of Distraction techniques in Obstetrics and Gynaecology. Material(s) and Method(s): This systematic review study was conducted on articles indexed in Cochrane Library, Web of Sciences, PubMed, Scopus, Google Scholar, CINHAL and Persian databases including SID, Magiran, and Barakat Knowledge Network System in October 2018 without time restriction. Search was conducted according to MeSH-based keywords, including distraction or distraction technique Distraction OR Distraction techniques and use + or AND with keywords Midwife, Birth Attendants, Traditional Midwives, Traditional Birth Attendant, Genital Diseases, Female, Gynaecologic Surgical Procedures, Reproductive Medicine, Obstetrics, Pregnancy Complications, Obstetric Surgical Procedures, Gynaecology and Gynaecological diseases. To ensure, the search process was conducted once again by using keywords of dysmenorrhea, vomiting, nausea, pregnancy, delivery and cesarean section. The inclusion criteria, based on PICOS were: Clients of obstetrics-gynaecology centres; receiving a distraction technique; clinical trials with a parallel design; psychosomatic outcomes; full-text articles in Persian and English. Evaluation of the quality of articles was done using Cochrane Handbook for Systematic Reviews of Interventions version 5.2.0. Result(s): Five out of 595 articles were included in this systematic review. Outcomes of these studies were intensity of pain, and stress and anxiety in patients visiting obstetrics-gynaecology centres. Results showed that the distraction techniques could reduce the intensity of pain in patients under obstetrics-gynaecology procedures, and also the stress of prepubescent girls caused by genital examination. Moreover, the meta-analysis results showed that the mean score of anxiety in pregnant women and women at labour, who received distraction interventions, was significantly lower than the control (mean difference: -7.0; 95% Confidence Interval: -13.7 to -0.4; p=0.04). Conclusion(s): According to the results, distraction is a simple, low-cost, and accessible technique for reducing pain, anxiety, and stress in the field of obstetrics and gynaecology. Moreover, given that there are scant studies into this field and their high risk of bias, it is recommended to use distraction techniques in different areas of clinical trials with higher quality.Copyright © 2019, Journal of Clinical and Diagnostic Research. All rights reserved.

Amjad, R., et al. (2024). "Hypofractionated Radiotherapy in Gynecologic Malignancies-A Peek into the Upcoming Evidence." Cancers 16(2).
	Radiotherapy (RT) has a fundamental role in the treatment of gynecologic malignancies, including cervical and uterine cancers. Hypofractionated RT has gained popularity in many cancer sites, boosted by technological advances in treatment delivery and image verification. Hypofractionated RT uptake was intensified during the COVID-19 pandemic and has the potential to improve universal access to radiotherapy worldwide, especially in low-resource settings. This review summarizes the rationale, the current challenges and investigation efforts, together with the recent developments associated with hypofractionated RT in gynecologic malignancies. A comprehensive search was undertaken using multiple databases and ongoing trial registries. In the definitive radiotherapy setting for cervical cancers, there are several ongoing clinical trials from Canada, Mexico, Iran, the Philippines and Thailand investigating the role of a moderate hypofractionated external beam RT regimen in the low-risk locally advanced population. Likewise, there are ongoing ultra and moderate hypofractionated RT trials in the uterine cancer setting. One Canadian prospective trial of stereotactic hypofractionated adjuvant RT for uterine cancer patients suggested a good tolerance to this treatment strategy in the acute setting, with a follow-up trial currently randomizing patients between conventional fractionation and the hypofractionated dose regimen delivered in the former trial. Although not yet ready for prime-time use, hypofractionated RT could be a potential solution to several challenges that limit access to and the utilization of radiotherapy for gynecologic cancer patients worldwide.

Amrita, M., et al. (2022). "The impact of exercise on fertility in women with a healthy weight: a systematic review."
	
Amstad, G., et al. (2022). "Perioperative management with ferric carboxymaltose and tranexamic acid to reduce transfusion rate in gynaecological carcinoma surgery (TRANAFER-Study): study protocol for a single-blind, monocentre, randomised trial." BMJ Open 12(9): e057381.
	Introduction Radical abdominal surgery is part of the standard treatment for women with advanced gynaecological carcinoma. The surgery often leads to intraoperative blood loss frequently exceeding 1000 mL. Approximately 50% of women undergoing radical surgery require blood transfusions. Perioperative blood transfusions have been shown to increase the risk of postoperative complications, delayed wound healing, increased length of stay, increased postoperative morbidity and mortality. Previous studies have demonstrated an association between perioperative anaemia and surgical morbidity and mortality. By reducing transfusions and improving recovery from surgery, preoperative diagnostic and management of perioperative anaemia is a great opportunity to optimise postoperative patient outcome. Methods and analysis This is a single-blind, monocentre, randomised trial with four parallel groups (three therapeutic groups and one control group without treatment according to current standards of care) conducted in women undergoing radical gynaecological surgery. The primary study objective is to determine the effect of perioperative treatment with either intravenous iron, tranexamic acid or with a combination of both medicines on the reduction of intraoperative and postoperative red blood cell transfusions in gynaecological carcinoma patients. A total of N=126 women with gynaecological carcinoma will be recruited at the University Hospital Basel, Department of Gynaecology. Blood parameters will be measured at the recruitment, prior to surgery, 2 days after surgery and on the 21st-28th day after surgery. Recruitment started in August 2021. Ethics and dissemination The study will be performed according to the guidelines of the Declaration of Helsinki and is approved by the Ethics Committee for Northwest and Central Switzerland in Basel (EKNZ Protocol ID 2020-01194). The results of this study will be published and presented in various scientific forums. Trial registration number NCT03792464.Copyright ©

Amsterdam, U. M. C. and V. location (2021). The Effect of Dietary Interventions, or no Intervention, on Pain and Quality of Life in Women Diagnosed With Endometriosis.
	No Results Available Other: Low FODMAP diet|Other: Endometriosis diet pain scores|Quality of Life (QoL)|Gastro-Intestinal Health|Adhesion to dietary intervention Female Not Applicable 62 Other Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care W20_534 # 20.593 December 31, 2022

Ana, D. n., et al. (2023). "Physiotherapy interventions in postpartum depression: a systematic review."
	
Ana, K., et al. (2023). "Intravaginal physical energy for treatment of genitourinary syndrome of menopause in breast cancer survivors: A systematic review and meta-analysis."
	
Ana, K., et al. (2023). "Efficacy of physiotherapy for treating vulvodynia: a systematic review and metanalysis." PROSPERO International prospective register of systematic reviews.
	
Ana, K., et al. (2022). "Physical energy for management of Genitourinary Syndrome of Menopause: A protocol for overview of systematic review and meta-analysis."
	
Ana Lívia, D., et al. (2022). "The impact of the Pilates Method as a treatment for pelvic floor disorders."
	
Ana, N., et al. (2023). "Dietary Approach to Premenstrual Syndrome Symptoms Alleviation – A Systematic Review."
	
Ana, R., et al. (2023). "Effect of Probiotics in Association with Antibiotics in Bacterial Vaginosis Compared to Treatment with Antibiotics Isolated: A Systematic Review."
	
Ana, R., et al. (2021). "Androgens and diminished ovarian reserve: The long road from basic science to clinical implementation. A comprehensive and systematic review with meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Anand, A., et al. (2023). "Stress urinary incontinence in females. Diagnosis and treatment modalities - past, present and the future." Journal of Clinical Urology 16(6): 622-630.
	Introduction: Stress urinary incontinence (SUI) can be defined as involuntary and unintentional loss of urine through the urethra when vesical pressure exceeds the urethral sphincter pressure during instances of coughing, sneezing or physical exercise. Stress urinary incontinence is the most common form of incontinence in females with an estimated prevalence of 4.5-53% in adult women with urinary incontinence. Yet despite its distressing nature and a negative impact on quality of life, very few women present with their symptoms to a urologist. Material(s) and Method(s): A literature search of the MEDLINE, Cochrane Library, Embase, NLH, ClinicalTrials.gov and Google Scholar databases was done up to November 2020, using terms related to SUI, medical therapy, surgical therapy and treatment options. The search terms included female stress urinary incontinence, mid-urethral sling, tension-free vaginal tape and trans obturator tape. The search included original articles, reviews and meta-analyses. Conclusion(s): Current guidelines for the management of stress urinary incontinence propose a step-ladder pattern, based on treatment invasiveness starting from conservative therapies, then drugs followed by minimally invasive procedures and culminating in invasive surgeries. The surgical approach is to be considered only after conservative therapies fail. The recent advances in the treatment of stress urinary incontinence have brought to light newer modalities and newer technologies that can be utilized which include laser therapy, stem cell therapy, intravesical balloon and others that show a lot of promise. This paper provides an in-depth analysis and reviews the literature on the current modalities and the future prospects of female stress urinary incontinence. Level of Evidence: Not applicable for this review article.Copyright © British Association of Urological Surgeons 2021.

Anastasia, V., et al. (2023). "Effect of extracorporeal shockwave therapy of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) on the patient pain outcome scores."
	
Anastasio Mary, K., et al. (2023). "Cryocompression to Reduce Peripheral Neuropathy in Gynecologic Cancer: A Randomized Controlled Trial." Obstetrics and Gynecology 142(6): 1459-1467.
	Objective: To investigate the efficacy of cryocompression therapy to prevent chemotherapy-induced peripheral neuropathy.; Methods: This single-institution, randomized, self-controlled trial of cryocompression enrolled gynecologic cancer patients planned for five to six cycles neurotoxic chemotherapy. Exclusion criteria were prior neurotoxic chemotherapy or baseline peripheral neuropathy. Participants were randomized to cryocompression on dominant versus non-dominant hand and foot (treatment), with no intervention on the opposite side (control). Compression socks and gloves and ice bags were applied 15 minutes before, during, and 15 minutes after infusion. Primary outcome measures included the PNQ (Patient Neurotoxicity Questionnaire) and the Semmes-Weinstein monofilament test; secondary outcomes included the FACT/GOG-NTX (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity) and patient acceptability and tolerability. Sixty patients completing the study were necessary to detect a 70% reduction in the odds of PNQ grade C or higher peripheral sensory neuropathy with 80% power.; Results: Ninety-one patients were enrolled from January 2021 to October 2022; 69 were eligible for final analysis. Of the 91 patients, 64.8% were White, 30.8% were Black, and 1.1% were Hispanic or Latina. With successive cycles, more patients had sensory PNQ grade C or higher neuropathy on the control side compared with the cryocompression side. Cryocompression decreased the odds of sensory neuropathy (PNQ grade C or higher) by 46% at final visit (odds ratio 0.54, 95% CI 0.31-0.94; P =.03). There was no difference in tactile sensitivity based on the monofilament test between sides at the final visit. At the final visit, average FACT/GOG-NTX-11 (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity 11 Item Version) scores were significantly lower on the cryocompression than the control side (estimate -0.97, 95% CI -1.89 to -0.06; P =.04), as were FACT/GOG-NTX-4 (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity 4 Item Version) scores (estimate -0.35, 95% CI -0.64 to -0.05; P =.02). More than 85% of patients assessed the intervention as acceptable and tolerable.; Conclusions: Cryocompression therapy reduces subjective chemotherapy-induced peripheral sensory neuropathy in patients who are receiving paclitaxel or cisplatin for gynecologic cancer.; Clinical Trial Registration: ClinicalTrials.gov , NCT04563130.; Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest. (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Anastasiou, E., et al. (2022). "The relationship between hormonal contraception and cervical dysplasia/cancer controlling for human papillomavirus infection: A systematic review." Contraception 107: 1-9.
	Objective: Studies on the effect of long-term use of combined oral contraceptives (COCs) on cervical dysplasia and/or cancer risk have been inconsistent. Less is known about the effects of other forms of hormonal contraception (HC). We examine whether HC use increases the risk of incident cervical intraepithelial neoplasia (CIN) 2, 3 and/or cancer after accounting for preexisting human papillomavirus (HPV) infection.; Study Design: Systematic review of prospective studies on HC use as risk factor for cervical dysplasia with HPV infection documented prior to outcome assessment including PubMed and EMBASE records between January 2000 and February 2020 (Prospero #CRD42019130725).; Results: Among nine eligible studies, seven described recency and type of HC use and therefore comprise the primary analysis; two studies limit comparisons to ever versus never use and are summarized separately. All seven studies explored the relationship between oral contraceptive (OC) use and cervical dysplasia/cancer incidence: two found increased risk (adjusted odds ratio, aOR = 1.5-2.7), one found no association but decreased risk when restricted to women with persistent HPV (adjusted hazard ratio = 0.5), and four found no association. None of the seven studies differentiated between COC and progestin-only pills (POPs) by use recency or duration. The only study that included injectable progestin-only contraception (DMPA) found increased CIN3 incidence among current versus never users (aOR = 1.6). The one study that included Norplant found no association. Two studies included intrauterine device (IUD) use, but did not differentiate between hormonal and copper IUDs, and found no association.; Conclusion: We found no consistent evidence that OC use is associated with increased risk for cervical dysplasia/cancer after controlling for HPV infection. There were too few studies of progestin-only injectables, implants or IUDs to assess their effect on cervical dysplasia/cancer risk.; Implications: Use of single self-reported HC measures and insufficient distinction by hormonal constituent cloud our understanding of whether some HCs increase risk for cervical cancer. Methodologically rigorous studies with distinct HCs measured as time-varying exposures are needed to inform cervical cancer prevention efforts and improve our understanding of cervical cancer etiology. (Copyright © 2021 Elsevier Inc. All rights reserved.)

Anaya, Y., et al. (2022). "Triggering with 1,500 IU of human chorionic gonadotropin plus follicle-stimulating hormone compared to a standard human chorionic gonadotropin trigger dose for oocyte competence in in vitro fertilization cycles: a randomized, double-blinded, controlled noninferiority trial." Fertility and Sterility 118(2): 266-278.
	Objective: To assess if triggering with 1,500 IU of human chorionic gonadotropin (hCG) with 450 IU of follicle-stimulating hormone (FSH) induces noninferior oocyte competence to a standard dose of hCG trigger used in in vitro fertilization (IVF). The alternative trigger will be considered noninferior if it is at least 80% effective in promoting oocyte competence. Design(s): Randomized, double-blinded, controlled noninferiority trial. Setting(s): Academic infertility practice. Patient(s): Women aged 18-41 undergoing IVF with antral follicle count >=8, body mass index <=30 kg/m2, and no history of >=2 IVF cycles canceled for poor response were enrolled. Participants with a serum estradiol >5,000 pg/mL on the day of trigger were excluded because of high risk of ovarian hyperstimulation syndrome. Intervention(s): Participants were randomized to receive an alternative trigger of 1,500 IU of hCG plus 450 IU of FSH or a standard trigger dose of hCG (5,000 or 10,000 IU) for final oocyte maturation. Main Outcome Measure(s): The primary outcome was total competent proportion, defined as the probability of 2 pronuclei from an oocyte retrieved. The alternative trigger will be considered noninferior to the standard trigger if a 1-sided 95% confidence interval (CI) of the relative risk (RR) is not <0.8. Secondary outcomes included oocyte recovery and maturity, intracytoplasmic sperm injection fertilization, embryo quality, pregnancy rates, as well as serum and follicular hormones. Secondary outcomes were compared using a 2-sided superiority test. Outcomes were analyzed by intention-to-treat and per-protocol. Result(s): A total of 105 women undergoing IVF were randomized from May 2015 to June 2018. The probability of the primary outcome was 0.59 with the alternative trigger and 0.65 with the standard trigger, with a RR of 0.91 and a 1-sided 95% CI of 0.83. Noninferiority of the alternative trigger was demonstrated. Live birthrate from all fresh transfers in the alternative trigger group vs. standard trigger was 46.9 vs. 46.4% (RR, 1.01; 95% CI, 0.62-1.62), respectively. Live birthrate per randomized participant was 48.1% in the alternative trigger group vs. 62.7% with the standard trigger (RR, 0.73; 95% CI, 0.48-1.11). No participants had a failed retrieval. Conclusion(s): Triggering with 1,500 IU of hCG plus 450 IU of FSH promoted noninferior oocyte competence compared to a standard hCG trigger dose. Trial registration: NCT02310919.Copyright © 2022

Andebrhan Sarah, B., et al. (2023). "Pelvic organ prolapse recurrence after pregnancy following uterine-sparing prolapse repair: a systematic review and meta-analysis." International Urogynecology Journal 34(2): 345-356.
	Introduction: We sought to determine rates of pelvic organ prolapse (POP) recurrence following pregnancy and delivery in reproductive-age women with prior hysteropexy.; Methods: Scopus, MEDLine, EMBASE, Cochrane Library, and ClinicalTrials.gov databases were searched from inception to May 2020 for combinations of any of the keywords: "pregnancy", "delivery", "fertility", or "cesarean" with a comprehensive list of uterine-sparing surgical procedures for POP repair. Using approach, 1,817 articles were identified describing surgical, uterine-sparing POP repair techniques and subsequent pregnancy and delivery outcomes in reproductive-age women. RESULTS: Twenty-seven studies describing 218 pregnancies, including 215 deliveries and 3 abortions, were summarized using narrative review and descriptive statistics. Successful pregnancies were reported following a diverse range of uterine-sparing prolapse repairs, both native tissue and mesh-augmented, that utilized vaginal, open abdominal, and laparoscopic approaches. We observed shifts from native tissue repairs to mesh-augmented laparoscopic repairs over time. POP recurrence occurred in 12% of subjects overall, 15% after vaginal and 10% after abdominal prolapse repairs. While meta-analysis identified higher recurrence rates after vaginal delivery (15%) than cesarean section (10%), due to small study numbers, multiple confounders, and heterogeneity between studies, no significant differences in recurrence rates could be identified between vaginal and abdominal surgical approaches, utilization of mesh augmentation, or mode of delivery.; Conclusion: Although literature on pregnancy following uterine-sparing POP repair is limited, available data suggest that prolapse recurrence after pregnancy and delivery remains similar to that after prolapse repair without subsequent pregnancies with few documented perinatal complications.; Systematic Review Registration: PROSPERO, CRD42021247722. (© 2022. The International Urogynecological Association.)

Andes, A., et al. (2022). "Does the real-world match the randomized trial? Reach and effectiveness of a community-based incontinence program." International Urogynecology Journal 33: S36.
	Introduction: Mind Over Matter: Healthy Bowels, Healthy Bladder (MOM) is a month‐long, small‐group (8‐12 women) behavior change intervention implemented by trained facilitators in community settings. In a 2017 randomized, controlled trial (RCT) MOM significantly improved urinary incontinence (UI) in older women and increased the proportion of participants doing pelvic floor muscle (Kegel) exercises consistently. Objective: In this program evaluation, we sought to describe the impact of MOM when implemented in the real world, delivered by community organizations serving older women, and compare its impact to that seen in the RCT. Methods: We analyzed program evaluation data from 295 women who attended 29 MOM workshops between March 1, 2019 and March 31, 2020 and data collected from the treatment arm inMOM's RCT (N=62). Women completed brief questionnaires at baseline (before their first MOM session) and at MOM completion (following the last MOM session). Participants completed the International Consultation on Incontinence Questionnaire (ICIQ‐UI) and Vaizey/St. Mark's at baseline (before their first MOM session) and at MOM completion (following the last MOM session) and provided information about their frequency of certain behaviors.Whereas RCT participants completed the patient global impression of improvement (PGI‐I) 3 months following MOM completion, community participants completed the global perception of improvement (GPI) immediately following MOM completion. Women in the RCT who reported improved PGI‐I for UI or FI were categorized as perceiving improvement for the purpose of this analysis. Descriptive analyses compared behaviors and symptoms before and after MOM among participants in both settings, with p‐value less than .05 as significant. Results: Community and RCT participants had similar mean ages (74+/‐ 8 and 75+/‐8) but RCT participants were more likely to live in rural areas (29% versus 23%) and had higher baseline incontinence severity. Mean number of participants per MOM workshop was 10 in both settings. Among community participants, 91% (212/232) had UI and 44% (77/ 175) had FI at baseline. The vast majority of participants in MOM in the community [90% (170/189)] and in the RCT [85% (50/59)] perceived incontinence symptoms to be improved following the MOM program. Details about changes in behaviors and symptoms from baseline toMOM completion are outlined in the table. Among both RCT and community participants, the proportion of women doing Kegels consistently increased significantly following MOM completion; the proportion of women experiencing stress UI decreased, and modest improvements were seen in ICIQ‐UI scores. The number of mean pads used per 24 hours increased slightly among RCT participants and decreased among community participants. There were no statistically significant differences in care‐seeking plans or FI severity as measured by the Vaizey / St. Marks. Conclusions: Community implementation of MOM reached similar women and achieved similar results to those seen in the RCT. The magnitude of symptom improvement was lower in the real world, possibly related to lower baseline symptom severity. Given these subtle differences, continued evaluation of intervention impact in real‐world implementation settings remains critical.

André, T., et al. (2023). "Antitumor Activity and Safety of Dostarlimab Monotherapy in Patients With Mismatch Repair Deficient Solid Tumors: A Nonrandomized Controlled Trial." JAMA Network Open 6(11): e2341165.
	Importance: Mismatch repair deficiency (dMMR) occurs in various cancers, and these tumors are attractive candidates for anti-programmed cell death 1 therapies, such as dostarlimab, a recently approved immune checkpoint inhibitor.; Objective: To assess the antitumor activity and safety of dostarlimab in patients with advanced or recurrent dMMR solid tumors.; Design, Setting, and Participants: The GARNET trial was a phase 1, open-label, single-group, multicenter study that began enrolling May 8, 2017. Participants had advanced or recurrent dMMR and microsatellite instability-high (MSI-H) or polymerase epsilon (POLE)-altered solid tumors. The data cut for this interim analysis was from November 1, 2021, with median follow-up of 27.7 months.; Interventions: Patients received 500 mg of dostarlimab intravenously every 3 weeks for 4 doses, then 1000 mg every 6 weeks until disease progression, discontinuation, or withdrawal.; Main Outcomes and Measures: The primary objective was to evaluate objective response rate and duration of response in patients with dMMR solid tumors by blinded independent central review using Response Evaluation Criteria in Solid Tumors, version 1.1.; Results: The efficacy population included 327 patients (median [range] age, 63 [24-85] years; 235 [71.9%] female; 7 [2.1%] Asian, 6 [1.8%] Black, and 206 [63.0%] White patients), with 141 patients (43.1%) with dMMR endometrial cancer, 105 patients (32.1%) with dMMR colorectal cancer, and 81 patients (24.8%) with other dMMR tumor types. All patients had at least 1 previous line of therapy. Objective response rate assessed per blinded independent central review for dMMR solid tumors was 44.0% (95% CI, 38.6% to 49.6%). Median duration of response was not reached (range, ≥1.18 to ≥47.21 months); 72.2% of responders (104 of 144) had a response lasting 12 or more months. Median progression-free survival was 6.9 months (95% CI, 4.2 to 13.6 months); probability of progression-free survival at 24 months was 40.6% (95% CI, 35.0% to 46.1%). Median overall survival was not reached (95% CI, 31.6 months to not reached). The most frequent immune-related adverse events were hypothyroidism (25 [6.9%]), alanine aminotransferase increase (21 [5.8%]), and arthralgia (17 [4.7%]). No new safety concerns were identified.; Conclusions and Relevance: In this nonrandomized controlled trial, dostarlimab was a well-tolerated treatment option with rapid, robust, and durable antitumor activity in patients with diverse dMMR solid tumors. These findings suggest that dostarlimab provides meaningful long-term benefit in a population with high unmet need.; Trial Registration: ClinicalTrials.gov Identifier: NCT02715284.

Andressa, S., et al. (2023). "Electrotherapy and manual therapy for chronic pelvic pain syndrome: systematic review with meta-analysis."
	
Andrews, R., et al. (2023). "The health &her app is associated with improved symptom outcomes among 1,900 menopausal women." Post Reproductive Health 29(3): 174-175.
	Objective: Symptom monitoring is associated with improvements in menopausal symptoms (Andrews et al., 2021; 2023). The Health &Her app enables menopausal women to monitor their symptoms, symptom triggers, and menstrual periods, and enables them to engage in a variety of digital activities designed to promote health and wellbeing. The aim of the present study was to examine whether sustained weekly engagement with the app is associated with improvements in menopausal symptoms. Method(s): This quasi-experimental study analysed data provided by 1,900 Health &Her app users across a 2-month period. Symptom change from baseline, over the 2-month period, was the outcome measure. A linear mixed effects model explored whether app engagement was predictive of symptom reductions. Secondary hypotheses assessed whether app-usage factors such as total number of days spent monitoring symptoms and symptom triggers, reporting menstrual periods, and using in-app activities were independently predictive of symptom changes from baseline. Covariates included hormone replacement therapy 174 Post Reproductive Health 29(3) (HRT) use, hormonal contraceptive use, present comorbidities, age, and dietary supplement use. To examine whether symptom types had varying impacts on symptom changes, symptom scores at baseline were evaluated and split according to specific symptom domains (i.e. psychological, urogenital, vasomotor, and physical). Result(s): Nine weeks of app engagement had the largest impact on symptom reductions: b =-4.0 [-5.8,-2.3] compared to 8 weeks: b =-3.8 [-5.2,-2.3], 7 weeks: b =-3.2 [-4.5,-1.8], 6 weeks: b =-3.3 [-4.5,-2.0], 5 weeks: b =-2.6 [-3.7,-1.5], 4 weeks: b =-2.7 [-3.8,-1.6], and 3 weeks: b =-1.2, 95% CI [-2.2,-0.26]. Monitoring symptoms, daily use of in-app activities, and logging menstrual periods were each independently associated with symptom reductions. Of the four symptom domains assessed, reporting psychological symptoms at baseline was associated with the greatest reductions in total symptom scores: b=-0.54 [-0.62,-0.46]. Conclusion(s): This study demonstrated that greater weekly engagement with the app was associated with greater reductions in symptoms over a 2-month period. It is recommended that women be made aware of menopausespecific apps in primary care settings, such as that provided by Health &Her, to support them to manage their menopausal symptoms and track the efficacy of menopausespecific treatments.

Andrews Robin, A. F., et al. (2023). "Symptom monitoring improves physical and emotional outcomes during menopause: a randomized controlled trial." Menopause (New York, N.Y.) 30(3): 267-274.
	Abstract: Objectives: A recent systematic review suggested that symptom monitoring can result in reductions in menopausal symptoms and improvements in health-related behaviors. To date, no studies have experimentally investigated whether symptom monitoring could be a beneficial intervention during the menopause transition.Methods: One hundred perimenopausal and postmenopausal women (mean age, 46 y; SD, 8 y) were randomized into either a monitoring-intervention or control group. A mixed between/within design was used, with group membership (ie, monitoring-intervention or control) as the between-subjects component and time (ie, baseline and 2-wk follow-up) as the within-subjects component. Dependent variables included symptom reductions and emotional reactions as measured via the Daily Record Keeping form. Secondary outcomes included help-seeking, communication, medical decision making, health awareness, self-efficacy, and health anxiety.Results: A linear mixed-effects model demonstrated that the monitoring-intervention group reported a 42% reduction in physical symptoms at follow-up versus a 12% reduction in the control group: ρ = 0.009, β = 6.3, 95% CI (1.5-11). Negative emotions also significantly reduced in the monitoring-intervention group but did not alter in the control group: ρ < 0.001, β = 3.4, and 95% CI (1.6-5.2). These effects remained significant after controlling for potential moderator variables such as trait neuroticism and coping preferences and potential confounders such as medical and demographic characteristics. Variances in other health outcomes were nonsignificant.Conclusions: Findings demonstrated that symptom monitoring reduced symptoms and negative emotions within a perimenopausal and postmenopausal sample, and these outcomes endured after controlling for key moderators and covariates. However, symptom monitoring was not related to improvements in health-related behavioral outcomes, which contrasts with previous findings. These findings show that symptom monitoring may be useful within healthcare settings by providing perimenopausal and postmenopausal women with a simple and accessible means of symptom alleviation while they await treatment or medical consultation.; Competing Interests: Financial disclosure/conflicts of interest: R.A.F.A. is currently employed by Health & Her. D.L. has received honoraria and expenses from Gedeon Richter: Preglem for expert speaker and web contributions. B.J. has no conflicts of interest to declare. (Copyright © 2023 by The North American Menopause Society.)

Andriani, L., et al. (2023). "Telehealth utilization in gynecologic oncology clinical trials." Gynecologic Oncology 177: 103-108.
	Objective: Prior to the COVID-19 pandemic, telehealth visits and remote clinical trial operations (such as local collection of laboratory tests or imaging studies) were underutilized in gynecologic oncology clinical trials. Current literature on these operational changes provides anecdotal experience and expert opinion with few studies describing patient-level safety data. We aimed to evaluate the safety and feasibility of telehealth and remote clinical trial operations during the COVID-19 Pandemic. Method(s): Gynecologic oncology patients enrolled and actively receiving treatment on a clinical trial at a single, academic institution during the designated pre-Telehealth and Telehealth periods were identified. Patients with at least 1 provider or research coordinator telehealth visit were included. Patient demographics, health system encounters, adverse events, and protocol deviations were collected. Pairwise comparisons were performed between the pre-Telehealth and Telehealth period with each patient serving as their own control. Result(s): Thirty-one patients met inclusion criteria. Virtual provider visits and off-site laboratory testing increased during the Telehealth period. Delays in provider visits, imaging, and laboratory testing did not differ between time periods. Total and minor protocol deviations increased in incidence during the Telehealth period and were due to documentation of telehealth and deferment of non-therapeutic testing. Major protocol deviations, emergency department visits, admissions, and severe adverse events were of low incidence and did not differ between time periods. Conclusion(s): Telehealth and remote clinical trial operations appeared safe and did not compromise clinical trial protocols in a small, single institutional study. Larger scale evaluations of such trial adaptations should be performed to determine continued utility following the Pandemic.Copyright © 2023

Andrielle, L., et al. (2021). "Effect of Physiotherapeutic Interventions on Chronic Pelvic Pain in Women: Systematic Review with Metanalysis."
	
Andring Lauren, M., et al. (2023). "Patient Reported Outcomes for Women Undergoing Definitive Chemoradiation for Gynecologic Cancer: A Prospective Clinical Trial." Practical radiation oncology 13(6): e538-e546.
	Purpose: Patients with gynecologic malignancies have high psychosocial and symptom burden. We report data from a prospective trial evaluating patient-reported outcome (PRO) metrics in women undergoing definitive chemoradiation with brachytherapy (BT).; Methods and Materials: A single-institution prospective trial evaluating outcomes of gynecologic cancer patients undergoing BT. Questionnaires to assess PROs at baseline, post-BT, and 60-day follow-up were collected, using European Organization for Research and Treatment of Cancer-Quality of Life Question-Core 30 and European Organization for Research and Treatment of Cancer-Quality of Life Question-Cervical Cancer Module validated metrics. Higher scores for functional scales/global health and lower scores for symptom items are favorable. European Organization for Research and Treatment of Cancer-Quality of Life Question-Core 30 mean scores were compared with a reference population. When comparing the study population between time points, medians, interquartile range, and nonparametric testing were used.; Results: Thirty-three patients were enrolled, and 29 (88%) completed baseline PRO metrics. Mean global health score was worse than the reference population of women with any cancer diagnosis at baseline (41 vs 59, P < .001) and decreased further at follow-up (42 vs 33, P = .005). Compared with the cervical cancer reference, our patients had significantly worse social function (62 vs 83, P = .03), financial toxicity (49 vs 10, P < .001), fatigue (49 vs 34, P = .04), nausea/vomiting (26 vs 9, P = .001), and appetite loss (36 vs 16, P = .004).The majority of patients described depression (53%), feeling less attractive (64%), life interference (66%), and/or worry (69%). At baseline, higher global health scores were associated with improved physical functioning (R 2 0.58, P < .001), social functioning (R 2 0.56, P < .001), and body image (R 2 0.40, P < .001); lower scores with more symptom burden (R 2 0.71, P < .001), financial toxicity (R 2 0.50, P < .001), and/or sexual worry (R 2 0.25, P = .001).; Conclusions: Patients with cervical cancer have significant symptom burden and psychosocial toxicity, contributing to decreased quality of life. These data highlight the need for improved support throughout treatment for this high-risk population.; Competing Interests: Disclosures None. (Copyright © 2023 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.)

Ang, X. Y., et al. (2022). "Lactobacilli reduce recurrences of vaginal candidiasis in pregnant women: a randomized, double-blind, placebo-controlled study." Journal of applied microbiology 132(4): 3168-3180.
	Aims: The aim of this study was to investigate the effects of lactobacilli strains in preventing the recurrences of vaginal candidiasis (VC) in 78 pregnant women with VC (lactobacilli, n = 39; placebo, n = 39) and the potential benefits on quality of life.; Methods and Results: The lactobacilli putative probiotic (SynForU-HerCare; two capsules/day of 9·5 log CFU per capsule) or placebo was administered for 8-weeks in a randomized, double-blind, placebo-controlled study. Subjects were assessed for vaginal and gut health conditions at baseline, week-4 and week-8 via questionnaires. The vulvovaginal symptom questionnaire not only covered aspects pertaining to vulvovaginal symptoms but also the quality of life impacts such as emotional, social and sexual. The administration of lactobacilli reduced symptoms of irritation (P = 0·023) and discharge (P = 0·011) starting week-4 and continued after week-8 (P < 0·05), accompanied by reduced symptoms for burning after week-8 (P = 0·046) as compared to the placebo. Patients consuming lactobacilli also showed reduced concern about symptoms after week-4 (P = 0·010) and continued after week-8 (P = 0·001), accompanied by reduced impairment of daily activities attributed to vulvovaginal symptoms (P = 0·012) and continued after week-8 (P = 0·026). Insignificant differences were observed for sexual impacts between treatment groups. The administration of lactobacilli also reduced recurrences of both emotional and social stress as compared to the placebo at both week-4 and week-8 (P < 0·05). Patients consuming lactobacilli showed higher defecation times per week at week-4 (P = 0·010) and week-8 (P = 0·001) as compared to the placebo group, indicating the potential to reduce risks of pregnancy-induced constipation.; Conclusions: Lactobacilli probiotics are beneficial towards pregnant women, especially in reducing vulvovaginal symptoms and recurrences of VC, accompanied by improved emotional and social distress attributed to VC.; Significance and Impact of the Study: The study demonstrated the preventive and modulatory roles of lactobacilli strains against VC in pregnant women. Taken altogether, our present data illustrated that lactobacilli probiotics are beneficial towards pregnant women, especially in reducing vulvovaginal symptoms and recurrences of VC, accompanied by improved emotional and social distress attributed to VC, thus could be a potential strategy for the maintenance of vaginal health during pregnancy. (© 2021 The Society for Applied Microbiology.)

Angela, F. and B. Hayley (2022). "A systematic review of community pharmacy interventions to improve peri- and post-menopausal health."
	
Anglès-Acedo, S., et al. (2021). "Sexual activity and function in women with advanced stages of pelvic organ prolapse, before and after laparoscopic or vaginal mesh surgery." International Urogynecology Journal 32(5): 1157-1168.
	INTRODUCTION AND HYPOTHESIS: The differential impact of specific pelvic organ prolapse (POP) surgery on sexual activity and function is unknown. Our primary aim was to analyse sexual inactivity and function in women with symptomatic advanced stages of POP and the changes incurred after laparoscopic or vaginal mesh surgery. METHODS: We performed a secondary analysis of sexual outcomes of a previously published randomised controlled trial comparing laparoscopic sacrocolpopexy/cervicopexy (LSC-Cx) and anterior vaginal mesh (AVM) in 120 women (60/group) with symptomatic anterior POP stage ≥ 3 and apical ≥ 2. Sexual activity and function were assessed preoperatively and 1 and 2 years postoperatively using the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-IUGA-Revised (PISQ-IR). RESULTS: Sexual activity was recovered in 42.9% of non-sexually active (NSA) women 1 year postoperatively, mainly in women with higher preoperative POP-related subscale scores of the PISQ-IR, which indicated a negative preoperative sexuality by POP. Recovery of sexual activity was greater after LSC-Cx, albeit not significantly (2 years: 35.5% AVM vs. 45% LSC-Cx). Among sexually active (SA) women preoperatively remaining SA postoperatively, the difference in the mean PISQ-IR summary score significantly improved [mean baseline difference - 2 years; all: 0.3 (95% CI 0.1 to 0.5) p = 0.001; AVM 0.19 (95% CI -0.1 to -0.5) p > 0.05; LSC-Cx 0.37 (95% CI 0.1 to 0.7) p = 0.003]. Preoperative dyspareunia was significantly reduced after LSC-Cx (baseline: 24.6%, 2 years: 9.8%, p = 0.0448), but not after AVM (baseline: 20.7%, 2 years: 18.2%, p = 0.7385). CONCLUSIONS: Most women reported improved sexual activity and function 2 years after LSC-Cx or AVM, mainly because of enhanced POP-related subscales in both NSA and SA women. Recovery of sexual activity and improved sexual function were greater after LSC-Cx compared to AVM, likely related to less postoperative dyspareunia.

Anglim, B., et al. (2022). "The effect of local estrogen therapy on the urinary microbiome composition of postmenopausal women with and without recurrent urinary tract infections." International Urogynecology Journal 33(8): 2107-2117.
	Introduction and Hypothesis: Recurrent urinary tract infections (rUTIs) occur in 2-10% of postmenopausal women. Local estrogen therapy (LET) has been shown to reduce UTIs. This study aimed to compare the urinary microbiome between patients with and without a history of rUTIs and to examine whether treatment with LET influences the diversity and richness of microbiome species in two groups.; Methods: Postmenopausal women with and without rUTIs attending the urogynecology clinic between April 2019 and December 2020 were recruited. Participant baseline characteristics and demographics were recorded. Aseptic transurethral urine samples were collected at recruitment and at 3-6 months following treatment with LET. The V1-V2 and ITS regions of the 16S rRNA gene were sequenced to identify bacteria.; Results: A total of 37 women were recruited, 20 controls and 17 patients with rUTI. During follow-up, symptomatic UTIs occurred in 3/17 (17.6%) and 0/20 in the rUTI group and control group, respectively. Klebsiella aerogenes was present in 80% of rUTI samples and in 53.3% of control samples before LET. Abundance of Finegoldia magna was present in 33.3% of samples before LET, but only in 6.7% after LET. There was no change in relative abundance of lactobacillus species following LET in both groups.; Conclusions: Treatment with vaginal LET altered the local hormonal environment of the urinary bladder and likely protected women from development of rUTI by decreasing the presence of F. magna. To confirm the significance of this bacterial species in rUTI symptomatology, our finding needs to be validated on a larger patient cohort. (© 2021. The International Urogynecological Association.)

Angoorani, P., et al. (2023). "The effects of probiotics, prebiotics, and synbiotics on polycystic ovarian syndrome: an overview of systematic reviews." Frontiers in Medicine 10: 1141355.
	Introduction: Accumulating evidence has highlighted the critical role of the gut microbiota and its potential action as a regulator of metabolic disorders including insulin resistance, obesity, and systemic inflammation in polycystic ovarian syndrome (PCOS). Microbiota-modulating interventions, such as probiotics, prebiotics, and synbiotics, could be effective in PCOS management.; Methods: We conducted an overview of systematic reviews (SRs) and meta-analyses to summarize reviews regarding the effectiveness of probiotics/prebiotics/synbiotics on the management of PCOS through a systematic literature search in PubMed, Web of Science, and Scopus databases until September 2021.; Results: Eight SRs and meta-analyses were included in this study. Our overview confirmed that probiotic supplementation had a potentially beneficial effect on some PCOS-related parameters including body mass index (BMI), fasting plasma glucose (FPG), and lipid profiles. Evidence shows that synbiotics in comparison with probiotics were less effective on these parameters. The methodological quality of SRs was assessed using the AMSTAR-2 assessment tool and was determined as high for four SRs, low for two SRs, and critically low for one SR. Due to limited evidence and high heterogeneity of the studies, it remains difficult to identify optimal probiotics strains, prebiotics types, length of duration, and doses.; Discussion: Future clinical trials with higher quality are recommended to clarify the efficacy of probiotics/prebiotics/synbiotics on the management of PCOS and provide more accurate evidence.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2023 Angoorani, Ejtahed, Ettehad Marvasti, Taghavi, Mohammadpour Ahranjani, Hasani-Ranjbar and Larijani.)

Anindita, A., et al. (2022). "Effectivity of Isoflavones in the Treatment of Postmenopausal Symptoms : Systematic Review and Meta-Analysis."
	
Anita, V. and S. Vartika (2021). "Effect of yoga therapy on health outcomes in women with polycystic ovary syndrome: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Anitua, E., et al. (2023). "Efficacy of Platelet-Rich Plasma in Women with a History of Embryo Transfer Failure: A Systematic Review and Meta-Analysis with Trial Sequential Analysis." Bioengineering (Basel, Switzerland) 10(3).
	Assisted reproductive technology (ART) is used to enhance pregnancy in infertile women. In this technique, the eggs are removed from the ovary and fertilized and injected with sperm to make embryos. Unfortunately, embryo implantation failures still occur in many of these women. Platelet-rich plasma (PRP) therapies use a patient's own platelets to promote tissue healing and growth, including endometrium. The growth factors provided by the platelets play a criterial role on the regenerative ability of PRP. In the last years, PRP treatments have been gaining a lot of popularity to treat women with repeated ART failures. In this study, we collected and summarized all information published in the scientific literature to assess the evidence of the PRP effect on pregnancy. We only considered randomized controlled trials (RCT), a type of study designed to be unbiased and considered at the highest level of evidence. Our analysis indicates that PRP therapies might be an effective treatment in cases of poor responsiveness to conventional ART. However, additional studies (well-designed) are necessary to confirm this beneficial effect of PRP.

Anitua Fundación, E. (2022). Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva.
	No Results Available Drug: PRGF|Drug: Clobetasol Propionate Evolution of quality of life measured by Skindex-29 index|Evolution of response to treatment at 1, 3, 6 and 8 months through the clinical scale of vulvar lichen sclerosus (CSS)|Evolution of pain at 1, 3, 6 and 8 months measured through the visual analog pain scale (VAS)|Evolution of the improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I)|Evolution of clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA)|Frequency of recurrences at 6 and 8 months of treatment|Frequency of complications|Platelet concentration|Platelet recovery|Presence of leukocyte Female Phase 3 30 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BTIIMD-01-EC/217LIQUEN October 2023

Anna, E., et al. (2022). "Effects of different dietary approaches in women with polycystic ovary syndrome: a systematic review and network meta-analysis."
	
Anna, K., et al. (2022). "Efficacy of bladder training in adults with overactive bladder syndrome: a systematic review."
	
Annelotte, v., et al. (2022). "Virtual Reality as pain and anxiety management in gynecological procedures: a systematic review."
	
Anneveldt, K. J., et al. (2022). "Increased MR-guided high intensity focused ultrasound (MR-HIFU) sonication efficiency of uterine fibroids after carbetocin administration." European Journal of Radiology Open 9: 100413.
	Purpose: We investigated whether administration of the long-acting uterus stimulant carbetocin increased intra-subject sonication efficiency during Magnetic Resonance image guided High Intensity Focused Ultrasound (MR-HIFU) treatment of uterine fibroids. Method(s): In this prospective cohort study, thirty women with symptomatic uterine fibroids undergoing MR-HIFU treatment were included between January 2018 and January 2019. Treatment started with three sonications on one side of the uterine fibroid. Subsequently, one ampoule of 1 mL carbetocin (100 microg/mL) was administered intravenously and treatment continued with three sonications on the other side of the uterine fibroid. We compared the intra-subject sonication efficiency, in terms of Energy Efficiency Factor (EEF), thermal dose volume and sonication time to ablate one cm3 of fibroid tissue, before and after carbetocin administration. Adverse events that occurred within 30 min after carbetocin administration were recorded. Result(s): Sonication efficiency improved after carbetocin administration as indicated by a significant decrease in EEF and sonication time (p = 0.006 and p = 0.001 respectively), and a significant increase in thermal dose volume reached (p = <0.001). Five women (16.7%) experienced temporary tachycardia, one women in combination with headache, within 30 min after carbetocin administration. Conclusion(s): Administration of the long-acting uterus stimulant carbetocin improved the MR-HIFU treatment intra-subject sonication efficiency in women with symptomatic uterine fibroids.Copyright © 2022 The Authors

Ann-Sophie, P., et al. (2021). "Efficacy and safety of the cervicosacropexy (CESA) vaginosacropexy (VASA) surgical procedure as treatment for pelvic organ prolapse and urinary incontinence: protocol for a systematic review (and meta-analysis)." PROSPERO International prospective register of systematic reviews.
	
Ansaari, N., et al. (2024). "Efficacy of in-person versus digital mental health interventions for postpartum depression: meta-analysis of randomized controlled trials." Journal of Reproductive and Infant Psychology.
	Aim: This meta-analysis aimed to compare the efficacy of in-person and digital mental health interventions in addressing Postpartum Depression. Method(s): Following PRISMA guidelines, the protocol for this meta-analysis was registered at the Open Science Framework (Retrieved from osf.io/wy3s4). This meta analysis included Randomized Controlled Trials (RCTs) conducted between 2013 and 2023. A comprehensive literature search identified 35 eligible RCTs from various electronic databases. Inclusion criteria focused on pregnant women over 18 years old, encompassing antenatal depression and up to two years postpartum. Diagnostic interviews or Edinburgh Postnatal Depression Scale (EPDS) were used to establish PPD. Digital interventions included telephonic, app-based, or internet-based approaches, while in-person interventions involved face-to-face sessions. Result(s): The meta-analysis revealed a moderate overall effect size of -0.69, indicating that psychological interventions are effective for PPD. Digital interventions (g = -0.86) exhibited a higher mean effect size than in-person interventions (g = -0.55). Both types of interventions displayed substantial heterogeneity (digital: I2 = 99%, in-person: I2 = 92%), suggesting variability in intervention content, delivery methods, and participant characteristics. Conclusion(s): Digital mental health interventions show promise in addressing PPD symptoms, with a potentially greater effect size compared to in-person interventions. However, the high heterogeneity observed in both modalities underscores the need for further research to identify key drivers of success and tailor interventions to diverse populations. Additionally, the choice between digital and in-person interventions should consider individual needs and preferences. Ongoing research should further investigate and optimise intervention modalities to better serve pregnant women at risk of PPD.Copyright © 2024 Society for Reproductive & Infant Psychology.

Ansari, A., et al. (2023). "Lactobacillus Probiotics Improve Vaginal Dysbiosis in Asymptomatic Women." Nutrients 15(8).
	Vaginal dysbiosis can lead to serious infections in asymptomatic women. Lactobacillus probiotics (LBPs) are being investigated as a promising therapy for reversing vaginal microbiota dysbiosis. This study aimed to investigate whether administering LBPs could improve vaginal dysbiosis and facilitate the colonization of Lactobacillus species in asymptomatic women. 36 asymptomatic women were classified based on the Nugent score as Low-NS (n = 26) and High-NS (n = 10) groups. A combination of Lactobacillus acidophilus CBT LA1, Lactobacillus rhamnosus CBT LR5, and Lactobacillus reuteri CBT LU4 was administered orally for 6 weeks. The study found that among women with a High-NS, 60% showed improved vaginal dysbiosis with a Low-NS after LBP intake, while four retained a High-NS. Among women with a Low-NS, 11.5 % switched to a High-NS. Genera associated with vaginal dysbiosis were positively correlated with the alpha diversity or NS, while a negative correlation was observed between Lactobacillus and the alpha diversity and with the NS. Vaginal dysbiosis in asymptomatic women with an HNS improved after 6 weeks of LBP intake, and qRT-PCR revealed the colonization of Lactobacillus spp. in the vagina. These results suggested that oral administration of this LBP could improve vaginal health in asymptomatic women with an HNS.

Antill, Y., et al. (2022). "Mismatch repair and clinical response to immune checkpoint inhibitors in endometrial cancer." Cancer 128(6): 1157-1161.
	Lay Summary: Endometrial cancer is common, and a subset recurs and requires additional treatment. Some of these are recognized as being susceptible to immune therapies and are said to have mismatch repair deficiency (dMMR). However, this clinical trial highlights which cases are more likely to respond well: those containing mutations in genes known as Lynch genes and also some with mutations in POLE/POLD1 ("ultra-hypermutation" genes). In contrast, the majority of dMMR endometrial cancers have silencing or DNA methylation of one of these genes, MLH1, and do not seem to be as responsive to single-agent immune therapy. The availability of combination therapies may be important to consider for these women. (© 2021 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.)

Antill, Y., et al. (2021). "Clinical activity of durvalumab for patients with advanced mismatch repair-deficient and repair-proficient endometrial cancer. A nonrandomized phase 2 clinical trial." Journal for Immunotherapy of Cancer 9(6): 002255.
	Background In this study, we assessed the activity of durvalumab, an antibody to programmed death ligand-1, in two cohorts of women with advanced endometrial cancers (AEC) - mismatch repair proficient (pMMR) and mismatch repair deficient (dMMR). Methods A multicenter phase two study was performed in women with AEC with pMMR tumor progressing after one to three lines of chemotherapy and women with AEC with dMMR tumor progressing after zero to three lines of chemotherapy. Mismatch repair status was based on immunohistochemistry expression. All women received durvalumab 1500 mg given every 4 weeks until progression or unacceptable toxicity. The primary endpoint was objective tumor response by RECIST V.1.1 modified for immune-based therapeutics. Results Seventy-one women were recruited: 35 dMMR and 36 pMMR. Median follow-up was 19 vs 21 months in dMMR versus pMMR, respectively. Median age was 67 years. Histology in dMMR versus pMMR included endometrioid (94% vs 57%) and serous (0% vs 31%) and was high grade in 26% vs 74%. The objective tumor response rate (OTRR) in the dMMR cohort was 47% (17/36, 95% CI 32 to 63), including 6 complete responses and 11 partial responses (PRs)) vs 3% in the pMMR cohort (1/35, 95% CI 1 to 15, PR). In the dMMR cohort, durvalumab was the first-line therapy in 58% (OTRR 57%) and the second-line therapy in 39% (OTRR 38%). Median progression-free survival was 8.3 months in the dMMR cohort vs 1.8 months in the pMMR cohort. The 12-month overall survival (OS) rate was 71% in dMMR vs 51% in pMMR, with median OS not reached for dMMR vs 12 months for pMMR. Immune-related adverse events occurred in 14 women, mostly grades 1-2. Conclusion Durvalumab monotherapy showed promising activity and acceptable safety in AEC with dMMR regardless of prior lines of chemotherapy, but activity was limited in AEC with pMMR. Trial registration numbers ANZGOG1601, ACTRN12617000106336, and NCT03015129.Copyright ©

Antonio, S., et al. (2022). "Obstructed hemivagina and ipsilateral renal anomaly (OHVIRA) syndrome: a systematic review about diagnosis and surgical management."
	
Antonio, S., et al. (2023). "Use of letrozole as treatment for ectopic pregnancy: a systematic review and meta-analysis."
	
Antonios, S. and P. Nikolaos (2023). "Endometrial injury during hysteroscopy in women undergoing in vitro fertilization treatment. A systematic review and meta-analysis."
	
Antosh Danielle, D., et al. (2021). "Sexual function after pelvic organ prolapse surgery: a systematic review comparing different approaches to pelvic floor repair." American Journal of Obstetrics and Gynecology 225(5): 475.e471-475.e419.
	Objective: Women consider preservation of sexual activity and improvement of sexual function as important goals after pelvic organ prolapse surgery. This systematic review aimed to compare sexual activity and function before and after prolapse surgery among specific approaches to pelvic organ prolapse surgery including native tissue repairs, transvaginal synthetic mesh, biologic grafts, and sacrocolpopexy.; Data Sources: MEDLINE, Embase, and ClinicalTrials.gov databases were searched from inception to March 2021.; Study Eligibility Criteria: Prospective comparative cohort and randomized studies of pelvic organ prolapse surgeries were included that reported the following specific sexual function outcomes: baseline and postoperative sexual activity, dyspareunia, and validated sexual function questionnaire scores. Notably, the following 4 comparisons were made: transvaginal synthetic mesh vs native tissue repairs, sacrocolpopexy vs native tissue repairs, transvaginal synthetic mesh vs sacrocolpopexy, and biologic graft vs native tissue repairs.; Methods: Studies were double screened for inclusion and extracted for population characteristics, sexual function outcomes, and methodological quality. Evidence profiles were generated for each surgery comparison by grading quality of evidence for each outcome across studies using a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.; Results: Screening of 3651 abstracts was performed and identified 77 original studies. The overall quality of evidence was moderate to high. There were 26 studies comparing transvaginal synthetic mesh with native tissue repairs, 5 comparing sacrocolpopexy with native tissue repairs, 5 comparing transvaginal synthetic mesh with sacrocolpopexy, and 7 comparing biologic graft with native tissue repairs. For transvaginal synthetic mesh vs native tissue repairs, no statistical differences were found in baseline or postoperative sexual activity, baseline or postoperative total dyspareunia, persistent dyspareunia, and de novo dyspareunia. Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form change scores were not different between transvaginal synthetic mesh and native tissue repairs (net difference, -0.3; 95% confidence interval, -1.4 to 0.8). For sacrocolpopexy vs native tissue repairs, baseline or postoperative sexual activity, baseline or postoperative total dyspareunia, de novo dyspareunia, and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form score differences were not different. For biologic graft vs native tissue repairs, baseline or postoperative sexual activity, baseline or postoperative total dyspareunia, and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form changes were also not different. For transvaginal synthetic mesh vs sacrocolpopexy, there was no difference in sexual activity and sexual function score change. Based on 2 studies, postoperative total dyspareunia was more common in transvaginal synthetic mesh than sacrocolpopexy (27.5% vs 12.2%; odds ratio, 2.72; 95% confidence interval, 1.33-5.58). The prevalence of postoperative dyspareunia was lower than preoperative dyspareunia after all surgery types.; Conclusion: Sexual function comparisons are most robust between transvaginal synthetic mesh and native tissue repairs and show similar prevalence of sexual activity, de novo dyspareunia, and sexual function scores. Total dyspareunia is higher after transvaginal synthetic mesh than sacrocolpopexy. Although sexual function data are sparse in the other comparisons, no other differences in sexual activity, dyspareunia, and sexual function score change were found. (Copyright © 2021 Elsevier Inc. All rights reserved.)

Antoun, L., et al. (2023). "LAparoscopic Versus Abdominal hysterectomy (LAVA): protocol of a randomised controlled trial." BMJ Open 13(9): e070218.
	Introduction There is uncertainty about the advantages and disadvantages of laparoscopic hysterectomy compared with abdominal hysterectomy, particularly the relative rate of complications of the two procedures. While uptake of laparoscopic hysterectomy has been slow, the situation is changing with greater familiarity, better training, better equipment and increased proficiency in the technique. Thus, a large, robust, multicentre randomised controlled trial (RCT) is needed to compare contemporary laparoscopic hysterectomy with abdominal hysterectomy to determine the safest and most cost-effective technique. Methods and analysis A parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial with integrated health economic evaluation and an internal pilot with an embedded qualitative process evaluation. A within trial-based economic evaluation will explore the cost-effectiveness of laparoscopic hysterectomy compared with open abdominal hysterectomy. We will aim to recruit 3250 women requiring a hysterectomy for a benign gynaecological condition and who were suitable for either laparoscopic or open techniques. The primary outcome is major complications up to six completed weeks postsurgery and the key secondary outcome is time from surgery to resumption of usual activities using the personalised Patient-Reported Outcomes Measurement Information System Physical Function questionnaire. The principal outcome for the economic evaluation is to be cost per QALY at 12 months' postsurgery. A secondary analysis is to be undertaken to generate costs per major surgical complication avoided and costs per return to normal activities. Ethics and dissemination The study was approved by the West Midlands-Edgbaston Research Ethics Committee, 18 February 2021 (Ethics ref: 21/WM/0019). REC approval for the protocol version 2.0 dated 2 February 2021 was issued on 18 February 2021. We will present the findings in national and international conferences. We will also aim to publish the findings in high impact peer-reviewed journals. We will disseminate the completed paper to the Department of Health, the Scientific Advisory Committees of the RCOG, the Royal College of Nurses (RCN) and the BSGE. Trial registration number ISRCTN14566195.Copyright © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Anufrieva, K. S., et al. (2023). "Unlocking DNA Damage Sensitivity of Cancer Cells: The Potential of Splicing Inhibitors." bioRxiv.
	Despite the growing interest in pre-mRNA alternative splicing (AS) as a therapeutic anticancer target, the potential of splicing inhibitors in treating solid tumors remains largely unexplored. We conducted a meta-analysis of transcriptome data from six different tumor types and revealed that splicing inhibitors induced similar patterns of AS, resulting in widespread exon-skipping and intron retention events that often lead to nonsense-mediated decay of the transcripts. Interestingly, in many cases exon skipping is induced by a compensatory cellular response to splicing inhibitor treatment. It involves an upregulation of multiple splicing factors and incomplete recognition of branch points by U2 snRNP. These post transcriptional changes downregulate one-third of essential DNA repair genes, thereby creating a therapeutic vulnerability that can be exploited for cancer treatment. To harness this vulnerability, we proposed a new approach to cancer treatment consisting of sequential addition of a splicing inhibitors followed by a DNA-damaging agent. Our in vitro and in vivo experiments demonstrated that this strategy exhibits promising therapeutic potential for a wide range of tumors.Copyright The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license.

Aoyama, T., et al. (2021). "Effects of Goshajinkigan (TJ-107) for oxaliplatin-induced peripheral neurotoxicity using the functional assessment of cancer therapy/gynecologic oncology group 12-item neurotoxicity questionnaire in a Phase II, multicenter, randomized, double-blind, placebo-controlled trial." Journal of cancer research and therapeutics 17(6): 1473-1478.
	BACKGROUND: The aim of the present study was to evaluate the efficacy of TJ-107 for oxaliplatin-induced peripheral neurotoxicity in prospective, multi-institutional, randomized, double-blind, placebo-controlled Phase II trials using the functional assessment of cancer therapy/gynecologic oncology group 12-item neurotoxicity questionnaire (FACT-GOG-NTX-12). PATIENTS AND METHODS: The patients who were registered to the Goshajinkigan oxaliplatin neurotoxicity evaluation study (UMIN000002211) were analyzed. A NTX-12 from the validated FACT/GOG-NTX-12 was assessed before treatment and at the end of every 2 cycles. RESULTS: The comparisons of the median scores for TJ-107 and the placebo at 8 and 26 weeks were as follows: numbness or tingling in the hands (P = 0.5820), numbness or tingling in the feet (P = 0.3236), feeling of discomfort in the hands (P = 0.8219), feeling of discomfort in the feet (P = 0.5361), joint pain or muscle cramps (P = 0.1974), feeling weak all over (P = 0.2771), trouble hearing (P = 0.2832), ringing or buzzing in ears (P = 0.1031), trouble buttoning buttons (P = 0.1653), trouble feeling the shape of small objects when held in hand (P = 0.2919), trouble walking (P = 0.5406), and pain in the hands or feet when exposed to cold temperatures (P = 0.1872). CONCLUSION: There might be no clinically significant difference between the use of TJ-107 and the severity and quality of life for patients treated with oxaliplatin.

Apolikhina, I. A., et al. (2023). "SYSTEMATIC REVIEW OF THE EFFICACY AND SAFETY OF NIFURATEL FOR WOMEN WITH DISEASES ACCOMPANIED BY PATHOLOGICAL DISCHARGE FROM THE GENITAL TRACT." Akusherstvo i Ginekologiya (Russian Federation) 2023(11): 48-58.
	Objective: To evaluate the clinical and laboratory efficacy and safety of nifuratel for women with diseases accompanied by pathological discharge from the genital tract. Material(s) and Method(s): This systematic review was conducted according to the PRISMA checklist. The analysis included controlled clinical studies for the period 1972-2023 which evaluated the efficacy and safety of oral and/or vaginal administration of nifuratel in women over the age of 18 with bacterial vaginosis, aerobic vaginitis, candidiasis vulvovaginitis, mixed vaginitis and trichomoniasis. Result(s): After selecting the proper publications and excluding duplicates, the qualitative analysis included 14 studies (5 randomized and 9 non-randomized); totally, there were 3,337 patients including 544 pregnant women. The quantitative synthesis and meta-analysis included 9 clinical studies. According to received data, a statistically significant difference in clinical and microbiological efficacy was determined in favor of nifuratel in comparison with other drugs (odds ratio (OR)=1.03, 95% CI [1.00, 1.07], p=0.03 and OR=1.15, 95% CI [1.04, 1.27], p=0.005, respectively). There was a statistically significant difference in the frequency of relapses after a course of therapy in favor of nifuratel in comparison with other drugs (OR=0.36, 95% CI [0.19, 0.68], p=0.001). None of the included studies showed any serious side effects after the treatment with the drug. Conclusion(s): The use of nifuratel both as monotherapy and in combination with nystatin surpasses other drugs in clinical and microbiological efficacy in the treatment of diseases accompanied by pathological discharge from the genital tract in women; it also shows a lower frequency of relapses. Nevertheless, additional well-planned studies with standardized criteria for evaluating results and long-term follow-up periods can allow the women with vaginitis and bacterial vaginosis to make a better choice among antimicrobial therapy options.Copyright © A group of authors, 2023.

Ara, U., et al. (2021). "Effectiveness of inositol, metformin and their combination in women with PCOS undergoing assisted reproduction: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Ara, U., et al. (2021). "Efficacy of photodynamic therapy in women with HSIL and LSIL and early stage of squamous cervical cancer: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Ara, U., et al. (2021). "Effect of menopausal hormone therapy on skin elasticity in women: a systematic review and meta-analysis."
	
Arab, A., et al. (2019). "The Association Between Vitamin D and Premenstrual Syndrome: A Systematic Review and Meta-Analysis of Current Literature." Journal of the American College of Nutrition 38(7): 648-656.
	A number of studies have assessed the association between vitamin D and premenstrual syndrome (PMS) in different populations, but the findings have been inconclusive. Herein, we systematically reviewed available observational and interventional evidence to elucidate the overall relationship between vitamin D and PMS. PubMed, Cochrane Library, ScienceDirect, Scopus, Google Scholar, and ISI Web of Science databases were searched for all available articles until September 2018. The Newcastle-Ottawa quality assessment scale and Jadad scale were used to assess the quality of the observational and interventional studies, respectively. A total of 16 studies out of 196 met our inclusion criteria and were included in the final analysis. Although no significant association between serum 25(OH)D and PMS (weighted mean difference (WMD) = 3.35; 95% confidence interval, -7.80 to 1.11; p = 0.14) was indicated in observational studies, vitamin D supplementation was effective in ameliorating PMS symptoms based upon findings from interventional studies. These results add to the existing literature supporting the fact that nutrition, especially vitamin D, plays an important role in women's health. Additional well-designed clinical trials should be considered in future research to develop firm conclusions on the efficacy of vitamin D on PMS. KEY TEACHING POINTS 5-8% of women experience severe PMS. Nutrition especially vitamin D plays an important role in the women's health. Vitamin D could exert significant clinical effects on PMS symptoms. This is a systematic review and meta-analysis in this regard.

Aranda-Gutierrez, A., et al. (2024). "Obstetric and neonatal outcomes following taxane use during pregnancy: a systematic review." BMC Cancer 24(1): 9.
	Background: The use of taxanes following the first trimester of pregnancy is endorsed by current clinical guidelines. However, evidence regarding their safety in terms of obstetric and neonatal outcomes is limited.; Methods: A comprehensive literature search was performed using the MEDLINE, CENTRAL and Web of Sciences databases from their inception up to 12/16/2022. Eligibility criteria included gestational taxane use, presentation of original findings, and individual case data presented. A descriptive statistical analysis was undertaken.; Results: A total of 159 patients treated with taxane-containing regimens during pregnancy were identified, resulting in 162 fetuses exposed in utero. The majority of patients had breast cancer (n = 88; 55.3%) or cervical cancer (n = 45; 28.3%). The most commonly employed taxane was paclitaxel (n = 131; 82.4%). A total of 111 (69.8%) patients were also treated with other cytotoxic drugs during pregnancy, including platinum salts (n = 70; 63.0%) and doxorubicin/cyclophosphamide (n = 20; 18.0%). While most patients received taxanes during the second trimester of pregnancy (n = 79; 70.0%), two were exposed to taxanes in the first trimester. Obstetric outcomes were reported in 105 (66.0%) cases, with the most frequent adverse events being preterm contractions or premature rupture of membranes (n = 12; 11.4%), pre-eclampsia/HELLP syndrome (n = 6; 5.7%), and oligohydramnios/anhydramnios (n = 6; 5.7%). All cases with pregnancy outcome available resulted in live births (n = 132). Overall, 72 (54.5%) neonates were delivered preterm, 40 (30.3%) were classified as small for gestational age (SGA), and 2 (1.5%) had an Apgar score of < 7 at 5 min. Perinatal complications included acute respiratory distress syndrome (n = 14; 10.6%), hyperbilirubinemia (n = 5; 3.8%), and hypoglycemia (n = 2; 1.5%). In addition, 7 (5.3%) cases of congenital malformations were reported. At a median follow-up of 16 months, offspring health status was available for 86 (65.2%), of which 13 (15.1%) had a documented complication, including delayed speech development, recurrent otitis media, and acute myeloid leukemia.; Conclusions: Taxanes appear to be safe following the first trimester of pregnancy, with obstetric and fetal outcomes being similar to those observed in the general obstetric population. Future studies should aim to determine the most effective taxane regimen and dosage for use during gestation, with a specific focus on treatment safety. (© 2023. The Author(s).)

Araújo Isabelle Maria Mendes, d., et al. (2021). "Non-pharmacological therapeutic approaches to painful sexual dysfunction in women: integrative review." BrJP 4(3): 239-244.
	ABSTRACT BACKGROUND AND OBJECTIVES: Sexual dysfunctions associated with pain symptoms can affect female genito-pelvic functionality. The objective of this study was to identify non-pharmacological analgesic therapies used in painful sexual dysfunctions to guide clinical and therapeutic practice in comprehensive care of women's sexual health. CONTENTS: An integrative review, carried out in the Pubmed, LILACS, Scielo, PEDro and Biblioteca Virtual de Saúde databases. The searches were performed using the combinations: "dysfunction" AND "pain" AND "sexual" AND "treatment". The inclusion criteria allowed the analysis of six articles published between January 2009 and August 2019. It was observed that dysfunctions in the muscles of the pelvic floor may be associated with pain and sexual dysfunctions, thus, non-pharmacological analgesic interventions can provide greater muscle relaxation and perineal self-perception, reducing painful symptoms in the sexual response cycle. CONCLUSION: The treatment of painful sexual dysfunctions with the use of non-pharmacological resources, using techniques such as perineal massage, myofascial release, muscle training, biofeedback, vaginal dilators, electrostimulation, and radiofrequency aim to improve sexual performance and quality of life for women.

Aravantinou-Fatorou, A., et al. (2021). "Pembrolizumab in endometrial cancer: Where we stand now." Oncology Letters 22(6): 821.
	Recently, immunotherapy has shown promising results in solid tumors. To the best of our knowledge, this is the first systematic review of published literature synthesizing all the available data and evaluating both the efficacy and safety of pembrolizumab in endometrial cancer. The present study was performed in accordance with the PRISMA guidelines. Eligible articles were identified by searching the MEDLINE and ClinicalTrials.gov databases, using a predefined combination of the terms 'endometrial cancer' and 'pembrolizumab'. Overall, nine articles incorporating data from 712 patients were eligible. Pembrolizumab was demonstrated to be an effective and safe therapeutic option for the management of advanced/metastatic endometrial cancer. Results of ongoing trials evaluating either pembrolizumab alone or in combination with other antineoplastic regimens are expected to confirm its efficacy in this setting of patients. Pembrolizumab appears to be both durable and robust in endometrial cancer. However, there is an emerging need for novel predictive biomarkers to guide clinical practice.; Competing Interests: FZ has received honoraria for lectures and has served in an advisory role for Astra-Zeneca, Daiichi, Eli-Lilly, Merck, Novartis, Pfizer and Roche. ML has received honoraria from Roche, Astra Zeneca, Astellas, MSD, Janssen, BMS and IPSEN. MG has received honoraria from Janssen, Genesis Pharm, Amgen, Karyopharm and Takeda. MAD has received honoraria and has served on advisory boards from Jannsen, Genesis Pharm, Amgen, Karyopharm and Takeda, outside the submitted work. AAF, AA, VEG and OF declare that they have no competing interests. (Copyright: © Aravantinou-Fatorou et al.)

Aravantinou-Fatorou, A., et al. (2021). "Pembrolizumab in endometrial cancer: Where we stand now (Review)." Oncology Letters 22(6): 13082.
	Recently, immunotherapy has shown promising results in solid tumors. To the best of our knowledge, this is the first systematic review of published literature synthesizing all the available data and evaluating both the efficacy and safety of pembrolizumab in endometrial cancer. The present study was performed in accordance with the PRISMA guidelines. Eligible articles were identified by searching the MEDLINE and ClinicalTrials.gov databases, using a predefined combina- tion of the terms 'endometrial cancer' and 'pembrolizumab'. Overall, nine articles incorporating data from 712 patients were eligible. Pembrolizumab was demonstrated to be an effective and safe therapeutic option for the management of advanced/metastatic endometrial cancer. Results of ongoing trials evaluating either pembrolizumab alone or in combination with other antineoplastic regimens are expected to confirm its efficacy in this setting of patients. Pembrolizumab appears to be both durable and robust in endometrial cancer. However, there is an emerging need for novel predictive biomarkers to guide clinical practice.Copyright © 2021 Spandidos Publications. All rights reserved.

Aravive, I., et al. (2021). Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer.
	No Results Available Drug: Batiraxcept|Drug: Paclitaxel|Other: Placebo Anti-tumor activity of batiraxcept in combination with PAC measured by progression free survival (PFS) in patients receiving batiraxcept + PAC versus patients receiving Placebo+PAC|Overall survival Female Phase 3 366 Industry|Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment AVB500-OC-004|GOG-3059|ENGOT OV66|AXLerate-OC August 4, 2023

Arch, J. (2023). "A Telehealth Acceptance and Commitment Therapy Intervention for Women with Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue: Preliminary Findings from a Pilot Randomized Trial." Psycho-Oncology 32(Supplement 1): 40-41.
	Background/Purpose: Oral PARP inhibitors have dramatically changed treatment for many women with advanced ovarian cancer, and are increasingly used to treat other advanced cancers (with over 300 active clinical trials). However, PARP inhibitors cause significant fatigue for nearly half of patients. Though cognitive behavioral approaches represent one of the most effective strategies for treating cancer-related fatigue, a recent Cochrane meta-analyses found very low quality evidence and no enduring benefit to address fatigue in advanced cancer; further, there are no trials in the context of PARP inhibitors. Finally, existing cancer-related fatigue interventions have generally been delivered in person over many sessions, limiting their accessibility and scalability. Method(s): In a pilot randomized trial among fatigued adults with latestage/ recurrent ovarian cancer on PARP inhibitors (n = 36), we developed, refined, and piloted a 6-session telehealth intervention. The intervention, known as REVITALIZE, was based on acceptance and commitment therapy and addressed modifiable contributors to PARP inhibitor-related fatigue. The trial randomized patients 1:1 to REVITALIZE or an enhanced usual care control across two sites, evaluated feasibility, acceptability, and preliminary efficacy through 3-month follow-up, and conducted exit interviews with all REVITALIZE patients. Result(s): The trial met or exceeded its acceptability and feasibility goals; exit interviews further indicated high acceptability. Relative to enhanced usual care, REVITALIZE significantly reduced fatigue interference at 12-week follow-up, p = 0.01, by a large effect (d = 0.84), improved current fatigue levels, fatigue self-efficacy, fatigue catastrophizing, depression, anxiety, and quality of life (ds = 0.43-0.67), and demonstrated a pattern of fewer PARP inhibitor dose reductions and delays. Conclusions and Implications: Among adults with advanced ovarian cancer on PARP inhibitors, a brief telehealth intervention based on acceptance and commitment therapy showed strong feasibility, acceptability, and efficacy potential to improve fatigue outcomes as well as anxiety, depression, and quality of life outcomes. This approach has good scalability potential and is worthy of further investigation.

Archer, D. F., et al. (2022). "Efficacy Outcomes with Relugolix Combination Therapy in Perimenopausal Women with Uterine Fibroids: LIBERTY Studies." Menopause 29(12): 1460.
	Objective: In the 24-week, Phase 3 LIBERTY 1 and 2 studies, relugolix combination therapy (Rel-CT; relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) significantly reduced menstrual blood loss (MBL) in women with uterine fibroids (UF) and heavy menstrual bleeding. Here, the efficacy and safety of Rel-CT through 24 weeks is reported in a subgroup of potentially perimenopausal women (defined as age >= 45 years) compared with the overall study population (age 18-50 years). Design(s): Premenopausal women with ultrasound-confirmed UF and MBL >=80 mL per cycle were randomized 1:1:1 to Rel-CT or placebo for 24 weeks, or Delayed Rel-CT (relugolix 40 mg monotherapy for 12 weeks, followed by Rel-CT for 12 weeks). Primary efficacy endpoint: proportion of treatment responders, defined as MBL volume <80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment, measured by the alkaline hematin method. Key secondary efficacy endpoints: 1) amenorrhea rate; 2) mean percent reduction in MBL volume; 3) reduction in distress from bleeding, passing of blood clots, and tightness/pressure in the pelvic area, as measured by the Bleeding and Pelvic Discomfort (BPD) scale; 4) proportion of women with moderate-to-severe pain at baseline (Numerical Rating Score [NRS] >=4) achieving minimal-to-no fibroid-associated pain; 5) proportion of women with anemia (hemoglobin <=10.5g/dL) at baseline who achieved an increase in hemoglobin levels of >2 g/dL; 6) percent change in largest UF volume; and 7) percent change in uterine volume. Analyses comparing the Rel-CT group vs placebo group were performed on the modified intent-to-treat population using pooled data from LIBERTY 1 and 2. Proportions were compared using Cochran-Mantel-Haenszel tests, and changes or percent changes from baseline to Week 24 were tested with mixed-effects or ANCOVA models, with treatment, visit, baseline MBL and treatment by visit interaction included as fixed effects. All reported P values are two-sided, and 95% confidence intervals (CIs) for treatment differences are provided. Result(s): Potentially perimenopausal women included 282/768 (36.7%) women from LIBERTY 1 and 2 (95 randomized to Rel-CT; 94 to placebo). Mean [standard deviation] baseline characteristics were similar (except for age) between potentially perimenopausal women and the overall pooled population: age (47.4 [1.7] vs 42.5 [5.2] years, respectively), body mass index (31.1 [6.4] vs 31.2 [7.1] kg/m2), MBL volume (228.6 [146.4] vs 243.0 [182.2] mL). Efficacy results are reported in Table 1. Adverse events for potentially perimenopausal women were consistent with those for the overall population. Conclusion(s): In potentially perimenopausal women from the LIBERTY studies, Rel-CT demonstrated a significant reduction of MBL volume; achievement of amenorrhea; improvements in hemoglobin levels, UF-associated pain and quality of life; and reductions in UF volume vs placebo, and was generally well-tolerated through 24 weeks. Results were consistent with the overall study population.

Archer, D. F., et al. (2019). "Ospemifene for the treatment of menopausal vaginal dryness, a symptom of the genitourinary syndrome of menopause." Expert Review of Endocrinology and Metabolism 14(5): 301-314.
	Introduction: Vulvovaginal atrophy (VVA), a component of the genitourinary syndrome of menopause, is a progressive condition due to decline in estrogen leading to vaginal and vulvar epithelial changes. Accompanying symptoms of dryness, irritation, burning, dysuria, and/or dyspareunia have a negative impact on quality of life. Ospemifene is a selective estrogen receptor modulator (SERM) approved by the FDA for moderate to severe dyspareunia and vaginal dryness due to postmenopausal VVA. Areas covered: PubMed was searched from inception to March 2019 with keywords ospemifene and vulvar vaginal atrophy to review preclinical and clinical data describing the safety and efficacy of ospemifene for vaginal dryness and dyspareunia due to VVA. Covered topics include efficacy of ospemifene on vaginal cell populations, vaginal pH, and most bothersome VVA symptoms; imaging studies of vulvar and vaginal tissues; effects on sexual function; and safety of ospemifene on endometrium, cardiovascular system, and breast. Expert opinion: Ospemifene is significantly more effective than placebo in all efficacy analyses studied, working through estrogen receptors and possibly androgen receptors. Safety as assessed by adverse events was generally comparable to that with placebo and to other SERMs, and/or adverse events were not clinically meaningful. No cases of endometrial or breast cancer were reported.Copyright © 2019, © 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Arcieri, M., et al. (2024). "Primary flap closure of perineal defects to avoid empty pelvis syndrome after pelvic exenteration in gynecologic malignancies: An old question to explore a new answer." European Journal of Surgical Oncology 50(2): 107278.
	Pelvic exenteration (PE) is a radical oncological surgical procedure proposed in patients with recurrent or persistent gynecological cancers. The radical alteration of pelvic anatomy and of pelvic floor integrity can cause major postoperative complications. Fortunately, PE can be combined with reconstructive procedures to decrease complications and functional and support problems of pelvic floor, reducing morbility and mortality and increasing quality of life. Many options for reconstructive surgery have been described, especially a wide spectrum of surgical flaps. Different selection criteria have been proposed to select patients for primary perineal defect flap closure without achieving any strict indication of the best option. The aim of this review is to focus on technical aspects and the advantages and disadvantages of each technique, providing an overview of those most frequently used for the treatment of pelvic floor defects after PE. Flaps based on the deep inferior epigastric artery, especially vertical rectus abdominis musculocutaneous (VRAM) flaps, and gracilis flaps, based on the gracilis muscle, are the most common reconstructive techniques used for pelvic floor and vaginal reconstruction. In our opinion, reconstructive surgery may be considered in case of total PE or type II/III PE and in patients submitted to prior pelvic irradiation. VRAM could be used to close extended defects at the time of PE, while gracilis flaps can be used in case of VRAM complications. Fortunately, numerous choices for reconstructive surgery have been devised. As these techniques continue to evolve, it is advisable to adopt an integrated, multi-disciplinary approach within a tertiary medical center.Copyright © 2023 The Author(s)

Arend, R., et al. (2023). "DKK1 is a predictive biomarker for response to DKN-01: Results of a phase 2 basket study in women with recurrent endometrial carcinoma." Gynecologic Oncology 172: 82-91.
	Purpose: Dickkopf-1 (DKK1) is a Wnt signaling modulator promoting tumor growth, metastasis, angiogenesis, and immunosuppression by regulating innate immunity. DKK1 is over-expressed in gynecologic cancers and is associated with shortened survival. DKN-01 is a humanized monoclonal antibody with DKK1 neutralizing activity that may provide clinical benefit to patients whose tumors have overexpression of DKK1 or Wnt genetic alterations.; Methods: We conducted an open-label, Phase 2 basket study with 2-stage design in patients with endometrial carcinoma (EC) and platinum-resistant/refractory epithelial ovarian cancer. DKN-01 was administered either as monotherapy or in combination with weekly paclitaxel at investigator's discretion. All patients underwent NGS testing prior to enrollment; tumor tissue was also tested for DKK1 expression by RNAscope pre-treatment and after cycle 1 if available. At least 50% of patients were required to have a Wnt signaling alteration either directly or tangentially. This publication reports results from the EC population overall and by DKK1-expression.; Results: DKN-01 monotherapy and in combination with paclitaxel was more effective in patients with high DKK1-expressing tumors compared to low-expressing tumors. DKN-01 monotherapy demonstrated an objective response rate [ORR] of 25.0% vs. 0%; disease control rate [DCR] of 62.5% vs. 6.7%; median progression-free survival [PFS] was 4.3 vs. 1.8 months, and overall survival [OS] was 11.0 vs. 8.2 months in DKK1-high vs DKK1-low patients. Similarly, DKN-01 in combination with paclitaxel demonstrated greater clinical activity in patients with DKK1-high tumors compared to DKK1-low tumors: DCR was 55% vs. 44%; median PFS was 5.4 vs. 1.8 months; and OS was 19.1 vs. 10.1 months. Wnt activating mutations correlated with higher DKK1 expression. DKN-01 was well tolerated as a monotherapy and in combination with paclitaxel.; Conclusions: Collectively, data demonstrates promising clinical activity of a well-tolerated drug, DKN-01, in EC patients with high tumoral DKK1 expression which frequently corresponded to the presence of a Wnt activating mutation. Future development will focus on using DKN-01 in DKK1-high EC patients in combination with immunotherapy.; Competing Interests: Declaration of Competing Interest Dr. Arend participates in Data Safety Monitoring/Advisory Boards (DSMB) for Astra Zeneca, Caris Life Sciences, Clovis, Merck, Seagen, Sutro, Glaxo Smith Kline, VBL Therapeutics. Dr. Matulonis reports relationships with the Med Learning Group and participates in DSMB for: Allarity, NextCure, Alkermes, Symphogen, Trillium, Agenus, Immunogen, Novartis, Boerhinger Ingelheim, Rivkin Foundation, Ovarian Cancer Research Alliance, Clearity Foundation, and Morphosys. Dr. Kagey and Dr. Sirard are employed by and own stock in Leap Therapeutics. Dr. Hamilton reports consulting or advisory for: Pfizer (Inst), Genentech/Roche (Inst), Lilly (Inst), Puma Biotechnology (Inst), Daiichi Sankyo (Inst), Mersana (Inst), Boehringer Ingelheim (Inst), AstraZeneca (Inst), Novartis (Inst), Silverback Therapeutics (Inst), Black Diamond (Inst). Dr. Sachdev participates in DSMB for Pfizer, Immunomedics, AstraZeneca, Tempus, and Ipsen; discloses stock/options in Biosplice Therapeutics; and is employed by Biosplice Therapeutics. Dr. Duska reports royalties from JB Learning, consulting fees from UpToDate, serves as an expert law review, and participates in DSMB for Regeneron and Inovio. She reports leadership in SGO, ASCO, the NCI, and the British Journal of OBGYN. Dr. ElNaggar reports employment and stock/options with Natera. Ms. Liu and Ms. Piper were employed by LEAP Therapeutics during manuscript preparation. Dr. O'Malley participates in DSMB for: AbbVie, AdaptImmune, Agenus, Arquer Diagnostics, Arcus Biosciences, AstraZeneca, Atossa Therapeutics, Boston Biomedical, Cardiff Oncology, Celcuity, Clovis Oncology, Corcept Therapeutics, Duality Biom, Eisai, Elevar, Exelixis, Genentech, Genelux, GlaxoSmithKline, GOG Foundation, Hoffman-LaRoche, ImmunoGen, Imvax, InterVenn, INX ED, IOVANCE Biotherapeutics, Janssen, Laekna, Leap Therapeutics, Luzsana Biotechnology, Merck, Merck Sharp & Dohme, Mersana, Myriad, Novartis, NovoCure, OncoC4, Onconova, Regeneron, RepImmune, R Pharm, Roche, SeaGen, Sorrento, Sutro, Tarveda, Toray, Trillium, Umoja, Verastem, VBL Therapeutics, Vincerx, Xencor, Zentalis. All other authors report no disclosures. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Arend, R. C., et al. (2021). "Utilizing an interim futility analysis of the OVAL study (VB-111-701/GOG 3018) for potential reduction of risk: A phase III, double blind, randomized controlled trial of ofranergene obadenovec (VB-111) and weekly paclitaxel in patients with platinum resistant ovarian cancer." Gynecologic Oncology 161(2): 496-501.
	OBJECTIVE: Report the results from a preplanned interim analysis of a phase III, double blind, randomized controlled study of ofranergene obadenovec (VB-111), a targeted anti-cancer gene therapy, in combination with paclitaxel in patients with platinum resistant ovarian cancer (PROC). METHODS: The OVAL (NCT03398655) study is an on-going study where patients are randomly assigned in a 1:1 ratio to weekly paclitaxel 80 mg/m2 with VB-111 or placebo. The protocol specifies a pre-planned unblinded futility interim analysis of CA-125 response per GCIG criteria in the first 60 evaluable patients. The futility rule determined for this analysis was that the response rate of VB-111 must be greater than the response rate of placebo by at least 10% in order to continue the study. Coincident with the interim analysis, the blinded CA-125 response rate was estimated as a proportion of the first 60 evaluable patients with CA-125 response per GCIG criteria. Post-treatment fever is provided as a possible surrogate marker of VB-111 therapy activity. RESULTS: The median age of the evaluable patients was 62 years (range 41-82); 97% had high-grade serous cancer; 58% had been treated with 3 or more previous lines of therapy, 70% received prior anti-angiogenic treatment, 43% received prior PARP inhibitors. CA-125 response in the VB-111 and weekly paclitaxel treated arm met the pre-specified interim criterion of an absolute advantage of 10% or higher compared to the control. Blinded results show a 53% CA-125 response rate (32/60) with 15% complete response (n=9). Assuming balanced randomization and an absolute advantage of 10% or higher to the VB-111 arm, it may be deducted that the response in the VB-111 treatment arm is 58% or higher. Among patients with post-treatment fever, the CA-125 response rate was 69%. CONCLUSIONS: At the time of the interim analysis, response rate findings are comparable to the responses seen in a similar patient population in the phase I/II study. The independent data and safety monitoring committee (iDSMC) recommended continuing the OVAL trial as planned. No new safety signals were identified.

Aretha, G., et al. (2024). "The Effects of Probiotics in the Treatment of Vaginal Candidiasis: A Systematic Review."
	
Ari Sabahattin, A., et al. (2022). "Effectiveness of paracervical block in endometrial sampling procedures for pain control: a randomized controlled clinical trial." Ginekologia polska 93(11): 889-895.
	Objectives: We aimed to evaluate the effect of paracervical block (PCB) on endometrial sampling procedures, to assess the effect on pain of waiting between PCB and intervention, and to compare the effectiveness of PCB with oral non-steroidal anti-inflammatory drugs (NSAID) for decreasing the pain levels associated with endometrial biopsy.; Material and Methods: A total of 123 participants were divided into four groups as Group 1: Waiting 1 minute after PCB, Group 2: Waiting 3 minute after PCB, Group 3: Control group, and Group 4: Waiting 60 minute after taking oral NSAIDs. The success of analgesic measures used for endometrial biopsy during and 30 minutes after the procedure was compared with the Numeric Pain Rating Scale (NPRS) system.; Results: The Numeric Pain Rating Scale (NPRS) 0 score was 2.60 (± 2.42) in Group 1; 1.60 (± 1.73) in Group 2; 5.30 (± 2.10) in Groups 3; 5.63 (± 1.99) in Groups 4. NPRS 30 score was 0.80 (± 0.88) in Group 1; 0.43 (± 0.81) in Group 2; 1.90 (± 1.32) in Groups 3; 2.70 (± 1.41) in Groups 4. The pain was significantly less in the paracervical block groups compared to control and oral NSAIDs groups. However, there was no significant difference in NPRS 0 (p = 0.196) and NPRS 30 (p = 0.191) scores between Group 1 and Group 2. There was no significant difference in NPRS 0 and NPRS 30 scores between control group and oral NSAID group.; Conclusions: Paracervical block (PCB) is an effective method and superior to oral NSAIDs. Waiting 1 minute or 3 minutes after PCB were equally effective.

Arian Sara, E., et al. (2023). "Endometrial receptivity array before frozen embryo transfer cycles: a systematic review and meta-analysis." Fertility and Sterility 119(2): 229-238.
	Objective: To investigate the impact of endometrial receptivity array (ERA) before frozen embryo transfer in patients undergoing in vitro fertilization (IVF). There is a lack of consensus regarding the use of ERA for increasing the success rate of IVF cycles, mainly in terms of the live birth rate.; Design: PubMed, Web of Science and Embase were searched from inception up to February 15, 2022.; Setting: Not applicable.; Patient(s): Patients undergoing ERA vs no ERA before frozen embryo transfer.; Intervention(s): Only comparative studies evaluating pregnancy rates of patients undergoing frozen embryo transfer cycles with or without prior ERA were included. Inter-study heterogeneity was also assessed using Cochrane's Q test and the I 2 statistic. The random-effects model was used to pool the odds ratio (OR) with the corresponding 95% confidence intervals (CIs). Subgroup analyses were performed to investigate the impact of ERA on pregnancy rates according to the number of previous embryo transfer (ET) failures (≤ 2 previous failed ETs vs. > 2 failed ETs, defined as recurrent implantation failure). Separate analyses were performed according to the study design and adjustment for confounders.; Main Outcome Measures(s): The primary outcomes of the study were live birth rate and/or ongoing pregnancy rate. Implantation rate, biochemical pregnancy rate, clinical pregnancy rate, and miscarriage rate were considered secondary outcomes.; Result(s): Eight studies (representing data on n = 2,784 patients; n = 831 had undergone ERA and n = 1,953 without ERA) were found to be eligible for this meta-analysis. The live birth or ongoing pregnancy rate for the ERA group was not significantly different compared with the non-ERA group (OR, 1.38; 95% CI, 0.79-2.41; I 2 83.0%), nor was a difference seen in subgroup analyses based on the number of previous failed ETs. The rates of implantation, biochemical pregnancy, clinical pregnancy, and miscarriage were also comparable between the ERA and the non-ERA groups. After separate analyses according to the study design and adjustment for confounding factors, overall pooled estimates remained statistically nonsignificant.; Conclusion(s): The findings of the current meta-analysis did not reveal a significant change in the rate of pregnancy after IVF cycles using ERA, and it is not clear whether ERA can increase the pregnancy rate or not.; Systematic Review Registration: Prospectively registered in PROSPERO (CRD42022310862). (Copyright © 2022. Published by Elsevier Inc.)

Arik Meltem, I., et al. (2022). "The effect of TENS for pain relief in women with primary dysmenorrhea: A systematic review and meta-analysis." Explore (New York, N.Y.) 18(1): 108-113.
	Objective: Primary dysmenorrhea (PD) is a chronic health condition that affects primarily young women and interferes with daily activities, causes loss of work productivity, and reduces quality of life. Transcutaneous electrical nerve stimulation (TENS) is a complementary and alternative therapy used to reduce pain related to PD. The purpose of this meta-analysis study was to evaluate the effectiveness of TENS in the treatment of pain in women with PD.; Methods: A search of the English literature in the Cochrane Library, MEDLINE (EBSCO), Physiotherapy Evidence Database (PEDro), CINAHL (EBSCO), PUBMED, OVID, Science Direct, Scopus, Academic Search Complete databases was conducted using combinations of the following search terms: 'primary dysmenorrhea', 'pain', 'transcutaneous electrical nerve stimulation', 'TENS', and 'electrical stimulation'. All content from database inception through April 2020 was included in the search.; Results: The initial search strategy based on date range and language yielded 571 relevant records and 4 of them were about both TENS and PD. A total of 260 patients were enrolled in the included studies. In all of the included studies, the comparison intervention consisted of sham TENS. The primary outcome of interest was pain intensity. Our analysis indicated that TENS was statistically more effective than sham TENS in reducing PD-related pain (SMD=1.384; 95% CI=0.505, 2.262; p = 0.002).; Conclusion: TENS is a safe and well-tolerated electrophysical therapy that may be effective for relieving pain in PD. (Copyright © 2020 Elsevier Inc. All rights reserved.)

Armah, D., et al. (2021). "Holistic management of female infertility: A systematic review." African journal of reproductive health 25(2): 150-161.
	Although issues pertaining to infertility affect both males and females, women often become victims of stigmatization and rejection, making them susceptible to emotional pain and suffering. Due to these psychosocial problems, they require not only biomedical treatment, but also psychological, social, and spiritual support. Unfortunately, many women with infertility are not treated holistically. The aim of this review was to retrieve existing evidence of holistic healthcare interventions for women with infertility. Global databases were searched for articles published anywhere in the world between 2010 to 2018 that explored holistic healthcare interventions for women diagnosed with infertility. A total of 18 articles meeting the inclusion criteria were assessed, and data extraction was performed. Findings revealed that interventions adopted in managing infertile women alongside the bio-medical management included: counseling; cognitive behavioral therapy; acceptance and commitment therapy; educational interventions; spiritual interventions; emotionally focused therapy/intervention and integrative body-mind-spirit interventions. The results of this review have implications for healthcare professionals to ensure holistic care of women diagnosed with infertility in Ghana and Africa at large.

Armbrust, R., et al. (2021). "Impact of health-related quality of life (HRQoL) on short-term mortality in patients with recurrent ovarian, fallopian or peritoneal carcinoma (the NOGGO-AGO QoL Prognosis-Score-Study): results of a meta-analysis in 2209 patients." ESMO Open 6(2): 100081.
	Objective: Recurrent ovarian cancer is an incurable disease with variable but poor prognosis. Health-related quality of life (HRQoL) is a patient-reported outcome measure generally applied to measure effects of therapies. Our aim was the development and validation of a risk score for the prediction of short-term mortality using the combination of sociodemographic and clinical factors and HRQoL.; Methods: For exploratory and validation analysis, the North-Eastern German Society of Gynecological Oncology (NOGGO) and Working Group Gynecological Oncology (AGO) study databases were screened for trials. Only trials which obtained defined HRQoL measurements were included in the final analysis. Multivariable logistic regression analyses were used to identify risk factors and their weighting for the risk score. Modulation with cubic regression analyses revealed median survival and short-term mortality defined as 1-year mortality for each value.; Results: For exploration, 974 patients from three clinical studies of the NOGGO and for validation, 1235 patients from several clinical studies of the AGO were eligible. The risk score included platinum-free interval, performance status, age, global QoL and nausea/vomiting. Receiver operating characteristic analysis showed a good predictive value with an area under the curve of 0.81 for model 1 in the exploration and 0.74 in the validation. Short-term mortality in model 1 was 8.2%, 23.5% and 58.4% in the exploration sample, and 19.7%, 38.1% and 63.4% in the validation sample for patients under low, medium and high risk, respectively.; Conclusions: This risk score discriminates well between recurrent ovarian cancer patients under low, medium and high risk of short-term mortality. It may help to identify a risk group under high risk for short-term mortality that can be used for randomization in clinical trials and may support decision making for palliative chemotherapy.; Competing Interests: Disclosures The authors have declared are no conflicts of interest. (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Armbruster, S. D., et al. (2021). "A phase III study of transdermal granisetron versus oral ondansetron for women with gynecologic cancers receiving pelvic chemoradiation." Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 29(1): 213-222.
	PURPOSE: To compare rates of complete response (no emesis, retching, or rescue antiemetics) in the late phase (days 4-7 post-chemotherapy) of cycle 1 between transdermal granisetron and oral ondansetron in cervical, endometrial, or vaginal cancer survivors undergoing chemoradiation at The University of Texas MD Anderson Cancer Center and LBJ Hospital in Houston, TX. METHODS: In this non-blinded parallel design trial, eligible patients received a granisetron patch replaced every 7 days or 8 mg of ondansetron thrice daily continued for 72 h after chemotherapy completion. Data were collected on medication compliance, episodes of chemotherapy-induced nausea and vomiting (CINV), use of rescue antiemetics, and effects of CINV on quality of life. RESULTS: Seventy-five survivors receiving chemoradiation for cervical (n = 61), endometrial (n = 12), or vaginal (n = 2) cancer were electronically randomized to transdermal granisetron (n = 41) or oral ondansetron (n = 34). In the late phase of cycle 1, the rate of complete response was 49.8% (95% CI, 35.2-64.3%) for transdermal granisetron and 39.7% (95% CI, 24.4-56.1%) for oral ondansetron. The posterior probability that transdermal granisetron achieved a higher success rate in controlling late-onset CINV compared with oral ondansetron was 82%. During the acute phase (day 1 post-chemotherapy) of cycles 2 and 3, transdermal granisetron patients used more rescue antiemetics than oral ondansetron patients (p = 0.006 and p = 0.003, respectively). Otherwise, no between-group differences in CINV events were observed. Medication compliance and the effect of CINV on quality of life were similar between groups. CONCLUSION: Transdermal granisetron was 82% more like to control CINV than oral ondansetron in the late phase of cycle 1 and performed similarly to oral ondansetron in all other cycles. Transdermal granisetron should be considered an option as prophylactic antiemetic therapy for gynecologic cancer survivors undergoing chemoradiation.

Armeni, E. and I. Lambrinoudaki (2022). "Menstrual irregularity and bone health in premenopausal women: Are oral contraceptives the best option?" Maturitas 155: 70-71.
	Competing Interests: The authors declare that they have no competing interests.

Armour, M., et al. (2021). "The effectiveness of a modified Gui Zhi Fu Ling Wan formulation (Gynoclear™) for the treatment of endometriosis: a study protocol for a placebo-controlled, double-blind, randomised controlled trial." Trials 22(1): 299.
	Background: Endometriosis is the presence of tissue similar to that of the endometrium outside the uterine cavity and is the most common cause of chronic pelvic pain. Current non-surgical treatments such as non-steroidal anti-inflammatories, oral contraceptive pills and hormonal treatments have limited effectiveness, and the side effect profile is bothersome. This study will evaluate the efficacy of Gynoclear™ by change in endometriosis-related pain based on the Endometriosis Pain Daily Diary (EPPD) scores.; Methods: This randomised, double-blind, placebo-controlled trial will recruit a minimum of 90 adult participants across Australia who have a laparoscopic visualisation/confirmation of endometriosis in the last 5 years and have current moderate or greater pelvic pain. Participants will be randomly allocated in a 1:1 ratio to receive either Gynoclear™ (active) or placebo. Gyncolear's active ingredients are Carthamus tinctorius (Safflower), Cinnamomum cassia (Chinese cinnamon), Poria cocos (Hoelen), Paeonia suffriticosa (Tree peony), Paeonia lactiflora (Peony) and Salvia miltiorrhiza (Red sage). Participants are asked to complete a total of 5 months' worth of pain diary entries via the EPDD v3, including 1-month screening, 2-month treatment period and 1-month post-treatment follow-up. The primary outcome variable is change in endometriosis-related pain based on the EPDD v3 scores. Secondary outcomes include change in health-related quality of life via the Endometriosis Health Profile (EHP-30), SF-12 and EQ-5D scores as well as changes in rescue analgesic usage, dyspareunia and fatigue via the EPDD.; Discussion: This study will determine the safety and efficacy of Gynoclear™ to reduce the severity and duration of non-cyclical pelvic pain, dysmenorrhoea, dyspareunia and other symptoms of endometriosis. Study outcomes will be of interest to health professionals and members of the public who suffer from endometriosis.; Trial Registration: Australia and New Zealand Clinical Trials Registry ACTRN12619000807156 . Registered on 3 June 2019.

Armstrong, E., et al. (2022). "Metronidazole treatment rapidly reduces genital inflammation through effects on bacterial vaginosis-associated bacteria rather than lactobacilli." The Journal of clinical investigation 132(6).
	BackgroundBacterial vaginosis (BV) causes genital inflammation and increases HIV risk, whereas a vaginal microbiota dominated by Lactobacillus species is associated with immune quiescence and relative HIV protection. BV treatment reduces genital inflammation, but it is unclear whether this reduction is driven by a decrease in BV-associated bacteria or an increase in Lactobacillus species.METHODSTo evaluate the short-term effect of standard BV treatment on genital immunology and the vaginal microbiota, vaginal swabs were collected immediately before and after metronidazole treatment for BV and analyzed with multiplex ELISA, metagenomic sequencing, and quantitative PCR.RESULTSTopical metronidazole treatment rapidly reduced vaginal levels of proinflammatory cytokines, chemokines, and soluble immune markers of epithelial barrier disruption. Although the vaginal microbiota shifted to dominance by L. iners or L. jensenii, this proportional shift was primarily driven by a 2 to 4 log10-fold reduction in BV-associated bacteria absolute abundance. BV treatment induced no change in the absolute abundance of L. crispatus or L. iners and only minor (<1 log10-fold) increases in L. gasseri and L. jensenii that were not independently associated with reduced inflammation in multivariable models.CONCLUSIONThe genital immune benefits that are associated with Lactobacillus dominance after BV treatment were not directly attributable to an absolute increase in lactobacilli, but rather to the loss of BV-associated bacteria.Trial REGISTRATIONParticipants were recruited as part of a randomized controlled trial (ClinicalTrials.gov NCT02766023) from 2016 to 2019.FUNDINGCanadian Institutes of Health Research (PJT-156123) and the National Institute of Allergy and Infectious Diseases (HHSN2722013000141 and HHSN27200007).

Armstrong, E., et al. (2022). "Sustained effect of LACTIN-V (Lactobacillus crispatus CTV-05) on genital immunology following standard bacterial vaginosis treatment: results from a randomised, placebo-controlled trial." The Lancet. Microbe 3(6): e435-e442.
	Background: Bacterial vaginosis might increase HIV risk by eliciting genital inflammation and epithelial barrier disruption, whereas vaginal Lactobacillus crispatus is associated with immune quiescence and HIV protection. We investigated the effect of a live biotherapeutic containing L crispatus CTV-05 (LACTIN-V) on genital immunology and key vaginal bacteria.; Methods: This substudy included women aged 18-45 years who participated in the randomised, placebo-controlled, phase 2b trial of LACTIN-V to reduce bacterial vaginosis recurrence, conducted at four universities and hospitals in the USA. Women with negative results for sexually transmitted infection, pregnancy, and urinary tract infection were provided a 5-day course of vaginal metronidazole 0·75% gel. Those who met at least three of four clinical Amsel criteria for bacterial vaginosis and had a Nugent score of 4-10 from Gram staining were eligible. Participants in the LACTIN-V trial were randomly assigned (2:1) to receive either LACTIN-V or placebo, applied vaginally once per day for 5 days during the first week and then twice per week for 10 more weeks. Follow-up visits occurred 4, 8, 12, and 24 weeks after enrolment. Soluble immune factors and the absolute abundance of bacterial taxa were assayed by mutliplex ELISA and quantitative PCR. The primary outcomes were vaginal levels of IL-1α and soluble E-cadherin at 24 weeks (ie, 13 weeks after treatment cessation).; Findings: Between Feb 21, 2020 and March 18, 2021, we characterised genital immune parameters and the vaginal microbiota in a subset of 66 highly adherent participants who were randomly selected, with no exclusion criteria, from those who had attended all study follow-up visits (n=166) in the larger LACTIN-V clinical trial (n=288). 32 (48%) participants received LACTIN-V and 34 (52%) received placebo. LACTIN-V treatment was significantly associated with lower concentrations of the proinflammatory cytokine IL-1α (β coefficient 0·310, SE 0·149; p=0·042) and soluble E-cadherin (0·429, 0·199; p=0·035), a biomarker of epithelial barrier disruption.; Interpretation: Vaginal administration of LACTIN-V following standard bacterial vaginosis therapy resulted in a sustained reduction in genital inflammation and a biomarker of epithelial integrity. The potential of LACTIN-V to reduce HIV susceptibility merits further investigation.; Funding: Canadian Institutes of Health Research and the National Institutes of Health National Institute of Allergy and Infectious Diseases.; Competing Interests: Declaration of interests CRC is chair of the scientific advisory board for Osel. BC reports grants from Western Foundation, Canadian Institutes of Health Research, Canadian Cancer Society, McLaughlin Foundation, National Cancer Institute, and Cystic Fibrosis Foundation; and material receipts for research from Nubiyota. CRC reports grants from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases and NIH National Institute of Child Health and Human Development (HHSN2722013000141 and HHSN27200007); and holds stock options in Osel and Evvy. RK reports a grant from Canadian Institutes of Health Research (#PJT-156123). All other authors declare no competing interests. (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Arnreiter, C. and P. Oppelt (2021). "A Systematic Review of the Treatment of Uterine Fibroids Using Transcervical Ultrasound-Guided Radiofrequency Ablation with the Sonata® System." Journal of Minimally Invasive Gynecology.
	OBJECTIVE: To evaluate the treatment success, possible side effects, and safety of radiofrequency ablation with the Sonata® System. DATA SOURCES: An electronic literature search in the PubMed and MEDLINE database was carried out from inception to August 2020. METHODS OF STUDY SELECTION: The review was performed in accordance with the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). Keywords such as "Sonata," "transcervical ablation," and "uterine myoma" were used to identify all relevant articles independently by both authors. Full-text articles in English that reported at least one of the following outcomes were included in the study: reduction in perfused/absolute myoma volume, effect of treatment on bleeding intensity and myoma-related symptoms, number of surgical reinterventions, adverse events, return to activities of daily life, effects on surrounding tissue and safety during pregnancy. TABULATION, INTEGRATION AND RESULTS: 10 studies matching the inclusion criteria were identified and used for further analysis. A reduction in total and perfused myoma volume of 63.2% and 64.5% was achieved. One of the studies showed a 53.8 ± 50.5% (n=48) reduction in Menstrual Pictogram Score and another study a 51.1 ± 40.9% (n=142) reduction in Pictoral Blood Loss Assessment Chart at 12 months, and 87.2% (n=190) reported a clinically meaningful reduction in menstrual blood loss after 12 months. While Symptom Severity Scores dropped by 28.8 ± 19.3, 23.3 ± 23.7, and 23.7 ± 19.4 points at 3, 6, and 12 months, respectively, Health-Related Quality of Life Scores increased to 77.5 ± 22.0, 82.8 ± 19.0, and 83.3 ± 20.5 points. One study had an 8% reintervention rate after 12 months and another study showed a 0.7% and 5.2% rate after 12 and 24 months. After an average of 64 months postablation the reintervention rate was 11.8%. Return to activities of daily life was 2.9 ± 2.5 days. No related complications during pregnancy and delivery were reported. CONCLUSION: Radiofrequency ablation with the Sonata® System represents a minimally invasive, organ-preserving treatment option in patients with symptomatic uterine myomas, associated with clinically meaningful improvement of myoma related symptoms.

Arnreiter, C. and P. Oppelt (2021). "A Systematic Review of the Treatment of Uterine Myomas Using Transcervical Ultrasound-Guided Radiofrequency Ablation with the Sonata System." Journal of Minimally Invasive Gynecology 28(8): 1462-1469.
	Objective: To evaluate the treatment success, possible side effects, and safety of radiofrequency ablation with the Sonata System.; Data Sources: An electronic literature search in the PubMed and Medline databases was carried out from inception to August 2020.; Methods of Study Selection: The review was performed in accordance with the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. Keywords such as "Sonata," "transcervical ablation," and "uterine myoma" were used to identify all relevant articles independently by both authors. Full-text articles in English that reported at least 1 of the following outcomes were included in the study: reduction in perfused/total myoma volume, effect of treatment on bleeding intensity and myoma-related symptoms, number of surgical reinterventions, adverse events, return to activities of daily life, effects on surrounding tissue, and safety during pregnancy.; Tabulation, Integration, and Results: 10 studies matching the inclusion criteria were identified and used for further analysis. A reduction in total and perfused myoma volume of 63.2% and 64.5% was achieved. One of the studies showed a 53.8 ± 50.5% (n = 48) reduction in Menstrual Pictogram Score, and another study showed a 51.1 ± 40.9% (n = 142) reduction in Pictorial Blood Loss Assessment Chart at 12 months. 87.2% (n = 190) of the patients reported a clinically meaningful reduction in menstrual blood loss after 12 months. While Symptom Severity Scores dropped by 28.8 ± 19.3, 23.3 ± 23.7, and 23.7 ± 19.4 points at 3, 6, and 12 months, respectively, Health-Related Quality of Life Scores increased to 77.5 ± 22.0, 82.8 ± 19.0, and 83.3 ± 20.5 points. One study had an 8% reintervention rate after 12 months, and another study showed a 0.7% and 5.2% rate after 12 and 24 months. After an average of 64 months after ablation, the reintervention rate was 11.8%. Time to return to activities of daily life was 2.9 ± 2.5 days. No related complications during pregnancy and delivery were reported.; Conclusion: Radiofrequency ablation with the Sonata System represents a minimally invasive, organ-preserving treatment option in patients with symptomatic uterine myomas, associated with clinically meaningful improvement of myoma-related symptoms. (Copyright © 2021 AAGL. Published by Elsevier Inc. All rights reserved.)

Aronson, S. L., et al. (2024). "Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy in Patients With Advanced Ovarian Cancer (OVHIPEC-1): Final Survival Analysis of a Randomised, Controlled, Phase 3 Trial." Obstetrical and Gynecological Survey 79(2): 96-98.
	Background: The OVHIPEC-1 trial previously showed that the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery resulted in improved progression-free and overall survival compared with cytoreductive surgery alone at 4·7 years of follow-up in patients with stage III epithelial ovarian cancer who were ineligible for primary cytoreduction. We report the final survival outcomes after 10 years of follow-up.; Methods: In this open-label, randomised, controlled, phase 3 trial, patients with primary epithelial stage III ovarian cancer were recruited at eight HIPEC centres in the Netherlands and belgium. Patients were eligible if they were aged 18-76 years, had not progressed during at least three cycles of neoadjuvant carboplatin plus paclitaxel, had a WHO performance status score of 0-2, normal blood counts, and adequate renal function. Patients were randomly assigned (1:1) to undergo interval cytoreductive surgery without HIPEC (surgery group) or with HIPEC (100 mg/m 2 cisplatin; surgery-plus-HIPEC group). randomisation was done centrally by minimisation with a masked web-based allocation procedure at the time of surgery when residual disease smaller than 10 mm diameter was anticipated, and was stratified by institution, previous suboptimal cytoreductive surgery, and number of abdominal regions involved. The primary endpoint was progression-free survival and a secondary endpoint was overall survival, analysed in the intention-to-treat population (ie, all randomly assigned patients). This study is registered with ClinicalTrials.gov, NCT00426257, and is closed.; Findings: Between April 1, 2007, and April 30, 2016, 245 patients were enrolled and followed up for a median of 10·1 years (95% CI 8·4-12·9) in the surgery group (n=123) and 10·4 years (95% CI 9·5-13·3) in the surgery-plus-HIPEC group (n=122). Recurrence, progression, or death occurred in 114 (93%) patients in the surgery group (median progression-free survival 10·7 months [95% CI 9·6-12·0]) and 109 (89%) patients in the surgery-plus-HIPEC group (14·3 months [12·0-18·5]; hazard ratio [HR] 0·63 [95% CI 0·48-0·83], stratified log-rank p=0·0008). Death occurred in 108 (88%) patients in the surgery group (median overall survival 33·3 months [95% CI 29·0-39·1]) and 100 (82%) patients in the surgery-plus-HIPEC group (44·9 months [95% CI 38·6-55·1]; HR 0·70 [95% CI 0·53-0·92], stratified log-rank p=0·011).; Interpretation: These updated survival results confirm the long-term survival benefit of HIPEC in patients with primary stage III epithelial ovarian cancer undergoing interval cytoreductive surgery.; Funding: dutch Cancer Foundation (KWF Kankerbestrijding).; Competing Interests: Declaration of interests IHJTdH has received institutional research support from Roche and Quality in Products & Service/RanD. PV has received conference fees and travel expenses from Roche and honoraria from Roche (Genentech), Novartis, and MSD Oncology. KKVdV has served on advisory boards for Exact Sciences and AstraZeneca. GSS has received institutional research support from Merck Sharp & Dohme, Agendia, AstraZeneca, Roche, and Novartis, and consulting fees from Biovica and Seagen. All other authors declare no competing interests. (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Arsenio, S., et al. (2023). "Recurrent vulvovaginal candidiasis. A network meta-analysis of available pharmacological topical and oral antifungal treatments."
	
Arslanca, T., et al. (2020). "Single-Port Laparoscopic Surgery for Endometrial Cancer: a Systematic Review." Current Obstetrics and Gynecology Reports 9(2): 45-50.
	Purpose of Review: This review aimed to provide an overview of single-port laparoscopic surgery and related literature. Based on previous reviews on endometrial cancer, we focused on the benefit of single-port laparoscopic surgery in endometrium cancer. Recent Findings: Endometrial cancer is the most common gynecological cancer and can be treated with laparoscopic surgery without negatively affecting the oncological outcome. Single-port laparoscopic surgery is a recently emerging endoscopic technique, and it was shown that endometrial cancer could be staged using this method. Summary: Research shows that endometrial staging with SILS is a feasible strategy that might become a common alternative to the conventional laparoscopic technique. In the future, this novel technique might take on a prominent role in advancing the evolution of minimally invasive gynecologic oncology surgery.Copyright © 2020, Springer Science+Business Media, LLC, part of Springer Nature.

Artacho-Cordón, F., et al. (2023). "Effect of a Multimodal Supervised Therapeutic Exercise Program on Quality of Life, Pain, and Lumbopelvic Impairments in Women With Endometriosis Unresponsive to Conventional Therapy: A Randomized Controlled Trial." Archives of physical medicine and rehabilitation 104(11): 1785-1795.
	Objective: To evaluate the effectiveness of "Physio-EndEA", a multimodal nine-week supervised exercise intervention, on quality of life, pain, and lumbopelvic impairments in women with endometriosis unresponsive to conventional therapy.; Design: Parallel-group randomized controlled trial. Outcomes were measured at baseline, post-intervention, and at 1 year.; Setting: Two Public University Hospitals.; Participants: This trial included 31 women with endometriosis (N=31) randomly allocated to "Physio-EndEA" group (n=16) or control group (n=15). Four participants dropped out of the study for causes unrelated to the intervention.; Interventions: The "Physio-EndEA" program consisted of a 1-week lumbopelvic stabilization learning phase followed by an 8-week phase of stretching, aerobic, and resistance exercises focused on the lumbopelvic area. It was sequentially instructed and supervised by a trained physiotherapist (with volume and intensity progression) and adapted daily to the potential of each participant. Control group received the usual treatment stipulated by their gynecologist.; Main Outcome Measures: The primary outcome was quality of life. Secondary outcomes were pain intensity, pressure pain thresholds, pain-related catastrophic thoughts, abdominal and back strength, lumbopelvic stability, and muscle architecture.; Results: Adherence rate was 90.6% and mean (±standard deviation) satisfaction was 9.44±0.73 out of 10. No remarkable health problems were reported during the trial. In comparison with controls, the quality of life was improved post-intervention and at 1 year in the Physio-EndEA group with large effect sizes (d>0.80). This group also evidenced: a reduced intensity of dyspareunia, catastrophic thoughts; an increase in pelvic, lumbar, and distal pressure pain thresholds; increases in abdominal and back strength and lumbopelvic stability; and increased thickness of transversus abdominis (right side) and width of lumbar multifidus (left side).; Conclusion: A 9-week program of multimodal supervised therapeutic exercise is a feasible and effective intervention to improve QoL in women with endometriosis. This program also offers benefits in terms of pain/sensitization and lumbopelvic impairments. (Copyright © 2023 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Arumugaswamy, P. R., et al. (2022). "Impact of bariatric surgery on urinary incontinence in morbidly obese individuals." Surgical Endoscopy 36(7): 4771-4779.
	Background: There is scanty evidence on the impact of bariatric surgery on urinary incontinence (UI) in the Asian population. Methodology: Patients who underwent bariatric surgery from June 2018 to June 2019 were screened using the International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) questionnaire. Patients having UI were identified and followed until 1 year of surgery using the ICIQ-UI-SF. These were classified as having stress, urge, or mixed type of UI. The prevalence, change in scores, and the number of pads used were compared at baseline and at follow-up. Result(s): A total of 148 patients underwent bariatric surgery of whom, 41 patients (M = 2, F = 39) had UI. Stress incontinence was seen in 70.7%, 19.5% had urge incontinence, and rest had the mixed type. Using logistic regression, it was found that female gender was the most important predictor of having UI (OR: 8.33). The prevalence of UI decreased from 27.7% at baseline to 8.1% at 6 months and 3.4% at 12 months. The mean ICIQ-UI-SF score improved from 8.76 (SD = 3.2) at baseline to 0.66 (SD = 2.1) at 12 months of follow-up. The proportion of patients with UI using any number of pads decreased from 92.7% at baseline to 9.8% at 12 months. There was a decrease in the number of patients having moderate to very severe UI from 35 (85.4%) at baseline to 2 (4.9%) at 12 months. Proportion of patients showing resolution was highest among the stress incontinence group at 96.5%. Presence or absence of comorbidities did not significantly influence the ICIQ-UI-SF scores. Conclusion(s): Bariatric surgery leads to profound improvement in UI in obese individuals which is well sustained until 1 year of follow-up. Resolution rates might be higher in Asian population.Copyright © 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Arya, S., et al. (2021). "Metabolic syndrome in obesity: treatment success and adverse pregnancy outcomes with ovulation induction in polycystic ovary syndrome." American Journal of Obstetrics and Gynecology 225(3): 280.e281-280.e211.
	BACKGROUND: Obesity is common in women with polycystic ovary syndrome. polycystic ovary syndrome and obesity are associated with reduced fertility. The effect of metabolic syndrome on the success of infertility treatment and pregnancy outcomes in women with polycystic ovary syndrome undergoing ovulation induction has not been investigated. OBJECTIVE: The objectives of this study were to determine the associations of metabolic syndrome on the rate of live birth after ovulation induction and pregnancy complications in obese women with polycystic ovary syndrome and determine whether there is a difference in outcomes concerning specific medications used for ovulation induction. STUDY DESIGN: This prospective cohort analysis used data collected from participants in the Pregnancy in Polycystic Ovary Syndrome II clinical trial conducted by the Reproductive Medicine Network. In the Pregnancy in Polycystic Ovary Syndrome II trial, 750 women with polycystic ovary syndrome and infertility were randomized to either clomiphene citrate or letrozole for ovulation induction for 1 to 5 cycles or until pregnancy occurred. Cox regression and modified Poisson regression, chi-square test, and Student t test or Wilcoxon test were used in this study. Outcomes of interest were rates of live birth and clinical pregnancy and pregnancy complications. Having metabolic syndrome was defined by the presence of at least 3 of 5 cardiometabolic risk factors (waist circumference of >88 cm, low high-density lipoprotein cholesterol of <50 mg/dL, triglycerides of ≥150 mg/dL, systolic blood pressure of ≥130 or diastolic blood pressure of ≥85 mm Hg, and fasting glucose of >100 mg/dL). In addition, we used a continuous metabolic syndrome z score. Body mass index categories were defined as normal (body mass index of <25 kg/m2), high (25 to 35 kg/m2), and very high (>35 kg/m2). RESULTS: As illustrated in the Table, early pregnancy losses showed no difference by metabolic syndrome. Fewer women achieved a clinical pregnancy (20.5% vs 29.7%; P=.007) or had a live birth (16.5% vs 27%; P=.001) in the presence of metabolic syndrome. Early pregnancy losses showed no difference by metabolic syndrome status. However, at least 1 pregnancy complication occurred more often with metabolic syndrome: 61.9% (26 of 42 cases) with metabolic syndrome vs 44.4% (59 of 133 cases) (P=.05) without metabolic syndrome. Gestational diabetes mellitus (35.7% vs 18.2%; P=.02) and macrosomia (21.4% vs 8.3%; P=.02) were more common in the presence of metabolic syndrome. After adjustment for other potential confounders, the rate ratio for live births for a 1-unit change in the metabolic syndrome z score was 0.89 (95% confidence interval, 0.79-1.00; P=.04) for those whose body mass index was 25 to 35 kg/m2. For the very high body mass index subgroup (>35 kg/m2), the independent effects of metabolic syndrome from obesity were harder to discern. The rate of live birth was higher with the use of letrozole, although metabolic syndrome had a different detrimental effect concerning the medication given. The overall incidence of pregnancy complications was high (approximately 49%) in the Pregnancy in Polycystic Ovary Syndrome II trial and the 2 medications. Letrozole was associated with more obstetrical complications in the presence of metabolic syndrome, and clomiphene was associated with a lower rate of live birth rate when metabolic syndrome was present. CONCLUSION: Metabolic syndrome is a risk factor that lowers the rate of live birth after ovulation for women with polycystic ovary syndrome, independent of obesity, and it is particularly associated with a lower rate of live birth for women using clomiphene compared with women using letrozole. In addition, metabolic syndrome is a risk factor for pregnancy complications for women with obesity using letrozole. Furthermore, having metabolic syndrome is a risk factor for gestational diabetes mellitus and macrosomia.

Asano, H., et al. (2022). "Status of the Current Treatment Options and Potential Future Targets in Uterine Leiomyosarcoma: A Review." Cancers 14(5).
	Uterine leiomyosarcoma (uLMS) is the most common subtype of mesenchymal tumors in the uterus. This review aims to summarize the current standard therapies and the molecular properties of uLMS for novel molecular-targeted therapies. Although 65% of uLMS cases are diagnosed in stage I, the 5-year overall survival rate is less than 60%. The only effective treatment for uLMS is complete and early resection, and chemotherapy is the main treatment for unresectable advanced or recurrent cases. No chemotherapy regimen has surpassed doxorubicin monotherapy as the first-line chemotherapy for unresectable advanced or recurrent cases in terms of overall survival in phase 3 trials. As a second-line treatment, pazopanib, trabectedin, and eribulin are used, but their therapeutic effects are not sufficient, highlighting the urgent need for development of novel treatments. Recent developments in gene analysis have revealed that homologous recombination deficiency (HRD), including breast cancer susceptibility gene 2 ( BRCA2 ) mutations, are frequently observed in uLMS. In preclinical studies and several case series, poly(adenosine diphosphate-ribose)polymerase inhibitors showed antitumor effects on uLMS cell lines with BRCA2 mutations or HRD and in recurrent or persistent cases of uLMS with BRCA2 mutations. Thus, HRD, including BRCA mutations, may be the most promising therapeutic target for uLMS.

Aschenbrenner, D. (2023). "First Oral Treatment for Postpartum Depression." The American journal of nursing 123(12): 16-17.
	
Aschenbrenner Diane, S. (2022). "New Approved Use for Keytruda." The American journal of nursing 122(7): 26-27.
	Pembrolizumab (Keytruda) is now approved as a single agent to treat advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient in those whose disease has progressed following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Aschenbrenner Diane, S. (2022). "New Drug Treats Cervical Cancer." The American journal of nursing 122(1): 21.
	Tisotumab vedotin-tftv (Tivdak) has received accelerated approval to treat adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.Ocular adverse effects occurred in 60% of patients in clinical trials. To minimize this risk, nurses should follow the guidelines for premedication and required eye care. (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Aschenbrenner Diane, S. (2023). "New Drug Treats Female Reproductive Cancers." The American journal of nursing 123(4): 25.
	Mirvetuximab soravtansine-gynx (Elahere) has been granted accelerated approval to treat adult patients with folate receptor α-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.The drug's labeling includes a boxed warning for ocular toxicity. Other warnings include a risk of pneumonitis, peripheral neuropathy, and embryo-fetal toxicity. (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Aschenbrenner Diane, S. (2023). "Second Nonhormonal Drug for Menopausal Hot Flashes." The American journal of nursing 123(11): 22-23.
	Fezolinetant (Veozah) has been approved to treat severe vasomotor symptoms—also called hot flashes—during menopause. Adverse effects of treatment include abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevations in hepatic transaminases. Nurses and NPs should confirm that liver function studies are completed at baseline and at three, six, and nine months after starting therapy.

Asgharpoor, M., et al. (2021). "Medicinal plants used in treatment of vaginal atrophy in postmenopausal women: A systematic review." Journal of Mazandaran University of Medical Sciences 30(194): 140-155.
	Background and purpose: Volvovaginal atrophy is a common and progressive complication in menopausal women, affecting their daily life activities, sexual health, and quality of life. Hormone therapy is associated with some problems and many women prefer herbal medicine to reduce the symptoms. This systematic review aimed to explore the effect of medicinal plants on treatment of vaginal atrophy in postmenopausal women Material(s) and Method(s): Electronic databases, including Scopus, Pubmed, Web of Science, Science Direct, SID, Magiran and Google Scholar search engine were searched by two researchers independently. The following keywords were used in English and Persian: Herbal Medicine, Medicinal Plants, vagina, Atrophy, Postmenopausal Period, Clinical Trial, and relevant articles published until December 2020 were selected. The CONSORT 2010 checklist was used to assess the quality of studies and those with score 18 or higher entered this systematic review. Result(s): Out of 747 articles, 12 clinical trials were investigated in current review. These articles studied seven medicinal plants (chamomile, licorice, fennel, Pueraria mirifica, flaxseed, black cohosh, and red clover). Herbal products can have beneficial effects on reducing the symptoms of vaginal atrophy in postmenopausal women. Conclusion(s): Medicinal plants containing phytoestrogens can be considered as a treatment of choice for improving vaginal atrophy and a suitable alternative to chemical drugs following further studies that prove their efficacy.Copyright © 2021, Mazandaran University of Medical Sciences. All rights reserved.

Ashmita, G., et al. (2021). "Comparison on Efficiency of Ginger with NSAIDs and Complementary Therapy in Primary Dysmenorrhea; A Systematic Review."
	
Ashraf, M., et al. (2022). "Menopause, skin and common dermatoses. Part 4: oral disorders." Clinical and experimental dermatology 47(12): 2130-2135.
	The physiological impact of declining oestrogen levels during menopause has been well documented. We conducted a literature review to assess the impact of menopause on oral health. Falling oestrogen levels are associated with adverse effects on the gingival, oral and buccal epithelia. The symptoms prevalent in perimenopausal and postmenopausal women range from dry mouth to immune-mediated mucocutaneous disease and burning mouth syndrome. Our review has highlighted the need for further research into potential treatments for oral symptoms in menopause, particularly with regard to hormone replacement therapy. (© 2022 The Authors. Clinical and Experimental Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)

Ashrafizaveh, A., et al. (2019). "Application of Medicinal Plants, Acupuncture, Massage Therapy and Transcutaneous Electric Nerve Stimulation in Treatment of Endometriosis: Review Study." Iranian Journal of Obstetrics, Gynecology and Infertility 22(5): 90-100.
	Introduction: Endometriosis is a common gynecologic problem which can lead to destruction of a woman's life. Some pharmacological techniques and surgical resection are effective in treating endometriosis pain, but are associated with high recurrence rate. This narrative review study was performed with aim to evaluate the efficacy of some complementary therapies on the control of endometriosis complications. Method(s): In this review, the related articles were reviewed by searching the databases such as Pubmed, Cochrane, Scopus, Web of Science, Uptodate, SID, Irandoc, Magiran, and as well as Google Scholar search engine without time limitations up to February 2019. Search was conducted using the keywords of "Endometriosis", "Complementary Therapies", "Acupuncture", "Massage", "Herbal Medicine", "Transcutaneous Electric Nerve Stimulation" and their Persian equivalent. Result(s): According to search strategy, 8702 articles were found in the first stage, ultimately, among them, 12 articles had inclusion criteria to enter the current review. Based on the findings of these studies, the use of acupuncture and herbal medicine have significant effect on the improvement of endometriosis parameters such as pelvic chronic pain, dyspareunia, dysmenorrhea and infertility. In addition, the results of two studies about comparison of herbal medicine and routine chemical drugs used in endometriosis treatment indicated the equality of their effects in reducing pain and improving fertility. The effect of massage therapy and use of transcutaneous electric nerve stimulation on pain management in these patients was confirmed in two separate studies. Conclusion(s): The findings of present study indicate the positive effects of acupuncture, medicinal herbs, massage therapy and transcutaneous electric nerve stimulation in managing the complications of endometriosis. Therefore, the use of these therapeutic approaches and referral of patients to complementary medicine specialists is suggested as one of the most important priorities in the management of endometriosis complications.Copyright © 2019, Mashhad University of Medical Sciences. All rights reserved.

Aslam, B., et al. (2023). "Exploring the potential impact of GLP-1 receptor agonists in cancer therapy." Minerva Endocrinology.
	Glucagon-like peptide-1 (GLP-1) receptor agonists are used in diabetes management and can have a potential application in cancer therapy. While their involvement in cancer treatment is still being studied, recent research suggests they may have benefits in cancer therapy. A comprehensive literature search was conducted using search engines like Google Scholar, Scopus, and PubMed to explore the effects of GLP-1 receptor agonists in tumor suppression and regression. Mostly in-vitro studies on GLP-1 receptor agonists have shown promising effects in inhibiting cancer cell growth, inducing apoptosis, and modulating angiogenesis and have been reported to be beneficial in colon, prostate, gall bladder, ovarian, and endometrial carcinomas. However, concerns have been raised about potential tumorigeneses, as liraglutide has been reported to be associated with increased incidence of breast, thyroid, and pancreatic carcinomas. Whereas combination therapy of exendin-4 with gemcitabine may be beneficial in pancreatic cancer. GLP-1 receptor agonists may have significant potential in oncology, due to their various mechanisms of action and favorable safety profiles. Limited clinical application, lack of awareness, and the need for further research are current barriers. Future studies should focus on optimal dosage, patient selection, and interdisciplinary collaboration to integrate GLP-1 receptor agonists into routine oncological practice for improved outcomes, warranting large randomized clinical trials in this field.

As-Sanie, S., et al. (2022). "RELUGOLIX COMBINATION THERAPY IN NORTH AMERICAN WOMEN WITH ENDOMETRIOSIS-ASSOCIATED PAIN: SPIRIT 1 AND 2 TRIALS." Fertility and Sterility 118(4 Supplement): e223.
	Objective: Once-daily relugolix combination therapy (Rel-CT; relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) significantly improved endometriosis-associated pain in the phase 3 multinational SPIRIT 1 and 2 studies. The present analysis evaluated whether there was a difference in treatment response to Rel-CT over 24 weeks (wks) between the overall and North American (NA) SPIRIT study populations. Material(s) and Method(s): Premenopausal women with moderate-to-severe dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP) who enrolled in the SPIRIT 1 and 2 trials were randomized 1:1:1 to receive Rel-CT or placebo for 24 wks, or delayed Rel-CT (relugolix 40 mg monotherapy for 12 wks, followed by Rel-CT for 12 wks). Randomization ratio remained balanced when stratified by region (NA vs Rest of World). Coprimary endpoints were the proportion of DYS and NMPP responders at Wk 24, based on daily patient-reported Numerical Rating Scale (NRS) scores (0=no pain, 10=worst pain imaginable). Responders were women who achieved a predefined, clinically meaningful reduction from baseline in NRS score and no increase in analgesic use. Demographics and baseline characteristics were summarized descriptively. Estimated odds ratio and 95% confidence interval (OR, 95% CI) were calculated for DYS and NMPP; a value > 1 favors Rel-CT over placebo. Adverse events (AEs) and bone mineral density (BMD) were summarized descriptively. Result(s): Of 1261 women randomized in SPIRIT 1/2, 1251 were included in the analyses; of these, 270 enrolled from NA. Mean age (years) was similar in the NA (32.2) and overall (33.9) populations. The NA cohort demographics had a higher proportion of Black/African American (21.5%) and Hispanic/Latino women (21.5%) vs the overall population (5.7% and 11.9%, respectively). Mean [SD] body mass index was higher in the NA (29.8 [7.4]) vs overall (25.9 [6.1]) population. Baseline characteristics were generally similar between the NA and overall populations: time since surgical diagnosis (4.1 [3.1] and 4.0 [3.4] years); mean NRS scores for DYS (7.2 [1.8] and 7.0 [1.6]), NMPP (5.7 [2.2] and 5.7 [1.9]) and dyspareunia (5.7 [2.6] and 5.5 [2.3]). While the proportion of opioid users was modestly higher in the NA (43.3%) vs overall (38.4%) population, the proportion of current smokers was similar (~18.5%). At Wk 24, a significantly higher proportion of women in the Rel-CT vs placebo group met the definition for responder in both NA and overall populations: OR (95% CI) for DYS [NA: 5.93 (2.96, 11.87) vs overall: 8.15 (5.92, 11.23)] and NMPP [NA: 2.19 (1.15, 4.16) vs overall: 2.44 (1.83, 3.24)]. Rates of AEs were generally similar in NA (67%) and overall populations (75%). Mean percent change from baseline in BMD at the lumbar spine at Wk 24 for Rel-CT and placebo was similar: NA: -0.85% and 0.12% and overall: -0.72% vs 0.12%, respectively. Conclusion(s): Treatment effect of Rel-CT in the NA subgroup was consistent with that seen in the SPIRIT overall population. Impact Statement: Consistency of outcomes between NA and overall SPIRIT populations support generalizability of overall results for NA women with endometriosis-associated pain.Copyright © 2022

Assis, G. M., et al. (2019). "Urotherapy in the treatment of children and adolescents with bladder and bowel dysfunction: a systematic review." Jornal de pediatria 95(6): 628-641.
	OBJECTIVE: To identify and describe the protocols and clinical outcomes of urotherapy interventions in children and adolescents with bladder bowel dysfunction. METHOD: Systematic review carried out in June 2018 on MEDLINE/PubMed, CINAHL, EMBASE, SciELO, Cochrane, and PsycInfo databases. Clinical trials and quasi-experimental studies carried out in the last ten years in children and/or adolescents with bladder and bowel symptoms and application of at least one component of urotherapy were included. RESULTS: Thirteen clinical trials and one quasi-experimental study were included, with moderate methodological quality. The heterogeneity of the samples and of the methodological design of the articles prevented the performance of a meta-analysis. The descriptive analysis through simple percentages showed symptom reduction and improvement of uroflowmetry parameters. The identified urotherapy components were: educational guidance, water intake, caffeine reduction, adequate voiding position, pelvic floor training, programmed urination, and constipation control/management. CONCLUSION: This review indicates positive results in terms of symptom reduction and uroflowmetry parameter improvement with standard urotherapy as the first line of treatment for children and adolescents with bladder bowel dysfunction. It is recommended that future studies bring contributions regarding the frequency, number, and time of urotherapy consultations.

Astasio-Picado, A. and M. Garcia-Cano (2022). "Neuromodulation of the Posterior Tibial Nerve for the Control of Urinary Incontinence." Medicina (Kaunas, Lithuania) 58(3).
	Urinary incontinence is considered a health problem that both elderly and young people can suffer, most often elderly women. This problem can lead to difficulties in establishing social relationships and dependence, negatively affecting the quality of life of the people who suffer from it. To evaluate and analyze the studies that demonstrate the efficacy of interventions based on the neuromodulation of the posterior tibial nerve as a treatment for the control of urinary incontinence. The search period for articles focused on those published between March 2011 to March 2021, in five databases (Pubmed, Cochrane Library, Scielo, Google Academic and WOS) based on the clinical question, using the keywords derived from the DeCS and MeSH thesauri, combined with the Boolean operators "AND", "NOT" and "OR". The search was limited to publications from the last 10 years, in English and Spanish. After applying the selection criteria and evaluating the quality of the methodology, 5.28% (n = 27) of the 511 results were included with filters: 9 systematic reviews, 10 cohorts and 8 randomized controlled trials. After comparing the different articles, it was found that percutaneous stimulation of the tibial nerve is a suitable technique for treating overactive bladder. It is a promising technique in case of pelvic floor dysfunctions and effective for the control of urinary incontinence.

Astellas Pharma Global Development, I. and P. Inc Astellas (2021). A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause.
	No Results Available Drug: fezolinetant|Drug: placebo Mean change in the frequency of moderate to severe Vasomotor Symptoms (VMS) from baseline to week 24|Mean change in the severity of moderate to severe VMS from baseline to week 24|Mean change in the patient-reported sleep disturbance by the PROMIS SD SF 8b total score from baseline to week 24|Mean change in the frequency of moderate to severe VMS|Mean change in the severity of moderate to severe VMS|Mean percent change in the frequency of moderate and severe VMS|Percent reduction ≥ 50% in the frequency of moderate and severe VMS|Percent reduction ≥ 75% in the frequency of moderate and severe VMS|Percent reduction at 100% in the frequency of moderate and severe VMS|Number of participants with Treatment Emergent Adverse Events (TEAEs)|Number of participants with laboratory value abnormalities and/or adverse events (AEs)|Number of participants with vital sign abnormalities and/or adverse events (AEs)|Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs) Female Phase 3 453 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment 2693-CL-0312|2021-001685-38 April 20, 2023

Astellas Pharma Global Development, I. and P. Inc Astellas (2022). Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants.
	No Results Available Drug: ASP0739|Drug: Pembrolizumab Incidence of Dose Limiting Toxicities (DLTs) for ASP0739 Single Agent|Incidence of Dose Limiting Toxicities (DLTs) for ASP0739 + Pembrolizumab Safety Lead-in|Number of Participants with adverse events (AEs)|Number of Participants with Serious Adverse Events (SAEs)|Number of participants with laboratory value abnormalities and/or AEs|Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs|Number of participants with vital sign abnormalities and/or AEs|Number of participants with physical exam abnormalities and/or AEs|Number of participants at each grade of the Eastern Cooperative Oncology Group (ECOG) performance status|Objective Response Rate per Immune Response Evaluation Criteria in Solid Tumors (iRECIST) (iORR) by Independent Central Review|Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|Disease Control Rate per iRECIST (iDCR)|Disease Control Rate per RECIST v1.1 (DCR)|Progression-Free Survival per iRECIST (iPFS) by Independent Central Review|iPFS per iRECIST by local assessment|Progression-Free Survival per RECIST v1.1 (PFS) by Independent Central Review|PFS per RECIST v1.1 by local assessment|Duration of Overall Survival (OS)|Duration of Response per iRECIST (iDOR) by Independent Central Review|iDOR per iRECIST by local assessment|Duration of Response per RECIST (DOR) v1.1 by Independent Central Review|DOR per RECIST v1.1 by local assessment|ORR per iRECIST (iORR) by local assessment All Phase 1|Phase 2 16 Industry Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 0739-CL-0101 June 1, 2023

AstraZeneca (2021). First in Human Study to Evaluate AZD8205 in Patients With Advanced or Metastatic Solid Malignancies.
	This study is a Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Solid Tumors

AstraZeneca, et al. (2023). Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical).
	No Results Available Biological: Volrustomig|Other: Placebo Progression-free Survival (PFS) in participants with PD-L1 expression based on the investigator assessment|Progression-free Survival (PFS) in participants regardless of PD-L1 expression based on the investigator assessment|Overall Survival (OS) in participants regardless of PD-L1 expression.|Overall Survival (OS) in participants with PD-L1 expression|Objective Response Rate (ORR) in participants with PD-L1 expression/regardless of PD-L1 expression.|Duration of Response (DoR) in participants with a CR or PR in the PD-L1 expression analysis set/FAS.|Time to First Subsequent Therapy or death (TFST) in the PD-L1 expression analysis set/FAS|Time to second progression or death (PFS2) in the PD-L1 expression analysis set/FAS.|PFS by BICR in the PD-L1 expression analysis set/FAS.|The incidence of local progression, and distant disease progression as the first documented progression event in the PD-L1 expression analysis set/FAS.|PK of Volrustomig|The immunogenicity of volrustomig.|Incidence of adverse events of Volrustomig compared to placebo;|Participant-reported disease-related symptoms|Participant-reported physical functioning|Participant-reported global health status/Quality of Life. Female Phase 3 1000 Industry|Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment D7984C00002|GOG-3092|ENGOT-cx19/GEICO|165663|2023-504374-38-00 October 24, 2029

Astrid, K., et al. (2023). "Psychiatric treatments for premenstrual syndrome and premenstrual dysphoric disorder – a systematic review and meta-analysis."
	
Ata, B., et al. (2021). "Progestins for pituitary suppression during ovarian stimulation for ART: a comprehensive and systematic review including meta-analyses." Human Reproduction Update 27(1): 48-66.
	Background: Progestins are capable of suppressing endogenous LH secretion from the pituitary. Progestins can be used orally and are less expensive than GnRH analogues. However, early endometrial exposure to progestin precludes a fresh embryo transfer (ET), but the advent of vitrification and increasing number of oocyte cryopreservation cycles allow more opportunities for using progestins for pituitary suppression.; Objective and Rationale: This review summarizes: the mechanism of pituitary suppression by progestins; the effectiveness of progestins when compared with GnRH analogues and with each other; the effect of progestins on oocyte and embryo developmental potential and euploidy status; and the cost-effectiveness aspects of progestin primed stimulation. Future research priorities are also identified.; Search Methods: The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via PubMed, the Web of Science and Scopus were screened with a combination of keywords related to ART, progesterone, GnRH analogue and ovarian stimulation, in various combinations. The search period was from the date of inception of each database until 1 April 2020. Only full text papers published in English were included.; Outcomes: Overall, the duration of stimulation, gonadotrophin consumption and oocyte yield were similar with progestins and GnRH analogues. However, sensitivity analyses suggested that progestins were associated with significantly lower gonadotrophin consumption than the long GnRH agonist protocol (mean difference (MD) = -648, 95% CI = -746 to -550 IU) and significantly higher gonadotrophin consumption than the short GnRH agonist protocol (MD = 433, 95% CI = 311 to 555 IU). Overall, live birth, ongoing and clinical pregnancy rates per ET were similar with progestins and GnRH analogues. However, when progestins were compared with GnRH agonists, sensitivity analyses including women with polycystic ovary syndrome (risk ratio (RR) = 1.27, 95% CI = 1.06 to 1.53) and short GnRH agonist protocols (RR = 1.14, 95% CI = 1.02 to 1.28) showed significantly higher clinical pregnancy rates with progestins. However, the quality of evidence is low. Studies comparing medroxyprogesterone acetate, dydrogesterone and micronized progesterone suggested similar ovarian response and pregnancy outcomes. The euploidy status of embryos from progestin primed cycles was similar to that of embryos from conventional stimulation cycles. Available information is reassuring regarding obstetric and neonatal outcomes with the use of progestins. Despite the lower cost of progestins than GnRH analogues, the mandatory cryopreservation of all embryos followed by a deferred transfer may increase cost per live birth with progestins as compared to an ART cycle culminating in a fresh ET.; Wider Implications: Progestins can present an effective option for women who do not contemplate a fresh ET, e.g. fertility preservation, anticipated hyper responders, preimplantation genetic testing, oocyte donors, double stimulation cycles. (© The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Ata, B. and E. Kalafat (2024). "Progestin-primed ovarian stimulation: for whom, when and how?" Reproductive Biomedicine Online 48(2): 103639.
	Progestin-primed ovarian stimulation (PPOS) is being increasingly used for ovarian stimulation in assisted reproductive technology. Different progestins have been used with similar success. The available studies suggest a similar response to ovarian stimulation with gonadotrophin-releasing hormone (GnRH) analogues. Any differences in the duration of stimulation or gonadotrophin consumption are minor and clinically insignificant. PPOS has the advantage of oral administration and lower medication costs than GnRH analogues. As such it is clearly more cost-effective for fertility preservation and planned freeze-all cycles, but when fresh embryo transfer is intended PPOS can be less cost-effective depending on the local direct and indirect costs of the additional initial frozen embryo transfer cycle. Oocytes collected in PPOS cycles have similar developmental potential, including blastocyst euploidy rates. Frozen embryo transfer outcomes of PPOS and GnRH analogue cycles seem to be similar in terms of both ongoing pregnancy/live birth rates and obstetric and perinatal outcomes. While some studies have reported lower cumulative live birth rates with PPOS, they have methodological issues, including arbitrary definitions of the cumulative live birth rate. PPOS has been used in all patient types (except progesterone receptor-positive breast cancer patients) with consistent results and seems a patient friendly and cost-effective choice if a fresh embryo transfer is not intended.Copyright © 2023 Reproductive Healthcare Ltd.

Atak, Z., et al. (2023). "Levonorgestrel-releasing intrauterine device to treat abnormal uterine bleeding; not one treatment option fits all." Journal of the Turkish German Gynecological Association 24(4): 246-251.
	Objective: Initially, medical treatment options are preferred in patients with abnormal uterine bleeding (AUB) who are hemodynamically stable. The aim of the present study was to investigate the effectiveness of a levonorgestrel-releasing intrauterine device (LNG-IUD) in reducing bleeding symptoms in patients with AUB stratified by underlying pathology.; Material and Methods: In line with the polyp, adenomyosis, leiomyoma, malignancy (and hyperplasia), coagulopathy, ovulatory disorders, endometrial, iatrogenic and not otherwise classified classification system, patients who were administered LNG-IUD due to adenomyosis, endometrial hyperplasia, leiomyoma and AUB due to not otherwise classified causes were included in the study.; Results: A total of 172 otherwise patients with a mean age of 42.58±5.00 years were included. The distributions in the adenomyosis, endometrial hyperplasia, leiomyoma and otherwise unclassified groups were 30.8%, 12.8%, 26.2%, and 30.2%, respectively. Overall effectiveness of LNG-IUD in reducing menstrual bleeding was 82%. The proportion whose bleeding decreased was 95.50% in the endometrial hyperplasia group, 88.70% in the adenomyosis group, 55.60% in the leiomyoma group and 92.30% in the not otherwise classified group. The power of the current study was 99%. The efficacy of LNG-IUD was significantly less in the leiomyoma group (p<0.05) and thus this group were more likely to require surgical intervention. The overall incidence of spotting was 50%. Amenorrhea developed in 14% of patients.; Conclusion: While LNG-IUD was more effective in reducing symptoms of AUB in patients with adenomyosis, endometrial hyperplasia and not otherwise classified causes, LNG-IUD was less effective in cases of leiomyoma.; Competing Interests: Conflict of Interest: No conflict of interest is declared by the authors. (©Copyright 2023 by the Turkish-German Gynecological Education and Research Foundation. Journal of the Turkish-German Gynecological Association is published by Galenos Publishing House.)

Athanasiou, A., et al. (2022). "Comparative effectiveness and risk of preterm birth of local treatments for cervical intraepithelial neoplasia and stage IA1 cervical cancer: a systematic review and network meta-analysis." The Lancet. Oncology 23(8): 1097-1108.
	Background: The trade-off between comparative effectiveness and reproductive morbidity of different treatment methods for cervical intraepithelial neoplasia (CIN) remains unclear. We aimed to determine the risks of treatment failure and preterm birth associated with various treatment techniques.; Methods: In this systematic review and network meta-analysis, we searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials database for randomised and non-randomised studies reporting on oncological or reproductive outcomes after CIN treatments from database inception until March 9, 2022, without language restrictions. We included studies of women with CIN, glandular intraepithelial neoplasia, or stage IA1 cervical cancer treated with excision (cold knife conisation [CKC], laser conisation, and large loop excision of the transformation zone [LLETZ]) or ablation (radical diathermy, laser ablation, cold coagulation, and cryotherapy). We excluded women treated with hysterectomy. The primary outcomes were any treatment failure (defined as any abnormal histology or cytology) and preterm birth (<37 weeks of gestation). The network for preterm birth also included women with untreated CIN (untreated colposcopy group). The main reference group was LLETZ for treatment failure and the untreated colposcopy group for preterm birth. For randomised controlled trials, we extracted group-level summary data, and for observational studies, we extracted relative treatment effect estimates adjusted for potential confounders, when available, and we did random-effects network meta-analyses to obtain odds ratios (ORs) with 95% CIs. We assessed within-study and across-study risk of bias using Cochrane tools. This systematic review is registered with PROSPERO, CRD42018115495 and CRD42018115508.; Findings: 7880 potential citations were identified for the outcome of treatment failure and 4107 for the outcome of preterm birth. After screening and removal of duplicates, the network for treatment failure included 19 240 participants across 71 studies (25 randomised) and the network for preterm birth included 68 817 participants across 29 studies (two randomised). Compared with LLETZ, risk of treatment failure was reduced for other excisional methods (laser conisation: OR 0·59 [95% CI 0·44-0·79] and CKC: 0·63 [0·50-0·81]) and increased for laser ablation (1·69 [1·27-2·24]) and cryotherapy (1·84 [1·33-2·56]). No differences were found for the comparison of cold coagulation versus LLETZ (1·09 [0·68-1·74]) but direct data were based on two small studies only. Compared with the untreated colposcopy group, risk of preterm birth was increased for all excisional techniques (CKC: 2·27 [1·70-3·02]; laser conisation: 1·77 [1·29-2·43]; and LLETZ: 1·37 [1·16-1·62]), whereas no differences were found for ablative methods (laser ablation: 1·05 [0·78-1·41]; cryotherapy: 1·01 [0·35-2·92]; and cold coagulation: 0·67 [0·02-29·15]). The evidence was based mostly on observational studies with their inherent risks of bias, and the credibility of many comparisons was low.; Interpretation: More radical excisional techniques reduce the risk of treatment failure but increase the risk of subsequent preterm birth. Although there is uncertainty, ablative treatments probably do not increase risk of preterm birth, but are associated with higher failure rates than excisional techniques. Although we found LLETZ to have balanced effectiveness and reproductive morbidity, treatment choice should rely on a woman's age, size and location of lesion, and future family planning.; Funding: National Institute for Health and Care Research: Research for Patient Benefit.; Competing Interests: Declaration of interests OE has received consulting fees from Biogen (payments were made to their University). All other authors declare no competing interests. (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Athanasiou, A., et al. (2019). "Comparative fertility and pregnancy outcomes after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE group." BMJ Open 9(10): e028009.
	Introduction: There are several local treatment methods for cervical intraepithelial neoplasia that remove or ablate a cone-shaped part of the uterine cervix. There is evidence to suggest that these increase the risk of preterm birth (PTB) and that this is higher for techniques that remove larger parts of the cervix, although the data are conflicting. We present a protocol for a systematic review and network meta-analysis (NMA) that will update the evidence and compare all treatments in terms of fertility and pregnancy complications.; Methods and Analysis: We will search electronic databases (CENTRAL, MEDLINE, EMBASE) from inception till October 2019, in order to identify randomised controlled trials (RCTs) and cohort studies comparing the fertility and pregnancy outcomes among different excisional and ablative treatment techniques and/or to untreated controls. The primary outcome will be PTB (<37 weeks). Secondary outcomes will include severe or extreme PTB, prelabour rupture of membranes, low birth weight (<2500 g), neonatal intensive care unit admission, perinatal mortality, total pregnancy rates, first and second trimester miscarriage. We will search for published and unpublished studies in electronic databases, trial registries and we will hand-search references of published papers. We will assess the risk of bias in RCTs and cohort studies using tools developed by the Cochrane collaboration. Two investigators will independently assess the eligibility, abstract the data and assess the risk of bias of the identified studies. For each outcome, we will perform a meta-analysis for each treatment comparison and an NMA once the transitivity assumption holds, using the OR for dichotomous data. We will use CINeMA (Confidence in Network meta-analysis) to assess the quality of the evidence for the primary outcome.; Ethics and Dissemination: Ethical approval is not required. Results will be disseminated to academic beneficiaries, medical practitioners, patients and the public.; Prospero Registration Number: CRD42018115495.; Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Athanasiou, S., et al. (2020). "Intravaginal energy-based devices and sexual health of female cancer survivors: a systematic review and meta-analysis." Lasers in Medical Science 35(1): 1-11.
	A systematic review and meta-analysis was undertaken to assess the efficacy and safety of intravaginal energy-based therapies (laser and radiofrequency) on sexual health of cancer survivors (CS) (breast cancer (BCS) and/or gynecological cancer (GCS)). PubMed, Scopus, Web of Science, and Cochrane Library were searched until 21/02/2019. Quality of reporting, methodology, and body of evidence were assessed using STROBE, MINORS, and GRADE. Primary outcomes were dyspareunia, dryness, and sexual health (FSFI, FSDS-R). Secondary outcomes were burning, itching, dysuria, incontinence, Vaginal Health Index Score (VHIS), microbiome-cytokine evaluation, and adverse events. Main analyses, subgroup analyses, and sensitivity analyses were performed. Eight observational studies (n = 274) were eligible for inclusion. None of the studies evaluated radiofrequency. BCS and BCS-GCS were included in 87% and 13% of studies, respectively. All primary outcomes improved significantly with the exception of FSDS-R (dyspareunia (5 studies (n = 233), standardized mean difference (StdMD) (- 1.17), 95%CI [- 1.59, - 0.75]; p < 0.001; I 2 = 55%), vaginal dryness (4 studies (n = 183), StdMD (- 1.98), 95%CI [- 3.31, - 0.65]; p = 0.003; I 2 = 91%), FSFI (2 studies, n = 28, MD (12.79), 95%CI [7.69, 17.89]; p < 0.001; I 2 = 0%). Itching, dysuria, and VHIS increased significantly, while burning was not improved. Serious adverse events were not observed by any of the studies. Intravaginal laser therapies appear to have a positive effect on dyspareunia, vaginal dryness, and FSFI of CS. However, the quality of evidence is "very low," with no data on intravaginal radiofrequency therapy. Further research with high-quality RCTs and long-term follow-up is needed to evaluate the value of energy-based devices as a therapeutic option for CS with sexual problems.

Athanasiou, S., et al. (2020). "A study protocol of vaginal laser therapy in gynecological cancer survivors." Climacteric : the journal of the International Menopause Society 23(1): 53-58.
	Objectives: Sexual dysfunction and radiation cystitis are common adverse events following radiotherapy for gynecological cancer (GC). This study aims to assess the efficacy of intravaginal CO 2 laser on GC survivors with dyspareunia following pelvic radiation and/or brachytherapy. Methods: This is the study protocol of a randomized double-blind placebo-controlled trial. All participants will receive five therapies (active or placebo) at monthly intervals. Outcomes will include a 10-cm visual analog scale measuring dyspareunia, vaginal dryness, and other symptom intensity, 3-day voiding diary, Day-to Day Impact of Vaginal Aging questionnaire, Female Sexual Function Index, European Organization for Research and Treatment of Cancer Quality of Life questionnaire cervical cancer module, Urogenital Distress Inventory short form, King's Health Questionnaire, International Consultation on Incontinence Questionnaire short form/female lower urinary tract symptoms, patient perception of improvement, sexual satisfaction of male partners, vaginal maturation value, and Vaginal Health Index. Differences between groups will be assessed at baseline and 1, 3, 6, 9, and 12 months following the five laser therapies. Results: As this is a study protocol, the study is ongoing with an expected end of recruitment and analysis date of 2021. Conclusion: Pelvic radiotherapy for GC increases the 5-year survival rate but with a negative impact on women's quality of life due to sexual dysfunction and radiation cystitis onset. With this study, CO 2 laser therapy will be evaluated for the first time in GC survivors treated with radiotherapy. ClinicalTrials.gov registration number: NCT03714581.

Atılgan, A. E. and A. Aydın (2021). "Cystocele Repair with Platelet-Rich Plasma." Indian journal of surgery 83(3): 726‐730.
	
Atkinson, A., et al. (2022). "Systematic review of randomized control trials into effective preoperative weight loss interventions and impact on surgical outcomes for major benign gynecological surgery." Journal of Obstetrics and Gynaecology Research 48(8): 2093-2099.
	Aims: Limited information exists on what preoperative weight loss interventions (lifestyle, pharmacological, surgical) are effective in improving outcomes of elective, nononcological, gynecological surgery. Obesity rates are increasing and associated with poorer operative outcomes. We aimed to identify high quality studies into preoperative weight loss interventions and perform a systematic review of the literature to guide recommendations for reducing gynecological surgical complications and guide future research. Primary outcomes were mortality and surgical complications including conversion to open surgery, duration of surgery, and recovery. Method(s): The review was pre-registered with PROPSERO. A systematic search was undertaken of the major electronic bibliographic databases. Search results were compiled and abstracts of studies identified before application of the Cochrane highly sensitive search strategy (CHSSS) were reviewed. Full text of studies after application of the CHSSS were evaluated for suitability. For data collection and analysis, a minimum three high-quality randomized control trials were required to synthesize data in relation to the primary outcome. Result(s): No trials met the inclusion criteria. No randomized control trials in gynecological cohorts were identified. Studies in gynecology-oncology were excluded due to the confounding nature of weight loss as a feature of illness as opposed to health optimization. Conclusion(s): There is limited evidence regarding preoperative weight loss interventions in gynecology. Further research is needed as the prevalence of obesity among women is increasing and definitive surgical management options in gynecology remain essential. PROSPERO registration ID: 165643.Copyright © 2022 Japan Society of Obstetrics and Gynecology.

Attama, A. A., et al. (2022). "Nanogels as target drug delivery systems in cancer therapy: A review of the last decade." Frontiers in Pharmacology 13: 874510.
	Cancer is an important cause of morbidity and mortality worldwide, irrespective of the level of human development. Globally, it was estimated that there were 19.3 million new cases of cancer and almost 10 million deaths from cancer in 2020. The importance of prevention, early detection as well as effective cancer therapies cannot be over-emphasized. One of the important strategies in cancer therapy is targeted drug delivery to the specific tumor sites. Nanogels are among the several drug delivery systems (DDS) being explored as potential candidates for targeted drug delivery in cancer therapy. Nanogels, which are new generation, versatile DDS with the possession of dual characteristics of hydrogels and nanoparticles have shown great potential as targeted DDS in cancer therapy. Nanogels are hydrogels with a three-dimensional (3D) tunable porous structure and a particle size in the nanometre range, from 20 to 200 nm. They have been visualized as ideal DDS with enormous drug loading capacity, and high stability. Nanogels can be modified to achieve active targeting and enhance drug accumulation in disease sites. They can be designed to be stimulus-responsive, and react to internal or external stimuli such as pH, temperature, light, redox, thus resulting in the controlled release of loaded drug. This prevents drug accumulation in non-target tissues and minimizes the side effects of the drug. Drugs with severe adverse effects, short circulation half-life, and easy degradability by enzymes, such as anti-cancer drugs, and proteins, are suitable for delivery by chemically cross-linked or physically assembled nanogel systems. This systematic review summarizes the evolution of nanogels for targeted drug delivery for cancer therapy over the last decade. On-going clinical trials and recent applications of nanogels as targeted DDS for cancer therapy will be discussed in detail. The review will be concluded with discussions on safety and regulatory considerations as well as future research prospects of nanogel-targeted drug delivery for cancer therapy.Copyright © 2022 Attama, Nnamani, Onokala, Ugwu and Onugwu.

Attanasio Laura, B., et al. (2022). "Postpartum visit attendance in the United States: A systematic review." Women's Health Issues 32(4): 369-375.
	Introduction: Adequate postpartum care, including the comprehensive postpartum visit, is critical for long-term maternal health and the reduction of maternal mortality, particularly for people who may lose insurance coverage postpartum. However, variation in previous estimates of postpartum visit attendance in the United States makes it difficult to assess rates of attendance and associated characteristics. Methods: We conducted a systematic review of estimates of postpartum visit attendance. We searched PubMed, CINAHL, PsycInfo, and Web of Science for articles published in English from 1995 to 2020 using search terms to capture postpartum visit attendance and use in the United States. Results: Eighty-eight studies were included in this analysis. Postpartum visit attendance rates varied substantially, from 24.9% to 96.5%, with a mean of 72.1%. Postpartum visit attendance rates were higher in studies using patient self-report than those using administrative data. The number of articles including an estimate of postpartum visit attendance increased considerably over the study period; the majority were published in 2015 or later. Conclusions: Our findings suggest that increased systematic data collection efforts aligned with postpartum care guidelines and attention to postpartum visit attendance rates may help to target policies to improve maternal wellbeing. Most estimates indicate that a substantial proportion of women do not attend at least one postpartum visit, potentially contributing to maternal morbidity as well as preventing a smooth transition to future well-woman care. Estimates of current postpartum visit attendance are important for informing efforts that seek to increase postpartum visit attendance rates and to improve the quality of care. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Attawet, J., et al. (2022). "Pregnancy and birth outcomes of single versus multiple embryo transfer in gestational surrogacy arrangements: a systematic review and meta-analysis." Human fertility (Cambridge, England) 25(2): 217-227.
	Multiple embryo transfer (MET) is associated with both an increased risk of multiple pregnancy and of live birth. In recent years, MET has become standard practice for most surrogacy arrangements. There is limited review of the use of MET versus single embryo transfer (SET) in surrogacy practice. The present review systematically evaluated the pregnancy outcomes of surrogacy arrangements between MET versus SET among gestational carriers. A systematic search of five computerized databases without restriction to the English language or study type was conducted to evaluate the primary outcomes: (i) clinical pregnancy; (ii) live delivery; and (iii) multiple delivery rates. The search returned 97 articles, five of which met the inclusion criteria. The results showed that clinical pregnancy (RR = 1.21, 95% CI: 1.06-1.39, n = 5, I 2 = 41%), live delivery (RR = 1.29, 95% CI: 1.10-1.51, n = 4, I 2 = 35%) and multiple delivery rates (RR = 1.42, 95% CI: 6.58-69.73, n = 4, I 2 = 54%) were statistically significantly different in MET compared to SET. Adverse events including miscarriage, preterm birth and low birthweight were found following MET. Our findings support the existing evidence that MET results in multiple pregnancy and subsequently more adverse outcomes compared to SET. From a public health perspective, SET should be advocated as the preferred treatment for gestational carriers.

Aue-Aungkul, A., et al. (2021). "Postoperative interventions for preventing bladder dysfunction after radical hysterectomy in women with early-stage cervical cancer." The Cochrane Database of Systematic Reviews 1: CD012863.
	Background: Bladder dysfunction is a common complication following radical hysterectomy, caused by the damage to pelvic autonomic nerves that innervate the muscles of the bladder, urethral sphincter, and pelvic floor fasciae. Bladder dysfunction increases the rates of urinary tract infection, hospital visits or admission, and patient dissatisfaction. In addition, bladder dysfunction can also negatively impact patient quality of life (QoL). Several postoperative interventions have been proposed to prevent bladder dysfunction following radical hysterectomy. To our knowledge, there has been no systematic review evaluating the effectiveness and safety of these interventions for preventing bladder dysfunction following radical hysterectomy in women with cervical cancer.; Objectives: To evaluate the effectiveness and safety of postoperative interventions for preventing bladder dysfunction following radical hysterectomy in women with early-stage cervical cancer (stage IA2 to IIA2).; Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 4) in the Cochrane Library, MEDLINE via Ovid (1946 to April week 2, 2020), and Embase via Ovid (1980 to 2020, week 16). We also checked registers of clinical trials, grey literature, conference reports, and citation lists of included studies.; Selection Criteria: We included randomised controlled trials (RCTs) evaluating the effectiveness and safety of any type of postoperative interventions for preventing bladder dysfunction following a radical hysterectomy in women with stage IA2 to IIA2 cervical cancer.; Data Collection and Analysis: Two review authors independently selected potentially relevant RCTs, extracted data, assessed risk of bias, compared results, and made judgments on the quality and certainty of the evidence. We resolved any disagreements through discussion or consultation with a third review author. Outcomes of interest consisted of spontaneous voiding recovery one week after the operation, quality of life (QoL), adverse events, post-void residual urine volume one month after the operation, urinary tract infection over the one month following the operation, and subjective urinary symptoms.; Main Results: We identified 1464 records as a result of the search (excluding duplicates). Of the 20 records that potentially met the review criteria, we included five reports of four studies. Most of the studies had unclear risks of selection and reporting biases. Of the four studies, one compared bethanechol versus placebo and three studies compared suprapubic catheterisation with intermittent self-catheterisation. We identified two ongoing studies. Bethanechol versus placebo The study reported no information on the rate of spontaneous voiding recovery at one week following the operation, QoL, adverse events, urinary tract infection in the first month after surgery, and subjective urinary symptoms for this comparison. The volume of post-void residual urine, assessed at one month after surgery, among women receiving bethanechol was lower than those in the placebo group (mean difference (MD) -37.4 mL, 95% confidence interval (CI) -60.35 to -14.45; one study, 39 participants; very-low certainty evidence). Suprapubic catheterisation versus intermittent self-catheterisation The studies reported no information on the rate of spontaneous voiding recovery at one week and post-void residual urine volume at one month following the operation for this comparison. There was no difference in risks of acute complication (risk ratio (RR) 0.77, 95% CI 0.24 to 2.49; one study, 71 participants; very low certainty evidence) and urinary tract infections during the first month after surgery (RR 0.77, 95% CI 0.53 to 1.13; two studies, 95 participants; very- low certainty evidence) between participants who underwent suprapubic catheterisation and those who underwent intermittent self-catheterisation. Available data were insufficient to calculate the relative measures of the effect of interventions on QoL and subjective urinary symptoms.; Authors' Conclusions: None of the included studies reported rate of spontaneous voiding recovery one week after surgery, time to a post-void residual volume of urine of 50 mL or less, or post-void residual urine volume at 6 and 12 months after surgery, all of which are important outcomes for assessing postoperative bladder dysfunction. Limited evidence suggested that bethanechol may minimise the risk of bladder dysfunction after radical hysterectomy by lowering post-void residual urine volume. The certainty of this evidence, however, was very low. The effectiveness of different types of postoperative urinary catheterisation (suprapubic and intermittent self-catheterisation) remain unproven. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Auer Rebecca, C., et al. (2020). "Indications for hyperthermic intraperitoneal chemotherapy with cytoreductive surgery: a systematic review." European journal of cancer (Oxford, England : 1990) 127: 76-95.
	The purpose of the present review was to describe evidence-based indications for hyperthermic intraperitoneal chemotherapy (HIPEC), with cytoreductive surgery (CRS), in patients with a diagnosis of mesothelioma, appendiceal (including appendiceal mucinous neoplasm), colorectal, gastric, ovarian or primary peritoneal carcinoma. Relevant studies were identified from a systematic MEDLINE and EMBASE search of studies published from 1985 to 2019. Studies were included if they were RCTs. If no RCTs were identified, prospective and retrospecctive comparative studies (where confounders are controlled for studies with greater than 30 patients) were included. Overall survival, progression-free survival, recurrence-free survival, adverse events and quality of life data were extracted. For patients with newly diagnosed, primary stage III epithelial ovarian, fallopian tube or primary peritoneal carcinoma, HIPEC with CRS should be considered for those with at least stable disease following neoadjuvant chemotherapy at the time of interval CRS if complete or optimal cytoreduction is achieved. There is insufficient evidence to recommend the addition of HIPEC when primary CRS is performed for patients with newly diagnosed, primary advanced epithelial ovarian, fallopian tube or primary peritoneal carcinoma or in those with recurrent ovarian cancer outside of a clinical trial. There is insufficient evidence to recommend HIPEC with CRS for the prevention of or for the treatment of peritoneal colorectal carcinomatosis outside of a clinical trial. There is insufficient evidence to recommend HIPEC with CRS for the prevention of or for the treatment of gastric peritoneal carcinomatosis outside of a clinical trial. There is insufficient evidence to recommend HIPEC with CRS in patients with malignant peritoneal mesothelioma or in those with disseminated mucinous neoplasm in the appendix as a standard of care; however, these patients should be referred to HIPEC specialty centres for assessment for treatment as part of an ongoing research protocol.; Competing Interests: Conflict of interest statement None declared. (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Augoulea, A., et al. (2021). "Assessing the efficacy of a structured stress management program in reducing stress and climacteric symptoms in peri- and postmenopausal women." Archives of Women's Mental Health 24(5): 727‐735.
	To evaluate the effectiveness of a structured education program on lifestyle habits, which is also incorporating teaching on deep breathing, progressive muscle relaxation, and guided visualization, in the control of various components of the climacteric symptomatology in peri‐ and postmenopausal women. Sixty‐one women aged 40–65 years with varying climacteric and stress symptoms were included in this study. Women were randomly assigned to the intervention group (31) or the control group (30). The intervention group followed an 8‐week stress management program. The following parameters were assessed at baseline and at the end of the 8‐week follow‐up period in both groups: climacteric symptoms (Green Climacteric Scale (GCS)), sleep quality (Pittsburg Sleep Quality Index (PSQI)), mood status (Depression‐Anxiety‐Stress Scale), self‐esteem (Rosenberg Self‐esteem Scale), and health‐related control (health locus of control (HLC)). A mixed‐model ANOVA showed significant time × group × GCS interaction (within subjects: F = 23.830, p value<0.001; between subjects: F = 39.078, p value<0.001). With regard to HLC, there was a non‐significant between subjects but a significant within‐subjects effect (HLC × group × time, F = 3.848, p value = 0.024). Regarding DASS scores, there was a significant between‐subjects’ effect (F = 10.258, p value = 0.003) but a non‐significant within‐subjects’ effect. With regard to PSQI, the analysis showed significant within‐subjects’ effects (PSQI × group × time: F = 4.691, p value = 0.003) and non‐significant between‐subjects’ effects (F = 0.022, p = 0.883). Finally, regarding RSS, there was a significant within‐subjects’ (RSS × group × time, F = 4.183, p value = 0.029) but non‐significant between‐subjects’ effect (F = 1.582, p value = 0.213). Stress management may offer an alternative approach to the management of climacteric symptoms.

Austin, M. N., et al. (2022). "Impact of Dapivirine and Placebo Vaginal Rings on the Microbiota of Adolescent, Lactating, and Postmenopausal Females." Journal of Infectious Diseases 225(12): 2208-2218.
	Background: A 25-mg dapivirine vaginal ring has been demonstrated to reduce risk of human immunodeficiency virus (HIV) acquisition in nonpregnant adult women. In this secondary analysis of studies conducted in US adolescent, lactating, and postmenopausal females, vaginal microbiota was assessed prior to and after ring use, and between dapivirine and placebo ring users. Method(s): Vaginal fluid swabs were collected before and after product use for the evaluation of microbiota using Nugent criteria, quantitative culture, and quantitative polymerase chain reaction. Result(s): Vaginal ring use did not impact bacterial vaginosis prevalence among the 3 populations and was associated with minimal shifts in microbiota. Adolescents in both arms demonstrated an increased prevalence of Lactobacillus crispatus and a decrease in quantity of Megasphaera lornae. Postmenopausal active and placebo ring users demonstrated an increased prevalence of lactobacilli and non-albicans yeast, while dapivirine ring users demonstrated an increased prevalence of Candida albicans and increased quantity of group B Streptococcus and non-albicans yeasts. Prevotella species were increased in lactating women, whereas Prevotella timonensis increased in prevalence and concentration among adolescent and postmenopausal females and Prevotella bivia increased in prevalence among adolescent dapivirine ring users. Conclusion(s): Dapivirine vaginal ring use was associated with minimal changes in the vaginal microbiota that are likely not clinically significant.Copyright © 2021 The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved.

Averbuch, S., et al. (2022). "Pregnancy Reverses Abdominoplasty Aesthetic Outcome: Myth or Misconception? A Cross-Sectional Study." Aesthetic surgery journal 42(1): NP20-NP26.
	Background: The common recommendation for female abdominoplasty candidates is to conclude family planning before undergoing the procedure. However, no evidence demonstrates a correlation between aesthetic outcome compromise, risk for fetal complications, or risk for maternal complications when abdominoplasty is followed by pregnancy.; Objectives: The aim of this study was to evaluate maternal, fetal, and aesthetic outcomes among pregnant females with a history of abdominoplasty.; Methods: The authors conducted an online survey among women who became pregnant after having an abdominoplasty. Participants were recruited via social media groups related to abdominoplasty. The survey included demographic-, aesthetic outcome-, and pregnancy-related questions utilizing a score from 1 (no effect) to 10 (worst effect) to assess abdominal aesthetic outcome compromise.; Results: Thirty-two participants completed the online survey, 15 (46.8%) of which reported their pregnancy was unplanned. Pregnancy-related findings included 5 (15.6%) late premature births (between gestational week 35 and 37), 1 miscarriage, and 1 emergency C-section. Compromised aesthetic outcomes following pregnancy included new abdominal stretch marks (50%, N = 16), widened abdominoplasty scar (28%, N = 9), abdominal skin excess (37.5%, N = 12), and abdominal bulge (25.8%, N = 8). A new hernia was reported by 2 participants (6.3%). The average abdominal aesthetic severity score was 2.7 (range, 1-8), and only 3 scores were above 5 (9.3%). Two women (6.2%) underwent abdominoplasty revision, and 18 (56.2%) stated they would recommend others to undergo abdominoplasty before pregnancy (56.3%).; Conclusions: This survey shows there is room to reevaluate whether future pregnancy should be considered a relative contraindication for undergoing abdominoplasty. (© 2021 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.)

Avery, J., et al. (2020). "Polycystic ovary syndrome support groups and their role in awareness, advocacy and peer support: A systematic search and narrative review." Current Opinion in Endocrine and Metabolic Research 12: 98-104.
	Polycystic ovary syndrome (PCOS) is a common and distressing condition in which women often lack adequate support and information to achieve the best health and well-being outcomes. PCOS support groups provide evidence-based information, provide peer support, raise awareness and advocate for woman-centred care. We summarise recent evidence and provide reflections from PCOS support group leaders. Women seek and receive information, as well as emotional and social support, from support groups. They report benefits such as confidence to manage the condition, having greater agency in their healthcare. Some support groups have long-standing partnerships with healthcare providers and researchers, making substantial contributions to advocacy and raising awareness. Major opportunities exist for healthcare providers, professional societies and support groups to collaborate, improving the availability of evidence-based information through support groups.Copyright © 2020 Elsevier Ltd

Avila, P. M., et al. (2022). "Emergency department frequentation and unscheduled readmissions within the first year after liver transplantation, and their impact on survival." Revista Espanola de Enfermedades Digestivas 114(5): 266-271.
	The aim of this study was to assess emergency room frequentation, visit causes, and unscheduled readmissions within the first year after discharge from hospital following liver transplantation. Their impact on graft and patient survival was also assessed. This was a retrospective study of the medical records of 98 patients (mean age, 55.6 +/- 8.59 years, 77.6 % males) who were consecutively discharged from hospital after undergoing a first liver transplant in our institution during 2012-2015. All visits to the emergency room during the first years after transplantation were analyzed, and survival at two years after transplantation was calculated. Fifty-six of the 98 patients (57.15 %) visited the emergency room on 117 occasions within the first year post-transplantation. Fever (n = 34; 29.05 %) and digestive symptoms (n = 32; 27.35 %) were the most common causes of consultation, and resulted in over half of visits. Thirty-five of these 56 patients (62.5 %) required an urgent readmission during 50 of the 117 (42.7 %) visits. This was primarily due to infectious complications (44 %) of diverse causes, (bacterial pneumonia, cholangitis, Clostridium difficile colitis) and biliary tract-related issues. The likelihood of readmission increased from 11.22 % at 30 days after discharge to 22.4 % at 90 days after discharge. Patient survival at 1 and 2 years after transplantation was lower for patients who were readmitted (88.4 % and 80.7 %, respectively) when compared to those who were not readmitted (95.56 % and 91.17 %, respectively, p = 0.002).Copyright © 2022 ARAN Ediciones S.A.. All rights reserved.

Avilés-Martínez María, A., et al. (2022). "[Benefits of a community physical exercise program prescribed from primary care for perimenopausal/menopausal women]." Atencion primaria 54(1): 102119.
	Objective: To measure the benefits of a physical exercise program in a community, through the modifications in quality of life, and perimenopausal-menopausal women physical condition.; Setting: The participants were recruited in PC consultations from two health centers in Molina de Segura (Murcia).; Participants: Women between 40 and 70 years old, or under 40 of age diagnosed with early menopause.; Design: Quasi-experimental study, non-randomized, controlled, open and single-center with 2 parallel branches to study.; Intervention: Experimental group: ACTIVA Bone Health Program for six months.; Control: inactive.; Main Measurements in Both Groups: The SF 36 questionnaire was used to measure the Quality of life.; Physical Condition: Aerobic condition, flexibility, balance and strength measured with the mile, flamenco, flexibility box tests, and throwing the medicine ball, respectively. Physical activity level through the GPPAQ Questionnaire. Sociodemographic variables were collected and the adherence to the program was measured.; Results: The quality of life improved in the intervention group compared to the control group, except «Body Pain» dimension (p = 0.412). As regards the intragroup level, all dimensions showed significant improvement except both «Physical Function» (p = 0.263) and «Body Pain» (p = 0.136). The physical capacities that benefited most were aerobic fitness, strength and balance.; Conclusions: The Active Bone Health Physical Exercise Program piloting showed benefits on participants' physical and mental quality of life. In addition, it has been shown that performing a specific physical exercise for premenopausal-menopausal women improves their physical condition. (Copyright © 2021 The Authors. Publicado por Elsevier España, S.L.U. All rights reserved.)

Aya, E., et al. (2021). "A comprehensive systematic review and network meta-analysis of anti-angiogenic agents in the treatment of ovarian cancer." PROSPERO International prospective register of systematic reviews.
	
Ayala, N., et al. (2024). Mindfulness, Optimism, and Resilience for Perinatal Health and Equity Study.
	No Results Available Behavioral: Digital Mindfulness Training Percentage of participants completing the assigned mindfulness exercises|Intervention acceptability|Dispositional optimism|Cesarean delivery|Hypertensive disorder of pregnancy|Gestational diabetes mellitus|Preterm birth|Traumatic birth|Postpartum post-traumatic stress symptoms Female Not Applicable 100 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 1983168 March 1, 2026

Aydin Cansu, M. and K. University (2023). Effect of Sage Essential Oil Inhalation Aromatherapy on Premenstrual Symptoms and Quality of Life.
	No Results Available Other: sage essential oil Personal Information Form:|Premenstrual Syndrome Scale (PMSS):|SF-36 Quality of Life Scale Female Not Applicable 86 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care KAFKAS-SAG-CMAYDIN-001 June 30, 2024

Ayele, T. M., et al. (2022). "Role of JAK2/STAT3 Signaling Pathway in the Tumorigenesis, Chemotherapy Resistance, and Treatment of Solid Tumors: A Systemic Review." Journal of Inflammation Research 15: 1349-1364.
	Janus kinase 2/signal transducer and activator of transcription 3 (JAK2/STAT3) pathway is a common signaling pathway used to transduce signals from the extracellular to the intracellular (nucleus) upon the binding of cytokines and growth factors to the extracellular domain of specific cell surface receptors. This signaling pathway is tightly regulated and has a multitude of biological functions such as cell proliferation, differentiation, and apoptosis. Besides, the regulated JAK2/STAT3 signaling plays a crucial role in embryonic development, hemopoiesis, and controlling the immune system. Conversely, aberrantly activated JAK2/STAT3 is frequently detected in varieties of tumors and involved in oncogenesis, angiogenesis, and metastasis of many cancer diseases that are usually refractory to the standard chemotherapy. However, the JAK3/STAT3 pathway recently emerged interestingly as a new site for the development of novel anti-tumor agents and becomes a promising therapeutic target in the treatment of many solid malignancies. Herein, this review aimed to provide insight into the JAK2/STAT3 pathway, in the hope to gain an understanding of its potential role in the pathogenesis, progression, chemotherapy resistance, and cancer therapy of solid tumors.Copyright © 2022 terms.php.

Aysu Yildiz, K., et al. (2023). "The Effect of Exercises Given to Menopausal Women on Symptom Severity and Sexuality: A Systematic Review and Meta-Analysis of Randomized Controlled Studies."
	
Azadi, A., et al. (2021). "Complications and objective outcomes of uterine preserving surgeries for the repair of pelvic organ prolapse versus procedures removing the Uterus, a systematic review." European Journal of Obstetrics, Gynecology, and Reproductive Biology 267: 90-98.
	Background: Several authors have recently compared the outcomes and complications of surgical procedures that preserve or remove the uterus in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Following the publication of several high quality randomized control trials on this topic we performed a new systematic review and meta analysis of this data.; Methods: We performed a systematic literature search in ClinicalTrials.gov, PubMed, Scopus, Ovid, EBSCO host, Science Direct, Web of Science, and Cochrane CENTRAL for randomized controlled and cohort trials of uterine sparing prolapse repair (hysteropexy) versus hysterectomy with suspension. A total of 1285 patients from 14 studies were included in our systematic review and meta-analysis.; Results: Uterine sparing procedures (hysteropexy) were comparable to hysterectomy with suspension for recurrence rates (RR = 0.908, 95% CI [0.385, 2.143]), reoperation rates (RR = 1.517, 95% CI [0.802, 2.868]), length of hospital stay, (SMD = - 0.159 days, 95% CI [-0.375, 0.057]), voiding dysfunction (RR = 1.089, 95% CI [0.695, 1.706]), and intraoperative blood loss (SMD = - 0.339, 95% CI [-0.631, 0.047]). However, hysteropexy had shorter operative time than hysterectomy with suspension (SMD = - 1.191 h, 95% CI [-1.836, -0.545]), and fewer visceral injuries (RR = 0.421, 95% CI [0.244, 0.725]).; Conclusion: We found no significant differences in the outcomes or major complications of uterine preserving surgical procedures versus those which include hysterectomy in the treatment of POP. Hysteropexy procedures may be associated with a shorter operative time and fewer visceral injuries. This is consistent with older analyses.; Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2021 Elsevier B.V. All rights reserved.)

Azadi, A., et al. (2023). "Vaginal Hysterectomy Compared With Laparoscopic Hysterectomy in Benign Gynecologic Conditions: A Systematic Review and Meta-analysis." Obstetrics and Gynecology 142(6): 1373-1394.
	OBJECTIVE:To compare surgical efficacy outcomes and complications after laparoscopic hysterectomy and vaginal hysterectomy performed for benign gynecologic conditions.DATA SOURCES:We performed an online search in major databases, including PubMed, Scopus, Web of Science, ClinicalTrials.gov, and the Cochrane Library from 2000 until February 28, 2023.METHODS OF STUDY SELECTION:We searched for randomized controlled trials (RCTs) that compared vaginal hysterectomy with laparoscopic hysterectomy in benign gynecologic conditions. We located 3,249 articles. After reviewing titles and abstracts, we identified 32 articles that were eligible for full-text screening. We excluded nine articles as not-RCT or not comparing vaginal hysterectomy with laparoscopic hysterectomy. Twenty-three articles were included in the final systematic review, with 22 articles included in the meta-analysis.TABULATION, INTEGRATION, AND RESULTS:Twenty-three eligible RCTs included a total population of 2,408, with 1,105 in the vaginal hysterectomy group and 1,303 in the laparoscopic hysterectomy group. Blood loss and postoperative urinary tract infection rates were lower in the vaginal hysterectomy group than in the laparoscopic hysterectomy group (mean difference -68, 95% CI -104.29 to -31.7, P<.01, I2=95% and odds ratio 1.73, 95% CI 0.92-3.26, P=.03, I2=0%, respectively). Vaginal hysterectomy was associated with less total operative time, less recovery time, and greater postoperative pain on the day of surgery. Other complications, including conversion to laparotomy, visceral organ damage, or wound dehiscence, were uncommon. Because of insufficient data, we were not able to stratify by surgical indication. CONCLUSION(S):Vaginal hysterectomy had a shorter total operative time and recovery time but greater postoperative pain on day of surgery compared with laparoscopic hysterectomy.SYSTEMATIC REVIEW REGISTRATION:PROSPERO, CRD42023338538.Copyright © 2023 Lippincott Williams and Wilkins. All rights reserved.

Azam, S., et al. (2020). "Hormone replacement therapy and mammographic density: a systematic literature review." Breast cancer research and treatment 182(3): 555-579.
	Purpose: Hormone replacement therapy (HRT) is used to reduce climacteric symptoms of menopause and prevent osteoporosis; however, it increases risk of breast cancer. Mammographic density (MD) is also a strong risk factor for breast cancer. We conducted this review to investigate the association between HRT use and MD and to assess the effect of different HRT regimens on MD.; Methods: Two of authors examined articles published between 2002 and 2019 from PubMed, Embase, and OVID using Covidence systematic review platform. Any disagreements were discussed until consensus was reached. The protocol used in this review was created in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Quality of each eligible study was assessed using the Oxford Center for Evidence-Based Medicine (OCEBM) hierarchy.; Results: Twenty-two studies met the inclusion criteria. Six studies showed that using estrogen plus progestin (E + P) HRT was associated with higher MD than estrogen alone. Four studies reported that continuous estrogen plus progestin (CEP) users had higher MD than sequential estrogen plus progestin (SEP) and estrogen alone users. However, two studies showed that SEP users had slightly higher MD than CEP users and estrogen alone users.; Conclusions: Epidemiological evidence is rather consistent suggesting that there is a positive association between HRT use and MD with the highest increase in MD among current users, and CEP users. Our results suggest that due to increase in MD and masking effect, current E + P users may require additional screening procedures, shorter screening intervals, or using advanced imaging techniques.

Azenkot, T. and B. Schwarz Eleanor (2022). "Special Considerations for Women of Reproductive Age on Anticoagulation." Journal of General Internal Medicine 37(11): 2803-2810.
	Anticoagulation poses unique challenges for women of reproductive age. Clinicians prescribing anticoagulants must counsel patients on issues ranging from menstruation and the possibility of developing a hemorrhagic ovarian cyst to teratogenic risks and safety with breastfeeding. Abnormal uterine bleeding affects up to 70% of young women who are treated with anticoagulation. As such, thoughtful clinical guidance is required to avoid having young women who are troubled by their menses, dose reduce, or prematurely discontinue their anticoagulation, leaving them at increased risk of recurrent thrombosis. Informed by a review of the medical literature, we present current recommendations for assisting patients requiring anticoagulation with menstrual management, prevention of hemorrhagic ovarian cysts, and avoiding unintended pregnancy. The subdermal implant may be considered a first-line option for those requiring anticoagulation, given its superior contraceptive effectiveness and ability to reliably reduce risk of hemorrhagic ovarian cysts. All progestin-only formulations-such as the subdermal implant, intrauterine device, injection, or pills-are generally preferred over combined hormonal pills, patch, or ring. Tranexamic acid, and in rare cases endometrial ablation, may also be useful in managing menorrhagia and dysmenorrhea. During pregnancy, enoxaparin remains the preferred anticoagulant and warfarin is contraindicated. Breastfeeding women may use warfarin, but direct oral anticoagulants are not recommended given their limited safety data. This practical guide for clinicians is designed to inform discussions of risks and benefits of anticoagulation therapy for women of reproductive age. (© 2022. The Author(s).)

Azienda Ospedaliero Universitaria, P. (2023). Laparoscopic Sacropexy and Vaginal Natural Orifice Transluminal Endoscopic Surgery Shull Suspension Comparison Trial.
	No Results Available Procedure: Laparoscopic cervicosacropexy|Procedure: Shull technique via V-NOTES operating time|post-operative pain|time to mobilization with standing|hospital stay|patient satisfaction|sexual function|recurrence of prolapse in apical compartment|recurrence of prolapse in the anterior and posterior compartments when present|postoperative complications|anesthesiological parameters Female Not Applicable 90 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Investigator, Outcomes Assessor)|Primary Purpose: Treatment V-PULSE study December 2024

Azin, F. and H. Khazali (2022). "Phytotherapy of polycystic ovary syndrome: A review." International Journal of Reproductive Biomedicine 20(1): 13-20.
	BACKGROUND: Polycystic ovary syndrome (PCOS) is a complex heterogeneous disease with various symptoms, which can affect females of reproductive age. Endocrine and metabolic abnormalities such as infertility, being overweight or obese, type 2 diabetes, hyperandrogenism and increased luteinizing hormone (LH) are common in women with PCOS. OBJECTIVE: This review aimed to assess the efficacy of non-chemical and herbal substances for PCOS recovery. MATERIALS AND METHODS: The keywords "non-chemical treatment", "herbal treatment", "polycystic ovary syndrome" and "PCOS" were used to search for articles in the electronic databases PubMed/MEDLINE, Web of Science, Scopus, and Reaxys, published from January 2009 to December 2019. RESULTS: 34 relevant studies were found and were briefly described in this review. The most effective herbal treatments in animal models of PCOS were used to restore abnormality in serum sex steroid profile, LH: follicle stimulating hormone ratio, steroidogenic enzymes, cardiovascular parameters, lipid profile, and glucose and estrous cycles. In PCOS patients, positive effects on PCOS due to reductions in testosterone, estrogen, LH, LH: follicle stimulating hormone ratio, and insulin levels were observed. CONCLUSION: The results of this reviewrevealed the variability and efficacy of phytotherapy and non-chemical treatments associated with PCOS disease. These findings may help future studies on the etiology and treatment of this syndrome.

Babbar, S., et al. (2021). "Meditation and Mindfulness in Pregnancy and Postpartum: A Review of the Evidence." Clinical Obstetrics and Gynecology 64(3): 661-682.
	Given their growing popularity, mindfulness practices including meditation are actively being studied in clinical trials to assess their efficacy at improving health outcomes during pregnancy and the postpartum period. We conducted a literature review to compile these studies and assessed their findings. There is sufficient evidence to support the practice of mindfulness practices in pregnancy to reduce anxiety, depression, and stress during pregnancy, which may continue to have beneficial effects through the postpartum period. There is limited evidence on the benefits of mindfulness and meditation for other aspects of pregnancy. However, due to the low-risk nature of these techniques, all women should be encouraged to engage in mindfulness practices during pregnancy.Copyright © 2021 Lippincott Williams and Wilkins. All rights reserved.

Babiker, H., et al. (2022). "Tilsotolimod Exploits the TLR9 Pathway to Promote Antigen Presentation and Type 1 IFN Signaling in Solid Tumors: A Multicenter International Phase I/II Trial (ILLUMINATE-101)." Clinical Cancer Research 28(23): 5079-5087.
	Purpose: Tilsotolimod is an investigational synthetic Toll-like receptor 9 (TLR9) agonist that has demonstrated antitumor activity in preclinical models. The ILLUMINATE-101 phase I study explored the safety, dose, efficacy, and immune effects of intratumoral (it) tilsotolimod monotherapy in multiple solid tumors. Patients and Methods: Patients with a diagnosis of refractory cancer not amenable to curative therapies received tilsotolimod in doses escalating from 8 to 32 mg into a single lesion at weeks 1, 2, 3, 5, 8, and 11. Additional patients with advanced malignant melanoma were enrolled into an expansion cohort at the 8 mg dose. Objectives included characterizing the safety, establishing the dose, efficacy, and immunologic assessment. Blood samples and tumor biopsies of injected and noninjected lesions were obtained at baseline and 24 hours after treatment for immune analyses. Result(s): Thirty-eight and 16 patients were enrolled into the dose escalation and melanoma expansion cohorts, respectively. Deep visceral injections were conducted in 91% of patients. No dose-limiting toxicities (DLT) or grade 4 treatment-related adverse events were observed. Biopsies 24 hours after treatment demonstrated an increased IFN pathway signature and dendritic cell maturation. Immunologic profiling revealed upregulation of IFN-signaling genes and modulation of genes for checkpoint proteins. In the dose escalation cohort, 12 (34%) of 35 evaluable patients achieved a best overall response rate (ORR) of stable disease (SD), whereas 3 (19%) of 16 evaluable patients in the melanoma cohort achieved stable disease. Conclusion(s): Overall, tilsotolimod monotherapy was generally well tolerated and induced rapid, robust alterations in the tumor microenvironment.Copyright © 2022 American Association for Cancer Research.

Bacchi Ambrosano, G., et al. (2021). "Is the addition of vaginal electrical stimulation to transcutaneous tibial nerve electrical stimulation more effective for overactive bladder treatment? A randomized controlled trial." Actas Urologicas Espanolas 45(1): 64-72.
	INTRODUCTION AND OBJECTIVES: Overactive bladder (OAB) is a prevalent disorder that increases with age and impairs patients' quality of life. Guidelines recommend behavior modifications as the first-line treatment; however, physiotherapy has also been used with success, safety, and low cost. Transcutaneous tibial nerve electrical stimulation (TTNS) and vaginal electrical stimulation (VS) are being used in clinical physiotherapy practice. This study aimed to verify whether the addition of VS to TTNS is more beneficial than TTNS alone for women with OAB. PATIENTS AND METHODS: In all, 106 women aged >18 years diagnosed with OAB or mixed urinary incontinence with prevalent OAB symptoms were randomly divided into 2 groups: Group 1: TTNS (n = 52); Group 2: TTNS + VS (n = 54). The 3 day voiding diary, pelvic floor muscle strength (Ortiz Scale), King's Health Questionnaire, and Overactive Bladder Questionnaire were assessed before and after treatment. Urinary frequency was considered the primary outcome, and a reduction of ≥ 3 micturitions/day was considered clinically relevant. Mixed linear models were used to compare the 2groups. RESULTS: Initially, the groups were similar in age, body mass index, number of pregnancies, time of OAB onset, and prevalence of OAB symptoms. After treatment, a reduction in urinary frequency of 1.5 micturitions was observed in Group 2, which was not clinically relevant despite being statistically significant. CONCLUSIONS: The addition of VS to TTNS for the treatment of OAB was not more effective than TTNS as a single therapy.

Bachmann, C. (2023). "New Achievements from Molecular Biology and Treatment Options for Refractory/Relapsed Ovarian Cancer-A Systematic Review." Cancers 15(22).
	Ovarian cancer (OC) has a high rate of mortality and is the fifth most common cause of death in females all over the world. The etiology is still unclear. Numerous factors such as smoking, obesity, and unhealthy diet may affect the risk of OC. Having a family history of breast and OC is one of the main risks for developing OC. Mutations of BRCA1/2 are associated with OC risk as well. The histopathological classification of OC reveals the four most common types: serous, clear cell, endometrioid, and mucinous; these are epithelial OC types, and other types are rare. Furthermore, OC can be subdivided into types I and II. Type I tumors are most probably caused by atypical proliferative tumors. Type II tumors include high-grade carcinoma of the serous type, carcinosarcoma, and carcinoma, which are not differentiated and generally originate from tubal intraepithelial carcinoma of the serous type. Typically, type I tumors are present in early stages, usually with good prognosis. Type II tumors are classified as high-grade tumors and are most often diagnosed at advanced FIGO stages with poor prognosis. High-grade serous OC accounts for 90% of serous OC. Tumor heterogeneity aggravates OC treatment. The standard care for primary epithelial ovarian cancer (EOC) is cytoreductive surgery followed by platinum-based chemotherapy. Neoadjuvant chemotherapy can be used in certain cases followed by cytoreductive surgery. The main prognostic factor is complete tumor resection. However, about 70% of patients relapse. Resistance to chemotherapeutic agents remains a major challenge in EOC treatment, in which many different factors are involved. In recent years, the examination of molecular parameters and their prognostic impact has become increasingly relevant in EOC, and furthermore, the use of immunotherapy has expanded the therapeutic range. As the clinical need is greatest for relapsed patients, this systematic review will focus on recent advances in molecular biology with prognostic and predictive markers and treatment options for recurrent/refractory OC. Inclusion criteria for the review: potential prospective or predictive biomarkers in preclinical or clinical use in relapsed and refractory OC, prognostic impact, clinical and preclinical trials, and immunotherapy. Exclusion criteria for the review: primary OC, no full text or abstract available, not the topic mentioned above, and text not available in English. Risk of bias: the included studies were evaluated descriptively for the topics mentioned above, and data were not compared with each other. The objective is to highlight the molecular mechanisms of the most promising targeted agents under clinical investigation to demonstrate their potential relevance in recurrent/refractory OC.

Backes, F. J., et al. (2021). "Phase I evaluation of lenvatinib and weekly paclitaxel in patients with recurrent endometrial, ovarian, fallopian tube, or primary peritoneal Cancer." Gynecologic Oncology 162(3): 619-625.
	OBJECTIVES: To estimate the maximally tolerated dose (MTD) and describe toxicities associated with lenvatinib and weekly paclitaxel in patients with recurrent endometrial and platinum resistant epithelial ovarian cancer. METHODS: Using a 3 + 3 design patients were given weekly paclitaxel 80 mg/m2 IV day 1, 8, 15 and oral levantinib daily on a 28-day cycle. Lenvatinib dose levels were 8 mg, 12 mg, 16 mg, 20 mg. Toxicities were recorded using CTCAE v4.03 and response was determined with imaging after cycle 2, then every 3rd cycle, using RECIST 1.1 criteria. RESULTS: 26 patients were enrolled; 19 with ovarian cancer (14 high grade serous, 1 low grade serous, 2 clear cell, 1 endometrioid, and 1 carcinosarcoma), and 7 with endometrial cancer (3 serous, and 4 endometrioid). The MTD was established at lenvatinib 16 mg and weekly paclitaxel 80 mg/m2. Toxicities (all grades) occurring in ≥25% of patients included anemia, neutropenia, lymphopenia, mucositis, nausea, diarrhea, anorexia, hypertension, fatigue, proteinuria, epistaxis, hoarseness. Twenty-three patients were evaluable for response and PFS; 15 (65%) had a partial response, 7 (30%) stable, 1 (4%) progressive disease with an objective response rate of 65%; 71% in ovarian and 50% in endometrial cancer. Median progression free survival (PFS) is 12.4 months; 14.0 months in endometrial cancer, 7.2 months in ovarian cancer; 54% had a PFS > 6 months. The median duration of response for PR patients (n = 15) was 10.9 months. CONCLUSIONS: The regimen was tolerable with manageable side effects. Encouraging activity was observed in endometrial and ovarian cancer, and warrants further development.

Bacorro, W., et al. (2022). "Outcomes with definitive radiotherapy among patients with locally advanced cervical cancer with relative or absolute contraindications to cisplatin: A systematic review and meta-analysis." Gynecologic Oncology 166(3): 614-630.
	Background: The standard treatment for locally advanced cervical cancer (LACC) is chemoradiation (CRT) with cisplatin, followed by brachytherapy, but is less defined for cisplatin-intolerant patients. We synthesized evidence on treatment outcomes with definitive radiotherapy (RT) with or without chemotherapy (ChT) in these patients.; Methods: We performed a systematic search and included 20 relevant studies. We extracted data on response, survival, compliance, and toxicity, and performed meta-analyses of outcome rates and risk ratios. Sensitivity and subgroup analyses were performed to explore sources of heterogeneity. Meta-regression was performed to examine the effects of other variables.; Results: Due to lack of comparative data, most comparisons were indirect and derived from the proportional meta-analyses. Complete response (85%) and survival (62% 5yOS) rates are comparable to those published for LACC without contraindications to cisplatin. Survival rate is better with CRT than RT alone (5yOS, 73% vs 58%), and with nodal boost (NB) than without (5yOS, 71% vs 56%). Carboplatin CRT is associated with lower 5yOS (44%) but better ChT compliance (86%) when compared to other interventions. ChT compliance is better in renal failure than elderly cohorts (89% vs 67%). RT compliance is lower with CRT than RT alone (90% vs 96%), and higher with NB than none (96% vs 93%). NB is associated with lower RT compliance than no NB, when ChT is given. Meta-regression results affirm ChT and NB to be significant positive factors for survival, and NB, which is associated with greater use of advanced RT techniques, for RT compliance.; Conclusion: For those with relative contraindications, cisplatin CRT is effective and well-tolerated. For those with absolute contraindications, carboplatin is well-tolerated but with unclear effectiveness. Nodal boost is effective and well-tolerated, but is less tolerated when concurrent ChT is given.; Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Bączyk, G., et al. (2023). "Quality of Life for Polish Women with Ovarian Cancer during First-Line Chemotherapy." Healthcare (Basel, Switzerland) 11(18).
	Ovarian cancer is the worst prognostic gynaecological cancer and represents a grave clinical and social problem. Therefore, the study aimed to assess female patients' emotional, cognitive, physical, and social quality of life. The study included 100 patients diagnosed with ovarian cancer and treated with chemotherapy in a day hospital setting at the Department of Radiotherapy and Gynaecological Oncology at the Wielkopolska Oncology Centre in Poznań. The patients were given a standard treatment regimen: paclitaxel 175 mg/m 2 in a 3 h infusion and carboplatin at an AUC of 6 (5-7) following Calvert as a 1 h infusion for six cycles administered every 21 days. In addition, standardised questionnaires of the Polish version of the EORTC QLQ-C30 and QLQOV28 were used. The analysis of the collected material shows that the patients reported the highest level of general health and quality of life at the study's first stage, i.e., before chemotherapy (mean value of 59.67 points). In contrast, the patients' lowest level of general health and quality of life was observed in the fourth stage of the study (mean value of 45.04 points). The problem of side effects, such as nausea and vomiting, affected the entire study group and was more troublesome in the final stage of treatment for all patients. In the study's first stage, the mean score on the nausea and vomiting symptom scale was 16 points; in the fourth stage, the mean score was 40.07. Of the clinical factors, the symptom of fatigue was the most severe health problem for the subjects. The mean score of the fatigue scale in the study's first stage was 37.11 points, while a score of 70.33 was obtained in the fourth stage of the research. The multivariate linear regression model showed that the lack of professional activity lowers quality of life, especially combined with other side effects of chemotherapy, including hair loss in Stage IV of the study. This study shows that women with ovarian cancer undergoing chemotherapy need exceptional support from psychologists, nurses, dieticians, and physiotherapists.

Badawy, A., et al. (2023). "Retraction notice to "Extending clomiphene treatment in clomiphene-resistant women with PCOS: a randomized controlled trial" (RBMO 16/6 (2008) 825-829(10.1016/S1472-6483(10)60148-4))." Reproductive Biomedicine Online 47(5): 103374.
	This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/policies/article-withdrawal). This article has been retracted at the request of the Editors. In response to several reports concerning the above paper, regarding the collection of data, the accuracy of analysis and data presentation, and conclusions presented in the article, RBMO editors investigated to verify the validity of the issues raised and determine the appropriate status of the paper. The investigation followed Elsevier's policy on publishing ethics, the flowcharts and guidelines provided by COPE, and the 'REAPPRAISED' checklist for the evaluation of publication integrity. The corresponding author, A. Badawy, and the institution where the trial took place responded to the editors' enquiries and are unable to provide the trial data required to resolve the concerns. The corresponding author advised that at the time the research was conducted, local policy required records to be destroyed after 5 years, thus, as the trial data are no longer available, post-publication concerns cannot be further investigated. Note at the time of submission, retention of raw data and data sharing was not a requirement. Additionally, an independent statistical review of the article found that the sample size was not appropriately calculated and not reproducible. Also, it was not discernible how the statistically significant treatment effect was obtained. Without the possibility of publishing a correction or explanation, the data presented in the paper remain unreliable, and therefore, in line with COPE recommendations, the journal editors agree that retraction is appropriate. The corresponding author, A. Badawy, does not agree with the retraction. The co-authors of the article, A. Allam and M. Abulatta, could not be contacted by the journal.Copyright © 2023

Badehnoosh, B., et al. (2024). "MiRNAs: Emerging Agents for Therapeutic Effects of Polyphenols on Ovarian Cancer." Mini reviews in medicinal chemistry 24(4): 440-452.
	In terms of female reproductive tract cancers, ovarian cancer remains the principal reason for mortality globally and is notably difficult to identify in its early stages. This fact highlights the critical need to establish prevention strategies for patients with ovarian cancer, look for new robust diagnostic and prognostic markers, and identify potential targets of response to treatment. MicroRNAs (miRNAs) are one of the novel treatment targets in cancer treatment. Thus, understanding the part of miRNAs in the pathogenesis and metastasis of ovarian cancer is at the center of researchers' attention. MiRNAs are suggested to play a role in modulating many essential cancer processes, like cell proliferation, apoptosis, differentiation, adhesion, epithelial-mesenchymal transition (EMT), and invasion. In two recent decades, natural polyphenols' anti-cancer features have been a focal point of research. Meanwhile, polyphenols are good research subjects for developing new cancer treatments. Polyphenols can modify miRNA expression and impact the function of transcription factors when used as dietary supplements. Multiple works have indicated the impact of polyphenols, including quercetin, genistein, curcumin, and resveratrol, on miRNA expression in vitro and in vivo . Here, we provide an in-depth description of four polyphenols used as dietary supplements: quercetin, genistein, curcumin, and resveratrol, and we summarize what is currently known about their regulatory abilities on influencing the miRNA functions in ovarian tumors to achieve therapeutic approaches. (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Baekelandt, J., et al. (2021). "Adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery versus laparoscopy: results of a first randomised controlled trial (NOTABLE trial)." BJOG 128(11): 1782‐1791.
	Objective: To compare adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus laparoscopy. Design: Parallel group, 1:1 single‐centre single‐blinded randomised trial, designed as non‐inferiority study with a margin of 15%. Setting: Belgian teaching hospital. Population: Non‐pregnant non‐virgin women with an intact uterus and without obliteration of the pouch of Douglas scheduled to undergo removal of an adnexal mass assessed to be benign on ultrasound by IOTA criteria. Methods: Randomisation to laparoscopy (control group) or vNOTES (experimental group). Stratification according to adnexal size. Blinding of participants and outcome assessors by sham incisions. Main outcome measures: The primary outcome measure was adnexectomy by the allocated technique. Secondary outcomes included duration of surgery, pain scores and analgesics used, quality of life and adverse events. Results: We randomly assigned 67 participants (34 to the vNOTES group and 33 to the laparoscopy group). The primary end point was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the laparoscopy group: the one‐sided 95% upper limit for the differences in proportions of conversion was estimated as 13%, which is below the predefined non‐inferiority margin of 15%. The secondary outcomes demonstrated a shorter duration of surgery, lower pain scores, lower total dose of analgesics and a trend for more adverse events in the vNOTES group. Conclusions: vNOTES is non‐inferior to laparoscopy for a successful adnexectomy without conversion. vNOTES allowed shorter operating times and less postoperative pain but there was a trend for more adverse events.

Baena-García, L., et al. (2022). "A 16-week multicomponent exercise training program improves menopause-related symptoms in middle-aged women. The FLAMENCO project randomized control trial." Menopause (New York, N.Y.) 29(5): 537-544.
	Objective: To investigate the influence of a supervised multicomponent exercise training program on menopause-related symptoms, particularly vasomotor symptoms (VMS), in middle-aged women.; Methods: A total of 112 middle-aged women (mean age 52 ± 4 y old, age range 45-60 y) from the FLAMENCO project (exercise [n = 59] and counseling [n = 53] groups) participated in this randomized controlled trial (perprotocol basis). The exercise group followed a multicomponent exercise program composed of 60-minute sessions 3 days per week for 16 weeks. The 15-item Cervantes Menopause and Health Subscale was used to assess the frequency of menopause-related symptoms.; Results: After adjusting for body mass index and Mediterranean diet adherence, the subscales measuring menopause-related symptoms and VMSs decreased 4.6 more in the exercise group compared to the counseling group (between-group differences [B]: 95% CI: -8.8 to -0.2; P = 0.040). The exercise group also showed significant improvements in the subscales of couple relationships (between-group differences [B]: -1.87: 95% CI: -3.29 to - 0.45; P = 0.010), psychological state (between-group differences [B]: -2.3: 95% CI: -5 to -0.2; P = 0.035), and VMSs (between-group differences [B]: -4.5: 95% CI: -8.8 to -0.2; p = 0.040) in the Cervantes Menopause and Health Subscale compared with the counseling group.; Conclusions: A 16-week multicomponent physical exercise program showed a positive effect on menopause- related symptoms especially in couple relationships, psychological state, and VMS, among 45 to 60 year old women.; Competing Interests: Financial disclosures/conflicts of interest: None reported. (Copyright © 2022 by The North American Menopause Society.)

Bagkou, D., et al. (2022). "Understanding human immunity in idiopathic recurrent pregnancy loss." European Journal of Obstetrics, Gynecology, and Reproductive Biology 270: 17-29.
	Miscarriage, defined as the loss of a pregnancy before a viable gestation, affects 1 in 6 couples. Recurrent pregnancy loss (RPL), defined as two or more miscarriages, affects up to 1.9% of couples. The physical, psychological, and financial impact of miscarriage can be substantial. However, despite its multifactorial etiology, for up to 50% of couples a reason behind this condition cannot be identified, termed 'idiopathic RPL'. Much recent research has strived to understand this, with immune dysregulation being a source of particular interest. In this short review we summarize the current evidence on the complex role of the immune system both pre- and early post-conception in RPL. A key question is whether systemic peripheral blood markers, in particular natural killer cell and T cells, may be utilized to accurately predict and/ or diagnose those pregnancies at high risk of loss. Given the invasive nature of endometrial testing, identification of reliable peripheral immune biomarkers is particularly appealing. Clinical trials using potent immunomodulatory agents, including intravenous immunoglobulin, donor leukocyte immunization, and tumor necrosis factor (TNF)-α inhibitors, have been undertaken with the primary objective of preventing miscarriage in women with RPL. Standardisation of both diagnostic and prognostic immune cell testing assays is required to permit accurate identification of those women who may benefit from immunomodulation. Prompt clarification is required to meet the increasing expectation from couples and clinicians, as without these advancements women are at risk of exposure to potent immune-therapies and subsequent studies are at risk of failure, generating further controversy regarding the role of immune dysregulation in women with RPL. Through this review we highlight clear gaps in our current knowledge on immune activity in RPL. (Copyright © 2021 Elsevier B.V. All rights reserved.)

Baglini, E., et al. (2023). "Tyrosine kinase inhibitors (TKIs) for ovarian cancer treatment: from organic to inorganic chemotherapeutics towards selectivity-a perspective overview." Biometals : an international journal on the role of metal ions in biology, biochemistry, and medicine.
	Ovarian cancer (OC) is a lethal gynecologic cancer in industrialized countries. Treatments for OC include the surgical removal and chemotherapy. In the last decades, improvements have been made in the surgery technologies, drug combinations and administration protocols, and in diagnosis. However, mortality from OC is still high owing to recurrences and insurgence of drug resistance. Accordingly, it is urgent the development of novel agents capable to effectively target OC. In this respect, tyrosine kinase inhibitors (TKIs) may play an important role. Most of TKIs developed and tested so far are organic. However, owing to their chemical versatility, also metals can be exploited to design selective and potent TKIs. We provide a short and easy-to-read overview on the main organic TKIs with a summary of those that entered clinical trials. Additionally, we describe the potential of metal-based TKIs, focusing on this overlooked family of compounds that may significantly contribute towards the concept of precision-medicine. (© 2023. The Author(s).)

Bagrat, G., et al. (2021). "Pentosan polysulfate in patients with bladder pain syndrome/interstitial cystitis: systematic review and meta-analysis."
	
Bahena, J. A., et al. (2021). "Retrospective analysis of the impact of bevacizumab dose-intensity on the survival of platinum-resistant ovarian cancer patients." Annals of Oncology 32(Supplement 5): S750-S751.
	Background: Bevacizumab (BVZ) is a humanized monoclonal antibody that has demonstrated benefit in the front-line, recurrent platinum-sensitive and recurrent platinum-resistant ovarian cancer settings. Phase III trials of BVZ in ovarian cancer show a benefit in the dose-intensity range of 2.5 mg/kg/week to 5 mg/kg/week, but the optimal dose of this drug is still unknown. Some evidence suggests that high-dose BVZ is associated with a higher incidence of adverse events. In addition, in many countries, health services have restricted access to BVZ due its high cost. Method(s): We carried out a retrospective study comparing low-dose (< 2.5 mg/kg/week) and high-dose (> 2.5 mg/kg/week) BVZ in combination with chemotherapy, in patients with recurrent platinum-resistant ovarian cancer that received treatment in the Instituto Nacional de Cancerologia between 2012 and 2017. Demographic and clinicopathological characteristics were retrieved from medical records. We compared PFS and OS by use of a log-rank test. We also examined BVZ adverse events of special interest. Result(s): Of 79 patients that received BVZ, 41 received low dose and 38 received high dose. Mean dose was 2.3 mg/kg/week in the low-dose group and 4.22 mg/kg/week in the high-dose group. No differences in mean age, history of hypertension and number of BVZ cycles were found between groups. The low-dose group had a higher proportion of low-grade serous histology (9.8% vs 0%), and a lower proportion of clear-cell histology (4.9% vs 10.5%). Median PFS was 7.5 months (CI 95%, 0.56 - 1.7) with low dose and 7.7 months (CI 95%, 0.58 - 1.7) with high dose (p = 0.81). OS was 28.1 months (CI 95%, 0.68 - 2.4) and 21.6 months (CI 95%, 0.40 - 1.4) (p = 0.09). There were no differences in the incidence of adverse events of special interest. Conclusion(s): Results from this retrospective study suggest that low-dose BVZ may have a similar efficacy compared to high-dose. The administered dose did not affect the incidence of BVZ-related adverse events. However, clinical data from prospective studies need to be assessed in order to validate these results. If low-dose BVZ treatment demonstrates to be non-inferior, a larger number of patients will be able to receive this treatment with a better cost-effectiveness ratio. Legal entity responsible for the study: The authors. Funding(s): Has not received any funding. Disclosure: All authors have declared no conflicts of interest.Copyright © 2021 European Society for Medical Oncology

Bahmani, M., et al. (2022). "The effect of pomegranate seed oil on human health, especially epidemiology of polycystic ovary syndrome; a systematic review." JBRA Assisted Reproduction 26(4): 631-636.
	Polycystic ovary syndrome is the most common endocrine disorder in women. Today, medicinal plants have been considered by women, especially in the reproductive and pregnancy ages. Multiple drug treatments and the length of the treatment period often lead to incomplete treatment by patients. Therefore, due to the side effects of chemical drugs, this study was conducted to assess investigate the effect of pomegranate seed oil on polycystic ovary syndrome. The prevalence of polycystic ovary syndrome is increasing by 15 to 20% and clinically includes oligomenorrhea or amenorrhea, hirsutism, and often infertility. Databases such as Cochran library, Medline, PubMed, SID, and Science Direct were used to access the related articles. To collect the required information, first, the articles that had one of the keywords of medicinal plants, polycystic ovary syndrome, plant, pomegranate extract, and menstrual irregularities in their text were searched in databases. All studies from 1985 to 2021 are included in the study. Conjugated linolenic acid (CLN) is a group of geometric and positional isomers of linolenic acid in which double bonds are conjugated. CLN has been reported to have a very strong cytotoxic effect on tissue tumor cells in the body, preventing cancer, reducing the accumulation of triacylglycerol in the liver, polycystic ovary syndrome, and LDL cholesterol in the blood. So far, seven CLN isomers have been identified, including ponic acid in pomegranate seed oil. Conjugated linoleic acid (CLA) is a group of situational and geometric isomers of linoleic acid in which double bonds are conjugated. The positive effects of the two main CLA isomers (cis-9, trans-11, and trans-10, cis-12) include inhibiting the growth of cancer, reducing the risk of atherosclerosis, and reducing body fat.

Bahrami, F., et al. (2023). "Complications following surgeries for endometriosis: A systematic review protocol." PloS One 18(5): e0285929.
	Background: Endometriosis is a common gynecological condition with a wide range of symptoms, including infertility, dyspareunia, intestinal disorders, and pelvic pain. Laparoscopy and laparotomy are used widely for diagnosing and managing endometriosis. We will conduct a systematic review and meta-analysis with the aims of reporting complications rates following each type of surgeries for endometriosis and determinants of complications.; Method: We will search Medline (via PubMed), Embase, the Cochrane Library, Web of Science, and Google Scholar for both retrospective and prospective cohorts or trials of at least 30 participants reporting perioperative and postoperative complications for endometriosis surgeries. We will restrict the studies to those conducted after 2011, to be representative of current practices, and will exclude studies of surgeries for gynecological cancer, or other concomitant benign gynecologic surgeries such as myomectomy. Two reviewers will independently screen references and select eligible studies. A standardized form will be used to collect data related to the baseline characteristics, potential determinants of complications, types of interventions, and outcomes. Cumulative incidences of complications will be pooled using DerSimonian and Laird random-effects method. The relation between potential determinants and complications will be reported with risk ratios and their 95% of confidence intervals. Subgroup analysis of surgical approach, surgical procedure, superficial and deep infiltrating endometriosis, and the indication of surgery will be conducted. Sensitivity analyses restricted to studies with low risk of bias will be performed.; Discussion: This systematic review will provide information on the rates of complications for different surgical approaches and procedures for the treatment of endometriosis. It will contribute to inform patients when making decisions regarding their care. Identifying potential determinants of complications will also help to improve care by identifying women being at higher risk of complications.; Trial Registration: Systematic review registration: CRD42021293865.; Competing Interests: The authors have no conflict of interest to declare. (Copyright: © 2023 Bahrami et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Bahroudi, Z., et al. (2022). "Review of ovarian tissue cryopreservation techniques for fertility preservation." Journal of Gynecology Obstetrics and Human Reproduction 51(2): 102290.
	Ovarian failure and ovarian malfunction are among major fertility problems in women of reproductive age (18-35 years). It is known that various diseases, such as ovarian cancer and premature ovarian failure, besides certain treatments, such as radiotherapy and chemotherapy of other organs, can affect the normal process of folliculogenesis and cause infertility. In recent years, various procedures have been proposed for the treatment of infertility. One of the newest methods is the use of cryopreservation ovarian fragments after cancer treatment. According to some studies, this method yields very satisfactory results. Although ovarian tissue cryopreservation (OTC) is an accepted technique of fertility preservation, the relative efficacy of cryopreservation protocols remains controversial. Considering the controversies about these methods and their results, in this study, we aimed to compare different techniques of ovarian cryopreservation and investigate their advantages and disadvantages. Reviewing the published articles may be possible to identify appropriate strategies and improve infertility treatment in these patients.Copyright © 2021 Elsevier Masson SAS

bai, w. and S. Fenfang (2023). "The efficacy of platelet rich plasma on women with poor ovarian response: a systematic review and meta-analysis."
	
Bai, Y.-Y., et al. (2019). "Clinicopathological and prognostic significance of pretreatment thrombocytosis in patients with endometrial cancer: a meta-analysis." Cancer Management and Research 11: 4283-4295.
	Background: The prognostic and clinicopathological role of pretreatment thrombocytosis in cancer has been widely studied, but conclusions in endometrial cancer (EnCa) remain controversial. Therefore, we conducted a meta-analysis to assess the pathologic and prognostic impacts of pretreatment thrombocytosis in patients with EnCa. Methods: We searched PubMed, Embase, SpringerLink, ScienceDirect and China National Knowledge Infrastructure databases. Pooled HR or OR with their 95% CIs were applied to assess the association of pretreatment thrombocytosis with survival outcomes and clinical parameters of EnCa patients. Results: In total, 10 studies containing 2,995 cases of EnCa met the criteria. The results suggested that pretreatment thrombocytosis was significantly associated with high International Federation of Gynecology and Obstetrics (FIGO) stage (pooled OR 3.45, 95% CI 1.68-7.08, P =0.001), poor tumor differentiation (pooled OR 2.00, 95% CI 1.22-3.29, P =0.006), lymph-vascular space invasion (pooled OR 2.04, 95% CI 1.35-3.07, P =0.001); myometrial invasion (pooled OR 2.14, 95% CI 1.39-3.32, P =0.001); cervical involvement (pooled OR 2.54, 95% CI 1.56-4.15, P =0.000) and lymph node metastasis (OR 3.15, 95% CI 1.71-5.80, P =0.001). No significant difference existed between pretreatment thrombocytosis and overall survival ( P =0.012), cancer/disease-specific survival ( P =0.07) or disease-free survival ( P =0.25). Conclusion: pretreatment thrombocytosis was associated with advanced clinicopathological features in patients with EnCa, which may serve as a potential therapeutic target for EnCa.; Competing Interests: The authors report no conflicts of interest in this work.

Bai, Z., et al. (2024). "Prevalence and Risk Factors of Urinary Retention in Patients With Cervical Cancer: A Meta-analysis and Systematic Review." Cancer Nursing.
	Background: The literature is inconsistent on the prevalence and risk factors of urinary retention in patients with cervical cancer.; Objective: The aim of this study was to review the literature on the prevalence of urinary retention in patients with cervical cancer and consolidate the risk factors.; Methods: For this meta-analysis, eligible articles published in English or Chinese by December 10, 2021, were systematically searched for and retrieved from PubMed, Cochrane Library, Ovid-Embase Medline, Web of Science, PsycINFO, CINAHL, and Scopus. Prevalence, odds ratios (ORs), and 95% confidence intervals (CIs) were used for meta-analysis.; Results: Twenty-five studies were included in the analysis. The pooled overall prevalence was 0.26 (95% CI, 0.21-0.30, I2 = 95.0%). The identified risk factors were age (OR, 1.13; 95% CI, 1.08-1.19), urinary tract infection (UTI) (OR, 3.33; 95% CI, 1.48-7.49), surgical extent (OR, 2.95; 95% CI, 1.27-6.85), and catheter indwelling time (OR, 3.44; 95% CI, 2.43-3.87).; Conclusions: The prevalence of urinary retention in patients with cervical cancer is 0.26. Older age, UTI, longer catheter indwelling time, and a larger surgical extent may increase the risk of urinary retention. Clinicians should identify patients at risk and adopt interventions such as individualized catheter care.; Implications for Practice: Nursing staff should assess the risk of urinary retention in a patient with cervical cancer according to her age, presence of UTI, surgical extent, and catheterization time. A carefully chosen surgical procedure and interventions such as individualized education, timely catheter removal, treatment of UTI, and rehabilitation should be offered.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Baillargeon, J. P., et al. (2022). "An interdisciplinary intervention improves lifestyle behaviours in women living with obesity and infertility: a randomized controlled trial." Journal of the Endocrine Society 6(Supplement 1): A674-A675.
	Introduction: Lifestyle modifications should be the firstline treatment for improving reproductive function and preconception weight in women living with obesity who are seeking fertility treatments. Evidence is however scarce regarding the effectiveness of lifestyle programs in supporting these women. The study's objective was therefore to determine whether the Obesity-Fertility program leads to healthier lifestyle behaviours in women living with obesity and consulting at a fertility clinic. Method(s): Women with obesity and infertility were randomized to the control (CG=65) or intervention (IG=65) group. Based on the participant's medical record, randomization was stratified according to the polycystic ovarian syndrome status. The CG followed the usual fertility clinic approach while the IG participated in individual and group sessions with a registered dietician, a kinesiologist, and a psychologist. Before the intervention (baseline) and 6 months after (V6), frequency of food and beverages intakes, physical activity levels, sedentary time, daily sleep duration, alcohol consumption and smoking use were collected via a lifestyle behaviour questionnaire adapted from the 2009 Canadian Community Health Survey (Statistics Canada). Functional capacity was evaluated with a 6-minute walk test. Descriptive statistics, two-sample tests of means or proportions, generalized linear models and logistic regressions were performed. Result(s): At baseline, women who had a research visit at 6+/-1 months (n=85) were 30+/-5 years old and had a BMI of 39.8+/-7.7 kg/m2. Most of them held no university degree (81.2%) and were primiparous (56.5%). Both groups (CG=43 and IG=42) had similar sociodemographic and anthropometric characteristics as well as lifestyle behaviours at baseline except for smokers' proportion that was higher in CG (CG: 34.9% vs IG: 9.5%, p<0. 01). From baseline to 6 months, whole fruit and vegetable frequency intakes increased more in the IG vs CG (fruits: +1.1 vs +0.4/day, p<0. 01; vegetables: +0.7 vs +0.4/day, p<0. 01). Significant differences (IG vs CG) were also observed for frequency intakes of whole grain products (+1. 0 vs +0. 04/day, p<0. 01) and dairy products (+0.5 vs -0.2/day, p<0. 01) as well as in the percentage of active women (>3 kcal/kg/day: +14.2% vs +2.3%, p=0. 03) and the time spent in sedentary behaviours (-6.7 vs -0.1 h/ week, p<0. 01). Distance covered during the 6-minute walk test tended to increase more in IG vs CG (+28.8 vs +5.5 metres, p=0. 05). Sleep duration decreased by 19 and 12 minutes per day in the IG and CG, respectively (p=0.25). No significant difference was found between IG and CG for changes in sleep duration, alcohol consumption and smoking use. Conclusion(s): The Obesity-Fertility program significantly improved components of diet, physical activity levels and sedentary behaviours in women living with obesity and seeking fertility treatments. Such programs can therefore support these women to adopt healthier lifestyle behaviours and may improve their fertility as well as decrease risks of complications during pregnancy.

Bais, A. and P. Phansopkar (2021). "Impact of pilates training versus progressive muscle relaxation technique on quality of life in menopausal women-a comparative study." Indian journal of forensic medicine and toxicology 15(1): 7‐11.
	Background: Menopausal women shows common symptoms which includes night sweats and hot flushes, heart distress, disturbances in sleep, depression, irritability, anxiousness, weight changes, physical and mental fatigue, joint and muscle pain. This affects the Quality Of Life of the Menopausal women. Pilates Training has proven beneficial for enhancing Quality Of Life in menopausal women but there is paucity of evidence of effect of Progressive Muscle Relaxation Technique in Menopausal women on QOL. The research is an initiative study that focuses on the effectiveness of PMRT on the various aspects of Quality Of Life of the menopausal women and comparison of the Pilates training and PMRT in order to enhance the QOL of participants. Aim and Objective: Effect of Pilates training & Progressive Muscle Relaxation Technique on menopausal women’s Quality Of Life and comparison of both the technique. Methods: 42 participants aged more than 45 years will be randomly categorized in two groups: Group A (n= 21) and Group B (n=21). The study duration will be of 6 months. The pre and post Intervention will be taken from both the group and data will be analyzed with the help of main outcome measure which is Menopause specific Quality Of Life (MENQOL). Result‐The expected result would include the details about whether the measures are effective for improving the quality of life in menopausal women, as well as the comparison of both the interventions. Data will be analyzed using paired t‐test. Conclusion‐It will be published after results are analyzed.

Bajalan, Z., et al. (2019). "Nutrition as a Potential Factor of Primary Dysmenorrhea: A Systematic Review of Observational Studies." Gynecologic and Obstetric Investigation 84(3): 209-224.
	Background: The incidence and severity of primary dysmenorrhea are influenced by various factors. The aim of the present study was to review nutritional factors influencing primary dysmenorrhea.; Methods: Academic databases including Web of Science, EMBASE, Scopus, and PubMed (including Medline) were searched using keywords of nutrition, diet, and primary dysmenorrhea. In this study, observational studies that were published in English from 1990 to April 2018, which focused on nutritional factors affecting primary dysmenorrhea, were selected. The evaluation of studies was performed using a modified STROBE checklist with 10 items.; Results: Out of 5,814 retrieved studies, 38 articles met inclusion criteria and were included for final data synthesis. The increased consumption of fruits and vegetables as the sources of vitamins and minerals, as well as fish and milk and dairy products have positive associations with less menstrual pain. Inconsistent results were reported on the consumption of other nutritional groups. Studies showed negative associations of meal skipping and following diet to lose weight with severity of dysmenorrhea.; Conclusion: A few studies showed inconclusive findings due to methodological heterogeneities for assessing nutritional habits and different methods of measuring dysmenorrhea pain. Therefore, further analysis and future interventional studies with stronger methodologies are required. (© 2019 S. Karger AG, Basel.)

Bak Malene, E., et al. (2023). "Clinical experiences with online adaptive radiotherapy of vulvar carcinoma." Acta oncologica (Stockholm, Sweden) 62(10): 1230-1238.
	Background and Purpose: Radiotherapy for vulvar carcinoma is challenging due to relatively high risk of locoregional disease recurrence, a technically challenging target, and postoperative lymphocele, and a high risk radiation sequelae. We aim to explore, if it is possible to reduce dose to normal tissue, while maintaining CTV coverage for this patient group with online adaptive radiotherapy.; Materials and Methods: 20 patients with vulvar carcinoma (527 fractions) were treated with online adaptation on a Varian Ethos accelerator. Setup CBCTs were acquired daily for adaptive planning. Verification CBCTs were acquired immediately prior to dose delivery. CTV dose coverage and dose to bladder and rectum were extracted from the scheduled and adapted plans as well as from adapted plans recalculated based on verification CBCTs. In addition, analysis of the decision of the adaptive procedure was performed for 17 patients (465 fractions).; Results: Mean CTV D95% and standard deviation was 98% ± 5% for the scheduled plan compared to 100.0 ± 0.3% and 100.0 ± 0.8% for the adapted plan on the setup and verification CBCT respectively. Dose to OARs varied substantially and did not show any benefit from adaption itself, however a margin reduction was implemented after the first patients treated. The adapted plan was chosen for 63.5% of the fractions and dominant reasons for not adapting were 'no significant dosimetric gain' (75 fractions, 14%) and 'Medical doctor (MD) not available for treatment' (50 fractions, 9.5%). The median adaption time was 15 min and the 25th and 75th percentile was 12 and 17 min, respectively.; Conclusion: CTVs and PTVs dose coverage were significantly improved with adaptation compared to image-guided RT. This gain was robust during the treatment time.

Bakan, A. B., et al. (2021). "Effects of the Training Given to Older Adults on Urinary Incontinence." Ageing international 46(3): 324‐336.
	
Bakay, K., et al. (2021). "Hypogastric artery ligation in laparoscopic hysterectomy: results from a randomized controlled trial." Clinical and experimental obstetrics & gynecology 48(6): 1304‐1310.
	Background: Concerning total laparoscopic hysterectomy (TLH), opening the retroperitoneum and prophylactic ligation of both uterine arteries (UA) is not a routine procedure during a simple hysterectomy and it is not practiced widely in gynecology education. Methods: In this study, we tried to show the prophylactic ligation of internal iliac artery anterior division (IIAD) and provide hemostasis of UA at an anatomical plane where we considered it would be easier to perform and relatively safer, in terms of distance, regarding ureteric injury, in a prospective randomized controlled trial. Results: When this technique was used the duration of the operation got longer approximately 3 minutes (min) (57.15 ± 5.46 vs. 53.66 ± 8.96 p = 0.018 and p < 0.05), but the amount of bleeding was detected to be at a significantly lower level (73.84 ± 7.18 vs. 113.96 ± 21.5 p = 0.001 and p < 0.05). Discussion: In this method, not only we found out that it is easier to ligate IIAD compared to other surgical techniques but also allows for better control of the retroperitoneal area during the procedure therefore minimizing the risk of surgical complications such as ureter damage. Moreover, as was hypothesized, IIAD ligation dramatically reduced blood loss hence verifying its use in more complex hysterectomies and pelvic lymphadenectomy.

Bakhbakhi, D., et al. (2023). "Interventions, outcomes and outcome measurement instruments in stillbirth care research: A systematic review to inform the development of a core outcome set." BJOG: An International Journal of Obstetrics and Gynaecology 130(6): 560-576.
	Background: A core outcome set could address inconsistent outcome reporting and improve evidence for stillbirth care research, which have been identified as an important research priority. Objective(s): To identify outcomes and outcome measurement instruments reported by studies evaluating interventions after the diagnosis of a stillbirth. Search strategy: Amed, BNI, CINAHL, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase, MEDLINE, PsycINFO, and WHO ICTRP from 1998 to August 2021. Selection Criteria: Randomised and non-randomised comparative or non-comparative studies reporting a stillbirth care intervention. Data Collection and Analysis: Interventions, outcomes reported, definitions and outcome measurement tools were extracted. Main Result(s): Forty randomised and 200 non-randomised studies were included. Fifty-eight different interventions were reported, labour and birth care (52 studies), hospital bereavement care (28 studies), clinical investigations (116 studies), care in a multiple pregnancy (2 studies), psychosocial support (28 studies) and care in a subsequent pregnancy (14 studies). A total of 391 unique outcomes were reported and organised into 14 outcome domains: labour and birth; postpartum; delivery of care; investigations; multiple pregnancy; mental health; emotional functioning; grief and bereavement; social functioning; relationship; whole person; subsequent pregnancy; subsequent children and siblings and economic. A total of 242 outcome measurement instruments were used, with 0-22 tools per outcome. Conclusion(s): Heterogeneity in outcome reporting, outcome definition and measurement tools in care after stillbirth exists. Considerable research gaps on specific intervention types in stillbirth care were identified. A core outcome set is needed to standardise outcome collection and reporting for stillbirth care research.Copyright © 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.

Bakker, A., et al. (2022). "Comparison of the clinical performance of a hybrid Alba 4D and the AMC-4 locoregional hyperthermia systems." International Journal of Hyperthermia 39(1): 1408-1414.
	Objective: The in-house developed 70 MHz AMC-4 locoregional hyperthermia system has been in clinical use since 1984. This device was recently commercialized as the Alba 4D (Medlogix, Rome, Italy), with a similar geometrical 4-waveguide design. At the time of this study a hybrid Alba 4D was installed at our center, which incorporated elements of the AMC-4. This study aims to compare clinical performance of both devices. Method(s): During one year after clinical acceptance of the hybrid Alba 4D, both devices were used for treatment delivery in patients scheduled for locoregional hyperthermia. Each patient started with the AMC-4, next sessions were allocated to either device. Possible differences between Alba 4D and AMC-4 sessions in power, achieved temperature T0, T10, T50, T90, T100, treatment time and complaints per session, were evaluated using linear mixed models (LMMs) for repeated measures with patient as random effect. Result(s): From March 2018 to April 2019, eleven patients with cervical, pancreatic, vaginal carcinoma and uterine leiomyosarcoma received 27 locoregional hyperthermia sessions with the Alba 4D and 34 sessions with the AMC-4. Median number of sessions per patient was 5 (range 3-13). Treatment results for both devices were not significantly different: T50 was 40.5 +/- 1.0 degreeC vs. 40.8 +/- 0.7 degreeC, applied power was 500 +/- 79 W vs. 526 +/- 108 W, for the Alba 4D vs. AMC-4, respectively. Conclusion(s): Results of the first patients treated with the hybrid Alba 4D demonstrated comparable clinical performance of the Alba 4D and AMC-4 locoregional hyperthermia systems, and both devices are expected to yield similar favorable clinical results.Copyright © 2022 The Author(s). Published with license by Taylor & Francis Group, LLC.

Bakun Oksana, V., et al. (2023). "A NEW APPROACH TO ASSISTED REPRODUCTIVE TECHNOLOGIES PREPARATION IN WOMEN WITH ENDOMETRIOSIS ASSOCIATED INFERTILITY USING PROBIOTICS." Polski merkuriusz lekarski : organ Polskiego Towarzystwa Lekarskiego 51(3): 234-238.
	Objective: Aim: To examine the expression Nlrp3-inflammasome in the blood of women with endometriosis-associated infertility using assisted reproductive technologies with included probiotic and estimate a new approach with included probiotic for preparation to assisted reproductive technologies.; Patients and Methods: Materials and methods: For the purpose of the research we examined 30 infertile women. Control group consisted of 10 women with tubal infertility due to an inflammatory process in the anamnesis, in whom, as a result of a complex clinical and laboratory examination, no other diseases were detected and in terms of their health they could be equated with practically healthy women (age from 21 to 42 years, the average age was 29.75 years) and who did not take probiotic. The main group consists from 20 women with external genital endometriosis were included in assisted reproductive technologies. Patients from main group took probiotic produced by Unic Biotech Ltd, India. 1 tablet twice a day with 10×109 Lactobacillus during 1 month in complex preparation (treatment) before assisted reproductive technologies. The indices of Nlrp3 - Inflammasome determined before and after preparation. The study was performer in Bukovinian State Medical University and Centre of Reproductive Medicine. To analyze the expression of the NLPP3-inflammasome gene and determine the relative normalized expression of NLPP3 mRNA, we used the polymerase chain reaction with reverse transcription in real time (RT-PCR). The object for molecular genetic studies by the RT-PCR method was the fraction of mononuclear cells isolated from the whole blood of patients with endometriosis. The value of p (authenticity difference) was determined by Student's table-Fischer. Differences between contrasting averages were considered significant at p <0.05.; Results: Results: Analized the results of our research stated that in main group expression of Nlrp-3 inflammasome was 24,43, which is significantly higher than after preparation (0,70 accordingly). In control group expression of Nlrp3-inflammasome was 0,54. Expression of Nlrp-3 inflammasome increased in patients before preparation more than 34 times compare with patients after preparation accordingly.; Conclusion: Conclusions: consequently, after using probiotic, the increased level of Nlrp3-inflammasome sharply decreases, indicating the effectiveness and the possibility of use in the programme for assisted reproductive technologies preparation.

Bal, Z. and T. Uçar (2023). "The effect of cognitive behavioural therapy and eye movement desensitization and reprocessing techniques on infertile women: a randomized controlled trial." Reproductive Biomedicine Online 48(2): 103612.
	RESEARCH QUESTION: What effects do training programmes based on cognitive behavioural therapy (CBT) and eye movement desensitization and reprocessing (EMDR) techniques applied to infertile women affected psychologically and emotionally by infertility have on post-traumatic stress disorder (PTSD) and psychological development? DESIGN: This randomized controlled study was conducted between May 2021 and August 2022. The study population included 90 infertile women referred to the IVF unit of a hospital in a province in eastern Turkey: 30 in the CBT group, 30 in the EMDR group and 30 in the control group. Data were collected using a personal information form, the Subjective Units of Disturbance Scale (SUDS), the Validity of Cognition (VoC) scale, the Infertility Distress Scale (IDS), the Impact of Event Scale-Revised (IES-R) and the Post-traumatic Growth Inventory (PTGI). Women in the experimental groups (CBT and EMDR groups) received the intervention in six sessions over 3 weeks. Pre-tests were administered to both experimental groups and the control group, and post-tests were conducted 3 weeks after the intervention. RESULTS: The mean scores on the SUDS, IDS and IES-R for women in the experimental groups were significantly lower compared with those for women in the control group following the interventions (P < 0.001). The mean scores on the VoC scale and PTGI for women in the experimental groups were significantly higher compared with those for women in the control group following the interventions (P < 0.001). CONCLUSION: The use of CBT and EMDR techniques reduced the negative psychological and emotional effects of infertility among infertile women.

Bala, R., et al. (2024). "Revitalizing allicin for cancer therapy: advances in formulation strategies to enhance bioavailability, stability, and clinical efficacy." Naunyn-Schmiedeberg's archives of pharmacology 397(2): 703-724.
	The main objective of this review is to highlight the therapeutic potential of allicin, a defense molecule in garlic known for its diverse health benefits, and address the key challenges of its bioavailability and stability. The research further aims to evaluate various formulation strategies and nanotechnology-based delivery systems that can resolve these issues and improve allicin's clinical efficacy, especially in cancer therapy. We conducted a comprehensive review of the available literature and previous studies, focusing on the therapeutic properties of allicin, its bioavailability, stability issues, and novel formulation strategies. We assessed the mechanism of action of allicin in cancer, including its effects on signaling pathways, cell cycle, apoptosis, autophagy, and tumor development. We also evaluated the outcomes of both in vitro and in vivo studies on different types of cancers, such as breast, cervical, colon, lung, and gastric cancer. Despite allicin's significant therapeutic benefits, including cardiovascular, antihypertensive, cholesterol-lowering, antimicrobial, antifungal, anticancer, and immune-modulatory activity, its clinical utility is limited due to poor stability and unpredictable bioavailability. Allicin's bioavailability in the gastrointestinal tract is dependent on the activity of the enzyme alliinase, and its stability can be affected by various conditions like gastric acid and intestinal enzyme proteases. Recent advances in formulation strategies and nanotechnology-based drug delivery systems show promise in addressing these challenges, potentially improving allicin's solubility, stability, and bioavailability. Allicin offers substantial potential for cancer therapy, yet its application is hindered by its instability and poor bioavailability. Novel formulation strategies and nanotechnology-based delivery systems can significantly overcome these limitations, enhancing the therapeutic efficacy of allicin. Future research should focus on refining these formulation strategies and delivery systems, ensuring the safety and efficacy of these new allicin formulations. Clinical trials and long-term studies should be carried out to determine the optimal dosage, assess potential side effects, and evaluate their real-world applicability. The comparative analysis of different drug delivery approaches and the development of targeted delivery systems can also provide further insight into enhancing the therapeutic potential of allicin. (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Balakrishnan, P. S. and A. Thomas (2022). "Stress Urinary Incontinence among Young Nulliparous Females-A Systematic Review." Journal of Pharmaceutical Negative Results 13: 1384-1389.
	Unintentional urination, also known as urinary incontinence (UI), is most frequently observed in postpartum and postmenopausal women. There is an association between UI and high-impact physical activity. Levator ani muscle (LAM) typically aids in urethral closure. However, in young female athletes, it indirectly places pressure on the lower tier of pelvic support by raising intraabdominal pressure and experience stress incontinence. The first line of treatment for young nulliparous females is pelvic floor muscle training(PFM).The objective of this study is to identify potential risk factors and explore the relationship between stress urinary incontinence(SUI) and athletic sports and dancers in young nulliparous females. Due to ignorance and underreporting, SUI frequently goes undiagnosed and unreported. Literature was retrieved through searching 5 electronic data-bases (PubMed, MEDLINE, CINAHL, Cochrane, and Google Scholar). Articles published from the year 2012 up to including 2022 with full text were included. 6 studies were included in this systematic review. Results indicated that SUI can be managed with few preventive techniques and PFM training. Thus it can be concluded its prevalence and exercises in reduction of SUI in nulliparous female athletes and dancers.Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.

Balasubramanian, R., et al. (2023). "A Review of Clinical and Preclinical Studies on the Therapeutic Potential of Black Seeds (Nigella sativa) in the Management of Polycystic Ovarian Syndrome (PCOS)." Journal of Pharmacopuncture 26(1): 1-9.
	Objectives: Polycystic ovary syndrome (PCOS) is a condition that occurs frequently among women of reproductive age and is a polygenic, multifactorial, endocrine, and metabolic disorder. PCOS is becoming more common as a result of risk factors such as current lifestyle, overnutrition, and stress. The use of traditional herbal medicine is higher among the global population. Hence, this review article focuses on the potential of Nigella sativa to manage women with PCOS. Method(s): A literature search was carried out using databases including Medline, Google Scholar, EBSCO, Embase, and Science Direct, as well as reference lists, to identify relevant publications that support the use of N. sativa in the management of women with PCOS. Result(s): Several clinical and preclinical studies have demonstrated that the major bioactive constituent of black seed (N. sativa), thymoquinone, has potential for managing women with PCOS. Moreover, N. sativa may help to manage oligomenorrhea and amenorrhea in women with PCOS through its anti-inflammatory and antioxidant properties. Conclusion(s): N. sativa has potential for use as a herbal medicine for managing women with PCOS as an integrative medicine along with traditional and modern medicine in conjunction with calorie restriction and regular exercise.Copyright © Korean Pharmacopuncture Institute.

Balazs, H., et al. (2022). "The effect of topical imiquimod treatment on reducing cervical intraepitheilal neoplasia: systematic review and meta-analysis."
	
Baldini, G. M., et al. (2023). "Evaluation of the ideal vaginal Progesterone effectiveness doses for luteal support in embryo thawing cycles after endometrial preparation without using the GnRh analogue." European Review for Medical and Pharmacological Sciences 27(5): 2018-2026.
	Objective: Frozen-thawed embryo transfer (FET) cycles require the use of luteal phase support (LPS) for supporting implantation, endometrial and embryo maturity. Individualized LPS should be chosen according to the used endometrial preparation protocol. The aim of the study was to analyze the effectiveness of two different vaginal Progesterone doses for women who underwent FET cycle and the same endometrial preparation without using the GnRh analogue.; Patients and Methods: 607 women who underwent FET cycle were included in the study. 305 patients received luteal support with 600 mg/day vaginal Progesterone and 302 patients were treated with 800 mg/day of vaginal Progesterone.; Results: In the 800 mg/day group, the mean serum Progesterone concentration on the day of embryo transfer was higher than in the 600 mg group (14.00±6.18 ng/mL and 12.22±5.39, respectively, p < 0.001). Moreover, human chorionic gonadotrophin (hCG) positive and ongoing pregnancy rates were higher in the group of patients who received LPS with 800 mg/day of Progesterone than in the group of patients treated with 600 mg/day of Progesterone. CONCLUSIONS: In patients undergoing FET cycles following endometrial preparation made without previously using the GnRh analogue, 800 mg doses of vaginal Progesterone as LPS improve reproductive outcomes.

Baldini, G. M., et al. (2022). "The abortion rate in trans-myometrial eggs retrieval is the same as in classical transvaginal retrieval." European Review for Medical and Pharmacological Sciences 26(9): 3282-3288.
	OBJECTIVE: This study compares the miscarriage rate of pregnancies after trans-myometrial eggs retrieval to transvaginal eggs retrieval. PATIENTS AND METHODS: In the period between January 2004 and December 2020, 13,323 egg retrievals were carried out. In 699 cases, the ovaries were unreachable. Alternative maneuvers were performed to solve this problem, but despite this, in 132 patients the technique of trans-myometrial sampling had to be used. 26 patients were excluded from the study, because of the inclusion criteria, and therefore two groups of 106 patients were selected, Group A and Group B (control). RESULT(S): In the comparison between the two groups, there were no statistically significant differences in abortion rates, pregnancy rates and complications after the technique. CONCLUSION(S): This study shows that the abortion rate in trans-myometrial oocyte retrieval does not change when compared to classic retrieval, despite the sampling needle completely crossing the myometrium. Furthermore, the pregnancy rate and the complication rate do not appear to have worsened with this technique.Copyright © 2022 Verduci Editore s.r.l. All rights reserved.

Balears Fundació d'investigació Sanitària de les, I. and B. Islands University of the (2021). Radiofrequency and Pelvic Organ Prolapse.
	No Results Available Device: Non-ablative radiofrequency application|Other: Usual intervention Change in degree of prolapse|Changes in prolapse symptoms: bulging, pelvic heaviness and low back pain - related to POP-|Changes in quality of life|Satisfaction with treatment Female Not Applicable 40 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment IB4459/21PS October 23, 2022

Balemans, D., et al. (2021). Live Birth After Additional Tubal Flushing With Oil-based Contrast Versus no Additional Flushing.
	No Results Available Drug: Lipiodol Ultra Fluide® Live birth|Type of pregnancy|Number of miscarriages|Amount of pregnancy complications|Number of ectopic pregnancies|Number of clinical pregnancies|Complication during or after Hyfosy with intervention|Pain score of the Hyfosy with or without intervention|Pain score of the intervention with IMP if applicable|Thyroid function of baby|Birthweight|Gestational age at delivery|Neonatal care|Number of babies|Maternal thyroid function|General quality of life|Disease-specific quality of life|Neonatal Mortality|Major Congenital Anomaly|Gender of baby Female Phase 4 736 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment HYOIL November 1, 2024

Baliou, E., et al. (2022). "Testicular plasmacytoma. A case report and correlation with imaging findings." Virchows Archiv 481(Supplement 1): S276.
	Background & objectives: Plasmacytoma refers as a malignant plasma cell tumour growing within bones or extraosseous (extramedullary). Testicular plasmacytomas are rare malignant neoplasms with relatively poor prognosis. At the time of diagnosis, our patient did not have multiple myeloma Methods: A 87 year-old -patient presented to our hospital with a painless testicular mass, accompanied by a sense of heaviness. CT scan reveals a solid mass 6,5X5X4 cm in dimensions. An orchiectomy was the surgery of choice. On dissection of the surgical specimen, a brownish mass was recognized. Result(s): Microscopic examination showed a lesion composed entirely of mature and immature plasma cells, ranging from small and mature to large in size and atypical cells with prominent nucleoli. Sheets of plasma cells with abundant pink cytoplasm were also present invading the seminiferous tubules. Sparse, single, pale staining nuclear inclusions, with the morphologic features of "Dutcher bodies" were also present. Immunohistochemically, the neoplasm had the following profile: CD138 (+), CD19 (-), CD20 (-), CD117 (-), PLAP(-), CD56 (-), KLMW rarely (+). Confirmation of a clonal plasma cell lesion was accomplished immunohistochemically for Ig light chains. Conclusion(s): Plasmacytomas have been described in bones and in other tissues, most commonly in the upper respiratory tract with spread to cervical lymph nodes, but they may occur also in the gastrointestinal tract, breast, testis and in many other anatomical locations. Very few have been reported in the testis. Isolated testicular plasmacytoma accounts for only 0,03-0,1 %. The vast majority of patients with testicular plasmacytoma either have disseminated disease at the time of diagnosis, or develop disseminated disease later in life.

Balk, E. M., et al. (2019). "Adverse Events Associated with Nonsurgical Treatments for Urinary Incontinence in Women: a Systematic Review." Journal of General Internal Medicine 34(8): 1615-1625.
	Background: Urinary incontinence (UI) is a common malady in women. Numerous nonsurgical treatments are available, each associated with risk of adverse events (AEs). Method(s): We systematically reviewed nonsurgical interventions for urgency, stress, or mixed UI in women, focusing on AEs. We searched MEDLINE, Cochrane Central Trials Registry, Cochrane Database of Systematic Reviews, and Embase through December 4, 2017. We included comparative studies and single-group studies with at least 50 women. Abstracts were screened independently in duplicate. One researcher extracted study characteristics and results with verification by another independent researcher. When at least four studies of a given intervention reported the same AE, we conducted random effects model meta-analyses of proportions. We also assessed the strength of evidence. Result(s): There is low strength of evidence that AEs are rare with behavioral therapies and neuromodulation, and that periurethral bulking agents may result in erosion and increase the risk of voiding dysfunction. High strength of evidence finds that anticholinergics and alpha agonists are associated with high rates of dry mouth and constitutional effects such as fatigue and gastrointestinal complaints. Onabotulinum toxin A (BTX) is also associated with increased risk of urinary tract infections (UTIs) and voiding dysfunction (moderate strength of evidence). Discussion(s): Behavioral therapies and neuromodulation have low risk of AEs. Anticholinergics and alpha agonists have high rates of dry mouth and constitutional effects. BTX is associated with UTIs and voiding dysfunction. Periurethral bulking agents are associated with erosion and voiding dysfunction. These AEs should be considered when selecting appropriate UI treatment options. AE reporting is inconsistent and AE rates across studies tended to vary widely. Trials should report AEs more consistently.Copyright © 2019, Society of General Internal Medicine.

Ballav, S., et al. (2022). "PPAR-gamma Partial Agonists in Disease-Fate Decision with Special Reference to Cancer." Cells 11(20): 3215.
	Peroxisome proliferator-activated receptor-gamma (PPAR-gamma) has emerged as one of the most extensively studied transcription factors since its discovery in 1990, highlighting its importance in the etiology and treatment of numerous diseases involving various types of cancer, type 2 diabetes mellitus, autoimmune, dermatological and cardiovascular disorders. Ligands are regarded as the key determinant for the tissue-specific activation of PPAR-gamma. However, the mechanism governing this process is merely a contradictory debate which is yet to be systematically researched. Either these receptors get weakly activated by endogenous or natural ligands or leads to a direct over-activation process by synthetic ligands, serving as complete full agonists. Therefore, fine-tuning on the action of PPAR-gamma and more subtle modulation can be a rewarding approach which might open new avenues for the treatment of several diseases. In the recent era, researchers have sought to develop safer partial PPAR-gamma agonists in order to dodge the toxicity induced by full agonists, akin to a balanced activation. With a particular reference to cancer, this review concentrates on the therapeutic role of partial agonists, especially in cancer treatment. Additionally, a timely examination of their efficacy on various other disease-fate decisions has been also discussed.Copyright © 2022 by the authors.

Balsamo, R., et al. (2022). "Anterior colporrhaphy and sacrospinous hysteropexy in women with pelvic organ prolapse: Urodynamic findings and functional outcomes." European Journal of Obstetrics and Gynecology and Reproductive Biology 271: 255-259.
	Objectives: Aim of this study was to evaluate urodynamic effects and functional outcomes after anterior colporrhaphy and bilateral sacrospinous hysteropexy (SSH) in patients with stages II-IV pelvic organ prolapse (POP). Study design: This is a single-centre prospective study. Sixty-two women affected by anterior/central compartment prolapse of stage II-IV u ndergoing anterior colporrhaphy and bilateral SSH were recruited from our pelvic center. The preoperative evaluation included history, clinical examination, uroflowmetry and urodynamic studies (UDS). Six months after surgery, all patients performed UDS, completed the Urogenital Distress Inventory (UDI)-6, the Incontinence Impact Questionnaire (IIQ-7) and the Patient Global Impression of Improvement (PGI-I) questionnaire. Result(s): Median follow-up study was 11 months (range 6-24). Q max significantly improved compared with baseline (21.1 +/- 7.3 vs 12.3 +/- 7.1 ml/s; p = 0.005) and the percentage of patients with PVR > 30% of premicturitional bladder volume significantly decreased (33.3% vs 11.1%; p = 0.001). At baseline, 24 (38.7%) women had typical phasic DO. Six months after surgery, DO was detected in only eleven women (17.7%) (p < 0.0001), with no de novo cases. Thirteen (21%) women reported SUI preoperatively which persisted in 5 patients (8.1%) after surgery, with no de novo cases. BOO was observed in only eight (12.9%) patients postoperatively compared with 51 (82.3%) at baseline (p < 0.0001). At last follow up visit, the UDI-6 and IIQ-7 total median scores improved significantly (p < 0.001). Conclusion(s): Combination of anterior colporrhaphy and bilateral SSH in women with advanced POP provides good functional outcomes, as demonstrated by the urodynamic findings before and after surgery.Copyright © 2022 Elsevier B.V.

Baltacioglu, M., et al. (2023). "Does Peritoneal Metastasis Evaluation with 18F-FDG PET/ MRI Contribute to Prognosis Prediction in Patients with Ovarian Cancer." European Journal of Nuclear Medicine and Molecular Imaging 50(Supplement 1): S556.
	Aim/Introduction: The entity of peritoneal metastases in patients with ovarian cancer significantly affects the prognosis. Timely and accurate detection of ovarian cancer recurrences is important for disease survival. In this study, in patients who underwent 18F-FDG PET/CT and 18F-FDG PET/MRI for peritoneal metastasis evaluation in ovarian cancer; We aimed to compare the effects of both imaging modalities on prognosis. Material(s) and Method(s): 45 patients (median age: 58.1 years; min-max: 33-79 years) with ovarian cancer who developed elevated serum Ca-125 during follow-up after primary surgery and underwent 18F-FDG PET/ CT followed by PET/MR imaging for peritoneal disease restaging were prospectively included in this study. Peritoneal recurrences were evaluated on both imaging modalities and peritoneal carcinomatosis index (PCI) was calculated for each patient. PET/ CT and PET/MR images were evaluated on a patient basis for the presence and localization of peritoneal recurrences. After peritoneal disease staging by PET/CT and PET/MRI, patients received the treatment deemed appropriate by their clinicians and were followed up for survival analysis. The date of death was noted in exitus patients. Result(s): In patient-based analysis; PET/MRI was positive in 33 patient (73%), while PET/CT was positive in 27 patient (60%) (p=0.03). The median PCI score was 2 (min-max:0-26) in PET/CT and 4 (min-max:0-26) in PET/MRI (p<0.001). In Kaplan Meier survival analysis, FIGO stage (p<0.001), number of peritoneal lesions detected in PET/CT (p=0.017), PCI score in PET/CT (p=0.014), abdominopelvic lymph node SUVmax value in PET/CT (p=0.007), peritoneal lesion SUVmax value in PET/ MRI (p=0.035), abdominopelvic lymph node SUVmax value in PET/MRI (p=0.047) and PCI score in PET/MRI (p=0.027) were found to be parameters associated with overall survival. Conclusion(s): Although PET/MRI is more successful than PET/CT in showing peritoneal metastases, peritoneal uptake in PET/CT has been associated with prognosis. This suggests that PET/CT can be used for prognosis in patients with recurrent ovarian cancer.

Baltzer, H. (2022). "Treating post-menopausal women with symptomatic hand osteoarthritis with hormone replacement therapy." The Lancet Rheumatology 4(10): e654-e655.
	
Bambhroliya, Z., et al. (2022). "Diabetes, Polycystic Ovarian Syndrome, Obstructive Sleep Apnea, and Obesity: A Systematic Review and Important Emerging Themes." Cureus 14(6): e26325.
	Type 2 diabetes mellitus (DM), polycystic ovarian syndrome (PCOS), obstructive sleep apnea (OSA), and obesity represent four large and growing patient populations. A great deal of scientific and clinical knowledge has been developed for them individually, and significant advancements made. Taken as a group, however, the interrelationships are not as well understood. The purpose of this systematic review is to identify the body of existing research that ties them together and then to identify and discuss the prevailing themes, particularly for cause-and-effect mechanisms. PubMed, Google Scholar, and ScienceDirect were used to identify systematic reviews and meta-analysis articles to establish the broadest reach. Initially, 434 articles were carefully screened, out of which 22 most relevant studies were reviewed. Five important themes were distilled from these papers based on continued and consistent emphasis in the literature. These themes include topics such as the importance of considering visceral obesity rather than Body Mass Index (BMI), the most effective treatment approaches, including mounting support for melatonin and circadian rhythm management, the results of OSA in its feed-forward contribution to hormone imbalance, the role of non-obesity-related risk factors to PCOS and OSA such as age and genetic predisposition, and growing evidence to suggest the importance of mental health as a comorbidity in addition to the more traditional ones such as cardiovascular pathology. A new framework for investigating the interaction across these four disorders is offered that includes a revised perspective on the specific role of PCOS, perhaps being further upstream relative to the others. There currently exists a lack of well-designed randomized controlled trials in this particular area of medicine, an endeavor we believe could result in significant value, particularly as it relates to treatment approaches.; Competing Interests: The authors have declared that no competing interests exist. (Copyright © 2022, Bambhroliya et al.)

Ban, M., et al. (2024). "Association between maternal polycystic ovarian syndrome undergoing assisted reproductive technology and pregnancy complications and neonatal outcomes: a systematic review and meta-analysis." Journal of Ovarian Research 17(1): 6.
	Background: Polycystic ovarian syndrome (PCOS) is recognized as the most prevalent endocrine disorder among women of reproductive age. While the utilization of assisted reproductive technology (ART) has resulted in favorable outcomes for infertility treatment in PCOS patients, the inherent pathophysiological features of the condition give rise to complications and consequences during pregnancy and delivery for both the mother and offspring. This study was to assess the correlation between maternal PCOS and various pregnancy complications and neonatal outcomes undergone ART.; Methods: A systematic search was conducted on PubMed, EmBase, and the Cochrane Library to identify observational studies that investigated the association between PCOS and the risk of various pregnancy complications and neonatal outcomes, including gestational diabetes mellitus (GDM), hypertension in pregnancy (PIH), preeclampsia (PE), preterm birth, abortion, congenital malformations (CA), small for gestational age (SGA), large for gestational age (LGA), low birth weight (LBW), macrosomia, neonatal intensive care unit (NICU) admission and birth weight. Eligible studies were selected based on predetermined inclusion and exclusion criteria. The meta-analysis was conducted using Review Manager and Stata software, with odds ratios (ORs) or mean difference (MD), confidence intervals (CIs), and heterogeneity (I 2 ) being calculated. The search was conducted up to March 2023.; Results: A total of 33 studies with a combined sample size of 92,810 participants were identified. The findings indicate that PCOS is significantly associated with an increased risk of GDM (OR 1.51, 95% CI:1.17-1.94), PIH (OR 1.72, 95% CI:1.25-2.39), PE (OR 2.12, 95% CI:1.49-3.02), preterm birth (OR 1.29, 95% CI:1.21-1.39), and LBW (OR 1.29, 95% CI:1.14-1.47). In subgroup analyses, the risks of GDM (OR 1.80, 95% CI:1.23-2.62) and abortion (OR 1.41, 95% CI:1.08-1.84) were elevated in fresh embryo transferred (ET) subgroup, whereas elevated risk of PE (OR 1.82, 95% CI:1.17-2.83) and preterm birth (OR 1.31, 95% CI:1.21-1.42) was identified in frozen ET subgroup. Whatever with or without hyperandrogenism, patients with PCOS had a higher risk in preterm birth (OR 1.69, 95% CI: 1.31-2.18; OR 1.24, 95% CI:1.02-1.50) and abortion (OR 1.38, 95% CI:1.12-1.71; OR 1.23, 95% CI:1.06-1.43).; Conclusion: Our findings suggest that individuals with PCOS undergone ART are at a notably elevated risk for experiencing pregnancy complications and unfavorable neonatal outcomes. Nevertheless, to establish a definitive association between PCOS and pregnancy-related outcomes, it is necessary to conduct extensive prospective, blinded cohort studies and effectively control for confounding variables. (© 2024. The Author(s).)

Banas, J., et al. (2023). "Outcome of transobturator sling for treatment of female stress urinary incontinence applied as a single procedure or concomitantly with pelvic organ prolapse surgery." Annals of agricultural and environmental medicine : AAEM 30(1): 190-194.
	Introduction and Objective: The aim of the study was to check the safety and efficacy of transobturator tape (TOT) combined with various prolapse procedures. The results were compared with outcomes of sling performed as an alone surgery. Risk factors for TOT failure were also identified.; Material and Methods: The study comprised 219 patients with sling alone (Group SUI) and 221 after TOT combined with concomitant prolapse surgery (Group POP/SUI). Medical records were carefully reviewed to obtain demographic and clinical data, details of surgery, including intra-and postoperative complications.; Results: Subjective cure rate was slightly, but statistically significantly, higher in POP/SUI group (89.6% vs 82.6%; ch 2 = 4.44; p = 0.035). There was no significant difference in sling efficacy dependant of type of POP surgery. Post-operative urine retention was more frequent in POP/SUI group compared to SUI group (18.6% vs 3.2%; ch 2 = 34.36; p < 0.001). Logistic regression showed that age, BMI and prolonged pos-operative urine retention are independent factors affecting TOT outcome. Age ≥65years and BMI ≥30kg,m 2 more than doubled the risk of failure: OR 2.348, CI 95% (1.330-4.147); p = 0.003 and 2.030, (95% CI 1.148-3.587); p = 0.015; respectively. Interestingly, post-operative urine retention appeared to be a positive prognostic factor OR 0.145, (95% CI 0.019-1.097); p < 0.05.; Conclusions: Subjective efficacy of TOT used concomitantly with POP procedures is slightly higher than TOT alone. Better sling outcomes can be expected both for POP procedures involving both the anterior and posterior compartments. Age and obesity are independent factors of TOT failure, whereas prolonged post-operative urine retention is a positive predictive factor of TOT success.

Banaszewska, B., et al. (2019). "Current and future aspects of several adjunctive treatment strategies in polycystic ovary syndrome." Reproductive biology 19(4): 309-315.
	Polycystic ovary syndrome (PCOS) is a common endocrinopathy in women of reproductive age. PCOS is characterized by hyperandrogenism, menstrual disorders, and polycystic ovarian morphology. PCOS patients have an increased risk of type 2 diabetes, cardiovascular disease, and infertility. The mechanism of PCOS is not yet fully understood, but insulin resistance and genetic factors may play distinct roles in the pathomechanism. There is ongoing research on new therapeutic modalities for women with PCOS. In this minireview, we assessed the evidence for the effectiveness and safety of selected adjunctive agents (metformin, statins, resveratrol, melatonin, and inositols) for the treatment of women with PCOS. Metformin is a safe medication used in PCOS for 25 years that is currently recommended in select PCOS subpopulations, such as adolescents, women with metabolic disorders, and infertility infertile women undergoing ovarian hyperstimulation. Statins are also suggested in PCOS therapy, as these compounds decrease testosterone concentrations, improve lipid profiles, and ameliorate inflammatory reactions. Despite promising results, the role of statins in PCOS management needs to be further validated. Dietary supplements have also been tested in PCOS patients. Resveratrol was shown to decrease total testosterone production and improve fasting insulin but, until recently, only in one randomized study. Data on the therapeutic efficacy of melatonin and inositols on endocrine and metabolic abnormalities are limited and inconclusive. The multifactorial etiology of PCOS makes tailoring of its treatment more demanding, and there is a constant need for causative and effective modes of PCOS therapy. (Copyright © 2019. Published by Elsevier B.V.)

Banerjee, S., et al. (2022). "Title: A Randomised, Multi-centre Phase II Trial of Weekly Paclitaxel and Vistusertib in Platinum-Resistant Ovarian High-Grade Serous Carcinoma: OCTOPUS Arm 1." MedRxiv.
	Background Preclinical studies support targeting PI3K/AKT/mTOR signalling in platinum-resistant ovarian cancer (PROC). A phase I study of the dual mTORC1/mTORC2 inhibitor vistusertib with weekly paclitaxel (wP) showed activity. We report the results of Arm 1 of OCTOPUS, the first randomised trial of weekly paclitaxel and dual mTORC1/2 inhibition in ovarian cancer. Methods Patients with platinum-resistant or refractory high grade serous carcinoma were randomised (1:1) to wP (80mg/m2 D1,8,15 of 28 day cycle) plus oral vistusertib (50mg BD) or placebo (P). The primary endpoint was progression-free survival (PFS). Secondary endpoints included response rate (RR) and overall survival (OS). Results 140 patients (median age 63, range: 36-86; 18% platinum-refractory; 54% >=3 prior therapies) were randomised. There was no difference in PFS (median 4.5 vs 4.1m (HR 0.84; 80% CI (0.67, 1.07); 1-sided p=0.18), OS (median 9.7 vs 11.1m (HR 1.21; 80% CI (0.91, 1.60); 1-sided p=0.80) or RR (odds ratio 0.86; 80% CI (0.55, 1.36); 1-sided p=0.66). Grade 3/4 adverse events were 41.2% (wP+V) vs 36.7% (wP+P). Low tumour PTEN expression was associated with longer PFS in the wP+V arm (9.4 vs 4.1m p=0.003) but not in the wP arm (4.8 vs 4.2m p=0.60). Tumour genome-wide copy number (CN) analysis suggested that high CN signature 4 was associated with worse outcome in the wP+P arm (2.3 vs 4.6m p=0.018) but not the wP+V arm (5.4 vs 3.3m). Conclusions Vistusertib did not improve clinical activity of wP in PROC. However, low tumour cell PTEN expression may be a predictive biomarker for vistusertib activity.Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-ND 4.0 International license.

Banerjee, S., et al. (2022). "A Phase I Trial of CT900, a Novel α-Folate Receptor-Mediated Thymidylate Synthase Inhibitor, in Patients with Solid Tumors with Expansion Cohorts in Patients with High-Grade Serous Ovarian Cancer." Clinical cancer research : an official journal of the American Association for Cancer Research 28(21): 4634-4641.
	Purpose: CT900 is a novel small molecule thymidylate synthase inhibitor that binds to α-folate receptor (α-FR) and thus is selectively taken up by α-FR-overexpressing tumors.; Patients and Methods: A 3+3 dose escalation design was used. During dose escalation, CT900 doses of 1-6 mg/m2 weekly and 2-12 mg/m2 every 2 weeks (q2Wk) intravenously were evaluated. Patients with high-grade serous ovarian cancer were enrolled in the expansion cohorts.; Results: 109 patients were enrolled: 42 patients in the dose escalation and 67 patients in the expansion cohorts. At the dose/schedule of 12 mg/m2/q2Wk (with and without dexamethasone, n = 40), the most common treatment-related adverse events were fatigue, nausea, diarrhea, cough, anemia, and pneumonitis, which were predominantly grade 1 and grade 2. Levels of CT900 more than 600 nmol/L needed for growth inhibition in preclinical models were achieved for >65 hours at a dose of 12 mg/m2. In the expansion cohorts, the overall response rate (ORR), was 14/64 (21.9%). Thirty-eight response-evaluable patients in the expansion cohorts receiving 12 mg/m2/q2Wk had tumor evaluable for quantification of α-FR. Patients with high or medium expression had an objective response rate of 9/25 (36%) compared with 1/13 (7.7%) in patients with negative/very low or low expression of α-FR.; Conclusions: The dose of 12 mg/m2/q2Wk was declared the recommended phase II dose/schedule. At this dose/schedule, CT900 exhibited an acceptable side effect profile with clinical benefit in patients with high/medium α-FR expression and warrants further investigation. (©2022 The Authors; Published by the American Association for Cancer Research.)

Banerjee, S., et al. (2021). "Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial." The Lancet. Oncology 22(12): 1721-1731.
	BACKGROUND: There is a high unmet need for treatment regimens that increase the chance of long-term remission and possibly cure for women with newly diagnosed advanced ovarian cancer. In the primary analysis of SOLO1/GOG 3004, the poly(ADP-ribose) polymerase (PARP) inhibitor olaparib significantly improved progression-free survival versus placebo in patients with a BRCA mutation; median progression-free survival was not reached. Here, we report an updated, post-hoc analysis of progression-free survival from SOLO1, after 5 years of follow-up. METHODS: SOLO1 was a randomised, double-blind, placebo-controlled, phase 3 trial, done across 118 centres in 15 countries, that enrolled patients aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0-1 and with BRCA-mutated, newly diagnosed, advanced, high-grade serous or endometrioid ovarian cancer with a complete or partial clinical response after platinum-based chemotherapy. Patients were randomly assigned (2:1) via a web-based or interactive voice-response system to receive olaparib (300 mg twice daily) or placebo tablets orally as maintenance monotherapy for up to 2 years; randomisation was by blocks and was stratified according to clinical response after platinum-based chemotherapy. Patients, treatment providers, and data assessors were masked to group assignment. The primary endpoint was investigator-assessed progression-free survival. Efficacy is reported in the intention-to-treat population and safety in patients who received at least one dose of treatment. The data cutoff for this updated, post-hoc analysis was March 5, 2020. This trial is registered with ClinicalTrials.gov (NCT01844986) and is ongoing but closed to new participants. FINDINGS: Between Sept 3, 2013, and March 6, 2015, 260 patients were randomly assigned to olaparib and 131 to placebo. The median treatment duration was 24·6 months (IQR 11·2-24·9) in the olaparib group and 13·9 months (8·0-24·8) in the placebo group; median follow-up was 4·8 years (2·8-5·3) in the olaparib group and 5·0 years (2·6-5·3) in the placebo group. In this post-hoc analysis, median progression-free survival was 56·0 months (95% CI 41·9-not reached) with olaparib versus 13·8 months (11·1-18·2) with placebo (hazard ratio 0·33 [95% CI 0·25-0·43]). The most common grade 3-4 adverse events were anaemia (57 [22%] of 260 patients receiving olaparib vs two [2%] of 130 receiving placebo) and neutropenia (22 [8%] vs six [5%]), and serious adverse events occurred in 55 (21%) of 260 patients in the olaparib group and 17 (13%) of 130 in the placebo group. No treatment-related adverse events that occurred during study treatment or up to 30 days after discontinuation were reported as leading to death. No additional cases of myelodysplastic syndrome or acute myeloid leukaemia were reported since the primary data cutoff, including after the 30-day safety follow-up period. INTERPRETATION: For patients with newly diagnosed advanced ovarian cancer and a BRCA mutation, after, to our knowledge, the longest follow-up for any randomised controlled trial of a PARP inhibitor in this setting, the benefit derived from 2 years' maintenance therapy with olaparib was sustained beyond the end of treatment, extending median progression-free survival past 4·5 years. These results support the use of maintenance olaparib as a standard of care in this setting. FUNDING: AstraZeneca; Merck Sharpe & Dohme, a subsidiary of Merck & Co, Kenilworth, NJ, USA.

Banerjee, S., et al. (2021). "ATARI trial: ATR inhibitor in combination with olaparib in gynecological cancers with ARID1A loss or no loss (ENGOT/GYN1/NCRI)." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 31(11): 1471-1475.
	BACKGROUND: ARID1A (AT-rich interactive domain containing protein 1A) loss-of-function mutations have been reported in gynecological cancers, including rarer subtypes such as clear cell carcinoma. Preclinical studies indicate that ARID1A mutant cancers display sensitivity to ATR inhibition while tumors without ARID1A mutations may be sensitive to Ataxia telangiectasia and Rad3 related (ATR) inhibitors in combination with poly-ADP ribose polymerase (PARP) inhibitors. PRIMARY OBJECTIVE: To determine whether the ATR inhibitor, ceralasertib, has clinical activity as a single agent and in combination with the PARP inhibitor, olaparib, in patients with ARID1A 'loss' and 'no loss' clear cell carcinomas and other relapsed gynecological cancers. STUDY HYPOTHESIS: ARID1A deficient clear cell carcinoma of the ovary or endometrium is sensitive to ATR inhibition, while the combination of ATR and PARP inhibition has activity in other gynecological tumors, irrespective of ARID1A status. TRIAL DESIGN: ATARI (ENGOT/GYN1/NCRI) is a multicenter, international, proof-of-concept, phase II, parallel cohort trial assessing ceralasertib activity as a single agent and in combination with olaparib in ARID1A stratified gynecological cancers. Patients with relapsed ovarian/endometrial clear cell carcinoma with ARID1A loss will receive ceralasertib monotherapy (cohort 1A). Relapsed ovarian/endometrial clear cell carcinoma patients with no ARID1A loss (cohort 2) or patients with other histological subtypes (endometrioid, carcinosarcoma, cervical) (cohort 3) will receive combination therapy (olaparib/ceralasertib). Treatment will continue until disease progression. MAJOR INCLUSION/EXCLUSION CRITERIA: Patients with histologically confirmed recurrent clear cell (ovarian, endometrial, or endometriosis related), endometrioid (ovarian, endometrial, or endometriosis related), cervical (adenocarcinomas or squamous), or carcinosarcomas (ovarian or endometrial) are eligible. Patients progressing after ≥1 prior platinum with evidence of measurable (RECIST v1.1) radiological disease progression since last systemic anticancer therapy and prior to trial entry are eligible. Previous ATR or PARP inhibitor treatment is not permissible. PRIMARY ENDPOINT: Best overall objective response rate (RECIST v1.1). SAMPLE SIZE: A minimum of 40 and a maximum of 116. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Accrual is anticipated to be complete by the second quarter of 2022, with reporting of results by the fourth quarter of 2022. Overall accrual targets and reporting timelines are dependent on individual cohort progression to stage 2. TRIAL REGISTRATION NUMBER: NCT0405269.

Banerjee, S. N., et al. (2022). "ENGOT-ov60/GOG-3052/RAMP 201: A phase 2 study of VS-6766 (RAF/MEK clamp) alone and in combination with defactinib (FAK inhibitor) in recurrent low-grade serous ovarian cancer (LGSOC)." Journal of Clinical Oncology 40(16 Supplement 1).
	Background: Low-grade serous ovarian cancer (LGSOC) constitutes up to 10% of all ovarian cancer and has clinical and molecular characteristics distinct from high-grade serous ovarian cancer. Approximately a third of patients (pts) with recurrent LGSOC harbor KRAS mutations (mt) and pts with KRAS wild-type (wt) LGSOC may have mutations in NRAS, BRAF, or other RAS pathway-associated genes. Prior clinical studies with single agent MEK inhibitors have shown response rates of 16-26% in recurrent LGSOC. VS-6766 is a unique small molecule RAF/MEK clamp that inhibits both RAF and MEK activities by trapping them in inactive complexes. This mechanism of blockade has been shown to limit compensatory MEK activation, thereby potentially enhancing efficacy of MEK inhibition. Focal adhesion kinase (FAK) activation is a putative resistance mechanism to RAF and MEK inhibition, and defactinib, a small molecule inhibitor of FAK, has shown synergistic anti-tumor activity with VS-6766 in preclinical models, including organoids from LGSOC pts. Furthermore, FAK inhibition combined with VS-6766 induces tumor regression in a KRAS mt ovarian cancer xenograft model. The combination of VS-6766 and defactinib is currently being evaluated in the ongoing Investigator Sponsored FRAME study (NCT03875820). In this proof-of-concept study, durable objective responses (ORR = 46%; 11/ 24) have been reported in recurrent LGSOC pts, including pts who have had a prior MEK inhibitor (Banerjee ESMO 2021) and the combination of VS-6766 + defactinib has received FDA Breakthrough Therapy Designation for recurrent LGSOC. These initial preclinical and clinical results support the ongoing phase 2 ENGOT-ov60/GOG-3052 in recurrent LGSOC. Method(s): This is an international phase 2, adaptive, multicenter, randomized, open label study designed to evaluate the efficacy and safety of VS-6766 vs VS-6766 in combination with defactinib currently open to enrollment (NCT04625270). The study will be conducted in two parts. Part A will determine the optimal regimen based on confirmed overall response rate (independent radiology review) in KRAS mt and KRAS wt LGSOC. Part B will determine the efficacy of the optimal regimen identified in Part A in KRAS mt and KRAS wt LGSOC. The minimum expected enrollment is 104 pts, 52 pts with KRAS mt and 52 KRAS wt (64 pts in Part A and 40 pts in Part B). Pts will be randomized to receive VS-6766 (4.0 mg orally (PO), twice weekly 3 wks on, 1 wk off) or VS-6766 with defactinib (VS-6766 3.2 mg PO, twice weekly + defactinib 200 mg PO BID 3 wks on, 1 wk off) till progression. Key inclusion criteria include histologically confirmed LGSOC, known KRAS mutation status, prior systemic therapy including platinum for metastatic disease and up to 1 prior line of MEK inhibitor therapy permitted. Part A of this study has completed enrollment and Part B is currently enrolling pts.

Bang, Y. J., et al. (2024). "Analgesic efficacy of erector spinae plane block in patients undergoing major gynecologic surgery: A randomized controlled study." Journal of Clinical Anesthesia 93: 111362.
	Study objective: To investigate the analgesic efficacy of erector spinae plane block (ESPB) in major gynecologic surgery, expressed as cumulative opioid consumption 24 h after surgery. Design(s): A single-center, patient-assessor blinded, randomized controlled study. Setting(s): Samsung medical center (tertiary university hospital), between February 2022 to January 2023. Patient(s): Eighty-eight females undergoing major surgery with long midline incision for gynecologic malignancy. Intervention(s): Patients were randomly assigned to receive standard systemic analgesia (Control group) or ESPB (ESPB group). ESPB was performed bilaterally at the level of the 9th thoracic vertebra with a mixture of 20 mL of 0.5% ropivacaine and 100 mug of epinephrine. Measurements: The primary outcome was cumulative opioid consumption at 24 h postoperatively. Secondary outcomes included opioid consumption and pain severity during the 72 h after surgery. The variables regarding postoperative recovery and patient-centered outcomes were compared. Main Result(s): The mean cumulative opioid consumption 24 h after surgery was 35.8 mg in the ESPB group, which was not significantly different from 41.4 mg in the control group (mean difference, 5.5 mg; 95% CI -1.7 to 12.8 mg; P = 0.128). However, patient satisfaction regarding analgesia was significantly higher in the ESPB group compared with the control group at 24 h postoperative (median difference, -1; 95% CI -3 to 0; P = 0.038). There were no significant differences in the variables associated with postoperative recovery. Conclusion(s): ESPB did not reduce opioid consumption during the 24 h postoperative but attenuated pain intensity during the early period after surgery.Copyright © 2023 Elsevier Inc.

Bang Yu, J., et al. (2023). "The Effect of Intrathecal Morphine on Postoperative Opioid Consumption in Patients Undergoing Abdominal Surgery for Gynecologic Malignancy: A Randomized Sham-Controlled Trial." Anesthesia and analgesia 137(3): 525-533.
	Background: Surgery for gynecologic malignancy via midline-laparotomy leads to severe postoperative pain. Adequate pain control while sparing opioid consumption does offer benefits in postoperative complications and recovery. Intrathecal morphine (ITM) provides simple and effective analgesia. In this randomized trial, we compared postoperative opioid consumption in patients who received either ITM or a sham procedure.; Methods: We enrolled 68 adult patients undergoing open gynecologic oncology surgery from June 2021 to November 2021. They were randomly allocated to the ITM group (ITM; 200 μg injection) or sham group (sham procedure) to achieve a final 1:1 ratio between groups. We compared opioid consumption and pain severity during 72 hours after surgery. The variables regarding postoperative recovery and patient-centered outcomes were collected. The primary outcome is cumulative intravenous (IV) opioid consumption 24 hours after surgery.; Results: The median (interquartile range) cumulative IV opioid consumption during 24 hours after surgery was 18 mg (12-29) in the ITM group and 36 mg (27-42) in the sham group (median difference, 13; 95% confidence interval, 7.2-20.7; P < .001). Patient satisfaction regarding pain control was statistically significantly higher in the ITM group than in the sham group at postoperative 24 and 48 hours ( P < .001 and P = .005, respectively). There were no significant differences in the variables associated with postoperative recovery and frequency of complications requiring treatment.; Conclusions: ITM is a safe and effective analgesic method after curative intent laparotomy for gynecologic malignancy. ITM provides better pain relief, reduces opioid consumption, and improves patient satisfaction without additional evident adverse events.; Competing Interests: The authors declare no conflicts of interest. (Copyright © 2023 International Anesthesia Research Society.)

Bánhidi, A. and Z. Novák (2022). "[Robotic surgery in gynecologic cancer, especially in cervical cancer]." Magyar onkologia 66(4): 295-301.
	The development of robotic surgery is another step in the evolution of modern surgery. Robot-assisted minimally invasive procedures undoubtedly have many advantages compared to traditional laparotomy, which is why they have also been introduced in the treatment of gynecological cancers. Numerous studies have confirmed the advantages of robotic surgery in terms of quicker recovery, reduced blood loss, and shorter hospitalization. The technique provides a significant advantage in the minimally invasive treatment of overweight patients. However, in the treatment of cervical cancer, the use of minimally invasive procedures have declined in recent years due to worse oncological results. It is necessary to carry out further clinical trials in this indication using surgical solutions that prevent the spread of the tumor, in order to find out whether minimally invasive surgery regains its important role in the surgical treatment of early cervical cancer.

Bansal, K., et al. (2023). "Herbal Medicines - a Fruitful Approach to Periodic Illness Dysmenorrhoea: Evidence-based Review." Current pharmaceutical biotechnology.
	Dysmenorrhea (menstrual or periodic pain) is a discomfort that occurs during painful periods. It is the first and most prominent reason for female lower abdominal pain. Most adolescent girls consider it a curse due to the periodic occurrence of painful cramps and bleeding. The pathogenesis of painful periods is most likely because of increased prostanoids, notably prostaglandins, produced by the cyclooxygenase pathway (PGs). Misuse of synthetic medications leads to the development of medication resistance and deposits toxic residues in the body; thus, there is a critical need for safe and effective alternatives. In recent decades, herbal treatment approaches have found extensive applications in the treatment of various ailments. Herbal therapies are an alternate source, which include several bioactive chemicals, and recent improvements in our understanding of the value of herbal therapy methods have caused a sharp rise in their production. The main focus of this review was to study herbal treatment options; the recent studies conducted on herbal therapies and various experimental investigations on dysmenorrhea and herbal therapy methods have been studied, and randomized controlled trials and animal models have been discussed describing the anti-inflammatory properties of some potential herbal medicines that can be used as treatment options for dysmenorrhoea. This review aimed to present herbal treatments that can be used as alternative traditional synthetic medications and oral hormonal contraceptives in the treatment of painful menstruation. (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Bantum, E. O., et al. (2023). "Hula as a physical activity and social support intervention for sustained activity in female breast and gynecologic cancer survivors." Frontiers in psychology 14: 1190532.
	BACKGROUND: Physical activity improves health and psychosocial functioning for people who have been diagnosed with cancer. Native Hawaiians face disparities for some cancers, including breast cancer. Delivering culturally grounded interventions has the potential to improve enjoyment and adherence to the intervention. We sought to test the adherence and impact of a 6 month randomized wait-list controlled trial of hula. METHODS: In this randomized wait-list controlled design people who had been diagnosed with breast or gynecologic cancers were invited to participate with other cancer survivors in a group based setting. Participants were randomized to begin hula immediately or after six months. Attendance was collected and heart-rate measured three times per session. In addition, demographic data, self-report psychosocial data, and biological data (findings will be reported elsewhere) were collected at three time points: baseline, 6 months, and 12 months. The study included six months of hula, twice per week, 60 min each session. In addition, participants committed to practice 60 min per week at home. RESULTS: Participants in the study (n = 42) attended, on average, 72% of the sessions. Significant increase in moderate physical activity (d = 0.50, p = 0.03) was observed in the intervention versus control group. For the measures of intra-individual changes pre-and post-intervention, an increase in total physical activity were seen in the intervention group (d = 0.69, p = 0.003), daily caloric intake decreased (d = -0.62, p = 0.007), and a reduction in waist circumference (d = -0.89, p = 0.0002) that was sustained six months after completion of the intervention. Psychosocially, cognitive functioning significantly declined from baseline to 12 months (d = -0.50, p = 0.03), with role functioning improving (d = 0.55, p = 0.02), social constraints increasing (d = 0.49, p = 0.03), and financial difficulties improving (d = -0.55, p = 0.02). CONCLUSION: Sustainable physical activity is crucial to improve both the survival and quality of life of cancer survivors. Culturally grounded interventions, such as hula have the potential to increase the maintenance of physical activity. In addition, they create a support group where the benefits of people who have all experienced cancer can gather and garner those benefits of social support, too. This study was registered as a clinical trial through the National Cancer Institute (NCT02351479). CLINICAL TRIAL REGISTRATION: Clinicaltrails.gov, NCT02351479.

Banys-Kotomska, J., et al. (2023). "Physical activity and pelvic floor muscle training during pregnancy: review of international recommendations." Ginekologia polska.
	Physical activity is associated with beneficial health effects for both mother and her future child, as well as the course of pregnancy. The aim of this review was the comparison of international guidelines with Polish recommendations. Data were collected from PubMed platform and international guidelines and narrowed to open access studies published between 1990-2023 in English, German and Polish. The existing literature shows an increase of interest in the impact of body activity during pregnancy and pelvic floor muscle training (PFMT). The recommendations move away from the more conservative approach, that previously suggested limitation of all exercise-related activities. Recently, The Polish Society of Gynecologists and Obstetricians and Polish Society of Sports Medicine announced a planned release of joint recommendations on physical activity during pregnancy and after childbirth, as well as the translation of the "Get Active Questionnaire for Pregnancy", a screening tool for pregnant women, doctors and midwives, developed in accordance with the recommendations of international gynecological societies.

Bao, T., et al. (2021). "Health-Related Quality of Life in Cancer Survivors with Chemotherapy-Induced Peripheral Neuropathy: A Randomized Clinical Trial." The Oncologist 26(11): e2070-e2078.
	BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a common, debilitating adverse effect of neurotoxic chemotherapy that significantly worsens the quality of life of cancer survivors. MATERIALS AND METHODS: Survivors of solid tumors with persistent moderate-to-severe CIPN defined as numbness, tingling, or pain rated ≥4 on an 11-point numeric rating scale (NRS) were randomized in a 1:1:1 ratio to 8 weeks of real acupuncture (RA) versus sham acupuncture (SA) versus usual care (UC). We previously reported the primary endpoint (NRS); here we report the following health-related quality of life endpoints: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), Hospital Anxiety and Depression Scale (HADS), Insomnia Severity Index (ISI), and Brief Fatigue Inventory (BFI). For each endpoint, the mean changes from baseline and 95% confidence intervals were estimated within each arm and compared between arms using linear mixed models. RESULTS: We enrolled 75 survivors of solid tumors with moderate-to-severe CIPN into the study. Compared with baseline, at week 8, FACT/GOG-Ntx, HADS anxiety, and ISI scores significantly improved in RA and SA, but not in UC. Compared with UC, at week 8, FACT/GOG-Ntx scores significantly increased in RA and SA arms indicating improved CIPN-related symptoms and quality of life (p = .001 and p = .01). There was no statistically significant difference between RA and SA. There was no difference in HADS depression or BFI among RA, SA, and UC at weeks 8 and 12. CONCLUSION: Acupuncture may improve CIPN-related symptoms and quality of life in cancer survivors with persistent CIPN. Further large sample size studies are needed to delineate placebo effects. IMPLICATIONS FOR PRACTICE: The authors conducted a randomized sham acupuncture- and usual care-controlled clinical trial to evaluate the impact of acupuncture on health-related quality of life outcomes in patients with solid tumors with chemotherapy-induced peripheral neuropathy (CIPN). Statistically significant improvements in quality of life, anxiety, insomnia, and fatigue were achieved with 8 weeks of real acupuncture when compared with baseline, without statistically significant differences between real and sham acupuncture. These findings suggest that acupuncture may be effective for improving CIPN-related symptoms and quality of life and reducing anxiety and insomnia in cancer survivors with persistent CIPN, with further study needed to delineate placebo effects.

Bao, W. and Z. Li (2024). "Efficacy and safety of neoadjuvant chemotherapy containing anti-angiogenic drugs, immunotherapy, or PARP inhibitors for ovarian cancer." Critical Reviews in Oncology/Hematology 194: 104238.
	Ovarian cancer is the most lethal gynecologic malignancy. The standard treatment involves chemotherapy with platinum-paclitaxel following cytoreductive surgery. For patients battling widespread and aggressive tumor spread, neoadjuvant chemotherapy (NACT) followed by interval debulking surgery emerges as an encouraging alternative. However, the effectiveness of this strategy is often limited by advanced-stage diagnosis and high likelihood of recurrence. The high mortality rate necessitates the exploration of targeted therapies. Present results signal promising efficacy and acceptable toxicities of anti-angiogenic drugs, immunotherapy, or PARP inhibitors used in chemotherapy. However, the potential integration of these drugs into NACT raises questions about response rates, surgical outcomes, and adverse events. This review delves into the findings from all published articles and ongoing studies, aiming to summarize the clinical use of anti-angiogenic drugs, immunotherapy, or PARP inhibitors in NACT, highlight the positive and negative aspects, and outline future perspectives.; Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare. (Copyright © 2024 Elsevier B.V. All rights reserved.)

Bao, X., et al. (2021). "Meta-analysis on current status, efficacy, and safety of laparoscopic and robotic ventral mesh rectopexy for rectal prolapse treatment: can robotic surgery become the gold standard?" International Journal of Colorectal Disease 36(8): 1685-1694.
	Purpose: Robotic-assisted surgery and robotic-assisted ventral mesh rectopexy are gaining attention in the treatment of rectal prolapse and increased positive findings are proposed. The objective of this meta-analysis was to investigate whether robotic-assisted ventral mesh rectopexy is comparable with the conventional laparoscopic approach surgery.; Methods: Five major databases (PubMed, Sciencedirect, Web of Science, Embase, and Cochrane Library) were searched for eligible studies. Observational studies of the effect and safety of robotic-assisted and laparoscopic approaches on ventral mesh rectopexy were included. Odd ratios (OR) and weight mean difference (WMD) were used for dichotomous data and continuous data analysis. Clinical outcomes, functional outcomes, and cost-effectiveness data were extracted for meta-analysis.; Results: Compared to the laparoscopic approach, a significant shorter length of hospital stay (LOS), lesser intraoperative blood loss, and lower post-operative complication rate of RVMR group were observed. However, operation time of RVMR was significant increased. The expense of RVMR was higher than LVMR; mean Wexner scores and fecal incontinence were lower in RVMR group while there were no statistical differences.; Conclusion: The result of the current analysis revealed that the robotic-assisted ventral mesh rectopexy is effective and feasible in the treatment of rectal prolapse. However, long-term follow-up and results are needed for the promotion of this approach. There is a long way for robotic-assisted surgery to become a gold standard in rectal surgery. (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature.)

Barachisio, L., et al. (2023). "Transobturator Versus Minisling for Urinary Incontinence: A Randomized Controlled Trial." Urogynecology (Philadelphia, Pa.).
	IMPORTANCE: The comparison between single-incision slings (SISs) and midurethral slings has been documented in the literature, but results vary according to the SIS device. OBJECTIVE(S): The purpose of this study is to assess whether SIS (Solyx) is noninferior to transobturator (TOT) (Obtryx) sling for treating women with confirmed stress-predominant urinary incontinence. STUDY DESIGN: A prospective, parallel, nonblinded, multicenter, noninferiority, randomized controlled study with 114 patients were randomized and followed 6 and 12 months after surgery. Interventions were midurethral TOT sling (Obtryx-halo; n = 58) or SIS (Solyx; n = 56). The primary outcome was improvement in the Patient Global Impression of Improvement (PGI-I). Secondary outcomes were the Kings Health Questionnaire (KHQ) instruments after treatment, subjective improvement, and surgical outcomes. RESULT(S): Both groups were homogeneous (P = NS) regarding sociodemographic and clinical variables. There was improvement in the PGI-I after 6 (P = 0.001) and 12 months (P = 0.001) of treatment for women who underwent TOT sling. After 6 months, KHQ scores improved in the TOT group for the following domains: role limitations (P = 0.026) and physical limitations (P = 0.006). After 12 months, the TOT group presented better KHQ scores that were statistically significant from the SIS group in incontinence impact (P = 0.012), physical limitations (P = 0.001), and severity measures (P = 0.017). Moreover, the TOT group presented higher subjective improvement after 6 months (P = 0.006) than the SIS group. Mesh erosion was higher in the SIS group (P = 0.006). Reoperations were not statistically different between groups. CONCLUSION(S): There were higher scores in the PGI-I score and higher subjective improvement for the TOT sling after 6 and 12 months of treatment when compared with the SIS group.Copyright © 2023 American Urogynecologic Society. All rights reserved.

Baradwan, S., et al. (2023). "What is the effect of sildenafil citrate intake on women undergoing assisted reproduction? A systematic review and meta-analysis of randomized controlled trials." Turkish Journal of Obstetrics and Gynecology 20(4): 293-313.
	Assisted reproductive technologies (ART) have become a vital option for women facing fertility challenges. One of the potential interventions being explored is the use of sildenafil citrate (SC) to improve clinical outcomes in ART procedures. The aim of this study was to assess the impact of SC on clinical outcomes in women undergoing ART. A comprehensive literature search was conducted using multiple databases, including PubMed, Scopus, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials. The search covered studies from inception until April 15, 2023, and identified relevant randomized controlled trials (RCTs) for inclusion in the analysis. The endpoints were summarized as risk ratio (RR) or standardized mean difference (SMD) with 95% confidence interval (CI). After meticulous analysis, twenty-eight RCTs comprising 3,426 women were included in the study. The results revealed significant findings regarding the impact of SC on clinical pregnancy (CP) rates. Women receiving SC demonstrated a significantly higher probability of CP compared to the control group (n=21 RCTs, RR=1.43; 95% CI: 1.29, 1.59). Additionally, when SC was combined with other medications like clomiphene citrate (CC) or estradiol valerate, it further improved the likelihood of CP compared to these medications alone (RR=1.35, 95% CI: 1.19, 1.53; RR=1.55, 95% CI: 1.08, 2.22, respectively). Furthermore, the study observed that the mean endometrial thickness (ET) was significantly higher in women who received SC compared to the control group, which involved other active interventions or placebo (SMD=0.77, 95% CI: 0.20, 1.34). Particularly, the administration of SC resulted in a notably higher ET level compared to the placebo (SMD: 1.33, 95% CI: 0.15, 2.51). The findings suggest that luteal supplementation of SC can be considered a beneficial approach to enhance ET and improve the CP rate in women undergoing ART.

Baradwan, S., et al. (2023). "The Effect of Endometrial Scratch on Pregnancy Rate in Women with Previous Intrauterine Insemination Failure: a Systematic Review and Meta-analysis of Randomized Controlled Trials." Reproductive sciences (Thousand Oaks, Calif.) 30(5): 1399-1407.
	The objective of this study was to evaluate the impact of endometrial scratch on the pregnancy rate among women with previous failed intrauterine insemination (IUI). A systematic search was done in PubMed, Cochrane Library, Scopus, and ISI web of science from inception to November 2021. We selected randomized clinical trials (RCTs) that compared endometrial scratch in the intervention group versus placebo or no intervention in the control group among infertile women with previous failure of IUI regarding different pregnancy outcomes. Revman software was utilized for performing our meta-analysis. Our main outcomes were biochemical pregnancy, clinical pregnancy, and live birth rates. Five RCTs met our inclusion criteria with a total number of 989 patients. We found endometrial scratch significantly improved the biochemical and clinical pregnancy rates in comparison with the control group among women with previous IUI failure (p < 0.001). Moreover, the live birth rate was significantly increased among the endometrial scratch group (RR = 2.00, 95% CI [1.20, 3.34], p = 0.008). In conclusion, endometrial scratch is effective in improving pregnancy outcomes among women with previous IUI failure. More trials are required to confirm our findings. (© 2022. The Author(s), under exclusive licence to Society for Reproductive Investigation.)

Baradwan, S., et al. (2021). "Ultrasound guidance versus classical method for intrauterine insemination: A systematic review and meta-analysis of randomized controlled trials." European Journal of Obstetrics, Gynecology, and Reproductive Biology 263: 223-230.
	Objective: There is a great controversy regarding the benefits of ultrasound-guided intrauterine insemination (IUI) in improving pregnancy rates. Thus, we aimed to compare ultrasound-guided IUI versus classical IUI regarding the pregnancy rates improvement.; Methods: A systematic search was done in Cochrane Library, PubMed, ISI web of science, and Scopus during June 2021. We selected randomized clinical trials (RCTs) that compared ultrasound-guided IUI versus classical IUI in different pregnancy outcomes. We extracted the available data from included studies and pooled them in a meta-analysis model using RevMan software. Our primary outcome was clinical pregnancy rate. Our secondary outcomes were miscarriage, live birth rates, and incidence of difficulty reported during the procedure. The overall quality of evidence was assessed through GRADEpro GDT software.; Results: Seven RCTs met our inclusion criteria with a total number of 1338 patients. We found that ultrasound-guided IUI significantly improved the clinical pregnancy rate when compared to the classical group (RR = 1.33, 95% CI [1.05, 1.68], p = 0.02). However, there were no significant differences between both groups in terms of miscarriage and live birth rates. Ultrasound-guided IUI significantly reduced the incidence of difficulty reported during the procedure (RR = 0.42, 95% CI [0.21, 0.84], p = 0.01). The GRADEpro GDT tool showed high quality of evidence for the evaluated outcomes.; Conclusions: There is evidence of high quality that ultrasound-guided IUI improves the pregnancy rate and reduces the incidence of difficulty reported during the procedure.; Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2021 Elsevier B.V. All rights reserved.)

Baradwan, S., et al. (2024). "Effects of letrozole alone or in combination with gonadotropins on ovulation induction and clinical pregnancy in women with polycystic ovarian syndrome: a systematic review and meta-analysis of randomized controlled trials." Hormones.
	Objective: To compare letrozole in combination with gonadotropins versus letrozole monotherapy in ovulation induction and clinical pregnancy among infertile women with polycystic ovarian syndrome (PCOS). Method(s): Several databases were searched for available clinical trials from inception until March 2023. We selected randomized controlled trials (RCTs) that compared sequential letrozole/gonadotropin versus letrozole alone among infertile women who met the Rotterdam criteria for PCOS. RevMan software was used to perform our meta-analysis. Our primary outcomes were ovulation and clinical pregnancy rates. Our secondary outcomes were endometrial thickness, number of mature follicles (diameter >= 18 mm), and incidence of miscarriage and ovarian hyperstimulation syndrome (OHSS). Result(s): Six RCTs were retrieved with a total number of 723 patients. The ovulation and clinical pregnancy rates were significantly higher among the letrozole/gonadotropin group versus the letrozole monotherapy group (p < 0.001). In addition, there were significant improvements in endometrial thickness and number of mature follicles in the letrozole/gonadotropin group. There were no significant differences between the two groups regarding incidence of miscarriage and ovarian hyperstimulation syndrome. Conclusion(s): Letrozole in combination with gonadotropin is superior to letrozole alone in improving ovulation induction and clinical pregnancy among PCOS patients. More trials are required to confirm our findings.Copyright © 2024, The Author(s), under exclusive licence to Hellenic Endocrine Society.

Baradwan, S., et al. (2022). "Prophylactic tranexamic acid during myomectomy: A systematic review and meta-analysis of randomized controlled trials." European Journal of Obstetrics and Gynecology and Reproductive Biology 276: 82-91.
	Objective: To conduct a systematic review and meta-analysis of randomized controlled trials on the clinical efficacy and safety of prophylactic tranexamic acid (TXA) versus control (normal saline/no treatment) during myomectomy. Method(s): Six databases were screened from inception until 21-February-2022. The eligible studies were assessed for risk of bias. The outcomes were summarized as mean difference (MD) and risk ratio (RR) with 95% confidence intervals (CI) in a random-effects model. Result(s): Seven studies, comprising eight arms and 571 patients (TXA = 304 patients, control = 267 patients) were analyzed. The included studies had an overall low risk of bias. The mean intraoperative blood loss (MD = -224.34 ml, 95% CI [-303.06, -145.61], p < 0.001), mean postoperative blood loss, and mean total blood loss were significantly reduced in favor of the prophylactic TXA group. Additionally, the mean postoperative hemoglobin (MD = 0.4 mg/dl, 95% CI [0.11, 0.68], p = 0.006) and mean postoperative hematocrit levels were significantly higher in favor of the prophylactic TXA group. While the mean hospital stay was significantly reduced in favor of the prophylactic TXA group (MD = -0.39 d, 95% [-0.74, -0.04], p = 0.03), there was no significant difference between both groups regarding the mean operation time and rate of blood transfusion. None of the participants in both groups developed any incidence of thromboembolic events. The rate of nausea was significantly higher in disfavor of the prophylactic TXA group (RR = 2.68, 95% CI [1.11, 6.43], p = 0.03). Conclusion(s): Among patients undergoing myomectomy, prophylactic TXA was largely safe and linked to substantial reductions in perioperative blood loss and related morbidities.Copyright © 2022 Elsevier B.V.

Barahona, V. I. A., et al. (2024). "EFFICACY OF HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY IN OVARIAN CANCER IN ADULT WOMEN (RS)." Journal of Population Therapeutics and Clinical Pharmacology 31(1): 1054-1064.
	Context: In ovarian cancer, cytoreductive surgery is the treatment of choice, followed by adjuvant chemotherapy; where, hyperthermic intraperitoneal chemotherapy controls residual disease, with the combination of physical (thermal) and chemical (chemotherapeutic) methods prior to the formation of adhesions. Objective(s): To determine the efficacy of hyperthermic intraperitoneal chemotherapy in ovarian cancer in adult women. Procedures: Systematic review of primary studies published in PubMed, Scopus and Web of Science from 2013 to 2023, in Spanish and English. Result(s): A total of 133,393 articles were obtained, 108 were selected after the first reading, later considering the inclusion and exclusion criteria, 9 studies were used for the present review. The categories hyperthermic intraperitoneal chemotherapy, Cytoreductive Surgery, Survival, Endothelial Ovarian Cancer are described. Conclusion(s): Research results support the efficacy of HIPEC as a promising therapeutic approach for ovarian cancer treatment., demonstranting an overall survival of 35 months and progression - free survival of 15.6 months.Copyright © 2024, Codon Publications. All rights reserved.

Barakat, B., et al. (2020). "A systematic review and meta-analysis of clinical and functional outcomes of artificial urinary sphincter implantation in women with stress urinary incontinence." Arab Journal of Urology 18(2): 78-87.
	Objective: To evaluate the complications and results of artificial urinary sphincter (AUS) implantation in women with stress urinary incontinence (SUI). Method(s): A selective database search using keywords (1990-2019) was conducted to validate the effectiveness of the AUS in women. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were utilised. The meta-analysis included 964 women (15 studies) with persistent SUI. The Newcastle-Ottawa score was used to determine the quality of the evidence in each study. The success rate and complications associated with the AUS were analysed. Result(s): Meta-analysis of the published studies showed that complete continence was achieved at a mean rate of 79.6% (95% confidence interval [CI] 72.2-86.6%) and a significant improvement was achieved in 15% (95% CI 10-25%). The mean (range) follow-up was 22 (6-204) months. The mean number of patients per study was 68. The mean (range) explantation rate was 13 (0-44)%. Vaginal erosion occurred in a mean (range) of 9 (0-27)% and mechanical complications in 13 (0-47)%. Infections accounted for 7% of the complications. The total mean (range) revision rate of the implanted AUS was 15.42 (0-44)%. The mean (range) size of the cuff used was 6.7 (5-10) cm. Conclusion(s): Our present analysis showed that implantation of an AUS in women with severe UI is an effective treatment option after failure of first-line therapy. However, the currently available study population is too small to draw firm conclusions. Abbreviations: AMS: American Medical Systems; AUS: artificial urinary sphincter; EAU: European Association of Urology; LE: Level of Evidence; PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses; QoL: quality of life; SHELTER: Services and Health for Elderly in Long TERm care (study); SUI: (stress) urinary incontinence.Copyright © 2020, © 2020 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Barakat, B., et al. (2020). "Stem cell applications in regenerative medicine for stress urinary incontinence: A review of effectiveness based on clinical trials." Arab Journal of Urology 18(3): 194-205.
	Objective: To evaluate the current state, therapeutic benefit and safety of urethral injection of autologous stem cells for the treatment stress urinary incontinence (SUI). Material(s) and Method(s): A selective database search of PubMed, the Excerpta Medica dataBASE (EMBASE), Cochrane Library and Google Scholar was conducted to validate the effectiveness of stem cell-based therapy. The search included clinical trials published up until 4 January 2020, written in English, and included cohorts of women and men who had received stem cell-based therapy for SUI. The search used the following keywords in various combinations: 'stem cell therapy', 'cell-based therapy for SUI', 'regenerative medicine for SUI', and 'tissue engineering'. The success rates were assessed according to cough test, urodynamics, pad tests, and International Consultation on Incontinence Questionnaire-Urinary Incontinence. The primary endpoint was continence rate to measure objectively the effect of the treatment. Result(s): We identified four clinical trials using local injections of adipose-derived stem cells (ADSCs), 11 trails with muscle-derived stem cells (MDSCs), and two trails with human umbilical cord blood stem cells (HUCBs) and total nucleated cells (TNCs). The median improvement rate of intrinsic sphincter deficiency after ADSCs, MDSCs, TNCs, HUCBs injections were 88%, 77%, 89%, 36% (improvement rate: 1-2 pads) at a mean (range) follow-up of 6 (1-72) months. The cell sources, methods of cell processing, cell number, and implantation techniques differed considerably between studies. Most of the periurethral injections were at the 3, 5, 7, and 9 o'clock positions and for submucosa were at the 4, 6, and 8 o'clock positions. No significant postoperative complications were reported. Conclusion(s): Despite many challenges in stem cell-based therapy for treating SUI, it appears to provide, in both male and female patients, acceptable functional results with minimal side-effects and complications. In the future, more clinical trials should be funded in order to optimise stem cell-based therapy and evaluate long-term outcomes. Abbreviations: ADSC: adipose-derived stem cell; BMSCs: bone marrow-derived mesenchymal stem cell; CLPP: cough leak-point pressure; FPL: functional profile length; HUCB: human umbilical cord blood stem cell; ICIQ-(QOL)(SF)(UI): International Consultation on Incontinence Questionnaire (Quality of life) (-Urinary incontinence Short Form) (-Urinary Incontinence); IIQ-7: Incontinence Impact Questionnaire-short form; I-QOL: Incontinence quality of life questionnaire; ISD: intrinsic urinary sphincter deficiency; MDSC: muscle-derived stem cell; MUCP: maximum urethral closure pressure; NR: not reported; Pdet-max: maximum detrusor pressure; PVR: post-void residual urine volume; Qmax: maximum urinary flow; QOL: quality of life; RP: radical prostatectomy; TNC: total nucleated cell; (S)UI: (stress) urinary incontinence; UDSCs: urine-derived stem cells; UTUS: upper tract ultrasonography; VLPP: Valsalva leak-point pressure.Copyright © 2020 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Barba, M., et al. (2021). "Stem cells in clinical trials for pelvic floor disorders: A systematic literature review." Neurourology and Urodynamics 40(SUPPL 3): S99-S100.
	Introduction and aim of the study: Pelvic floor disorders (PFDs) include a series of conditions that can be poorly tolerated, negatively affecting the quality of life. Current treatment options pelvic floor rehabilitation and subsequent surgical repair in case of conservative therapy failure [1]. Regenerative medicine might offer an alternative treatment strategy. Stem cells (SCs) represent a promising tool for tissue engineering, in particular for skeletal and connective tissue repair [2]. This systematic review aims to define the state of art of SC therapy for PFDs in clinical trials, by systematically reviewing the best available evidence. Material(s) and Method(s): A systematic search strategy was conducted up to Nov 7, 2020 in PubMed, Scopus, Cochrane Library, and ISI Web of Science. Preclinical studies on animal models were not considered. Studies were included when the patients were affected by any PFDs and cells were isolated, cultured, and characterized as SC. The study protocol was registered in PROSPERO (CRD42020216551). Result(s): A total of 11 prospective clinical studies were included in the final assessment. Specifically, 7 single-arm studies dealing with SC therapy for urinary incontinence and 4 with anal incontinence. No papers concerning the use of SC for prolapse repair were retrieved. Due to the great heterogeneity, data pooling was not possible. Interpretation of results: The number of patients who underwent SCs therapy was limited. Regarding stem cells injection for urinary incontinence therapy, studies with muscle-derived stem cells or with human cord blood stem cells reported a higher benefit in terms of patient satisfaction [3]. At the same time, stem cell therapy for anal incontinence showed promising results with the use of muscle-derived stem cells in terms of objective, subjective, and instrumental functional findings. Stem cell injection resulted in a safe procedure, with few and mild adverse effects, mostly related to harvesting sites. Unfortunately, due to great heterogeneity in terms of study design, inclusion criteria, stem cells harvesting/ delivery, outcome measures, and timepoints, data pooling was not possible. Conclusion(s): This review highlighted that SC therapy for PFDs is a safe procedure, but there is no clear evidence of its efficacy. Further larger targeted studies with control arms are needed before any conclusions can be made. (Table Presented).

Barba, M., et al. (2021). "Obstetric outcomes after uterus-sparing surgery for uterine prolapse: A systematic review and meta-analysis." European Journal of Obstetrics, Gynecology, and Reproductive Biology 256: 333-338.
	Up-to-date there are no guidelines about uterus-sparing prolapse repair procedures for women desiring childbearing. This systematic review and meta-analysis aims to evaluate obstetrical outcomes after uterus-sparing apical prolapse repair in terms of pregnancy rate, obstetrical adverse outcomes and delivery mode according to the type of procedure. To identify potentially eligible studies, we searched PubMed, Scopus, Cochrane Library and ISI Web of Science (up to April 15, 2020). Case reports, reviews, letters to Editor, book chapters, guidelines, Cochrane reviews, and expert opinions were excluded. Twenty-four studies met inclusion criteria and were incorporated into the final assessment, which included 1518 surgical procedures. In total 151 patients got pregnant after prolapse surgical repair, for a resulting pregnancy raw rate of 9.9 %. Overall, adverse obstetric outcomes resulted low, rating 4.6 %. Manchester procedure resulted associated with the highest risk of adverse obstetrical outcomes and preterm premature rupture of membranes (p < 0.0001). After exclusion of Manchester procedure, sacrohysteropexy was found to be associated with higher risk of obstetrical adverse outcomes compared to native-tissue procedures (p = 0.04). Native-tissue surgery might represent the most cautious option for women wishing for pregnancy.; Competing Interests: Declaration of Competing Interest The authors report no declarations of interest. (Copyright © 2020 Elsevier B.V. All rights reserved.)

Barber, K. and A. Charles (2023). "Barriers to Accessing Effective Treatment and Support for Menopausal Symptoms: A Qualitative Study Capturing the Behaviours, Beliefs and Experiences of Key Stakeholders." Patient Preference and Adherence 17: 2971-2980.
	Background: Historically, menopausal symptoms have been hugely under-treated and under-reported, with many women struggling to manage intrusive, bothersome symptoms which can significantly affect quality of life. In the past couple of years, awareness of the impact of the menopause has risen in the public health agenda but many women are still not receiving adequate information and support. Aim(s): To gain an in-depth understanding of the barriers that impact women's access to treatment and uptake of hormone replacement therapy (HRT). Design and Setting: Qualitative study with perimenopausal and menopausal women, general practitioners (GPs) and gynaecologists in the UK. Method(s): Sixty-minute in-depth interviews conducted with 20 menopausal women, 30 GPs and 10 gynaecologists. Data from the interviews were analysed thematically. Result(s): Barriers to seeking help for menopausal symptoms include: a lack of knowledge of the full range of symptoms, stigma, embarrassment and the belief that it is part of normal ageing. Previous negative experience in accessing advice or treatment discouraged women from pursuing help. There are substantial differences in the beliefs and attitudes towards the menopause amongst GPs and often a lack of confidence in prescribing HRT. Secondary care services can consequently be overwhelmed by an explosion in uncomplicated referrals which could be effectively managed in primary care. Conclusion(s): There are barriers at each point in the management pathway: from women not feeling empowered to seek medical advice, to some women feeling their symptoms are dismissed by healthcare professionals (HCP); or HCPs not recognising some of the less common menopausal symptoms, not offering options for treatment, both hormonal and non-hormonal, or offering onward specialist referral for complex issues outside their expertise. There are multiple opportunities to address these gaps in knowledge, including the use of HCP education and culturally appropriate leaflets to reach a wider range of perimenopausal and menopausal women.Copyright © 2023 Barber and Charles.

Barbier, H., et al. (2023). "International Urogynecology consultation chapter 2 committee 3: the clinical evaluation of pelvic organ prolapse including investigations into associated morbidity/pelvic floor dysfunction." International Urogynecology Journal 34(11): 2657-2688.
	Introduction and Hypothesis: This manuscript from Chapter 2 of the International Urogynecology Consultation (IUC) on Pelvic Organ Prolapse (POP) reviews the literature involving the clinical evaluation of a patient with POP and associated bladder and bowel dysfunction.; Methods: An international group of 11 clinicians performed a search of the literature using pre-specified search MESH terms in PubMed and Embase databases (January 2000 to August 2020). Publications were eliminated if not relevant to the clinical evaluation of patients or did not include clear definitions of POP. The titles and abstracts were reviewed using the Covidence database to determine whether they met the inclusion criteria. The manuscripts were reviewed for suitability using the Specialist Unit for Review Evidence checklists. The data from full-text manuscripts were extracted and then reviewed.; Results: The search strategy found 11,242 abstracts, of which 220 articles were used to inform this narrative review. The main themes of this manuscript were the clinical examination, and the evaluation of comorbid conditions including the urinary tract (LUTS), gastrointestinal tract (GIT), pain, and sexual function. The physical examination of patients with pelvic organ prolapse (POP) should include a reproducible method of describing and quantifying the degree of POP and only the Pelvic Organ Quantification (POP-Q) system or the Simplified Pelvic Organ Prolapse Quantification (S-POP) system have enough reproducibility to be recommended. POP examination should be done with an empty bladder and patients can be supine but should be upright if the prolapse cannot be reproduced. No other parameters of the examination aid in describing and quantifying POP. Post-void residual urine volume >100 ml is commonly used to assess for voiding difficulty. Prolapse reduction can be used to predict the possibility of postoperative persistence of voiding difficulty. There is no benefit of urodynamic testing for assessment of detrusor overactivity as it does not change the management. In women with POP and stress urinary incontinence (SUI), the cough stress test should be performed with a bladder volume of at least 200 ml and with the prolapse reduced either with a speculum or by a pessary. The urodynamic assessment only changes management when SUI and voiding dysfunction co-exist. Demonstration of preoperative occult SUI has a positive predictive value for de novo SUI of 40% but most useful is its absence, which has a negative predictive value of 91%. The routine addition of radiographic or physiological testing of the GIT currently has no additional value for a physical examination. In subjects with GIT symptoms further radiological but not physiological testing appears to aid in diagnosing enteroceles, sigmoidoceles, and intussusception, but there are no data on how this affects outcomes. There were no articles in the search on the evaluation of the co-morbid conditions of pain or sexual dysfunction in women with POP.; Conclusions: The clinical pelvic examination remains the central tool for evaluation of POP and a system such as the POP-Q or S-POP should be used to describe and quantify. The value of investigation for urinary tract dysfunction was discussed and findings presented. The routine addition of GI radiographic or physiological testing is currently not recommended. There are no data on the role of the routine assessment of pain or sexual function, and this area needs more study. Imaging studies alone cannot replace clinical examination for the assessment of POP. (© 2023. The Author(s).)

Barbosa, C., et al. (2023). "Mapping acceptance and commitment therapy outcomes in the context of infertility: A systematic review." Current Psychology: A Journal for Diverse Perspectives on Diverse Psychological Issues: No-Specified.
	Evidence suggests that individuals with infertility are confronted with psychosocial challenges. This has led to a significant number of studies highlighting the subsequent negative effects on mental health. Acceptance and Commitment Therapy (ACT) has already been established as having a beneficial effect on psychological issues related to other health conditions. Since infertility is a relevant stressor, ACT was also expected to have a protective effect on the mental health of individuals with this disease. A systematic review of the literature was conducted to identify studies assessing Infertility and ACT. Empirical and quantitative studies were considered when they assessed mental health variables and ACT hexagon model components in patients with infertility. Out of the 137 studies initially identified, six met the eligibility criteria and were included in the review. The samples were composed of women (three) and couples (three). Since ACT variables appear to be associated with better mental health outcomes, couples with infertility were expected to benefit from intervention addressing ACT components. Implications for future research include the need for a distinction between ACT variables, the use of validated assessment methods and the empirical examination of predictors of changes in ACT variables. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Barbosa Marina, Z., et al. (2019). "Three-dimensionally-printed models in reproductive surgery: systematic review and clinical applications." Minerva ginecologica 71(3): 235-244.
	Introduction: 3D printing has wide application in medicine while it provides customizability and precision for anatomical model development. Our aims were to perform a systematic review and to explore the use of 3D printing applications on human reproduction and reproductive surgery.; Evidence Acquisition: We have performed a systematic review in PubMed database to assess previous publications within 3D printing in human reproduction and gynecology. We have developed 3D models according to patients' magnetic resonance images (MRI). MRI were transformed into DICOM images that originated our 3D virtual models and PolyJet technology was applied for the printing process. We included two infertile patients in reproductive age with surgical indication for hysteroscopy septoplasty and myomectomy.; Evidence Synthesis: Of 1965 studies searched, we excluded 1934 publications based on their titles. Abstracts of 31 remained studies were read, and 24 studies were selected for full-text analysis. We included 11 studies for the systematic review, based on our eligibility criteria. We have designed four 3D models (uterus, ovaries, uterine cervix and uterus with fibroids) that provided enriched information to improve pre-surgical planning, medical training, fertility-sparing surgery, patient comprehension of surgical procedures and assisted reproduction applications.; Conclusions: 3D models for human reproduction are feasible. They might improve assisted reproductive techniques, help in pre-surgical planning for reproductive surgeries, and provide accurate measures of ovarian reserve. Besides, we see future applications in endometrioma research and in the fabrication of devices, such as embryo transfer catheter and a 3D printed embryo.

Barbosa Pâmela Maria, M., et al. (2023). "Parameters and results of non-invasive neuromodulation in the management of chronic pelvic pain: integrative literature review." BrJP 6(3): 313-319.
	ABSTRACT BACKGROUND AND OBJECTIVES: Chronic Pelvic Pain (CPP) is characterized by persistent pain in the pelvic region for more than six months, affecting both men and women and causing significant impairment in quality of life (QoL). Two of the main non-invasive approaches are Transcranial Magnetic Stimulation (TMS) and Transcranial Direct Current Stimulation (tDCS). These techniques aim to modulate neural activity and promote pain relief. In this context, this research conducted an integrative literature review to summarize the results of relevant studies, aiming to identify the key parameters used in TMS and tDCS for CPP treatment. The objective was to assess the effect and efficacy of non-invasive neuromodulation as a therapeutic intervention for CPP. CONTENTS: For this integrative review, electronic searches were conducted in Pubmed, Scielo, PEDro, Medline, Cochrane, and Scopus databases, examining studies in Portuguese, English, or Spanish. The keywords "pelvic pain," "transcranial direct current stimulation," and "transcranial magnetic stimulation" and their derivatives were searched in the three languages in studies from 2013 to 2023. Seven studies were included for analysis. Both techniques showed positive effects in managing CPP, improving pain levels and quality of life to a relevant extent. However, there is still no consensus on the parameters applied in TMS and tDCS techniques for CPP. CONCLUSION: Non-invasive neuromodulation improves pain levels and quality of life in patients with CPP. Further studies are needed to establish more reliable parameter relationships, and the limited number of studies restricts definitive conclusions on the subject.

Barbounaki, S. G., et al. (2021). "Fuzzy logic intelligent systems and methods in midwifery and obstetrics." Acta Informatica Medica 29(3): 210-215.
	Background: Fuzzy logic can be used to model and manipulate imprecise and subjective knowledge imitating the human reasoning. Objective(s): The aim of this systematic review was to analyze research studies pertaining to fuzzy logic and fuzzy intelligent systems applications in midwifery and obstetrics. Method(s): A thorough literature review was performed in four electronic databases (PubMed, APA PsycINFO, SCOPUS, ScienceDirect). Only the papers that discussed fuzzy logic and fuzzy intelligent systems applications in midwifery and obstetrics were considered in this review. Selected papers were critically evaluated as for their relevance and a contextual synthesis was conducted. Result(s): Twentynine papers were included in this systematic review as they met the inclusion and methodological criteria specified in this study. The results suggest that fuzzy logic and fuzzy intelligent systems have been successfully applied in midwifery and obstetrics topics, such as diagnosis, pregnancy risk assessment, fetal monitoring, bladder tumor, etc. Conclusion(s): This systematic review suggests that fuzzy logic is applicable to midwifery and obstetrics domains providing the means for developing affective intelligent systems that can assist human experts in dealing with complex diagnosis and problem solving. However, its full potential is not yet been examined, thus presenting an opportunity for further research.Copyright © 2021 Stavroula G Barbounaki, Antigoni Sarantaki, Kleanthi Gourounti

Barboza Josianne, R., et al. (2023). "Molecular mechanisms of action and chemosensitization of tumor cells in ovarian cancer by phytochemicals: A narrative review on pre-clinical and clinical studies." Phytotherapy research : PTR 37(6): 2484-2512.
	Ovarian cancer is the second-leading cause of death among women with cancer of the genital tract. Currently, drugs derived from platinum and taxanes constitute the majority of ovarian cancer treatments. Patients undergoing this chemotherapy are susceptible to cumulative toxic effects and resistance to chemotherapy. Therefore, it is crucial to identify treatment options that are both more effective and better tolerated by patients. Phytochemicals in this context are plant-derived chemicals with antitumor activity that can be used as therapeutic or adjuvant agents in the treatment of ovarian cancer. Consequently, the purpose of this literature review is to demonstrate through existing pre-clinical and clinical trials the potential of phytochemicals in the treatment of ovarian cancer, the mechanisms of action involved, and to contribute to the development of new therapeutic options for ovarian cancer. For this review, the databases PubMed, Scopus, Science Direct, and ClinicalTrials.gov were queried between 2010 and 2022 using terms such as "ovarian cancer," "phytochemicals," "phenolic compounds," "terpenes," and "alkaloids." The present review summarized the possible molecular mechanisms of action by which phytochemicals, such as phenolic acids, flavonoids, diterpenes, triterpenes, saponins, and alkaloids, inhibit this type of cancer, specifically the ability of phytochemicals to induce cell growth regulation, apoptosis, oxidative stress reduction, anti-angiogenesis, and chemosensitization of tumors in ovarian cancer. As their action and cellular mechanism have already been demonstrated in several pre-clinical trials, the phytochemicals identified in our study have the potential to be investigated for the treatment of ovarian cancer. Through pre-clinical and clinical trials, our study demonstrates the potential of phytochemicals in the treatment of ovarian cancer, contributing to the development of novel therapeutic options for ovarian cancer. (© 2023 John Wiley & Sons Ltd.)

Barcellini, A., et al. (2022). "Sexual Health Dysfunction After Radiotherapy for Gynecological Cancer: Role of Physical Rehabilitation Including Pelvic Floor Muscle Training." Frontiers in Medicine 8: 813352.
	Introduction: The present study aims to describe: 1. How the side effects of radiotherapy (RT) could impact sexual health in women; 2. The effectiveness of physical rehabilitation including pelvic floor muscle training (PFMT) in the management of sexual dysfunction after RT.; Materials and Methods: Search keys on PubMed, Web of Science, Scopus, PEDro, and Cochrane were used to identify studies on women treated with radical or adjuvant RT and/or brachytherapy for gynecological cancers with an emphasis on vulvo-vaginal toxicities and PFMT studies on sexual dysfunction for this group of women.; Results: Regarding the first key question, we analyzed 19 studies including a total of 2,739 women who reported vaginal dryness, stenosis, and pain as the most common side effects. Reports of dosimetric risk factors and dose-effect data for vaginal and vulvar post-RT toxicities are scant. Only five studies, including three randomized controlled trials (RCTs), were found to report the effect of PFMT alone or in combination with other treatments. The results showed some evidence for the effect of training modalities including PFMT, but to date, there is insufficient evidence from high-quality studies to draw any conclusion of a possible effect.; Conclusions: Gynecological toxicities after RT are common, and their management is challenging. The few data available for a rehabilitative approach on post-actinic vulvo-vaginal side effects are encouraging. Large and well-designed RCTs with the long-term follow-up that investigate the effect of PFMT on vulvo-vaginal tissues and pelvic floor muscle function are needed to provide further guidance for clinical management.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Barcellini, Dominoni, Dal Mas, Biancuzzi, Venturini, Gardella, Orlandi and Bø.)

Barcellini, A., et al. (2023). "Primary neuroendocrine neoplasms of the vulva: A review of the MITO rare cancer group." Critical Reviews in Oncology/Hematology 193: 104201.
	Gynecological neuroendocrine neoplasms are rare entities and can be divided into two groups: carcinoids and neuroendocrine carcinomas. Due to their rarity their management is not standardized. The aim of this work is to summarize and discuss the current literature evidence on this pathology. A scoping literature review was performed in multiple databases. Thirty-one studies were included: 30 case reports and one case series. Patients' age ranged between 28 and 92 years. Surgery was the most used treatment and the surgical approach included local excision (N = 16/31; 51.6%) with (N = 5/16; 31.25%) or without (N = 11/16; 68.75%) inguinal lymphadenectomy. Adjuvant radiotherapy was delivered in 12 (38.7%) cases; instead, platinum-based therapies were frequently used when chemotherapy was chosen for adjuvant treatment. The overall survival ranged between 20 days to 4 years. However, further research is needed; currently, multimodal approach including surgery, chemotherapy and radiotherapy appeared safe and feasible for the treatment of these rare and aggressive diseases.

Barcellini, A., et al. (2023). "Granulosa cell tumors (GCTs) of the ovary: What is the role of radiotherapy?" Critical Reviews in Oncology/Hematology 181: 103889.
	Granulosa cell tumors of the ovary have an indolent behavior and a good prognosis, but a high incidence of local recurrence after surgery. The best treatment in the recurrent setting is unclear and randomized clinical trials on the management in the recurrent setting are lacking. The role of radiotherapy is controversial in adjuvant settings and unknown in case of relapse after surgery. This review aims to summarize the level of evidence of the role of radiation treatments for granulosa cell tumors of the ovary.; Competing Interests: Declaration of Competing Interest The authors declare that they have no competing interests. (Copyright © 2022 Elsevier B.V. All rights reserved.)

Barcelona Hospital Clinic, o. (2021). Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders.
	To evaluate changes from baseline in brain activation patterns, by using functional magnetic resonance imaging (fMRI) techniques and sexual stimuli, in postmenopausal women with moderate to severe vulvovaginal atrophy and FSIAD after 3 months treatment with ospemifene 60mg/day compared to those treated with placebo. fMRI technique allows the study of brain activation by detecting brain blood flow and oxygen level dependent changes induced by neuronal activation.

Barcelona Hospital Clinic, o. and d. Octubre Hospital Universitario (2024). A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in Patients Treated for Cervical Cancer (PROVIDENCE).
	No Results Available Combination Product: Multimodal intervention on sexual dysfunction and quality-of-life FSFI score|FSFI (6 months)|EORTC QLQ-30|EORTC QLQ-30 (6 months)|EORTC Cx-24 (6 months)|EORTC Cx-24 Female Phase 4 122 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment PROVIDENCE April 2025

Barcikowska, Z., et al. (2022). "Effect of Manual Therapy Compared to Ibuprofen on Primary Dysmenorrhea in Young Women-Concentration Assessment of C-Reactive Protein, Vascular Endothelial Growth Factor, Prostaglandins and Sex Hormones." Journal of Clinical Medicine 11(10).
	Background: The study aimed to assess if manual therapy, compared to ibuprofen, impacts the concentration of inflammatory factors, sex hormones, and dysmenorrhea in young women Methods: Thirty-five women, clinically diagnosed with dysmenorrhea, were included in the study. They were divided into group A-manual therapy ( n = 20) and group B-ibuprofen therapy ( n = 15). Inflammatory factors such as vascular endothelial growth factor (VEGF), C-reactive protein (CRP), prostaglandin F2α (PGF 2α ), E2 (PGE2) and sex hormones levels were measured. Dysmenorrhea assessed with the numerical pain rating scale (NPRS), myofascial trigger points, and muscle flexibility were examined before and after the interventions.; Results: The difference in the level of 17-β-estradiol after manual and ibuprofen therapy was significant, as compared to baseline ( p = 0.036). Progesterone levels decreased in group A ( p = 0.002) and B ( p = 0.028). The level of CRP was negatively correlated with sex hormones. Decrease in dysmenorrhea was significant in both groups (group A p = 0.016, group B p = 0.028). Non-significant differences were reported in prostaglandins, VEGF and CRP levels, in both groups.; Conclusions: There were no significant differences in CRP, prostaglandins and VEGF factors after manual or ibuprofen therapy. It has been shown that both manual therapy and ibuprofen can decrease progesterone levels. Manual therapy had a similar effect on the severity of dysmenorrhea as ibuprofen, but after manual therapy, unlike after ibuprofen, less muscles with dysfunction were detected in patients with primary dysmenorrhea.

Barcroft Jennifer, F., et al. (2021). "Fertility treatment and cancers-the eternal conundrum: a systematic review and meta-analysis." Human reproduction (Oxford, England) 36(4): 1093-1107.
	Study Question: Does fertility treatment (FT) significantly increase the incidence of breast, ovarian, endometrial or cervical cancer?; Summary Answer: Overall, FT does not significantly increase the incidence of breast, ovarian or endometrial cancer and may even reduce the incidence of cervical cancer.; What Is Known Already: Infertility affects more than 14% of couples. Infertility and nulliparity are established risk factors for endometrial, ovarian and breast cancer, yet the association with FT is more contentious.; Study Design, Size, Duration: A literature search was carried out using Cochrane Library, EMBASE, Medline and Google Scholar up to December 2019. Peer-reviewed studies stating cancer incidence (breast, ovarian, endometrial or cervical) in FT and no-FT groups were identified. Out of 128 studies identified, 29 retrospective studies fulfilled the criteria and were included (n = 21 070 337).; Participants/materials, Setting, Methods: In the final meta-analysis, 29 studies were included: breast (n = 19), ovarian (n = 19), endometrial (n = 15) and cervical (n = 13), 17 studies involved multiple cancer types and so were included in each individual cancer meta-analysis. Primary outcome of interest was cancer incidence (breast, ovarian, endometrial and cervical) in FT and no-FT groups. Secondary outcome was cancer incidence according to specific fertility drug exposure. Odds ratio (OR) and random effects model were used to demonstrate treatment effect and calculate pooled treatment effect, respectively. A meta-regression and eight sub-group analyses were performed to assess the impact of the following variables, maternal age, infertility, study size, outliers and specific FT sub-types, on cancer incidence.; Main Results and the Role of Chance: Cervical cancer incidence was significantly lower in the FT group compared with the no-FT group: OR 0.68 (95% CI 0.46-0.99). The incidences of breast (OR 0.86; 95% CI 0.73-1.01) and endometrial (OR 1.28; 95% CI 0.92-1.79) cancers were not found to be significantly different between the FT and no-FT groups. Whilst overall ovarian cancer incidence was not significantly different between the FT and no-FT groups (OR 1.19; 95% CI 0.98-1.46), separate analysis of borderline ovarian tumours (BOT) revealed a significant association (OR 1.69; 95% CI 1.27-2.25). In further sub-group analyses, ovarian cancer incidence was shown to be significantly higher in the IVF (OR 1.32; 95% CI 1.03-1.69) and clomiphene citrate (CC) treatment group (OR 1.40; 95% CI 1.10-1.77), respectively when compared with the no-FT group. Conversely, the incidences of breast (OR 0.75; 95% CI 0.61-0.92) and cervical cancer (OR 0.58; 95% CI 0.38-0.89) were significantly lower in the IVF treatment sub-group compared to the no-FT group.; Limitations, Reasons for Caution: The large, varied dataset spanning a wide study period introduced significant clinical heterogeneity. Thus, results have to be interpreted with an element of caution. Exclusion of non-English citations, unpublished work and abstracts, in order to ensure data accuracy and reliability was maintained, may have introduced a degree of selection bias.; Wider Implications of the Findings: The results for breast, ovarian, endometrial and cervical cancer are reassuring, in line with previously published meta-analyses for individual cancers but the association between IVF and CC treatment and an increase in ovarian cancer incidence requires additional work to understand the potential mechanism driving this association. In particular, focusing on (i) discriminating specific treatments effects from an inherent risk of malignancy; (ii) differential risk profiles among specific patient sub-groups (refractory treatment and obesity); and (iii) understanding the impact of FT outcomes on cancer incidence.; Study Funding/competing Interest(s): This study did not receive any funding. The authors have no financial, personal, intellectual and professional conflicts of interest to declare.; Prospero Registration Number: CRD42019153404. (© Th Author(s) 2021. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Barczyński, B., et al. (2022). "Perspectives of metformin use in endometrial cancer and other gynaecological malignancies." Journal of drug targeting 30(4): 359-367.
	Insulin resistance and hyperinsulinemia play a key role in type 1 endometrial cancer pathogenesis. Most of these cancers develop on a background of overweight or type 2 diabetes mellitus (T2DM). One of the medications widely used in the treatment of T2DM is biguanide derivative, metformin, which exerts promising anticancer properties principally through activation of adenosine monophosphate kinase (AMPK) and inhibition of mammalian target of rapamycin (mTOR) pathways. Many epidemiological studies on diabetic patients show potential preventative role of metformin in endometrial cancer patients, but data regarding its therapeutic role is still limited. So far, most of attention has been paid to the concept of metformin use in fertility sparing treatment of early-stage cancer. Another investigated alternative is its application in patients with primary advanced or recurrent disease. In this review we present the latest data on clinical use of metformin in endometrial cancer patients and potential underlying mechanisms of its activity. Finally, we present some most important clinical information regarding metformin efficacy in other gynaecological malignancies, mainly breast and ovarian cancer.

Bardia, A., et al. (2021). "Sacituzumab govitecan, a Trop-2-directed antibody-drug conjugate, for patients with epithelial cancer: final safety and efficacy results from the phase I/II IMMU-132-01 basket trial." Annals of oncology : official journal of the European Society for Medical Oncology 32(6): 746-756.
	BACKGROUND: Sacituzumab govitecan (SG), a trophoblast cell surface antigen-2 (Trop-2)-directed antibody-drug conjugate, has demonstrated antitumor efficacy and acceptable tolerability in a phase I/II multicenter trial (NCT01631552) in patients with advanced epithelial cancers. This report summarizes the safety data from the overall safety population (OSP) and efficacy data, including additional disease cohorts not published previously. PATIENTS AND METHODS: Patients with refractory metastatic epithelial cancers received intravenous SG (8, 10, 12, or 18 mg/kg) on days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity. Endpoints for the OSP included safety and pharmacokinetic parameters with investigator-evaluated objective response rate (ORR per RECIST 1.1), duration of response, clinical benefit rate, progression-free survival, and overall survival evaluated for cohorts (n > 10 patients) of small-cell lung, colorectal, esophageal, endometrial, pancreatic ductal adenocarcinoma, and castrate-resistant prostate cancer. RESULTS: In the OSP (n = 495, median age 61 years, 68% female; UGT1A1∗28 homozygous, n = 46; 9.3%), 41 (8.3%) permanently discontinued treatment due to adverse events (AEs). Most common treatment-related AEs were nausea (62.6%), diarrhea (56.2%), fatigue (48.3%), alopecia (40.4%), and neutropenia (57.8%). Most common treatment-related serious AEs (n = 75; 15.2%) were febrile neutropenia (4.0%) and diarrhea (2.8%). Grade ≥3 neutropenia and febrile neutropenia occurred in 42.4% and 5.3% of patients, respectively. Neutropenia (all grades) was numerically more frequent in UGT1A1∗28 homozygotes (28/46; 60.9%) than heterozygotes (69/180; 38.3%) or UGT1A1∗1 wild type (59/177; 33.3%). There was one treatment-related death due to an AE of aspiration pneumonia. Partial responses were seen in endometrial cancer (4/18, 22.2% ORR) and small-cell lung cancer (11/62, 17.7% ORR), and one castrate-resistant prostate cancer patient had a complete response (n = 1/11; 9.1% ORR). CONCLUSIONS: SG demonstrated a toxicity profile consistent with previous published reports. Efficacy was seen in several cancer cohorts, which validates Trop-2 as a broad target in solid tumors.

Bardin Marcela, G., et al. (2023). "Does the addition of electrical stimulation or kinesiotherapy improve outcomes of amitriptyline treatment for women with vulvodynia? A randomized clinical trial." International Urogynecology Journal 34(6): 1293-1304.
	Introduction and Hypothesis: Women diagnosed with provoked vulvodynia frequently report a great deal of frustration in achieving symptomatic relief. Physical therapy and drug treatment are among the interventions most indicated by guidelines; however, whether those modalities are effective when combined remains unclear. The objective was to evaluate the effectiveness of adding a physical therapy modality compared with amitriptyline alone for the treatment of vulvodynia.; Methods: Eighty-six women with vulvodynia were randomized to (G1) 25 mg amitriptyline, once a day (n=27), (G2) amitriptyline + electrical stimulation therapy (n=29) or (G3) amitriptyline + kinesiotherapy (n=30). All treatment modalities were administered for 8 weeks. The primary endpoint was the reduction in vestibular pain. Secondary measurements focused on sexual pain, frequency of vaginal intercourse, Friedrich score, and overall sexual function. Data were analyzed using intention-to-treat.; Results: All treatment modalities resulted in a significant decrease in vestibular pain (p<0.001), sexual pain (p<0.05), Friedrich score (p<0.001), and an increase in the frequency of sexual intercourse (p<0.05). G3 was more effective than G1 at reducing sexual pain (G1: 5.3±3.3 vs G3: 3.2±2.7; p=0.01) and at improving sexual function (G1: 18.8±9.8 vs G3: 23.9±7.8; p=0.04).; Conclusion: Kinesiotherapy and electrotherapy additions to amitriptyline administration as well as amitriptyline alone, were effective at improving vestibular pain in women with vulvodynia. Women receiving physical therapy had the greatest improvement in sexual function and frequency of intercourse at post-treatment and follow-up. (© 2023. The International Urogynecological Association.)

Barel, O., et al. (2021). "Addition of Lidocaine to the Distension Medium in Hysteroscopy Decreases Pain during the Procedure-A Randomized Double-blind, Placebo-controlled Trial." Journal of Minimally Invasive Gynecology 28(4): 865‐871.
	STUDY OBJECTIVE: To evaluate the effect of adding a local anesthetic to the distension medium in office diagnostic hysteroscopy using the vaginoscopic approach on pain during the procedure. Secondary aims included documenting side effects, patient satisfaction, and the time needed to complete the procedure. DESIGN: Randomized double‐blind placebo‐controlled study. SETTING: University‐affiliated hospital; office hysteroscopy clinic. PATIENTS: Total of 100 patients who underwent office hysteroscopies divided in half with 50 in the intervention group and 50 in the control group. INTERVENTIONS: Ten mL of lidocaine 2% added to 1000 mL of saline solution that was used as the distension medium for hysteroscopy in the study group vs 1000 mL of saline alone in the control group. MEASUREMENTS AND MAIN RESULTS: A significant difference was found in the increment of pain as measured by visual analog scale after the hysteroscopy between the 2 groups. Patients receiving lidocaine had an average rise of 1.9 in the visual analog scale score after the procedure compared with 2.9 in the control group (p = .033). There was also a nonsignificant trend for shorter duration of hysteroscopy in the intervention group compared with the control group (180.1 vs 222.1 seconds, p = .08). Patients' satisfaction was high in both groups (98% for the study group and 92% for the control group). Success rates were also similar between the 2 groups at approximately 95%. No side effects were recorded in either group. CONCLUSION: The addition of local anesthetic to the distension medium in office hysteroscopy produces significant reduction in pain during the procedure without adding time to the procedure and without side effects.

Barfoot, K. L., et al. (2021). "Mental Health in New Mothers: A Randomised Controlled Study into the Effects of Dietary Flavonoids on Mood and Perceived Quality of Life." Nutrients 13(7).
	The postnatal period is a significant period of physical, physiological and psychological change for mothers, rendering them particularly vulnerable to changes in mood or disorders such as postnatal depression (PND). Previous interventions with foods high in flavonoids have demonstrated beneficial acute and chronic mood effects in healthy child, adolescent and adult populations. It is unclear whether mood effects persist in populations who are potentially at-risk of developing mood disorders, such as postnatal mothers. This exploratory study investigated the effects of a 2-week daily dietary flavonoid intervention on mood (PANAS-NOW), anxiety (STAI), depressive symptoms (PHQ-8) and perceived quality of life (WHOQOL-BREF) in forty-one new mothers in the 0-12-month postnatal period, before and after flavonoid intervention. Mothers either added high flavonoid foods to their daily diet, or did not include additions following a randomised, between-groups, controlled design. Significant effects were observed in the flavonoid group with mothers reporting lower state anxiety and higher perceived quality of physical health at the 2-week timepoint. These findings suggest that regular dietary consumption of flavonoids may benefit mothers' anxiety and perceived quality of life in the postnatal period. Replication of these results may indicate the potential for dietary flavonoids to promote healthy mood regulation in mothers or prevent the onset or severity of symptoms in postnatal psychological disorders, both of which would be beneficial for women's health services and public mental health.

Barinov, S. V., et al. (2021). "The use of an osmotic dilator for induction of miscarriage in patients with the second trimester missed miscarriage." Journal of maternal-fetal & neonatal medicine 34(17): 2778‐2782.
	Aim: The aim of this study was to assess the outcomes of combined use of dilapan‐S and pharmacological induction of miscarriage with mifepristone and misoprostol versus mifepristone and misoprostol only in patients with a second‐trimester pregnancy loss. Materials and methods: Our study included 74 patients with a second‐trimester antenatal death who were randomized into two groups to receive pharmacological induction of miscarriage combined with intracervical insertion of dilapan‐S (n = 37) or pharmacological induction of miscarriage only (n = 37). Efficacy endpoints included: blood loss volume, length of time between the procedure initiation and complete miscarriage, and the number of complications. Results: The use of dilapan‐S together with mifepristone and misoprostol for induction of miscarriage in the second trimester in women with antenatal fetal death reduced the time from the start of the procedure to complete miscarriage by 1.98‐fold. However, the use of dilapan‐S did not significantly reduce the odds of such post‐procedural complications as hematometra and retention of the products of conception in the uterus (p = .2501). Conclusions: Combined management of antenatal pregnancy loss in the second trimester including intracervical insertion of dilapan‐S and conventional induction with miscarriage may be considered a valuable clinical strategy. However, future studies should focus on ways to prevent postprocedural complications in this group of women.

Barlin, J., et al. (2023). "Lunchbox trial: a randomized phase III trial of Cisplatin and irradiation followed by Carboplatin and Paclitaxel vs. sandwich therapy of Carboplatin and Paclitaxel followed by irradiation then Carboplatin and Paclitaxel for advanced endometrial carcinoma (168)."  176: S63‐S64.
	Objectives: Advanced endometrial cancer comprises a heterogeneous group of patients whose survival generally remains poor. The optimal adjuvant treatment strategy for these patients is still not well defined. The objective of this study was to provide a real‐world evidence‐based answer to the most appropriate sequencing of combined modality treatment for advanced endometrial carcinoma. Methods: In this multicenter prospective study, patients were eligible if they had either FIGO 2009 surgical stage III or IVA endometrial carcinoma or stage I or II serous or clear cell endometrial carcinoma and positive cytology. Patients were randomized to receive cisplatin 50 mg/m2 IV days 1 and 29 plus volume‐directed radiation therapy followed by carboplatin AUC 5 or 6 plus paclitaxel 175 mg/m2 q 21 days for 4 cycles (ChemoRT then Chemo) versus carboplatin AUC 6 plus paclitaxel 175 mg/m2 q 21 days for 3 cycles followed by volume‐directed radiation therapy followed by carboplatin AUC 5 or 6 plus paclitaxel 175 mg/m2 q 21 days for 3 cycles (Sandwich Therapy). A futility analysis was planned. The primary objective was to determine if treatment with ChemoRT then Chemo improves progression‐free survival (PFS) when compared to Sandwich Therapy. The secondary objective was to evaluate overall survival (OS), whereas the tertiary objective was to compare the regimens with respect to tolerability and adverse effects of therapy. Patient characteristics of the two treatment groups were compared via Fisher's exact test, and Wilcoxon rank sum test as appropriate. PFS and OS of the two groups were described using Kaplan‐Meier survival curves and compared via Log‐rank test for equality of survivor functions. Statistical software STATA 16.0 was used for analysis. Results: This investigator‐initiated study was opened at 8 sites throughout the United States and Canada. Of the 48 patients enrolled, 42 patients were eligible for futility analysis, and the trial was closed early. The median follow‐up period was 30.9 months. Twenty‐two patients were randomized to ChemoRT then Chemo, and 20 patients were randomized to Sandwich Therapy. The 3‐year PFS was 85.7% (95% CI: 62–95) in the ChemoRT then Chemo arm and 73.4% (95% CI: 43–89) in the Sandwich Therapy group (P = 0.58). The 3‐year OS was 88.4% (95% CI: 61–97) in the ChemoRT then Chemo arm, and 80.9% (95% CI: 51–93) in the Sandwich Therapy group (P = 0.55). Ninety percent of patients were Caucasian, with a mean age of 61.7 and a BMI of 34.6. Ninety percent were in stage III at diagnosis, and 76.2% had endometrioid histology. Adverse events were similar between groups. All patients in the ChemoRT then Chemo group completed all cycles of chemotherapy. Ten percent of patients in the Sandwich Therapy arm were unable to complete their chemotherapy. Conclusions: The trial was limited by small numbers. After futility analysis, there was no difference observed between ChemoRT then Chemo and Sandwich Therapy in terms of progression‐free survival, overall survival, or adverse events. [Formula presented]

Barnard, N. D., et al. (2021). "The Women's Study for the Alleviation of Vasomotor Symptoms (WAVS): a randomized, controlled trial of a plant-based diet and whole soybeans for postmenopausal women." Menopause (New York, N.Y.) 28(10): 1150-1156.
	OBJECTIVE: This study aimed to assess the effects of the combination of a low-fat plant-based diet and soybeans on the frequency and severity of menopausal hot flashes. METHODS: Postmenopausal women (n = 38) reporting two or more hot flashes/day were randomly assigned to a low-fat, vegan diet, including ½ cup (86 g) of cooked soybeans daily, or to no diet changes for 12 weeks. Frequency and severity of hot flashes were recorded using a mobile application, and vasomotor, psychosocial, physical, and sexual symptoms were assessed using the Menopause-Specific Quality of Life Questionnaire. Significance was assessed using t-tests (continuous outcomes) and chi-squared/McNemar tests (binary outcomes). RESULTS: Total hot flashes decreased 79% in the intervention group (P < 0.001) and 49% in the control group (P = 0.002; between-group P = 0.01). Moderate-to-severe hot flashes decreased 84% in the intervention group (P < 0.001) and 42% in the control group P = 0.009; between-group P = 0.01). From 0 to 12 weeks, 59% (10/17) of intervention-group participants reported becoming free of moderate and severe hot flashes (P = 0.002). There was no change in this variable in the control group (between-group P < 0.001). The Menopause-Specific Quality of Life Questionnaire revealed significantly greater reductions in the intervention group in vasomotor (P < 0.0001), psychosocial (P = 0.04), physical (P < 0.002), and sexual (P = 0.01) domains. CONCLUSIONS: The combination of a low-fat, vegan diet and whole soybeans was associated with reduced frequency and severity of hot flashes and improved quality of life in vasomotor, psychosocial, physical, and sexual domains in postmenopausal women. During the 12-week study period, the majority of intervention-group participants became free of moderate-to-severe hot flashes.

Barnes, H. C., et al. (2022). "Using clinical estimate or catheter measurement of urethral mid-point result in similar retropubic mid-urethral sling position: a randomized trial." International Urogynecology Journal 33(12): 3555-3561.
	Introduction and hypothesis: The objective was to determine whether standardized, intraoperative urethral measurement improves retropubic mid-urethral sling (RPMUS) positioning and if the intraoperative position remains stable at 2 weeks postoperatively. Method(s): Participants undergoing a RPMUS were randomized to mid-urethral placement as per usual surgical care (no Foley catheter measurement, no-FCM) vs urethral mid-point Foley catheter measurement (FCM). The primary outcomes were RPMUS location as determined by 2D and 3D ultrasound 2 weeks postoperatively (as percentage from urethral meatus - relative to the urethral length) and intraoperatively following the RPMUS placement. Result(s): Forty-four women enrolled, underwent RPMUS, and provided baseline data and intraoperative ultrasound measurements; of these, 36 (82%) had interpretable intraoperative and postoperative ultrasound measurements. Demographic data were similar in the two groups. The mean RPMUS mid-point was 57 % and 55 % in measured and controls (p = 0.685); this same measurement was relatively unchanged at 2 weeks postoperatively at 57% and 54% respectively (p = 0.538). Very much and much improvement was reported on the PGI-I by 84% and 85% of participants in the FCM and no-FCM groups respectively. Conclusion(s): Intraoperative RPMUS position at 2 weeks after surgery is similar to the intraoperative position. Compared with usual surgical care, intraoperative measurement of urethral mid-point with a Foley catheter did not affect RPMUS sling position.Copyright © 2022, The International Urogynecological Association.

Barnes Kylie, N., et al. (2023). "Zuranolone: The First FDA-Approved Oral Treatment Option for Postpartum Depression." The Annals of Pharmacotherapy: 10600280231204953.
	Objective: The objective of this study was to review the characteristics, efficacy, and safety of zuranolone in the management of postpartum depression (PPD).; Data Sources: Literature was identified using PubMed (1966-August 2023) and EMBASE (1973-August 2023) and clinicaltrials.gov. Search terms included zuranolone, SAGE-217, and PPD with further limitation of those published in English.; Study Selection and Data Extraction: Articles selected for inclusion included trials evaluating zuranolone for the treatment of PPD.; Data Synthesis: Zuranolone was evaluated for the treatment of moderate to severe PPD in 2 phase III trials. Both studies resulted in statistically significant improvement in depressive symptoms at day 15 ( P = 0.003 and P < 0.001). Sustained differences in remission rates favoring zuranolone were found in both studies at day 45 compared with placebo ( P = 0.01 and P < 0.05). Zuranolone was well tolerated, with somnolence, dizziness, headache, and sedation reported as the most common side effects.; Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs: Zuranolone is only the second medication approved by the Food and Drug Administration (FDA) for PPD and offers an advantage over brexanolone in that it can administered orally in the outpatient setting. The rapid onset of effect of zuranolone is advantageous to traditional antidepressant therapy which can be weeks to months; however, limited information is available on safety during lactation.; Conclusions: The recent FDA approval of oral zuranolone for PPD offers a second rapid-acting treatment for PPD, extending the opportunity for treatment to patients in the outpatient setting.; Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Barnes Kylie, N., et al. (2023). "Ibrexafungerp in the Treatment of Vulvovaginal Candidiasis." The Annals of Pharmacotherapy 57(1): 99-106.
	Objective: To review the pharmacology, efficacy, and safety of ibrexafungerp in the management of vulvovaginal candidiasis (VVC).; Data Sources: Literature was sought using PubMed (1966-February 2022) and EMBASE (1973-February 2022), and clinicaltrials.gov. Search terms included ibrexafungerp, SCY-078, and VVC.; Study Selection and Data Extraction: All studies including humans and published in English with data assessing the efficacy and safety of ibrexafungerp for the treatment of VVC were evaluated.; Data Synthesis: A phase 2 dose-finding study found ibrexafungerp had similar efficacy to fluconazole in the clinical cure of VVC (51.9% vs 58.3%, respectively). Two phase 3 clinical trials demonstrated ibrexafungerp had statistical superiority over placebo for clinical cure in moderate to severe VVC ( P < 0.001 and P = 0.023, respectively). The most frequently reported adverse reactions in the clinical trials were gastrointestinal-related symptoms. To date, data comparing efficacy of ibrexafungerp and topical imidazoles in the treatment of VVC are nonexistent.; Relevance to Patient Care and Clinical Practice: Topical imidazoles and oral fluconazole are effective for the treatment of uncomplicated VVC. Due to increased resistance, limited fluconazole coverage for non- Candida albicans species, and potential for significant drug interactions associated with fluconazole use, alternative treatments for VVC are needed. Ibrexafungerp is a new oral triterpenoid antifungal agent indicated for the treatment of VVC. Additional clinical trials are needed to evaluate long-term safety data as well as efficacy and safety in specialty populations.; Conclusion: Ibrexafungerp, a recently approved triterpenoid antifungal agent, is an effective and well-tolerated option for the treatment of VVC.

Barnhart, K. T., et al. (2021). "Effect of an Active vs Expectant Management Strategy on Successful Resolution of Pregnancy Among Patients With a Persisting Pregnancy of Unknown Location: the ACT or NOT Randomized Clinical Trial." JAMA 326(5): 390‐400.
	Importance: Women with an early nonviable pregnancy of unknown location are at high risk of ectopic pregnancy and its inherent morbidity and mortality. Successful and timely resolution of the gestation, while minimizing unscheduled interventions, are important priorities. Objective: To determine if active management is more effective in achieving pregnancy resolution than expectant management and whether the use of empirical methotrexate is noninferior to uterine evacuation followed by methotrexate if needed. Design, Setting, and Participants: This multicenter randomized clinical trial recruited 255 hemodynamically stable women with a diagnosed persisting pregnancy of unknown location between July 25, 2014, and June 4, 2019, in 12 medical centers in the United States (final follow up, August 19, 2019). Interventions: Eligible patients were randomized in a 1:1:1 ratio to expectant management (n = 86), active management with uterine evacuation followed by methotrexate if needed (n = 87), or active management with empirical methotrexate using a 2‐dose protocol (n = 82). Main Outcomes and Measures: The primary outcome was successful resolution of the pregnancy without change from initial strategy. The primary hypothesis tested for superiority of the active groups combined vs expectant management, and a secondary hypothesis tested for noninferiority of empirical methotrexate compared with uterine evacuation with methotrexate as needed using a noninferiority margin of ‐12%. Results: Among 255 patients who were randomized (median age, 31 years; interquartile range, 27‐36 years), 253 (99.2%) completed the trial. Ninety‐nine patients (39%) declined their randomized allocation (26.7% declined expectant management, 48.3% declined uterine evacuation, and 41.5% declined empirical methotrexate) and crossed over to a different group. Compared with patients randomized to receive expectant management (n = 86), women randomized to receive active management (n = 169) were significantly more likely to experience successful pregnancy resolution without change in their initial management strategy (51.5% vs 36.0%; difference, 15.4% [95% CI, 2.8% to 28.1%]; rate ratio, 1.43 [95% CI, 1.04 to 1.96]). Among active management strategies, empirical methotrexate was noninferior to uterine evacuation followed by methotrexate if needed with regard to successful pregnancy resolution without change in management strategy (54.9% vs 48.3%; difference, 6.6% [1‐sided 97.5% CI, ‐8.4% to ∞]). The most common adverse event was vaginal bleeding for all of the 3 management groups (44.2%‐52.9%). Conclusions and Relevance: Among patients with a persisting pregnancy of unknown location, patients randomized to receive active management, compared with those randomized to receive expectant management, more frequently achieved successful pregnancy resolution without change from the initial management strategy. The substantial crossover between groups should be considered when interpreting the results. Trial Registration: ClinicalTrials.gov Identifier: NCT02152696.

Baron, M., et al. (2022). "Management of post-operative urinary incontinence after midurethral sling explantation for pelvic or perineal pain." International Urogynecology Journal 33(4): 1001-1006.
	Introduction and Hypothesis: The objective was to report the management of post-operative urinary incontinence after midurethral sling (MUS) revision for chronic pelvic pain (CPP), and to report functional outcomes.; Methods: From November 2004 to February 2018, a total of 89 women who underwent removal or section of MUS for CPP, were enrolled. Patients were divided into the transobturator tape (TOT) group (50 patients) and the tension-free vaginal tape (TVT) group (37 patients); 2 patients had had both slings implanted. We report the rate of stress urinary incontinence (SUI) recurrence, the rate of de novo urge urinary incontinence (UUI), the need for subsequent SUI or UUI surgery, and functional outcomes (pain and continence).; Results: Median follow-up was 41.4 months [0.9-138.8]. SUI recurrence or de novo UUI occurred in 52 cases (58.4%): 19 (51.3%) patients in the TVT group, 31 (62%) in the TOT group, and both patients (100%) who underwent total removal of both slings. Among patients with SUI recurrence or de novo UUI, 39 (75%) had pain relief after sling removal. Seventeen patients (32.6%) refused any treatment, 14 (26.9%) were cured with conservative therapy, and 21 (40.3%) underwent SUI or UUI surgery. One patient had de novo pelvic pain after reoperation. The overall continence rate for all patients who underwent sling revision was 82% (73 out of 89) at the last follow-up.; Conclusion: After MUS revision for CPP, post-operative UI may occur in 58.4% of patients, of which, one-fourth may be managed with conservative measures only. Forty percent of them had redo surgery with a low risk of pain recurrence and a high rate of urinary continence. (© 2021. The International Urogynecological Association.)

Baroni, L., et al. (2020). "Vegetarian diets during pregnancy: effects on the mother's health. A systematic review." Food & Function.
	While interest in vegetarian nutrition has been steadily increasing, some aspects have not yet been consistently investigated. One topic requiring evidence-based confirmation is the adoption of a vegetarian diet during pregnancy and lactation. Maternal diet is not only correlated with the fetus's and infant's health, but appears relevant for that of the mother as well. Not only is an adequate delivery of nutrients to the fetus and infant mandatory, but the increased physiological needs of the maternal body require an adequate supply of nutrients and can represent harmful stress events that may lead to well-defined pathological conditions. In this review, we aim to systematically investigate state-of-the-art of vegetarian diets during pregnancy and lactation, focusing on maternal nutritional status and pregnancy outcomes. Data are scarce, often inconsistent and not homogeneous for many of the topics we considered, mainly because only a few studies have been performed in developed countries, whereas other studies have derived from developing countries, where vegetarianism can be a proxy indicator of malnutrition. For this reason, we did not find sufficient data to provide evidence-based information and recommendations. To date, the available literature does not clearly support a negative impact on the mother's health and pregnancy outcomes, but, analogously with the findings in the vegetarian adult population, an improvement in the quality of studies might facilitate finding more information on the possible positive impact of well-planned vegetarian diets during pregnancy and lactation. More epidemiological and interventional studies are warranted, in order to address the question as to whether vegetarian nutrition represents an advantage for the mother or poses nutritional issues that need further attention.

Barr, C. E., et al. (2021). "Weight loss during intrauterine progestin treatment for obesity-associated atypical hyperplasia and early-stage cancer of the endometrium." Cancer Prevention Research 14(11): 1041-1050.
	Intrauterine progestin is a treatment option for women with atypical hyperplasia or low-risk endometrial cancer who wish to preserve their fertility, or whose poor surgical fitness precludes safe hysterectomy. We hypothesized that in such women with obesity, weight loss during progestin treatment may improve oncological outcomes. We conducted a prospective nonrandomized study of women with obesity and atypical hyperplasia or low-grade stage 1a endometrial cancer undergoing progestin treatment. Women with a body mass index (BMI) >= 35 kg/m2 were offered bariatric surgery; those who declined and those with a BMI of 30 to 34.9 kg/m2 were encouraged to lose weight by lowcalorie diet. We assessed uptake of bariatric surgery; weight lost during progestin treatment; and the impact of more than 10% total body weight loss on progestin treatment response at 12 months. 71 women [median age 58 years (interquartile range; IQR 35-65); mean BMI 48 kg/m2 (SD 9.3)] completed the study. Twenty-three women (32%) had bariatric surgery, on average 5 months (IQR 3-8) after progestin treatment commenced. Weight change during progestin treatment was -33.4 kg [95% confidence interval (CI) -42.1, -24.7] and -4.6 kg (95% CI -7.8, -1.4) in women receiving bariatric surgery and low-calorie diet, respectively (P < 0.001). Fortythree women (61%) responded to progestin, while 23 (32%) showed stabilized and 5 (7%) progressive disease. Response at 12 months was not predicted by age or baseline BMI, but women who lost more than 10% of their total body weight were more likely to respond to progestin than those who did not (adjusted odds ratio 3.95; 95% CI 1.3, 12.5; P = 0.02). Thus weight loss may improve oncological outcomes in women with obesity-associated endometrial neoplastic abnormalities treated with progestin.Copyright © 2021 The Authors.

Barra, F., et al. (2019). "Nintedanib for Advanced Epithelial Ovarian Cancer: A Change of Perspective? Summary of Evidence from a Systematic Review." Gynecologic and Obstetric Investigation 84(2): 107-117.
	Background/aims: Epithelial ovarian cancer (EOC) is the sixth most commonly diagnosed cancer among women. Results with available therapies are far from being satisfactory and, therefore, current research is focusing on new anticancer drugs to improve the clinical response of these patients. Nintedanib is an oral multiple tyrosine kinases inhibitor, which targets angiogenesis. Considering the current scenario, the aim of this systematic review is to highlight the prevailing knowledge about pharmacokinetics, pharmacodynamics, clinical efficacy, and safety of Nintedanib for the treatment of advanced EOC.; Methods: We performed a systematic review of the literature, screening all available articles about the treatment of advanced EOC with Nintedanib, including phase I, II, and III trials.; Results: Although in early phase clinical trials, Nintedanib has demonstrated anticancer activity and tolerability as monotherapy or in combination with carboplatin and paclitaxel. In the phase III trial AGO-OVAR 12, it obtained a modest improvement in progression-free survival (PFS) as first-line combination therapy for patients with advanced EOC. Interestingly, a PFS increase was observed in patients with non-high progression risk or low tumor burden.; Conclusion: Despite the promising results, further studies are needed to evaluate Nintedanib efficacy in women affected by EOC. (© 2018 S. Karger AG, Basel.)

Barra, F., et al. (2020). "The potential role of elagolix for treating uterine bleeding associated to uterine myomas." Expert Opinion on Pharmacotherapy 21(12): 1419-1430.
	Introduction: Uterine myomas represents a widespread gynecological disease of women in reproductive age. Although surgery remains the first choice for treating most patients, in the last years, new medical approaches have been considered in order to ameliorate heavy menstrual bleeding (HMB) related to their presence. Elagolix is a second-generation gonadotropin-releasing hormone (GnRH) antagonist under investigation for the long-term treatment of uterine myomas. Areas covered: The aim of this drug evaluation is to give a complete overview of pharmacokinetic and pharmacodynamic data on elagolix for treating HMB related to uterine myomas and to report the results of the current clinical trials in this setting. Expert opinion: In two previous phase II studies, this drug succeeded in ameliorating blood loss and quality of life of patients affected by uterine myomas with a good safety profile. Three phase III trials (ELARIS UF-I, UF-II, and EXTEND) investigated the efficacy, tolerability, and safety of elagolix at 300 mg twice daily with add-back therapy. The primary endpoint, consisting in the reduction in HMB compared to placebo, was met in the majority of patients under treatment. Currently, elagolix is under investigation in two other ongoing multicenter phase III clinical studies.Copyright © 2020 Informa UK Limited, trading as Taylor & Francis Group.

Barrenetxea, Z., et al. (2022). "Time to bust some myths about progesterone supplementation in the luteal phase. Role of the route of administration and usefulness (or uselessness) of plasma determination." Human Reproduction 37(Supplement 1): i514.
	Study question: Is it worth measuring plasma progesterone levels after FET? Is there any difference in results depending on the route of progesterone administration? Summary answer: The administration route of progesterone supplementation after FET entails different plasmatic levels (whose determination is useless) but without any correlation with ongoing pregnancy. What is known already: Embryonic aneuploidy is likely to be the major contributor to human implantation failure, but not all failures are due to embryonic defects. The need for progesterone supplementation in ART frozen-thawed cycles is well accepted. Several studies have demonstrated an increase in live birth rate with progesterone luteal support although there is a discussion on the association of Progesterone levels on day of embryo transfer and birth or pregnancy loss rates. Moreover, although the effect of route of administration of progesterone on serum levels and pregnancy rates have been thoroughly studied, there is no consensus on the optimal endometrial preparation protocol. Study design, size, duration: Prospective, randomized study performed during the 2020-21. A total of 201 genetically screened blastocyst (after PGT-A) transfers were performed after endometrial preparation, performed with exogenous estrogen administration followed by progesterone administration before embryo transfer (ET) . After embryo transfer, two different Progesterone regimens were randomly administered. Group I and Group II (see Participants) Participants/materials, setting, methods: Group I patients (n = 100): 800 mg of micronized Progesterone was administered vaginally (CyclogestVR 1-0-1). Group II patients (n = 101): vaginal administration of 400 mg of micronized progesterone was combined with the subcutaneous administration of 25 mg of Progesterone (Prolutex 25VR ) Plasmatic progesterone (PP) levels on day of B-HCG determination (pregnancy test) (10 days after ET) and ultrasound confirmation of pregnancy (3 weeks after ET) were determined. The relationship between progesterone levels and ongoing pregnancy rates was amalyzed. Main results and the role of chance: The rate of positive pregnancy test among the 201 FET was 71,64%. The overall ongoing pregnancy was 58,71%. PP on day of pregnancy test was 24,92+/-1,27 ng/ml (mean+/-SEM). The corresponding figures por positive (n=144) and negative (n=57) HCG were 27,65+/-1,09 and 20,33+/-2,13 respectively (t=2,68; p=0,008). The PP levels on day of HCG determination were 23,12+/-1,48 among ongoing pregnancies whereas the levels among non-evolutive gestations were 48,78+/-3,55 (t=7,19; p=0,000). PP levels were significantly higher among group II patients (combined treatment) both, on day of B-HCG determination (28,25+/-1,22 ng/ml) and on day of ultrasound confirmation of a gestational sac (33,61+/-2,39) than among group I patients (vaginal treatment) (15,12+/-1,60 and 19,77+/-1,50 ng/ml) (t=0651, p=0,000 and t=5,38, p=0,000 respectively). But these differences do not correlate with ongoing pregnancy rates: 59 out of 101 (58,42%) in group I patients and 59 out of 100 (59%) in group II patients. Limitations, reasons for caution: Even though only euploid embryos have been transferred, ee must be cautious when drawing conclusions from the present study taking into account the limited number of cases evaluated. Wider implications of the findings: Since only euploid embryos have been transferred in the present study, results in terms of successful ongoing pregnancies may be influenced by endometrial factors. Although the need of progesterone supplementation among frozen-thawed cycles is accepted, some debate exists on the route of administration and the need of progesterone serum determinations.

Barretina-Ginesta, M.-P., et al. (2022). "Quality-adjusted time without symptoms of disease or toxicity and quality-adjusted progression-free survival with niraparib maintenance in first-line ovarian cancer in the PRIMA trial." Therapeutic advances in medical oncology 14: 17588359221126149.
	Background: The PRIMA phase 3 trial showed niraparib significantly prolongs median progression-free survival (PFS) versus placebo in patients with advanced ovarian cancer (OC) responsive to first-line platinum-based chemotherapy, including those who had tumors with homologous recombination deficiency (HRd). This analysis of PRIMA examined the quality-adjusted PFS (QA-PFS) and quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) of patients on maintenance niraparib versus placebo.; Methods: Patients were randomized 2:1 to receive once-daily maintenance niraparib ( n = 487) or placebo ( n = 246). QA-PFS was defined as the PFS of patients adjusted for their health-related quality of life (HRQoL) prior to disease progression, measured using European Quality of Life Five-Dimension (EQ-5D) questionnaire index scores from the PRIMA trial. Q-TWiST was calculated by combining data on PFS, duration of symptomatic grade ⩾2 adverse events (fatigue or asthenia, nausea, vomiting, abdominal pain, and abdominal bloating) prior to disease progression, and EQ-5D index scores. Analyses used data collected up to the last date of PFS assessment (May 17, 2019).; Results: The restricted mean QA-PFS was significantly longer with niraparib versus placebo in the HRd ( n = 373) and overall intention-to-treat (ITT; n = 733) populations (mean gains of 6.5 [95% confidence interval; CI, 3.9-8.9] and 4.1 [95% CI, 2.2-5.8] months, respectively). There were also significant improvements in restricted mean Q-TWiST for niraparib versus placebo (mean gains of 5.9 [95% CI, 3.5-8.6] and 3.5 [95% CI, 1.7-5.6] months, respectively) in the HRd and ITT populations.; Conclusions: In patients with advanced OC, first-line niraparib maintenance was associated with significant gains in QA-PFS and Q-TWiST versus placebo. These findings demonstrate that niraparib maintenance treatment is associated with a PFS improvement and that treatment benefit is maintained even when HRQoL and/or toxicity data are combined with PFS in a single measure.; Trial Registration: ClinicalTrials.gov: NCT02655016; trial registration date: January 13, 2016.; Plain Language Summary: Background: In a large clinical trial called PRIMA, patients with advanced cancer of the ovary (ovarian cancer) were given either niraparib (a type of cancer medicine) or placebo (a pill containing no medicine/active substances) after having chemotherapy (another type of cancer medicine). Taking niraparib after chemotherapy is called maintenance therapy and aims to give patients more time before their cancer returns or gets worse than if they were not given any further treatment. In the PRIMA trial, patients who took niraparib did have more time before their cancer progressed than if they took placebo. However, it is important to consider patients' quality of life, which can be made worse by cancer symptoms and/or side effects of treatment. Here, we assessed the overall benefit of niraparib for patients in PRIMA. Methods: Both the length of time before disease progression (or survival time) and quality of life were considered using two different analyses:● The first analysis was called quality-adjusted PFS (QA-PFS) and looked at how long patients survived with good quality of life.● The second analysis was called quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) and looked at how long patients survived without cancer symptoms or treatment side effects. Results: The PRIMA trial included 733 patients; 487 took niraparib and 246 took placebo. Around half of the patients in both groups had a type of ovarian cancer that responds particularly well to drugs like niraparib - they are known as homologous recombination deficiency (HRd) patients.● When information on quality of life (collected from patient questionnaires) and survival was combined in the QA-PFS analysis, HRd patients who took niraparib had approximately 6.5 months longer with a good quality of life before disease progression than those who took placebo. In the overall group of patients (including HRd patients and non-HRd patients), those who took niraparib had approximately 4 months longer than with placebo.● Using the second analysis (Q-TWiST) to combine information on survival with cancer symptoms and treatment side effects, the HRd patients taking niraparib had approximately 6 months longer without cancer symptoms or treatment side effects (such as nausea or vomiting) than patients taking placebo. In the overall group of patients, those taking niraparib had approximately 3.5 months longer without these cancer symptoms/side effects than patients receiving placebo. Conclusions: These results show that the survival benefits of niraparib treatment remain when accounting for patients' quality of life. These benefits were seen not only in HRd patients who are known to respond better to niraparib, but in the overall group of patients who took niraparib.; Competing Interests: Competing interests: MPBG reports receiving lecture fees, advisory board fees, and travel support from AstraZeneca, Clovis Oncology, GSK, Merck, PharmaMar, Roche, and Tesaro. BJM has received honoraria and lecture fees from Tesaro. BP has received institutional grant support from AstraZeneca, Celsion, Clovis Oncology, Genentech/Roche, Merck, Mersana, Tesaro/GSK, Toray, I-Mab, Incyte, and Seagen; and advisory board compensation from Arquer, AstraZeneca, Eisai, Elevar, Lilly, Merck, Mersana, Tesaro/GSK, I-Mab, ImmunoGen, InxMed, Onconova Therapeutics, Seagen, and Toray. AAu reports receiving consulting fees from GSK. DMC reports personal fees from GSK; has received honoraria from Roche; has served as a consultant to AstraZeneca and Mateon Therapeutics; and has received research grants to her institution from Genentech. DL reports receiving advisory board fees from Amgen, AstraZeneca, Clovis Oncology, Genmab, and ImmunoGen; grant support, paid to her institution, and consulting fees from PharmaMar; and grant support, paid to her institution, and advisory board fees from Merck. EIB reports receiving consulting fees, lecture fees, and travel support from AstraZeneca, Clovis, GSK, Tesaro, Roche, Roche Diagnostics, Eisai, and Merck Sharp & Dohme; and grant support to their institution from Roche Diagnostics, Merck Sharp & Dohme, and Bayer. AR has received grant support, advisory fees, and travel support from PharmaMar and Roche; advisory fees and travel support from AstraZeneca and Tesaro/GSK; advisory fees from Clovis; and grant support from Eisai. RS is an employee of Open Health Evidence and Access, which received research funding from GSK for this study. NK was an employee of Open Health Evidence and Access at the time of the study. CH and DG are employees of GSK. TW is a former employee of GSK. DMO reports grants and personal fees from Clovis; has served on advisory boards for Agenus, AstraZeneca, Eisai, Genentech/Roche, ImmunoGen, Iovance Biotherapeutics, Janssen/Johnson & Johnson, Merck, Mersana, Myriad, Novartis Pharmaceuticals, Novocure, Regeneron Pharmaceuticals, Seagen, Tarveda, and Tesaro/GSK; has served on steering committees for Amgen; has served as a consultant to AbbVie, Agenus, Ambry, AstraZeneca, Eisai, Genentech/Roche, GOG Foundation, ImmunoGen, Iovance Biotherapeutics, Merck, Mersana, Novartis Pharmaceuticals, Novocure, Seagen, and Tesaro/GSK; and has received research support to his institution from AbbVie, Agenus, Ajinomoto, Amgen, Array BioPharma, AstraZeneca, Bristol-Myers Squibb, Cerulean Pharma, Eisai, EMD Serono, Ergomed Clinical Research, Genentech/Roche, Genmab, GOG Foundation, ImmunoGen, INC Research, inVentiv Health Clinical, Iovance Biotherapeutics, Janssen/Johnson & Johnson, Ludwig Institute for Cancer Research, Merck, Mersana, New Mexico Cancer Care Alliance, Novocure, PRA International, Regeneron Pharmaceuticals, Seagen, Serono, Stemcentrx, Tesaro/GSK, TRACON Pharmaceuticals, VentiRx, and Yale University. AGM reports receiving consulting fees from Alkermes, Amgen, AstraZeneca, Clovis, Genmab, GSK, Immunogen, Mersana, Merck Sharp & Dohme, Oncoinvent, PharmaMar, Roche, SOTIO, and Takeda; ecture fees rom AstraZeneca, Clovis, GSK, Merck Sharp & Dohme, PharmaMar, and Roche; travel support from AstraZeneca, GSK, and PharmaMar; grant support to their institution from Roche Holding and Tesaro. SH, CA, SAL, NC, and AAm have no conflicts to disclose. (© The Author(s), 2022.)

Barrington, D., et al. (2022). "Pembrolizumab for persistent, recurrent, or metastatic cervical cancer: a cost-effectiveness analysis (025)." Gynecologic Oncology 166(Supplement 1): S19.
	Objectives: To determine the cost-effectiveness of pembrolizumab in patients with persistent, recurrent, or metastatic cervical cancer. Method(s): A decision analysis model was created to evaluate the cost-effectiveness of platinum-based chemotherapy plus bevacizumab and pembrolizumab (CBP) relative to chemotherapy plus pembrolizumab (CP) and chemotherapy plus bevacizumab (CB). Published data from KEYNOTE-826 was used to estimate quality-adjusted life-years (QALYs), and drug cost estimates were obtained using average wholesale prices. Incremental cost-effectiveness ratios (ICERs) were calculated to determine cost/QALY. The willingness to pay (WTP) threshold was set at $100,000 per QALY saved. Sensitivity analyses were performed on cost and effectiveness for regimens containing pembrolizumab. Result(s): The cost of treatment with CB and CP were $416 million (M) and $713 M, respectively. The cost of treatment with CBP was $1.51 billion (B). Relative to CB, the ICER for CP was $92,678. CBP was dominated. Sensitivity analyses were performed varying the efficacy of CP and CBP. If overall survival (OS) after treatment with CP was less than 23.4 months, the ICER would exceed the WTP. If the OS from CP was assumed to be 20.4 months (midway between control and experimental arms of KEYNOTE-826), the ICER would increase to $183,039. If OS for CBP improved to 38 months, this regimen would be cost-effective. If CP is eliminated from the model, CBP becomes cost-effective relative to CB if the cost of pembrolizumab decreases from $12,080 to $2,913 per cycle. Conclusion(s): CP is cost-effective relative to CB for persistent, recurrent, or metastatic cervical cancer. In the baseline model, CBP was dominated. The efficacy of CBP would need to far exceed CP in order to be cost-effective. The cost-effectiveness of pembrolizumab-containing regimens improves with a decrease in drug cost. A closer look at the comparative efficacy between CP and CBP is needed to help inform treatment decisions for patients with persistent, recurrent, or metastatic cervical cancer.Copyright © 2022 Elsevier Inc.

Barry Parul, N., et al. (2022). "Definitive chemoradiation or radiation therapy alone for the management of vulvar cancer." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 32(3): 332-337.
	Vulvar cancer is rare, and unresectable disease provides a therapeutic conundrum. Although definitive surgery remains the mainstay for curative treatment of vulvar cancer, a minority of patients present with advanced disease for which surgical resection would be extraordinarily morbid. Pre-operative and definitive radiation with radiosensitizing systemic therapy allows such patients an opportunity for cure. In this review, we explore the origins of pre-operative radiation, current treatment standards for pre-operative and definitive chemoradiation, and future directions.; Competing Interests: Competing interests: SB: Elsevier pathway consultant; Xoft DSMBVarian employer. PNB: Elsevier pathway consultant. DCL: None. (© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Bartels Helena, C., et al. (2020). "Quality of life following minimally invasive hysterectomy compared to abdominal hysterectomy: A metanalysis." European Journal of Obstetrics, Gynecology, and Reproductive Biology 252: 206-212.
	Objective: The aim of this meta-analysis is to review quality of life (QoL) in patients who underwent simple minimally invasive (MIS) hysterectomy compared to abdominal hysterectomy (AH) for benign conditions or endometrial cancer.; Methods: A literature search was performed of electronic databases including Cochrane, Medline, Pubmed, Pubmed Central, clinicaltrials.gov and Embase from study inception until December 2019. Search terms included "QoL", "minimally invasive surgery" "laparoscopic hysterectomy" "abdominal hysterectomy". The literature search was performed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results were reported as mean differences or pooled odds ratios (OR) with 95 % confidence intervals (95 % CI).; Results: A total of 4988 citations were reviewed; 9 studies comprising 3116 patients were selected for the analysis. Publications reporting QoL in patients undergoing simple MIS hysterectomy compared to AH were included. 9 studies reporting 3 different QoL assessment tools were included: EuroQoL five dimensions visual analogue scale (EQ-5D-VAS), Functional Assessment of Cancer Therapy-General (FACT-G) and Short Form-36 (SF-36). For EQ-5D, patients in the MIS group had a significantly higher QoL compared to those in the AH group at 1 week (OR 9.82, 95 % CI 4.61-15.03, p = 0.0002) and 4 weeks (OR 4.83 95 % CI 0.71-8.95, p = 0.02) post-operatively. Similarly, for FACT-G, at 1 week and at 4 weeks post operatively, patients in the MIS group reported a significantly higher score compared to those in the AH group (1 week: OR 6.39, 95 % CI 3.16-9.61, p = 0.0001, 4 weeks: OR 6.33, 95 % CI 3.55-9.12, p = <0.00001). There was no difference in SF-36 scores at any time point between the groups.; Conclusion: MIS hysterectomy is associated with improved QoL in the short term post-operative phase compared to AH both for benign disease and endometrial cancer.; Competing Interests: Declaration of Competing Interest The authors have no conflict of interest to declare. (Copyright © 2020. Published by Elsevier B.V.)

Bartels Helena, C., et al. (2019). "A meta-analysis of morbidity and mortality in primary cytoreductive surgery compared to neoadjuvant chemotherapy in advanced ovarian malignancy." Gynecologic Oncology 154(3): 622-630.
	Aim The aim of this meta-analysis is to review the morbidity and mortality associated with primary cytoreductive surgery (PCS) compared to neoadjuvant chemotherapy and interval cytoreductive surgery (NACT + ICS) for advanced ovarian cancer.; Methods: A literature search was performed for publications reporting morbidity and mortality in patients undergoing PCS compared to NACT + ICS. Databases searched were Cochrane, Medline, Pubmed, Pubmed Central, clinicaltrials.gov and Embase. Two independent reviewers applied inclusion and exclusion criteria to select included papers, with differences agreed by consensus. A total of 1341 citations were reviewed; 17 studies comprising 3759 patients were selected for the analysis. The literature search was performed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results were reported as mean differences or pooled odds ratios (OR) with 95% confidence intervals (95% CI).; Results: Patients in the PCS group were significantly more likely to have a Clavien-Dindo grade ≥ 3 morbidity with an overall rate of 21.2% compared to 8.8% (95%CI 1.9-4.0, p < 0.0001) and were more likely to die within 30 days of surgery (OR 6.1, 95% CI 2.1-17.6, p = 0.0008). Patients who underwent NACT + ICS had significantly shorter procedural times (MD -35 min, p = 0.01), lost less blood intraoperatively (MD-382 ml, p < 0.001) and had an average admission 5.0 days shorter (MD -5.0 days, 95% CI -8.1 to -1.9 days, p = 0.002) than those undergoing PCS. While NACT was associated with significantly increased optimal and complete cytoreduction rates (OR 1.9, 95% CI 1.3-2.9, p = 0.001, and OR 2.2, 95% CI 1.5-3.3, p = 0.0001 respectively), this did not confer any additional survival benefit (OR 1.0, p = 0.76).; Conclusion: NACT is associated with less morbidity and mortality and improved complete cytoreduction compared to PCS, with no survival benefit. Hence NACT is an acceptable alternative in selected patients in particular with medical co-morbidities or a high tumour burden. (Copyright © 2019 Elsevier Inc. All rights reserved.)

Barthwal, M., et al. (2021). "Music Therapy to Alleviate Anxiety in Cervical Brachytherapy – Do We Change a Tune? A Randomized, Single Institute Study." International journal of radiation oncology biology physics 111(3): e610.
	Purpose/Objective(s): The procedure of Intracavitary Brachytherapy (ICBT) involves use of spinal anesthesia and invasive procedure leading to anxiety among the patients. Music therapy (MT) has been established as an excellent measure to alleviate anxiety; however, the role is scarcely employed. This randomized study evaluates the impact of MT on anxiety and distress during the procedure of ICBT in cervical malignancies. Materials/Methods: In this single institute, Randomized trial comparing MT versus no MT in patients undergoing ICBT for cervical malignancies, subjective assessment for stress and anxiety was done with use of pre‐State‐Trait Anxiety Inventory (STAI‐S Anxiety) questionnaire and Symptom Distress Thermometer (SDT). Patients under the MT group were counselled for their choice of music prior to the treatment and the non‐MT group did not receive any such counselling. After the completion of treatment, both the questionnaires were again repeated and repeated‐measures analysis of variance was used to assess treatment effects on STAI and SDT. Correlation between STAI and SDT was also assessed at both time points and by group with Spearman correlation coefficients. Results: A total of 70 patients with histopathological proven cervical malignancy were enrolled with 35 each in the MT and non‐MT group. The median age was 48.5 years and both groups were matched in the treatment and patient characteristics. The overall mean pre‐ and post‐simulation STAI‐S scores were 42.3 (range, 22‐62) and 37.7 (range, 20‐64), respectively. The overall mean pre‐ and post‐simulation SDT scores were 4.6 (range, 0‐10) and 3.2 (range, 0‐10), respectively. The MT group had mean pre‐ and post‐simulation STAI‐S scores of 42.8 and 32.3, respectively (P < 0.001) and the mean SDT scores before and after simulation were 4.5 and 1.9, respectively (P < 0.001) The no‐MT group's mean pre‐ and post‐simulation STAI‐S scores were 41.9 and 39.9, respectively (P = 0.54), and the mean SDT scores were 4.7 and 3.9, respectively (P = 0.76). Conclusion: The role of Music therapy as a method to reduce the patient anxiety has been well established in our study. The reduced anxiety in the patient helps the oncologist in performing a better implant which indirectly would lead to better disease control and survival. MT should be incorporated in the Brachytherapy Operating room to help alleviate the patients alleviate their procedure related stress and anxiety. Author Disclosure: M. Barthwal: None. V. Pareek: None. P.A. Patil: None. S. Mallick: None. A. Sharma: None. D. Sharma: None.

Bartiromo, L., et al. (2021). "Endometriosis and Phytoestrogens: Friends or Foes? A Systematic Review." Nutrients 13(8).
	The aim of this systematic review was to provide comprehensive and available data on the possible role of phytoestrogens (PE) for the treatment of endometriosis. We conducted an advanced, systematic search of online medical databases PubMed and Medline. Only full-length manuscripts written in English up to September 2020 were considered. A total of 60 studies were included in the systematic review. According to in vitro findings, 19 out of 22 studies reported the ability of PE in inducing anti-proliferative, anti-inflammatory and proapoptotic effects on cultured cells. Various mechanisms have been proposed to explain this in vitro action including the alteration of cell cycle proteins, the activation/inactivation of regulatory pathways, and modification of radical oxidative species levels. Thirty-eight articles on the effects of phytoestrogens on the development of endometriotic lesions in in vivo experimental animal models of endometriosis have been included. In line with in vitro findings, results also derived from animal models of endometriosis generally supported a beneficial effect of the compounds in reducing lesion growth and development. Finally, only seven studies investigated the effects of phytoestrogens intake on endometriosis in humans. The huge amount of in vitro and in vivo animal findings did not correspond to a consistent literature in the women affected. Therefore, whether the experimental findings can be translated in women is currently unknown.

Bartoletti, M., et al. (2020). "Bevacizumab or PARP-Inhibitors Maintenance Therapy for Platinum-Sensitive Recurrent Ovarian Cancer: A Network Meta-Analysis." International Journal of Molecular Sciences 21(11).
	Introduction: Targeted agents such as bevacizumab (BEV) or poly (ADP-ribose) polymerase inhibitors (PARPi) which have been added as concomitant or maintenance therapies have been shown to improve progression-free survival (PFS) in patients with platinum-sensitive recurrent ovarian cancer (PS rOC). In the absence of direct comparison, we performed a network meta-analysis considering BRCA genes status.; Methods: We searched PubMed, EMBASE, and MEDLINE for trials involving patients with PS rOC treated with BEV or PARPi. Different comparisons were performed for patients included in the PARPi trials, according to BRCA genes status as follows: all comers (AC) population, BRCA 1/2 mutated (BRCAm), and BRCA wild type patients (BRCAwt).; Results: In the overall population, PARPi prolonged PFS with respect to BEV (hazard ratio (HR) = 0.70, 95% CI 0.54-0.91). In the BRCA mutated carriers, the PFS improvement in favor of PARPi appeared to be higher (HR = 0.46, 95% CI 0.36-0.59) while in BRCAwt patients the superiority of PARPi over BEV failed to reach a statistically significance level (HR = 0.87, 95% CI 0.63-1.20); however, according to the SUCRA analysis, PARPi had the highest probability of being ranked as the most effective therapy (90% and 60%, for PARPi and BEV, respectively).; Conclusions: PARPi performed better as compared with BEV in terms of PFS for the treatment of PS rOC, especially in BRCAm patients who had not previously received PARPi.; Competing Interests: F.P. reports grants from AstraZeneca; grants, personal fees, and other from Roche; personal fees and other from Eli Lilly; personal fees from Amgen; personal fees from Ipsen; personal fees from MSD; personal fees from Takeda; grants and other from Eisai; other from Novartis and Pfizer, outside the submitted work. L.G. reports personal fees from Eli lilly, outside the submitted work. The other authors have nothing to disclose.

Barton Debra, L., et al. (2022). "Randomized Controlled Phase II Evaluation of Two Dose Levels of Bupropion Versus Placebo for Sexual Desire in Female Cancer Survivors: NRG-CC004." Journal of clinical oncology : official journal of the American Society of Clinical Oncology 40(4): 324-334.
	Purpose: Because of the negative impact of cancer treatment on female sexual function, effective treatments are warranted. The purpose of this multisite study was to evaluate the ability of two dose levels of extended-release bupropion, a dopaminergic agent, to improve sexual desire more than placebo at 9 weeks, measured by the desire subscale of the Female Sexual Function Index (FSFI), and to evaluate associated toxicities.; Methods: Postmenopausal women diagnosed with breast or gynecologic cancer and low baseline FSFI desire scores (< 3.3), who had completed definitive cancer therapy, were eligible. Women were randomly assigned to receive 150 mg or 300 mg once daily of extended-release bupropion or a matching placebo. t -tests were performed on the FSFI desire subscale to evaluate whether there was a significantly greater change from baseline to 9 weeks between placebo and each bupropion arm as the primary end point. Sixty-two patients per arm provided 80% power using a one-sided t -test.; Results: Two hundred thirty women were randomly assigned from 72 institutions through the NRG Oncology NCORP network. At 9 weeks, there were no statistically significant differences in change of the desire subscale scores between groups; participants in all three arms reported improvement. The mean changes for each arm were placebo 0.62 (standard deviation [SD] = 1.18), 150-mg once daily bupropion 0.64 (SD = 0.95), and 300-mg once daily bupropion 0.60 (SD = 0.89). Total and subscale scores on the FSFI were low throughout the study, indicating dysfunction in all groups.; Conclusion: Bupropion was not more effective than placebo in improving the desire subscale of the FSFI. Subscale and total scores of the FSFI demonstrated dysfunction throughout the 9 weeks of the study. More research is needed to support sexual function in female cancer survivors.; Competing Interests: Debra L. BartonResearch Funding: Merck Stephanie L. PughResearch Funding: Pfizer (Inst), Millennium (Inst) Patricia A. GanzLeadership: Intrinsic LifeSciences (I)Stock and Other Ownership Interests: Xenon Pharma (I), Intrinsic LifeSciences (I), Teva, Novartis, Merck, Johnson & Johnson, Pfizer, GlaxoSmithKline, Abbott LaboratoriesConsulting or Advisory Role: InformedDNA, Vifor Pharma (I), Ambys Medicines (I), Global Blood Therapeutics (I), GlaxoSmithKline (I), Ionis Pharmaceuticals (I), Protagonist Therapeutics (I), Akebia Therapeutics (I), Regeneron (I), Sierra Oncology (I), Rockwell Medical Technologies Inc (I), Astellas Pharma (I), Gossamer Bio (I), American Regent (I), Disc Medicine (I), Blue Note Therapeutics (I), Grail (I)Research Funding: Blue Note Therapeutics (Inst)Patents, Royalties, Other Intellectual Property: Related to iron metabolism and the anemia of chronic disease, UpToDate royalties for section editor on survivorshipTravel, Accommodations, Expenses: Intrinsic LifeSciences (I) Steven C. PlaxeStock and Other Ownership Interests: Pfizer, Merck, Zimmer Biomet, GlaxoSmithKline, AstraZeneca, Bristol Myers Squibb/Pfizer, Johnson & Johnson/JanssenResearch Funding: Endocyte, Incyte, MedImmune, Novartis, Pfizer, Janssen Oncology, BIND Therapeutics, PharmaMar, AstraZeneca, Kevelt, Millennium, Tesaro Bridget F. KoontzEmployment: GenesisCareLeadership: GenesisCareConsulting or Advisory Role: Blue Earth Diagnostics, Myovant Sciences, Rythera TherapeuticsResearch Funding: Janssen, Merck, Blue Earth DiagnosticsPatents, Royalties, Other Intellectual Property: Demos Publishing Matthew L. HillStock and Other Ownership Interests: AstraZeneca, Newlink Genetics, Kazia Therapeutics, Leap Therapeutics, OncoSec, MEI Pharma, PLx Pharma, Radius Health, Crispr Therapeutics, Cassava SciencesOpen Payments Link: https://openpaymentsdata.cms.gov/physician/820072 Carolyn Y. MullerResearch Funding: AstraZeneca, Genmab, VBL Therapeutics, Roche/Genentech, TapImmune Inc, Linnaeus Therapeutics, Agenus, Incyte, MerckPatents, Royalties, Other Intellectual Property: Have a pending patent on the cancer use for R-ketorolac—not yet its own new drugOther Relationship: NCI, Department of D fense Lisa A. KachnicConsulting or Advisory Role: New B InnovationResearch Funding: Varian Medical SystemsPatents, Royalties, Other Intellectual Property: UpToDateNo other potential conflicts of interest were reported.

Barts, et al. (2021). Virtual Reality in MVA for Miscarriage.
	No Results Available Device: Virtual reality Anxiety rating|Pain rating Female Not Applicable 50 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 271029 January 31, 2023

Baruch, Y., et al. (2023). "Pre- versus Post-Menopausal Onset of Overactive Bladder and the Response to Vaginal Estrogen Therapy: A Prospective Study." Medicina (Kaunas, Lithuania) 59(2).
	Background and Objectives: This study examined the utility of local estrogen therapy for improving urinary symptoms in women diagnosed with Overactive Bladder allied to the time of onset of urinary symptoms whether pre- or post-menopausal. Materials and Methods : Subject to informed consent, menopausal women diagnosed with Overactive Bladder (OAB) and Genitourinary Syndrome of Menopause (GSM) were enrolled at three urogynecological units. OAB symptoms were scored using the Global Pelvic Floor Symptoms Bother Questionnaire (GPFSBQ), with explicit attention to question number 3 that specifically addresses the presence or absence of urgency and the Patient Perception of Intensity of Urgency Scale (PPIUS). The Vaginal Health Index (VHI) was used to assess the vaginal mucosa trophism. Exclusion criteria included: Pelvic organ prolapse (POP) ≥ stage II, urinary tract infection or disease, diabetes, inflammatory diseases, use of diuretics, alcohol or drug addictions, neurological and/or psychiatric disorders, and other precluding conditions. Women were treated with local estrogens for 3 months and re-evaluated. Results : Forty-three post-menopausal women were enrolled. Of these, ten women developed OAB symptoms before menopause (Group I) and 33 developed symptoms after menopause (Group II). Following local estrogen therapy, based on the Global Pelvic Floor Symptoms Bother Questionnaire, improvement of OAB symptoms was reported by 20% of patients in Group I ( p = 0.414) and 64% of patients in Group II, ( p = 0.002). Based on the PPIUS scale, diminution in urinary urgency was experienced by 20% of patients in Group I ( p = 0.68) and 66% of patients in Group II ( p = 0.036). Improved VHI scores were graded statisticaly significant in both groups (Group I in 100% of women, p = 0.005 vs. 76% in Group II, p = 0.004). Conclusions : Our results indicate that local estrogen therapy is more effective in women who develop OAB after menopause.

Bashir, R., et al. (2022). "Insights into New Therapeutic Approaches for the Treatment and Management of Polycystic Ovary Syndrome: An Updated Review." Current Pharmaceutical Design 28(18): 1493-1500.
	Background: Polycystic ovary syndrome (PCOS) is a long-term, highly prevalent, complex heterogeneous, polygenic endocrine disorder characterized by both metabolic and reproductive disorders. It affects 6-23% of reproductive-age women globally.; Objective: This review aims to facilitate an understanding of novel PCOS management approaches and highlight the results from relevant interventional animal and human studies.; Methods: Manual search on PubMed, Cochrane, and Scopus databases was performed for relevant articles, preclinical and clinical trials based on related keywords.; Results: According to a multitude of studies, PCOS has evolved over time, but a substantial lag remains in management approaches. New insights into the cross-talk between muscle, brain, fat, and ovaries pointed out new therapeutic targets. This review has highlighted the efficacy of a wide spectrum of novel therapeutic agents [Phosphodiesterase-4 Inhibitors, Glucagon-like peptide-1 receptor agonists, nutritional supplements (Vitamins D and K, omega-3, prebiotics, probiotics and synbiotics), fecal microbiota transplantation (FMT) and intestinal cytokine IL-22] as PCOS therapeutic options. These novel therapies combine anti-inflammatory, insulinsensitizing, and anti-obesity activities, along with the restoration of the gut microbiota and thus hold the potential to address the basic pathogenic mechanisms of PCOS.; Conclusion: Exhaustive, multicentric and multiethnic studies are vital to generating a network of normative data to better figure out the PCOS trajectory and change prognostic outcomes. Preclinical and clinical data are warranted to corroborate the new therapeutics and direct health care resources accordingly. (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Baskar, T., et al. (2022). "Interventions For Postpartum Depression: Systematic Review." NeuroQuantology 20(14): 1136-1146.
	Postpartum depression (PPD) is a common complication of childbearing, and has increasingly been identified as a major public health problem. Untreated maternal depression has multiple potential negative effects on maternal-infant attachment and child development. Despite available treatments for postpartum depression, numerous barriers hinder women to access care including time, financial constraints, and childcare concerns. Therefore therefore the interventions needs to be conifirmed for the effectiveness. The review aims to explore available interventions for the postpartum depression in Asia. The study involved a systematic review from internet databases such as Pubmed and CINHAL. Following that, databases were accessed to conduct a more detailed search of the literature using key phrases and Boolean operators to create articles pertinent to the issue. 1740 records identified. The duplicates andthose not matching with the criteria were excluded. 8 articles were filtered using aninclusion/exclusion criterion. Results showed overall the systematic reviews on interventions for PPD are of low-moderate quality and are not improving over time. Traditional Chinese herbal medicine was effective in the management of PPD and thus could provide a useful therapeutic alternative for women who prefer natural options over conventional therapies. The efficacy of physical exercise, and CBT for the treatment of PPD remain equivocal. Hypnosis in PPD dosent support with any evidence.Copyright © 2022, Anka Publishers. All rights reserved.

Baskiran, Y., et al. (2023). "The impact of maternal electrolyte and albumin levels on the efficacy of single-dose methotrexate treatment for ectopic pregnancies." Turkish Journal of Obstetrics and Gynecology 20(3): 214-218.
	Objective: This study aims to investigate the impact of maternal albumin and serum electrolyte levels on the efficacy of single-dose methotrexate (SD-Mtx) therapy for ectopic pregnancies. Building on previous research, recommendations are provided to enhance the success of SD-Mtx therapy in the management of ectopic pregnancy. Material(s) and Method(s): Conducted at a tertiary center gynecology clinic, the study included 353 patients diagnosed with ectopic pregnancy and treated with SD-Mtx from 2012 to 2023. Patients who responded positively to SD-Mtx treatment comprised Group 1 (n=313), while those requiring surgical intervention due to failed SD-Mtx therapy constituted Group 2 (n=40). Through the hospital's digital database, patient data including complete blood count, biochemistry, and hormone test results were retrospectively examined. Result(s): The mean beta-hCG value was 1996 IU/mL for Group 1 in contrast to 2058 IU/mL for Group 2. There was no statistically significant difference in beta-hCG levels between the two groups. Notably, Group 1 patients exhibited lower serum magnesium levels but higher potassium levels compared to Group 2 patients, with statistically significant differences. Furthermore, Group 1 patients had higher albumin levels than those in Group 2, with a statistically significant difference. Conclusion(s): Successful SD-Mtx treatment was associated with lower maternal serum magnesium levels and higher potassium and albumin levels. Considering electrolyte levels before administering SD-Mtx and addressing any imbalances could potentially enhance treatment success. Additionally, restoring low albumin levels might improve the efficacy of SD-Mtx treatment for ectopic pregnancies. While this study suggests these trends, further extensive studies with a larger sample size are necessary to establish more definitive evidence.Copyright © 2023, Turkish Society of Obstetrics and Gynecology. All rights reserved.

Basnet, R. (2021). "Impact of pelvic floor muscle training in pelvic organ prolapse." International Urogynecology Journal 32(6): 1351-1360.
	Introduction and hypothesis: This review article was aimed at evaluating the effectiveness of pelvic floor muscle training (PFMT) during conservative management and as an adjunct to prolapse surgery based on recently published articles. Method(s): The PubMed and PEdro databases were searched from 2005 to 2020 for all types of studies reporting on PFMT as the primary treatment for conservative management of prolapse as well as an adjunct for prolapse surgery. Result(s): The result of this review demonstrated that PFMT is effective in conservative management, especially in women with mild to moderate prolapse(stages I-III), for those who wish to have more children, who are not willing to undergo surgery, who are frail because of co-morbidities, and for those who need to delay surgery. However, results evaluating the effectiveness of PFMT as an adjunct to surgery demonstrated insufficient evidence to support the benefit of PFMT in addition to prolapse surgery over the use of surgery alone. Conclusion(s): Through this review, we have concluded that PFMT shows a more prominent effect when applied as conservative management. Currently available evidence demonstrated no additional clinically significant augmentation of PFMT as an adjunct to surgery compared with prolapse surgery alone.Copyright © 2021, The International Urogynecological Association.

Bassel, H. A. W. and R. Michael (2021). "Fresh vs frozen embryo transfer in women with polycystic ovary syndrome: a systematic review and meta-analysis."
	
Bastawros, D., et al. (2021). "Twice-Daily Nitrofurantoin Administration Following Short-term Transurethral Catheterization After Pelvic Reconstructive Surgery: a Randomized Clinical Trial." Female Pelvic Medicine & Reconstructive Surgery 27(3): 202‐207.
	OBJECTIVE: The objective of this study was to evaluate if twice‐daily nitrofurantoin for 5 days after discontinuation of transurethral catheterization decreases the rate of urinary tract infection (UTI) in women with postoperative urinary retention (POUR) after pelvic reconstructive surgery. METHODS: This was a double‐blind, placebo‐controlled, randomized trial conducted across 2 clinical sites between October 2017 and April 2019. Women with acute POUR after pelvic reconstructive surgery were included and randomized to nitrofurantoin (100 mg) or placebo twice‐daily for 5 days. The primary outcome was clinically suspected UTI (defined as dysuria, frequency, and irritation in the absence of vaginal discharge) and/or culture‐proven UTI (defined as greater than 105 colony forming units of a single organism) within 30 days of surgery. Secondary outcomes included evaluation of adverse events related to study medication and medication adherence. RESULTS: Data from 164 participants were eligible for intention‐to‐treat analysis (nitrofurantoin, n = 82; placebo, n = 82). There were no significant demographic or intraoperative differences except for body mass index and race. Median duration of catheterization was 3 days (interquartile range, 2‐5 days, P = 0.12). Fifteen women in the nitrofurantoin group and 14 women in the placebo group experienced UTI within 30 days (18.3% vs 17.1%; P = 0.84; odds ratio, 1.09; 95% confidence interval, 0.49‐2.43). There were no study medication allergies; however, nausea was the most common intolerance. Most women in each group completed the study drug treatment (91.5% vs 86.4%, P = 0.30). CONCLUSIONS: Nitrofurantoin prophylaxis after transurethral catheter removal did not reduce the risk of UTI in women with acute POUR after pelvic reconstructive surgery.

Batista, T., et al. (2021). "A phase II trial of short-course Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) for high tumor burden ovarian cancer: updated report with preliminary survival outcomes." Gynecologic Oncology 162(Supplement 1): S78.
	Objectives: To present an updated report with preliminary survival outcomes from our feasibility study. Method(s): This study was a non-randomized, open-label, multi-center, single-arm trial on the safety and efficacy of neoadjuvant chemotherapy (NACT) followed by fast-track cytoreductive surgery (CRS) plus short-course HIPEC (i.e.: 30 min) in advanced ovarian cancer (NCT02249013). HIPEC was performed according to the closed-abdomen technique using a concentration-based regimen of cisplatin (25 mg/m2/L) or cisplatin plus doxorubicin (15mg/L) at 41-43degreeC. Dextrose perfusate was circulated using the Performer HT device (RAND Srl, Medolla, MO, Italy) at a flow rate of 700ml/min. Primary endpoint was PD9 (i.e.: proportion of patients with disease progression or death occurring within 9 months of interval CRS plus HIPEC) and secondary endpoints were morbidity (mortality and complication rates related to CRS plus HIPEC), time to start adjuvant chemotherapy, length of ICU and hospital stay, QoL over treatment (EORTC QLQ-C30), and ultimately progression-free (PFS) and overall (OS) survivals. Funding sources were from Decit/SCTIE/MS - CNPq/FACEPE/SES-PE (APQ:0187-4.01/13) and FAPE/IMIP. Result(s): A total of 15 patients with stage III epithelial malignancies were recruited from our public health system between February 2015 and July 2019 in four Brazilian centers. The median (range) age was 46 years (19-67), with preoperative serum CA125 levels of 737.7U/mL (161.6-6550). The median number of preoperative cycles of IV chemotherapy was 3 (2-4), resulting in PCI scores of 11 (3-18) at the time of interval CRS plus HIPEC performed after a median of 29 days (26-43) from the last neoadjuvant cycle. Time to restarts IV chemotherapy was 39 days (31-74) and fourteen (93.3%) patients completed all the six cycles of IV chemotherapy as planned. Only 1 patient did not start the systemic adjuvant therapy due to poor recovery after surgery. Median operation time was 490 minutes (235-865), with 9 (60%) patients requiring major bowel resection as rectosigmoidectomy (n=8) or partial colectomy (n=1), but with a nil rate of ostomies. Median length of hospital stay was 5 days (3-10), with ICU stay of 1 day (1-5). Four patients experienced no postoperative complications, whereas 5 suffered only minor G1/G2 complications, and 6 suffered major G3 complications, according to the NCI/CTCAE classification. The most common complications were electrolytes imbalance and anemia. Two patients experienced reoperation because of G3 postoperative hemorrhage or peritoneal infection, whereas no deaths were recorded. No significant difference over time in the QLQ-C30 summary scores was observed (p>0.05). With a median follow-up of 32 (18.2-61.2) months, PD9 and median PFS was 6.7% and 18 months, respectively. At this time, median OS was not reached and our 2y- PFS and OS was 30.8% and 92.8%, respectively. Conclusion(s): We confirm the preliminary hypothesis of safety and efficacy for our comprehensive approach involving the use of short-course HIPEC in high tumor burden ovarian cancer. Median overall survival is pending to confirm short-course HIPEC at the time of interval CRS as a promising approach in terms of survival outcomes.Copyright © 2021 Elsevier Inc.

Batman, S., et al. (2021). "Trastuzumab with carboplatin/paclitaxel for treatment of advanced stage and recurrent uterine papillary serous carcinoma: A cost-effectiveness analysis." Gynecologic Oncology 160(1): 214-218.
	Objective: Uterine papillary serous carcinoma (UPSC) is a variant of endometrial cancer that is aggressive and associated with poor outcomes. We sought to evaluate the cost effectiveness of carboplatin/paclitaxel alone versus carboplatin/paclitaxel with trastuzumab among patients with Her2/neu-positive advanced or recurrent UPSC. Method(s): We designed a Markov model in TreeAge Pro 2019 software to simulate management of a theoretical cohort of 4000 patients with Her2/neu-positive advanced or recurrent uterine papillary serous carcinoma (UPSC) followed for four years. In the carboplatin/paclitaxel with trastuzumab strategy, we included the cost of testing for Her2/neu status. We obtained all model inputs from the literature and a societal perspective was assumed. Outcomes included progression-free survival, progression, UPSC-specific mortality, cost, and quality-adjusted life years (QALYs). The intervention was considered cost effective if the incremental cost-effectiveness ratio (ICER) was below the willingness-to-pay threshold of $100,000 per QALY. Sensitivity analyses were used to determine the robustness of the results. Result(s): In our theoretical cohort of 4000 women, treatment with the addition of trastuzumab resulted in 637 fewer deaths and 627 fewer cases of progression compared with treatment with carboplatin/paclitaxel alone. Treatment with trastuzumab was associated with an additional cost of $144,335,895, but was associated with an increase of 2065 QALYs. The ICER was $69,903 per QALY, which was below our willingness-to-pay threshold. Sensitivity analysis demonstrated that this treatment strategy was cost-effective until the cost of 6 months of treatment surpassed $38,505 (baseline input: $27,562). Conclusion(s): We found that the addition of trastuzumab to carboplatin/paclitaxel was a cost-effective treatment strategy for patients with advanced/recurrent Her2/neu-positive UPSC.Copyright © 2020 Elsevier Inc.

Batur, P. (2021). "In postmenopausal women, multimodal or US screening for ovarian cancer did not reduce ovarian cancer mortality." Annals of Internal Medicine 174(10): JC114.
	Menon U, Gentry-Maharaj A, Burnell M, et al. Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet. 2021;397:2182-93. 33991479.

Bauer Todd, M., et al. (2023). "A Phase Ib Study Assessing the Safety, Tolerability, and Efficacy of the First-in-Class Wee1 Inhibitor Adavosertib (AZD1775) as Monotherapy in Patients with Advanced Solid Tumors." Targeted oncology 18(4): 517-530.
	Background: Adavosertib (AZD1775) is a first-in-class, selective, small-molecule inhibitor of Wee1.; Objective: The safety, tolerability, pharmacokinetics, and efficacy of adavosertib monotherapy were evaluated in patients with various solid-tumor types and molecular profiles.; Patients and Methods: Eligible patients had the following: confirmed diagnosis of ovarian cancer (OC), triple-negative breast cancer (TNBC), or small-cell lung cancer (SCLC); previous treatment for metastatic/recurrent disease; and measurable disease. Patients were grouped into six matched cohorts based on tumor type and presence/absence of biomarkers and received oral adavosertib 175 mg twice a day on days 1-3 and 8-10 of a 21-day treatment cycle.; Results: Eighty patients received treatment in the expansion phase; median total treatment duration was 2.4 months. The most common treatment-related adverse events (AEs) were diarrhea (56.3%), nausea (42.5%), fatigue (36.3%), vomiting (18.8%), and decreased appetite (12.5%). Treatment-related grade ≥ 3 AEs and serious AEs were reported in 32.5% and 10.0% of patients, respectively. AEs led to dose interruptions in 22.5%, reductions in 11.3%, and discontinuations in 16.3% of patients. One patient died following serious AEs of deep vein thrombosis (treatment related) and respiratory failure (not treatment related). Objective response rate, disease control rate, and progression-free survival were as follows: 6.3%, 68.8%, 4.5 months (OC BRCA wild type); 3.3%, 76.7%, 3.9 months (OC BRCA mutation); 0%, 69.2%, 3.1 months (TNBC biomarker [CCNE1/MYC/MYCL1/MYCN] non-amplified [NA]); 0%, 50%, 2 months (TNBC biomarker amplified); 8.3%, 33.3%, 1.3 months (SCLC biomarker NA); and 0%, 33.3%, 1.2 months (SCLC biomarker amplified).; Conclusion: Adavosertib monotherapy was tolerated and demonstrated some antitumor activity in patients with advanced solid tumors.; Trial Registration: ClinicalTrials.gov identifier NCT02482311; registered June 2015. (© 2023. The Author(s).)

Bautrant, E., et al. (2022). "PHASE-III Randomized monocentric controlled trial comparing clinical and cost-effectiveness analysis of botulinum toxin uterine injections versus placebo for severe dysmenorrhea and chronic pelvic pain from uterine origin after standard therapeutic failure." European journal of obstetrics gynecology and reproductive biology. Conference: EBCOG 2021. European congress of obstetrics and gynaecology 270: e102.
	Introduction and aims of the study: severe dysmenorrhea and chronic pelvic pain (CPP) from uterine origin may be followed by psycho‐social consequences and professional absenteism. Despite a negative magnetic resonance imaging and laparoscopy, current available treatments (analgesics, anti‐inflammatory drugs and hormones) are ineffective with low quality of life gains. As published previously, injections of botulinum toxin (BT) type A under hysteroscopy into uterine myometrium revealed significant decrease of patient‐reported symptoms and improvement of global quality of life scores at 8 and 12‐week post‐injection. The aims of this study are to evaluate clinical and cost‐effectiveness of BT use for severe dysmenorrhea/CPP after treatment failure. Methods: phase‐III randomized monocentric controlled trial comparing BT versus placebo among 100 participants. Randomization will be centralized. Study investigators, analysis team, and subjects will remain blinded. Participants will be informed and will sign a written informed consent. Data will be collected and registered in a secure electronic platform before enrollment, at inclusion, 8‐week and 4‐month follow‐up. Main clinical outcome: patient Global Impression of Improvement. Secondary clinical outcomes: health‐Related Quality of Life (HRQoL) by Endometriosis Health Profile, Generic HRQoL EQ‐5D‐3L, Female Sexual Function Index, dysmenorrhea and dyspareunia numerical rating scale, pain visual analogue scale, side effects, drug tolerance, surgical complications, global patient satisfaction. Effectiveness and costs outcomes: quality‐adjusted life years (QALYs), direct and indirect costs, net social benefit, incremental cost‐effectiveness ratios. Discussion: this study will provide the most reliable evidence on the effectiveness of a novel therapy for patients suffering from severe dysmenorrhea and CPP from uterine origin, in the event of standard therapeutic failure. The health economic evaluation will give evidence to guide collective decision‐making on marketing authorization for this clinical indication. Conclusions: evidence‐based clinical and cost‐effectiveness of BT will guide the proposal and implementation of a new treatment for severe dysmenorrhea and CPP from uterine origin

Bayefsky, M., et al. (2022). "Navigating parent-child disagreement about fertility preservation in minors: scoping review and ethical considerations." Human Reproduction Update 28(5): 747-762.
	Background: Offering fertility preservation (FP) prior to gonadotoxic therapy, including cancer care and gender-affirming treatment, is now considered standard of care. Periodically, parents and children disagree about whether to pursue FP. However, it is unknown how often this occurs and how disagreement is handled when it arises. Moreover, there is no clear guidance on how to resolve these difficult situations.; Objective and Rationale: The purpose of this scoping review is to provide an overview of available research evidence about parent-child disagreement regarding FP in order to establish that disagreement occurs in practice, understand the basis for disagreement and explore suggestions for how such disputes could be resolved. Based on our findings, we offer a discussion of the ethical principles at stake when disagreement occurs, which can be used to guide clinicians' approaches when these challenging scenarios present.; Search Methods: A comprehensive literature search was run in several databases, including PubMed/Medline, Embase and the Cochrane Library. The search was performed in February 2021 and updated in August 2021. Articles were included in the final review if they discussed how parents or children wanted their views on FP taken into account, presented evidence that parent-child discordance regarding FP exists, discussed how to handle disagreement in a particular case or offered general suggestions for how to approach parent-child discordance about FP. Studies were excluded if the patients were adult only (age 18 years and older), pertained to fertility-sparing treatments (e.g. gonad shielding, gonadopexy) rather than fertility-preserving treatments (e.g. testicular tissue cryopreservation, ovarian tissue cryopreservation, oocyte cryopreservation or sperm cryopreservation) or explored the views of clinicians but not patients or parents. Meta-synthesis was used to synthesize and interpret data across included studies and thematic analysis was used to identify common patterns and themes.; Outcomes: In total, 755 publications were screened, 118 studies underwent full-text review and 35 studies were included in the final review. Of these studies, 7 discussed how parents or children wanted their opinions to be incorporated, 11 presented evidence that discordance exists between parents and children regarding FP, 4 discussed how disagreement was handled in a particular case and 21 offered general suggestions for how to approach parent-child disagreement. There was a range of study designs, including quantitative and qualitative studies, case studies, ethical analyses and commentaries. From the thematic analysis, four general themes regarding FP disagreement emerged, and four themes relating to the ethical principles at stake in parent-child disagreement were identified. The general themes were: adolescents typically desire to participate in FP decision-making; some parents prefer not to involve their children; minors may feel more favorably about FP than their parents; and transgender minors and their parents may have unique reasons for disagreement. The ethical principles that were identified were: minor's best interest; right to an open future; minor's autonomy; and parental autonomy.; Wider Implications: This study offers an overview of available research on the topic of parent-child disagreement regarding FP and discusses the ethical considerations at stake when disagreement occurs. The findings can be used to inform guidance for clinicians presented with FP disagreement in practice. (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Bayer (2021). A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2).
	No Results Available Drug: Elinzanetant (BAY3427080)|Drug: Placebo Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])|Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)|Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD)|Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)|Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)|Mean change in frequency of moderate to severe HF from baseline over time|Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12|Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12|Mean change in Beck depression inventory (BDI-II) total score from baseline to Week 12|Mean change in BDI-II total score from baseline to Week 26 Female Phase 3 400 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 21652|2020-004855-34 October 4, 2023

Bayer (2023). A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause.
	No Results Available Drug: Elinzanetant|Other: Placebo Change from baseline in WASO as measured by PSG|Change from baseline in SE as measured by PSG|Change from baseline in PROMIS SD SF 8b total score|Change from baseline in ISI total score|Number of participants with Treatment-emergent Adverse Events (TEAEs)|Number of participants with Abnormal laboratory parameters Female Phase 2 78 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 22423|2023-504955-28-00 January 7, 2025

Bazzazian, S., et al. (2021). "The relationship between depression, stress, anxiety, and postpartum weight retention: A systematic review." Journal of education and health promotion 10: 230.
	Postpartum weight retention (PPWR) is a factor that causes permanent obesity and subsequent chronic and noncommunicable diseases. The relationship between depression/stress/anxiety and PPWR has been studied in some articles, but there is no definitive conclusion in this regard. The present systematic review was conducted to investigate the relationship between depression/stress/anxiety and PPWR. An extensive search was performed in the PubMed, Scopus, Embase, Web of Science, Google Scholar, SID, and Magiran, Irandoc databases using Medical Subject Headings terms (or their Persian synonyms) from 2000 to 2020. Inclusion and exclusion criteria were used for articles selection. The quality of the selected articles was assessed using the Newcastle-Ottawa Scale. Out of 371 reviewed articles, 24 articles were selected. The total sample size was 51,613 (range: 49-37,127). The mean of PPWR ranged from 0.5 kg (standard deviation [SD] = 6.49) to 6.4 kg (SD = 8.5). There was a statistically significant relationship between depression/stress/anxiety and PPWR in 12 of 23, 4 of 6, and 3 of 8 studies. This review demonstrates the relationship between depression/stress/anxiety and PPWR. Time of depression/stress/anxiety assessment is an important issue, as well as different measurement tools. Prevention of the mothers' psychological problems through educational and supportive programs may help to limit PPWR.

Bear Katie, A., et al. (2022). "The Impact of a Mindfulness App on Postnatal Distress." Mindfulness 13(11): 2765-2776.
	Objectives: The present study investigated the effectiveness of an 8-week mindfulness mobile phone app on women's depression, anxiety, stress and mindful attention/awareness in the postnatal period.; Methods: The study enrolled 99 mothers of a child under 1 year old, and randomly assigned them to intervention ( n = 49, mean age = 31.11, SD = 4.30, years) and control ( n = 50, mean age = 31.35, SD = 5.29, years) groups. Multiple regression examined intervention effects on depression, anxiety, stress and mindful attention/awareness measured post-intervention and at 4-week follow-up, controlling for the baseline and post-intervention measurement of the specific outcome, respectively.; Results: The intervention group showed significant decreases in depression, anxiety and stress levels and an increase of mindful attention/awareness post-intervention compared to the control group, with medium to large effect sizes after controlling for effects of corresponding variables at baseline. The intervention group showed further decrease in depression and stress levels and an increase in mindful attention/awareness at 4 weeks post-intervention compared to the control group, with small to medium effect sizes, after controlling for effects of corresponding variables at post-intervention.; Conclusions: The outcomes of the study suggest that delivery of mindfulness via smartphones could be a viable and affordable resource for reducing postnatal depression, anxiety and stress.; Competing Interests: Conflict of InterestThe authors declare no competing interests. (© The Author(s) 2022.)

Beaucage-Charron, J., et al. (2022). "A randomized double-blind feasibility study comparing cetirizine and diphenhydramine in the prevention of paclitaxel-associated infusion-related reactions: the PREMED-F1 study." Supportive Care in Cancer 30(4): 3389-3399.
	Purpose: Cetirizine is a less sedative alternative to diphenhydramine for the prevention of infusion-related reactions (IRR) to paclitaxel. However, its use remains controversial. In this study, we assessed feasibility for a future definitive non-inferiority trial comparing cetirizine to diphenhydramine as premedication to prevent paclitaxel-related IRR. Method(s): This was a single-center randomized prospective feasibility study. Participants were paclitaxel-naive cancer patients scheduled to start paclitaxel chemotherapy. They were randomly assigned to receive either intravenous diphenhydramine 50 mg + oral placebo (control) or intravenous placebo + oral cetirizine 10 mg (intervention) for their first two paclitaxel treatments. The percentage of eligible patients completing a first paclitaxel treatment and the recruitment rate were assessed (feasibility outcomes). Drowsiness was measured at baseline and at selected time points using the Stanford Sleepiness Scale (SSS) (safety outcome). IRR events were also documented (efficacy outcome). Result(s): Among 37 eligible patients, 27 were recruited and randomized (control 13; intervention 14) and 25 completed the study. The recruitment rate was 4.8 participants/month, meeting the primary feasibility target. Drowsiness was the main adverse effect associated with the premedication. The increase in drowsiness compared to baseline (DELTASSS) was greater in the diphenhydramine group compared to the cetirizine group (median DELTASSS 2 (IQR 3.25) vs median DELTASSS 0 (IQR 1), p < 0.01) when measured one hour after the premedication administration. One participant had an IRR and no unexpected serious adverse event occurred. Conclusion(s): The trial methods were feasible in terms of recruitment, retention, and safety. Cetirizine was significantly less sedating than diphenhydramine. IRR were infrequent and a larger trial is warranted to confirm non-inferiority for IRR prevention. Trial registration: ClinicalTrials.gov, NCT04237090 (22.01.2020).Copyright © 2021, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Beauchamp, U. L., et al. (2020). "The Use of Wearables in Clinical Trials During Cancer Treatment: Systematic Review." JMIR mHealth and uHealth 8(11): e22006.
	BACKGROUND: Interest in the use of wearables in medical care is increasing. Wearables can be used to monitor different variables, such as vital signs and physical activity. A crucial point for using wearables in oncology is if patients already under the burden of severe disease and oncological treatment can accept and adhere to the device. At present, there are no specific recommendations for the use of wearables in oncology, and little research has examined the purpose of using wearables in oncology. OBJECTIVE(S): The purpose of this review is to explore the use of wearables in clinical trials during cancer treatment, with a special focus on adherence. METHOD(S): PubMed and EMBASE databases were searched prior and up to October 3, 2019, with no limitation in the date of publication. The search strategy was aimed at studies using wearables for monitoring adult patients with cancer during active antineoplastic treatment. Studies were screened independently by 2 reviewers by title and abstract, selected for inclusion and exclusion, and the full-text was assessed for eligibility. Data on study design, type of wearable used, primary outcome, adherence, and device outcome were extracted. Results were presented descriptively. RESULT(S): Our systematic search identified 1269 studies, of which 25 studies met our inclusion criteria. The types of cancer represented in the studies were breast (7/25), gastrointestinal (4/25), lung (4/25), and gynecologic (1/25); 9 studies had multiple types of cancer. Oncologic treatment was primarily chemotherapy (17/25). The study-type distribution was pilot/feasibility study (12/25), observational study (10/25), and randomized controlled trial (3/25). The median sample size was 40 patients (range 7-180). All studies used a wearable with an accelerometer. Adherence varied across studies, from 60%-100% for patients wearing the wearable/evaluable sensor data and 45%-94% for evaluable days, but was differently measured and reported. Of the 25 studies, the most frequent duration for planned monitoring with a wearable was 8-30 days (13/25). Topics for wearable outcomes were physical activity (19/25), circadian rhythm (8/25), sleep (6/25), and skin temperature (1/25). Patient-reported outcomes (PRO) were used in 17 studies; of the 17 PRO studies, only 9 studies reported correlations between the wearable outcome and the PRO. CONCLUSION(S): We found that definitions of outcome measures and adherence varied across studies, and limited consensus among studies existed on which variables to monitor during treatment. Less heterogeneity, better consensus in terms of the use of wearables, and established standards for the definitions of wearable outcomes and adherence would improve comparisons of outcomes from studies using wearables. Adherence, and the definition of such, seems crucial to conclude on data from wearable studies in oncology. Additionally, research using advanced wearable devices and active use of the data are encouraged to further explore the potential of wearables in oncology during treatment. Particularly, randomized clinical studies are warranted to create consensus on when and how to implement in oncological practice.Copyright ©Ulrikke Lyng Beauchamp, Helle Pappot, Cecilie Hollander-Mieritz. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 11.11.2020.

Beauquier-Maccotta, B. (2021). "Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress." ClinicalTrials.gov.
	No Results Available Behavioral: Interaction Guidance Therapy|Behavioral: Mother's child psychotherapeutic session|Behavioral: Interview|Behavioral: Self-rated questionnaires Maternal sensitivity|Maternal sensitivity at 12 months|Prevalence of PN-PTSD|Prevalence of post natal depressive symptoms|Infant development ASQ|Infant symptoms SCL|fathers' Post-traumatic stress disorder|Father's depressive symptoms|both parents' anxiety|both parents' perception of social support|both parents' perception of their marital relationship|both parents' bonding to the child All Not Applicable 90 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment APHP180615|ID-RCB Number December 2024

Becattini, C., et al. (2020). "Updated meta-analysis on prevention of venous thromboembolism in ambulatory cancer patients." Haematologica 105(3): 838-848.
	Randomized clinical trials have evaluated the role of anticoagulants in the prevention of venous thromboembolism (VTE) in ambulatory cancer patients treated with chemotherapy. This meta-analysis is aimed at providing an updated evaluation of the efficacy and safety of anticoagulant prophylaxis in this clinical setting. Medline and Scopus were searched to retrieve randomized controlled trials on the prevention of VTE in ambulatory cancer patients. Two groups of trials were identified with VTE or death as the primary outcome, respectively. VTE was the primary outcome of this analysis. Anticoagulant prophylaxis reduced the incidence of VTE in studies in which the primary outcome was VTE [14 studies, 8,226 patients; odds ratio (OR)=0.45; 95% confidence interval (95% CI): 0.36- 0.56] or death (8 studies, 3,727 patients; OR=0.61; 95% CI: 0.47-0.81). When these studies were pooled together, VTE was reduced by 49% (95% CI: 0.43-0.61) with no significant increase in major bleeding (OR=1.30, 95% CI: 0.98-1.73). The risk of major bleeding was increased in studies with VTE as the primary outcome (OR=1.43, 95% CI: 1.01-2.04). Similar reductions of VTE were observed in studies with parenteral (OR=0.43, 95% CI: 0.33- 0.56) or oral anticoagulants (OR=0.49, 95% CI: 0.33-0.74). The reduction in VTE was confirmed in patients with lung (OR=0.42, 95% CI: 0.26-0.67) or pancreatic cancer (OR=0.26, 95% CI: 0.14-0.48), in estimated high-risk patients, in high-quality studies and with respect to symptomatic VTE. In conclusion, prophylaxis with oral or parenteral anticoagulants reduces the risk of VTE in ambulatory cancer patients, with an acceptable increase in major bleeding.Copyright ©2020 Ferrata Storti Foundation

Bechini, A., et al. (2023). "Efficacy of HPV Vaccination Regarding Vulvar and Vaginal Recurrences in Previously Treated Women: The Need for Further Evidence." Vaccines 11(6).
	Vulvar and vaginal cancers are relatively rare cancers, but their incidence is increasing worldwide. Overall, 78% of vaginal cancers and 25% of vulvar cancers are associated with Human papillomavirus (HPV) infection. Immunization could be an option for the management of these cases. We researched and assessed the evidence on the efficacy of HPV vaccination administered to women previously treated with surgery, radiotherapy, or chemotherapy with respect to the recurrence of vulvovaginal disease. From 2006 to November 2022, only one study evaluated the efficacy of HPV vaccination with respect to preventing vulvovaginal recurrences in treated women and showed that a quadrivalent HPV vaccine administered after the surgical treatment of vulvar high-grade squamous intraepithelial lesion (HSIL) can reduce vulvar recurrence of the disease. Therefore, the efficacy of HPV vaccination with respect to vulvovaginal recurrence is still an unexplored field. Further studies are needed to produce stronger evidence in order to appropriately support interventions to protect women's health.

Beck, C. T. and S. Casavant (2019). "Synthesis of Mixed Research on Posttraumatic Stress Related to Traumatic Birth." Journal of obstetric, gynecologic, and neonatal nursing : JOGNN 48(4): 385-397.
	OBJECTIVE: To synthesize mixed-research results (quantitative and qualitative) on posttraumatic stress in women who experienced traumatic births. DATA SOURCES: PubMed, Scopus, and PsycINFO databases. STUDY SELECTION: Quantitative and qualitative studies were included if they were published in English from January 1, 2009, through December 31, 2018, and focused on posttraumatic stress in the postpartum period related to traumatic childbirth. DATA EXTRACTION: The final sample consisted of 59 studies: 4 qualitative and 55 quantitative. Both authors independently appraised each study using the Critical Appraisal Skills Programme. Quantitative studies were synthesized by narrative synthesis and vote counting, and qualitative studies were synthesized by content analysis. DATA SYNTHESIS: In the included studies, prevalence rates of elevated posttraumatic stress ranged from 0.8% to 26%. Significant predictors of posttraumatic stress that occurred before childbirth and those that were birth related were identified. Reports of six intervention studies to decrease posttraumatic stress symptoms after traumatic births were included. These interventions focused on postnatal debriefing, expressive writing, online cognitive behavioral therapy, a brief cognitive intervention, and the implementation of the nine instinctive stages of the infant during the first hour after birth. We created four themes from the findings of the qualitative studies: Distressing Symptoms, Detrimental Effect of Posttraumatic Stress on Women's Relationships With Their Infants and Partners, Critical Influence ofSupport, and Debriefing. CONCLUSION(S): When a woman experiences posttraumatic stress related to a traumatic birth, the entire family unit is vulnerable. Findings from quantitative predictor studies can be used to develop an instrument to screen women for risk factors for posttraumatic stress related to birth trauma. Primary interventions are needed to prevent women from experiencing traumatic births.Copyright © 2019 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses. Published by Elsevier Inc. All rights reserved.

Beck, D., et al. (2022). "Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids." Clinical pharmacokinetics 61(4): 577-587.
	Background and Objectives: Elagolix is an orally active, gonadotropin-releasing hormone receptor antagonist approved for the management of endometriosis-associated pain and heavy menstrual bleeding associated with uterine fibroids. Elagolix population pharmacokinetics and factors affecting elagolix exposure in healthy women and women with endometriosis have been reported previously. The purpose of this study was to extend the population pharmacokinetics model with additional modifications to incorporate data from phase III studies of elagolix with hormonal add-back therapy in women with uterine fibroids.; Methods: Data from 13 clinical studies (a total of 2168 women) consisting of six phase I studies in healthy premenopausal women, four phase III studies in premenopausal women with endometriosis, and three phase III studies in premenopausal women with uterine fibroids were analyzed using a non-linear mixed-effects modeling approach.; Results: Elagolix population pharmacokinetics was best described by a two-compartment model with first-order absorption, lag time in absorption, and first-order elimination. Out of the covariates tested on elagolix apparent clearance, apparent volume of distribution, and/or relative bioavailability, only organic anion transporting polypeptide 1B1 genotype status and body weight had a statistically significant but no clinically meaningful effect on elagolix relative bioavailability and apparent volume of distribution, respectively. There were no clinically meaningful differences in elagolix population pharmacokinetics in healthy women or women with endometriosis or uterine fibroids.; Conclusions: Elagolix population pharmacokinetics modeling did not reveal any patient-related factors or clinical parameters that would require dose adjustments for the approved dosage of 300 mg twice daily with estradiol 1 mg /norethindrone acetate 0.5 mg daily, in women with heavy menstrual bleeding associated with uterine fibroids.; Clinical Trial Registration: ClinicalTrials.gov identifiers: NCT01620528 (EM-1), NCT01760954 (EM-1-Extend), NCT01931670 (EM-2), NCT02143713 (EM-2-Extend), NCT02654054 (UF-1), NCT02691494 (UF-2), NCT0295494 (UF-Extend). (© 2021. The Author(s).)

Becker, C., et al. (2022). "SPIRIT long-term extension study: two-year efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain." Human Reproduction 37(Supplement 1): i110.
	Study question: To assess the long-term efficacy and safety of once-daily Relugolix combination therapy (Relugolix-CT) in the treatment of endometriosis- associated pain over two years. Summary answer: Relugolix-CT previously demonstrated sustained improvement ofendometriosis-associated pain and was generally well tolerated over 52 weeks. Research is ongoing: two-year results will be reported. What is known already: SPIRIT 1&2 were international, Phase 3, replicate, randomized, double-blind, placebo-controlled studies of Relugolix-CT (relugolix 40mg, estradiol 1mg, norethisterone acetate 0.5mg) in premenopausal women with moderate-to-severe endometriosis-associated pain, which were followed by the open-label, 80-week, long-term extension. 52-week results showed sustained improvement in dysmenorrhea and non-menstrual pelvic pain (NMPP) with 84.8% and 73.3% of responders, respectively. Efficacy was evidenced by reductions in dysmenorrhea (82.8%,) NMPP (62.9%,) proportion of women using opioids, and improvements in function. Relugolix-CT was generally well tolerated. Bone mineral density (BMD) assessment showed minimal initial decline (<1%) from baseline followed by stabilization from Week 24 to 52. Study design, size, duration: Women who completed the 24-week pivotal studies (SPIRIT 1&2) were eligible to enroll in an 80-week open-label, singlearm, long-term extension study of safety and efficacy, representing up to 104 weeks of treatment in total. All women enrolled in the long-term extension study received once-daily oral Relugolix-CT. Analyses were performed based on the initial randomized treatment groups in pivotal studies: Relugolix-CT, delayed Relugolix-CT (relugolix 40mg alone for 12 weeks, then Relugolix-CT for 12 weeks), or placebo. Participants/materials, setting, methods: Primary endpoints are proportion of dysmenorrhea and NMPP responders at Weeks 52 and 104 based on daily Numerical Rating Scale (NRS) scores (0=no pain, 10=worst pain imaginable) and analgesic use. Responders are women who achieved a predefined, clinically meaningful reduction from baseline in NRS score and no increase in analgesic use. Secondary efficacy endpoints include change in Endometriosis Health Profile-30 pain domain scores, use of opioids/analgesics. Safety endpoints include adverse events and BMD (percent change). Main results and the role of chance: Of 1251 randomized patients in SPIRIT 1&2, 1044 (83.4%) completed the pivotal studies; 802 (76.8%) enrolled in the long-term extension, and 681 (84.9%) completed 52 weeks of treatment. Baseline demographics and clinical characteristics of the long-term extension population were consistent with those of the pivotal study population. The study remains ongoing at the time of writing. Efficacy and safety data with Relugolix-CT for up to Week 104, will be presented at the scientific session of the 2022 congress. Limitations, reasons for caution: The study was conducted as an open-label study without a control group over the 80 weeks of the extension period. Wider implications of the findings: Through 52 weeks of treatment, Relugolix-CT demonstrated sustained improvement of dysmenorrhea, NMPP, function, and reduced need for opiates in women with endometriosis-associated pain. No new safety concerns were identified, and treatment was associated with BMD loss <1%. Data from 104 weeks of treatment will be presented at the 2022 congress.

Becker, C., et al. (2021). "The effect of time since surgical diagnosis of endometriosis on treatment outcomes with relugolix combination therapy in women with endometriosis-associated pain: SPIRIT program." Human reproduction (Oxford, England) 36(SUPPL 1): i57.
	Study question: To assess the efficacy of Relugolix‐CT vs placebo in women who were surgically diagnosed with endometriosis <5 and >= 5 years ago. Summary answer: Treatment outcomes did not differ for dysmenorrhea and daily functioning between subgroups of patients with <5 years or ≥5 years since surgical diagnosis. What is known already: Time since clinical manifestation and diagnosis of endometriosis may influence the treatment success of patients with endometriosis‐ associated pain. SPIRIT 1 and 2 were randomized, double‐blind, placebo‐ controlled Phase 3 studies of Relugolix‐CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) in premenopausal women (age 18‐50 years) with surgically diagnosed endometriosis and a history of moderate‐to‐severe dysmenorrhea and non‐menstrual pelvic pain (NMPP). These studies previously demonstrated that Relugolix‐CT significantly reduced dysmenorrhea and NMPP, and improved daily functioning measured by the Endometriosis Health Profile‐30 (EHP‐30) pain domain score vs placebo over 24 weeks. Study design, size, duration: Premenopausal women with surgically diagnosed endometriosis and moderate‐to‐severe dysmenorrhea and NMPP at baseline were randomized 1:1:1 to 24 weeks of treatment with once daily oral Relugolix‐CT, delayed Relugolix‐CT (relugolix 40 mg monotherapy for 12 weeks followed by Relugolix‐CT for 12 weeks), or placebo. The proportion of dysmenorrhea and NMPP responders at Week 24/End‐of‐Treatment (EoT), based on daily Numerical Rating Scale (NRS), and analgesic use status were co‐primary endpoints. Participants/materials, setting, methods: Pooled SPIRIT 1 and 2 data of patients who received 24 weeks of treatment with once daily Relugolix‐CT (N=418) or placebo (N=416) are presented. Outcomes for the delayed Relugolix‐CT group were only for the safety assessment and therefore not reported here. Analyses of NRS scores for dysmenorrhea, NMPP, and EHP‐30 pain domain score were carried out in the subgroups of patients with time since diagnosis of <5 years (N=579) and ≥5 years (N=255). Main results and the role of chance: Baseline demographics and clinical characteristics were comparable between the time since diagnosis subgroups except for a numerically higher mean age in the ≥5‐years subgroup. Mean time since diagnosis (standard deviation) was 2.1 (1.5) years with both Relugolix‐CT and placebo for <5‐years subgroup, and 8.0 (2.8) and 7.8 (2.3) years, respectively, for ≥5‐years subgroup. In Relugolix‐CT‐treated patients, mean NRS score for dysmenorrhea decreased from 7.5 (severe) to 1.8 (mild) in the <5‐years subgroup and from 6.9 (moderate) to 1.8 (mild) in the ≥5‐years subgroup with a significant difference to placebo (p<0.0001, both subgroups), and demonstrating 74.8% and 72.7% reduction in pain from baseline to Week 24/EoT, respectively. Mean NRS score for NMPP decreased from 6.0 (moderate) to 3.0 (mild) with a significant difference compared with placebo (p<0.0001), equating to 48.8% pain reduction in the <5‐years subgroup, and from 5.6 (moderate) to 2.7 (mild) equating to 51.5% pain reduction (p=0.089) in the ≥5‐years subgroup. Improvement of daily functioning as measured by EHP‐30 pain domain score was significantly greater with Relugolix‐CT vs placebo in both subgroups, with decrease in EHP‐30 pain score from 59.1 to 24.0 in the <5‐years subgroup, and from 57.4 to 21.1 in the ≥5‐years subgroup (p<0.0001, both subgroups). Limitations, reasons for caution: A lower number of patients were included into the subgroup with ≥5‐years since surgically diagnosed endometriosis. Fiveyear dichotomy was close to the mean time since surgical diagnosis in the studies and to certain extent is arbitrary. Furthermore, time since surgical diagnosis is not the same as time since symptom onset. Wider implications of the findings: In women with endometriosis‐associated pain, Relugolix‐CT vs placebo significantly reduced dysmenorrhea and improved daily functioning in both groups: wit urgical diagnosis of <5 years or ≥5 years. Substantial decrease in NMPP was also observed and was significantly different to placebo in the <5‐years subgroup.

Becker, C., et al. (2023). "Effect of relugolix combination therapy in women with endometriosis-associated pain who received prior first-line hormonal treatment: SPIRIT 1 and 2." Human Reproduction 38(Supplement 1): i17-i18.
	Study question: To assess the effect of oral relugolix combination therapy (Relugolix-CT) in the subgroup of women with endometriosis-associated pain who received prior first-line hormonal treatment. Summary answer: Relugolix-CT significantly reduced dysmenorrhoea and non-menstrual pelvic pain (NMPP) through 24 weeks in women with endometriosis-associated pain who received prior first-line hormonal treatment. What is known already: ESHRE recommends hormonal contraceptives or progestogens as first-line therapy for endometriosis; however, these treatments may not be efficacious for all women. SPIRIT 1&2 were Phase 3, replicate, randomised studies of oral Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethisterone acetate 0.5 mg) in premenopausal women (aged 18-50 years) with moderate-to-severe endometriosis-associated pain. In SPIRIT 1&2, Relugolix-CT significantly improved dysmenorrhoea, NMPP and daily functioning (measured by the Endometriosis Health Profile-30 pain domain score) compared with placebo over 24 weeks. Relugolix-CT was well-tolerated and bone mineral density showed a minimal decline (<1%) from baseline to Week 24. Study design, size, duration: At screening, women were required to have at least moderate menstrual and non-menstrual pain during their last cycle. In total, 1261 women with diagnosed endometriosis and moderate-to-severe dysmenorrhoea and NMPP at baseline were randomised 1:1:1 to receive once-daily Relugolix-CT or placebo for 24 weeks, or delayed Relugolix-CT (relugolix 40 mg then Relugolix-CT; 12 weeks each). Study candidates who received hormonal treatment for endometriosis completed a washout period prior to the screening and run-in period. Participants/materials, setting, methods: Analyses were performed using pooled SPIRIT 1&2 data in women previously receiving first-line hormonal treatment (e.g. oral contraceptives and/or progestogens; N=392). Co-primary endpoints: proportion of dysmenorrhoea and NMPP responders at Week 24. Responders were women achieving a predefined, clinically meaningful reduction from baseline in daily Numerical Rating Scale (NRS [0=no pain, 10=worst pain imaginable]) score and no increase in analgesic use. Least squares (LS) mean changes in NRS scores were assessed by a mixedeffects model. Main results and the role of chance: In total, 121 women in the Relugolix-CT group and 134 in the placebo group had received prior first-line hormonal treatment, of which combined oral contraceptives and/or dienogest were the most common medications. Data for the delayed Relugolix-CT group were used for safety assessment only and are not reported here. Baseline demographics and clinical characteristics were comparable between the subgroup of women who received prior first-line hormonal treatment and the overall study population. In this subgroup, the proportion of dysmenorrhoea responders with Relugolix-CT vs placebo at Week 24 was 70.2% vs 27.6%, respectively (p<0.0001); the proportion of NMPP responders was 60.3% vs 40.3%, respectively (p=0.0013). In the Relugolix-CT group, LS mean NRS scores for dysmenorrhoea decreased from 7.2 (severe) at baseline to 1.7 (mild) at Week 24, with a significant change from baseline vs placebo (p<0.0001). LS mean NRS scores for NMPP decreased from 5.6 (moderate) at baseline to 2.8 (mild) at Week 24 with Relugolix-CT, with a significant change from baseline vs placebo (p=0.0097). The proportion of women who were analgesic-free at baseline was 7.4% with Relugolix-CT and 3.7% with placebo; this increased to 48.8% with Relugolix-CT and 18.7% with placebo at Week 24 (p<0.0001). Limitations, reasons for caution: Assessment of endometriosis-associated pain at screening visit was done after the wash-out period; therefore, data for endometriosis symptoms experienced by women while receiving hormonal treatment prior to study entry, as well as the duration of the previous treatments, were not available. Wider implications of the findings: Relugolix-CT significantly reduced dysmenorrhoea and NMPP, vs placebo, through 24 weeks in women with endometriosis-a sociated pain who received prior first-line hormonal treatment. The proportion of women in this subgroup who were analgesic-free increased through 24 weeks with Relugolix-CT. Results were comparable to the overall SPIRIT 1&2 population.

Becker Christian, M., et al. (2022). "ESHRE guideline: endometriosis." Human Reproduction Open 2022(2): hoac009.
	Study Question: How should endometriosis be diagnosed and managed based on the best available evidence from published literature?; Summary Answer: The current guideline provides 109 recommendations on diagnosis, treatments for pain and infertility, management of disease recurrence, asymptomatic or extrapelvic disease, endometriosis in adolescents and postmenopausal women, prevention and the association with cancer.; What Is Known Already: Endometriosis is a chronic condition with a plethora of presentations in terms of not only the occurrence of lesions, but also the presence of signs and symptoms. The most important symptoms include pain and infertility.; Study Design Size Duration: The guideline was developed according to the structured methodology for development of ESHRE guidelines. After formulation of key questions by a group of experts, literature searches and assessments were performed. Papers published up to 1 December 2020 and written in English were included in the literature review.; Participants/materials Setting Methods: Based on the collected evidence, recommendations were formulated and discussed within specialist subgroups and then presented to the core guideline development group (GDG) until consensus was reached. A stakeholder review was organized after finalization of the draft. The final version was approved by the GDG and the ESHRE Executive Committee.; Main Results and the Role of Chance: This guideline aims to help clinicians to apply best care for women with endometriosis. Although studies mostly focus on women of reproductive age, the guideline also addresses endometriosis in adolescents and postmenopausal women. The guideline outlines the diagnostic process for endometriosis, which challenges laparoscopy and histology as gold standard diagnostic tests. The options for treatment of endometriosis-associated pain symptoms include analgesics, medical treatments and surgery. Non-pharmacological treatments are also discussed. For management of endometriosis-associated infertility, surgical treatment and/or medically assisted reproduction are feasible. While most of the more recent studies confirm previous ESHRE recommendations, there are five topics in which significant changes to recommendations were required and changes in clinical practice are to be expected.; Limitations Reasons for Caution: The guideline describes different management options but, based on existing evidence, no firm recommendations could be formulated on the most appropriate treatments. Also, for specific clinical issues, such as asymptomatic endometriosis or extrapelvic endometriosis, the evidence is too scarce to make evidence-based recommendations.; Wider Implications of the Findings: The guideline provides clinicians with clear advice on best practice in endometriosis care, based on the best evidence currently available. In addition, a list of research recommendations is provided to stimulate further studies in endometriosis.; Study Funding/competing Interests: The guideline was developed and funded by ESHRE, covering expenses associated with the guideline meetings, with the literature searches and with the dissemination of the guideline. The guideline group members did not receive payments. C.M.B. reports grants from Bayer Healthcare and the European Commission; Participation on a Data Safety Monitoring Board or Advisory Board with ObsEva (Data Safety Monitoring Group) and Myovant (Scientific Advisory Group). A.B. reports grants from FEMaLE executive board member and European Commission Horizon 2020 grant; consulting fees from Ethicon Endo Surgery, Medtronic; honoraria for lectures from Ethicon; and support for meeting attendance from Gedeon Richter; A.H. reports grants from MRC, NIHR, CSO, Roche Diagnostics, Astra Zeneca, Ferring; Consulting fees from Roche Diagnostics, Nordic Pharma, Chugai and Benevolent Al Bio Limited all paid to the institution; a pending patent on Serum endometriosis biomarker; he is also Chair of TSC for STOP-OHSS and CERM trials. O.H. reports consulting fees and speaker's fees from Gedeon Rich er and Bayer AG; support for attending meetings from Gedeon-Richter, and leadership roles at the Finnish Society for Obstetrics and Gynecology and the Nordic federation of the societies of obstetrics and gynecology. L.K. reports consulting fees from Gedeon Richter, AstraZeneca, Novartis, Dr KADE/Besins, Palleos Healthcare, Roche, Mithra; honoraria for lectures from Gedeon Richter, AstraZeneca, Novartis, Dr KADE/Besins, Palleos Healthcare, Roche, Mithra; support for attending meetings from Gedeon Richter, AstraZeneca, Novartis, Dr KADE/Besins, Palleos Healthcare, Roche, Mithra; he also has a leadership role in the German Society of Gynecological Endocrinology (DGGEF). M.K. reports grants from French Foundation for Medical Research (FRM), Australian Ministry of Health, Medical Research Future Fund and French National Cancer Institute; support for meeting attendance from European Society for Gynaecological Endoscopy (ESGE), European Congress on Endometriosis (EEC) and ESHRE; She is an advisory Board Member, FEMaLe Project (Finding Endometriosis Using Machine Learning), Scientific Committee Chair for the French Foundation for Research on Endometriosis and Scientific Committee Chair for the ComPaRe-Endometriosis cohort. A.N. reports grants from Merck SA and Ferring; speaker fees from Merck SA and Ferring; support for meeting attendance from Merck SA; Participation on a Data Safety Monitoring Board or Advisory Board with Nordic Pharma and Merck SA; she also is a board member of medical advisory board, Endometriosis Society, the Netherlands (patients advocacy group) and an executive board member of the World Endometriosis Society. E.S. reports grants from National Institute for Health Research UK, Rosetrees Trust, Barts and the London Charity; Royalties from De Gruyter (book editor); consulting fees from Hologic; speakers fees from Hologic, Johnson & Johnson, Medtronic, Intuitive, Olympus and Karl Storz; Participation in the Medicines for Women's Health Expert Advisory Group with Medicines and Healthcare Products Regulatory Agency (MHRA); he is also Ambassador for the World Endometriosis Society. C.T. reports grants from Merck SA; Consulting fees from Gedeon Richter, Nordic Pharma and Merck SA; speaker fees from Merck SA, all paid to the institution; and support for meeting attendance from Ferring, Gedeon Richter and Merck SA. The other authors have no conflicts of interest to declare.; Disclaimer: This guideline represents the views of ESHRE, which were achieved after careful consideration of the scientific evidence available at the time of preparation. In the absence of scientific evidence on certain aspects, a consensus between the relevant ESHRE stakeholders has been obtained. Adherence to these clinical practice guidelines does not guarantee a successful or specific outcome, nor does it establish a standard of care. Clinical practice guidelines do not replace the need for application of clinical judgement to each individual presentation, nor variations based on locality and facility type . ESHRE makes no warranty, express or implied, regarding the clinical practice guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose (Full disclaimer available at www.eshre.eu/guidelines.). (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Becker, C. M., et al. (2024). "Two-year efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain: SPIRIT open-label extension study." Human Reproduction 39(3): 526-537.
	STUDY QUESTION: What is the efficacy and safety of long-term treatment (up to 2 years) with relugolix combination therapy (CT) in women with moderate to severe endometriosis-associated pain? SUMMARY ANSWER: For up to 2 years, treatment with relugolix CT improved menstrual and non-menstrual pain, dyspareunia, and function in women with endometriosis; after an initial decline of <1%, the mean bone mineral density (BMD) remained stable with continued treatment. WHAT IS KNOWN ALREADY: Endometriosis is a chronic condition characterized by symptoms of dysmenorrhea, non-menstrual pelvic pain (NMPP), and dyspareunia, which have a substantial impact on the lives of affected women, their partners, and families. SPIRIT 1 and 2 were phase 3, randomized, double-blind, placebo-controlled studies of once-daily relugolix CT (relugolix 40 mg, oestradiol 1 mg, norethisterone acetate 0.5 mg) in premenopausal women (age 18-50 years) with endometriosis and moderate-to-severe dysmenorrhea and NMPP. These trials demonstrated a significant improvement of dysmenorrhea, NMPP, and dyspareunia in women treated with relugolix CT, with minimal decline (<1%) in BMD versus placebo at 24 weeks. STUDY DESIGN, SIZE, DURATION: Patients participating in this open-label, single-arm, long-term extension (LTE) study of the 24-week SPIRIT pivotal studies (SPIRIT 1 and 2) received up to an additional 80 weeks of once-daily oral relugolix CT treatment between May 2018 and January 2023. PARTICIPANTS/MATERIALS, SETTING, METHODS: Premenopausal women with confirmed endometriosis and moderate to severe dysmenorrhea and NMPP who completed the 24-week pivotal studies (SPIRIT 1 and 2 trials; Giudice et al., 2022) and who met all entry criteria were eligible to enrol. Two-year results were analysed by treatment group based on original randomization in pivotal studies: relugolix CT, delayed relugolix CT (relugolix 40 mg monotherapy for 12 weeks, followed by relugolix CT), or placebo!relugolix CT (placebo for 24 weeks followed by relugolix CT). The primary endpoints of the LTE study were the proportion of dysmenorrhea and NMPP responders at Week 52 and Week 104/end-of-treatment (EOT). A responder was a participant who achieved a predefined, clinically meaningful reduction from baseline in Numerical Rating Scale (NRS) scores (0 1/4 no pain, 10 1/4 worst pain imaginable) for the specific pain type with no increase in analgesic use. The predefined clinically meaningful threshold for dysmenorrhea was 2.8 points and for NMPP was 2.1 points. Secondary efficacy endpoints included change from baseline in Endometriosis Health Profile-30 (EHP-30) pain domain scores, a measure of the effects of endometriosis-associated pain on daily activities (function), NRS scores for dysmenorrhea, NMPP, dyspareunia, and overall pelvic pain, and analgesic/opioid use. Safety endpoints included adverse events and changes in BMD. MAIN RESULTS AND THE ROLE OF CHANCE: Of 1261 randomized patients, 1044 completed the pivotal studies, 802 enrolled in the LTE, 681 completed 52 weeks of treatment, and 501 completed 104 weeks of treatment. Demographics and baseline characteristics of the extension population were consistent with those of the original randomized population. Among patients randomized to relugolix CT at pivotal study baseline who continued in the LTE (N 1/4 277), sustained improvements in endometriosis-associated pain were demonstrated through 104 weeks. The proportion of responders at Week 104/EOT for dysmenorrhea and NMPP was 84.8% and 75.8%, respectively. Decreases in dyspareunia and improvement in function assessed by EHP-30 pain domain were also sustained over 2 years. At Week 104/EOT, 91% of patients were opioid-free and 75% of patients were analgesic-free. Relugolix CT over 104 weeks was well tolerated with a safety profile consistent with that observed over the first 24 weeks. After initial least squares mean BMD loss <1% at Week 24, BMD plateaued at Week 36 and was sustained for the duration of 104 weeks of treatment. Efficacy and safety results were generally consistent in women i the placebo!relugolix CT and delayed relugolix CT groups. LIMITATIONS, REASONS FOR CAUTION: The study was conducted as an open-label study without a control group over the 80 weeks of the extension period. Of the 802 patients who were enrolled in this LTE study, 681 patients (84.9%) and 501 patients (62.5%) of patients completed 52 and 104 weeks of treatment, respectively. In addition, there currently are no comparative data to other hormonal medications. Finally, a third (37.4%) of the study population terminated participation early. WIDER IMPLICATIONS OF THE FINDINGS: In conclusion, relugolix CT offers an additional option to help address an important unmet clinical need for effective, safe, and well-tolerated medical treatments for endometriosis that can be used longer-term, reducing the need for opioids and improving quality of life. The findings from this study may help support the care of women with endometriosis seeking longer-term effective medical management of their symptoms. STUDY FUNDING/COMPETING INTEREST(S): This study was funded by Myovant Sciences GmbH (now Sumitomo Pharma Switzerland GmbH). C.M.B. reports fees from Myovant, grants from Bayer Healthcare, fees from ObsEva, and Chair of ESHRE Endometriosis Guideline Group (all funds went to the University of Oxford); N.P.J. reports personal fees from Myovant Sciences, during the conduct of the study, personal fees from Guerbet, personal fees from Organon, personal fees from Roche Diagnostics; S.A.-S. reports personal fees from Myovant Sciences, personal fees from Bayer, personal fees from Abbvie, personal fees from UpToDate; J.S.P., and R.B.W. are employees and shareholders of Myovant Sciences; J.C.A.F. and S.J.I. are shareholders of Myovant Sciences (but at time of publicaion are no longer employess of Myovant Sciences); M.S.A. and K.W. have no conflicts to declare; V.M. is a consultant to Myovant; L.C.G. reports personal fees from Myovant Sciences, Inc and Bayer. The authors did not receive compensation for manuscript writing, review, and revision.Copyright © 2024 Oxford University Press. All rights reserved.

Becker, C. M., et al. (2021). "The Effect of Time Since Surgical Diagnosis of Endometriosis on Treatment Outcomes with Relugolix Combination Therapy: spirit Program." Journal of Minimally Invasive Gynecology 28(11): S11.
	Study Objective: To assess efficacy of relugolix combination therapy (Relugolix‐CT) in women who were surgically diagnosed with endometriosis <5 years and ≥5 years ago. Design: SPIRIT 1/2 were 24‐week randomized, double‐blind, placebo‐controlled Phase 3 studies. Setting: 124 (SPIRIT 1) and 95 (SPIRIT 2) clinical research centers globally. Patients or Participants: Premenopausal women (age 18–50 years) with surgically diagnosed endometriosis, moderate‐to‐severe dysmenorrhea and non‐menstrual pelvic pain (NMPP). Interventions: Once‐daily Relugolix‐CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) or placebo. Measurements and Main Results: Change in dysmenorrhea/NMPP NRS scores and Endometriosis Health Profile‐30 (EHP‐30) pain domain scores analyzed in women with endometriosis diagnosis <5 years (N=579) and ≥5 years (N=255) ago. Baseline demographics/clinical characteristics were comparable between subgroups. Mean (standard deviation) time since surgical diagnosis for Relugolix‐CT and for placebo: 2.1 (1.5) and 2.1 (1.5) years (<5‐years subgroup); 8.0 (2.8) and 7.8 (2.3) years (≥5‐years subgroup), respectively. With Relugolix‐CT, mean dysmenorrhea NRS and EHP‐30 pain domain score decreased significantly (both subgroups) vs placebo; mean NMPP NRS score decreased significantly in the <5‐years subgroup (Table). Conclusion: Relugolix‐CT reduced dysmenorrhea and improved daily functioning in both groups: surgical diagnosis <5 years and ≥5 years ago. Reduction in NMPP was statistically significant in women with surgical diagnosis <5 years ago.

Beckmann Matthias, W., et al. (2022). "Diagnosis, Therapy and Follow-up of Cervical Cancer. Guideline of the DGGG, DKG and DKH (S3-Level, AWMF Registry No. 032/033OL, May 2021) - Part 1 with Recommendations on Epidemiology, Screening, Diagnostics and Therapy." Geburtshilfe und Frauenheilkunde 82(2): 139-180.
	Aim This update of the interdisciplinary S3 guideline on the Diagnosis, Therapy and Follow-up of Cervical Cancer (AWMF Registry No. 032/033OL) was published in March 2021. This updated guideline was funded by German Cancer Aid (Deutsche Krebshilfe) as part of the German Guideline Program in Oncology. The guideline was coordinated by the German Society of Gynecology and Obstetrics ( Deutsche Gesellschaft für Gynäkologie und Geburtshilfe , DGGG) and the Working Group on Gynecological Oncology ( Arbeitsgemeinschaft Gynäkologische Onkologie , AGO) of the German Cancer Society ( Deutsche Krebsgesellschaft , DKG). Method The process of updating the S3 guideline dating from 2014 was based on an appraisal of the available evidence using the criteria of evidence-based medicine, adaptations of existing evidence-based national and international guidelines or - if evidence was lacking - on a consensus of the specialists involved in compiling the update. After an initial review of the current literature was carried out according to a prescribed algorithm, several areas were identified which, in contrast to the predecessor version from September 2014, required new recommendations or statements which took account of more recently published literature and the appraisal of the new evidence. Recommendations The short version of this guideline consists of recommendations and statements on the epidemiology, screening, diagnostic workup and therapy of patients with cervical cancer. The most important new aspects included in this updated guideline include the newly published FIGO classification of 2018, the radical open surgery approach for cervical cancers up to FIGO stage IB1, and use of the sentinel lymph node technique for tumors ≤ 2 cm. Other changes include the use of PET-CT, new options in radiotherapy (e.g., intensity-modulated radiotherapy, image-guided adaptive brachytherapy), and drug therapies to treat recurrence or metastasis.; Competing Interests: Conflict of Interest/Interessenkonflikt The conflicts of interest of all the authors are listed in the long German-language version of the guideline report./Die Interessenkonflikte der Autoren sind im Leitlinienreport aufgelistet. (Thieme. All rights reserved.)

Beckmann Matthias, W., et al. (2021). "The Diagnosis, Treatment, and Aftercare of Cervical Carcinoma." Deutsches Arzteblatt international 118(47): 806-812.
	Background: Approximately 4380 cases of cervical carcinoma were diagnosed in Germany in 2016. In women who had not participated in early detection programs, cervical carcinoma was usually already in an advanced stage at the time of diagnosis. Certified structures for care in conformity with the existing guidelines are available.; Methods: The new German clinical practice guideline was revised with the participation of 50 medical societies under the expert guidance of the Guideline Program in Oncology, which includes the German Association of the Scientific Medical Societies (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF). A systematic literature review was conducted. Systematic reviews, meta-analyses, and randomized controlled trials (RCTs) were considered.; Results: The histologic tumor stage and lymph-node stage are essential determinants of the treatment strategy. The main innovation regarding surgical treatment is the revival of open hysterectomy (overall survival [minimally invasive vs open hysterectomy]: 94.04% vs 99.4%; hazard ratio [HR]: 6.00; 95% confidence interval [1.77; 20.30]). In addition, for tumors measuring 2 cm or less, sentinel node biopsy is recommended rather than radical pelvic lymphadenectomy. MRI-guided brachytherapy is an oblig atory component of radiochemotherapy (overall survival [radiochemotherapy with vs without brachytherapy]: 58.2% vs 46.2%, p<0.001). The standard palliative treatment consists of bevacizumab combined with a platinum-containing agent (overall survival: HR: 0.77 [0.62; 0.95]; p = 0.007).; Conclusion: Despite the introduction of new treatments, the outcome of patients with advanced cervical carcinoma has not much improved. In the surgical treatment of cervical carcinoma, the open approach is now favored. The sentinel node biopsy technique has become well established for the surgical staging of small tumors. Controlled trials are needed so that the outcome of women with cervical carcinoma, particularly in its advanced and metastatic stages, can be improved.

Becky, M., et al. (2022). "Interventions following a stillbirth, second trimester miscarriage or recurrent miscarriage to improve a women&#39;s health and subsequent pregnancy outcomes."
	
Bednar, E. M., et al. (2023). "Outcomes of the "BRCA Quality Improvement Dissemination Program": An initiative to improve patient receipt of cancer genetics services at five health systems." Gynecologic Oncology 172: 106-114.
	Objective: A quality improvement initiative (QII) was conducted with five community-based health systems' oncology care centers (sites A-E). The QII aimed to increase referrals, genetic counseling (GC), and germline genetic testing (GT) for patients with ovarian cancer (OC) and triple-negative breast cancer (TNBC). Method(s): QII activities occurred at sites over several years, all concluding by December 2020. Medical records of patients with OC and TNBC were reviewed, and rates of referral, GC, and GT of patients diagnosed during the 2 years before the QII were compared to those diagnosed during the QII. Outcomes were analyzed using descriptive statistics, two-sample t-test, chi-squared/Fisher's exact test, and logistic regression. Result(s): For patients with OC, improvement was observed in the rate of referral (from 70% to 79%), GC (from 44% to 61%), GT (from 54% to 62%) and decreased time from diagnosis to GC and GT. For patients with TNBC, increased rates of referral (from 90% to 92%), GC (from 68% to 72%) and GT (81% to 86%) were observed. Effective interventions streamlined GC scheduling and standardized referral processes. Conclusion(s): A multi-year QII increased patient referral and uptake of recommended genetics services across five unique community-based oncology care settings.Copyright © 2023 Elsevier Inc.

Bednarikova, M., et al. (2022). "Can Schlafen 11 Help to Stratify Ovarian Cancer Patients Treated with DNA-Damaging Agents?" Cancers 14(10): 2353.
	Platinum-based chemotherapy has been the cornerstone of systemic treatment in ovarian cancer. Since no validated molecular predictive markers have been identified yet, the response to platinum-based chemotherapy has been evaluated clinically, based on platinum-free interval. The new promising marker Schlafen 11 seems to correlate with sensitivity or resistance to DNA-damaging agents, including platinum compounds or PARP inhibitors in various types of cancer. We provide background information about the function of Schlafen 11, its evaluation in tumor tissue, and its prevalence in ovarian cancer. We discuss the current evidence of the correlation of Schlafen 11 expression in ovarian cancer with treatment outcomes and the potential use of Schlafen 11 as the key predictive and prognostic marker that could help to better stratify ovarian cancer patients treated with platinum-based chemotherapy or PARP inhibitors. We also provide perspectives on future directions in the research on this promising marker.Copyright © 2022 by the authors. Licensee MDPI, Basel, Switzerland.

Beebeejaun, Y., et al. (2022). "Mode of conception and pregnancy outcomes: systematic review and meta-analysis of 110 studies and 33,655,021 singleton pregnancies." Human Reproduction 37(Supplement 1): i558-i559.
	Study question: Does mode of conception such as in-vitro fertilisation (IVF), ovulation induction (OI), intra-uterine insemination (IUI) affect singleton pregnancy outcomes when compared to spontaneous conception (SC)? Summary answer: Singleton pregnancies resulting from OI, IUI, IVF are associated with higher risks of adverse pregnancy outcomes compared to spontaneous pregnancies. What is known already: Several meta-analysis have shown singleton pregnancies resulting from IVF have adverse pregnancy outcomes However, these studies had much smaller sample size and did not compare OI or IUI to SC. Additionally, when matched studies were analysed, the pooled events used were not adjust for medical conditions such as polycystic ovaries (PCO) and chronic hypertension which predispose patients to gestational diabetes(GDM) and pre-eclampsia (PET).he lack of consensus on how PET and GDM was defined was also a cause of bias. Our study is the largest meta-analysis to date and aims to provide clinician with the latest evidence when offering fertility treatment. Study design, size, duration: Literature search in MEDLINE, COCHRANE Library, and Scopus was performed, up to November 2021. Randomised controlled trials (RCTs), non-randomised studies, cohort and case control studies, reporting on any association between pregnancy outcome, such as pre-eclampsia (PET), gestational diabetes mellitus (GDM), preterm birth, (<37 weeks (TB), very preterm birth , (<32 weeks (vVPTB), low birthweight (<2500g,LBW), very low birth weight (<1500g,VLBW) and small gestational age (SGA) in relation to mode of conception were included. Participants/materials, setting, methods: 110 studies consisting of 31 cohort studies and 79 case control were included comprising a total of 32,463,058spontaneous singleton conception compared to 1,191,963 singleton pregnancies following OI, IUI and IVF treatment .Matching criteria used for adjustment were also identified For PET and GDM, only studies which defined the condition according to international agreed consensus were included Any inconsistency between studies was quantified through Higgins' Chi-square (Chi2) and I-squared (I2) using statistical software R. Main results and the role of chance: Singleton pregnancies following, OI, IUI, or IVF had a higher odds of PET compared to SC (odds ratio [OR]1.95,, 95% confidence interval [CI]1.61-2.31; I2=97%), OR 1.53, 95%CI 1.36 -1.71,, I2=84% and OR1.62, 95%CI 0.94-2.78, I2=11%).respectively. For GDM, pregnancies following, OI, IUI, or IVF had a higher odds compared to SC (OR1.59, 95%CI 1.59 -1.71, I2=83%, OR 1.62, 95%CI 0.94-2.78, I2=11% and OR1.72, 95% CI 1.49-1.98; I2=13%). Higher odds of TB and vPTB were seen in pregnancies following OI and IVF compared to SC (PTB: OR1.80, 95% CI 1.76-1.85; I2=94% and , (OR 1.47, 95% CI 1.22-1.77 I2=66% and vPTB OR 2.92, 95% CI 2.76-3.09; I2=91%). Only one study reported PTB when comparing IUI to SC (OR 1.88, 95% CI 1.40-2.53) and comparing vPTB in OI vs SC (OR 1.73 95% CI 0.71-4.18). Singleton pregnancies following, OI or IVF had a higher odds of LBW and vLBW compared to SC (OR1.98, 95% CI 1.93-2.04; I2=96%),OR1.72, 95% CI 1.49-1.98 I2=13% and OR4.57, 95% CI 4.34-4.81; I2=98% and OR2.32, 95% CI 1.60-3.37; I2=56% respectively. The rate of SGA was comparable in IVF (OR 0.91, 95% CI 0.90-0.93; I2=99%), OI (OR 0.96, 95% CI 0.95-0.97; I2=100%) and IUI (RR 0.92, 95% CI 0.90-0.94; I2=31%). Limitations, reasons for caution: In cases of PE and GDM, published definitions differed in various studies and there was limited information given past medical history which increase the risk of such conditions. This made it impossible to separate the baseline confounders which may increase the risk of PE and consequently PTB, SGA and LBW. Wider implications of the findings: Our meta-analysis confirmed that IVF/ICSI pregnancies are at higher odds of adverse pregnancy outcomes. This is the largest systematic review to date analysing pregnancy outcomes and mode of conception comparing OI, IUI and IVF respectively. It provides the latest evidence possi le for clinicians to choose the safest fertility treatment.

Beelen, P., et al. (2021). "Predictive factors for failure of the levonorgestrel releasing intrauterine system in women with heavy menstrual bleeding." BMC Women's Health 21(1): 57.
	BACKGROUND: This study was conducted to identify factors that are associated with failure of treatment using the levonorgestrel releasing intrauterine system (LNG-IUS) in women with heavy menstrual bleeding. METHODS: For this study, data of a cohort of women treated with an LNG-IUS was used. Women who suffered from heavy menstrual bleeding, aged 34 years and older, without intracavitary pathology and without a future child wish, were recruited in hospitals and general practices in the Netherlands. Eight potential prognostic baseline variables (age, body mass index, caesarean section, vaginal delivery, previous treatment, anticoagulant use, dysmenorrhea, and pictorial blood assessment score) were analyzed using univariable and multivariable regression models to estimate the risk of failure. The main outcome measure was discontinuation of the LNG-IUS within 24 months of follow up, defined as removal of the LNG-IUS or receiving an additional intervention. RESULTS: A total of 209 women received the LNG-IUS, 201 women were included in the analyses. 93 women (46%) discontinued LNG-IUS treatment within 24 months. Multivariable analysis showed younger age (age below 45) (adjusted RR 1.51, 95% CI 1.10-2.09, p = .012) and severe dysmenorrhea (adjusted RR 1.36, 95% CI 1.01-1.82, p = .041) to be associated with a higher risk of discontinuation. CONCLUSIONS: High discontinuation rates are found in women who receive an LNG-IUS to treat heavy menstrual bleeding. A younger age and severe dysmenorrhea are found to be risk factors for discontinuation of LNG-IUS treatment. These results are relevant for counselling women with heavy menstrual bleeding.

Beelen, P., et al. (2021). "Treatment of women with heavy menstrual bleeding: Results of a prospective cohort study alongside a randomised controlled trial." European Journal of Obstetrics, Gynecology, and Reproductive Biology 257: 1-5.
	OBJECTIVE: The objective of this study was to compare the reintervention rate of women who opted for treatment with the levonorgestrel-releasing intrauterine system (LNG-IUS) to women who opted for endometrial ablation. Furthermore, the difference in reintervention rate between women in this observational cohort and women who were randomised was compared, with the hypothesis that women who actively decide on treatment have lower reintervention rates compared to women in a RCT. STUDY DESIGN: An observational cohort study alongside a multicentre randomised controlled trial (RCT) was conducted between April 2012 and January 2016, with a follow-up time of 24 months, in 26 hospitals and nearby general practices in the Netherlands. Women suffering from heavy menstrual bleeding, aged 34 years and older, without intracavitary pathology and without a future fertility desire, were eligible for this trial. Women who declined randomisation were asked to participate in the observational cohort. The outcome measure was reintervention rate at 24 months of follow-up. RESULTS: 276 women were followed in the observational cohort of which 87 women preferred an initial treatment with LNG-IUS and 189 women preferred an initial treatment with endometrial ablation. At 24 months of follow-up women in the LNG-IUS-group were more likely to receive a reintervention compared to the women in the ablation group, 28/81 (35 %) versus 25/178 (14 %) (aRR 2.42, CI 1.47-3.98, p-value 0.001). No differences in reintervention rates were found between women in the observational cohort and women in the RCT. CONCLUSIONS: Women who receive an LNG-IUS are more likely to undergo an additional intervention compared to women who receive endometrial ablation. Reintervention rates of women in the cohort and RCT population were comparable. The results of this study endorse the findings of the RCT and will contribute to shared decision making in women with heavy menstrual bleeding.

Beesley Vanessa, L., et al. (2019). "A systematic literature review of trials of survivorship interventions for women with gynaecological cancer and their caregivers." European journal of cancer care 28(3): e13057.
	Core components of survivorship care include treatment of late and long-term effects, care coordination, promotion of psychological well-being, health and addressing special populations' needs. Women affected by gynaecological cancer and their caregivers can experience disease-specific issues. This review presents an overview of survivorship interventions that have been trialled among this population. Databases were searched in October/November 2016 to identify eligible studies. Titles, abstracts then full-text were assessed for inclusion by two reviewers until consensus was reached. Data were abstracted using standard tables. Study quality was independently appraised. Twenty-eight articles were included (five reviews; 23 trials). In regards to late and long-term treatment effects, our review found mounting high-level evidence for the effectiveness of psycho-educational programmes to improve physical aspects of sexual function and for exercise interventions for reducing fatigue. We also found emerging evidence for nurse-led follow-up care to improve care coordination and cognitive behavioural therapy to improve psychological wellbeing. There were gaps in the evidence for interventions to effectively address psychosexual issues specific to gynaecological cancer and needs of caregivers. Further research is required to explore strategies to improving psychosexual concerns after gynaecological cancer and the dynamics and supportive care needs of the patient-partner dyad. (© 2019 John Wiley & Sons Ltd.)

Begic, M., et al. (2023). "Comparison of Kegel exercises and a combination of Kegel exercises with the use of the KegelSmart biofeedback device in the treatment of static urinary incontinence." Medicinski Glasnik 20(2): 276-281.
	Aim To determine which of the two methods, Kegel exercises or combination of Kegel exercises with the use of the KegelSmart biofeedback device, has better therapeutic effects on the symptoms of SUI in females. Methods Fifty female patients with SUI were randomly divided into two groups: 25 treated with Kegel exercises, and 25 with the combination of Kegel exercises with the use of the KegelSmart biofeedback device. Patients in both groups performed Kegel exercises 30 minutes daily for 30 days. Patients in the second group, in addition to Kegel exercises, applied the KegelSmart device intra-vaginally for 20 minutes daily for 30 days. All patients filled out a questionnaire based on 12 questions consisting of an objective and a subjective component. Results The basic characteristics of the patients from both groups were not statistically significantly different: age 55.16 vs 54.52 years; number of births 1.80 vs 1.96; body mass index 29.12 vs 28.40. There was a statistically significant reduction in the values of all analysed objective and subjective parameters in the group treated with combination of Kegel exercises with the use of the Ke-gelSmart biofeedback device compared to Kegel exercises group. Conclusion Combination of Kegel exercises with the use of the KegelSmart biofeedback device has better therapeutic effects than Kegel exercises on the objective and subjective symptoms of SUI.Copyright © 2023, Medical Association of Zenica-Doboj Canton. All rights reserved.

Begovich, E., et al. (2021). "Endometriosis-associated cancer: Modern aspects of etiopathogenesis, treatment and rehabilitation." Obstetrics, Gynecology and Reproduction 15(3): 287-294.
	Aim: to analyze current literature sources on endometriosis-associated cancer (IEAS) in gynecology. Materials and Methods. We searched for publications in the international scientific databases: eLibrary, Google Scholar, ScienceDirect, Cochrane Library, PubMed/MEDLINE and clinical research registries. For this systematic analysis, only full-text publications were used. We evaluated the reliability of evidence and the methodological quality of the studies. The data on the modern approach to the therapy and rehabilitation of women with external genital endometriosis (EGE) are presented. Search terms for publications in Russian and English were used: <>, <>, <>, <>. Results. Despite the fact that EGE is considered a benign disease, there is a risk for its malignant transformation. However, the pathogenesis and pathomorphological mechanisms of IEAS are not yet fully understood. Conclusion. Active management of the rehabilitation period for women with EGE provides an opportunity for early diagnosing recurrences that will provide early diagnostics ovarian IEAS and improve the main indicators of the quality of life for such patients.Copyright © 2021 IRBIS LLC. All Rights Reserved.

Begovich, E., et al. (2022). "Assessing sexual dysfunction in patients with external genital endometriosis." Obstetrics, Gynecology and Reproduction 16(4): 354‐364.
	Introduction. External genital endometriosis (EGE) is a chronic, relapsing disease that affects various aspects of sexual function, the quality of sexual and interpersonal relationships, physical and psycho‐emotional health and leads to social maladjustment and anxiety‐depressive disorders, resulting in progressively decreased quality of life (QoL). Aim: to analyze an impact of sexual disorders on QoL of women with painful and painless EGEs. Materials and Methods. A prospective comparative randomized interventional study involved 160 patients (110 and 50 women with painful and painless EGE, respectively) of reproductive age, with laparoscopically and morphologically verified diagnosis according to the revised American Fertility Society scoring system (R‐AFS, 1996). Pain syndrome and sexual dysfunction were assessed using specialized questionnaires: visual analogue scale (VAS), PainDETECT, and Female Sexual Function Index (FSFI). After surgical treatment, 8 patients refused to participate in the study (6 with painful EGE and 2 with painless EGE). Thus, only 152 women passed all stages of the study. The patients were divided into 4 groups depending on the presence and/or absence of pain syndrome and the tactics of the rehabilitation period ("active" or "passive"): group IA consisted of 49 (47.1 %) women with pain and "active" rehabilitation; group IБ – 55 (52.9 %) women with pain syndrome and "passive" rehabilitation tactics; group IIA – 23 (47.9 %) patients without pain syndrome with "active" rehabilitation; group IIБ – 25 (52.1 %) patients without pain syndrome with "passive" rehabilitation tactics. Results. Women with painful vs. painless EGE were found to have a more severe course of the disease and a markedly decreased quality of sexual life. It was observed that patients with "active" rehabilitation tactics (groups IA and IIA) had intensity of the pain syndrome and the neuropathic pain component significantly decreased, improved parameters of the quality of sexual life, sexual desire and sexual excitability compared to patients with "passive" rehabilitation tactics applied with the measures within the framework of the National Clinical Guidelines (groups IБ and IIБ). Conclusion. A significantly decreased quality of sexual life of EGE patients indicates a need for assessing and correcting sexual disorders as well as introducing early onset of rehabilitation measures by using a multidisciplinary approach.

Behbehani, S., et al. (2019). "Mortality Rates in Laparoscopic and Robotic Gynecologic Oncology Surgery: A Systemic Review and Meta-analysis." Journal of Minimally Invasive Gynecology 26(7): 1253.
	Objective: To review early operative mortality (<30 days) for minimally invasive surgery (MIS), laparoscopic and robotic, in gynecologic oncology.; Data Sources: An electronic-based search was performed in PubMed, Embase, Scopus, Web of Science, and Cochrane Database in the last 10 years.; Methods of Study Selection: All MIS studies in gynecologic oncology reporting operative mortality from any cause (within 30 days) were included. Studies were excluded if mortality was not reported for MIS or included benign gynecology.; Tabulation, Integration, and Results: Meta-analysis was applied to calculate pooled mortality rates using the inverse-variance method. The relative risks and their corresponding 95% confidence intervals (CIs) were calculated using the Mantel-Haenszel method. Sixty-five studies were included (39 183 patients) for an operative mortality of 1:381 (95% CI, 1:306-1:474). Studies were subselected and analyzed by procedures, malignancy, and surgical approach. Of 39 183 patients, 38 619 underwent any type of hysterectomy for a mortality of 1:379 (95% CI, 1:304-1:472). The mortality was 1:281 (95% CI, 1:169-1:469) for a laparoscopic approach and 1:476 (95% CI, 1:365-1:620) for a robotic approach. There were 3369 patients with early cervical cancer undergoing radical hysterectomy with a mortality of 1:2049 (95% CI, 1:356-1:11 832). There were 3501 patients with endometrial cancer undergoing hysterectomy with lymph node dissection with a mortality of 1:195 (95% CI, 1:109-1:349). There were 418 patients with ovarian cancer undergoing MIS procedures with a mortality of 1 in 685 (95% CI, 1:44-1:10971). Eleven studies with 4037 patients compared mortality of gynecologic oncology surgery of any type (laparoscopic [1:626] vs robotic [1:716] for a relative risk of 1.12 [95% CI, 0.35-3.49]).; Conclusion: The overall operative mortality for minimally invasive surgery in gynecologic oncology is 1 in 381 (95% CI, 1:306-1:474). For patients with early cervical cancer, it is 1:2049 (95% CI, 1:356-1: 11832), for endometrial cancer with node dissection it is 1:195 (95% CI, 1:109-1:349), and for ovarian cancer it is 1 in 685 (95% CI, 1:44-1:10 971). There is no difference between the type of MIS approach for patients undergoing any type of gynecologic oncology surgery. (Copyright © 2019 AAGL. Published by Elsevier Inc. All rights reserved.)

Behbehani, S., et al. (2022). "Pregnancy Rates after Surgical Resection of Deep Infiltrating Endometriosis in Patients with Infertility: A Systematic Review and Meta-Analysis." Journal of Gynecologic Surgery 38(1): 24-32.
	Objective: The aim of this review and meta-analysis was to assess spontaneous pregnancy rates after excision of deep infiltrating endometriosis (DIE) in patients with infertility. Material(s) and Method(s): An electronic-based search was performed on PubMed, Embase, Scopus, Web of Science, and the Cochrane Database from the last 10 years. All studies, including surgical resection of DIE (>5 mm depth confirmed on pathology) and pregnancy rates published in English, French, Spanish, and Italian during the last 10 years were reviewed. Studies with only ovarian involvement were excluded. A meta-analysis was performed to calculate pooled pregnancy rates, using a random-effects model with inverse-variance weighting. The 95% confidence intervals (95% CIs) for the pregnancy rates were calculated with Wilson Score with continuity correction (WSCC). Studies with extreme heterogeneity and influence were excluded. Result(s): Fourteen articles fit the inclusion criteria (for estimation of overall pregnancy rates) for a total of 587 patients with a mean age of 32.4 years (2 prospective studies and 12 retrospective studies). DIE locations included the intestinal and genitourinary tracts, and other nonvisceral locations. Infertility was defined as preoperative infertility of > 1 year. Overall pregnancy rate after surgical resection was 44.8% (95% CI: 39.7%-50.1%) with a 30% (95% CI: 25%-35.5%) spontaneous pregnancy rate. Live birth rate was 41.9% (95% CI 35.2%-48.9%). Conclusion(s): Resection of DIE improves pregnancy rates in patients with infertility. The spontaneous pregnancy rate after surgical resection is 30%. (J GYNECOL SURG 38:24)Copyright © 2022, Mary Ann Liebert, Inc., publishers.

Behery, M. A., et al. (2021). "Assisted Oocyte Activation in Recurrent Fertilization Failure." Journal of Reproductive Medicine 66(6): 371‐377.
	OBJECTIVE: Despite the high success rate of intracy‐toplasmic sperm injection (ICSI), total fertilization failure still occurs in up to 3% of all ICSI cycles and can recur in subsequent cycles, even when enough oocytes and motile spermatozoa are available. Several reports show that most couples suf‐fering from ICSI failure ben‐efit from the application of ICSI combined with assisted oocyte activation. A variety of artificial activating meth‐ods is used in human assisted reproduction treatment, including physical, mechan‐ical, or chemical stimuli, which provoke one or more calcium rises in the oocyte cytoplasm. STUDY DESIGN: Randomized controlled trial. Set‐ting: a university fertility center. Subjects: 150 infertile patients who underwent ICSI and all had a history of recurrent fertilization failure. The patients were randomly allocated into 2 equal groups. Group 1=75 patients who underwent ICSI without oocyte activa‐tion. Group 2=75 patients who underwent ICSI with oocyte activation. Reproductive outcomes were compared between both groups. RESULTS: There were significant differences between the groups regarding the number of oocytes retrieved, number of the mature oocytes, fertilization rate, and pregnancy rate. CONCLUSION: Assisted oocyte activation with calcium ionophore results in significant improvement in the fertilization, cleavage, and pregnancy rates after ICSI. (J Reprod Med 2021;66: 371–377).

Beinert, S. V., et al. (2021). "Effects of progesterone on vasomotor symptoms in postmenopausal women- an RPCDBT." Maturitas 152: 86-87.
	Introduction: In 2012, a Canadian study found significant reductions of hot flushes with a daily dose of 300mg progesterone in healthy, non-obese women. The PROGEST-study was designed to validate these results and to fulfill FDA-criteria for this indication. Methods and Participants: This prospective multi-center randomized, double-blind placebo-controlled trial studied 3 doses of progesterone (200 mg, 300 mg, 400 mg) against placebo for 12 weeks. After a one-week screening phase with diary-documentation of hot flushes, patients with >50 hot flushes in 7 days were randomized 1:1:1:1. Menopause Rating Scale and Pittsburgh Sleep Quality Index were documented 3 times per week, clinical and ultrasound parameters were recorded at screening and after 12 weeks. Result(s): 74 women were recruited, the full analysis set (FAS) comprised 54 subjects; 44 remained in the study as per protocol (PP);. Mean age was 56,5 yrs, and average BMI was 27,9; two thirds of the participants had co-morbidities, mostly hypertension (42,6%). The main result, namely the effect on the number of moderate to severe hot flushes between baseline and week 12 was - 7,4/d in the placebo-Arm, -7,7 VMS/d with 200 mg progesterone/day, -8,3 VMS/d on 300mg/d progesterone and -9,0/d on 400mg/d. The trial noted 32 treatment emergent adverse events (TEAE) in 18 participants. Most of these were minor AEs, one SAE involved the occurrence of a syncope requiring hospitalization on the day after the initiation of progesterone, which lead to discontinuation of the drug. Discussion(s): Baseline VMS frequency was higher in the German than in the Canadian study and the German placebo-group had a stronger decrease in VMS-frequency during the PROGEST-study (-7,4 VMS/d) than in the Canadian trial (-1,4 VMS/d). Study participants in Germany were older (56,5 yrs) than the Canadian women (age: 55,5 yrs under progesterone vs. 54,4 yrs. in the placebo group). Time since the final menstrual period in Canada averaged 3,9 years in the progesterone group and only 2,5 years in the placebo group. 94% vs. 98% of women in the Canadian study experienced natural menopause, only 3% vs 2% had a hysterectomy. This proportion was much higher in the German cohort. In Canada, CVD, smoking, BMI 35 or over, diabetes mellitus, hypertension or abnormal ECG, fasting lipids and glucose were exclusion criteria. In the PROGEST study, two thirds of the participants had any type of comorbidity, mainly (in 42,6%) hypertension.Copyright © 2021

Beishembaev, A. M., et al. (2022). "Ovarian carcinosarcoma (a literature review)." Obstetrics, Gynecology and Reproduction 16(5): 575-587.
	Introduction. Despite that ovarian carcinosarcoma (OCS) is an extremely rare disease, it is of great medical and social importance by taking into account very high level of overall mortality, recurrence, metastasis, and economic costs. Aim(s): to summarize current data on various aspects of OCS. Materials and Methods. The search strategy for English written papers published in databases PubMed/MEDLINE, Scopus, Web of Science, Google Scholar was based on the following keyword queries: <>, <>, <>, <>, <>, <>, <>. The search depth was limited within the years 2010-2022, by prioritizing the search depth within the last 5 years (2017-2022). Results. We found 48 articles in English, published from 2016 to 2022, of which 47 (97.9 %) articles were published within the last 5 years. Scientific data are represented by studies with a small patient sample and with low evidence base. The results of the analysis for identified publications showed a limited, fragmented and inconsistent scientific data both in terms of etiology, pathogenesis and treatment, as well as an impact of OCS stages, age and other risk factors on the likelihood of relapses. Conclusion. The lack of extensive clinical studies along with observed substantial number of controversial issues may be accounted for by OCS low prevalence and complex pathogenesis. Nevertheless, the results obtained during the generalization of scientific knowledge provide a realistic insight into the current state of global science about this medical and social disease and may be used to improve the diagnostics and treatment of OCS patients.Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.

Bektas, H., et al. (2022). "Development and evaluation of the efficacy of a web-based education program among cancer patients undergoing treatment with systemic chemotherapy: a randomized controlled trial." Supportive Care in Cancer 30(7): 6021-6033.
	Purpose: The study aimed to develop a web-based education program among cancer patients undergoing treatment with systemic chemotherapy and to evaluate the efficacy of the program on symptom control, quality of life, self-efficacy, and depression. Method(s): A web-based education program was prepared in line with patient needs, evidence-based guidelines, and expert opinions and tested with 10 cancer patients. The single-blind, randomized controlled study was conducted at a medical oncology unit of a university hospital. Pretests were applied to 60 cancer patients undergoing treatment with systemic chemotherapy, and the patients (intervention: 30, control: 30) were randomized. The intervention group used a web-based education program for 3 months, and they were allowed to communicate with researchers 24/7 via the website. The efficacy of a web-based education program at baseline and after 12 weeks was evaluated. The CONSORT 2010 guideline was performed. Result(s): In the first phase results of the study, it was found that most of the patients with cancer wanted to receive education about symptom management and the side effects of the treatment. Expert opinions on the developed website were found to be compatible with each other (Kendall's Wa = 0.233, p = 0.008). According to the randomized controlled study results, patients who received web-based education reported significantly fewer symptoms (p = 0.026) and better quality of life (p = 0.001), but there was no statistically significant difference in the self-efficacy and depression levels during the 3-month follow-up period (p0.05). The most frequently visited links in the web-based education program by the patients with cancer were the management of chemotherapy-related symptoms (62.6%). Conclusion(s): A web-based education program was found to be efficacy in remote symptom management and improving the quality of life of cancer patients. Trial registration: www.clinicaltrials.gov, NCT05076916 (October 12, 2021, retrospectively registered).Copyright © 2022, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Belan, M., et al. (2021). "Cost-Effectiveness Analysis of an Interdisciplinary Lifestyle Intervention Targeting Women With Obesity and Infertility in Comparison to Usual Care."  5: A730.
	Although lifestyle modification is considered as the firstline treatment for women with obesity and infertility, these women generally do not have access to a program supporting them in adopting healthy habits that is integrated to fertility care. Implementing such a program requires to demonstrate its efficiency. The purpose of this study was to conduct a cost‐effectiveness analysis (CEA) of an interdisciplinary lifestyle intervention (Fit‐for‐Fertility (FFF) program) for women with obesity and infertility, in comparison with the usual care protocol, i.e. fertility treatments. Methods: A CEA was conducted alongside a randomized controlled trial, recruiting women at the fertility clinic of the Centre hospitalier universitaire de Sherbrooke. Women were randomized to: i) the intervention group (IG): FFF program alone for 6 months (individual follow‐ups every 6 weeks and 12 group sessions), and in combination with usual care for infertility after 6 months if not pregnant; or ii) control group (CG): usual care from the outset. Data were collected in both groups, during 18 months or until the end of the pregnancy for those who became pregnant. Costs related to the management of infertility, obesity, pregnancy and childbirth, and the FFF program were considered and collected by self‐reported questionnaires, review of medical records and administrative databases. Live birth (LB) rate was used to assess effectiveness. The CEA's parameter of interest was the incremental cost‐effectiveness ratio (ICER), calculated by non‐parametric bootstrap with 5,000 iterations. All costs are in Canadian dollars, 2019. Results: A total of 130 women were randomized (65 CG, 65 IG). We present results for the 108 women (57 CG, 51 IG) who completed at least 6 months in the study. We observed an absolute difference of 14.2% (p=0.328) in LB rate between groups (IG: 51.0%; CG: 36.8%). Total mean costs per patient were significantly higher in the IG vs the CG for healthcare system's ($5,660 ± $3,200 vs $3,631 ± $3,389; p=0.002) and society's ($9,745 ± $5,899 vs $6,898 ± 7,021; p=0.026) perspectives. We observed an ICER of $12,633 per additional LB [$5,319‐$19,947] from the healthcare system's perspective, and $5,980 [$3,086‐$8 874] from the patients' perspective. Overall, the ICER for the society's perspective, which includes both previous perspectives, was estimated at $24,393 per additional LB [$15,509‐ $33,276]. Conclusion: According to our results, a lifestyle intervention may be clinically more effective than the usual protocol of care for women with obesity and infertility, but generates higher costs as well, resulting in a positive ICER (of $12,600 per additional life birth for the healthcare system). Such an intervention could be considered efficient compared to the usual standard of care, but studies are needed to assess the willingness to pay of stakeholders for this type of intervention.

Belgium, B. V. A. C. (2021). Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis.
	No Results Available Drug: Miconazole Nitrate 2% + Domiphen Bromide Low Dose|Drug: Miconazole Nitrate 2% + Domiphen Bromide High Dose|Drug: Miconazole Nitrate 2% The proportion of subjects with clinical cure|The proportion of subjects with mycological eradication|The proportion of subjects with overall therapeutic success|Change from Baseline in vulvovaginitis symptom questionnaire total score|Change from Baseline in the EQ-5D questionnaire total score Female Phase 2 90 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment FHP-2021-2-26 October 2022

Bell, J. G., et al. (2022). "The impact of art therapy on anxiety and hope in patients with gynecologic cancer undergoing chemotherapy." Arts in Psychotherapy 80: 101947.
	Clinical research investigating the benefits of art therapy in individuals undergoing cancer treatment is growing, yet study designs focusing on certain cancers such as gynecologic malignancies are lacking. This study aimed to assess the impact of art therapy interventions on both anxiety and hope in patients with gynecologic cancer patients. The study design was prospective and non-randomized. Eligible patients had a primary or recurrent gynecologic malignancy, and were scheduled to receive at least six cycles of chemotherapy over eighteen weeks. Patients completed State Hope and State Anxiety questionnaires before and after each of five art therapy interventions during chemotherapy. Eighteen patients completed the study. Both anxiety and hope significantly improved after each art therapy session except for one. In addition, both anxiety and hope significantly improved between visit 1 and visit 5: State Hope -Visit 1 vs. Visit 5 (35.3 +/- 7.8 vs. 40.0 +/- 7.2), p = 0.019, effect size = 0.63; State Anxiety -Visit 1 vs. Visit 5 (32.8 +/- 9.3 vs. 27.8 +/- 8.8), p = 0.038, effect size = -0.53. The results showed art-based interventions facilitated by a board-certified art therapist positively impacted two domains in the quality of life of gynecologic cancer patients undergoing chemotherapy. The attitude of patients, namely, a willingness to accept art therapy, may influence the outcome of the interventions.Copyright © 2022 Elsevier Ltd

Bell, S., et al. (2023). "Prophylactic anticoagulation after minimally invasive hysterectomy for endometrial cancer: a cost-effectiveness analysis." International Journal of Gynecological Cancer 33(12): 1875-1881.
	Objective To determine our institutional rate of venous thromboembolism (VTE) following minimally invasive surgery for endometrial cancer and to perform a cost-effectiveness analysis of extended prophylactic anticoagulation after minimally invasive staging surgery for endometrial cancer. Methods All patients with newly diagnosed endometrial cancer who underwent minimally invasive staging surgery from January 1, 2017 to December 31, 2020 were identified retrospectively, and clinicopathologic and outcome data were obtained through chart review. Event probabilities and utility decrements were obtained through published clinical data and literature review. A decision model was created to compare 28 days of no post-operative pharmacologic prophylaxis, prophylactic enoxaparin, and prophylactic apixaban. Outcomes included no complications, deep vein thrombosis (DVT), pulmonary embolism, clinically relevant non-major bleeding, and major bleeding. We assumed a willingness-to-pay threshold of $100 000 per quality-adjusted life year (QALY) gained. Results Three of 844 patients (0.36%) had a VTE following minimally invasive staging surgery for endometrial cancer. In this model, no pharmacologic prophylaxis was less costly and more effective than prophylactic apixaban and prophylactic enoxaparin over all parameters examined. When all patients were assigned prophylaxis, prophylactic apixaban was both less costly and more effective than prophylactic enoxaparin. If the risk of DVT was >=4.8%, prophylactic apixaban was favored over no pharmacologic prophylaxis. On Monte Carlo probabilistic sensitivity analysis for the base case scenario, no pharmacologic prophylaxis was favored in 41.1% of iterations at a willingness-to-pay threshold of $100 000 per QALY. Conclusions In this cost-effectiveness model, no extended pharmacologic anticoagulation was superior to extended prophylactic enoxaparin and apixaban in clinically early-stage endometrial cancer patients undergoing minimally invasive surgery. This model supports use of prophylactic apixaban for 7 days post-operatively in select patients when the risk of DVT is 4.8% or higher.Copyright © 2023 BMJ Publishing Group. All rights reserved.

Bellanti, D. M., et al. (2022). "Rapid Review on the Effectiveness of Telehealth Interventions for the Treatment of Behavioral Health Disorders." Military medicine 187(5-6): e577-e588.
	INTRODUCTION: The Psychological Health Center of Excellence conducted a rapid review of the literature to investigate the effectiveness of behavioral health treatments (i.e., evidence-based psychotherapy and psychiatry) delivered in person compared to telehealth (TH; i.e., video teleconference and telephone). MATERIALS AND METHODS: The rapid review methods included a systematic search of a single database (PubMed), hand-searching of relevant systematic reviews, dual screening, single-person data abstraction verified by a second person, and dual risk of bias assessment. Due to heterogeneity across studies, no quantitative analyses were conducted. RESULTS: Twenty-two randomized controlled trials (RCTs), eight of which were non-inferiority trials, evaluated the effectiveness of TH via telephone or video teleconferencing compared to in-person (IP) delivery for patient populations with posttraumatic stress disorder, depression, and mixed diagnoses. The majority of RCTs and all but one of the eight non-inferiority trials found that clinical outcomes did not differ between TH and IP treatment delivery. Two studies found that subgroups with higher symptom severity (hopelessness and anxiety disorders, respectively) in the TH group had worse treatment-related outcomes than IP participants with similar symptom profiles. The majority of studies found no significant differences in satisfaction with care, quality of the therapeutic alliance, or study discontinuation between TH and IP groups. CONCLUSION: Based on evidence from 22 RCTs, the use of TH platforms, including video conference and telephone modalities, generally produces similar outcomes as face-to-face provision of psychotherapy and psychiatry services.

Bellone, S., et al. (2021). "A phase II evaluation of pembrolizumab in recurrent microsatellite instability-high (MSI-H) endometrial cancer patients with Lynch-like versus MLH-1 methylated characteristics (NCT02899793)." Annals of oncology : official journal of the European Society for Medical Oncology 32(8): 1045‐1046.
	
Ben-Arye, E., et al. (2023). "Acupuncture and integrative oncology for taxane-induced peripheral neuropathy: a randomized multicentered study." International Journal of Gynecological Cancer 33(5): 792-801.
	Objective To compare the effectiveness of acupuncture alone or with additional integrative oncology modalities for taxane-induced peripheral neuropathy-related symptoms in patients with gynecological and breast cancer. Methods The study was a prospective evaluation of patients undergoing twice-weekly treatments with either acupuncture alone (single-modality, group A) or with additional manual-movement and mind-body therapies (multimodality, group B), for 6 weeks. Symptom severity was assessed at baseline, 6 weeks, and 9 weeks using the Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) tool; and von Frey perception thresholds. Additional symptoms were also assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Measure Yourself Concerns and Wellbeing (MYCaW) study tool. Results For the 120 participants (60 in each study arm), baseline to 6-week scores were similar in both groups for improved FACT-Tax physical wellbeing and scores for hand numbness/tingling; EORTC physical functioning and global health status; and MYCaW scores. FACT-Tax taxane subscales and scores for foot numbness/tingling improved only in group A (p=0.038), while emotional wellbeing FACT-Tax (p=0.02) and EORTC pain (p=0.005) improved only in group B. Group B showed greater improvement for FACT-Tax neuropathy-related concerns than group A at 24 hours (p=0.043) and 7 days (p=0.009) after the first treatment. Conclusion Acupuncture alone or with additional integrative oncology modalities may help reduce neuropathy-related symptoms. The single-modality group demonstrated greater improvement for foot numbness/tingling, and the multimodality group demonstrated improvement for pain and improved emotional wellbeing and neuropathy-related concerns in the first week of treatment. Trial registration number NCT03290976.Copyright © 2023 BMJ Publishing Group. All rights reserved.

Ben-Arye, E., et al. (2022). "Impact of acupuncture and integrative therapies on chemotherapy-induced peripheral neuropathy: A multicentered, randomized controlled trial." Cancer 128(20): 3641-3652.
	Background: To explore the impact of acupuncture with other complementary and integrative medicine (CIM) modalities on chemotherapy-induced peripheral neuropathy (CIPN) and quality of life (QoL) in oncology patients. Method(s): In this prospective, pragmatic, and patient-preference study, patients with CIPN were treated with acupuncture and CIM therapies (intervention group) or standard care alone (controls) for 6 weeks. Patients in the intervention arm were randomized to twice-weekly acupuncture-only (group A) or acupuncture with additional manual-movement or mind-body CIM therapies (group B). Severity of CIPN was assessed at baseline and at 6 weeks using the Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) tool. Other QoL-related outcomes were assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC); and the Measure Yourself Concerns and Well-being questionnaire. Von Frey measurements examined perception thresholds. Result(s): Of 168 participants, 136 underwent the study intervention (group A, 69; group B, 67), with 32 controls. Baseline-to-6-week assessment scores improved significantly in the intervention arm (vs controls) on FACT-Tax (p =.038) and emotional well-being (p =.04) scores; FACT-TAX scores for hand numbness/tingling (p =.007) and discomfort (p <.0001); and EORTC physical functioning (p =.045). Intervention groups A and B showed improved FACT-Tax physical well-being (p <.001), FACT-TAX total score (p <.001), FACT-TAX feet discomfort (p =.003), and EORTC pain (p =.017) scores. Conclusion(s): Acupuncture, with or without CIM modalities, can relieve CIPN-related symptoms during oncology treatment. This is most pronounced for hand numbness, tingling, pain, discomfort, and for physical functioning.Copyright © 2022 American Cancer Society.

Ben-Arye, E., et al. (2023). "A randomized-controlled trial assessing the effect of intraoperative acupuncture on anesthesia-related parameters during gynecological oncology surgery." Journal of Cancer Research and Clinical Oncology 149(11): 8177-8189.
	Context and objectives: The present study examined the impact of intraoperative acupuncture on anesthesia-related parameters in patients undergoing gynecological oncology surgery. Method(s): Participants underwent preoperative integrative oncology (IO) touch/relaxation treatments, followed by intraoperative acupuncture (Group A); preoperative IO treatments without acupuncture (Group B); or standard care only (Group C). Mean arterial pressure (MAP), heart rate (HR), MAP variability (mean of MAP standard deviation), bispectral index (BIS), and calculated blood pressure Average Real Variability (ARV) were measured intraoperatively. Result(s): A total of 91 patients participated: Group A, 41; Group B, 24; Group C, 26. Among patients undergoing open laparotomy, Group A showed lower and more stable MAP and HR compared to Group B, (MAP, p = 0.026; HR, p = 0.029) and Group C (MAP, p = 0.025). Mean BIS, from incision to suture closing, was lower in Group A (vs. controls, p = 0.024). In patients undergoing laparoscopic surgery, MAP was elevated within Group A (p = 0.026) throughout surgery, with MAP variability significantly higher in Group A (P = 0.023) and Group B (P = 0.013) 10 min post-incision (vs. pre-incision). All groups showed similar intraoperative and post-anesthesia use of analgesic medication. Conclusion(s): Intraoperative acupuncture was shown to reduce and stabilize MAP and HR, and reduce BIS in gynecology oncology patients undergoing laparotomy, with no impact on perioperative analgesic medication use. In the laparoscopic setting, intraoperative acupuncture was associated with elevated MAP. Further research is needed to explore the hemodynamic and BIS-associated benefits and risks of intraoperative acupuncture, and the impact on the use of analgesic drugs in response to these changes.Copyright © 2023, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Ben-Arye, E., et al. (2022). "Can integrative oncology increase adherence to chemotherapy in advanced gynecologic cancer?" Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 30(5): 4345-4354.
	Objective: Integrative oncology (IO) has been shown to improve quality-of-life (QoL) and increase adherence to planned chemotherapy regimens. This study examined the impact of a patient-tailored IO program on adherence to chemotherapy among patients with advanced gynecological cancer.; Methods: This prospective non-randomized, pragmatic, preference study examined patients with stage III/IV gynecological cancers undergoing 6 weeks of weekly IO treatments. Adherence to the planned chemotherapy regimen was assessed using the relative dose intensity (RDI) calculation. Patients consistently attending IO treatments (consistent-IO group) were compared to those who were not (non-consistent IO group).; Results: RDI was calculated for 73 patients in the consistent-IO group (99 chemotherapy cycles) and 61 in the non-consistent-IO group (96 cycles with IO care, 126 cycles without). Both groups had similar baseline demographic characteristics, with endometrial cancer more prevalent in the consistent-IO group. RDI was significantly less reduced in the consistent-IO chemotherapy group (p = 0.005). During taxane-based regimens, RDI was better maintained in the consistent-IO group (0.93 vs. 0.87, p = 0.012), though not with platinum-based cycles. Linear regression model found a correlation between preserved RDI and consistent attendance at weekly IO treatments, and lower rates of chemotherapy-induced peripheral neuropathy and pain.; Conclusion: Patient-tailored IO programs for patients with advanced gynecological cancer may help preserve adherence to chemotherapy at 6 weeks, especially with taxane-based regimens. Further research needs to explore whether this correlation is chemotherapy agent-specific. (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Benbrook Doris, M., et al. (2023). "Association of Sialyl Tn antigen with cervical cancer lymph node status: An NRG oncology/GOG study." Gynecologic Oncology 171: 67-75.
	Objective: Detection of lymph node metastases in cervical cancer patients is important for guiding treatment decisions, however accuracies of current detection methods are limited. We evaluated associations of abnormal glycosylation, represented by Tn and STn antigens on mucin (MUC) proteins, in primary tumor specimens with lymph node metastasis or recurrence of cervical cancer patients.; Methods: Surgical specimens were prospectively collected from 139 patients with locally-advanced cervical cancer undergoing lymphadenectomy enrolled in a nation-wide clinical trial (NCT00460356). Of these patients, 133 had primary cervix tumor, 67 had pelvic lymph node (PLN) and 28 had para-aortic lymph node (PALN) specimens. Fixed tissue serial sections were immunohistochemically stained for Tn, STn, MUC1 or MUC4. Neuraminidase was used to validate Tn versus STn antibody specificity. Stain scores were compared with clinical characteristics.; Results: Primary tumor STn expression above the median was associated with negative PLN status (p-value: 0.0387; odds ratio 0.439, 95% CI: 0.206 to 0.935). PLN had higher STn compared to primary tumor, while primary tumor had higher MUC1 compared to PALN, and MUC4 compared to PALN or PLN (p = 0.017, p = 0.011, p = 0.016 and p < 0.001, respectively). Tn and STn expression correlated in primary tumor, PALN, and PLN, Tn and MUC1 expression correlated in primary tumors only (Spearman correlation coefficient [r] = 0.301, r = 0.686, r = 0.603 and r = 0.249, respectively).; Conclusions: STn antigen expression in primary cervical tumors is a candidate biomarker for guiding treatment decisions and for mechanistic involvement in PLN metastases.; Competing Interests: Declaration of Competing Interest Dr. Wei Deng, Dr. Christopher West, Dr. Rajani Rai, Dr. Rachel Conrad, Mrs. Hanke van der Wel, Dr. Sanam Husain, Dr. Mae Zakhour, Dr. Amanda Jackson and Dr. Doris Benbrook have no conflicts of interest to disclose. Dr. Michael Gold reports receiving honoraria from ASCCP as well as serving as a past member of the Board as well as serving as Secretary, Treasurer, Vice-President, and President for ASCCP. Dr. Moore reports personal fees and other from Astra Zeneca, grants, personal fees and other from Genentech/Roche, grants, personal fees and other from Immunogen, grants, personal fees and other from GSK/Tesaro, other from Pfizer, personal fees from Aravive, personal fees from VBL Therapeutics, personal fees and other from Onco Med, grants and other from Lilly, personal fees from Eisai, personal fees from Vavotar, personal fees from Abbvie, personal fees from Tarveda, personal fees from Myriad, personal fees from Rubius, personal fees from Elevar, personal fees from Merck, personal fees from Mersana, personal fees from Sorrento, personal fees from OncXerna, personal fees from Alkemeres, personal fees from blueprint pharmaceuticals, personal fees from Mereo, personal fees from IMab, outside the submitted work; and serves as the Associate Director for GOG Partners and a GOG Foundation Board of Directors member. Dr. Nick Spirtos would like to disclose receiving research funding to his Institution from AbbVie, AstraZeneca, Genentech/Roche, Clovis Oncology, and Seattle Genetics. With regard to Patents, Royalties, and Other Intellectual Property, Dr. Spirtos wishes to disclose Application No. PCT/US 2019/19465 Cannabis based therapeutic and method of use Application No. Title Country Status Filed Date Application No. Patent Ref. No.199236–701,611/EP Title: CANNABIS BASED THERAPEUTIC AND METHOD OF USE Country: European Patent Status: Published 2/25/2019 19,710,540.6 Patent Ref. No.199236–701,691/PCT-BR Title: CANNABIS BASED THERAPEUTIC AND METHOD OF USE Country Brazil Status: Application 2/25/2019 1,120,200,170,232 Patent Ref. No.199236–701,831/PCT-US Title: CANNABIS BASED THERAPEUTIC AND METHOD OF USE Country United States of America Status: Published 2/25/2019 16/971,781 Patent Ref. No.199236–701,891/HK Title: CANNABIS BASED THERAPEUTIC AND METHOD OF USE Country Hong Kong Status: Published 6 25/2021 62,021,033,676.9 Patent Ref. No. Title Country Status Filed Date Application No. Patent Ref. No.199237–701,601/PCT Title: COMPOSITIONS COMPRISING CANNABIDIOL AND FLAVANONES Country: Patent Cooperation Treaty Status: Application 7/1/2021 PCT/US21/40115 Patent Ref. No.199237–701,691/BR Title: COMPOSITIONS COMPRISING CANNABIDIOL AND FLAVANONES Country: Brazil Status: Application 11/19/2020 1,020,200,236,644 Patent Ref. No.199237–7,019,761/UY Title: COMPOSITIONS COMPRISING AND FLAVANONES Country: Uruguay Status: Application 11/20/2020 38,965. Dr. Cara Mathews reports receiving funding from the NCI to her institution. Dr. Mathews also reports funding from Syros, Decophera, Astellas Pharma, Tesaro/GSK, Seattle Genetics, Regeneron, Moderna, Laekna Therapeutics, outside of the submitted work. In addition, Dr. Mathews reports receiving support from GSK and Seattle Genetics to attend investigator meetings and served on an Advisory Board for IMAB Biopharma. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Bender, A., et al. (2023). "ESHRE guideline: recurrent pregnancy loss: an update in 2022." Human Reproduction Open 2023(1): hoad002.
	Study Question: What are the updates for the recommended management of women with recurrent pregnancy loss (RPL) based on the best available evidence in the literature from 2017 to 2022?; Summary Answer: The guideline development group (GDG) updated 11 existing recommendations on investigations and treatments for RPL, and how care should be organized, and added one new recommendation on adenomyosis investigation in women with RPL.; What Is Known Already: A previous ESHRE guideline on RPL was published in 2017 and needs to be updated.; Study Design Size Duration: The guideline was developed and updated according to the structured methodology for development and update of ESHRE guidelines. The literature searches were updated, and assessments of relevant new evidence were performed. Relevant papers published between 31 March 2017 and 28 February 2022 and written in English were included. Cumulative live birth rate, live birth rate, and pregnancy loss rate (or miscarriage rate) were considered the critical outcomes.; Participants/materials Setting Methods: Based on the collected evidence, recommendations were updated and discussed until consensus was reached within the GDG. A stakeholder review was organized after the updated draft was finalized. The final version was approved by the GDG and the ESHRE Executive Committee.; Main Results and the Role of Chance: The new version of the guideline provides 39 recommendations on risk factors, prevention, and investigation in couples with RPL, and 38 recommendations on treatments. These includes 62 evidence-based recommendations-of which 33 were formulated as strong recommendations and 29 as conditional-and 15 good practice points. Of the evidence-based recommendations, 12 (19.4%) were supported by moderate-quality evidence. The remaining recommendations were supported by low (34 recommendations; 54.8%), or very low-quality evidence (16 recommendations; 25.8%). Owing to the lack of evidence-based investigations and treatments in RPL care, the guideline also clearly mentions those investigations and treatments that should not be used for couples with RPL.; Limitations Reasons for Caution: The guidelines have been updated; however, several investigations and treatments currently offered to couples with RPL have not been well studied; for most of these investigations and treatments, a recommendation against using the intervention or treatment was formulated based on insufficient evidence. Future studies may require these recommendations to be revised.; Wider Implications of the Findings: The guideline provides clinicians with clear advice on best practice in RPL, based on the best and most recent evidence available. In addition, a list of research recommendations is provided to stimulate further studies in RPL. Still, the absence of a unified definition of RPL is one of the most critical consequences of the limited scientific evidence in the field.; Study Funding/competing Interests: The guideline was developed and funded by ESHRE, covering expenses associated with the guideline meetings, with the literature searches and with the dissemination of the guideline. The guideline group members did not receive payment.O.B.C. reports being a member of the executive board of the European Society for Reproductive Immunology and has received payment for honoraria for giving lectures about RPL in Australia in 2020. M.G. reports unconditional research and educational grant received by the Centre for Reproductive Medicine, Amsterdam UMC from Guerbet, Merck and Ferring, not related to the presented work. S.L. reports position funding from EXAMENLAB Ltd. and ownership interest by stock or partnership of EXAMENLAB Ltd (CEO). S.Q. reports being a deputy director of Tommy's National centre for miscarriage research, with payment received by the institution for research, staff time, and consumables for research. H.S.N. reports grants with payment to institution from Freya Biosciences ApS, Ferring Pharmaceuticals, BioInnovation Institute, the Danish ministry of Education, Novo Nordic Foundation, Aug stinus Fonden, Oda og Hans Svenningsens Fond, Demant Fonden, Ole Kirks Fond, and Independent Research Fund Denmark and speakers' fees for lectures from Ferring Pharmaceuticals, Merck A/S, Astra Zeneca, IBSA Nordic and Cook Medical. She also reports to be an unpaid founder and chairman of a maternity foundation. M.-L.v.d.H. received small honoraria for lectures on RPL care. The other authors have no conflicts of interest to declare.; Disclaimer: This guideline represents the views of ESHRE, which were achieved after careful consideration of the scientific evidence available at the time of preparation. In the absence of scientific evidence on certain aspects, a consensus between the relevant ESHRE stakeholders has been obtained.Adherence to these clinical practice guidelines does not guarantee a successful or specific outcome, nor does it establish a standard of care. Clinical practice guidelines do not replace the need for application of clinical judgment to each individual presentation, nor variations based on locality and facility type.ESHRE makes no warranty, express or implied, regarding the clinical practice guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose. (Full disclaimer available at www.eshre.eu/guidelines.). (© The Author(s) 2023. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Bender, R. A. (2022). "Medroxyprogesterone Acetate for Abnormal Uterine Bleeding Due to Ovulatory Dysfunction: The Effect of 2 Different-Duration Regimens." Medical Science Monitor 28: e936727.
	Background: Abnormal uterine bleeding (AUB) lowers the quality of life of women. This study attempted to determine which treatment protocol of medroxyprogesterone acetate (MPA), 15 vs 10 day-administration in a luteal phase, provides better outcomes in women with ovulatory dysfunction-related AUB (AUB-O). Material/Methods: The study included a total of 52 patients with AUB-O: Women in Group A were given MPA between days 11 and 25 of the menstrual cycle (15-day protocol), whereas women in Group B were given MPA between days 16 and 25 (10-day protocol). Outcomes were compared between the 2 groups. Result(s): Women in group B, compared with those in group A, more often showed regular menstrual cycles and decrement of AUB. In group B, 3 cycles of treatment were sufficient to achieve AUB-stop (p<0.05). Post-treatment hemogram parameters and surgical treatment requirements were not different between the 2 groups. Conclusion(s): In the second half of the cycle/predicted luteal phase, 10-day cyclic use of MPA (the group B) better regulated the menstrual cycle and more frequently stopped AUB-O.Copyright © Med Sci Monit, 2022

Bendifallah, S., et al. (2021). "Surgical Outcomes after Colorectal Surgery for Endometriosis: A Systematic Review and Meta-analysis." Journal of Minimally Invasive Gynecology 28(3): 453-466.
	Objective: To assess the impact of type of surgery for colorectal endometriosis-rectal shaving or discoid resection or segmental colorectal resection-on complications and surgical outcomes.; Data Sources: We performed a systematic review of all English- and French-language full-text articles addressing the surgical management of colorectal endometriosis, and compared the postoperative complications according to surgical technique by meta-analysis. The PubMed, Clinical Trials.gov, Cochrane Library, and Web of Science databases were searched for relevant studies published before March 27, 2020. The search strategy used the following Medical Subject Headings terms: ("bowel endometriosis" or "colorectal endometriosis") AND ("surgery for endometriosis" or "conservative management" or "radical management" or "colorectal resection" or "shaving" or "full thickness resection" or "disc excision") AND ("treatment", "outcomes", "long term results" and "complications").; Methods of Study Selection: Two authors conducted the literature search and independently screened abstracts for inclusion, with resolution of any difference by 3 other authors. Studies were included if data on surgical management (shaving, disc excision, and/or segmental resection) were provided and if postoperative outcomes were detailed with at least the number of complications. The risk of bias was assessed according to the Cochrane recommendations.; Tabulation, Integration, and Results: Of the 168 full-text articles assessed for eligibility, 60 were included in the qualitative synthesis. Seventeen of these were included in the meta-analysis on rectovaginal fistula, 10 on anastomotic leakage, 5 on anastomotic stenosis, and 9 on voiding dysfunction <30 days. The mean complication rate according to shaving, disc excision, and segmental resection were 2.2%, 9.7%, and 9.9%, respectively. Rectal shaving was less associated with rectovaginal fistula than disc excision (odds ratio [OR] = 0.19; 95% confidence interval [CI], 0.10-0.36; p <.001; I 2 = 33%) and segmental colorectal resection (OR = 0.26; 95% CI, 0.15-0.44; p <.001; I 2 = 0%). No difference was found in the occurrence of rectovaginal fistula between disc excision and segmental colorectal resection (OR = 1.07; 95% CI, 0.70-1.63; p = .76; I 2 = 0%). Rectal shaving was less associated with leakage than disc excision (OR = 0.22; 95% CI, 0.06-0.73; p = .01; I 2 = 86%). No difference was found in the occurrence of leakage between rectal shaving and segmental colorectal resection (OR = 0.32; 95% CI, 0.10-1.01; p = .05; I 2 = 71%) or between disc excision and segmental colorectal resection (OR = 0.32; 95% CI, 0.30-1.58; p = .38; I 2 = 0%). Disc excision was less associated with anastomotic stenosis than segmental resection (OR = 0.15; 95% CI, 0.05-0.48; p = .001; I 2 = 59%). Disc excision was associated with more voiding dysfunction <30 days than rectal shaving (OR = 12.9; 95% CI, 1.40-119.34; p = .02; I 2 = 0%). No difference was found in the occurrence of voiding dysfunction <30 days between segmental resection and rectal shaving (OR = 3.05; 95% CI, 0.55-16.87; p = .20; I 2 = 0%) or between segmental colorectal and discoid resections (OR = 0.99; 95% CI, 0.54-1.85; p = .99; I 2 = 71%).; Conclusion: Colorectal surgery for endometriosis exposes patients to a risk of severe complications such as rectovaginal fistula, anastomotic leakage, anastomotic stenosis, and voiding dysfunction. Rectal shaving seems to be less associated with postoperative complications than disc excision and segmental colorectal resection. However, this technique is not suitable for all patients with large bowel infiltration. Compared with segmental colorectal resection, disc excision has several advantages, including shorter operating time, shorter hospital stay, and lower risk of postoperative bowel stenosis. (Copyright © 2020 AAGL. Published by Elsevier Inc. All rights reserved.)

Bendifallah, S., et al. (2020). "Recurrence after Surgery for Colorectal Endometriosis: A Systematic Review and Meta-analysis." Journal of Minimally Invasive Gynecology 27(2): 441.
	Objective: The recurrence rate after colorectal surgery for endometriosis is up to 50% at 5 years. The aim of the current review and meta-analysis was to assess recurrence associated with shaving, disc excision, and segmental resection for endometriosis with colorectal involvement.; Data Sources: A systematic review was performed by searching the PubMed, ClinicalTrials.gov, EMBASE, Cochrane Library, and Web of Science databases for publications before February 28, 2019, using the terms "colorectal endometriosis" and "recurrence" in English. The outcome measure was histologically proven recurrence 1 year after the index surgery.; Methods of Study Selection: Studies rated as good or fair by a study quality assessment tool were included. Two reviewers independently assessed the quality of the studies; discrepancies were discussed, and if a consensus was not reached, a third reviewer was consulted.; Tabulation, Integration, and Results: Of 156 relevant published trials, 41 were systematically reviewed and 4 were included in the meta-analysis. The risk of recurrence was higher after rectal shaving than after both segmental resection (odds ratio [OR], 5.53; 95% confidence interval [CI], 2.33-13.12; I 2 = 0%; p = .001) and disc excision for histologically proven recurrence (OR, 3.83; 95% CI, 1.33-11.05; I 2 = 0%; p = .01). This difference was not significant when comparing disc excision with segmental resection (OR, 2.63; 95% CI, 0.8-8.65; I 2 = 0%; p = .11).; Conclusion: The current analysis shows that the risk of recurrence is lower when segmental resection or disc excision is performed than when rectal shaving is performed. This finding is important when deciding the most appropriate surgical management. (Copyright © 2019 AAGL. Published by Elsevier Inc. All rights reserved.)

Benna-Doyle, S., et al. (2024). "Nutritional interventions during treatment for ovarian cancer: A narrative review and recommendations for future research." Maturitas 183: 107938.
	Most women with ovarian cancer are diagnosed at an advanced stage (stage III or IV), when the intraabdominal spread of the tumour impacts nutrient intake and absorption. Up to 70 % of women with ovarian cancer are malnourished and approximately 40 % are affected by muscle loss at the time of diagnosis. Women with ovarian cancer are at high risk of nutritional decline due to invasive treatment and the severity of side-effects. This review explores the evidence evaluating nutritional interventions during treatment for ovarian cancer and their effect on nutritional status, muscle mass, and clinical outcomes. Perioperative immunonutrition has been investigated with mixed results for immediate postoperative outcomes. Individualised nutrition counselling as part of a multimodal prehabilitation programme prior to surgery shows promising results; however, the effects are limited by sample size. Nutrition counselling as part of a mixed intervention with exercise shows high acceptability and suggests improvements in dietary intake and quality of life during chemotherapy treatment, while oral nutritional supplements and nutrition education appear to reduce symptom burden. Individualised nutrition counselling during treatment also appears to be associated with improved overall survival; however, the evidence is limited to a single retrospective study. A key finding from this review is that, despite the high prevalence of malnutrition and muscle loss in women with ovarian cancer and the critical importance of addressing these modifiable prognostic factors, nutrition intervention studies are limited. Prospective studies with samples large enough to provide adequate power to evaluate intervention effectiveness are urgently required to inform optimal management.Copyright © 2024 The Authors

Bennett, A., et al. (2019). "Effectiveness of Outpatient Versus Operating Room Hysteroscopy for the Diagnosis and Treatment of Uterine Conditions: A Systematic Review and Meta-Analysis." Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC 41(7): 930-941.
	Traditionally, hysteroscopy has been performed in the main operating room with the patient under general anaesthesia. Hysteroscopy performed in an office setting avoids the risks of general anaesthesia. The aim of this review was to evaluate the effectiveness of outpatient hysteroscopy compared with hysteroscopy performed in the operating room to diagnose and/or treat intrauterine pathology. Relevant electronic databases were searched, including Medline, EMBASE, and the Cochrane Library. RCTs and nonrandomized studies that compared the efficacy of outpatient hysteroscopy and traditional hysteroscopy performed in the operating room were included. The primary outcome of interest was diagnostic accuracy, and secondary outcomes included treatment success, adverse events, pain, patient satisfaction, and cost. The Cochrane risk of bias tool was used to assess RCTs, and the Downs and Black tool was used for nonrandomized studies. A total of 12 658 abstracts and 347 full-text articles were assessed, from which a total of 20 full-text studies met our eligibility criteria. No study compared the diagnostic accuracy of outpatient hysteroscopy with hysteroscopy performed in the operating room. There was no significant difference between hysteroscopy performed in the outpatient and operating room setting for treatment success, adverse events, and patient satisfaction. In the included RCTs, there was greater reported postoperative pain in the outpatient setting (standard mean difference 0.19, 95% CI 0.01-0.37). All seven economic studies concluded that outpatient hysteroscopy (range US$97-1258) is substantially less expensive than hysteroscopy performed in the operating room (range US$258-3144). Included RCTs had serious risks of selection, performance, and detection bias. The results of this review demonstrate that implementing hysteroscopy in an outpatient setting without general anaesthesia should be thoughtfully considered. The current available evidence demonstrates greater reported postoperative pain in the outpatient setting and no statistically significant differences in all other studied outcome measures between outpatient and intraoperative hysteroscopy procedures. (Copyright © 2019 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.)

Berahman, H., et al. (2021). "The effect of water-based rhythmic exercise training on glucose homeostasis and thyroid hormones in postmenopausal women with metabolic syndrome." Hormone molecular biology and clinical investigation 42(2): 189‐193.
	OBJECTIVES: The present study aimed to explore the effect of water‐based rhythmic exercise training on fasting blood sugar (FBS), homeostatic model assessment (HOMA), insulin, thyroid stimulating hormone (TSH), and T4 in postmenopausal women with metabolic syndrome. METHODS: In this clinical trial, 31 postmenopausal woman with metabolic syndrome aged 69.16 ± 2.02 years were randomly assigned to an experimental (n=16) and a control group (n=15). The training program was composed of 12 weeks of water‐based rhythmic exercise training performed intermittently for 60 min three times a week. Before and after training, blood was analyzed for glucose homeostasis, T4, and TSH. Data were subjected to analysis by paired t‐test and covariance analysis at the p<0.05 level. RESULTS: The exercise training intervention reduced the FBS and insulin significantly (p=0.000). The growth hormone (GH) index was increased significantly only in the experimental group (p=0.037) whereas no significant variations occurred in the insulin‐like growth factor‐1 (p=0.712). It was also found that TSH and T4 change in the experimental group as compared to the pre‐test. CONCLUSIONS: Water‐based rhythmic exercise training may improve blood glucose homeostasis, TSH, and T4.

Bercow, A., et al. (2021). "Outcomes after Fertility-sparing Surgery for Women with Ovarian Cancer: A Systematic Review of the Literature." Journal of Minimally Invasive Gynecology 28(3): 527.
	Objective: To compare reproductive and oncologic outcomes of patients diagnosed with early-stage epithelial ovarian carcinoma, borderline ovarian tumors, or nonepithelial ovarian carcinoma according to receipt of fertility-sparing surgery or conventional surgery.; Data Sources: PubMed was searched from January 1, 1995, to May 29, 2020.; Methods of Study Selection: Studies were included if they (1) enrolled women of childbearing age diagnosed with ovarian cancer between the ages of 18 years and 50 years, (2) reported on oncologic and/or reproductive outcomes after fertility-sparing surgery for ovarian cancer, and (3) included at least 20 patients.; Tabulation, Integration, and Results: The initial search identified 995 studies. After duplicates were removed, we abstracted 980 unique citations. Of those screened, 167 publications were identified as potentially relevant, and evaluated for inclusion and exclusion criteria. The final review included 44 studies in epithelial ovarian cancer, 42 in borderline ovarian tumors, and 31 in nonepithelial ovarian carcinoma. The narrative synthesis demonstrated that overall survival does not seem to be compromised in patients undergoing fertility-sparing surgery compared with those undergoing conventional surgery, although long-term data are limited. Areas of controversy include safety of fertility-sparing surgery in the setting of high-risk factors (stage IC, grade 3, and clear cell histology), as well as type of surgery (salpingo-oophorectomy vs cystectomy). It seems that although there may be some fertility compromise after surgery, pregnancy and live-birth rates are encouraging.; Conclusion: Fertility-sparing surgery is safe and feasible in women with early-stage low-risk ovarian cancer. Pregnancy outcomes for these patients also seem to be similar to those of the general population. (Copyright © 2020. Published by Elsevier Inc.)

Bercow, A. S., et al. (2023). "Association of hospital-level factors with utilization of sentinel lymph node biopsy in patients with early-stage vulvar cancer." Gynecologic Oncology 169: 47-54.
	Objective: To evaluate utilization of sentinel lymph node biopsy (SLNB) for early-stage vulvar cancer at minority-serving hospitals and low-volume facilities. Method(s): Between 2012-2018, individuals with T1b vulvar squamous cell carcinoma were identified using the National Cancer Database. Patient, facility, and disease characteristics were compared between patients undergoing SLNB or inguinofemoral lymph node dissection (IFLD). Multivariable logistic regression, adjusted for patient, facility, and disease characteristics, was used to evaluate factors associated with SLNB. Kaplan-Meier survival analysis using log rank test and Cox regression was performed. Result(s): Of the 3,532 patients, 2,406 (68.1%) underwent lymph node evaluation, with 1,704 (48.2%) undergoing IFLD and 702 (19.8%) SLNB. In a multivariable analysis, treatment at minority-serving hospitals (OR 0.39, 95% CI 0.19-0.78) and low-volume hospitals (OR 0.44, 95% CI 0.28-0.70) were associated with significantly lower odds of undergoing SLNB compared to receiving care at non-minority-serving and high-volume hospitals, respectively. While SLNB utilization increased over time for the entire cohort and stratified subgroups, use of the procedure did not increase at minority-serving hospitals. After controlling for patient and tumor characteristics, SLNB was not associated with worse OS compared to IFLD in patients with positive (HR 1.02, 95% CI 0.63-1.66) or negative (HR 0.92, 95% CI 0.70-1.21) nodal pathology. Conclusion(s): For patients with early-stage vulvar cancer, treatment at minority-serving or low-volume hospitals was associated with significantly decreased odds of undergoing SLNB. Future efforts should be concentrated toward ensuring that all patients have access to advanced surgical techniques regardless of where they receive their care.Copyright © 2022 Elsevier Inc.

Berd, D. (2023). "Portrait of an autologous cancer vaccine: Then and now." Human vaccines & immunotherapeutics 19(1): 2172925.
	Active immunotherapy of cancer with therapeutic vaccines has been the subject of experimental and clinical studies for at least 50 years. Our approach has employed 1) autologous, human cancer cells because of extensive evidence that tumor rejection antigens may differ between multiple tumors of the same histology; 2) the immunopotentiating drug, cyclophosphamide; and 3) haptens, particularly dinitrophenyl. Multiple clinical trials in 455 patients with melanoma and ovarian cancer have shown that administration of haptenized vaccines at the proper dosage-schedule regularly induces T cell-mediated immunity to autologous tumor cells as measured by delayed-type hypersensitivity. Moreover, the vaccine causes changes in the tumor site suggestive of an immune reaction, including inflammation and infiltration with CD8+ T lymphocytes that are activated and produce cytokines. The T cell response is oligoclonal, and dominant Vβ families differ between patients. Studies of measurable metastases show clinically important tumor regression. Commercial development of this technology is clearly feasible.

Berestoviy, V. O., et al. (2021). "AN OVERVIEW OF AUTOIMMUNITY IN IMPLANTATION FAILURE: A LITERATURE REVIEW." Wiadomosci lekarskie (Warsaw, Poland : 1960) 74(3 cz 2): 777-783.
	OBJECTIVE: The aim: This review was aimed to understand the role of different types of autoantibodies like antiphospholipid, antithyroid, antisperm, antinuclear, anti-ovarian autoantibodiesand heat shock protein HSP 60 in the process of implantation in the normal way of conceiving and IVF and also to estimate that how the presence of these autoantibodies affect the normal pregnancy outcome. PATIENTS AND METHODS: Material(s) and Method(s): This review process performed in the obstetrics and gynaecology postgraduate department, Bogomolets national medical university, Kyiv, Ukraine. It was a review of already published papers not to need the ethical board committee's approval. By following the literature review guidelines, this paper was written and searched for relevant studies regarding autoantibodies and implantation, published in medical literature till 2020 were included in this review process. The search is done for studies published till 2020 in the English language from the Medline database, including Google Scholar, PubMed, Web of Science and Cochrane library database. CONCLUSION(S): Conclusion(s): Our recent work found that the involvement of APA, ANA and/or ATA in recipients of oocyte donations did not affect their pregnancy outcomes. Some researchers did not give any clear conclusion about these risks, and some stated that the use of some immunodepressant agents could be useful to reduce the harmful effects of these autoantibodies associated with implantation failure. Each autoantibody has a different mechanism of action to create the pathological state, some have direct effect, and some indirectly impact implantation. In future, further high-quality studies need to be performed for better understanding.

Berezowska, A., et al. (2021). "Professional patient navigation in a hospital setting: a randomized controlled trial." Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 29(4): 2111-2123.
	PURPOSE: This study aimed to determine the effect of patient navigation on health-related quality of life, distress, self-care knowledge, self-efficacy, satisfaction, and healthcare usage. METHODS: Patients newly diagnosed with ovarian, vulvar, endometrial, melanoma stage III/IV, lung, or renal cancer were randomly assigned to either care as usual or care as usual plus consultations with a patient navigator (i.e., specially trained oncology nurse who monitors, advises, and refers patients to supportive cancer care). Measures included the EORTC-QLQ-C30, distress thermometer, and study-specific questions inspired by the Symptom-Management Self-Efficacy Scale Breast Cancer, Patient Satisfaction with Cancer Care Scale, and the Medical Consumption Questionnaire. Measures were completed before randomization (baseline) and at 1 month, 3 months, and 5 months after baseline. RESULTS: In the case of health-related quality of life, no significant difference was observed between the intervention (n = 42) and the control group (n = 47). Consumption of supportive cancer care was low for both the intervention and the control group but relatively lower for the intervention group. Also, participants who consulted the patient navigator seemed to have higher levels of self-efficacy and satisfaction. CONCLUSION: Although the intervention sorted no relevant effects on health-related quality of life, it did affect patients' experience of cancer care and self-efficacy. We recommend that patient navigators monitor and advise on unmet supportive care needs, but only in the case of high-risk patients. Furthermore, considering current and prior research, it is wise to study patient navigation using more sensitive outcome measures than health-related quality of life.

Bergamini, A., et al. (2022). "Fertility sparing surgery in sex-cord stromal tumors: oncological and reproductive outcomes." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 32(8): 1063-1070.
	Sex cord stromal tumors are rare neoplasms, frequently diagnosed in young women often as early-stage disease. In patients who desire to preserve fertility, when possible, unilateral salpingo-oophorectomy with peritoneal surgical staging is a safe alternative to radical treatment. In this review, we analyze the available literature on the obstetrical outcomes after fertility-sparing surgery in a total of 255 patients with sex cord stromal tumors. We found that the spontaneous conception rate in granulosa cells tumor is encouraging (88.5%). In particular, juvenile granulosa cell tumors are associated with a more successful pregnancy rate than adult granulosa cells tumors (11/26 (42.3%) in juvenile granulosa cells tumors compared with 28.5% in adult granulosa cell tumors, respectively.) On the other hand, the results of obstetrical outcomes in Sertoli-Leydig cells tumors are less promising (7/36 (19.4%)). Unfortunately, no evidence on this topic is available for sex cord tumor with annular tubules due to the low incidence. Regarding the oncological outcomes of 900 cases of sex cord stromal tumors treated conservatively, data are reassuring with comparable outcomes between patients treated with conservative and radical surgery. Given the limited available data on this rare tumor, further studies are needed to evaluate the safety of conservative approaches and to define the obstetrical outcomes in this patient population.

Bergenheim Sara, J., et al. (2021). "Immediate versus postponed single blastocyst transfer in modified natural cycle frozen embryo transfer (mNC-FET): a study protocol for a multicentre randomised controlled trial." BMJ Open 11(10): e053234.
	Introduction: Today, it is widespread practice to postpone frozen embryo transfer (FET) in a modified natural cycle (mNC) for at least one menstrual cycle after oocyte retrieval and failed fresh embryo transfer or freeze-all. The rationale behind this practice is the concern that suboptimal ovarian, endometrial or endocrinological conditions following ovarian stimulation may have a negative impact on endometrial receptivity and implantation. However, two recent systematic reviews and meta-analyses based on retrospective data did not support this practice. As unnecessary delay in time to transfer and pregnancy should be avoided, the aim of this study is to investigate if immediate single blastocyst transfer in mNC-FET is non-inferior to standard postponed single blastocyst transfer in mNC-FET in terms of live birth rate.; Methods and Analysis: Multicentre randomised controlled non-blinded trial including 464 normo-ovulatory women aged 18-40 years undergoing single blastocyst mNC-FET after a failed fresh or freeze-all cycle. Participants are randomised 1:1 to either FET in the first menstrual cycle following the stimulated cycle (immediate FET) or FET in the second or subsequent cycle following the stimulated cycle (postponed FET). The study is designed as a non-inferiority trial and primary analyses will be performed as intention to treat and per protocol.; Ethics and Dissemination: Ethical approval has been granted by the Scientific Ethical Committee of the Capital Region of Denmark (J-nr.: H-19086300). Data will be handled according to Danish law on personal data protection in accordance with the general data protection regulation. Participants will complete written consent forms regarding participation in the study and storage of blood samples in a biobank for future research. The study will be monitored by a Good Clinical Practice (GCP)-trained study nurse not otherwise involved in the study. The results of this study will be disseminated by publication in international peer-reviewed scientific journals.; Trial Registration Number: NCT04748874; Pre-results.; Competing Interests: Competing interests: ABP and KL has received a research grant from Merck supporting the present study. SJB has received a research grant from Rigshospitalet’s research fund supporting the present study. As a partner of Reprounion, ABP has received a grant from Ferring as well as a research grant from Gedeon Richter. ABP has received consulting fees from Novo Nordisk, honoraria from Merck and Ferring, honoraria as well as support for attending meetings from Gedeon Richter. KL has received honoraria from pharmakon and support for attending meetings from Gedeon Richter. PH has received unrestricted grants from Merck, Gedeon Richter, IBSA, Ferring and MSD as well as honoraria for lectures from Merck and Gedeon Richter. MF has received a research grant from Gedeon Richter. NLCF has received an unrestricted grant from Gedeon Richter, honoraria for lectures from Merck and support for attending meetings by Ferring, Merck and Gedeon Richter. Since 2018, NLCF is head of the steering committee for Danish fertility guidelines. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Berger, T., et al. (2019). "Importance of Technique, Target Selection, Contouring, Dose Prescription, and Dose-Planning in External Beam Radiation Therapy for Cervical Cancer: Evolution of Practice From EMBRACE-I to II." International Journal of Radiation Oncology, Biology, Physics 104(4): 885-894.
	Purpose: To describe the evolution of external beam radiation therapy (EBRT) from EMBRACE-I (general guidelines for EBRT) to the initial phase of the EMBRACE-II study (detailed protocol for EBRT).; Methods and Materials: EMBRACE-I enrolled 1416 locally advanced cervical cancer patients treated with chemoradiation including image-guided adaptive brachytherapy during 2008 to 2015. From March 2016 until March 2018, 153 patients were enrolled in the ongoing EMBRACE-II study, which involves a comprehensive detailed strategy and accreditation procedure for EBRT target contouring, treatment planning, and image guidance. EBRT planning target volumes (PTVs), treated volumes (V43 Gy), and conformity index (CI; V43 Gy/PTV) were evaluated in both studies and compared.; Results: For EMBRACE-I, conformal radiation therapy (60% of patients) or intensity-modulated radiation therapy (IMRT) and volumetric arc therapy (VMAT; 40%) was applied with 45 to 50 Gy over 25 to 30 fractions to the elective clinical target volume (CTV). For pelvic CTVs (82%), median PTV and V43 Gy volumes were 1549 and 2390 mL, respectively, and CI was 1.54. For pelvic plus paraortic nodal (PAN) CTVs (15%), median PTV and V43 Gy volumes were 1921 and 2895 mL, and CI was 1.51. For pelvic CTVs treated with 45 to 46 Gy, the use of conformal radiation therapy was associated with a median V43 Gy volume that was 546 mL larger than with IMRT/VMAT. For pelvic CTVs treated with IMRT, the use of a dose prescription ≥48 Gy was associated with a median V43 Gy volumes that was 428 mL larger than with a dose prescription of 45 to 46 Gy. For EMBRACE-II, all patients were treated with: IMRT/VMAT, daily IGRT, 45 Gy over 25 fractions for the elective CTV, and simultaneously integrated boost for pathologic lymph nodes. For pelvic CTVs (61%), median PTV and V43 Gy volumes were 1388 and 1418 mL, and CI was 1.02. For pelvic plus PAN CTVs (32%), median PTV and V43 Gy volumes were 1720 and 1765 mL, and CI was 1.03. From EMBRACE-I to initial II, median V43 Gy was decreased by 972 mL (41%) and 1130 mL (39%), and median CI decreased from 1.54 to 1.02 and 1.51 to 1.03 for pelvic and pelvic plus PAN irradiation, respectively.; Conclusions: Application of IMRT/VMAT, IGRT, and a 45-Gy dose provides the potential of higher conformality inducing significant reduction of treated volume. Adherence to a detailed protocol including comprehensive accreditation, as in EMBRACE-II, reduces considerably V43 Gy and V50 Gy and improves conformality and interinstitutional consistency. (Copyright © 2019 Elsevier Inc. All rights reserved.)

Bergeron, C., et al. (2020). "Endometrial ablation or resection versus levonorgestrel intra-uterine system for the treatment of women with heavy menstrual bleeding and a normal uterine cavity: a systematic review with meta-analysis." Human Reproduction Update 26(2): 302-311.
	Background: Endometrial ablation/resection and the levonorgestrel intra-uterine system (LNG-IUS) are well-established treatment options for heavy menstrual bleeding to avoid more invasive alternatives, such as hysterectomy.; Objective: The aim was to compare the efficacy and safety of endometrial ablation or resection with the LNG-IUS in the treatment of premenopausal women with heavy menstrual bleeding and to investigate sources of heterogeneity between studies.; Search Methods: We searched the databases MEDLINE, EMBASE, CENTRAL, Web of Science, Biosis and Google Scholar as well as citations and reference lists published up to August 2019. Two authors independently screened 3701 citations for eligibility. We included randomized controlled trials published in any language, comparing endometrial ablation or resection to the LNG-IUS in the treatment of premenopausal women with heavy menstrual bleeding and a normal uterine cavity.; Outcomes: Thirteen studies (N = 884) were eligible. Two independent authors extracted data and assessed the quality of included studies. Random effect models were used to compare the modalities and evaluate sources of heterogeneity. No significant differences were observed between endometrial ablation/resection and the LNG-IUS in terms of subsequent hysterectomy (primary outcome, risk ratio (RR) = 1.13, 95% CI 0.60 to 2.11, P = 0.71, I2 = 14%, 12 studies, 726 women), satisfaction, quality of life, amenorrhea and treatment failure. However, side effects were less common in women treated with endometrial ablation/resection compared to the LNG-IUS (RR = 0.52, 95% CI 0.37 to 0.71, P < 0.001, I2 = 0%, 10 studies, 580 women). Three complications were reported in the endometrial ablation/resection group and none in the LNG-IUS group (P = 0.25). Mean age of the studied populations was identified as a significant source of heterogeneity between studies in subgroup analysis (P = 0.01). In fact, endometrial ablation/resection was associated with a higher risk of subsequent hysterectomy compared to the LNG-IUS in younger populations (mean age ≤ 42 years old, RR = 5.26, 95% CI 1.21 to 22.91, P = 0.03, I2 = 0%, 3 studies, 189 women). On the contrary, subsequent hysterectomy seemed to be less likely with endometrial ablation/resection compared to the LNG-IUS in older populations (mean age > 42 years old), although the reduction did not reach statistical significance (RR = 0.51, 95% CI 0.21 to 1.24, P = 0.14, I2 = 0%, 5 studies, 297 women). Finally, sensitivity analysis taking into account the risk of bias of included studies and type of surgical devices (first and second generation) did not modify the results. Most of the included studies reported outcomes at up to 3 years, and the relative performance of endometrial ablation/resection and LNG-IUS remains unknown in the longer term.; Wider Implications: Endometrial ablation/resection and the LNG-IUS are two excellent treatment options for heavy menstrual bleeding, although women treated with the LNG-IUS are at higher risk of experiencing side effects compared to endometrial ablation/resection. Otherwise, younger women seem to present a lower risk of eventually requiring hysterectomy when treated with the LNG-IUS compared to endometrial ablation/resection. (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Bergeron, S., et al. (2021). "Cognitive-behavioral couple therapy versus lidocaine for provoked vestibulodynia: A randomized clinical trial." Journal of Consulting and Clinical Psychology 89(4): 316-326.
	Public Health Significance-This study shows that CBCT is an efficacious treatment for women with a subset of genito-pelvic pain and that involving partners may be beneficial. (PsycInfo Database Record (c) 2021 APA, all rights reserved), Objective: This randomized clinical trial compared a novel cognitive-behavioral couple therapy (CBCT) and topical lidocaine for provoked vestibulodynia. Method(s): Participants were 108 women (M age = 27.06) and their partners randomized to one of two treatments and assessed at pre- and post-treatment and 6-month follow-up via questionnaires pertaining to the primary outcomes of women's pain (numerical rating scales of pain intensity and unpleasantness), and secondary outcomes of pain anxiety (Pain Anxiety Symptoms Scale), both partners' sexual function (Female Sexual Function Index; International Index of Erectile Function), sexual distress (Female Sexual Distress Scale Revised), pain-related psychological distress (Pain Catastrophizing Scale), treatment satisfaction, and global ratings of improvements in pain and sexuality. Result(s): Intent-to-treat multilevel analyses showed that for women, CBCT yielded significantly more improvements than lidocaine in pain unpleasantness at 6-month follow-up, pain anxiety and pain catastrophizing at post-treatment and 6-month follow-up, and sexual distress at post-treatment, and resulted in better treatment satisfaction and global sexuality improvements at both time points. Partners significantly improved in their sexual function, sexual distress, and pain catastrophizing from pre- to post-treatment and pre-treatment to 6-month follow-up, with no significant group differences. Partners in the CBCT condition reported significantly greater treatment satisfaction at both time points, and greater sexuality improvements at post-treatment. Conclusion(s): CBCT yielded better outcomes on more dimensions of provoked vestibulodynia than lidocaine. (PsycInfo Database Record (c) 2021 APA, all rights reserved)Copyright © 2021 American Psychological Association

Bergersen, A., et al. (2019). "Management of vaginal mesh exposure: A systematic review." Arab Journal of Urology 17(1): 40-48.
	Objectives: To identify various predisposing factors, the clinical presentation, and the management of vaginal mesh-related complications, with special emphasis on mesh exposure and the indications for and results of vaginal mesh removal. Method(s): A systematic literature review was performed using a search strategy based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses criteria. PubMed was queried for studies regarding aetiology, risk factors, and management of vaginal mesh exposure from 1 January 2008 to June 2018. Full-text articles were obtained for eligible abstracts. Relevant articles were included, and the cited references were used to identify relevant articles not previously included. Result(s): A total of 102 abstracts were identified from the PubMed search criteria. An additional 45 studies were identified based on review of the cited references. After applying eligibility criteria and excluding impertinent articles, 58 studies were included in the final analysis. Conclusion(s): Numerous studies have found at least some degree of symptomatic improvement regardless of the amount of mesh removed. Focal areas of exposure or pain can be successfully managed with partial mesh removal with low rates of complications. With partial mesh removal, many patients will ultimately require subsequent mesh removal procedures. For this reason, complete mesh excision is an alternative for patients with diffuse vaginal pain, large mesh exposure, and extrusion of mesh into adjacent viscera. However, when considering complete mesh removal, it is important to counsel patients regarding possible complications of removal and the increased risk of recurrent stress urinary incontinence and pelvic organ prolapse postoperatively. Abbreviations: MUS: midurethral sling; OR: odds ratio; POP: pelvic organ prolapse; PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-analyses; SUI: stress urinary incontinence; TOT: transobturator; TVT: tension-free vaginal tape.Copyright © 2019, © 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Bergonié, I. (2021). Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery.
	No Results Available Other: Arm A : intraoperative ANI monitoring of nociception|Other: Arm B : no specific monitoring of nociception Proportion of patients with a pain score on the self-assessment VAS > 4, three months after the surgery.|Arm A : total dose of opioids received intraoperatively|Arm B : total dose of opioids received intraoperatively|Arm A : Patients' pain score on the VAS immediately postoperatively|Arm B : Patients' pain score on the VAS immediately postoperatively|Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery|Arm B : Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery Female Not Applicable 126 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Other IB 2020-04|2020-A02767-32 August 25, 2024

Berlin, J., et al. (2022). "First-in-human trial exploring safety, antitumor activity, and pharmacokinetics of Sym013, a recombinant pan-HER antibody mixture, in advanced epithelial malignancies." Investigational New Drugs 40(3): 586-595.
	Purpose. Sym013 contains six humanized monoclonal antibodies that bind to non-overlapping epitopes on three human epidermal growth factor receptors (HER1-3). Preclinical studies suggested Sym013 strongly suppresses growth of multiple epithelial tumors. This is a first-in-human study exploring safety and efficacy of Sym013 in patients with advanced epithelial malignancies. Methods. Dose escalation used single-patient cohorts until the stopping rule was met, followed by 3 + 3 design. Dose levels planned were: 1, 2, 4, 6, 9, 12, 15, and 18 mg/kg. Treatment cycles were 28 days with imaging every eight weeks. Serum samples were collected at multiple time points for assessment of pharmacokinetics and development of anti-drug antibodies. Results. Thirty-two patients were enrolled with multiple solid tumors, most common being colorectal cancer (CRC; 10/32, 31%). Due to mucositis, rash, and diarrhea at 4 mg/kg once-weekly, dosing was changed to biweekly (Q2W). Mandatory prophylaxis was added due to Grade 3 infusion-related reaction and oral mucositis at 9 mg/kg Q2W. The 15 mg/kg Q2W cohort was enrolling when the study was terminated for business reasons. Most common adverse events were skin (81%) and gastrointestinal (75%) disorders, including dermatitis/rash, stomatitis, and diarrhea. One patient with CRC achieved a partial response; 12 patients with varied malignancies had stable disease. Conclusion. During the conduct of the study, management of frequent infusion-related reactions, skin toxicities, and mucosal disorders, which are indicative of HER inhibition, necessitated multiple protocol amendments. The investigators, in concert with the Sponsor, agreed that achieving a tolerated regimen with acceptable target saturation was unlikely. Trial registry: www.clinicaltrials.gov; NCT02906670 (September 20, 2016).Copyright © 2022, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Bernabeu, I. (2022). Continuous Double Ovarian Stimulation.
	No Results Available Drug: Corifollitropin Alfa|Drug: Follitropin Alfa|Drug: Follitropin Alfa Biosimilar|Drug: Urinary Human follicle stimulating hormone number of retrieved oocytes - study group|number of retrieved oocytes - comparison|number of MII oocytes - comparison|duration of DUOSTIM cycle - comparison|fertilization rate - comparison Female Phase 4 30 Other Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IBMR31|2022-003177-32 May 30, 2023

Bernard, L., et al. (2021). "The levonorgestrel intrauterine system (LNG-IUS) for prevention of endometrial cancer in women with obesity is cost effective." Gynecologic Oncology 162(Supplement 1): S300-S301.
	Objectives: To estimate the cost-effectiveness of the levonorgestrel intrauterine system (LNG-IUS) as an endometrial cancer prevention strategy in women with obesity. Method(s): A Markov decision-analytic model was used to compare 5 strategies in women with a body mass index of 30 or greater: 1) Usual care 2) LNG-IUS for 5 years 3) LNG-IUS for 7 years 4) LNG-IUS for 5 years, replaced once for a total of 10 years 5) LNG-IUS for 7 years, replaced once for a total of 14 years. Obesity was presumed to be associated with a 3-fold relative risk of endometrial cancer incidence and a 2.65-fold disease-specific mortality. The LNG-IUS was assumed to confer a 50% reduction in cancer incidence over the period of the LNG-IUS insertion. Costs of LNG-IUS and cancer care were included. Outcomes were incremental cost-effectiveness ratios, calculated in 2019 Canadian dollars per year of life saved. One-way and two-way sensitivity analyses were performed. Result(s): The LNG-IUS strategy was considered cost-effective if the cost of the intervention is less than 66 400 CAD (50 000 USD) per year of life saved. The strategy becomes cost-effective if 1 LNG-IUS is inserted in 57-year-old women for 5 years, 1 LNG-IUS is inserted in 52-year-old women for 7 years, 2 subsequent LNG-IUS for a total of 10 years are inserted in 51-year-old women or 2 subsequent LNG-IUS for a total of 14 years are inserted in 45-year-old women, when compared to usual care. The results are stable to variations in cost but sensitive to the estimated risk reduction of the LNG-IUS and the impact of obesity on endometrial cancer incidence and disease-specific mortality. Conclusion(s): The LNG-IUS is a cost-effective method of endometrial cancer prevention in women with obesity. This intervention warrants investigation in a prospective study in this high-risk population.Copyright © 2021 Elsevier Inc.

Bernard, L., et al. (2021). "The levonorgestrel intrauterine system for prevention of endometrial cancer in women with obesity: A cost-effectiveness study." Gynecologic Oncology 161(2): 367-373.
	Objective: To estimate the cost-effectiveness of the levonorgestrel intrauterine system (LNG-IUS) as an endometrial cancer prevention strategy in women with obesity. Method(s): A Markov decision-analytic model was used to compare 5 strategies in women with a body mass index of 30 or greater: 1) Usual care 2) LNG-IUS for 5 years 3) LNG-IUS for 7 years 4) LNG-IUS for 5 years, replaced once for a total of 10 years 5) LNG-IUS for 7 years, replaced once for a total of 14 years. Obesity was presumed to be associated with a 3-fold relative risk of endometrial cancer incidence and a 2.65-fold disease-specific mortality. The LNG-IUS was assumed to confer a 50% reduction in cancer incidence over the period of the LNG-IUS insertion. Outcomes were incremental cost-effectiveness ratios, calculated in 2019 Canadian dollars (CAD) per year of life saved. One-way and two-way sensitivity analyses were performed. Result(s): The LNG-IUS strategy was considered cost-effective if the cost of the intervention is less than $66,400 CAD ($50,000 US dollars) per year of life saved. The strategy becomes cost-effective if the LNG-IUS is inserted at age 57 (strategy #2), at age 52 for strategy #3, at age 51 for strategy #4 and at age 45 for strategy #5, when compared to usual care. The results are stable to variations in cost but sensitive to the estimated risk reduction of the LNG-IUS and the impact of obesity on endometrial cancer incidence and disease-specific mortality. Conclusion(s): The LNG-IUS is a cost-effective method of endometrial cancer prevention in women with obesity.Copyright © 2021 Elsevier Inc.

Bernard, L., et al. (2023). "A Double-blinded, Randomized Trial Comparing Surgeon-Administered Transversus Abdominis Plane Block With Placebo After Midline Laparotomy in Gynecologic Oncology Surgery." Obstetrical and Gynecological Survey 78(7): 404-405.
	Background: Surgeon-administered transversus abdominis plane block is a contemporary approach to providing postoperative analgesia, and this approach is performed by transperitoneally administering local anesthetic in the plane between the internal oblique and transversus abdominis muscles to target the sensory nerves of the anterolateral abdominal wall. Although this technique is used in many centers, it has not been studied prospectively in patients undergoing a midline laparotomy. Objective: This study aimed to evaluate whether surgeon-administered transversus abdominis plane block reduces postoperative opioid requirements and improves clinical outcomes. Study design: In this double-blind, randomized, placebo-controlled trial, patients with a suspected or proven gynecologic malignancy undergoing surgery through a midline laparotomy at 1 Canadian tertiary academic center were randomized to either the bupivacaine group (surgeon-administered transversus abdominis plane blocks with 40 mL of 0.25% bupivacaine) or the placebo group (surgeon-administered transversus abdominis plane blocks with 40 mL of normal saline solution) before fascial closure. The primary outcome was the total dose of opioids (in morphine milligram equivalents) received in the first 24 hours after surgery. The secondary outcomes included opioid doses between 24 and 48 hours, pain scores, postoperative nausea and vomiting, incidence of clinical ileus, time to flatus, and hospital length of stay. The exclusion criteria included contraindications to study medication, history of chronic opioid use, significant adhesions on the anterior abdominal wall preventing access to the injection site, concurrent nonabdominal surgical procedure, and the planned use of neuraxial anesthesia or analgesia. To detect a 20% decrease in opioid requirements with a 2-sided type 1 error of 5% and power of 80%, a sample size of 36 patients per group was calculated. Results: From October 2020 to November 2021, 38 patients were randomized to the bupivacaine arm, and 41 patients were randomized to the placebo arm. The mean age was 60 years, and the mean body mass index was 29.3. A supraumbilical incision was used in 30 of 79 cases (38.0%), and bowel resection was performed in 10 of 79 cases (12.7%). Patient and surgical characteristics were evenly distributed. The patients in the bupivacaine group required 98.0±59.2 morphine milligram equivalents in the first 24 hours after surgery, whereas the patients in the placebo group required 100.8±44.0 morphine milligram equivalents (P=.85). The mean pain score at 4 hours after surgery was 3.1±2.4 (0-10 scale) in the intervention group vs 3.1±2.0 in the placebo group (P=.93). Clinically significant nausea or vomiting was reported in 1 of 38 patients (2.6%) in the intervention group vs 1 of 41 patients (2.4%) in the placebo group (P=.95). Time to first flatus, rates of clinical ileus, and length of stay were similar between groups. Subgroup analysis of patients with a body mass index of <25 and patients who received an infraumbilical incision showed similarly comparable outcomes. Conclusion: Surgeon-administered transversus abdominis plane block with bupivacaine was not found to be superior to the placebo intervention in reducing postoperative opioid requirements or improving other postoperative outcomes for patients undergoing a midline laparotomy. These results differed from previous reports evaluating the ultrasound-guided transversus abdominis plane block approach. Surgeon-administered transversus abdominis plane block should not be considered standard of care in postoperative multimodal analgesia.

Bernard, L., et al. (2023). "A double-blinded, randomized trial comparing surgeon-administered transversus abdominis plane block with placebo after midline laparotomy in gynecologic oncology surgery." American Journal of Obstetrics and Gynecology 228(5): 553.e551-553.e558.
	Background: Surgeon-administered transversus abdominis plane block is a contemporary approach to providing postoperative analgesia, and this approach is performed by transperitoneally administering local anesthetic in the plane between the internal oblique and transversus abdominis muscles to target the sensory nerves of the anterolateral abdominal wall. Although this technique is used in many centers, it has not been studied prospectively in patients undergoing a midline laparotomy.; Objective: This study aimed to evaluate whether surgeon-administered transversus abdominis plane block reduces postoperative opioid requirements and improves clinical outcomes.; Study Design: In this double-blind, randomized, placebo-controlled trial, patients with a suspected or proven gynecologic malignancy undergoing surgery through a midline laparotomy at 1 Canadian tertiary academic center were randomized to either the bupivacaine group (surgeon-administered transversus abdominis plane blocks with 40 mL of 0.25% bupivacaine) or the placebo group (surgeon-administered transversus abdominis plane blocks with 40 mL of normal saline solution) before fascial closure. The primary outcome was the total dose of opioids (in morphine milligram equivalents) received in the first 24 hours after surgery. The secondary outcomes included opioid doses between 24 and 48 hours, pain scores, postoperative nausea and vomiting, incidence of clinical ileus, time to flatus, and hospital length of stay. The exclusion criteria included contraindications to study medication, history of chronic opioid use, significant adhesions on the anterior abdominal wall preventing access to the injection site, concurrent nonabdominal surgical procedure, and the planned use of neuraxial anesthesia or analgesia. To detect a 20% decrease in opioid requirements with a 2-sided type 1 error of 5% and power of 80%, a sample size of 36 patients per group was calculated.; Results: From October 2020 to November 2021, 38 patients were randomized to the bupivacaine arm, and 41 patients were randomized to the placebo arm. The mean age was 60 years, and the mean body mass index was 29.3. A supraumbilical incision was used in 30 of 79 cases (38.0%), and bowel resection was performed in 10 of 79 cases (12.7%). Patient and surgical characteristics were evenly distributed. The patients in the bupivacaine group required 98.0±59.2 morphine milligram equivalents in the first 24 hours after surgery, whereas the patients in the placebo group required 100.8±44.0 morphine milligram equivalents (P=.85). The mean pain score at 4 hours after surgery was 3.1±2.4 (0-10 scale) in the intervention group vs 3.1±2.0 in the placebo group (P=.93). Clinically significant nausea or vomiting was reported in 1 of 38 patients (2.6%) in the intervention group vs 1 of 41 patients (2.4%) in the placebo group (P=.95). Time to first flatus, rates of clinical ileus, and length of stay were similar between groups. Subgroup analysis of patients with a body mass index of <25 and patients who received an infraumbilical incision showed similarly comparable outcomes.; Conclusion: Surgeon-administered transversus abdominis plane block with bupivacaine was not found to be superior to the placebo intervention in reducing postoperative opioid requirements or improving other postoperative outcomes for patients undergoing a midline laparotomy. These results differed from previous reports evaluating the ultrasound-guided transversus abdominis plane block approach. Surgeon-administered transversus abdominis plane block should not be considered standard of care in postoperative multimodal analgesia. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Berntsen, S., et al. (2020). "Endometrial scratch injury with office hysteroscopy before IVF/ICSI: A randomised controlled trial." European Journal of Obstetrics, Gynecology, and Reproductive Biology 252: 112-117.
	Objective: Endometrial scratch injury (ESI) has been proposed to improve endometrial receptivity and thereby increase implantation rates in assisted reproductive technology (ART) treatment. ESI has been widely incorporated into clinical practice despite inconclusive evidence of its effect on reproductive outcomes. We aimed to assess pregnancy and live birth rates in subfertile women receiving ESI before IVF treatment in comparison to controls.; Study Design: This was a randomised controlled trial (RCT) with no blinding of participants, investigators or health care personnel. Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group). In total 184 women in IVF/ICSI treatment with minimum one previous failed IVF/ICSI cycle, were included in the final analysis. The primary outcome was positive serum hCG (s-hCG). Secondary outcomes were ongoing pregnancy and live birth rate. Only per-protocol analyses were performed as all patients included at one centre had to be excluded. The trial is registered at ClinicalTrials.gov, NCT01743391.; Results: Our results showed a non-significant increase in positive s-hCG (OR 1.23, 95 % CI (0.65-2.33)), ongoing pregnancy (OR 1.52, 95 % CI (0.73-3.17)), and live birth rates (OR 1.69, 95 % CI (0.78-3.64)) per randomised woman between the ESI and the control group.; Conclusion: We observed no significant differences in positive s-hCG or other reproductive outcomes in the ESI vs. the control group. While the crude estimates of positive reproductive outcomes were higher in the ESI group, statistical significance was not reached, and the study was not powered to show smaller differences. However, data from this study will be re-evaluated in the context of an individual participant data meta-analysis (IPD-MA) of RCTs on ESI.; Competing Interests: Declaration of Competing Interest None. (Copyright © 2020 Elsevier B.V. All rights reserved.)

Beroukhim, G. and B. Seifer David (2023). "Racial and Ethnic Disparities in Access to and Outcomes of Infertility Treatment and Assisted Reproductive Technology in the United States." Endocrinology and metabolism clinics of North America 52(4): 659-675.
	Infertility disproportionately affects the minority, non-White populace, with Black women having twofold higher odds than White women. Despite higher infertility rates, minority racial and ethnic groups access and utilize fertility care less frequently. Even once care is accessed, racial and ethnic disparities exist in infertility treatment and ART outcomes. Preliminary studies indicate that Asian and American Indian women have lower intrauterine insemination pregnancy rates. Many robust studies indicate significant racial and ethnic disparities in rates of clinical pregnancy, live birth, pregnancy loss, and obstetrical complications following in vitro fertilization, with lower favorable outcomes in Black, Asian, and Hispanic women. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Berry, S., et al. (2022). "Vitamin D deficiency and female infertility: A mechanism review examining the role of vitamin D in ovulatory dysfunction as a symptom of polycystic ovary syndrome." Journal of Reproductive Immunology 151: 103633.
	Around one billion people worldwide are understood to have sub-optimal levels of vitamin D. Polycystic ovary syndrome (PCOS) is reportedly a primary reason for female infertility. The main objective of this research was to understand the mechanistic role of vitamin D in the pathogenesis of female infertility in PCOS, specifically in relation to ovarian follicle development. In addition, the impact of vitamin D deficiency on oxidative stress and hormone production central to folliculogenesis was explored. The efficacy of vitamin D supplementation as an intervention to ameliorate ovulatory dysfunction in individuals with PCOS was evaluated. The systematic search strategy included three stages of search with a critical appraisal of the accepted papers: 1) other review papers; 2) primary mechanistic animal, in vitro and human studies; 3) primary intervention studies. In total, 80 papers were examined in detail and results analysed and evaluated. Mechanistic evidence indicated an association between vitamin D deficiency and impaired ovulatory function. Sub-optimal vitamin D levels were implicated in disrupted reproductive hormone balance, including overproduction of anti-mullerian hormone (AMH); accumulation of pro-inflammatory Advanced Glycation End Products (AGEs) and formation of Reactive Oxygen Species (ROS) in ovarian tissue, leading to abnormal folliculogenesis. Human intervention studies demonstrated the capability of vitamin D supplementation for restoring sufficient serum calcidiol (25(OH)D) levels in deficient individuals. Furthermore, the anti-inflammatory benefit of vitamin D was illustrated in studies examining the impact on oxidative stress. Co-supplementation with calcium was shown to benefit follicle growth; oxidative stress reduced with calcium, omega-3 fatty acid or probiotic co-supplementation. (Copyright © 2022 Elsevier B.V. All rights reserved.)

Bertarello, C., et al. (2024). "Efficacy and safety of Lactobacillus plantarum P 17630 strain soft vaginal capsule in vaginal candidiasis: a randomized non-inferiority clinical trial." European Review for Medical and Pharmacological Sciences 28(1): 384-391.
	OBJECTIVE: To investigate the non-inferiority of efficacy and tolerability of Lactobacillus plantarum P 17630 soft vaginal capsules compared to the antifungal therapy with miconazole nitrate 400 mg soft vaginal capsules in patients with symptomatic vulvovaginal infection due to Candida. PATIENTS AND METHODS: Adult women with vulvovaginal candidiasis were randomized to either L. plantarum P17630 100,000,000 CFU soft vaginal capsules by vaginal route each day for 3 or 6 consecutive days or miconazole nitrate 400 mg soft vaginal capsule. Visual Analog Scale (VAS) scores for vaginitis symptoms were used, and vaginal fluid interleukin 6 (IL6) was dosed. The study was registered in EudraCT database (code LPP17630-C-018; number: 2018-003095-12). RESULT(S): 200 patients were included in the study. The mean VAS scores for vaginitis symptoms were progressively reduced in both treatment groups at each visit, without significant difference between groups (p>0.05 for each symptom, at each time point). The efficacy of L. plantarum and the reference medicinal product was maintained at follow-up (day 21). The mean concentration of IL-6 decreased from visit 1 to visit 3 in both groups without a significant difference (p>0.05). No adverse events were reported. CONCLUSION(S):L.plantarumP17630100,000,000 CFU soft vaginal capsules are effective and safe for treating vaginal candidiasis without the concomitant use of an antifungal product, which rules out the risk of antimicrobic resistance. The long-term effect on vaginal microflora may add the possibility of reducing the risk of recurrences.Copyright © 2024 Verduci Editore s.r.l. All rights reserved.

Berton, D., et al. (2021). "Real-World Experience of Bevacizumab as First-Line Treatment for Ovarian Cancer: the GINECO ENCOURAGE Cohort of 468 French Patients." Frontiers in Pharmacology 12.
	Introduction: Bevacizumab‐containing therapy is considered a standard‐of‐care front‐line option for stage IIIB–IV ovarian cancer based on results of randomized phase 3 trials. The multicenter non‐interventional ENCOURAGE prospective cohort study assessed treatment administration and outcomes in the French real‐world setting. Patients and Methods: Eligible patients were aged ≥ 18 years with planned bevacizumab‐containing therapy for newly diagnosed ovarian cancer. The primary objective was to assess the safety profile of front‐line bevacizumab in routine clinical practice; secondary objectives were to describe patient characteristics, indications/contraindications for bevacizumab, treatment regimens and co‐medications, follow‐up and monitoring, progression‐free survival, and treatment at recurrence. In this non‐interventional study, treatment was administered as chosen by the investigator and participation in the trial had no influence on the management of the disease. Results: Of 1,290 patients screened between April 2013 and February 2015, 468 were eligible. Most patients (86%) received bevacizumab 15 mg/kg every 3 weeks or equivalent, typically with carboplatin (99%) and paclitaxel (98%). The median duration of bevacizumab was 12.2 (range 0–28, interquartile range 6.9–14.9) months; 8% of patients discontinued bevacizumab because of toxicity. The most common adverse events were hypertension (38% of patients), fatigue (35%), and bleeding (32%). There were no treatment‐related deaths. Most physicians (90%) reported blood pressure measurement immediately before each bevacizumab infusion and almost all (97%) reported monitoring for proteinuria before each bevacizumab infusion. Median progression‐free survival was 17.4 (95% CI, 16.4–19.1) months. The 3‐year overall survival rate was 62% (95% CI, 58–67%). The most commonly administered chemotherapies at recurrence were carboplatin and pegylated liposomal doxorubicin. Discussion: Clinical outcomes and tolerability with bevacizumab in this real‐life setting are consistent with randomized trial results, notwithstanding differences in the treated patient population and treatment schedule. Clinical Trial Registration: ClinicalTrials.gov, Identifier NCT01832415.

Bertuit, J., et al. (2020). "Interest of mobile and internet applications in the management of stress urinary incontinence in women. A systematic review." Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie 30(16): 1022-1037.
	
Bese, T., et al. (2023). "3-4 Cycles vs 6 Cycles NACT in Advanced Stage Epithelial Ovarian Cancer: Survival is not Determined by the Number of NACT Cycles." Chemotherapy.
	INTRODUCTION: The aim of this study was to compare the disease-free survival (DFS) and overall survival (OS) of patients who underwent interval cytoreductive surgery after 3-4 cycles or 6 cycles of neoadjuvant chemotherapy (NACT) in advanced epithelial ovarian cancer patients. METHOD(S): Out of 219 patients with advanced epithelial ovarian cancer,123 patients received 3-4 cycles and 96 patients received 6 cycles of platinum-based NACT. Afterwards, laparotomy was performed for interval cytoreductive surgery. RESULT(S): No statistically significant difference was found for DFS and OS of the patients who received 3-4 cycles and those who received 6 cycles of NACT (HR:1.047,95.0%CI [0.779-1.407]; p:0.746 for DFS, and HR:1.181,95.0% CI [0.818-1.707]; p:0.368 for OS). Evaluating 123 patients who received 3-4 cycles of NACT;87 patients (70.7%) without macroscopic residual tumor after interval cytoreductive surgery had significantly longer DFS and OS compared to 36 patients(29.3%) with any residual tumor (HR:1.830,95.0% CI [1.194-2.806]; p:0.003 for DFS, and HR:1.946,95.0% CI [1.166-3.250]; p:0.009 for OS).96 patients who received 6 courses of NACT were evaluated;63 patients (65.6%) without macroscopic residual tumor after interval cytoreductive surgery had significantly longer DFS and OS than 33 patients (34.4%) with any residual tumor (HR:1.716,95.0% CI [1.092-2.697];p:0.010 for DFS, and HR:1.921,95.0%CI [1.125-3.282]; p:0.013 for OS). CONCLUSION(S): In patients with advanced ovarian cancer,there is no significant difference in DFS and OS between 3-4 cycles or 6 cycles of NACT.The most important factor determining survival is whether macroscopic residual tumor tissue remains after interval cytoreductive surgery following NACT.Copyright S. Karger AG, Basel.

Betof, A., et al. (2022). "TRIAL IN PROGRESS: A PHASE 1/2 OPEN-LABEL STUDY (IOV-GM1-201) OF TALEN-MEDIATED PD-1- INACTIVATED AUTOLOGOUS TUMOR-INFILTRATING LYMPHOCYTES (TIL; IOV-4001) IN PATIENTS WITH ADVANCED MELANOMA AND NSCLC." Journal for Immunotherapy of Cancer 10(Supplement 2): A814.
	Background Adoptive cell therapy with TIL has demonstrated efficacy in patients with advanced solid tumors, both as monotherapy in melanoma,1 NSCLC,2 and cervical cancer,3 and in combination with anti-PD-1 therapy in melanoma, head and neck cancer, and cervical cancer.4 IOV-4001 is a TALEN- mediated PDCD-1 knockout autologous TIL cell therapy product. Preclinical studies suggest that PD-1 inactivation by PDCD-1 gene knockout may enhance TIL cell therapy efficacy, with similar quality attributes and phenotypes to those of non-edited TIL.5 Methods This first-in-human phase 1/2, open-label, nonrandomized, multicenter study (NCT05361174; open to enrollment) will enroll ~53 adult patients. During the phase 1 portion, enrollment and dose level decisions will be based on emerging safety and tolerability data in a 28-day dose-limiting toxicity (DLT) observation period. Cohort 1 will include patients with unresectable/metastatic melanoma that has progressed during/within 12 weeks of last anti-PD-1/PD-L1 dose (patients must have also received a BRAF +/- MEK inhibitor if BRAF V600 mutation-positive). Cohort 2 will include patients with advanced NSCLC who have received <=3 prior therapies and whose disease progressed either: (1) during/within 12 weeks after last anti-PD-1/PD-L1 dose (patients without oncogene driver mutations) or (2) during/ after >=1 targeted therapy and either platinum doublet chemotherapy or during/within 12 weeks after last anti-PD-1/PDL1 dose (patients with oncogene-driven tumors). Patients must have ECOG performance status <=1, >=1 resectable lesion(s) (>=1.5 cm), >=1 remaining RECIST-measurable lesion(s) and recovered from prior surgery/anticancer treatment-related adverse events (AEs; grade <=1). IOV-4001 is generated from resected tumor in a centralized GMP process. The regimen includes nonmyeloablative lymphodepletion, IOV-4001 infusion, and a short course of high-dose IL-2. The primary endpoints of phases 1 and 2 are safety (DLTs and AEs) and objective response rate per RECIST v1.1, respectively. Secondary endpoints include complete response rate, duration of response, disease control rate, progressionfree survival, overall survival, feasibility, and additional safety.

Betül, S., et al. (2022). "Effect of Antioxidant Supplementation on Endometriosis Related Pain: A Systematic Review." PROSPERO International prospective register of systematic reviews.
	
Beucler, N., et al. (2021). "Brain metastases in endometrial cancer: A systematic review of the surgical prognostic factors." European Journal of Obstetrics, Gynecology, and Reproductive Biology 258: 240-252.
	Context: Although endometrial cancer is the fourth most common malignancy in women, dissemination to the brain is an exceptional event in the course of the disease. The aim of this review is to determine the important surgical prognostic factors for patients with endometrial cancer metastatic to the brain.; Materials and Methods: Report of two cases. Medline database was used to conduct a systematic literature review from inception to December 2020 looking for English-language articles focused on brain metastases from endometrial cancer.; Results: The research yielded 108 articles, among which 23 articles were retained for a total of 87 patients. Mean age was 60 years-old ±11 at the time of diagnosis of endometrial cancer, and most of the tumors were aggressive (grade 3) with an advanced-stage disease (FIGO III-IV). At the time of diagnosis of cerebral disease, a single brain metastasis (p < 0.0001) and no extra-cerebral metastatic site (p = 0.0011) were significant good prognostic factors for the median overall survival. Surgical excision of brain metastasis followed by radiotherapy provided the longest median overall survival compared to radiotherapy and/or chemotherapy, and surgery alone (respectively 32, 5.4 and 4.8 months, p < 0.0001). An age of 60-year-old or less was not associated with a better prognosis.; Conclusion: This review confirms that surgical excision followed by radiotherapy is a reliable option in patients with a single brain metastasis from endometrial cancer and no extra-cerebral metastatic site. This work could help to adapt the Graded Prognostic Assessment for brain metastases in endometrial cancer.; Competing Interests: Declaration of Competing Interest The authors report no declarations of interest. (Copyright © 2021 Elsevier B.V. All rights reserved.)

Beygi, Z., et al. (2023). "An Overview of Reviews on the Effects of Acceptance and Commitment Therapy (ACT) on Depression and Anxiety." Iranian journal of psychiatry 18(2): 248-257.
	Objective: Emotional disturbances are the most common mental health problems in different populations and societies. We intend to provide the latest evidence related to the effectiveness of Acceptance and Commitment Therapy (ACT) on depression and anxiety by reviewing systematic review and meta-analysis studies published in the last three years. Method : PubMed and Google Scholar databases were systematically searched between January 1, 2019 and November 25, 2022 with relevant keywords for English systematic review and meta-analysis articles reviewing the utilization of ACT to reduce anxiety and depression symptoms. Results: 25 articles were included in our study: 14 systematic review and meta-analysis studies and 11 systematic reviews. These studies have investigated the effects of ACT on depression and anxiety in populations of children or adults, mental health patients, patients with different cancers or multiple sclerosis, people with audiological problems, parents or caregivers of children with mental or physical illnesses as well as normal people. Furthermore, they have examined the effects of ACT in individual, group, Internet, computerized, or combined delivery formats. Most of the reviewed studies reported significant effect sizes (small to large effect sizes) of ACT, regardless of the delivery method, compared to passive (placebo, waitlist) and active (treatment as usual and other psychological interventions except cognitive behavioral therapy (CBT)) controls for depression and anxiety. Conclusion: Recent literature mainly agrees on the small to moderate effect sizes of ACT on depression and anxiety symptoms in different populations.

Bezerra, L. O., et al. (2021). "Impact of Pelvic Floor Muscle Training Isolated and Associated with Game Therapy on Mixed Urinary Incontinence: A Randomized Controlled Trial." Games for health journal 10(1): 43-49.
	Objective: To verify whether pelvic floor muscle training (PFMT) associated with game therapy (GT) can potentiate improvements in PFM pressure, urinary loss, and perception of improvement in women with mixed urinary incontinence (MUI). Materials and Methods: A randomized and blinded trial was conducted with 32 women aged between 45 to 70 years presenting diagnosis of MUI. They were randomly divided into two groups: PFMT group and PFMT+GT group. Interventions occurred twice a week during 8 weeks. Primary outcome was PFM pressure, assessed by manometry, and secondary outcomes were 1-hour pad-test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and patients global impression of improvement for incontinence (PGI-I). Two-way analysis of variance and post hoc Tukey analysis were performed. Results: Initially, no significant difference between groups was found in variables of age, body mass index, educational level, marital status, gynecological and obstetric variables, life habits, and sexual activity. Besides, at baseline clinical variables also showed similar results between groups for PFM pressure, 1-hour pad-test, and ICIQ-SF. Time-group interaction did not present statistically significant differences for PFM pressure (P = 0.56), 1-hour pad-test (P = 0.75), and ICIQ-SF (P = 0.30) in intergroup analysis. All women reported being "much better or better," considering the comparison of urinary complaints in the beginning and end of treatment. Conclusion: There were no statistically significant differences between groups for PFM pressure, 1-hour pad-test, and ICIQ-SF. However, both treatments proved to be effective for MUI symptoms. Perception of improvement was highly improved, according to women's report.

Bezier, E. (2021). "[Impact of biofeedback probes used in the self-rehabilitation of pelvic floor muscles in women with stress urinary incontinence. Literature review]." Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie 31(7): 385-391.
	OBJECTIVE: The purpose of this review was to identify the evaluated effects of the use of biofeedback probes used in the self-rehabilitation of the pelvic floor muscles, on the muscle function, symptom severity, quality of life, and compliance/adherence to exercise for women with stress urinary incontinence. MATERIAL AND METHOD: A literature review was conducted in March 2020 on the PubMed, PEDro and Science Direct databases. RESULTS: A total of 3 randomised controlled trials (n=167 participants) were included and analysed. The different results found show significant improvements in muscle function with a percentage of 87.5% (P=0.003) of patients improved on the modified Oxford scale, as well as perineometry increasing from 23.06 to 32 (P=0.011). Symptom severity is also improved with a decrease in the number of pads and pad weight in the Pad Test (P<0.005). Concerning quality of life, significant improvements in the King's Health Questionnaire (KHQ) and the Visual Analogue Scale of Psychological Stress were found, with an improvement in the number of patients in each group at the end of the study (P<0.0005). No results showed a superiority of pelvic floor muscle training with a biofeedback probe compared to training alone. CONCLUSION: This review didn't provide real recommendations for the use of home biofeedback probes as an adjunct to pelvic floor muscle training in women with stress urinary incontinence. She suggests that the use of biofeedback probes wouldn't be more effective than training without them.

Bhaduri, M., et al. (2022). "Systematic review of pregnancy and renal outcomes for women with chronic kidney disease receiving assisted reproductive therapy." Journal of nephrology 35(9): 2227-2236.
	Background: As awareness around infertility is increasing among patients with chronic kidney disease (CKD), ever more of them are seeking Assisted Reproductive Technology (ART). Our aim was to perform a systematic review to describe obstetric and renal outcomes in women with CKD following ART.; Methods: The following databases were searched from 1946 to May 2021: (1) Cochrane Central Register of Controlled Trials (CENTRAL), (2) Cumulative Index to Nursing and Allied Health Literature (CINAHL), (3) Embase and (4) MEDLINE.; Results: The database search identified 3520 records, of which 32 publications were suitable. A total of 84 fertility treatment cycles were analysed in 68 women. Median age at time of pregnancy was 32.5 years (IQR 30.0, 33.9 years). There were 60 clinical pregnancies resulting in 70 live births (including 16 multifetal births). Four women developed ovarian hyperstimulation syndrome which were associated with acute kidney injury. Hypertensive disorders complicated 26 pregnancies (38.3%), 24 (35.3%) pregnancies were preterm delivery, and low birth weight was present in 42.6% of pregnancies. Rates of live birth and miscarriage were similar for women with CKD requiring ART or having natural conception. However, more women with ART developed pre-eclampsia (p < 0.05) and had multifetal deliveries (p < 0.001), furthermore the babies were lower gestational ages (p < 0.001) and had lower birth weights (p < 0.001).; Conclusion: This systematic review represents the most comprehensive assessment of fertility outcomes in patients with CKD following ART. However, the high reported live birth rate is likely related to reporting bias. Patient selection remains crucial in order to maximise patient safety, screen for adverse events and optimise fertility outcomes. (© 2022. The Author(s).)

Bhat, A., et al. (2022). "Uterine externalization versus in situ repair of hysterotomy during cesarean delivery: a systematic review, equivalence meta-analysis, and trial sequential analysis." International journal of obstetric anesthesia 50: 103271.
	Background: Uterine positioning during hysterotomy repair is controversial, with both in situ and externalized approaches commonly performed. Despite many published trials, clinical equipoise remains. This meta-analysis and trial sequential analysis (TSA) summarizes studies comparing both techniques.; Methods: A systemic search for randomized controlled trials comparing in situ with externalized hysterotomy repair during cesarean delivery was performed. The primary outcomes were estimated blood loss (EBL) and surgical duration. Secondary outcomes were need for blood transfusion, incidence of endometritis, hospital length of stay, intra-operative hypotension, return of bowel function, intra-operative vomiting, intra-operative pain, and need for postoperative analgesia. Cochrane methodology was used to assess risk of bias. Data are presented as mean difference/standardized mean difference or odds ratio/risk difference with 95% confidence intervals (CI).; Results: Nineteen studies enrolling 20 739 patients were included. Estimated blood loss and surgical duration were equivalent between methods, with TSA confirming adequate information size for surgical duration but not EBL. In situ repair was associated with faster return of bowel function (MD -0.76 days; 95% CI -1.36 to -0.15; P=0.01) and a reduction in need for breakthrough postoperative analgesia (OR 0.44; 95% CI 0.28 to 0.68; P <0.01).; Conclusions: This analysis revealed equivalence between methods for EBL and surgical duration. While the small reduction in EBL with externalized repair was not clinically or statistically significant, TSA analysis revealed an unmet information size, suggesting a potentially inconclusive result. In situ repair may be associated with less breakthrough postoperative analgesia requirement and faster return of bowel function. (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Bhatt, A. and O. Glehen (2022). "Hyperthermic Intraperitoneal Chemotherapy in the Treatment Armamentarium of Epithelial Ovarian Cancer: Time to End the Dichotomy." Visceral medicine 38(2): 109-119.
	Background: Advanced epithelial ovarian cancer (EOC) is an incurable disease with over 75% of the patients developing recurrence in the peritoneum. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a promising treatment option for both first-line therapy and treatment of recurrence. In this article, we review the rationale and current evidence for performing HIPEC and the role of HIPEC in the light of targeted systemic therapies.; Summary: There are few randomized trials and several retrospective studies on the role of HIPEC in the management of EOC. A 12-month-overall survival (OS) benefit of the addition of HIPEC to interval cytoreductive surgery (CRS) was demonstrated in 1 randomized trial following which HIPEC has been included as a treatment option for this indication in several national/international guidelines. One retrospective propensity score-matched analysis showed a 16-month OS benefit of adding HIPEC to primary CRS. One randomized trial showed no benefit of the addition of carboplatin HIPEC to secondary CRS over secondary CRS alone. For patients undergoing primary CRS and secondary CRS for recurrence, the results of ongoing randomized trials are needed to define the role of HIPEC in these situations. All clinical trials have shown that the morbidity of HIPEC performed after CRS is acceptable. Along with the emergence of HIPEC as a promising surgical therapy, targeted therapies like bevacizumab and poly adenosine diphosphate-ribose polymerase inhibitors have been developed that have shown a survival benefit in selected patients. In principle, HIPEC and targeted therapies work in different ways and it is plausible to assume that their benefit could be additive, and their combination should be evaluated in clinical trials. The impact of prognostic factors like the disease extent, pathological response to systemic chemotherapy (SC), the histological subtype and molecular profile on the benefit of HIPEC, and targeted therapies has not been evaluated in clinical trials.; Key Messages: HIPEC is an important therapeutic strategy in the treatment of EOC. While its role in patients undergoing interval CRS has been established, the results of ongoing randomized trials are needed to define its benefit at other time points. The morbidity of HIPEC in addition to CRS is acceptable. More research is needed to define subgroups that benefit most from HIPEC based on the extent of disease, response to SC, histology, and molecular profile. The combination of HIPEC and maintenance therapies should be evaluated in well-designed randomized clinical trials that evaluate not just the survival benefit and morbidity but also the cost-effectiveness of each therapy.; Competing Interests: O. Glehen is a consultant for Gamida. A. Bhatt has no disclosures. The authors have no conflicts of interest to declare. (Copyright © 2022 by S. Karger AG, Basel.)

Bhattacharya, P., et al. (2023). "Delorme's vs. Altemeier's in the management of rectal procidentia: systematic review and meta-analysis." Langenbeck's archives of surgery 408(1): 454.
	Background: Rectal prolapse is a distressing condition for patients and no consensus exists on optimal surgical management. We compared outcomes of two common perineal operations (Delorme's and Altemeier's) used in the treatment of rectal prolapse.; Methods: A systematic search of multiple electronic databases was conducted. Peri- and post-operative outcomes following Delorme's and Altemeier's procedures were extracted. Primary outcomes included recurrence rate, anastomotic dehiscence rate and mortality rate. The secondary outcomes were total operative time, volume of blood loss, length of hospital stay and coloanal anastomotic stricture formation. Revman 5.3 was used to perform all statistical analysis.; Results: Ten studies with 605 patients were selected; 286 underwent Altemeier's procedure (standalone), 39 had Altemeier's with plasty (perineoplasty or levatoroplasty), and 280 had Delorme's. Recurrence rate [OR: 0.66; 95% CI [0.44-0.99], P = 0.05] was significantly lower and anastomotic dehiscence [RD: 0.05; 95% CI [0.00-0.09], P = 0.03] was significantly higher in the Altemeier's group. However, sub group analysis of Altemeier's with plasty failed to show significant differences in these outcomes compared with the Delorme's procedure. Length of hospital stay was significantly more following an Altemeier's operation compared with Delorme's [MD: 3.05, 95% CI [0.95 - 5.51], P = 0.004]. No significant difference was found in total operative time, intra-operative blood loss, coloanal anastomotic stricture formation and mortality rates between the two approaches.; Conclusions: A direct comparison of two common perineal procedures used in the treatment of rectal prolapse demonstrated that the Altemeier's approach was associated with better outcomes. Future, well-designed high quality RCTs with long-term follow up are needed to corroborate our findings. (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Bhide, A., et al. (2020). "Interstitial cystitis/bladder pain syndrome and recurrent urinary tract infection and the potential role of the urinary microbiome." Post Reproductive Health 26(2): 87-90.
	Interstitial cystitis/bladder pain syndrome and recurrent urinary tract infections carry significant burden for those affected. As women enter the menopause, other factors may influence how these conditions manifest. The urinary microbiome has shown that the urine contains extensive numbers of bacteria. There is some evidence to suggest that it is altered depending on the menopausal state of the individual. It is possible that this alteration may go on to influence how the disease course of interstitial cystitis/bladder pain syndrome and recurrent urinary tract infections runs in the post-menopausal group. The review will explore these two conditions and the potential role of the urinary microbiome.Copyright © The Author(s) 2020.

Bhide, A. A., et al. (2019). "The use of laser in urogynaecology." International Urogynecology Journal 30(5): 683-692.
	Introduction: The use of lasers in urogynaecology has increased in recent years. Their use has been described in pelvic organ prolapse, urinary incontinence and genito-urinary symptoms of menopause. The aim of this study was to review the published literature on CO2 and erbium:YAG laser use in urogynaecological conditions. Method(s): An extensive search of literature databases (PubMed, EMBASE) was performed for publications (full text and abstracts) written in English up to July 2018. Relevant trials were selected and analysed by an independent reviewer. Twenty-five studies were identified in total. Result(s): All studies were either prospective cohort or case-control studies. The results of individual studies indicate that both CO2 and erbium lasers are effective in treating urogynaecological conditions. Most studies use a vaginal approach with only two investigations of intraurethral application. Conclusion(s): The use of lasers to treat these conditions may seem appealing; however, the lack of good-quality evidence in the form of multi-centre randomised placebo-controlled trials is concerning. The safety and effectiveness of these laser devices have not been established. Use of lasers may lead to serious adverse events such as vaginal burns, scarring, dyspareunia and chronic pain. Randomised placebo-controlled trials in addition to formal evaluation of the laser devices are required before this treatment modality can be recommended.Copyright © 2018, The Author(s).

Bi, B., et al. (2022). "Bazedoxifene plus conjugated estrogens improve menopausal symptoms in postmenopausal women: a systematic review and meta-analysis." Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology 38(10): 813-821.
	Our aim is to evaluate the efficacy of bazedoxifene (BZA) plus conjugated estrogens (CE) on menopausal symptoms in postmenopausal women. A series of databases including PubMed, EMBASE, Medline, Web of science, China national knowledge internet and Wanfang database up to 31 October 2021 were searched, and randomized controlled trials (RCTs) of BZA/CE for menopausal symptoms were included. Seven RCTs involving 5431 patients were included in this study. Compared with placebo group, there were significantly reduce in daily number of hot flushes, daily number of moderate or severe hot flushes, the percentages of parabasal cells and the time to fall sleep when patients treated with BZA/CE. Besides, there were significant improvement in sleep disturbance and total MENQOL. However, no significant improvements in sleep adequacy were observed in the three groups. Furthermore, BZA 20 mg/CE 0.625 mg was more effective than BZA 20 mg/CE 0.45 mg in improving the menopausal symptoms. Therefore, both bazedoxifene 20 mg plus conjugated estrogens 0.45 mg and bazedoxifene 20 mg plus conjugated estrogens 0.625 mg could significantly improve the menopause-related symptoms and MENQOL in postmenopausal women, and the curative effects of BZA 20 mg/CE 0.625 mg were better than that of BZA 20 mg/CE 0.45 mg. These findings need to be further confirmed by more high-quality RCTs.

Bi, X., et al. (2022). "Modeling Pregnancy Outcomes through Sequentially Nested Regression Models." Journal of the American Statistical Association 117(538): 602-616.
	The polycystic ovary syndrome (PCOS) is a most common cause of infertility among women of reproductive age. Unfortunately, the etiology of PCOS is poorly understood. Large scale clinical trials for Pregnancy in Polycystic Ovary Syndrome (PPCOS) were conducted to evaluate the effectiveness of treatments. Ovulation, pregnancy, and live birth are three sequentially nested binary outcomes, typically analyzed separately. However, the separate models may lose power in detecting the treatment effects and influential variables for live birth, due to decreased sample sizes and unbalanced event counts. It has been a long-held hypothesis among the clinicians that some of the important variables for early pregnancy outcomes may continue their influence on live birth. To consider this possibility, we develop an ℓ 0 -norm based regularization method in favor of variables that have been identified from an earlier stage. Our approach explicitly bridges the connections across nested outcomes through computationally easy algorithms and enjoys theoretical guarantee of estimation and variable selection. By analyzing the PPCOS data, we successfully uncover the hidden influence of risk factors on live birth, which confirm clinical experience. Moreover, we provide novel infertility treatment recommendations (e.g., letrozole vs clomiphene citrate) for women with PCOS to improve their chances of live birth.

Bianca, P., et al. (2023). "Dydrogesterone as an alternative treatment in patients with endometriosis: a systematic review."
	
Bianchi, P., et al. (2022). "Utility of the Levonorgestrel-Releasing Intrauterine System in the Treatment of Abnormal Uterine Bleeding and Dysmenorrhea: A Narrative Review." Journal of Clinical Medicine 11(19): 5836.
	Introduction: We undertook a literature review of the use of levonorgestrel-releasing intrauterine devices when utilized for heavy menstrual bleeding and/or dysmenorrhea. Method(s): A narrative review of articles in the Scopus and Medline databases was conducted. Result(s): A number of options exist for the management of both abnormal uterine bleeding (AUB) and dysmenorrhea, and evidence is accumulating that the insertion of a levonorgestrel-releasing intrauterine system (LNG-IUS) represents a useful option for their long-term treatment. The idea of using a progestogen released in utero was initially conceived to achieve long-term contraception, but it was quickly found that these systems could be utilized for a number of therapeutic applications. The first device to be made commercially available, Progestasert, was withdrawn from the market because, in the event of contraceptive failure, it caused a disproportionate percentage of extrauterine pregnancies. On the other hand, the LNG-IUS continues to be successfully utilized in its various variants, releasing 20, 13, or 8 mug/day. These devices have a respective duration of action of 7 (possibly 8), 5, and 3 years, and there exist versions of frameless systems affixed to the myometrium of the uterine fundus. In the present review, following a brief description of the major causes of AUB and dysmenorrhea, the molecular bases for the use of the LNG-IUS are summarized. This is followed by a compendium of its use in AUB and dysmenorrhea, concluding that the insertion of the system improves the quality of life, reduces menstrual blood loss better than other medical therapies, and decreases the extent of dysmenorrhea and pelvic pain. In addition, there is no evidence of a significant difference in these outcomes when the use of the LNG-IUS was compared with improvements offered by endometrial ablation or hysterectomy. Possibly, the most important mechanism of action of the system consists of its ability to induce amenorrhea, which effectively eliminates heavy bleeding and dysmenorrhea. However, no method is ideal for every woman, and, in the case of the LNG-IUS, younger age and severe dysmenorrhea seem to be associated with a higher risk of discontinuation. Conclusion(s): The higher-dose LNG-IUS is a useful tool for HMB and dysmenorrhea in women of all ages. The low cost and ease of use make the LNG-IUS an attractive option, especially when contraception is also desired.Copyright © 2022 by the authors.

Bianchi, T., et al. (2023). "Radical Hysterectomy in Early-Stage Cervical Cancer: Abandoning the One-Fits-All Concept." Journal of Personalized Medicine 13(9).
	Two pillars in modern oncology are treatment personalization and the reduction in treatment-related morbidity. For decades, the one-fits-all concept of radical hysterectomy has been the cornerstone of early-stage cervical cancer surgical treatment. However, no agreement exists about the prevalent method of parametrial invasion, and the literature is conflicting regarding the extent of parametrectomy needed to achieve adequate surgical radicality. Therefore, authors started investigating if less radical surgery was feasible and oncologically safe in these patients. Two historical randomized controlled trials (RCTs) compared classical radical hysterectomy (RH) to modified RH and simple hysterectomy. Less radical surgery showed a drastic reduction in morbidity without jeopardizing oncological outcomes. However, given the high frequency of adjuvant radiotherapy, the real impact of reduced radicality could not be estimated. Subsequently, several retrospective studies investigated the chance of tailoring parametrectomy according to the tumor's characteristics. Parametrial involvement was shown to be negligible in early-stage low-risk cervical cancer. An observational prospective study and a phase II exploratory RCT have recently confirmed the feasibility and safety of simple hysterectomy in this subgroup of patients. The preliminary results of a large prospective RCT comparing simple vs. radical surgery for early-stage low-risk cervical cancer show strong probability of giving a final answer on this topic.

Bibault, J. E., et al. (2021). "Development and validation of a model to predict survival in colorectal cancer using a gradient-boosted machine." Gut 70(5): 884-889.
	OBJECTIVE: The success of treatment planning relies critically on our ability to predict the potential benefit of a therapy. In colorectal cancer (CRC), several nomograms are available to predict different outcomes based on the use of tumour specific features. Our objective is to provide an accurate and explainable prediction of the risk to die within 10 years after CRC diagnosis, by incorporating the tumour features and the patient medical and demographic information. DESIGN: In the prostate, lung, colorectal and ovarian cancer screening (PLCO) Trial, participants (n=154 900) were randomised to screening with flexible sigmoidoscopy, with a repeat screening at 3 or 5 years, or to usual care. We selected patients who were diagnosed with CRC during the follow-up to train a gradient-boosted model to predict the risk to die within 10 years after CRC diagnosis. Using Shapley values, we determined the 20 most relevant features and provided explanation to prediction. RESULTS: During the follow-up, 2359 patients were diagnosed with CRC. Median follow-up was 16.8 years (14.4-18.9) for mortality. In total, 686 patients (29%) died from CRC during the follow-up. The dataset was randomly split into a training (n=1887) and a testing (n=472) dataset. The area under the receiver operating characteristic was 0.84 (±0.04) and accuracy was 0.83 (±0.04) with a 0.5 classification threshold. The model is available online for research use. CONCLUSIONS: We trained and validated a model with prospective data from a large multicentre cohort of patients. The model has high predictive performances at the individual scale. It could be used to discuss treatment strategies.

Bick, D., et al. (2022). "Antenatal preventative pelvic floor muscle exercise intervention led by midwives to reduce postnatal urinary incontinence (APPEAL): protocol for a feasibility and pilot cluster randomised controlled trial." Pilot and Feasibility Studies 8(1): 231.
	Background: Antenatal pelvic floor muscle exercises (PFME) in women without prior urinary incontinence (UI) are effective in reducing postnatal UI; however, UK midwives often do not provide advice and information to women on undertaking PFME, with evidence that among women who do receive advice, many do not perform PFME. Method(s): The primary aim of this feasibility and pilot cluster randomised controlled trial is to provide a potential assessment of the feasibility of undertaking a future definitive trial of a midwifery-led antenatal intervention to support women to perform PFME in pregnancy and reduce UI postnatally. Community midwifery teams in participating NHS sites comprise trial clusters (n = 17). Midwives in teams randomised to the intervention will be trained on how to teach PFME to women and how to support them in undertaking PFME in pregnancy. Women whose community midwifery teams are allocated to control will receive standard antenatal care only. All pregnant women who give birth over a pre-selected sample month who receive antenatal care from participating community midwifery teams (clusters) will be sent a questionnaire at 10-12 weeks postpartum (around 1400-1500 women). Process evaluation data will include interviews with midwives to assess if the intervention could be implemented as planned. Interviews with women in both trial arms will explore their experiences of support from midwives to perform PFME during pregnancy. Data will be stored securely at the Universities of Birmingham and Exeter. Results will be disseminated through publications aimed at maternity service users, clinicians, and academics and inform a potential definitive trial of effectiveness. The West Midlands-Edgbaston Research Ethics Committee approved the study protocol. Discussion(s): Trial outcomes will determine if criteria to progress to a definitive cluster trial are met. These include women's questionnaire return rates, prevalence of UI, and other health outcomes as reported by women at 10-12 weeks postpartum. Progress to a definitive trial however is likely to be prevented in the UK context by new perinatal pelvic health service, although this may be possible elsewhere. Trial registration: https://doi.org/10.1186/ISRCTN10833250. Registered 09/03/2020Copyright © 2022, The Author(s).

Bidhendi Yarandi, R., et al. (2019). "Metformin therapy before conception versus throughout the pregnancy and risk of gestational diabetes mellitus in women with polycystic ovary syndrome: a systemic review, meta-analysis and meta-regression." Diabetology & metabolic syndrome 11: 58.
	The results of studies that assessed the impact of metformin treatments on gestational diabetes mellitus (GDM) in patients with polycystic ovary syndrome (PCOS) are inconclusive. In addition, the impact of time and duration of metformin therapy for an optimum reduction of GDM has not been reported in these studies. This study aimed to summarize current knowledge regarding the effect of metformin-therapy before conception versus throughout pregnancy on the risk of GDM in women with PCOS. PubMed, Scopus, Google Scholar and ScienceDirect databases were searched to identify relevant studies. Both fixed and random effect models were used. Subgroup analyses were performed based on the on the study methodology. The association between the PCOS status and GDM was assessed using the univariate and multiple meta-regression analysis adjusted by the BMI and metformin therapy. Forty-eight of 1397 identified studies were included involving 5711 PCOS patients and 20,296 controls. Regardless of metformin therapy, the prevalence of GDM diagnosed in the second trimester among women with PCOS was significantly higher than healthy controls that was independent of obesity. Including all studies, the increased risk of GDM among women with PCOS, compared to healthy controls, disappeared after the adjustment of metformin-therapy (β = 0.08, 95% CI 0.04, 0.2; p = 0.624). By excluding observational studies as a source of bias, the prevalence of GDM among women with PCOS treated using metformin before conception till the end of pregnancy did not differ from treated just before conception (β = - 0.09, 95% CI - 0.2, 0.02; p = 0.092) or those without metformin therapy (β = - 0.05, 95% CI - 0.07, 0.04; p = 0.301). The results remained unchanged after the subgroup analysis based on the methodology of RCTs and non-RCTs studies. The main body of literature in the current meta-analysis was observational, which may be mixed with some sources of bias. Also, a lack of well-designed and high quality interventional studies means that the findings should be interpreted with cautious. In this respect, decisions regarding the continuation or discontinuation of metformin therapy in women with PCOS are somewhat arbitrary and can be made individually based on the patient's condition given the presence or absence of other GDM risk factors. Additional well-designed RCTs still need for precise recommendation.; Competing Interests: Competing interestsThe authors declare that they have no competing interests.

Biehl, C., et al. (2019). "A systematic review of the efficacy and safety of vaginal estrogen products for the treatment of genitourinary syndrome of menopause." Menopause (New York, N.Y.) 26(4): 431-453.
	Objective: We updated a systematic review to evaluate the totality of evidence available for the efficacy and safety of vaginal estrogen products for the treatment of genitourinary syndrome of menopause (GSM) based on published randomized controlled trials.; Methods: We searched the Cochrane Library, Ovid, PubMed, Medline, Embase, and Clinicaltrials.gov for English-language articles from database inception to June 2018. Our search consolidated 2,086 potential sources to 53 full-text articles that were reviewed and found relevant to our systematic review.; Results: We identified 53 studies that met the inclusion criteria that evaluated the efficacy and safety of vaginal estrogen versus placebo or other hormone and nonhormone controls. Compared with placebo, all vaginal estrogens demonstrated superiority in objective endpoints and subjective endpoints of GSM, whereas some trials demonstrated superiority versus placebo in urogenital symptoms. No significant difference was observed between various dosages and dosage forms of vaginal estrogen products. Vaginal estrogen showed superiority over vaginal lubricants and moisturizers for the improvement of objective clinical endpoints of vulvovaginal atrophy but not for subjective endpoints. Unopposed vaginal estrogens seemed safe, although studies were not powered to detect a long-term estrogenic side effect.; Conclusion: Estrogen products were found to be clinically effective for the treatment of GSM with doses as low as 4 μg. Vaginal estrogen products seem to be safe with few adverse effects, although there is a lack of long-term controlled clinical trial safety data. This review supports the use of commercially available vaginal estrogen therapies as an effective and safe first-line therapy for the treatment of moderate-to-severe GSM.

Bieze, M., et al. (2024). "Spinal Cord Stimulation for Intractable Visceral Pain Originating from the Pelvic and Abdominal Region: A Narrative Review on a Possible New Indication for Patients with Therapy-Resistant Pain." Journal of Pain Research 17: 691-736.
	Aim: Visceral pain, characterized by pain that is diffuse and challenging to localize, occurs frequently and is difficult to treat. In cases where the pain becomes intractable despite optimal medical management, it can affect patients' Quality of Life (QoL). Spinal Cord Stimulation (SCS) has emerged as a potential solution for intractable visceral pain. Purpose(s): In this narrative review, we collected all evidence regarding the efficacy of SCS for visceral pain across various underlying conditions. Method(s): A comprehensive literature search was conducted in PubMed, Embase, and Web of Science in which articles published from October 1st, 1963 up to March 7th, 2023 were identified. Result(s): Seventy articles were included in this review of which most were retrospective cohort studies, case series and case reports. The studies, often with a small number of participants, reported on SCS for chronic pancreatitis, anorectal pain and bowel disorders, gynaecological diagnoses, visceral pelvic pain, urological disorders and finally general visceral pain. They found positive effects on pain and/or symptom relief, opioid consumption, anxiety and depression and QoL. Complications occurred frequently but were often minor and reversible. Conclusion(s): Better screening and selection criteria need to be established to optimally evaluate eligible patients who might benefit from SCS. A positive outcome of a sympathetic nerve block appears to be a potential indicator of SCS effectiveness. Additionally, women receiving SCS for endometriosis had a better outcome compared to other indications. Finally, SCS could also relief functional symptoms such as voiding problems and gastroparesis. Complications could often be resolved with revision surgery. Since SCS is expensive and not always covered by standard health insurance, the incorporation of cost-analyses is recommended. In order to establish a comprehensive treatment plan, including selection criteria for SCS, rigorous prospective, possibly randomized and controlled studies that are diagnosis-oriented, with substantial follow-up and adequate sample sizes, are needed.Copyright © 2024 Bieze et al. This work is published and licensed by Dove Medical Press Limited.

Bijlholt, M., et al. (2021). "The INTER-ACT E-Health Supported Lifestyle Intervention Improves Postpartum Food Intake and Eating Behavior, but Not Physical Activity and Sedentary Behavior-A Randomized Controlled Trial." Nutrients 13(4).
	Unhealthy postpartum lifestyle is related to long‐term adverse psychological, metabolic and cardiovascular health outcomes as well as to complications in the next pregnancy. Especially women with preceding excessive gestational weight gain are at risk. This paper aims to evaluate the effect of the postpartum phase of the INTER‐ACT randomized controlled trial (RCT) on food intake, eating behavior, physical activity and sedentary time at the end of the intervention (six months postpartum) and at six‐months follow‐up (12 months postpartum). The study population comprised women with excessive gestational weight gain in the preceding pregnancy. The lifestyle intervention combined a smartphone application with four face‐to‐face coaching sessions between six weeks and six months postpartum. After the intervention, restrained eating score was 1 point higher (95% CI 0.5, 1.5; p < 0.001), uncontrolled eating score was 1 point lower (95% CI −1.9, −0.2; p = 0.02) and energy intake was 69 kcal lower (95% CI −123, −15; p = 0.01) in the intervention group compared to the control group. The differences were no longer statistically significant at follow‐up. No significant effects on emotional eating, physical activity and sedentary behavior were found. In conclusion, the postpartum phase of the INTER‐ACT RCT was effective in improving nutrition‐related outcomes, however, these improvements could not be sustained at follow‐up. ClinicalTrials.gov identifier: NCT02989142.

Billon, E., et al. (2022). "Association of adrenal metastases with outcomes in patients with metastatic clear cell renal cell carcinoma (mccRCC) treated with nivolumab in the GETUG-AFU-26 NIVOREN phase II trial." Journal of Clinical Oncology 40(6 SUPPL).
	Background: Glandular metastases (GMs) (adrenal, pancreas, thyroid, ovary, breast, or prostate) are rare in mccRCC. Several studies have observed significantly longer overall survival (OS) for GM patients treated with anti-angiogenic therapy. This study assesses outcomes from mccRCC treated with nivolumab with or without GMs. Method(s): The GETUG-AFU 26 NIVOREN, phase II trial assessed the activity and safety of nivolumab in pts with mccRCC who failed antiangiogenic therapies (NCT03013335). Pts were stratified in two subgroups according to the presence of at least one GM. Specific analyzes were performed for pancreatic and adrenal metastases. Primary endpoint was OS, secondary endpoint were progression free survival (PFS) and overall response rate (ORR). Result(s): Between February 2016 and July 2017, among 720 patients treated by nivolumab 217 patients had GM (151: adrenal and 86: pancreatic metastases). Clinical characteristics were comparable between the two subgroups except for IMDC poor subgroup vs 23.4%) for GM and non GM respectively. Median time between metastatic disease and nivolumab was 3.2 years (y) vs 2 y for GM and non GM respectively and 2.8 vs 2.1 y with or without adrenal metastasis. There was no statistical difference in outcomes between pts with or without GMs. However, pts with adrenal metastases had worse OS (12-months survival: 64% vs 71.1%; HR 1.51 (1.19-1.92)); shorter PFS (6-months survival: 27.2% vs 36.6%; HR 1.29 (1.07-1.57)) and lower ORR (12.5% [7.6%; 19.0%] vs 23.2% [19.8%; 27.0%]; p = 0.005) than non-adrenal metastases. Conversely, patients with pancreatic metastases had significantly longer overall survival (12-months survival: 82.3% vs 67.9%; HR 0.59 (0.40-0.85)) in univariate analysis compared to non-pancreatic metastases. In multivariate analysis, only adrenal metastasis remained associated with dismal prognosis (Table). Conclusion(s): Adrenal metastasis is an independent poor prognostic factor for response and survival in the GETUG-AFU 26 NIVOREN phase II trial. Limited activity with nivolumab is observed for patients with adrenal metastases from mccRCC without difference with previous anti angiogenic therapy. Molecular characterization could help to identify the angiogenic profile of adrenal metastases.

Bina, R. (2020). "Predictors of postpartum depression service use: A theory-informed, integrative systematic review." Women and birth : journal of the Australian College of Midwives 33(1): e24-e32.
	Problem: Postpartum depression affects many women globally, yet rates of treatment use are low. A comprehensive view of factors associated with treatment use, from women's and providers' perspectives, based on a theoretical model is lacking.; Background: Several studies examined various factors associated with postpartum depression service use; however, each study focused on a small number of factors.; Aim: This study describes a systematic literature review based on the Behavioral Model of Health Service Use. The purpose of this article is to review and synthesize the available literature regarding factors associated with women's mental health service use for postpartum depression from women's and healthcare providers' perspectives, and provide a comprehensive integrative view of the subject.; Methods: Three electronic databases were searched, and 35 studies published up to 2018 in English language journals met inclusion criteria for review. Factors associated with postpartum depression service use were classified according to the Behavioral Model of Health Service Use's constructs.; Findings: Service use for postpartum depression is a function of a woman's predisposition to use mental health services; individual, familial, and communal factors which enable or pose barriers to use of mental health services; and the woman's perceived or evaluated need for treatment. In addition, societal determinants impact the woman's decision to seek help directly or through impacting the health and mental health care service system's resources and organization.; Conclusion: This review illustrates key factors for researchers and practitioners to consider when treating postpartum women and developing interventions to enhance postpartum depression treatment use. (Copyright © 2019 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)

Bio, B. (2023). Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy, in Subjects With Tumors With Oncogene Amplifications.
	No Results Available Drug: BBI-355 Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-355|Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-355|Maximum observed plasma concentration (Cmax) of BBI-355|Trough observed plasma concentration (Ctrough) of BBI-355|Time to Cmax (Tmax) of BBI-355|Area under the concentration time curve (AUC) of BBI-355|Anti-tumor activity of BBI-355 All Phase 1 47 Industry Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BBI-355-101 January 31, 2026

Bio, I. (2022). ITIL-306 in Advanced Solid Tumors.
	No Results Available Biological: ITIL-306 Frequency and severity of ITIL-306 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest (AESI)|Objective response rate (ORR)|Duration of response (DOR)|Progression-free survival (PFS)|Overall Survival (OS) All Phase 1 51 Industry Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ITIL-306-201 November 2039

BioClin, B. V., et al. (2021). Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis.
	No Results Available Device: vaginal gel Clinical cure rate of BV at 3 weeks after start of treatment (end-of treatment visit; Visit 2).|Microbiological cure rate (based on Nugent score <4) at Visit 2 Female Not Applicable 200 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment MGAP BV 001 December 1, 2024

Biologics, A. G. L. and GlaxoSmithKline (2023). Assessing the Safety, Immune Response, and Early Efficacy of a Candida Vaccine in Women With Recurrent Vulvovaginal Candidiasis: A Randomized Controlled Study.
	No Results Available Biological: Vaccine - Percentage of participants with solicited AEs at the administration site during the 7-day follow-up period (day of administration and 6 following days) after each dose, in the Candi5V arms and the placebo arm.|- Percentage of participants with each solicited systemic AE during the 7-day follow-up period (day of administration and 6 following days) after each dose, in the Candi5V arms and the placebo arm.|- Percentage of participants with unsolicited AEs during the 28-day follow-up period (day of administration and 27 following days) after each dose, in the Candi5V arms and the placebo arm.|- Percentage of participants with SAEs from the first dose to study end in the Candi5V arms and the placebo arm.|- Percentage of participants with medically relevant AEs from the first dose to study end.|- Percentage of participants with AEs leading to withdrawal from the study or to the withholding of further study intervention administration, during their entire study participation, in the Candi5V arms and the placebo arm.|- Percentage of participants with haematological and biochemical laboratory abnormalities at 7-days post-dose compared to pre-dose values (V3 vs V2, V7 vs V6) in the Candi5V arms and the placebo arm.|- Percentage of participants with AESIs (e.g., pIMDs, vulvovaginal candidiasis, extravaginal candidiasis or systemic fungal infection) from the first dose to study end in the Candi5V arms and the placebo arm.|- Evaluation of geometric mean titers (GMTs) for serum IgG against the five Candida antigens included in Candi5V, between baseline and post-vaccination samples collected at V8 (i.e., 28 days after the second vaccination).|- Evaluation of geometric mean titers (GMTs) for serum IgG against the five Candida antigens included in Candi5V, between baseline and post-vaccination samples collected at V5, in the Candi5V arms and the placebo arm.|- Evaluation of geometric mean ratios (GMRs) for serum IgG against the five Candida antigens included in Candi5V, between baseline and post-vaccination (fold increase) on samples collected at V5 and V8, in the Candi5V arms and the placebo arm.|- Percentage of participants in the Candi5V arms and the placebo arm achieving at least a four-fold rise (seroconversion) in the GMT of serum IgG against the Candi5V antigens at V5 and V8, compared to baseline.|- Evaluation of geometric mean titers (GMTs) for serum IgA against the five Candida antigens included in Candi5V, between baseline and post-vaccination samples collected at V8, in the Candi5V arms and the placebo arm.|- Evaluation of GMRs for serum IgA against the five Candida antigens included in Candi5V between baseline and post-vaccination (fold increase) on samples collected at V8, in the Candi5V arms and the placebo arm.|- Percentage of participants in the Candi5V arms and the placebo arm achieving at least a four-fold rise (seroconversion) in the GMT of serum IgA against the Candi5V antigens at V8, compared to baseline.|- Evaluation of GMTs for vaginal swab IgG and IgA against the five Candida antigens included in Candi5V between baseline and post-vaccination on samples collected at V8, in the Candi5V arms and the placebo arm.|- Evaluation of GMRs for vaginal swab IgG and IgA against the five Candida antigens included in Candi5V between baseline and post-vaccination on samples collected at V8, in the Candi5V arms and the placebo arm.|- Percentage of participants in the Candi5V arms and the placebo arm achieving at least a four-fold rise (seroconversion) in the GMT of vaginal swab IgG and IgA against the Candida antigens included in Candi5V at V8 compared to baseline.|- Incidence rates of VVC cases during the 12 months post 2nd vaccination, in the Candi5V arms and the placebo arm. For the purpose of the case definition, only the first confirmed VVC infection will be considered.|- Incidence rates of VVC cases from 28 days after 1st vaccination until end of the study, in the Candi5V arms and the placebo arm. For the purpose of the case definition, only the first confirmed VVC infection will be consid Female Phase 1|Phase 2 251 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention Candi5V01|2023-507527-28-00 December 31, 2025

BioNTech, S. E. (2022). Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors.
	No Results Available Biological: BNT141|Drug: Nab-paclitaxel|Drug: Gemcitabine Occurrence of treatment-emergent adverse events (TEAEs) within a patient including Grade ≥ 3, serious, fatal TEAE by relationship|Occurrence of dose reductions and discontinuation of BNT141 due to TEAEs throughout the study and up to 60 days after last subject last treatment|Occurrence of dose-limiting toxicities (DLTs) within a patient during the DLT evaluation period|BNT141 pharmacokinetic: Area under the concentration time curve (AUC)|BNT141 pharmacokinetic: Clearance (CL)|BNT141 pharmacokinetic: Volume of distribution (VD)|BNT141 pharmacokinetic: Maximum concentration of the drug (Cmax)|BNT141 pharmacokinetic: Time to maximum concentration (Tmax)|BNT141 pharmacokinetic: Concentration prior to next dose (Ctrough)|BNT141 pharmacokinetic: Elimination half-life (t half)|BNT141 - Objective response rate (ORR)|BNT141 - Disease control rate (DCR)|BNT141 - Duration of response (DOR) All Phase 1|Phase 2 13 Industry Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BNT141-01|2022-001843-25 July 24, 2023

Biosciences, S. (2022). A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens.
	No Results Available Drug: Tildacerfont|Drug: Placebo DHEAS level|Reduction in DHEAS|Normalization of DHEAS|Number of subjects with TEAE as assessed by CTCAE Version 5 Female Phase 2 27 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment SPR001-210 August 31, 2023

Birmingham University, o. (2021). Impact of 11-oxygenated Androgens on Metabolic Dysfunction of Women With Polycystic Ovary Syndrome.
	No Results Available Drug: oral androgen challenge with dehydroepiandrosterone (DHEA) The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline height|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline weight|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline body mass index (BMI)|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline waist circumference|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline blood pressure|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline urea & electrolytes|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline liver function test|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline haemoglobin|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline white cell and platelet count|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline lipid profile|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline glucose|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline glycated haemoglobin|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline thyroid function test|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline Dehydroepiandrosterone (DHEAS)|overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline androstenedione|overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline testosterone|overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline sex hormone binding globulin|overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline 17-hydroxyprogesterone|overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline prolactin|overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline Follicle-stimulating hormone|overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline luteinizing hormone|overall steroid profile and its impact on lipid and glucose metabolism-establishing baseline oestradiol|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism-understanding steroidal activity in peripheral blood mononuclear cells.|The impact of classic and 11-oxygenated androgen precursors on systemic circulation of overall steroid profile and its impact on lipid and glucose metabolism- to study th Female Not Applicable 100 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Other RG_19-038 May 30, 2025

Birmingham University of Alabama, a. (2022). Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery.
	No Results Available Drug: Estradiol 0.01% Vag Cream|Drug: Placebo vaginal cream sexual dysfunction symptom severity|Urinary incontinence|Anal incontinence Female Phase 4 50 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment 300008970 July 1, 2026

Birowo, P., et al. (2020). "Efficacy and safety of extracorporeal shockwave therapy for the treatment of chronic non-bacterial prostatitis: A systematic review and meta-analysis." PloS One 15(12): e0244295.
	Purpose: Chronic pelvic pain syndrome (CPPS) is one of the most common outpatient urological diagnoses, and its incidence is increasing. Extracorporeal shockwave therapy (ESWT) has been suggested for relieving local perineal symptoms associated with chronic prostatitis/CPPS. Despite several treatment methods, no causal or standardized treatment is available for CPPS. This study aimed to investigate the efficacy and safety profile of ESWT for the treatment of chronic non-bacterial prostatitis.; Materials and Methods: Studies were collected using four search engines (Pubmed, Cochrane, ScienceDirect, and EBSCOHost), on May 16, 2020; and assessed based on predetermined inclusion and exclusion criteria. Two reviewers performed study selection. Studies were then analyzed using Review Manager 5.3 for the meta-analysis.; Results: Seventy-four publications were initially retrieved, and three studies were considered for both qualitative and quantitative analyses. From these studies, we found that the use of ESWT was significantly associated with decreased pain domain (mean difference: -3.93; 95% confidence interval [CI] -5.13, -2.73; p<0.001), improved urinary score (mean difference: -1.79; 95% CI -2.38, -1.21; p<0.001), improved quality of life (mean difference: -1.71; 95% CI -2.12, -1.31; p<0.001), and improved National Institutes of Health chronic prostatitis symptom index (NIH-CPSI) score (mean difference: -5.45; 95% CI -5.74, -5.16; p<0.001) after 12 weeks of treatment.; Conclusion: ESWT is efficacious and safe in reducing pain and improving urinary condition, NIH-CPSI score, and quality of life in patients with chronic non-bacterial prostatitis.; Competing Interests: No authors have competing interests.

Bisch, S., et al. (2021). "Efficacy of pre-operative pharmacologic thromboprophylaxis on incidence of venous thromboembolism following major gynecologic and gynecologic oncology surgery: A systematic review and meta-analysis." International Journal of Gynecological Cancer 31(2): 257-264.
	Introduction Venous thromboembolism remains a significant complication following major gynecologic surgery. Evidence is lacking on whether it is beneficial to give pharmacologic thromboprophylaxis pre-operatively. The aim of this meta-analysis was to assess the role of pre-operative pharmacologic thromboprophylaxis in preventing post-operative venous thromboembolism. Methods PubMed, EMBASE, and the Cochrane Central Register of Clinical Trials were searched to find randomized controlled, cohort, and case-control trials comparing pre-operative pharmacologic thromboprophylaxis to no prophylaxis, mechanical prophylaxis, or only post-operative pharmacologic thromboprophylaxis for open and minimally invasive major gynecologic surgery (benign and malignant conditions). Two authors independently assessed abstracts, full-text articles, and methodological quality. Data were extracted and pooled using ORs for random effects meta-analysis. Heterogeneity was explored using forest plots, Q-statistic, and I 2 statistics. Planned subgroup analysis of use of sequential compression devices, equivalent versus non-equivalent post-operative prophylaxis, cancer diagnosis, and methodological quality were performed. Results Some 503 unique studies were found, and 16 studies (28 806 patients) were included in the systematic review. Twelve studies (14 273 patients) were included in the meta-analysis. The OR for incidence of post-operative venous thromboembolism was 0.59 (95% CI 0.39, 0.89), favoring pre-operative pharmacologic thromboembolism prophylaxis compared with no pre-operative pharmacologic prophylaxis (Q=13.80, I 2 =20.30). In studies where post-operative care was equivalent between groups, the OR for venous thromboembolism was 0.56 (95% CI 0.22, 1.40). Pre-operative pharmacologic prophylaxis demonstrated greatest benefit when utilized with both intra-operative and post-operative sequential compression devices (OR 0.43, 95% CI 0.30, 0.64) compared with when no sequential compression devices were utilized (OR 1.27, 95% CI 0.63, 2.56). When looking at only studies determined to be of high quality, the results no longer reached significance (OR 0.73, 95% CI 0.36, 1.46). Conclusions Pre-operative pharmacologic thromboprophylaxis decreases the odds of venous thromboembolism in the peri-operative period for major gynecologic oncology surgery by approximately 40%. It remains unclear whether this benefit is present in benign and minor procedures. Adequately powered studies are needed.Copyright © 2021 BMJ Publishing Group. All rights reserved.

Bisch, S. P., et al. (2021). "Outcomes of enhanced recovery after surgery (ERAS) in gynecologic oncology - A systematic review and meta-analysis." Gynecologic Oncology 161(1): 46-55.
	Objective: To assess the benefit of Enhanced Recovery After Surgery (ERAS) on length of stay (LOS), postoperative complications, 30-day readmission, and cost in gynecologic oncology.; Methods: A systematic literature search was performed in MEDLINE, EMBASE, Cochrane Register of Controlled Trials, and Web of Science for all peer-reviewed cohort studies and controlled trials on ERAS involving gynecologic oncology patients. Abstracts, commentaries, non-controlled studies, and studies without specific data on gynecologic oncology patients were excluded. Meta-analysis was performed on the primary endpoint of LOS. Subgroup analyses were performed based on risk of bias of the studies included, number of ERAS elements, and ERAS compliance. Secondary endpoints were readmission rate, complications, and cost.; Results: A total of 31 studies (6703 patients) were included: 5 randomized controlled trials, and 26 cohort studies. Meta-analysis of 27 studies (6345 patients) demonstrated a decrease in LOS of 1.6 days (95% confidence interval, CI 1.2-2.1) with ERAS implementation. Meta-analysis of 21 studies (4974 patients) demonstrated a 32% reduction in complications (OR 0.68, 95% CI 0.55-0.83) and a 20% reduction in readmission (OR 0.80, 95% CI 0.64-0.99) for ERAS patients. There was no difference in 30-day postoperative mortality (OR 0.61, 95% CI 0.23-1.6) for ERAS patients compared to controls. No difference in the odds of complications or reduction in LOS was observed based on number of included ERAS elements or reported compliance with ERAS interventions. The mean cost savings for ERAS patients was $2129 USD (95% CI $712 - $3544).; Conclusions: ERAS protocols decrease LOS, complications, and cost without increasing rates of readmission or mortality in gynecologic oncology surgery. This evidence supports implementation of ERAS as standard of care in gynecologic oncology.; Competing Interests: Declaration of Competing Interest Dr. Nelson reports advisory fees from Abbott, outside the submitted work; and Secretary of the ERAS® Society. Dr. Meyer reports research support from AstraZeneca and consulting for GlaxoSmithKline outside the submitted work. The remaining authors declare no conflict of interest. (Copyright © 2020 Elsevier Inc. All rights reserved.)

Bisht, N., et al. (2021). "A Comparative Study of Two Protocols of Concurrent Chemotherapy with External Beam Radiotherapy in Treatment of Locally Advanced Cervical Cancer: Cisplatin Versus Cisplatin Plus Capecitabine Combination." Indian Journal of Gynecologic Oncology 19(1): 18.
	Introduction: Cervical carcinoma is one of the commonest cancers affecting women in the low- and middle-income countries. The standard treatment of locally advanced cases by external beam radiotherapy (EBRT) along with single-agent cisplatin-based concurrent chemotherapy is effective, but rates of treatment failure and recurrence remain high. There exists a need to augment the treatment protocol. One modality to do that is by addition of another radiosensitizer/chemotherapeutic agent. Method(s): In total, 40 women with histologically proven locally advanced cervical cancer were included in the study. The first 20 (Arm 1) were treated with EBRT along with concurrent cisplatin at 40 mg/m2 (maximum 70 mg). The next 20 patients (Arm 2) received the same treatment but also received oral capecitabine 460 mg/m2 during EBRT. Treatment-related toxicity and disease response rates at 6 months were compared in the two arms. Overall survival at 5 years of patients in the two arms was also compared. Result(s): During treatment, 40% of patients in Arm 1 developed anemia compared to 45% in Arm 2. In total, 5% patients in Arm 1 and 10% in Arm 2 developed grade 2 leucopenia. A higher incidence of proctitis and diarrhea was seen in Arm 2 (30%) than in Arm 1 (15%). The grade of proctitis and diarrhea was also higher in Arm 2 than in Arm 1. None of the patients developed hand-foot syndrome. All the complications were managed symptomatically and did not cause significant treatment break in either treatment arms except in one patient in Arm 2. At 6-month follow-up, four patients (20%) in both arms had residual or progressive disease. At the end of 5 years, the mean overall survival in the two Arms 1 and 2 was 47.9 and 48.4 months, respectively. Conclusion(s): The addition of capecitabine to standard concurrent chemoradiotherapy with cisplatin for locally advanced cervical cancer is well tolerated even on an OPD basis though there is increased incidence of acute proctitis and diarrhea with this combination. No difference in treatment efficacy or improvement in survival between the two protocols was seen in our study though this may have been influenced by the small sample size and short period of follow-up of our study. We recommend a phase II/III study to further evaluate the efficacy and tolerability of this regimen.Copyright © 2021, Association of Gynecologic Oncologists of India.

Bisson Jonathan, I., et al. (2019). "The international society for traumatic stress studies new guidelines for the prevention and treatment of posttraumatic stress disorder: Methodology and development process." Journal of Traumatic Stress 32(4): 475-483.
	Over the last two decades, treatment guidelines have become major aids in the delivery of evidence‐based care and improvement of clinical outcomes. The International Society for Traumatic Stress Studies (ISTSS) produced the first guidelines for the prevention and treatment of posttraumatic stress disorder (PTSD) in 2000 and published its latest recommendations, along with position papers on complex PTSD (CPTSD), in November 2018. A rigorous methodology was developed and followed; scoping questions were posed, systematic reviews were undertaken, and 361 randomized controlled trials were included according to the a priori agreed inclusion criteria. In total, 208 meta‐analyses were conducted and used to generate 125 recommendations (101 for adults and 24 for children and adolescents) for specific prevention and treatment interventions, using an agreed definition of clinical importance and recommendation setting algorithm. There were eight strong, eight standard, five low effect, 26 emerging evidence, and 78 insufficient evidence to recommend recommendations. The inclusion of separate scoping questions on treatments for complex presentations of PTSD was considered but decided against due to definitional issues and the virtual absence of studies specifically designed to clearly answer possible scoping questions in this area. Narrative reviews were undertaken and position papers prepared (one for adults and one for children and adolescents) to consider the current issues around CPTSD and make recommendations to facilitate further research. This paper describes the methodology and results of the ISTSS Guideline process and considers the interpretation and implementation of the recommendations. (PsycINFO Database Record (c) 2019 APA, all rights reserved)

Bissonnette, F., et al. (2021). "Individualized ovarian stimulation for in vitro fertilization: a multicenter, open label, exploratory study with a mixed protocol of follitropin delta and highly purified human menopausal gonadotropin." Fertility and Sterility 115(4): 991-1000.
	Objective: To evaluate the safety profile and the number of usable blastocysts on day 5 and on day 6 after treatment with an individualized dosing regimen of a follitropin delta and highly purified human menopausal gonadotropin (HP-hMG) for controlled ovarian stimulation.; Design: Multicenter, open label, exploratory study.; Setting: Reproductive medicine clinics.; Patient(s): A total of 110 patients (aged 18-40 years).; Intervention(s): Follitropin delta coadministered with HP-hMG, with follitropin delta dose fixed according to an established algorithm and HP-hMG dose at 75 IU when the follitropin delta starting dosage was <12 μg; 150 IU when follitropin delta dosage was 12 μg and weight <100 kg, and 225 IU when follitropin delta dosage was 12 μg and weight ≥100 kg (dosage adjustments confined to HP-hMG only).; Main Outcome Measure(s): Mean number of good-quality blastocysts obtained at day 5 and day 6 as well as the proportion of women with ovarian hyperstimulation syndrome (OHSS).; Result(s): A cohort study was compared with the follitropin delta group from the Evidence-based Stimulation Trial with Human Recombinant Follicle-Stimulating Hormone in Europe and Rest of World 1 (ESTHER-1) study. Even when stratified by age, a statistically significantly higher mean in the number of oocytes retrieved and number of good-quality blastocysts was observed in this study compared with the ESTHER-1 trial in which follitropin delta was used alone. The rate of patients triggered with a gonadotropin-releasing hormone agonist was statistically significantly higher in our Menopur and Rekovelle Combined Study (MARCS) cohort (43%) when compared with the rates reported in the follitropin delta cohort in the ESTHER-1 study (2.3%). Incidence of any grade of OHSS was 9.3% in the present study compared to 2.6% in follitropin delta group from ESTHER-1 trial. No cases of moderate or severe OHSS were observed in our study compared with 1.4% in the follitropin delta group of ESTHER-1.; Conclusion(s): Optimizing the ovarian response during in vitro fertilization employing a mixed protocol of individualized dosing of follitropin delta and HP-hMG resulted in a statistically significant number of usable blastocysts on days 5 and 6 with an increased risk of mild OHSS, which did not require medical intervention or hospitalization.; Clinical Trial Registration Number: NCT03483545. (Copyright © 2020. Published by Elsevier Inc.)

Bittelbrunn Cleima, C., et al. (2023). "Pelvic floor physical therapy and mindfulness: approaches for chronic pelvic pain in women-a systematic review and meta-analysis." Archives of Gynecology and Obstetrics 307(3): 663-672.
	Purpose: Chronic pelvic pain (CPP) in women is a complex syndrome and symptoms are associated with sexual dysfunction, musculoskeletal and myofascial disorders, and comorbid psychiatric disorders. Its widespread prevalence results in substantial expense due to therapy and lost productivity, and it is perhaps one of the most urgent and neglected medical needs. This systematic review and meta-analysis aimed to estimate the role of mindfulness and pelvic floor physical therapy (PFPT) in the treatment or management of women with CPP.; Methods: This systematic review (CRD42020204987) searched for relevant publications between January 2000 and November 2020 on MEDLINE/PubMed, Web of Science, One File GALE, and Technology Research databases using the following search terms: chronic pelvic pain, pelvic floor physical therapy/physiotherapy, mindfulness, and their variants. Risk of bias and quality of evidence were evaluated.; Results: Seven clinical trials (n = 279) were included in the review, and five in the meta-analysis (n = 225). For the pain outcome and its catastrophizing, there was a statistical difference for the Pain Catastrophizing Scale after treatment and during follow-up with mindfulness and PFPT (MD = - 3.82 [- 6.97, - 0.68], p = 0.01, and MD = - 4.49 [- 7.61, - 1.37], p = 0.00, respectively). Sexual function, assessed by the female sexual function index, differed significantly during follow-up between PFPT and mindfulness (MD = - 0.72 [- 1.38, - 0.05], p = 0.03).; Conclusion: The small number of studies applying both PFPT and mindfulness to CPP suggests that a multidisciplinary approach is required to treat women with CPP, and further studies involving these therapeutic techniques throughout the CPP cycle are needed. (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Bitton Rachel, R., et al. (2023). "What predicts durable symptom relief of uterine fibroids treated with MRI-guided focused ultrasound? A multicenter trial in 8 academic centers." European radiology 33(11): 7360-7370.
	Objective: To identify variables predictive of durable clinical success after MRI-guided focused ultrasound (MRgFUS) treatment of uterine fibroids.; Materials and Methods: In this prospective, multicenter trial, 99 women with symptomatic uterine fibroids were treated using MRgFUS. Pelvic MRI was obtained at baseline and treatment day. The Uterine Fibroid Symptom-Quality of Life questionnaire was used to calculate a symptom severity score (SSS) at baseline and 6, 12, 24, and 36 months following treatment. Clinical, imaging, and treatment variables were correlated with symptom reduction sustained through the 12- and 24-month time points using univariable and multivariable logistic regression analyses. A novel parameter, the ratio of non-perfused volume to total fibroid load (NPV/TFL), was developed to determine association with durable outcomes.; Results: Post-treatment, mean symptom severity decreased at the 6-, 12-, 24-, and 36-month follow-ups (p < 0.001, all time points). In univariable analysis, three variables predicted treatment success (defined by ≥ 30-point improvement in SSS) sustained at both the 12-month and 24-month time points: increasing ratio of NPV/TFL (p = 0.002), decreasing total fibroid load (p = 0.04), and the absence of T2-weighted Funaki type 2 fibroids (p = 0.02). In multivariable analysis, the NPV/TFL was the sole predictor of durable clinical success (p = 0.01). Patients with ratios below 30% had less improvement in SSS and lacked durable clinical response compared with those between 30-79 (p = 0.03) and ≥ 80% (p = 0.01).; Conclusion: Increased non-perfused volume relative to total fibroid volume was significantly associated with durable reduction of symptoms of abnormal uterine bleeding and bulk bother.; Clinical Relevance Statement: Patient selection for sustained clinical benefit should emphasize those with likelihood of achieving high ablation ratios, as determined by imaging (e.g., device access, Funaki type) and by considering the total fibroid load, not just the primary symptomatic fibroid.; Trial Registration: Clinical trial ID: NCT01285960.; Key Points: • Patient selection/treatment approach associated with durable symptom relief in MRI-guided focused ultrasound ablation of uterine fibroids remains unclear. • The ablation ratio, non-perfused volume/total fibroid volume, was positively associated with sustained symptom relief in both bleeding and bulk bother at 1- and 2-year follow-ups. • Selecting patients with imaging features that favor a high ratio of ablation to total fibroid load (including non-targeted fibroids) is the main factor in predicting durability of symptom relief after uterine fibroid treatment. (© 2023. The Author(s), under exclusive licence to European Society of Radiology.)

Bizzarri, N., et al. (2024). "External beam radiotherapy boost versus surgical debulking followed by radiotherapy for the treatment of metastatic lymph nodes in cervical cancer: A systematic review and meta-analysis." European Journal of Surgical Oncology 50(4): 108013.
	Objective: We aimed to assess disease-free survival (DFS), overall survival (OS) and treatment-related toxicity of two therapeutic strategies for treating bulky lymph nodes on imaging in patients with locally advanced cervical cancer (LACC): radiotherapy boost versus surgical debulking followed by radiotherapy. Method(s): We performed a systematic review of studies published up to October 2023. We selected studies including patients with LACC treated by external beam radiotherapy (EBRT) boost or lymph node debulking followed by EBRT (with or without boost). Result(s): We included two comparative (included in the meta-analysis) and nine non-comparative studies. The estimated 3-year recurrence rate was 28.2% (95%CI:18.3-38.0) in the EBRT group and 39.9% (95%CI:22.1-57.6) in the surgical debulking plus EBRT group. The estimated 3-year DFS was 71.8% and 60.1%, respectively (p = 0.19). The estimated 3-year death rate was 22.2% (95%CI:11.2-33.2) in the EBRT boost group and 31.9% (95%CI:23.3-40.5) in the surgical debulking plus EBRT group. The estimated 3-year OS was 77.8% and 68.1%, respectively (p = 0.04). No difference in lymph node recurrence between the two comparative studies (p = 0.36). The meta-analysis of the two comparative studies showed no DFS difference (p = 0.13) but better OS in the radiotherapy boost group (p = 0.006). The incidence of grade>=3 toxicities (ranging 0-50%) was not different between the two approaches in the two comparative studies (p = 0.31). Conclusion(s): No DFS and toxicity difference when comparing EBRT boost with surgical debulking of enlarged lymph nodes and EBRT in patients with cervical cancer was evident. Radiotherapy boost had better OS. Further investigation is required to better understand the prognostic role of surgical lymph node debulking in light of radiotherapy developments.Copyright © 2024 The Authors

Bizzarri, N., et al. (2023). "Radiomics systematic review in cervical cancer: gynecological oncologists' perspective." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 33(10): 1522-1541.
	Objective: Radiomics is the process of extracting quantitative features from radiological images, and represents a relatively new field in gynecological cancers. Cervical cancer has been the most studied gynecological tumor for what concerns radiomics analysis. The aim of this study was to report on the clinical applications of radiomics combined and/or compared with clinical-pathological variables in patients with cervical cancer.; Methods: A systematic review of the literature from inception to February 2023 was performed, including studies on cervical cancer analysing a predictive/prognostic radiomics model, which was combined and/or compared with a radiological or a clinical-pathological model.; Results: A total of 57 of 334 (17.1%) screened studies met inclusion criteria. The majority of studies used magnetic resonance imaging (MRI), but positron emission tomography (PET)/computed tomography (CT) scan, CT scan, and ultrasound scan also underwent radiomics analysis. In apparent early-stage disease, the majority of studies (16/27, 59.3%) analysed the role of radiomics signature in predicting lymph node metastasis; six (22.2%) investigated the prediction of radiomics to detect lymphovascular space involvement, one (3.7%) investigated depth of stromal infiltration, and one investigated (3.7%) parametrial infiltration. Survival prediction was evaluated both in early-stage and locally advanced settings. No study focused on the application of radiomics in metastatic or recurrent disease.; Conclusion: Radiomics signatures were predictive of pathological and oncological outcomes, particularly if combined with clinical variables. These may be integrated in a model using different clinical-pathological and translational characteristics, with the aim to tailor and personalize the treatment of each patient with cervical cancer.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Bjarkadottir, B. D., et al. (2021). "Analysing culture methods of frozen human ovarian tissue to improve follicle survival." Reproduction & fertility 2(1): 59-68.
	In vitro follicle growth is a potential fertility preservation method for patients for whom current methods are contraindicated. Currently, this method has only been successful using fresh ovarian tissue. Since many patients who may benefit from this treatment currently have cryopreserved ovarian tissue in storage, optimising in vitro follicle growth (IVG) for cryopreserved-thawed tissue is critical. This study sought to improve the first step of IVG by comparing different short-term culture systems for cryopreserved-thawed human ovarian tissue, in order to yield a higher number of healthy multilayer follicles. We compared two commonly used culture media (αMEM and McCoy's 5A), and three plate conditions (300 µL, 1 mL on a polycarbonate membrane and 1 mL in a gas-permeable plate) on the health and development of follicles after 6 days of culture. A total of 5797 follicles from three post-pubertal patients (aged 21.3 ± 2.3 years) were analysed across six different culture conditions and non-cultured control. All culture systems supported follicle development and there was no difference in developmental progression between the different conditions tested. Differences in follicle morphology were evident with follicles cultured in low volume conditions having significantly greater odds of being graded as morphologically normal compared to other conditions. Furthermore, culture in a low volume of αMEM resulted in the highest proportion of morphologically normal primary and multilayer follicles (23.8% compared to 6.3-19.9% depending on condition). We, therefore, recommend culturing cryopreserved human ovarian tissue in a low volume of αMEM to support follicle health and development. LAY SUMMARY: Ovaries contain a large number of follicles, each containing an immature egg and other important cells. Cancer treatments can lead to long-lasting negative side effects to the ovaries including the destruction of follicles, resulting in infertility. One strategy to preserve fertility is freezing of ovaries or ovarian tissue in girls and women undergoing cancer treatment. The long-term aim is to thaw and grow their ovarian tissue in the laboratory to obtain mature eggs, which can then be fertilised. In this study, we compared six different methods of growing previously frozen human ovarian tissue in order to best support follicle growth and health. We found that using the lowest amount of αMEM medium (a specific type of nutrient-rich growth solution) resulted in the highest proportion of healthy follicles. Improving the methods used to grow ovarian tissue, particularly frozen tissue, is important for future fertility preservation.

Bjersand, K., et al. (2022). "Ex vivo assessment of cancer drug sensitivity in epithelial ovarian cancer and its association with histopathological type, treatment history and clinical outcome." International journal of oncology 61(4).
	Epithelial ovarian cancer (EOC) is divided into type I and type II based on histopathological features. Type I is clinically more indolent, but also less sensitive to chemotherapy, compared with type II. The basis for this difference is not fully clarified. The present study investigated the pattern of drug activity in type I and type II EOC for standard cytotoxic drugs and recently introduced tyrosine kinase inhibitors (TKIs), and assessed the association with treatment history and clinical outcome. Isolated EOC tumor cells obtained at surgery were investigated for their sensitivity to seven standard cytotoxic drugs and nine TKIs using a short‑term fluorescent microculture cytotoxicity assay (FMCA). Drug activity was compared with respect to EOC subtype, preoperative chemotherapy, cross‑resistance and association with progression‑free survival (PFS). Out of 128 EOC samples, 120 samples, including 21 type I and 99 type II, were successfully analyzed using FMCA. Patients with EOC type I had a significantly longer PFS time than patients with EOC type II (P=0.01). In line with clinical experience, EOC type I samples were generally more resistant than type II samples to both standard cytotoxic drugs and the TKIs, reaching statistical significance for cisplatin (P=0.03) and dasatinib (P=0.002). A similar pattern was noted in samples from patients treated with chemotherapy prior to surgery compared with treatment‑naive samples, reaching statistical significance for fluorouracil, irinotecan, dasatinib and nintedanib (all P<0.05). PFS time gradually shortened with increasing degree of drug resistance. Cross‑resistance between drugs was in most cases statistically significant yet moderate in degree (r<0.5). The clinically observed relative drug resistance of EOC type I, as well as in patients previously treated, is at least partly due to mechanisms in the tumor cells. These mechanisms seemingly also encompass kinase inhibitors. Ex vivo assessment of drug activity is suggested to have a role in the optimization of drug therapy in EOC.

Bjorkstrom, L. M., et al. (2021). "The Impact of Preoperative Assessment and Planning on the Outcome of Benign Hysterectomy - A Systematic Review." Geburtshilfe und Frauenheilkunde 81(2): 200-213.
	Knowledge concerning the impact of preoperative planning, patient information and patient factors on the outcome of benign hysterectomy is incomplete. This systematic review summarizes the current knowledge on the effect of preoperative planning and of preoperative patient factors on the outcome of benign hysterectomy. The PubMed/PubMed Central/MEDLINE, Scopus, Web of Science, TRIP Medical Database, Prospero and the Cochrane Library databases were searched. Inclusion criteria were prospective trials, hysterectomy for benign disease, systematic preoperative assessment, and article in English. Eighteen articles were included and categorized according to their main aims: use of a preoperative checklist, preoperative decision-making, preoperative information, and the effect on the outcome of surgery of factors that concerns patients preoperatively. Focused and well directed preoperative assessment and thoroughness in the preoperative decision-making was associated with positive postoperative outcomes. The use of a checklist reduced the overall rate of hysterectomy and increased the use of minimally invasive surgery. Women were often inadequately informed before hysterectomy about the possible side effects after surgery. Preoperative anxiety and preoperative pain were associated with postoperative pain and lower quality of life. The indication for surgery had an impact on the reported quality of life postoperatively. The extent of preoperative planning seemed to affect the outcome of surgery. Preoperative patient factors influenced the postoperative recovery. Prehabilitation measures need further development and should be integrated in the preoperative planning. Prospective studies are warranted to evaluate and improve the preoperative planning in a systematic setting before performing hysterectomy for benign disease.Copyright © 2021 Georg Thieme Verlag. All rights reserved.

Black Kristin, A., et al. (2024). "Incidence of venous thromboembolism in patients with ovarian cancer receiving neoadjuvant chemotherapy: systematic review and meta-analysis." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society.
	Objective: Venous thromboembolism is associated with significant patient morbidity, mortality, and can lead to delays in treatment for patients with cancer. The objectives of this study were to identify the incidence of venous thromboembolism in patients with advanced ovarian cancer receiving neoadjuvant chemotherapy, and identify risk factors for venous thromboembolism.; Methods: A systematic literature search of biomedical databases, including Ovid Medline, Web of Science, Scopus, CINAHL, and Embase was performed on December 6, 2022 and updated on December 21, 2023 for peer reviewed articles. Studies were included if they were cohort studies or randomized controlled trials that evaluated the incidence of venous thromboembolism for patients with ovarian cancer receiving neoadjuvant chemotherapy. Risk of bias assessment was performed using the Newcastle Ottawa Scale for cohort studies and the Cochrane risk of bias tool for randomized controlled trials. Random effects meta-analysis was used to pool results across studies.; Results: A total of 2636 studies were screened, and 11 were included in the review. Ten were retrospective cohort studies, and one was a randomized controlled trial. The incidence of venous thromboembolism in the included studies ranged from 0% to 18.9%. The pooled incidence rate of venous thromboembolism was 10% (95% confidence interval (CI) 7% to 13%). This remained significant when restricted to only studies with a low risk of bias (pooled incidence of 11%, 95% CI 9% to 14%). Body mass index of ≥30 kg/m 2 was a significant risk factor for venous thromboembolism with a pooled odds ratio of 1.76 (95% CI 1.13 to 2.76) CONCLUSIONS: The results from this study demonstrated a 10% incidence of venous thromboembolism for patients with advanced ovarian cancer receiving neoadjuvant chemotherapy. This suggests that there may be a role for universal thromboprophylaxis in this population.; Trial Registration: PROSPERO CRD42022339602.; Competing Interests: Competing interests: SP has received consultancy fees from GSK. (© IGCS and ESGO 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Black Tie, M. and Inc (2022). Ovarian Rejuvenation Using Platelet Rich Plasma (PRP) & Autologous Tissue Stromal Vascular Fraction (tSVF) and Cell Enriched tSVF.
	No Results Available Procedure: lipoaspiration harvest tSVF|Procedure: Platelet Rich Plasma|Procedure: Endovaginal Ultrasound|Device: Cellular Isolation cSVF|Drug: Normal Saline (NS) .9% 10 mL Injection|Device: emulsification tSVF Patient Safety For Procedure|Menstrual Resumption|Hormonal Response|Ovarian Morphology|Bone Density and Body Composition Female Phase 1 100 Industry Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment OVARIAN REJUV August 15, 2025

Blackburn, L., et al. (2021). "Effect of Foot Reflexology and Aromatherapy on Anxiety and Pain During Brachytherapy for Cervical Cancer." Oncology Nursing Forum 48(3): 265-276.
	OBJECTIVES: To determine if the addition of aromatherapy and foot reflexology to the standard of care improves pain and anxiety in patients receiving brachytherapy for cervical cancer. SAMPLE & SETTING: 41 women with locally advanced cervical cancer who received intracavitary brachytherapy as part of their treatment. METHODS & VARIABLES: Participants were randomized to either the control group, which received the standard-of-care management during brachytherapy, or the intervention group, which received the addition of aromatherapy and foot reflexology to standard of care. Participants rated their pain on a numeric rating scale and anxiety on the State-Trait Anxiety Inventory (STAI) and a numeric rating scale at five different time points. RESULTS: All average pain and anxiety scores were equal or lower at each key time point for the intervention group. Statistically significant differences were found for the intervention group for anxiety on the numeric rating scale and on the STAI, but only post-reflexology. IMPLICATIONS FOR NURSING: Nurses and other healthcare providers can be trained to provide reflexology during painful, anxiety-producing procedures to increase patient tolerance of these treatments and overall quality of life.

Blackwood, J. and K. Rybicki (2021). "Outcomes of Telehealth-Delivered Physical Activity Programs in Adult Cancer Survivors: A Systematic Review." Rehabilitation Oncology 39(3): 128-136.
	Background and Purpose: Reduced physical activity (PA) is associated with poor prognosis in cancer survivors. Clinicians and researchers have attempted to improve adherence to PA recommendations, essentially bridging the gap between the clinic and the home by incorporating telehealth technologies in patients with chronic diseases. However, various approaches to telehealth may be used and the effectiveness of these interventions in cancer survivors is unknown. The purpose of this systematic review was to describe the type of technology used and outcomes of telehealth-delivered PA programs in adult cancer survivors. Method(s): A systematic review was performed to examine telehealth methods used to deliver PA exercise programs in adult cancer survivors. Databases searched for articles included PubMed/Ovid, MEDLINE/Web of Science, and CINAHL Complete via EBSCO. All articles that met the inclusion criteria were appraised by 2 reviewers independently and discussed against inclusion/exclusion criteria. The Cochrane Risk of Bias Assessment was used to assess study quality. Result(s): The search located 21 articles, and 5 met inclusion criteria. Articles included survivors from breast cancer (n = 3), prostate cancer (n = 1), and mixed sample (n = 1), including breast, cervical, endometrial, lung, leukemia, lymphoma, urinary, melanoma, rectal, oral, ovarian, and prostate cancer survivors. Sample size ranged from 41 to 339 and comprised 81.2% breast cancer survivors. PA interventions were delivered via telehealth by telephone calls (2 studies), smartphone apps (2 studies), and one used a combination of telephone calls and text messaging. Limitation(s): Selection bias is possible. Limited types of telehealth technologies were used. Conclusion(s): Limited evidence exists describing better outcomes of telehealth-delivered PA programs in cancer survivors than by traditional home exercise program instruction, and further study is indicated.Copyright © 2021 Lippincott Williams and Wilkins. All rights reserved.

Blagden Sarah, P. (2022). "Targeting MAPK in recurrent, low-grade serous ovarian cancer." Lancet (London, England) 399(10324): 499-501.
	Competing Interests: SPB reports grants and institutional support for clinical trials from NuCana, Sierra Oncology, Redx Pharma, UCB Pharma, Astex Pharma, Tesaro, and BerGenBio, all unrelated to the area of work commented on here.

Blanc-Durand, F., et al. (2023). "A RAD51 functional assay as a candidate test for homologous recombination deficiency in ovarian cancer." Gynecologic Oncology 171: 106-113.
	Rationale: Homologous recombination deficiency (HRD), defined as BRCA1/2 mutation (BRCAmut) or high genomic instability, is used to identify ovarian cancer (OC) patients most likely to benefit from PARP inhibitors. While these tests are useful, they are imperfect. Another approach is to measure the capacity of tumor cells to form RAD51 foci in the presence of DNA damage using an immunofluorescence assay (IF). We aimed to describe for the first time this assay in OC and correlate it to platinum response and BRCAmut. Method(s): Tumor samples were prospectively collected from the randomized CHIVA trial of neoadjuvant platinum +/- nintedanib. IF for RAD51, GMN and gH2AX was performed on FFPE blocks. Tumors were considered RAD51-low if <=10% of GMN-positive tumor cells had >=5 RAD51 foci. BRCAmut were identified by NGS. Result(s): 155 samples were available. RAD51 assay was contributive for 92% of samples and NGS available for 77%. gH2AX foci confirmed the presence of significant basal DNA damage. 54% of samples were considered HRD by RAD51 and presented higher overall response rates to neoadjuvant platinum (P = 0.04) and longer progression-free survival (P = 0.02). In addition, 67% of BRCAmut were HRD by RAD51. Among BRCAmut, RAD51-high tumors seem to harbor poorer response to chemotherapy (P = 0.02). Conclusion(s): We evaluated a functional assay of HR competency. OC demonstrate high levels of DNA damage, yet 54% fail to form RAD51 foci. These RAD51-low OC tend to be more sensitive to neoadjuvant platinum. The RAD51 assay also identified a subset of RAD51-high BRCAmut tumors with unexpected poor platinum response.Copyright © 2023 Elsevier Inc.

Blauvelt, A., et al. (2023). "Malignancy rates through 5 years of follow-up in patients with moderate-to-severe psoriasis treated with guselkumab: Pooled results from the VOYAGE 1 and VOYAGE 2 trials." Journal of the American Academy of Dermatology 89(2): 274-282.
	Background: Malignancy risk surveillance among patients receiving long-term immunomodulatory psoriasis treatments remains an important safety objective.; Objective: To report malignancy rates in patients with moderate-to-severe psoriasis treated with guselkumab for up to 5 years versus general and psoriasis patient populations.; Methods: Cumulative rates of malignancies/100 patient-years (PY) were evaluated in 1721 guselkumab-treated patients from VOYAGE 1 and 2. Malignancy rates (excluding nonmelanoma skin cancer [NMSC]) were compared with rates in the Psoriasis Longitudinal Assessment and Registry. Standardized incidence ratios comparing malignancy rates (excluding NMSC and cervical cancer in situ) between guselkumab-treated patients and the general US population using Surveillance, Epidemiology, and End Results data were calculated, adjusting for age, sex, and race.; Results: Of 1721 guselkumab-treated patients (>7100 PY), 24 had NMSC (0.34/100PY; basal:squamous cell carcinoma ratio, 2.2:1), and 32 had malignancies excluding NMSC (0.45/100PY). For comparison, the malignancy rate excluding NMSC was 0.68/100PY in the Psoriasis Longitudinal Assessment and Registry. Malignancy rates (excluding NMSC/cervical cancer in situ) in guselkumab-treated patients were consistent with those expected in the general US population (standardized incidence ratio = 0.93).; Limitations: Inherent imprecision in determining malignancy rates.; Conclusions: In patients treated with guselkumab for up to 5 years, malignancy rates were low and generally consistent with rates in general and psoriasis patient populations.; Competing Interests: Conflicts of interest Dr Blauvelt has served as a speaker (received honoraria) for AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Pfizer, Regeneron, and Sanofi, served as a scientific advisor (received honoraria) for AbbVie, Abcentra, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, EcoR1, Eli Lilly and Company, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, LEO Pharma, Merck, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, TLL Pharmaceutical, TrialSpark, UCB Pharma, Vibliome, and Xencor, and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, Eli Lilly and Company, Evelo, Evommune, Galderma, Incyte, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron, Sun Pharma, and UCB Pharma. Dr Lebwohl is an employee of Mount Sinai and receives research funds from AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant Sciences, Eli Lilly, Incyte, Janssen Research & Development, LLC, Ortho Dermatologics, Regeneron, and UCB, Inc, and is a consultant for Aditum Bio, Almirall, AltruBio Inc., AnaptysBio, Arcutis, Inc, Arena Pharmaceuticals, Aristea Therapeutics, Arrive Technologies, Avotres Therapeutics, BiomX, Brickell Biotech, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, CorEvitas, Dermavant Sciences, Dr Reddy’s Laboratories, Evelo Biosciences, Evommune, Inc, Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Helsinn Therapeutics, Hexima Ltd, LEO Pharma, Meiji Seika Pharma, Mindera, Pfizer, Seanergy, and Verrica. Dr Langley has served, and has received compensation in the form of grant funding and/or honoraria, as principal investigator for and is on the scientific advisory board or served as a speaker for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, LEO Pharma, Merck, Novartis, Pfizer, SUN Pharma, and UCB. Ms Rowland and Dr Chan are employees of Janssen Scientific Affairs, LLC (a subsidiary of Johnson & Johnson), and own Johnson & Johnson ock/stock options. Dr Yang is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson and owns Johnson & Johnson stock/stock options. Ms Miller, Ms You, and Dr Yu are employees of Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), and own Johnson & Johnson stock/stock options. Dr Thaçi has received honoraria for participation on advisory boards, as a speaker, and for consultancy from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Janssen, Kyowa Hakko Kirin, LEO Pharma, Merck Sharp & Dohme, Morphosys, Novartis, Pfizer, Regeneron Pharmaceuticals, Sandoz-Hexal, Sanofi, and UCB, and has received research grants from LEO Pharma and Novartis. Dr Foley has received grant support, and/or served on advisory boards, and/or served as a consultant, and/or has received travel grants, and/or has served as a speaker for or received honoraria from AbbVie, Akaal, Amgen, Arcutis, Argenx, Aslan, AstraZeneca, Boehringer Ingelheim, Botanix, Bristol Myers Squibb, Celgene, Celtaxsys, CSL, Cutanea, Dermira, Evelo, Galderma, GenesisCare, Genentech, GlaxoSmithKline, Hexima, Janssen, Kymab, Leo Pharma, Lilly, Mayne Pharma, MedImmune, Melaseq/Geneseq, Merck, Novartis, Pfizer, Regeneron, Reistone, Roche, Sanofi, Sun Pharma, Teva, UCB Pharma, and Valeant. Dr Papp has received clinical research grants from, honoraria from, and/or served as a consultant, scientific advisor, investigator, speaker, and/or medical officer for AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Avillion, Bausch Health, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite Biopharma, Celgene, Celltrion, Coherus, Dermavant, Dermira, Dice Pharmaceuticals, Dow Pharma, Eli Lilly, Evelo, Galapagos, Galderma, Genentech, Gilead, GlaxoSmithKline, Incyte, Janssen, Kyowa Hakko Kirin, LEO Pharma, Medimmune, Meiji Seika Pharma, Merck Sharpe & Dohme, Merck-Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Reistone, Roche, Sandoz, Sanofi-Aventis/Genzyme, Sun Pharma, Takeda, UCB Pharma, Valeant, vTv Therapeutics, and Xenocor. (Copyright © 2023 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Blay, J. Y., et al. (2023). "Pembrolizumab in patients with rare and ultra-rare sarcomas (AcSe Pembrolizumab): analysis of a subgroup from a non-randomised, open-label, phase 2, basket trial." The Lancet Oncology 24(8): 892-902.
	Background: Sarcoma is a heterogeneous group of diseases with few treatment options. Immunotherapy has shown little activity in studies including unselected sarcomas, but immune checkpoint blockers have shown activity in specific histotypes. We evaluated the activity of pembrolizumab in rare and ultra-rare sarcomas. Method(s): AcSe Pembrolizumab is an ongoing phase 2, basket, multitumour study investigating the activity of pembrolizumab monotherapy in rare cancers. Here, we report the results obtained in patients with selected histotypes of rare sarcomas (incidence of less than one case per 1 000 000 people per year) recruited at 24 French hospitals. Key inclusion criteria were age 15 years or older, Eastern Cooperative Oncology Group performance status of 0-1, and advanced disease that was untreated and resistant to treatment. Patients were given pembrolizumab 200 mg intravenously on day 1 of every 21-day cycle for a maximum of 24 months. The primary endpoint was objective response rate at week 12 using Response Evaluation Criteria in Solid Tumours version 1.1, assessed by local investigators. The primary endpoint and safety were analysed in the intention-to-treat population. The AcSe Pembrolizumab study is registered with ClinicalTrials.gov, NCT03012620. Finding(s): Between Sept 4, 2017, and Dec 29, 2020, 98 patients were enrolled, of whom 97 received treatment and were included in analyses (median age 51 years [IQR 35-65]; 53 [55%] were male; 44 [45%] were female; no data were collected on race or ethnicity). 34 (35%) patients had chordomas, 14 (14%) had alveolar soft part sarcomas, 12 (12%) had SMARCA4-deficient sarcomas or malignant rhabdoid tumours, eight (8%) had desmoplastic small round cell tumours, six (6%) had epithelioid sarcomas, four (4%) had dendritic cell sarcomas, three (3%) each had clear cell sarcomas, solitary fibrous tumours, and myxoid liposarcomas, and ten (10%) had other ultra-rare histotypes. As of data cutoff (April 11, 2022), median follow-up was 13.1 months (range 0.1-52.8; IQR 4.3-19.7). At week 12, objective response rate was 6.2% (95% CI 2.3-13.0), with no complete responses and six partial responses in the 97 patients. The most common grade 3-4 adverse events were anaemia (eight [8%] of 97), alanine aminotransferase and aspartate aminotransferase increase (six [6%]), and dyspnoea (five [5%]). 86 serious adverse events were reported in 37 patients. Five deaths due to adverse events were reported, none of which were determined to be related to treatment (two due to disease progression, two due to cancer, and one due to unknown cause). Interpretation(s): Our data show the activity and manageable toxicity of pembrolizumab in some rare and ultra-rare sarcoma histotypes, and support the PD-1/PD-L1 pathway as a potential therapeutic target in selected histotypes. The completion of the basket study will provide further evidence regarding the activity and toxicity of pembrolizumab in identified rare types of cancer. Funding(s): The Ligue contre le cancer, INCa, MSD. Translation: For the French translation of the abstract see Supplementary Materials section.Copyright © 2023 Elsevier Ltd

Blay, J. Y., et al. (2023). "Long term activity of vemurafenib in cancers with BRAF mutations: the ACSE basket study for advanced cancers other than BRAF V600 -mutated melanoma." ESMO Open 8(6): 102038.
	Background: BRAF inhibitors are approved in BRAF V600 -mutated metastatic melanoma, non-small-cell lung cancer (NSCLC), Erdheim-Chester disease (ECD), and thyroid cancer. We report here the efficacy, safety, and long-term results of single-agent vemurafenib given in the AcSé vemurafenib basket study to patients with various BRAF-mutated advanced tumours other than BRAF V600 -mutated melanoma and NSCLC.; Patients and Methods: Patients with advanced tumours other than BRAF V600E melanoma and progressing after standard treatment were eligible for inclusion in nine cohorts (including a miscellaneous cohort) and received oral vemurafenib 960 mg two times daily. The primary endpoint was the objective response rate (ORR) estimated with a Bayesian design. The secondary outcomes were disease control rate, duration of response, progression-free survival (PFS), overall survival (OS), and vemurafenib safety.; Results: A total of 98 advanced patients with various solid or haematological cancers, 88 with BRAF V600 mutations and 10 with BRAF nonV600 mutations, were included. The median follow-up duration was 47.7 months. The Bayesian estimate of ORR was 89.7% in hairy cell leukaemias (HCLs), 33.3% in the glioblastomas cohort, 18.2% in cholangiocarcinomas, 80.0% in ECD, 50.0% in ovarian cancers, 50.0% in xanthoastrocytomas, 66.7% in gangliogliomas, and 60.0% in sarcomas. The median PFS of the whole series was 8.8 months. The 12-, 24-, and 36-month PFS rates were 42.2%, 23.8%, and 17.9%, respectively. Overall, 54 patients died with a median OS of 25.9 months, with a projected 4-year OS of 40%. Adverse events were similar to those previously reported with vemurafenib.; Conclusion: Responses and prolonged PFS were observed in many tumours with BRAF mutations, including HCL, ECD, ovarian carcinoma, gliomas, ganglioglioma, and sarcomas. Although not all cancer types responded, vemurafenib is an agnostic oncogene therapy of cancers. (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Blomqvist, L., et al. (2023). "Preconceptual thyroid peroxidase antibody positivity in women with recurrent pregnancy losses may contribute to an increased risk for another miscarriage." Clinical Endocrinology 98(2): 259‐269.
	OBJECTIVE: To investigate preconceptual thyroid peroxidase antibody (TPO‐ab) positivity and/or thyroid stimulating hormone (TSH) levels in the upper range of normal as risk factors for recurrent unexplained first‐trimester miscarriage. DESIGN: A post‐hoc study of a randomized trial, in which acetylsalicylic acid did not affect the risk of a new miscarriage. PATIENTS: Women (n = 483) with at least three unexplained recurrent first‐trimester miscarriages investigated at a Swedish secondary referral center. MEASUREMENTS: The levels of TPO‐ab and TSH were determined before pregnancy. The occurrence of a new first‐trimester miscarriage was analyzed by logistic regression with adjustments when applicable, for age, number of previous miscarriages, obesity and the investigated covariates levels of TPO‐ab and TSH. RESULTS: Including all first trimester miscarriages, odds ratio (OR) according to presence of TPO‐ab was 1.60 (95% confidence interval [CI]; 0.99‐2.57), after adjustment 1.54 (95% CI; 0.94‐2.53). Very early (biochemical) pregnancy losses occurred more often in women with than without preconceptual TPO‐ab (6.8% vs. 2.0%), OR 3.51 (95% CI; 1.15‐10.71), after adjustment 2.91 (95% CI; 0.91‐9.29). There was no association between TSH in the upper range of normal and a new miscarriage, adjusted OR 0.76 (95% CI; 0.32‐1.83). A prediction model for a new miscarriage included number of previous miscarriages, woman's age and presence of TPO‐ab. CONCLUSION: In women with at least three recurrent unexplained pregnancy losses, the presence of TPO‐ab may contribute to an increased risk of a first‐trimester miscarriage, possibly more pronounced in very early pregnancy. TSH levels 2.5‐4.0 mU/L do not seem to increase the miscarriage risk.

Blomqvist Lennart, R. F., et al. (2022). "Arachidonic acid-induced platelet aggregation and acetylsalicylic acid treatment during pregnancy in women with recurrent miscarriage, a post hoc study." Platelets 33(2): 278-284.
	In this post hoc study, arachidonic acid (AA)-induced platelet aggregation during pregnancy with and without acetylsalicylic acid (ASA) treatment was studied in 323 women with unexplained recurrent first-trimester miscarriage and in 59 healthy women with normal pregnancies. All women had normal AA-induced platelet aggregation in the non-pregnant state. Women with recurrent miscarriage were treated with 75 mg ASA or placebo daily. AA-induced platelet aggregation was measured with multiple electrode impedance aggregometry and presented in units (U), where 1 U = 10 aggregation units x minutes. There were no significant differences in platelet aggregation between placebo-treated women with recurrent miscarriage and healthy women. The mean differences were-0.7 (95%CI; -7.0; 5.6) U in the non-pregnant state, 3.8 (95%CI; -4.6; 12.2) U during the late first trimester and 1.7 (95%CI; -6.7; 10.3) U and 4.1 (95%CI; -3.9; 12.0) U during the early and late third trimester, respectively. ASA reduced platelet aggregation by median -84.0% (Q1; Q3; -89.8; -76.3), -79.9% (-84.7; -69.2) and -75.7% (-83.5; -49.5), respectively, during pregnancy. The degree of inhibition by ASA decreased during the third trimester ( p < .0001). There were two (1.9%) complete non-responders to ASA and 32.1% with a partial response. The rate of subsequent miscarriage was not affected by ASA, which did not seem to influence the rate of early miscarriage if treatment was initiated when a viable pregnancy was detectable by ultrasound.

Bø, K. (2024). "Is there evidence for pelvic floor muscle relaxation training in nonneurogenic female bladder outlet obstruction?-A narrative review." Neurourology and Urodynamics.
	INTRODUCTION: Functional bladder outlet obstruction (BOO) in women is postulated to be caused by pelvic floor muscle (PFM) dyssynergia or increased tone. The aim of the present review was to investigate the effect of PFM relaxation training on PFM tone and female BOO symptoms. MATERIALS AND METHODS: This was a narrative review using an open search strategy on PubMed with the search terms "Bladder outlet obstruction" AND "female" AND ("pelvic floor muscles" OR "Kegel"). The risk of bias of the randomized controlled trials (RCTs) was scored with the Physiotherapy Evidence Database (PEDro) scale (0-10). RESULTS: Only three RCTs were found. All three RCTs compared different types of exercise, and no trial compared relaxation training with no or sham treatment. None of the trials reported the effect between groups on the reduction of PFM tone. There was a tendency toward positive effect of PFM relaxation training to improve BOO symptoms in women. PEDro score varied between 4 and 7. Few studies yielded information on the immediate effect of any type of PFM relaxation technique on PFM tone. CONCLUSION: Few RCTs have been conducted on the effect of PFM relaxation training on PFM tone and functional female BOO symptoms. There is an urgent need for RCTs with high methodological and interventional quality in addition to basic research on mechanisms of different relaxation techniques on PFM activity.

Bø, K., et al. (2022). "International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training." International Urogynecology Journal 33(10): 2633-2667.
	Introduction and Hypothesis: This manuscript from Chapter 3 of the International Urogynecology Consultation (IUC) on Pelvic Organ Prolapse (POP) describes the current evidence and suggests future directions for research on the effect of pelvic floor muscle training (PFMT) in prevention and treatment of POP.; Methods: An international group of four physical therapists, four urogynecologists and one midwife/basic science researcher performed a search of the literature using pre-specified search terms on randomized controlled trials (RCTs) in Ovid Medline, EMBASE, CINAHL, Cochrane, PEDro and Scopus databases for publications between 1996 and 2021. Full publications or expanded abstracts in English or in other languages with abstracts in English were included. The PEDro rating scale (0-10) was used to evaluate study quality. Included RCTs were reviewed to summarize the evidence in six key sections: (1) evidence for PFMT in prevention of POP in the general female population; (2) evidence for early intervention of PFMT in the peripartum period for prevention and treatment of POP; (3) evidence for PFMT in treatment of POP in the general female population; (4) evidence for perioperative PFMT; (5) evidence for PFMT on associated conditions in women with POP; (6) evidence for the long-term effect of PFMT on POP. Full publications in English or in other languages with abstracts in English and expanded abstracts presented at international condition specific societies were included. Internal validity was examined by the PEDro rating scale (0-10).; Results: After exclusion of duplicates and irrelevant trials, we classified and included 2 preventive trials, 4 trials in the post-partum period, 11 treatment trials of PFMT for POP in the general female population in comparison with no treatment or lifestyle interventions, 10 on PFMT as an adjunct treatment to POP surgery and 9 long-term treatment trials. Only three treatment studies compared PFMT with the use of a pessary. The RCTs scored between 4 and 8 on the PEDro scale. No primary prevention studies were found, and there is sparse and inconsistent evidence for early intervention in the postpartum period. There is good evidence/recommendations from 11 RCTs that PFMT is effective in reducing POP symptoms and/or improving POP stage (by one stage) in women with POP-Q stage I, II and III in the general female population, but no evidence from 9/10 RCTs that adding PFMT pre- and post -surgery for POP is effective. There are few long-term follow-up studies, and results are inconsistent. There are no serious adverse effects or complications reported related to PFMT.; Conclusions: There are few studies on prevention and in the postpartum period, and the effect is inconclusive. There is high-level evidence from 11 RCTs to recommend PFMT as first-line treatment for POP in the general female population. PFMT pre- and post-POP surgery does not seem to have any additional effect on POP. PFMT is effective and safe but needs thorough instruction and supervision to be effective. (© 2022. The Author(s).)

Bø, K., et al. (2023). "Can you breathe yourself to a better pelvic floor? A systematic review." Neurourology and Urodynamics 42(6): 1261-1279.
	Introduction: Some authors suggest that breathing exercises should be recommended instead of or in combination with pelvic floor muscle training (PFMT) to prevent and treat urinary incontinence (UI) and pelvic organ prolapse (POP).; Aims: The primary aim of the present study was to investigate the evidence for breathing as an intervention alone or in addition to PFM contraction in treatment of UI and POP.; Materials & Methods: This systematic review included short-term experimental studies and randomize controlled trials (RCTs) indexed on PubMed, EMBASE, and PEDro database. A form was used to extract data that was analyzed qualitatively due to the heterogeneity in interventions and outcome measures of the included studies. The individual methodological quality of RCTs was analyzed using the PEDro scale.; Results: A total of 18 studies were included, 374 participants from short-term experimental studies and 765 from nine RCTs. PEDro score varied from 4 to 8. Activation of the PFM during expiration was significantly less than during a PFM contraction. In general, the RCTs showed that training the PFM is significantly more effective to improve PFM variables and UI and POP than breathing exercises, and that adding breathing exercises to PFMT have no additional effect.; Conclusion: This systematic review indicates that the evidence for incorporating breathing exercise in clinical practice in addition to or instead of PFMT is scant or non-existing, both based on short-term experimental studies and small RCTs. (© 2023 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.)

Bobisse, S., et al. (2023). "A phase 1 trial of adoptive transfer of vaccine-primed autologous circulating T cells in ovarian cancer." Nature Cancer 4(10): 1410-1417.
	We have previously shown that vaccination with tumor-pulsed dendritic cells amplifies neoantigen recognition in ovarian cancer. Here, in a phase 1 clinical study (NCT01312376 /UPCC26810) including 19 patients, we show that such responses are further reinvigorated by subsequent adoptive transfer of vaccine-primed, ex vivo-expanded autologous peripheral blood T cells. The treatment is safe, and epitope spreading with novel neopeptide reactivities was observed after cell infusion in patients who experienced clinical benefit, suggesting reinvigoration of tumor-sculpting immunity.Copyright © 2023, The Author(s), under exclusive licence to Springer Nature America, Inc.

Boccasanta, P., et al. (2021). "A Minimally Invasive Technique for the 1-Stage Treatment of Complex Pelvic Floor Diseases: Laparoscopic-Pelvic Organ Prolapse Suspension." Female Pelvic Medicine & Reconstructive Surgery 27(1): 28-33.
	OBJECTIVE: The aim of this prospective study was to assess the safety and effectiveness of a new single laparoscopic operation devised to relieve obstructed defecation, gynecologic and urinary symptoms in a large series of female patients with multiorgan pelvic prolapse. METHODS: We submitted 384 female patients to laparoscopic pelvic organ prolapse suspension operation, a new technique based on suspension of the middle pelvic compartment, by using a polypropylene mesh and followed up 368 of them, with defecography performed 12 months after surgery and a standardized protocol. RESULTS: The 368 patients were followed-up for 36.3 (±4.4) months, Recurrence rate was 4.9% for obstructed defecation syndrome and 3.3% for stress urinary incontinence. Complication rate was 2.9%. The mean period of daily activity resumption was 16.3 days (±4.8 days). Anorectal and urogynecologic symptoms and scores significantly improved after the operation (P < 0.001), with no worsening of anal continence. Incidence of postoperative fecal urgency was 0%. Postoperative defecography showed a significant (P < 0.001) improvement of all parameters in 315 patients (82%). Short Form 36 Health Survey score significantly improved after the operation (P < 0.01). An excellent/good overall Satisfaction Index was reported by 78.0% of patients. CONCLUSIONS: In our experience the Laparoscopic-Pelvic Organ Prolapse Suspension seems to be safe and effective as a 1-stage treatment of associated pelvic floor diseases. Randomized studies with an appropriate control group and longer follow-up are now needed to assess the effectiveness of this promising technique.

Bochum Ruhr University, o. (2021). Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia.
	No Results Available Procedure: LLETZ|Procedure: LEEP Surgical specimen margin status|Intraoperative and postoperative complication rate|Cone size|Patient's pain|HPV clearance|Cone volume Female Not Applicable 206 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment LLETZ-2 January 2024

Bochum Ruhr University, o. (2022). Large Loop Excision of the Transformation Zone (LLETZ) With vs Without IntraOperative Application of Lugol's Iodine.
	Aim of the study The aim of this study is to answer the question under prospective randomized conditions whether LLETZ performed with the aid of iodine assay with selection of the resection line in the iodine-positive region leads to a lower rate of R1 resections compared with standard LLETZ without iodine assay. Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Interventional Model Description: Prospective randomized trial with 2 groups (use vs not use of Lugol's iodine during LLETZ) Masking : Single (Participant) Masking Description: Participants are not aware of their treatment allocation in order not to influence patient reported outcomes

Bockorny, B., et al. (2023). "Botensilimab, a novel innate/adaptive immune activator, plus balstilimab (anti-PD-1) in patients with recurrent platinum refractory/resistant ovarian cancer (041)."  176: S35‐S36.
	Objectives: Botensilimab (BOT) promotes optimized T‐cell priming, activation, and memory formation by strengthening antigen‐presenting cell/T‐cell co‐engagement. As a fragment crystallizable (Fc)‐enhanced next‐generation anticytotoxic T‐lymphocyte antigen 4 (CTLA‐4) antibody, BOT also promotes intratumoral Treg depletion to improve potency while mitigating difficult‐to‐treat side effects associated with first‐generation CTLA‐4 therapy. Results from an expanded phase IA/B study (NCT03860272) in patients with recurrent platinum‐resistant/refractory ovarian cancer treated with BOT plus balstilimab (BAL; anti‐programmed cell death protein 1 [PD‐1]) are presented. Methods: Patients received BOT 1 or 2 mg/kg q6w + BAL 3 mg/kg every 2 weeks. Crossover to combination treatment from BOT monotherapy (rescue) is permitted. Endpoints include incidence of adverse events (AE), objective response rate (ORR; unconfirmed responses included), disease control rate (DCR; the best overall response of either stable disease [SD] or a complete [CR] or partial response [PR]), duration of response (DOR), progression‐free survival (PFS), and overall survival (OS). Enrollment is ongoing. Results: Seventeen patients were evaluated for safety and efficacy (treated as of April 7, 2022, with ≥1 q6w tumor imaging assessment), including one rescue patient; data cutoff August 10, 2022. Patients were heavily pretreated, and the median number of prior lines of therapy was 4 (range: 2–7). The most common histology type was high‐grade serous. The median duration of study treatment was 3.2 months (range: 0.9–19.6), with a median follow‐up of 8.8 months (range: 2.0–29.2). ORR measured 29% (5/17; 95% CI: 13–53; 4 confirmed PRs, 1 unconfirmed CR) (Graph). One patient has an ongoing PR at 24 weeks (−100% reduction of target lesions with residual non‐targets), another patient with an unconfirmed CR at 18 weeks developed a solitary new lesion which was radiated and now has no evidence of disease at 90+ weeks, and the rescue patient had prolonged SD on BOT monotherapy for 66 weeks followed by a PR once BAL was added. The safety profile in all 17 patients continues to be favorable, with no cases of hypophysitis, myocarditis, or pneumonitis of any grade. Grade 1/2, 3, or 4 treatment‐related adverse events (TRAEs) occurred in 94%, 24%, and 6% of patients, respectively, with no grade 5 TRAEs reported. The only grade 3 or 4 TRAE occurring in more than one patient was diarrhea or colitis (18%). Further evaluation of biomarkers is ongoing, including paired biopsies (before/during treatment). Conclusions: BOT plus BAL demonstrates meaningful activity in heavily pretreated patients with recurrent platinum‐resistant/refractory ovarian cancer who are historically unresponsive to immunotherapy. Randomized studies are planned. [Formula presented]

Bodepudi, R., et al. (2023). "Myoinositol Versus Metformin in the Treatment of Polycystic Ovarian Syndrome: A Systematic Review." Cureus 15(7): e41748.
	Polycystic ovarian syndrome (PCOS) is a widespread, complex, and multi-system hormonal disorder that occurs in women of reproductive age. The wide variation in practice in the treatment of PCOS is a direct consequence of the lack of sufficient evidence on alternative treatment strategies, as well as a poor understanding of the disorder itself. The aim of our systematic review was to assess the therapeutic advantages and adverse effects of metformin (MET), a standard treatment modality, with myoinositol (MI), a recent substitute that may be used alone or in combination with other remedies to treat PCOS. A literature search was done using PubMed Central, PubMed, Medline, Cochrane, Science Direct, and Google Scholar. Studies were limited to those published in English between 2012 and 2022 that focused on the management of PCOS with both MET and MI. The systematic review complied with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. Using standard quality assessment tools, two reviewers independently assessed the content of the incorporated studies. Three meta-analyses, eight randomized controlled trials (RCTs), and one non-randomized non-controlled trial (NN-RCT) were deemed eligible. Following extensive analysis, we found that MET and MI are comparable in their effects on clinical, hormonal, and biochemical profiles. MI, however, had a better safety profile and tolerance due to minimal side effects compared to MET. These results demonstrate the potential role of MI as a novel asset in the armamentarium in the management of PCOS.; Competing Interests: The authors have declared that no competing interests exist. (Copyright © 2023, Bodepudi et al.)

Boedt, T., et al. (2023). "A blended preconception lifestyle programme for couples undergoing IVF: lessons learned from a multicentre randomized controlled trial." Human Reproduction Open 2023(4).
	STUDY QUESTION: What is the effect of a blended preconception lifestyle programme on reproductive and lifestyle outcomes of couples going through their first 12 months of IVF as compared to an attention control condition? SUMMARY ANSWER: This randomized controlled trial (RCT) was stopped prematurely because of the coronavirus disease 2019 (Covid‐19) pandemic but the available data did not suggest that a blended preconception lifestyle programme could meaningfully affect time to ongoing pregnancy or other reproductive and lifestyle outcomes. WHAT IS KNOWN ALREADY: Increasing evidence shows associations between a healthy lifestyle and IVF success rates. Lifestyle programmes provided through a mobile phone application have yet to be evaluated by RCTs in couples undergoing IVF. STUDY DESIGN, SIZE, DURATION: A multicentre RCT (1:1) was carried out. The RCT started in January 2019 and was prematurely stopped because of the Covid‐19 pandemic, leading to a reduced sample size (211 couples initiating IVF) and change in primary outcome (cumulative ongoing pregnancy to time to ongoing pregnancy). PARTICIPANTS/MATERIALS, SETTING, METHODS: Heterosexual couples initiating IVF in five fertility clinics were randomized between an attention control arm and an intervention arm for 12 months. The attention control arm received treatment information by mobile phone in addition to standard care. The intervention arm received the blended preconception lifestyle (PreLiFe)‐programme in addition to standard care. The PreLiFe‐programme included a mobile application, offering tailored advice and skills training on diet, physical activity and mindfulness, in combination with motivational interviewing over the telephone. The primary outcome was 'time to ongoing pregnancy'. Secondary reproductive outcomes included the Core Outcome Measures for Infertility Trials and IVF discontinuation. Changes in the following secondary lifestyle outcomes over 3 and 6 months were studied in both partners: diet quality, fruit intake, vegetable intake, total moderate to vigorous physical activity, sedentary behaviour, emotional distress, quality of life, BMI, and waist circumference. Finally, in the intervention arm, acceptability of the programme was evaluated and actual use of the mobile application part of the programme was tracked. Analysis was according to intention to treat. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 211 couples were randomized (105 control arm, 106 intervention arm). The hazard ratio of the intervention for time to ongoing pregnancy was 0.94 (95% CI 0.63 to 1.4). Little to no effect on other reproductive or lifestyle outcomes was identified. Although acceptability of the programme was good (6/10), considerable proportions of men (38%) and 9% of women did not actively use all the modules of the mobile application (diet, physical activity, or mindfulness). LIMITATIONS, REASONS FOR CAUTION: The findings of this RCT should be considered exploratory, as the Covid‐19 pandemic limited its power and the actual use of the mobile application was low. WIDER IMPLICATIONS OF THE FINDINGS: This is the first multicentre RCT evaluating the effect of a blended preconception lifestyle programme for women and their partners undergoing IVF on both reproductive and lifestyle outcomes. This exploratory RCT highlights the need for further studies into optimal intervention characteristics and actual use of preconception lifestyle programmes, as well as RCTs evaluating effectiveness. STUDY FUNDING/COMPETING INTEREST(S): Supported by the Research foundation Flanders (Belgium) (FWO‐TBM; reference: T005417N). No competing interests to declare.

Boedt, T., et al. (2022). "Evaluation of a stand-alone mobile mindfulness app in people experiencing infertility: the protocol for an exploratory randomised controlled trial (MoMiFer-RCT)." BMJ Open 12(2): e050088.
	INTRODUCTION: Infertility and its treatment bring a considerable emotional burden. Increasing evidence demonstrates the effectiveness of smartphone-delivered mindfulness apps for reducing symptoms of emotional distress in both clinical and non-clinical populations. Evidence on this topic in women, men and couples experiencing infertility is currently under-represented. The aim of the MoMiFer study is, therefore, to investigate the efficacy of a stand-alone mobile mindfulness app on symptoms of emotional distress and fertility-related quality of life in people experiencing infertility. METHODS AND ANALYSIS: This study is an exploratory randomised controlled trial (RCT) with open enrollment. The primary outcomes are symptoms of emotional distress and fertility-related quality of life. Secondary outcomes are mindfulness skills, repetitive negative thinking, self-compassion, user-rated quality of the stand-alone mobile mindfulness app and use of the app. Experience sampling method and standardised self-report questionnaires are combined within a repeated measures design to measure the effects of the stand-alone mobile mindfulness app on the primary and secondary outcomes, apart from the use of the app. The latter will be evaluated through app tracking. People, including women, men and couples, experiencing infertility (n=60) will be randomised to an intervention group receiving the stand-alone mobile mindfulness app for 3 months or a wait-list control group. The app follows the format and content of Mindfulness-Based Stress Reduction. Data will be collected at baseline, at 1.5 months and 3 months after randomisation. Analysis will be according to intention to treat and based on general linear modelling and multilevel mixed-effects modelling. ETHICS AND DISSEMINATION: This study received approval from the Medical Ethical Committee of the Leuven University Hospital (Belgium). The findings of this exploratory RCT will be disseminated through presentations at public lectures, scientific institutions and meetings, and through peer-reviewed scientific articles. TRIAL REGISTRATION NUMBER: NCT04143828.

Boeira Jéssica Tamara, R., et al. (2022). "Pelvic floor physiotherapy's role in public health for pregnant women: an integrative review." Fisioter. Bras 22(6): 912-930.
	
Boelig, R. C., et al. (2022). "Vaginal progesterone vs intramuscular 17-hydroxyprogesterone caproate for prevention of recurrent preterm birth: a randomized controlled trial." American Journal of Obstetrics and Gynecology 226(5): 722.e721‐722.e712.
	BACKGROUND: Preterm birth is the leading cause of neonatal morbidity and mortality, and previous preterm birth is one of the strongest risk factors for preterm birth. National and international obstetrical societies have different recommendations regarding progesterone formulation for the prevention of recurrent preterm birth. OBJECTIVE: This study aimed to determine whether vaginal progesterone is superior to 17‐hydroxyprogesterone caproate in the prevention of recurrent preterm birth in patients with singleton pregnancies who had a previous spontaneous preterm birth. STUDY DESIGN: This was an open‐label multicenter pragmatic randomized controlled trial at 5 US centers of patients with singleton pregnancies at <24 weeks of gestation who had a previous spontaneous preterm birth randomized 1:1 to either 200 mg vaginal progesterone suppository nightly or 250 mg intramuscular 17‐hydroxyprogesterone caproate weekly from 16 to 36 weeks of gestation. Based on the estimated recurrent preterm birth rate of 36% with 17‐hydroxyprogesterone caproate, 95 participants were needed in each arm to detect a 50% reduction in preterm birth rate with vaginal progesterone, with 80% power and 2‐sided alpha of 0.05. The primary outcome was preterm birth at <37 weeks of gestation. Prespecified secondary outcomes included preterm birth at <34 and <28 weeks of gestation, mean gestational age at delivery, neonatal morbidity and mortality, and measures of adherence. Analysis was by intention to treat. The chi‐square test and Student t test were used as appropriate. P<.05 was considered significant. RESULTS: Overall, 205 participants were randomized; 94 participants in the vaginal progesterone group and 94 participants in 17‐hydroxyprogesterone caproate group were included. Although gestational age at enrollment was similar, those assigned to vaginal progesterone initiated therapy earlier (16.9±1.4 vs 17.8±2.5 weeks; P=.001). Overall continuation of assigned formulation until delivery was similar (73% vs 69%; P=.61). There was no significant difference in preterm birth at <37 (31% vs 38%; P=.28; relative risk, 0.81 [95% confidence interval, 0.54‐1.20]), <34 (9.6% vs 14.9%; P=.26; relative risk, 0.64 [95% confidence interval, 0.29‐1.41]), or <28 (1.1% vs 4.3%; P=.37; relative risk, 0.25 [95% confidence interval, 0.03‐2.20]) weeks of gestation. Participants in the vaginal progesterone group had a later mean gestational age at delivery than participants in the 17‐hydroxyprogesterone caproate group (37.36±2.72 vs 36.34±4.10 weeks; mean difference, 1.02 [95% confidence interval, 0.01‐2.01]; P=.047). CONCLUSION: Vaginal progesterone did not reduce the risk of recurrent preterm birth by 50% compared with 17‐OHPC; however, vaginal progesterone may lead to increased latency to delivery. This trial was underpowered to detect a smaller, but still clinically significant, difference in the efficacy of preterm birth prevention. Patient factors that impact adherence and ability to obtain medication in a timely fashion should be included in counseling on progesterone selection.

Boelig Rupsa, C. (2023). "Obstetric Indications for Progestin Therapy." Obstetrics and gynecology clinics of North America 50(1): 101-107.
	Specifically, meta-analyses of randomized trials demonstrate that vaginal progesterone reduces the risk of preterm birth in selected high-risk singleton pregnancies. 17-OHPC may also reduce the risk of recurrent preterm birth in singletons. Finally, one trial suggests that vaginal progesterone may also be beneficial in improving live birth rates in singletons with prior miscarriages and early pregnancy bleeding.; Competing Interests: Conflicts of interest No conflicts of interest, financial or otherwise, to disclose. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Boere, I., et al. (2023). "CINOVA: a phase II study of CPC634 (nanoparticulate docetaxel) in patients with platinum resistant recurrent ovarian cancer." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 33(8): 1247-1252.
	Objective: Recurrent platinum-resistant ovarian cancer has a poor prognosis with limited therapeutic options. Sub-therapeutic intra-tumoral drug concentrations may add to therapy resistance. CPC634 (docetaxel entrapped in CriPec nanoparticles) was designed to enhance tumor accumulation of drug with localized drug release at the target site to increase therapeutic efficacy. This study investigated the therapeutic effect of CPC634 in patients with platinum-resistant ovarian cancer.; Methods: According to a Simon 2-stage design trial, the first stage included 13 patients, and 12 patients were enrolled in the second stage. Eligible patients had measurable disease and had progressed ≤6 months after the last platinum-based therapy. Platinum-refractory disease was excluded. In stage 1, the number of previous treatment lines was unlimited; in the second stage, a maximum of two prior lines altogether were allowed. The primary endpoint was the objective response rate by Response Evaluation Criteria in Solid Tumor (RECIST) V1.1. Secondary endpoints included safety, progression-free survival at 6 months, cancer antigen 125 (CA125) response, and disease control rate.; Results: The patients' median age was 66 years (range 22-77) and most were International Federation of Gynecology and Obstetrics (FIGO) stage III (56%). The median number of previous treatment lines was 3 (range 3-5) in stage I and 2 (range 1-4) in stage II of the study. None of the patients had an objective response, one patient had a CA125 response (5%), and seven patients had stable disease at first evaluation (35%). Median progression-free survival was 1.4 months in stage 1 and 3.0 months in stage 2. Adverse events (all grades) were mainly gastrointestinal in 24 patients (96%), fatigue in 11 (44%), dyspnea in 10 (40%), and infections in 10 (40%) of patients. Grade 3 or higher adverse events occurred in 14 patients (36%), including gastrointestinal in 4 (16%), anemia in 3 (12%), and febrile neutropenia, fatigue, chronic kidney disease, dehydration, and hypertension each in 1 (4%) patient. The trial was stopped prematurely due to futility.; Conclusions: Treatment with CPC634 was feasible, but without apparent clinical activity in patients with recurrent platinum-resistant ovarian cancer. Side effects were mainly gastrointestinal in 24 (96%) patients, including nausea, vomiting, and decreased appetite, fatigue, anemia, and dyspnea.; Competing Interests: Competing interests: CJFR was employee and is meanwhile paid consultant for Cristal Therapeutics, while RH was employed till August 2021 by Cristal Therapeutics. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Boero, V., et al. (2023). "Fat Grafting in Vulvar Lichen Sclerosus: Long Term Follow-Up." Journal of Lower Genital Tract Disease 27(4): 365-372.
	Objective: The rationale for the use of autologous fat grafting in the treatment of vulvar lichen sclerosus (VLS) consists in reduction of inflammation, regeneration of tissues, volume increase, and pain fiber control. The main outcome of this study was the evaluation of patients' satisfaction after treatment. Secondary outcomes included modifications in symptoms, psychosexual wellbeing, vulvar hydration, and histology after surgery.; Methods: Eligible for this study were women aged 18-85 years with a histological diagnosis of VLS who underwent at least one autologous vulvar fat grafting at the authors' center, between 2010 and 2019. In 2021, all women underwent a clinical reevaluation, comprehensive of vulvoscopy, vulvar biopsy, and handing out of validated questionnaires.; Results: Overall, 88.7% of patients declared themselves very satisfied/satisfied with the procedure. All symptoms were improved postsurgery; in particular, the difference was statistically significant for pruritus, burning, and dyspareunia ( p < .05). Sexual function was also improved at time of reevaluation, as were depressive and anxiety symptoms ( p < .05). No cases of vulvar intraepithelial neoplasia or cancer occurred during follow-up and vulvar architecture remained stable, although patients reported a significantly reduced need for topical steroids ( p < .0001). Lastly, in postoperative biopsies, inflammatory infiltrate was stable or reduced, and the distribution of elastic fibers was comparable or restored in most patients.; Conclusions: Patient satisfaction with fat grafting is detectable up to 11 years after surgery, and as such, it may represent a valid therapeutic option in selected cases of VLS.; Competing Interests: The authors have declared they have no conflicts of interest. (Copyright © 2023, ASCCP.)

Boersen, Z., et al. (2021). "Determining the effectiveness of cognitive behavioural therapy in improving quality of life in patients undergoing endometriosis surgery: a study protocol for a randomised controlled trial." BMJ Open 11(12): e054896.
	Introduction: Endometriosis can cause chronic pain and subfertility thereby negatively affecting quality of life (QoL). Surgical removal of endometriosis lesions leads to improved health-related QoL, although not to the level of QoL of healthy controls. Pain intensity and cognitions regarding pain can play a crucial role in this health-related QoL following surgical treatment. Cognitive behavioural therapy (CBT) is a psychological treatment. In patients with chronic pain caused by a variety of medical conditions, CBT is effective in improving QoL. We designed a research protocol to investigate the effect of CBT on QoL in patients with endometriosis-associated chronic pain who are undergoing surgery.; Methods and Analysis: This is a study protocol for a randomised controlled trial in which 100 patients, undergoing endometriosis removal surgery due to endometriosis-associated chronic pain, will be randomised between post-surgery usual care with CBT and post-surgery usual care only. Participants in the CBT group will additionally receive seven sessions of CBT, focused on expectancy management, cognitions regarding pain and emotional and behavioural impact of pain. To determine the primary outcome Quality of life, both groups will complete questionnaires assessing QoL. The secondary outcomes pain intensity, pain cognitions, fatigue and perceived stress are also measured using questionnaires. Additionally, a marker for stress (cortisol extracted from a hair sample) will be assessed at T0 (baseline assessment), T1 (post-intervention; 2 weeks after completion of all CBT sessions) and T2 (follow-up; 14 weeks after T1). Statistical analysis will be performed using SPSS software.; Ethics and Dissemination: The study protocol has been approved by the Medical Ethical Committee of the region Arnhem-Nijmegen from the Radboud University Medical Centre on 2 September 2020. The findings of this study will be published in scientific journals and will be presented at scientific conferences.; Trial Registration Number: NCT04448366.; Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Bofill, R., et al. (2020). "Interventions commonly available during pandemics for heavy menstrual bleeding: an overview of Cochrane Reviews." The Cochrane Database of Systematic Reviews 7: CD013651.
	Background: Within the context of heavy menstrual bleeding, pandemics impact upon women's assessment and treatment by healthcare providers.; Objectives: To summarise the evidence from Cochrane Reviews evaluating interventions for heavy menstrual bleeding that are commonly available during pandemics.; Methods: We sought published Cochrane Reviews, evaluating interventions that can continue during pandemics for women with heavy menstrual bleeding with no known underlying cause. We identified Cochrane Reviews by searching the Cochrane Database of Systematic Reviews in June 2020. The primary outcome was menstrual bleeding. Secondary outcomes included quality of life, patient satisfaction, side effects, and serious adverse events. We undertook the selection of systematic reviews, data extraction, and quality assessment in duplicate. We resolved any disagreements by discussion. We assessed review quality using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) 2 tool, and the certainty of the evidence for each outcome using GRADE methods.; Main Results: We included four Cochrane Reviews, with 11 comparisons, data from 44 randomised controlled trials (RCTs), and 3196 women. We assessed all the reviews to be high quality. Non-steroidal anti-inflammatory drugs (NSAIDs) NSAIDs may be more effective in reducing heavy menstrual bleeding than placebo (mean difference (MD) -124 mL per cycle, 95% confidence interval (CI) -186 to -62 mL per cycle; 1 RCT, 11 women; low-certainty evidence). Mefenamic acid may be similar to naproxen (MD 21 mL per cycle, 95% CI -6 to 48 mL per cycle; 2 RCTs, 61 women; low-certainty evidence), and NSAIDs may be similar to combined hormonal contraceptives for heavy menstrual bleeding (MD 25 mL per cycle, 95% CI -22 to 73 mL per cycle; 1 RCT, 26 women; low-certainty evidence). NSAIDs may be be less effective in reducing menstrual bleeding than antifibrinolytics (relative risk (RR) 0.70, 95% CI 0.58 to 0.85; 2 RCTs, 161 women; low-certainty evidence). We are uncertain whether NSAIDs reduce menstrual blood loss more than short-cycle progestogens (RR 0.80, 95% CI 0.49 to 1.32; 1 RCT 32 women; very low-certainty evidence). Antifibrinolytics Antifibrinolytics appear to be more effective in reducing heavy menstrual bleeding than placebo (MD -53 mL per cycle, 95% CI -63 to -44 mL per cycle; 4 RCTs, 565 women; moderate-certainty evidence). Antifibrinolytics may be similar to placebo on the incidence of side effects (RR 1.05, 95% CI 0.93 to 1.18; 1 RCT, 297 women; low-certainty evidence), and they are probably similar on the incidence of serious adverse events (thrombotic events; RR 0.10, 95% CI 0.00 to 2.46; 2 RCT, 468 women; moderate-certainty evidence). Antifibrinolytics may be more effective in reducing heavy menstrual bleeding than short-cycle progestogen (MD -111 mL per cycle, 95% CI -178 mL to -44 mL per cycle; 1 RCT, 46 women; low-certainty evidence). We are uncertain whether antifibrinolytics are similar to short-cycle progestogens on quality of life (RR 1.67, 95% CI 0.76 to 3.64; 1 RCT, 44 women; very low-certainty evidence), patient satisfaction (RR 0.91, 95% CI 0.59 to 1.39; 1 RCT, 42 women; very low-certainty evidence), or side effects (RR 0.85, 95% CI 0.65 to 1.12; 3 RCTs, 211 women; very low-certainty evidence). We are uncertain whether antifibrinolytics are more effective in reducing heavy menstrual bleeding when compared with long-cycle progestogen (MD -9 points per cycle, 95% CI -30 to 12 points per cycle; 2 RCTs, 184 women; low-certainty evidence). Antifibrinolytics may increase self-reported improvement in menstrual bleeding when compared with long-cycle medroxyprogesterone acetate (RR 1.32, 95% CI 1.08 to 1.61; 1 RCT, 94 women; low-certainty evidence). Antifibrinolytics may be similar to long-cycle progestogens on quality of life (MD 5, 95% CI -2.49 to 12.49; 1 RCT, 90 women; low-certainty evidence). We are uncertain whether antifibrinolytics are similar to long-cycle progestogens on side effects (RR 0.58, 95% CI 0.33 to 1.00; 2 RCTs, 184 women; very low-certainty evidenc ). There were no trials comparing antifibrinolytics to combined hormonal contraceptives. Combined hormonal contraceptives Combined hormonal contraceptives appear to be more effective for heavy menstrual bleeding than placebo or no treatment (RR 13.25, 95% CI 2.94 to 59.64; 2 RCTs, 363 women; moderate-certainty evidence). Combined hormonal contraceptives are probably similar to placebo on the incidence of side effects (RR 1.53, 95% CI 0.90 to 2.60; 2 RCTs, 411 women; moderate-certainty evidence). Progestogens There were no trials comparing progestogens to placebo. Limitations in the evidence included risk of bias in the primary RCTs, inconsistency between the primary RCTs, and imprecision in effect estimates.; Authors' Conclusions: There is moderate-certainty evidence that antifibrinolytics and combined hormonal contraceptives reduce heavy menstrual bleeding compared with placebo. There is low-certainty evidence that NSAIDs reduce heavy menstrual bleeding compared with placebo. There is low-certainty evidence that antifibrinolytics are more effective in reducing heavy menstrual bleeding when compared with NSAIDs and short-cycle progestogens, but we are unable to draw conclusions about the effects of antifibrinolytics compared to long-cycle progestogens, on low-certainty evidence. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Bogani, G., et al. (2022). "Radiomics and Molecular Classification in Endometrial Cancer (The ROME Study): A Step Forward to a Simplified Precision Medicine." Healthcare (Basel, Switzerland) 10(12).
	Molecular/genomic profiling is the most accurate method to assess prognosis of endometrial cancer patients. Radiomic profiling allows for the extraction of mineable high-dimensional data from clinical radiological images, thus providing noteworthy information regarding tumor tissues. Interestingly, the adoption of radiomics shows important results for screening, diagnosis and prognosis, across various radiological systems and oncologic specialties. The central hypothesis of the prospective trial is that combining radiomic features with molecular features might allow for the identification of various classes of risks for endometrial cancer, e.g., predicting unfavorable molecular/genomic profiling. The rationale for the proposed research is that once validated, radiomics applied to ultrasonographic images would be an effective, innovative and inexpensive method for tailoring operative and postoperative treatment modalities in endometrial cancer. Patients with newly diagnosed endometrial cancer will have ultrasonographic evaluation and radiomic analysis of the ultrasonographic images. We will correlate radiomic features with molecular/genomic profiling to classify prognosis.

Bogani, G., et al. (2023). "Tisotumab vedotin in recurrent or metastatic cervical cancer." Current problems in cancer 47(3): 100952.
	Tisotumab vedotin (TV) is an antibody-drug conjugate used for the treatment of adult patients with recurrent or metastatic cervical cancer. TV comprised of a monoclonal antibody against tissue factor and monomethyl auristatin E (MMAE), a potent inhibitor of cell division. The innovaTV-201 and innovaTV-204/GO30xx/ENGOT-cx6 trials showed that TV has clinically meaningful and durable antitumor activity in pretreated patients with recurrent or metastatic cervical cancer. The innovaTV-204 trial showed that TV monotherapy resulted in an objective response rate of 24% (including 7% and 17% complete and partial responses, respectively). In September 2021, the US Food and Drugs Administration (FDA) granted accelerated approval to TV for the treatment of recurrent or metastatic cervical cancer patients with disease progression on or after chemotherapy. The ongoing randomized, open-label Phase 3 innovaTV-301/ENGOTcx12/GOG-30xx trial will assess the effect of TV in pre-treated recurrent or metastatic cervical cancer. Meanwhile, the phase 1b/2 trial ENGOT Cx8/GOG 3024/innovaTV-205 is testing other possible combination between TV and other treatments. TV is characterized by a promising antitumor activity and an acceptable safety profile. Moreover, the preliminary data highlighted the feasibility of using TV in first line. In the first line, TV in combination with carboplatin or pembrolizumab provides an ORR of 55% and 41%, respectively Although the effect of adding TV to the current standard of care in first-line (carboplatin plus pembrolizumab) is still under evaluation, we expected to observe impressive results in the cervical cancer population. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Bogani, G., et al. (2023). "Mirvetuximab soravtansine-gynx: first antibody/antigen-drug conjugate (ADC) in advanced or recurrent ovarian cancer." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society.
	Mirvetuximab soravtansine-gynx (MIRV) is a conjugate of a folate receptor alpha (FRα)-directed antibody and the maytansinoid microtubule inhibitor, DM4. Accumulating pre-clinical and clinical data supported the safety and anti-tumor activity of MIRV in tumors expressing FRα. In 2017, a phase I expansion study reported the first experience of MIRV in FRα-positive platinum-resistant ovarian cancer with promising results. However, the phase III FORWARD I study failed to demonstrate a significant benefit of MIRV in FRα-positive tumors. On the basis of the data reported from this latter study, MIRV was then explored in the FRα-high population only and using a different folate receptor assay. The phase II SORAYA trial supported the adoption of MIRV in this setting. Hence, the US Food and Drug Administration granted accelerated approval of MIRV for patients with FRα-positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic treatment regimens. Moreover, the results of the MIRASOL trial showed a significant reduction in the risk of tumor progression or death among patients treated with MIRV versus chemotherapy. VENTANA FOLR1 (FOLR-2.1) was approved as a companion diagnostic test to identify FRα patients. MIRV appears to be a significant asset in managing advanced or recurrent ovarian cancer. Further trials are needed to confirm these promising results, even in the neoadjuvant, adjuvant, and maintenance settings.; Competing Interests: Competing interests: GB: Consulting/advisory role with Novartis. RLC: Consulting/advisory role: Merck, Genentech/Roche, Paravance, AstraZeneca, Novartis, Genmab, GSK, Gilead, Daiichi-Sankyo, Easai, OncXerna, Immunogen, Mersana, Novocure, Verastem, AbbVie; research funding: AstraZeneca, Clovis, Merck, Roche/Genentech, Abbott/AbbVie, Karyopharm. IV: Consulting fees from Agenus, Akesobio, AstraZeneca, Bristol Myers Squibb, Deciphera Pharmaceuticals, Eisai, Elevar Therapeutics, F Hoffmann-La Roche, Genmab, GSK, Immunogen, Jazzpharma, Karyopharm, Mersana, MSD, Novocure, Novartis, Oncoinvent, OncXerna, Sanofi, Regeneron, Seagen, Sotio, Verastem Oncology, Zentalis. IRC: Consulting fees from Agenus, Amgen, Akesobio, AstraZeneca, Bristol Myers Squibb, Deciphera Pharmaceuticals, Eisai, F Hoffmann-La Roche, Genmab, GSK, Immunogen, Mersana, MSD, Novocure, Novartis, Netrispharma, OncXerna, Sanofi, Transgene, Seagen, Adaptimmune, Verastem Oncology. AO: Consulting/Advisory role: Roche, AstraZeneca, PharmaMar, Clovis Oncology, Tesaro, ImmunoGen, Genmab, Mersana, GSK, Deciphera, AGENUS, Corcept Therapeutics, Eisai, EMD Serono, Medison, Merck Sharp & Dohme, Novocure, prIME Oncology, Shattuck Labs, Sutro Biopharma, ITeos Therapeutics, Amgen; research funding: AbbVie, Abililty Pharmaceuticals, Advaxis, Aeterna Zentaris, Aprea Therapeutics, Clovis Oncology, Eisai, Roche, Regeneron, Agenus, AstraZeneca, BeiGene, Belgian Gynaecological Oncology Group (BGOG), Bristol Myers Squibb International Corporation (BMS), Corcept Therapeutics, ImmunoGen, Iovance Biotherapeutics, Lilly, Medimmune, Merck, Merck Sharp & Dohme, Mundipharma Research, Novartis FarmacÃutica, Seagen, Seattle Genetics, Sutro Biopharma, Tesaro, Verastem (all payments institutional); travel, accommodations, expenses: AstraZeneca, Clovis Oncology, PharmaMar, Roche. DOM: Consult and/or Advisory Boards: AbbVie, AdaptImmune, Agenus, Arquer Diagnostics, AstraZeneca, Atossa Therapeutics, Boston Biomedical, Cardiff Oncology, Celcuity, Clovis Oncology, Celcuity, Clovis Oncology, Corcept Therapeutics, Duality Bio, Eisai, Elevar, Exelixis, Genentech, Genelux, GlaxoSmithKline, GOG Foundation, Hoffmann-La Roche, ImmunoGen, Imvax, InterVenn, INXMED, IOVANCE Biotherapeutics, Janssen, Jazz Pharmaceuticals, Laekna, Leap Therapeutics, Luzsana Biotechology, Merck & Co, Merck Sharp & Dohme Corp, Mersana Therapeutics, Myriad, Novartis, NovoCure, OncoC4, Onconova, Regeneron Pharmaceuticals, RepImmune, R Pharm, Roche Diagnostics, Seattle Genetics (SeaGen), Sorrento, Sutro Biopharma, Tarveda Therape tics, Toray, Trillium, Umoja, Verastem, VBL Therapeutics, Vincerx Pharma, Xencor, Zentalis. Institution received funds for research: AbbVie, Advaxis, Agenus, AlkermesAravive, Aravive, Arcus Biosciences, AstraZeneca, BeiGene USA, Boston Biomedical, Bristol Myers Squibb, Clovis Oncology, Deciphera Pharma, Eisai, EMD Serono, Exelixis, Genentech, Genmab, GlaxoSmithKline, GOG Foundation, Hoffmann-La Roche, ImmunoGen, Incyte Corporation, IOVANCE Biotherapeutics, Karyopharm, Leap Therapeutics, Ludwig Institute, Merck & Co, Merck Sharp & Dohme Corp, Mersana Therapeutics, NCI, Novartis, NovoCure, NRG Oncology, OncoC4, OncoQuest, Pfizer, Precision Therapeutics, Prelude Therapeutics, Regeneron Pharmaceuticals, RTOG, Rubius Therapeutics, Seattle Genetics (SeaGen), Sutro Biopharma, SWOG, TESARO, Verastem. FR: Honoraria from GSK, Pharmamar, Clovis, MSD and Roche. UAM: Consulting or advisory fees: NextCure, Allarity, Ovarian Cancer Research Alliance, Pfizer, Profound Bio, Eisai, CureLab, Immunogen, Trillium, Agenus, Novartis, Boerhinger Ingelheim; participation in a Data Safety Monitoring Board: Alkermes, Symphogen; speakers’ bureau: Med Learning Group. TVG: Consulting/advising with AstraZeneca, Eisai, GSK, ImmunoGen, MSD/Merck, OncXerna Therapeutics, Seagen and Tubulis; travel, accommodations, and/or expenses from AstraZeneca, ImmunoGen, MSD/Merck, and PharmaMar; research funding from Amgen, Roche and AstraZeneca. All payments institutional. GS: research funding from MSD/Merck and honoraria from Clovis Oncology; consultant for Tesaro and Johnson & Johnson. BJM: consulting with Agenus, Akeso Bio, Amgen, Aravive, Bayer, Elevar, EMD Merck, Genmab/Seagen, GOG Foundation, Gradalis, ImmunoGen, Iovance, Karyopharm, Macrogenics, Mersana, Myriad, Novocure, Novartis, Pfizer, Puma, Regeneron, Sorrento, US Oncology Research, and VBL; speakers’ bureau honoraria from AstraZeneca, Clovis, Eisai, Merck, Roche/Genentech, and Tesaro/GSK. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Bogani, G., et al. (2020). "Adjuvant chemotherapy vs. observation in stage I clear cell ovarian carcinoma: A systematic review and meta-analysis." Gynecologic Oncology 157(1): 293-298.
	The role of adjuvant chemotherapy in surgically staged stage I clear cell ovarian cancer (OCCC) is unclear. Here, we performed a systematic review and meta-analysis in order to evaluate the role of chemotherapy vs. observation in stage I OCCC. This systematic review was registered in the International Prospective Register of Systematic Reviews (PROSPERO; ID: #129628). A protocol was defined prior to the search include the population criteria, description of interventions, comparisons, and the outcomes of interest, according to the PRIMA guidelines. Overall, the study population included 5073 women. Stage I OCCC experienced a 5-year disease-free survival and a 5-year overall survival of 83.7% and 86.9%, respectively. Pooled data suggested that in the overall population adjuvant chemotherapy did not impact on 5-year disease free survival (test for overall effect, Z = 0.18; p = 0.86) and 5-year overall survival (test for overall effect, Z = 0.62; p = 0.53). Focusing on 2264 stage IC OCCC we observed that adjuvant correlated with an improvement in overall survival (OR: 0.70 (95%CI: 0.52 to 0.93); Z = 2.44; p = 0.01). In conclusion our study underlines that adjuvant chemotherapy could be reserved for patients with stage IC OCCC; while in stage IA and IB it could be safely omitted. Owing to the inherent biases of the studies included in the meta-analysis further prospective evidences are needed.; Competing Interests: Declaration of competing interest The authors declare no conflicts of interest. No funding sources supported this investigation. (Copyright © 2020 Elsevier Inc. All rights reserved.)

Bogani, G., et al. (2024). "Adding immunotherapy to first-line treatment of advanced and metastatic endometrial cancer." Annals of oncology : official journal of the European Society for Medical Oncology.
	Background: Immunotherapy has transformed the endometrial cancer treatment landscape , particularly for those exhibiting mismatch repair deficiency (MMRd/MSI-H). A growing body of evidence supports the integration of immunotherapy with chemotherapy as a first-line treatment strategy. Recently, findings from ongoing trials such as RUBY (NCT03981796), NRG-GY018 (NCT03914612), AtTEnd (NCT03603184), and DUO-E (NCT04269200) have been disclosed.; Materials and Methods: This paper constitutes a review and meta-analysis of phase III trials investigating the role of immunotherapy in the first-line setting for advanced or recurrent endometrial cancer.; Results: The pooled data from 2,320 patients across these trials substantiate the adoption of chemotherapy alongside immunotherapy, revealing a significant improvement in progression-free survival compared to chemotherapy alone (Hazard Ratio (HR): 0.70, 95% Confidence Interval (CI): 0.62, 0.79) across all patient groups. Progression-free survival benefits are more pronounced in MMRd/MSI-H tumors (n=563; HR: 0.33, 95% CI: 0.23, 0.43). This benefit, albeit less robust, persists in the MMRp/MSS group (n=1,757; HR: 0.74, 95% CI: 0.60, 0.91). Pooled data further indicate that chemotherapy plus immunotherapy enhances overall survival compared to chemotherapy alone in all patients (HR: 0.75, 95% CI: 0.63, 0.89). However, overall survival data maturity remain low.; Conclusions: The incorporation of immunotherapy into the initial treatment for advanced and metastatic endometrial cancer brings about a substantial improvement in oncologic outcomes, especially within the MMRd/MSI-H subset. This specific subgroup is currently a focal point of investigation for evaluating the potential of chemotherapy-free regimens. Ongoing exploratory analyses aim to identify non-responding patients eligible for inclusion in clinical trials. (Copyright © 2024 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved.)

Bogani, G., et al. (2023). "Selinexor in patients with advanced and recurrent endometrial cancer." Current problems in cancer 47(6): 100963.
	Selinexor is an oral inhibitor of the nuclear export protein called Exportin 1 (XPO1) with demonstrated antitumor activity in hematological and solid tumors. Selinexor, blocking XPO1, induces nuclear localization of tumor suppressor proteins (including p53, p73, BRCA1, and pRB), leading to the selective induction of apoptosis, and inhibition of DNA damage repair proteins. XPO1 overexpression is common in endometrial cancers. Phase I and II trials reported the antitumor activity of selinexor in patients with endometrial carcinoma. The preliminary results of the phase III Selinexor in ENDOmetrial Cancer (SIENDO/ENGOT-EN5/GOG-3055) trial supported the use of selinexor as maintenance therapy in advanced endometrial cancer patients achieving at least partial response after a minimum of 12 weeks of first-line platinum-based chemotherapy. Selinexor maintenance resulted in a (nonsignificant) 30% reduction in the risk of disease progression or death. Looking at the endometrial cancer molecular subgroup characterized by TP53 wild type, the antitumor activity of selinexor seemed more pronounced, resulting in approximately a 60% reduction in the risk of disease progression or death. The SIENDO and the XPORT-EC trials will clarify the benefits and risks of adding selinexor as a first-line chemotherapy maintenance treatment in all-comer and TP53 wild-type endometrial cancers. Preclinical data highlights the potential for selinexor to be synthetically lethal with PARP inhibitors and may also plan a role in overcoming acquired resistance to those therapies. Therefore, new possible combinations with PARP inhibitors and should be evaluated. Furthermore, the combination of selinexor plus immune checkpoint inhibitors deserves further investigation in clinical trials.; Competing Interests: Declaration of Competing Interest Giorgio Bogani: Novartis AG Pharma (C/A, H), Italian Ministry of Health (RG); Bradley J Monk: AstraZeneca (SH, SAB), GSK (SH, SAB), Incyte (SAB), Merck (SH, SAB), Roche/Genentech (SH, SAB), Eisai (SAB), GOG-Foundation (E), US Oncology (E); Ana Oaknin: Roche (SAB), AstraZeneca (SAB), PharmaMar (SAB), Clovis Oncology (SAB), Tesaro (SAB), ImmunoGen (SAB), Genmab (SAB), Mersana (SAB), GSK (SAB), Deciphera (SAB), AGENUS (SAB), Corcept Therapeutics (SAB), Eisai (SAB), EMD Serono (SAB), Medison (SAB), Merck Sharp and Dohme (SAB), Novocure, prIME Oncology (SAB), Shattuck Labs (SAB), Sutro Biopharma (SAB), ITeos Therapeutics(SAB), Amgen (SAB), Karyopharm Therapeutics (RF); Ignace Vergote: Consulting fees from Agenus, Akesobio, AstraZeneca, Bristol Myers Squibb, Deciphera Pharmaceuticals, Eisai, Elevar Therapeutics, F. Hoffmann-La Roche, Genmab, GSK, Immunogen, Jazzpharma, Karyopharm, Mersana, MSD, Novocure, Novartis, Oncoinvent, OncXerna, Sanofi, Regeneron, Seagen, Sotio, Verastem Oncology, Zentalis. Contracted research (via KULeuven) Oncoinvent AS Corporate sponsored research: Amgen, Roche Accommodations, travel expenses: Karyopharm, Genmab, Novocure; Bruno Bolognese: Karyopharm Therapeutics (OI). The other authors indicated no financial relationship. Legend: consulting/advisory relationship (CA); speaker honoraria (SH); honoraria (H); research funding (RF); ownership interest (OI); intellectual propriety/patent holder (IP); scientific advisory board (SAB). (Copyright © 2023 Elsevier Inc. All rights reserved.)

Bogani, G., et al. (2019). "Sentinel node mapping vs. lymphadenectomy in endometrial cancer: A systematic review and meta-analysis." Gynecologic Oncology 153(3): 676-683.
	Sentinel node mapping is increasingly being utilized for endometrial cancer staging. However, only limited evidence supporting the adoption of sentinel node mapping instead of conventional lymphadenectomy is still available. Here, we aimed to review the current evidence comparing sentinel node mapping and lymphadenectomy in endometrial cancer staging. This systematic review was registered in the International Prospective Register of Systematic Reviews. Six comparative studies were included. Overall, 3536 patients were included: 1249 (35.3%) and 2287 (64.7%), undergoing sentinel node mapping and lymphadenectomy, respectively. Pooled data suggested that positive pelvic nodes were detected in 184 out of 1249 (14.7%) patients having sentinel node mapping and 228 out of 2287 (9.9%) patients having lymphadenectomy (OR: 2.03; (95%CI: 1.30 to 3.18); p = 0.002). No difference in detection of positive nodes located in the paraaortic was observed (OR: 93 (95%CI: 0.39 to 2.18); p = 0.86). Overall recurrence rate was 4.3% and 7.3% after sentinel node mapping and lymphadenectomy, respectively (OR: 0.90 (95%CI: 0.58 to 1.38); p = 0.63). Similarly, nodal recurrences were statistically similar between groups (1.2% vs. 1.7%; OR: 1.51 (95%CI: 0.70 to 3.29); p = 0.29). In conclusion, our meta-analysis underlines that sentinel node mapping is non-inferior to standard lymphadenectomy in term of detection of paraaortic nodal involvement and recurrence rates (any site and nodal recurrence); while, focusing on the ability to detect positive pelvic nodes, sentinel node mapping could be consider superior to lymphadenectomy. Further randomized studies are needed to asses long term effectiveness of sentinel node mapping. (Copyright © 2019 Elsevier Inc. All rights reserved.)

Bogani, G., et al. (2023). "An update on current pharmacotherapy for vulvar cancer." Expert Opinion on Pharmacotherapy 24(1): 95-103.
	Introduction: Limited data on the role of pharmacotherapy for patients with locally advanced, recurrent, or metastatic vulvar cancer are available.; Areas Covered: This article aims to provide an overview of the current treatment options for patients with vulvar cancer. PubMed (MEDLINE), Embase, CENTRAL, Scopus, and Web of Science databases, as well as ClinicalTrials.gov were searched to review the current evidence as well as future perspectives on the role of pharmacotherapy in patients with vulvar carcinoma.; Expert Opinion: There has been no consensus on the pharmacotherapy for patients with locally advanced, recurrent, or metastatic vulvar cancer. Concurrent platinum-based chemoradiation is the most widely used treatment modality for primary treatment or for neoadjuvant settings. Chemotherapy in metastatic disease is considered a palliative treatment. Anti-EGFR tyrosine kinase inhibitors seem to show promising anti-tumor activity in patients harboring EGFR alteration. Similarly, growing evidence supports the adoption of immune checkpoint inhibitors in both neoadjuvant and metastatic settings. Molecular and genomic profiling is advocated to identify target mutations. The PI3K/AKT/mTOR and HER/ErbB pathways might represent two intriguing treatment options. Treatments directed against HPV are discussed as well. Further evidence is warranted to identify the best treatment modalities for patients with locally advanced, recurrent, and metastatic disease.

Bogers, S. J., et al. (2021). "Current evidence on the adoption of indicator condition guided testing for HIV in western countries: A systematic review and meta-analysis." EClinicalMedicine 35: 100877.
	BACKGROUND: Indicator condition (IC) guided testing for HIV is an effective way to identify undiagnosed people living with HIV, but studies suggest its implementation is lacking. This systematic review provides an overview of the adoption of IC-guided testing in Western countries. METHODS: Seven ICs were selected: tuberculosis (TB), malignant lymphoma, hepatitis B, hepatitis C, cervical/vulvar carcinoma/intraepithelial neoplasia grade 2+ (CC/CIN2+, VC/VIN2+), and peripheral neuropathy (PN). Embase and Ovid MEDLINE were searched up to November 20th, 2020. Publications of all types, using data from ≥2009, reporting on HIV test ratios in patients ≥18 years in all settings in Western countries were eligible. HIV test ratios and positivity were reported per IC. A random effects-model for proportions was used to calculate estimated proportions (ES) with 95% CIs. This study was registered at PROSPERO, registration number CRD42020160243. FINDINGS: Fifty-seven references, including 23 full-text articles and 34 other publications were included. Most (28/57) reported on HIV testing in TB. No reports on HIV testing in VC/VIN2+ or PN patients were eligible for inclusion. Large variation in HIV test ratios was observed between and within ICs, resulting from different testing approaches. Highest HIV test ratios (pooled ratio: 0·72, 95%CI 0·63-0·80) and positivity (0·05, 95% CI 0·03-0·06) were observed among TB patients, and lowest among CC/CIN2+ patients (pooled ES test ratio: 0·12, 95%CI 0·01-0·31, positivity: 0·00, 95%CI 0·00-0·00). INTERPRETATION: IC-guided HIV testing is insufficiently implemented in Western countries. The large variation in test ratios provides insight into priority areas for implementing routine IC-guided HIV testing in the future. FUNDING: HIV Transmission Elimination in Amsterdam (H-TEAM) consortium and Aidsfonds (grant number P-42,702).

Boguszewski, D., et al. (2021). "Effectiveness of kinesiotaping for the treatment of menstrual pain." Physiotherapy quarterly 28(4): 20‐24.
	Introduction. dysmenorrhoea is a common gynaecological problem among teenage and young adult females. The aim of this work was to evaluate the effectiveness of kinesiotaping for treating menstrual pain. Methods. The subjects were 44 women with complaints of pain during menstruation. The participants were randomly assigned to 3 groups: group 1 (n = 16), in which a kinesio tape was applied to the abdominal area; group 2 (n = 14), in which an identically looking inelastic tape was applied; and group 3 (n = 14), in which no intervention occurred. The degree of menstrual discomfort was assessed by a visual analogue scale, modified Laitinen questionnaire, and Spielberger state‐trait anxiety inventory. Results. in all groups, within 24 hours after tape application, pain intensity diminished by approximately 50%. in groups 1 and 2, the reduction of pain occurred 2‐4 hours after the application of the tapes. in contrast, in group 3, an initial increase of pain intensity was observed, and pain decrease began after 11 hours. However, the differences between the groups did not reach statistical significance. The values obtained with the Laitinen pain questionnaire revealed that kinesiotaping significantly reduced the intensity (p = 0.004) and incidence (p = 0.006) of menstrual pain between the first and fifth day. Conclusions. Painful menstruation severely limits everyday functioning. The application of a kinesio tape to the abdominal area may reduce the severity of pain in women with complaints referring to menstruation.

Bohn, J., et al. (2021). "Does obesity influence the preferred treatment approach for early-stage cervical cancer? A cost-effectiveness analysis." Gynecologic Oncology 162(Supplement 1): S142.
	Objectives: Obesity is a major public health concern and can have a negative impact on surgical outcomes. In 2018, a large, randomized control trial evaluated outcomes of minimally invasive radical hysterectomy (MIH) versus open abdominal radical hysterectomy (TAH) for treatment of early stage cervical cancer finding lower rates of disease free and overall survival in TAH. Regarding cost, previous studies have investigated outcomes and costs between MIH and TAH as well as between primary radiation and TAH, yet limited data exists on the outcomes and cost effectiveness of these treatments when compared among different body mass index (BMI) levels. The objective of this study was to examine how outcomes varied by BMI between treatment options for early stage cervical cancer and to ascertain which option was cost effective. Method(s): A Markov decision analytic model was designed using TreeAge Pro software to compare the outcomes and costs of primary radiation versus surgery in women with stage IA1-IB1 cervical cancer. We used a theoretical cohort of 6,000 women who were definitively treated with either (1) TAH, (2) MIH, or (3) primary radiation therapy. We compared results for three BMI ranges: <30 kg/m2, 30-39.9 kg/m2, and >=40 kg/m2. Model inputs were derived from the literature and the model was run over a 5-year time period. Outcomes included complications, recurrence, death, costs, and quality-adjusted life years (QALYs). Sensitivity analyses were performed to determine the robustness of the results. An intervention was deemed cost effective with an incremental cost-effectiveness ratio (ICER) of less than $100,000 per QALY. [Formula presented] Results: Among our cohort of 6,000 women with stage IA1-IB1 cervical cancer, TAH was associated with fewer cervical cancer recurrences and deaths compared to MIH; however, TAH resulted in more complications at each BMI level. Surgical complications outnumbered radiation-related complications as BMI increased. Recurrence rates were similar between TAH and radiation therapy, while there were more deaths associated with surgery. Comparing TAH to MIH, women with a BMI less than 30 had an ICER of $6,800 per QALY and women with a BMI 30-39.9 had an ICER of $739 per QALY. In women with a BMI >= 40, TAH was dominant. Comparing TAH to radiation therapy, women with a BMI less than 30 had an ICER of $191,000/QALY and women with a BMI 30-39.9 had an ICER of $133,000/QALY, which were not cost effective. In women with a BMI >= 40, the ICER was $88,000/QALY, making radiation therapy cost effective. Conclusion(s): Increasing BMI affects surgical morbidity as well as cost effectiveness of treatment modality for early stage cervical cancer. We found that at a BMI >= 40, TAH is both cost effective and provides cost savings when compared to MIH. When compared to primary radiation, TAH is cost effective at a BMI < 30 and 30-39.9. When the BMI is >= 40, primary radiation becomes cost-effective. This suggests that for women with early stage cervical cancer with the greatest BMI, primary radiation may be the optimal management strategy.Copyright © 2021 Elsevier Inc.

Boisbouvier, S., et al. (2022). "Upright patient positioning for pelvic radiotherapy treatments." Technical Innovations and Patient Support in Radiation Oncology 24: 124-130.
	Radiotherapy is typically delivered in supine position. However, upright positioning may affect organ volume, positioning, and movement, compared to supine/prone positioning which might have beneficial impacts. In this study, we report patient positioning data in an upright positioning system designed by Leo Cancer Care. Sixteen patients with pelvic tumors were included in this study. They had 3 setups in an upright position: an initial setup with acquisition of reference optical images, and 2 repositioning setups. The intra-fraction motion was assessed during two 20-minute chair rotation sessions. The patient comfort in supine and upright position was assessed with a 5-point Likert scale questionnaire. Eight women and 8 men treated on regular linacs between October 2021 and June 2022 were included. Their median age and weight were 62.5 years (35 to 81 years) and 75.1 kg (41 to 107 kg). The inter-fraction shift means were -0.5 mm (SD = 2.5), -0.4 mm (SD = 1.3) and -0.9 mm (SD = 2.7) in left-right (LR), antero-posterior (AP), and cranio-caudal (CC) directions, respectively. The intrafraction shifts after 20 min were 0.0 mm (SD = 1.5), 0.2 mm (SD = 1.1) and 0.0 mm (SD = 0.3) in LR, CC, and AP directions, respectively. Average global comfort was 4.1 (3 to 5) for the upright position and 3.9 (2 to 5) for the supine position. In conclusion, the first study on pelvic cancer patients positioned in upright position on a chair is promising, and it opens a potential new direction for the treatment of cancer patients. Evaluation of thoracic and head and neck tumors is ongoing, and imaging with vertical CT is expected to start soon.Copyright © 2022

Bojie, F., et al. (2022). "Survival After Minimally Invasive Radical Hysterectomy With Protective Colpotomy for Cervical Cancer: A Systematic Review and Meta-Analysis."
	
Bok, S. K., et al. (2022). "Body Fluid Trend and Prevalence of Lymphedema after Gynecological Cancer Surgery." Lymphatic Research and Biology 20(2): 185-190.
	Background: This study aimed at understanding the trend in extracellular fluid (ECF) change and estimating the efficacy of the early complex decongestive therapy (CDT) program in terms of prevalence of lower limb lymphedema, as well as at identifying the quality of life (QoL) associated with response to CDT after gynecological cancer therapy. Methods and Results: Thirty-one patients undergoing gynecological cancer treatment were enrolled and randomly assigned to the CDT and control groups. In the CDT group, CDT was started within 2 weeks after surgery for 30 minutes a day, for 2 weeks (5 days per week). The patients' QoL was assessed through the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire; version 3. Inbody S10 (Biospace, Seoul, South Korea) was used to calculate the ECF. The assessment was performed at pre-and post-surgery and at 3, 6, and 12 months after surgery. Statistically significant differences, in favor of the CDT group, were encountered at the 3-month follow-up visit, especially with respect to the QoL score. Regarding the prevalence of lymphedema, no significant difference was observed between groups. The mean value of the impedance ratio was low in the CDT group during the entire 12 month follow-up. Conclusion(s): The results of the present study show that early CDT had a positive effect on the prevalence of lymphedema and body composition. Long-Term follow-up studies with a larger sample size are needed to warrant the time-group effect of early rehabilitation.© Copyright 2022, Mary Ann Liebert, Inc., publishers 2022.

Bologna, I. A. O.-U. d. (2022). Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer.
	No Results Available Drug: Carboplatin|Drug: Bleomycin Compare Local progression-free survival|Compare Health-Related Quality of life (HR-QoL) in patients undergoing BLM + AUC2-CARBOPLATIN vs BLM alone assessed with questionnaires in patients undergoing BLM + CBP vs BLM alone assessed with questionnaires.|Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the EQ-5D-5L (5-level EQ-5D version) questionnaire.|Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the FACT-V (Functional Assessment of Cancer Therapy-Vulva) questionnaire.|Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the FACIT-PAL ( Functional Assessment of Chronic Illness Therapy - Palliative Care) questionnaire.|Compare Overall Survival|Reporting of Adverse Events and Serious Adverse Events Female Phase 2 92 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 41/2022/Farm/AOUBo April 7, 2027

Bologna, I. A. O.-U. d. and P. group (2021). Ketogenic Diet in PCOS With Obesity and Insulin Resistance.
	No Results Available Combination Product: Very low calorie ketogenic diet|Behavioral: Low calorie standard diet Change in Body mass index|Change in body composition measured by bioimpedentiometry|Change in Homeostasis Model Assessment Index|Change in frequency of menstrual cycles|Change in hirsutism|Change in plasma concentrations of testosterone Female Not Applicable 30 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment VLCKD December 6, 2021

Bolt, B. and Inc (2023). Study of BDC-3042 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Malignancies.
	No Results Available Drug: BDC-3042|Drug: Pembrolizumab Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0|Incidence and nature of AEs considered by the Investigator or Sponsor to be clinically relevant, attributable to study treatment, and meeting dose-limiting toxicity (DLT) criteria|Objective response rate (ORR) using RECIST 1.1|Duration of response (DOR)|Disease control rate (DCR) of confirmed complete response (CR), partial response (PR), or stable disease (SD) lasting 4 or more weeks|Progression Free Survival (PFS)|Best overall response (CR, PR, SD, progressive disease)|PK (Cmax) of BDC-3042|PK (Cmin) of BDC-3042|PK (AUC0-t) of BDC-3042|PK (AUC0-inf) of BDC-3042|PK (CL) of BDC-3042|PK (Vc or Vss) of BDC-3042|PK (Terminal t1/2) of BDC-3042|Incidence of anti-BDC-3042 antibodies All Phase 1|Phase 2 167 Industry Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BBI-20233042 March 2028

Bolton Virginia, N., et al. (2023). "Human oocyte cryopreservation: revised evidence for practice." Human fertility (Cambridge, England) 26(1): 2-16.
	This article reviews the evidence regarding human oocyte cryopreservation by slow freezing and vitrification and provides evidence-based clinical and laboratory guidelines on the effectiveness and safety of these technologies. The guidelines address the stage of oocyte maturity; cryopreservation and thawing/warming using slow cooling or vitrification; techniques used for insemination of thawed/warmed oocytes; information and support counselling. These are an update of previous guidelines. The following outcome measures were examined: cryosurvival, fertilisation rate, cleavage rate, implantation and clinical pregnancy rate, miscarriage rate, live birth rate, psychosocial wellbeing, health of resulting children. This update does not include recommendations specific to fertility preservation for defined patient groups and specific ovarian stimulation regimens as they are covered in detail in recent guidance from the European Society of Human Reproduction and Embryology (ESHRE).

Bona Alberto, F., et al. (2020). "Incidence, prevalence, and factors associated with lymphedema after treatment for cervical cancer: a systematic review." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 30(11): 1697-1704.
	Background: Lower limb lymphedema is a frequent and debilitating complication after cervical cancer treatment.; Objective: To evaluate the incidence and prevalence of lymphedema after treatment for cervical cancer and evaluate the factors associated with this outcome.; Methods: The study was performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines and was registered in the International Prospective Register of Systematic Reviews (PROSPERO). Eligible studies were identified through the databases Medline (via PubMed), LILACS, Scopus, and Web of Science. For the search, descriptors, keywords, and synonyms were used for cervical cancer, lymphedema, and outcomes of interest (incidence, prevalence, frequency, occurrence, morbidity, risk factors, and prognosis). Observational studies were included that were published in English, Portuguese, or Spanish, between January 1, 2013 and December 31, 2019, with frequency data and associated factors for lymphedema after cervical cancer treatment. Studies that evaluated the presence of lymphedema less than 6 months after surgery or radiotherapy and those in which frequency data were not stratified by tumor topography, were excluded.; Results: Twenty-three studies were included. The incidence of lymphedema varied between 0% and 69%. Different designs and methods were employed for lymphedema assessment. The main factors associated with lymphedema included extension of lymphadenectomy, number of lymph nodes removed, removal of circumflex iliac lymph nodes, and adjuvant radiotherapy. Other factors associated with lymphedema included cellulitis, lymphocyst formation, increased age, invasive lymph node staging, higher body mass index, and insufficient physical activity.; Conclusions: The frequency of lymphedema after treatment for cervical cancer is variable. The different designs and methodology to measure this complication make it difficult to draw definitive conclusions about its prevalence. The method used for lymphedema assessment is not standardized.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Bonab, V. K., et al. (2023). "The effect of combination exercise training along with ginger supplementation on PGE2 levels and primary dysmenorrhea symptoms in sedentary girls." Iranian Journal of Obstetrics, Gynecology and Infertility 26(9): 29-39.
	Introduction: Primary dysmenorrhea is one of the most common menstrual disorders among women that have a negative impact on their social activities. However, regular exercise training and consumption of medicinal plants is common among women in order to treat primary dysmenorrhea. Therefore, the present study was conducted with aim to investigate the effect of combination exercise training along with ginger supplementation on PGE2 levels and primary dysmenorrhea symptoms (intensity and duration) in sedentary girls. Method(s): In this quasi-experimental study, 60 sedentary young girls with moderate/severe primary dysmenorrhea were randomly placed into one of the four groups: training along with ginger consumption, training along with placebo consumption, ginger and control placebo groups. The training groups performed combination exercise training in two sections of endurance training and strength training. The groups consuming supplementation used ginger capsules. The severity of pain dysmenorrhea was measured by the visual analog scale (VAS) and duration of pain by Cox menstrual cycle (CAS). PGE2 of all participants was examined in two stages before and after the research. Data were analyzed by SPSS software (version 23) and ANCOVA, paired t-test and non-parametric tests. P<0.05 was considered significant. Result(s): The PGE2 level significantly decreased in the groups of training with ginger, training with placebo and ginger (P<0.05). In addition, a significant reduction in the intensity and duration of dysmenorrhea pain was observed in all the intervention groups compared to the placebo group in the second and third cycle of menstruation. Also, a significant difference was found between the two training groups with the supplement and placebo consumption in the pain intensity values (P<0.05). Conclusion(s): Consumption of ginger supplementation and combination exercise training through reducing PGE2 levels can improve the symptoms of primary dysmenorrhea in sedentary girls; it seems that combination of ginger supplement and combination exercise training have the synergistic effect.Copyright © 2023, Mashhad University of Medical Sciences. All rights reserved.

Bonaca Marc, P., et al. (2023). "Left Ventricular Ejection Fraction in Patients With Ovarian Cancer Treated With Avelumab, Pegylated Liposomal Doxorubicin, or Both." The Oncologist 28(10): e977-e980.
	In the phase III JAVELIN Ovarian 200 trial, 566 patients with platinum-resistant/refractory ovarian cancer were randomized 1:1:1 to receive avelumab alone, avelumab plus pegylated liposomal doxorubicin (PLD), or PLD alone. Cardiac monitoring was included for all patients. We report left ventricular ejection fraction (LVEF) data from the trial. Grade ≥3 cardiac adverse events (AEs) occurred in 4 (2.1%), 1 (0.5%), and 0 patients in the avelumab, combination, and PLD arms, respectively. LVEF decreases of ≥10% to below institutional lower limit of normal at any time during treatment were observed in 1 (0.8%), 3 (1.9%), and 2 (1.5%) patients, respectively; 4 had subsequent assessments, and these showed transient decreases. No patient had a cardiovascular AE related to LVEF decrease. This analysis is, to our knowledge, the first analysis of LVEF in patients receiving immune checkpoint inhibitors.; Clinicaltrials.gov Identifier: NCT02580058. (© The Author(s) 2023. Published by Oxford University Press.)

Bondar, O. V., et al. (2021). "The impact of hyperthermic intraperitoneal chemotherapy and cytoreductive surgery on clinical outcomes and quality of life of patients with peritoneal carcinomatosis." Contemporary oncology (Poznan, Poland) 25(4): 270-278.
	AIM OF THE STUDY: To investigate the impact of hyperthermic intraperitoneal chemotherapy (HIPEC) on the clinical and oncological outcomes and quality of life (QOL) of patients with peritoneal carcinomatosis (PC). MATERIAL AND METHODS: The study involved 304 patients with PC of different origin, who were divided into 2 groups: Group I - cytoreductive surgery (CRS) + adjuvant chemotherapy (ACT) - 247 patients; Group II - CRS + HIPEC + ACT - 57 patients. Intraoperative characteristics and postoperative complications were compared. Patients' QOL was assessed at all phases of treatment using the international scales the Short Form-36 Health Survey (SF-36) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Breast Cancer Core 30 (EORTC QLQ-C30). RESULTS: No statistically significant differences were observed between the 2 groups comparing the average blood loss and the total rate of postoperative complications, although the rates of hyperthermia and acute renal failure in the early postoperative period were higher in the HIPEC group. The use of HIPEC significantly contributed to the worse restoration of intestinal function in the postoperative period and to prolonged hospital stay. Assessment of the QOL of patients in Group II using SF-36 showed no significant difference between the physical and psychological components of health compared with the control group. The analysis of EORTC data showed a significant deterioration in the QOL of patients in Group II due to increased scales of pain, nausea and vomiting, and constipation in the early postoperative period. No difference in QOL was observed in the subsequent phases of treatment and after its completion. Overall survival and disease-free survival of patients with ovarian cancer who underwent HIPEC were significantly better compared with CRS + ACT alone. CONCLUSIONS: The proposed HIPEC technique has demonstrated its clinical safety in the treatment of PC, no long-term negative impact on the QOL of patients, and better oncological results for ovarian cancer.

Boned-López, J., et al. (2021). "Severe pain during hysterosalpingo-contrast sonography (HyCoSy): a systematic review and meta-analysis." Archives of Gynecology and Obstetrics 304(6): 1389-1398.
	Purpose: To assess the frequency of severe pain perception during hysterosalpingo-contrast sonography (HyCoSy) in infertile women and to assess whether there are differences in the frequency of associated pain according to the contrast used.; Design: Systematic review and meta-analysis.; Patients: Women undergoing HyCoSy due to infertility.; Interventions: Searches were carried out in two databases (Pubmed and Web of Science). We included prospective or retrospective cohort observational studies that specified the type of contrast used during HyCoSy and reported data regarding the number of patients who perceived severe pain during the procedure and the scale used for pain perception score.; Main Outcome Measures: Pooled frequency of severe pain perception during HyCoSy and the pooled frequency of severe pain perception based on the contrast used.; Results: Twenty-nine studies were included in this meta-analysis including a total of 7139 patients. In 10 studies, Saline solution with air was used as contrast EchoVist™ was used in ten studies, in five studies, SonoVue™ was used and in four studies, ExEm-Foam™ was used as contrast. Pooled estimated frequency of severe pain perception during HyCoSy was 6% (95% CI 4-9). No statistically significant differences have been described regarding frequency of severe pain perception in relation to the different contrasts used.; Conclusions: HyCoSy is a tolerable outpatient procedure. We did not find any evidence that one specific contrast was better tolerated than any other was. (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Bonner, P. E., et al. (2024). "Osteopathic Manipulative Treatment in Dysmenorrhea: A Systematic Review." Cureus 16(1): e52794.
	The majority of women experience dysmenorrhea during their lifetime. The current standard-of-care treatment consists of nonsteroidal anti-inflammatory drugs, oral contraceptive pills, or intrauterine devices. Osteopathic manipulative treatment (OMT) is a beneficial tool for improving non-musculoskeletal (non-MSK) conditions such as migraines, gastroesophageal reflux disease (GERD), and anxiety. OMT should be utilized to improve other non-MSK conditions, such as dysmenorrhea. The current review aims to evaluate the effects of OMT in women with dysmenorrhea. An extensive search was conducted in Cumulative Index to Nursing and Allied Health Literature (CINAHL), MEDLINE, Biomedical Reference Collection: Comprehensive, and Nursing & Allied Health Collection: Comprehensive from inception to June 2022. Studies evaluating the use of OMT in patients with dysmenorrhea were included, while editorial/opinion articles were excluded. Three independent reviewers evaluated the studies. Ten studies evaluating the use of OMT in patients with dysmenorrhea were included. Overall, OMT was shown to provide relief of symptoms, including back and menstrual pain; however, there was no guideline on which OMT techniques are the most successful. Numerous positive effects were found, including a reduction in the duration of pain, reduction of pain intensity, and reduction of analgesic use. However, the low number of studies supports the need for further investigations. Dysmenorrhea patients could benefit from a prospective randomized controlled trial targeting spinal facilitation and viscerosomatic reflexes to decrease pain duration, pain intensity, and analgesic use. Non-MSK-focused OMT has a large body of mostly anecdotal evidence for relief of conditions such as migraine, GERD, and anxiety. It has helped when traditional standards of care have failed. Non-MSK-focused OMT research represents a relatively untouched field of research that can have a profound and positive global impact, particularly in areas with poor income/healthcare access.

Boo, M., et al. (2022). "Use of direct oral anticoagulants for postoperative venous thromboembolism prophylaxis after surgery for gynecologic malignancies." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 32(2): 189-194.
	Venous thromboembolism is a preventable cause of postoperative mortality in patients undergoing surgery for malignancy. Current standard of care based on international guideline recommends 28 days of extended thromboprophylaxis after major abdominal and pelvic surgery for malignancies with unfractionated heparin or low molecular weight heparin. Direct oral anticoagulants have been approved for the treatment of venous thromboembolism in the general population. This regimen has a significant advantage over other types of anticoagulation regimens, particularly being administered by non-parenteral routes and without the need for laboratory monitoring. In this review, we evaluate the role of direct anticoagulation and provide an update on completed and ongoing clinical trials.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Boos Elise, W., et al. (2023). "Trends in the Use of Mifepristone for Medical Management of Early Pregnancy Loss From 2016 to 2020." JAMA 330(8): 766.
	
Borčinová, M., et al. (2022). "Challenges in lower limb lymphoedema assessment based on limb volume change: Lessons learnt from the SENTIX prospective multicentre study." Gynecologic Oncology 164(1): 76-84.
	Background: Lower limb lymphoedema (LLL) is the most disabling adverse effect of surgical staging of pelvic lymph nodes. However, the lack of standardisation of volumetric LLL assessment hinders direct comparison between the studies and makes LLL reporting unreliable. The aim of our study is to report outcomes from a prospective trial that have implications for LLL assessment standardisation.; Methods: In the prospective international multicentre trial SENTIX, a group of 150 patients with stage IA1-IB2 cervical cancer treated by uterine surgery with bilateral sentinel lymph node biopsy was prospectively evaluated by objective LLL assessment, based on limb volume change (LVC) using circumferrential limb measurements and subjective patient-reported swelling. The assessments were conducted in six-month periods over 24 months post-surgery.; Results: Patient LVC substantially fluctuated in both positive and negative directions, which were comparable in frequency up to ±14% change. Thirty-eight patients experienced persistent LVC increase >10% classified as LLL, with nine months median time to onset. Some 34.2% of cases experienced onset later than one year after the surgery. Thirty-three patients (22%) experienced transient oedema characterised as LVC >10%, which resolved without intervention between two consequent follow-up visits. No significant correlation between LVC >10% and a patient-reported swelling was observed.; Conclusions: Given that we observed comparable fluctuations of the the lower-limb volumes after surgical treatment of cervical cancer in both positive and negative direction up to ±14%, the diagnostic threshold for LLL diagnosis based on LVC should be increased to >15% LVC. The distinction of transient oedema from persistent LLL requires repeated measurements. Also, as one-third of LLL cases are diagnosed >1-year post-surgery, a sufficient follow-up duration needs to be ensured. Patient-reported swelling correlated poorly with LVC and should only be used as an adjunct to objective LLL assessment.; Trial Registration: ClinicalTrials.gov: NCT02494063.; Competing Interests: Declaration of Competing Interest None declared. (Copyright © 2021 Elsevier Inc. All rights reserved.)

Bordewijk, E. M., et al. (2023). "Long-term outcomes of switching to gonadotrophins versus continuing with clomiphene citrate, with or without intrauterine insemination, in women with normogonadotropic anovulation and clomiphene failure: follow-up study of a factorial randomized clinical trial." Human reproduction (Oxford, England) 38(3): 421-429.
	Study Question: What are the long-term outcomes after allocation to use of gonadotrophins versus clomiphene citrate (CC) with or without IUI in women with normogonadotropic anovulation and clomiphene failure?; Summary Answer: About four in five women with normogonadotropic anovulation and CC failure had a live birth, with no evidence of a difference in pregnancy outcomes between the allocated groups.; What Is Known Already: CC has long been used as first line treatment for ovulation induction in women with normogonadotropic anovulation. Between 2009 and 2015, a two-by-two factorial multicentre randomized clinical trial in 666 women with normogonadotropic anovulation and six cycles of CC failure was performed (M-ovin trial). This study compared a switch to gonadotrophins with continued treatment with CC for another six cycles, with or without IUI within 8 months. Switching to gonadotrophins increased the chance of conception leading to live birth by 11% over continued treatment with CC after six failed ovulatory cycles, at a cost of €15 258 per additional live birth. The addition of IUI did not significantly increase live birth rates.; Study Design, Size, Duration: In order to investigate the long-term outcomes of switching to gonadotrophins versus continuing treatment with CC, and undergoing IUI versus continuing with intercourse, we conducted a follow-up study. The study population comprised all women who participated in the M-ovin trial.; Participants/materials, Setting, Methods: The participating women were asked to complete a web-based questionnaire. The primary outcome of this study was cumulative live birth. Secondary outcomes included clinical pregnancies, multiple pregnancies, miscarriage, stillbirth, ectopic pregnancy, fertility treatments, neonatal outcomes and pregnancy complications.; Main Results and the Role of Chance: We approached 564 women (85%), of whom 374 (66%) responded (184 allocated to gonadotrophins; 190 to CC). After a median follow-up time of 8 years, 154 women in the gonadotrophin group had a live birth (83.7%) versus 150 women in the CC group (78.9%) (relative risk (RR) 1.06, 95% CI 0.96-1.17). A second live birth occurred in 85 of 184 women (49.0%) in the gonadotrophin group and in 85 of 190 women (44.7%) in the CC group (RR 1.03, 95% CI 0.83-1.29). Women allocated to gonadotrophins had a third live birth in 6 of 184 women (3.3%) and women allocated to CC had a third live birth in 14 of 190 women (7.4%). There were respectively 12 and 11 twins in the gonadotrophin and CC groups. The use of fertility treatments in the follow-up period was comparable between both groups. In the IUI group, a first live birth occurred in 158 of 192 women (82.3%) and while in the intercourse group, 146 of 182 women (80.2%) reached at least one live birth (RR: 1.03 95% CI 0.93-1.13; 2.13%, 95% CI -5.95, 10.21).; Limitations, Reasons for Caution: We have complete follow-up results for 57% of the women.There were 185 women who did not respond to the questionnaire, while 102 women had not been approached due to missing contact details. Five women had not started the original trial.; Wider Implications of the Findings: Women with normogonadotropic anovulation and CC failure have a high chance of reaching at least one live birth. In terms of pregnancy rates, the long-term differences between initially switching to gonadotrophins are small compared to continuing treatment with CC.; Study Funding/competing Interest(s): The original study received funding from the Dutch Organization for Health Research and Development (ZonMw number: 80-82310-97-12067). A.H. reports consultancy for development and implementation of a lifestyle App, MyFertiCoach, developed by Ferring Pharmaceutical Company. M.G. receives unrestricted grants for scientific research and education from Ferring, Merck and Guerbet. B.W.M. is supported by an NHMRC Investigatorgrant (GNT1176437). B.W.M. reports consultancy for ObsEva and Merck and travel support from Merck. All other authors have nothing to declare.; Trial Registration Number: This f llow-up study was registered in the OSF Register, https://osf.io/pf24m. The original M-ovin trial was registered in the Netherlands Trial Register, number NTR1449. (© The Author(s) 2023. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Bordon, Y. (2023). "CXCL8 blockade reduces fibrosis in endometriosis." Nature reviews. Immunology 23(4): 203.
	CXCL8 blockade reduces fibrosis in endometriosis Endometriosis is a common condition that leads to pain and infertility, but treatment options are limited. The disease is associated with chronic inflammation, and several inflammatory chemokines have been implicated in its progression. Here, the authors examined the expression of inflammatory genes in endometriotic tissue samples and identified the chemokine CXCL8 (also known as IL-8) and its receptors CXCR1 and CXCR2 as being highly upregulated in women with endometriosis. CXCL8 was also highly expressed in cynomolgus monkeys that spontaneously developed endometriosis, and preliminary experiments suggested that targeting CXCL8 reduced fibrotic disease in these animals. The authors engineered a long-lasting antibody against CXCL8 (AMY109) and showed that therapeutic delivery of this agent reduced disease in a surgically induced model of endometriosis in cynomolgus monkeys. AMY109 seemed to reduce the fibrotic disease associated with endometriosis, at least in part by blocking neutrophil recruitment and activation. The authors report that trials of AMY109 in humans are now underway. Original article: Nishimoto-Kakiuchi, A. et al. A long-acting anti–IL-8 antibody improves inflammation and fibrosis in endometriosis. Sci. Transl. Med. https://doi.org/10.1126/scitranslmed.abq5858 (2023)

Borghese, G., et al. (2021). "Adhesion barriers in laparoscopic myomectomy: Evidence from randomized clinical trials." International Journal of Gynecology and Obstetrics 152(3): 308-320.
	Objective: To evaluate the effectiveness of different adhesion barriers in the prevention of de novo adhesion development after laparoscopic myomectomy. Method(s): A systematic review was performed by searching seven electronic databases for all randomized clinical trials (RCTs) comparing the use of any absorbable adhesion barrier (i.e. intervention group) with either no treatment or placebo (i.e. control group) in the prevention of adhesion development after laparoscopic myomectomy. Result(s): Eight RCTs with a total of 748 participants (392 in the intervention group and 356 in the control group) were included. The assessed adhesion barrier methods were: oxidized regenerated cellulose (ORC) in two studies, auto-crosslinked hyaluronic acid (HA) gel in two studies, 4% icodextrin solution in one study, modified HA and carboxy-methylcellulose in one study, polyethylene glycol ester trilysine amine solution plus a borate buffer solution in one study, and polyethylene glycol amine plus dextran aldehyde polymers in another study. Conclusion(s): Adhesion barrier methods showing the most promising results were: ORC, auto-crosslinked HA gel, and polyethylene glycol amine plus dextran aldehyde polymers.Copyright © 2020 International Federation of Gynecology and Obstetrics

Borodulina, I. V., et al. (2024). "[Sacral magnetic stimulation in overactive bladder syndrome: comparative analysis of protocols with a frequency of 1 and 5 Hz]." Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury 101(1): 22-29.
	UNLABELLED: Peripheral magnetic stimulation (pMS) has shown its effectiveness in the treatment of lower urinary tract symptoms, such as symptoms of an overactive bladder (OAB). The perineal region (pelvic floor) and the sacral roots area (projection S3 of the root) are used as the locus of stimulation. The published literature presents protocols with different parameters of stimulation, while each of them reliably demonstrates clinical efficacy, however, no comparative studies have been found to select priority stimulation modes when analyzing available sources. OBJECTIVE: To compare the efficacy and safety of different frequency - 1 and 5 Hz - modes of sacral MS in patients with symptoms of OAB. MATERIAL AND METHODS: A single blind prospective randomized comparative clinical study included 59 patients with OAB symptoms. The patients were divided by simple randomization into the group 1 (n=30), which received MS 3 times a week for 5 weeks with a frequency of 1 Hz per sacral root area (S2-S4), and the group 2 (n=29), in which stimulation was performed at a frequency of 5 Hz, while the remaining parameters and duration of therapy were identical to group 1. RESULTS: Sacral pMS with different frequency modes (1 and 5 Hz) is reliably equally effective against the clinical symptoms of OAB, which is confirmed by the absence of significant intergroup differences. In patients receiving MS with a frequency of 5 Hz, there was a more pronounced increase in maximum cystometric capacity, normalization of the maximum and average urine flow velocity and regression of the residual urine volume (p<0.001, p=0.007, p=0.011 and p=0.012 compared with group 1). The greatest difference in indicators was observed in the increase in the maximum cystometric capacity - +31±25 ml at MS with a frequency of 1 Hz and +109±96 ml at MS with a frequency of 5 Hz (p<0.001). MS is a safe procedure and is well tolerated by patients. CONCLUSION: pMS when exposed to the area of S2-S4 roots for 20 minutes 3 times a week with a course for 5 weeks is reliably effective against the clinical symptoms of OAB at different frequency modes (1 and 5 Hz). At the same time, MS with a frequency of 5 Hz may have an advantage over stimulation of 1 Hz in terms of its effect on urodynamic parameters (maximum cystometric capacity, peak and average urine flow velocity and residual urine volume), which may be associated with a large inhibitory effect on detrusor.

Borrego-Jimenez, P. S., et al. (2021). "Improvement in Quality of Life with Pelvic Floor Muscle Training and Biofeedback in Patients with Painful Bladder Syndrome/Interstitial Cystitis." Journal of Clinical Medicine 10(4).
	OBJECTIVE: To prove the benefits of pelvic floor muscle training with biofeedback (BFB) as a complementary treatment in women with bladder pain syndrome/interstitial cystitis (BPS/IC). METHODS: Prospective, randomized study in 123 women with BPS/IC. Groups: BFB+ (n = 48): women with oral drug treatment (perphenazine and amitriptyline) plus intravesical instillations (sodium hyaluronate) plus pelvic floor muscle training with BFB; BFB-: (n = 75): women with oral drug treatment plus intravesical instillations. VARIABLES: age, body mass index (BMI), time of follow-up, length of disease, time free of disease, diseases and health conditions concomitant, and responses to the SF-36 health-related quality of life questionnaire at the first consultation (SF-36 pre-treatment), and at the end of the study (SF-36 post-treatment). The treatment was considered successful when the SF-36 score reached values equal to or greater than 80 points or when the initial value increased by 30 or more points. RESULTS: Mean age was 51.62 years old (23-82). BMI was higher in BFB-. The mean length of BPS/IC condition was 4.92 years (1-20), shorter in BFB+ than in BFB-. Mean SF-36 score pre-treatment was 45.92 points (40-58), lower in BFB+ than in BFB-. Post-treatment SF-36 score was higher than pre-treatment SF-36 score both in BFB+ and BFB-. SF-36 values were higher in BFB+ compared to BFB- over the follow-up. CONCLUSIONS: BFB improves quality of life in women with BPS/IC as adjunct therapy to combined oral and intravesical treatment.

Borrelli Eric, P. and G. McGladrigan Conor (2020). "Real-world evidence of poly ADP-ribose polymerase inhibitors in the treatment of ovarian cancer: A systematic literature review." Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners 26(8): 1977-1986.
	Objective: The treatment landscape for ovarian cancer has shifted in recent years with the approval of poly ADP-ribose polymerase inhibitors in 2014. Most patients with ovarian cancer have advanced disease at diagnosis. Understanding how treatments for advanced disease work in real-world settings must be assessed to provide care for these patients. Therefore, the objective of this study was to locate and assess real-world studies measuring the safety and effectiveness of poly ADP-ribose polymerase inhibitors and analyze the results. Data sources: A targeted systematic literature review was conducted in April 2020 of PubMed/Medline. Inclusion criteria consisted of observational studies using real-world data of olaparib, rucaparib, or niraparib as an intervention in the treatment of ovarian cancer. In addition, studies needed to assess either clinical effectiveness or safety. Once studies were identified, we aimed to narratively describe the studies' patient population, intervention effectiveness, and/or safety. Data summary: Our systematic review identified six studies assessing the real-world effectiveness and/or safety of poly ADP-ribose polymerase inhibitors, with five assessing olaparib, one assessing poly ADP-ribose polymerase inhibitors as a composite, and none assessing either niraparib or rucaparib. The median progression free survival in the real-world trials for olaparib ranged from 12.7 to 15.6 months. The median overall survival in the real-world trials for olaparib ranged from 30.9 to 35.4 months. Rates of treatment discontinuation due to adverse events for olaparib ranged from 4.4% to 12.5%.; Conclusions: The identified studies showed slightly higher, but comparable results for median progression free survival, median overall survival, and discontinuation due to adverse events compared to the respective randomized controlled trials.

Bosas, J., et al. (2023). "Factors affecting female sexual well-being: A 5-year follow-up of a randomised clinical trial on post-abortion contraception." BMJ Sexual and Reproductive Health: bmjsrh-2023.
	Introduction: Sexual well-being is associated with general well-being. Several factors, such as overweight, infertility, anxiety and sex hormones, also play a role, but the effects of hormonal contraception remain a point of debate. We characterised the factors associated with sexual well-being in fertile-aged women following induced abortion. Method(s): A 5-year follow-up of a nested, longitudinal, cohort study examining the effects of routine provision of intrauterine contraception as part of abortion care. Sexual well-being, anxiety and quality of life were assessed annually using validated questionnaires (McCoy Female Sexuality Questionnaire, State-Trait Anxiety Inventory and EuroQoL), along with data on general and reproductive health, and relationship status. Of the 742 women participating in the trial, 290 (39%) provided sufficient follow-up data and were included in this study. Result(s): Based on trajectories of McCoy scores across the 5-year follow-up, two groups were identified: those with stable and higher (n=223, 76.9%) and those with declining sexual well-being (n=67, 23.1%). Women in the group of declining sexual well-being had significantly higher levels of anxiety and lower quality of life at all time points. They also had chronic diseases more often and were less happy in their relationships. No differences were found in method of contraception when classified as hormonal versus non-hormonal, or long-acting versus short-acting reversible contraception. Conclusion(s): Lower anxiety and higher quality of life are associated with stable and higher sexual well-being. Method of contraception or relationship status are not associated with sexual well-being during long-term follow-up in fertile-aged women.Copyright © Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.

Bosch, E., et al. (2023). "Serum progesterone is lower in ovarian stimulation with highly purified HMG compared to recombinant FSH owing to a different regulation of follicular steroidogenesis: a randomized controlled trial." Human reproduction (Oxford, England).
	STUDY QUESTION: Does ovarian stimulation with highly purified (hp)-HMG protect from elevated progesterone in the follicular phase compared to recombinant FSH (r-FSH) cycles through a different regulation of follicular steroidogenesis? SUMMARY ANSWER: hp-HMG enhanced the Δ4 pathway from pregnenolone to androstenodione leading to lower serum progesterone at the end of the cycle, while r-FSH promoted the conversion of pregnenolone to progesterone causing higher follicular phase progesterone levels. WHAT IS KNOWN ALREADY: Elevated progesterone in the follicular phase has been related to lower clinical outcome in fresh IVF cycles. Progesterone levels are positively correlated to ovarian response, and some studies have shown that when r-FSH alone is used for ovarian stimulation serum progesterone levels on the day of triggering are higher than when hp-HMG is given. Whether this is caused by a lower ovarian response in hp-HMG cycles or to a difference in follicular steroidogenesis in the two ovarian stimulation regimens has not been well characterized. STUDY DESIGN, SIZE, DURATION: A randomized controlled trial including 112 oocyte donors undergoing ovarian stimulation with GnRH antagonists and 225 IU/day of r-FSH (n = 56) or hp-HMG (n = 56) was carried out in a university-affiliated private infertility clinic. Subjects were recruited between October 2016 and June 2018. PARTICIPANTS/MATERIALS, SETTING, METHODS: The women were aged 18-35 years with a regular menstrual cycle (25-35 days) and normal ovarian reserve (serum anti-Müllerian hormone (AMH) = 10-30 pMol/l) undergoing ovarian stimulation for oocyte donation. FSH, LH, estradiol (E2), estrone, progesterone, pregnenolone, 17-OH-progesterone, androstenodione, dehidroepiandrostenodione, and testosterone were determined on stimulation Days 1, 4, 6, and 8 and on day of triggering in serum and in follicular fluid. Samples were frozen at -20°C until assay. Total exposures across the follicular phase were compared by polynomic extrapolation. MAIN RESULTS AND THE ROLE OF CHANCE: Subjects in both groups were comparable in terms of age, BMI, and AMH levels. Ovarian response was also similar: 17.5 ± 7.9 (mean ± SD) versus 16.5 ± 7.5 oocytes with r-FSH and hp-HMG, respectively (P = 0.49). Serum progesterone (ng/ml) on day of trigger was 0.46 ± 0.27 in the hp-HMG group versus 0.68 ± 0.50 in the r-FSH group (P = 0.010). Differences for progesterone were also significant on stimulation days 6 and 8. The pregnenolone: progesterone ratio was significantly increased in the r-FSH group from stimulation day 8 to the day of trigger (P = 0.019). Serum androstenodione (ng/ml) on day of trigger was 3.0 ± 1.4 in the hp-HMG group versus 2.4 ± 1.1 in the r-FSH group (P = 0.015). Differences in adrostenodione were also significant on stimulation Day 8. The pregnenolone:androstenodione ratio was significantly higher in the hp-HMG group (P = 0.012) on Days 6 and 8 and trigger. There were no other significant differences between groups. Follicular fluid E2, FSH, LH, dehidroepioandrostenodione, androstenodione, and testosterone were significantly higher in the hp-HMG than r-FSH group. No differences were observed for progesterone, estrone, 17-OH-progesterone, and pregnenolone in follicular fluid. LIMITATIONS, REASONS FOR CAUTION: All women included in the study were young, not infertile, and had a normal BMI and a good ovarian reserve. The findings might be different in other patient subpopulations. Hormone analyses with immunoassays are subject to intra-assay variations that may influence the results. WIDER IMPLICATIONS OF THE FINDINGS: Stimulation with hp-HMG may prevent progesterone elevation at the end of the follicular phase because of a different follicular steroidogenesis pathway, regardless of ovarian response. This should be considered, particularly in patients at risk of having high progesterone levels at the end of the follicular phase when a fresh embryo transfer is planned. STUDY FUNDING/COMPETING INTEREST(S): Roche Diag ostics provided unrestricted funding for all serum and follicular fluid hormone determinations. J.L.R., M.M., and A.P. have nothing to declare. E.B. has received consulting fees from Ferring, Merck, Gedeon Richter, and Roche and has participated in a research cooperation with Gedeon-Richter. In addition, the author has participated in speakers' bureau and received fees from Ferring, Gedeon Richter, Merck, and Roche. P.A. has received consulting fees from MSD and has participated in speakers' bureau and received fees from Ferring. P.A. also declares travel/meeting support from MSD. E.L. has received consulting fees from Ferring and MSD. In addition, the author has participated in a research cooperation with Gedeon-Richter. Also, the author has participated in speakers' bureau and received fees from Ferring and IBSA, as well as travel/meeting support from IBSA and Gedeon Richter. E.B., P.A., and E.L. also own stocks in IVIRMA Valencia. TRIAL REGISTRATION NUMBER: NCT: NCT02738580. TRIAL REGISTER DATE: 19 February 2016. DATE OF FIRST PATIENT’S ENROLMENT: 03 October 2016.

Bosdou Julia, K., et al. (2020). "Risk of gestational diabetes mellitus in women achieving singleton pregnancy spontaneously or after ART: a systematic review and meta-analysis." Human Reproduction Update 26(4): 514-544.
	Background: Women who achieve pregnancy by ART show an increased risk of obstetric and perinatal complications compared with those with spontaneous conception (SC).; Objective and Rationale: The purpose of this systematic review and meta-analysis was to synthesize the best available evidence regarding the association between ART and gestational diabetes mellitus (GDM) in women with singleton pregnancies. The research question asked was whether the risk of GDM is higher in women achieving singleton pregnancy by ART compared with those achieving singleton pregnancy spontaneously.; Search Methods: A literature search, in MEDLINE, Scopus and Cochrane databases, covering the period 1978-2019, was performed aiming to identify studies comparing the risk of GDM in singleton pregnancies after ART versus after SC. Both matched and unmatched studies were considered eligible. Meta-analysis of weighted data was performed using the random effects model. Results were reported as risk ratio (RR) with 95% CI. Heterogeneity was quantified with the I2 index.; Outcomes: The study reports on 63 760 women who achieved a singleton pregnancy after ART (GDM was present in 4776) and 1 870 734 women who achieved a singleton pregnancy spontaneously (GDM in 158 526). Women with singleton pregnancy achieved by ART showed a higher risk of GDM compared with those with singleton pregnancy achieved spontaneously (RR 1.53, 95% CI 1.39-1.69; I2 78.6%, n = 37, 1 893 599 women). The direction or the magnitude of the effect observed did not change in subgroup analysis based on whether the study was matched (n = 17) or unmatched (n = 20) (matched: RR 1.42, 95% CI 1.17-1.72; I2 61.5%-unmatched: RR 1.58, 95% CI 1.40-1.78; I2 84.1%) or whether it was prospective (n = 12) or retrospective (n = 25) (prospective studies: RR 1.52, 95% CI 1.27-1.83, I2 62.2%-retrospective studies: RR 1.53, 95% CI 1.36-1.72, I2 82.5%). Regarding the method of fertilization, a higher risk of GDM after ART versus SC was observed after IVF (n = 7), but not after ICSI (n = 6), (IVF: RR 1.95, 95% CI 1.56-2.44, I2 43.1%-ICSI: RR 1.42, 95% CI 0.94-2.15, I2 73.5%). Moreover, regarding the type of embryo transfer (ET), a higher risk of GDM after ART versus SC was observed after fresh (n = 14) but not after frozen (n = 3) ET (fresh ET: RR 1.38, 95% CI 1.03-1.85, I2 75.4%-frozen ET: RR 0.46, 95% CI 0.10-2.19; I2 73.1%). A higher risk of GDM was observed after ART regardless of whether the eligible studies included patients with polycystic ovary syndrome (RR 1.49, 95% CI 1.33-1.66, I2 75.0%) or not (RR 4.12, 95% CI 2.63-6.45, I2 0%), or whether this information was unclear (RR 1.46, 95% CI 1.22-1.75, I2 77.7%).; Wider Implications: The present systematic review and meta-analysis, by analysing 1 893 599 women, showed a higher risk of GDM in women achieving singleton pregnancy by ART compared with those achieving singleton pregnancy spontaneously. This finding highlights the importance of early detection of GDM in women treated by ART that could lead to timely and effective interventions, prior to ART as well as during early pregnancy. (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology.)

Bostwick, D. G., et al. (2023). "FIRST-IN-HUMAN PHASE 2 CLINICAL TRIAL OF MULTIPLEX COMBINATION INTRATUMORAL IMMUNOTHERAPY (MCII) IN PATIENTS WITH METASTATIC SOLID CANCER (ABSCOPAL 5001 TRIAL)." Journal for Immunotherapy of Cancer 11(Supplement 1): A801.
	Background Little is known of the synergy of combination intratumoral immunotherapy and ablation. We undertook a Phase 2 trial (Abscopal 5001) for patients with metastatic solid cancer (NCT04713371) to assess the safety and efficacy of cryoablation with concurrent injections of low-dose checkpoint inhibitors and chemotherapy, referred to as Multiplex Combination Intratumoral Immunotherapy (MCII). Methods Twelve patients with metastatic cancer and one with sacral chordoma received at least one intratumoral treatment of MCII, preceded by 3-5 days of oral cyclophosphamide. MCII consisted of CT-guided cryoablation followed by intratumoral injection of ipilimumab, pembrolizumab, and cyclophosphamide. GM-CSF was subcutaneously administered daily for a total of 4 weeks. Treatment was repeated every 4-6 weeks if tumor burden remained stable or reduced as noted by iRECIST criteria. Criteria were modified when follow-up biopsies revealed pathology with minimal or no cancer despite persistent mass(es) on imaging. Results Cancers included prostate (4 patients), sarcoma (2), and 1 each of breast, colon, bladder, uterine cervix, tongue, kidney, and sacral chordoma. Eight patients received at least 3 cycles of treatment, two received 2, and three received 1. All patients tolerated the outpatient procedure well and were discharged within 2 hours. Adverse event rate was 69%, all of which were Grade 1 or 2 except for one with delayed cryosurgical complication. At completion of up to 3 cycles of treatment. partial response (iPR) was observed in 5 patients (38.5%) and stable disease (iSD) in 5 (38.5%), for a disease control rate (iDCR) of 77%; progression was observed in 23%. Disparity between post-treatment imaging and pathologic findings was observed in 4 patients, requiring modification of the iRECIST criteria. Best response ranged from 0-91%, with a mean for responding patients of 38%. Injection site response was observed in 9 (69%), and distal abscopal effect was seen in 4 (31%), including one sarcoma patient with complete abscopal response of lung metastases. Biopsy-confirmed resolution of liver metastases was also noted in the bladder cancer patient. Patients are being followed to determine duration of response. Conclusions MCII appears promising, providing 77% disease control rate with manageable, predominantly low-grade adverse events in patients with metastatic cancer. Modification of iRECIST criteria for intratumoral treatment is needed to redefine the primary treatment site response and accommodate disparities between imaging (positive) and pathologic findings (minimal or negative disease).

Bou, K., et al. (2021). "[Home-based devices for the treatment of female urinary incontinence: A literature review]." Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie 31(4): 186-194.
	OBJECTIVE: Literature review on the home-based options for the conservative management of stress urinary incontinence including biofeedback and weighted vaginal cones.. METHODS: Research was conducted in the Cochrane Library and Pubmed to find articles, published until March 2020, dealing with the conservative management of incontinence. RESULTS: A total of 9 randomized controlled trials were included, 4 concerning biofeedback and 5 concerning vaginal cones. Most of them highlighted the superiority of these three methods compared to the absence of treatment but were not superior compared to the pelvic floor muscles training in the clinic setting. CONCLUSION: Home-based devices for female stress urinary incontinence is a safe and effective treatment for female urinary incontinence. It has not shown superiority to physiotherapist-guided pelvic floor muscle reinforcement and needs more evidence to gain its place as a first line therapeutic option.

Bou, K., et al. (2022). "OAB supraspinal control network, transition with age, and effect of treatment: A systematic review." Neurourology and Urodynamics.
	OBJECTIVE: In light of a better understanding of supraspinal control of nonneurogenic overactive bladder (OAB), the prevalence of which increases with age, functional imaging has gained significant momentum. The objective of this study was to perform a systematic review on the transition of supraspinal control of OAB with age, the effect of therapeutic modalities, and a coordinate-based meta-analysis of all neuroimaging evidence on supraspinal OAB control in response to bladder filling. METHODOLOGY: We performed a systematic literature search of all relevant libraries in November 2021. The coordinates of brain activity were extracted from eligible neuroimaging studies to perform an activation likelihood estimation (ALE) meta-analysis. RESULTS: A total of 16 studies out of 241 were selected for our systematic review. Coordinates were extracted from five experiments involving 70 patients. ALE meta-analysis showed activation of the insula, supplementary motor area, dorsolateral prefrontal cortex, anterior cingulate gyrus, and temporal gyrus with a transition of activation patterns with age, using a threshold of uncorrected p < 0.001. Among young patients, neuroplasticity allows the activation of accessory circuits to maintain continence, as in the cerebellum and temporoparietal lobes. Anticholinergics, pelvic floor muscle training, sacral neuromodulation, and hypnotherapy are correlated with supraspinal changes attributed to adaptability and possibly a substratum of an intrinsic supraspinal component. The latter is better demonstrated by a resting-state functional connectivity analysis, a promising tool to phenotype OAB with recent successful models of predicting severity and response to behavioral treatments. CONCLUSION: Future neuroimaging studies are necessary to better define an OAB neurosignature to allocate patients to successful treatments.

Bouchard, C. (2022). "Bleeding Patterns with Use of an Oral Contraceptive Containing Estetrol and Drospirenone: Pooled Analysis of Phase-3 Clinical Trials." Journal of Obstetrics and Gynaecology Canada 44(5): 603.
	Objectives: To evaluate bleeding patterns with use of a 24/4-day novel combined oral contraceptive regimen containing estetrol, a natural estrogen, and drospirenone. Method(s): Bleeding data from two parallel, multicentre, open-label, phase-3 trials (United States/Canada and Europe/Russia) were pooled. Healthy participants aged 16-50 years with body mass index of <=35.0 kg/m2 used estetrol 15 mg/drospirenone 3 mg for up to 13 cycles. Participants reported vaginal bleeding (blood loss requiring use of sanitary protection) or spotting (minimal blood loss, requiring no new use of sanitary protection) on daily diaries. Bleeding outcomes were evaluated in participants that started treatment and had at least 1 evaluable cycle. Mean frequency of scheduled and unscheduled bleeding and/or spotting and median duration of bleeding and/or spotting episodes were calculated. Result(s): Of 3417 participants starting treatment, 3265 were included in the bleeding analysis. Mean reported treatment compliance was >=99%. Across cycles, 87.2-90.4% of participants reported scheduled bleeding/spotting, with a median duration of 4-5 days/cycle. Unscheduled bleeding/spotting frequency decreased from 27.1% in Cycle 1 to <17.5% from Cycle 5 onwards, with a median duration of 3-4 days/cycle and most episodes (62.7%) were spotting-only. Of 2234 women completing 13 cycles, 754 (34%) reported unscheduled bleeding/spotting in only 1 or 2 cycles and 911 (41%) did not report any unscheduled bleeding/spotting. The most common bleeding adverse events (AEs) considered treatment-related were 'metrorrhagia' (159 [4.7%]) and 'vaginal hemorrhage' (101 [3.0%]). One hundred four (3.0%) participants discontinued for a bleeding-related AE. Conclusion(s): Most users of estetrol/drospirenone oral contraceptive experienced a predictable bleeding pattern and limited unscheduled bleeding. Keywords: estetrol; oral contraceptive; bleeding profile; drospirenoneCopyright © 2022

Bouchard, C., et al. (2023). "Effects of E4/DRSP on self-reported physical and emotional premenstrual and menstrual symptoms: Pooled data from two phase 3 clinical trials." Journal of Obstetrics and Gynaecology Canada 45(5): 349-350.
	Objectives: To describe the effects of estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg (24/4 regimen) on premenstrual and menstrual symptoms. Method(s): We pooled Menstrual Distress Questionnaire (MDQ) data from two open-label, phase-3 trials. The studies enrolled participants aged 16-50 years to use E4/DRSP for up to 13 cycles and included starters (no hormonal contraception use in the prior 3 months) and switchers. Participants completed MDQs at study entry and exit. For this analysis, we evaluated 4 MDQ domains (Pain [6 symptoms]; Water Retention [4 symptoms]; Negative Affect [8 symptoms]; and Impaired Concentration [8 symptoms] by converting raw total scores to t-scores for each domain using the MDQ manual, resulting in minimum domain t-scores ranging from 31-40 and maximum scores from 103-159. We compared changes in premenstrual (4 days before most recent flow) and menstrual (most recent flow) outcomes from baseline to end-of-trial using student's t-test. Result(s): Of 3417 treated participants, 2707 (79.2%) completed both MDQs, of whom 1207 (44.6%) were starters. Across the 4 domains, mean baseline t-scores were in the lower range (45-50). Starters reported improvements for menstrual Pain (-3.41, P <0.0001), premenstrual Water Retention (-2.29, P <0.0001), menstrual Water Retention (-2.58, P <0.0001), premenstrual Negative Affect (-1.77, P <0.0001) and menstrual Negative Affect (-1.72, P <0.0001), but not for premenstrual Impaired Concentration (-0.65, P =0.10) or menstrual Impaired Concentration (-0.44, P =0.32). For switchers, none of the differences were significant. Conclusion(s): Overall, E4/DRSP starters experienced improvements in menstrual pain and premenstrual and menstrual negative affect and water retention symptoms. Switchers showed no change.Copyright © 2023

Bouchard, M. E., et al. (2023). "The use of tissue adhesive in management of genitourinary fistulas: a systematic review and case report." International Urogynecology Journal 34(2): 445-451.
	Introduction and hypothesis: Articles are getting published on the use of tissue adhesive for vesicovaginal fistula. The objective is to carry out a systematic review on their effectiveness and complications. Method(s): A systematic review of the literature was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Two reviewers screened abstracts and full-text and extracted data independently. A narrative synthesis was conducted given the heterogeneity of studies. Result(s): A total of 1032 studies were identified after searching the database, and 14 articles were included in this systematic review. Of the 84 women included, 12 (14.3%) presented failure or recurrence of their fistula tract. The mean time of follow-up was 11.46 months. The average size of the fistula was 1.05 (range 0.1 to 3.9) cm. Most fistulas (81) included were vesicovaginal fistulas. Nine papers reported the usage of fibrin glue in which only three (6.5%) women reported recurrence of the fistula in a delay of 2 weeks to 26 months. The other studies used cyanoacrylate (14 women) and autologous fibrin injection from the patients' blood (31 women). No significant complications were reported. Complications reported were urinary tract infections in 3 women (3.6%), hematuria in 2 women (2.4%), overactive bladder symptoms in 6 women (7.2%) and septic pelvic thrombosis in one woman (1.2%). Conclusion(s): Tissue adhesive appears to be a promising alternative for management of urogenital fistulas without reported important complications.Copyright © 2022, The International Urogynecological Association.

Boulos, S., et al. (2023). "Management of a Large Endometriotic Nodule of the Right Parametrium Involving the Sacral Roots, Vagina, Rectum and Sigmoid Colon, with Intraoperative Bleeding." Journal of Minimally Invasive Gynecology 30(5): 357-358.
	OBJECTIVE: Deep endometriotic lesions may involve the deep parametrium which is highly vascular and includes numerous somatic and autonomous nerves (1,2). Surgeons who dissect in this area, must always be prepared to deal with major bleeding, and to master the different techniques of hemostasis. The goal of this video is to show the steps of laparoscopic excision of deep endometriotic lesion of the parametrium and the steps taken to control the bleeding encountered from one of the venous branches. DESIGN: Surgical educational video. SETTING: Endometriosis referral center. INTERVENTION: Excision of the endometriotic parametrial nodule and the release of the sacral plexus, with excision of the vaginal involvement, rectal disc excision, and segmental resection of the sigmoid colon. The video shows the excision of a deep endometriosis involving the right parametrium, the mid rectum, the sigmoid colon, and the vagina. The excision of deep endometriosis of the parametrium followed the 10 steps previously described (1). During this procedure, careful dissection of arteries and veins branching from the internal iliac vessels is a crucial step. However, injury of one or more of the vessels can still occur. The movie presents the different techniques used to control the bleeding from a venous injury faced during the dissection around the nodule in the parametrium, including energy use, clips, hem-o-loks, and direct continuous pressure. Of note, hemostatic agents are available, however we have not yet successfully employed them in these circumstances in which large veins were injured. The ultimate solution in our case was the clamping of the injured vessels, allowing meticulous dissection and sectioning of all the feeding vessels, while taking care not to injure the sacral roots which were just beneath these veins. Total operative time was 4 hours. CONCLUSION: Surgery of deep endometriosis involving the sacral plexus may be successfully done laparoscopically. Thorough knowledge of the deep pelvis anatomy is mandatory, and the surgeon should master various techniques of hemostasis, particularly on deep veins.

Boulter, A. C., et al. (2023). "Phase I trial of intravenous fenretinide (4-HPR) plus safingol in advanced malignancies." Cancer Chemotherapy and Pharmacology 92(2): 97-105.
	Purpose: Fenretinide (4-HPR) is a synthetic retinoid that induces cytotoxicity through dihydroceramide production. Safingol, a stereochemical-variant dihydroceramide precursor, exhibits synergistic effects when administered with fenretinide in preclinical studies. We conducted a phase 1 dose-escalation clinical trial of this combination. Method(s): Fenretinide was administered as a 600 mg/m2 24-h infusion on Day 1 of a 21-day cycle followed by 900 mg/m2/day on Days 2 and 3. Safingol was concurrently administered as a 48-h infusion on Day 1 and 2 using 3 + 3 dose escalation. Primary endpoints were safety and maximum tolerated dose (MTD). Secondary endpoints included pharmacokinetics and efficacy. Result(s): A total of 16 patients were enrolled (mean age 63 years, 50% female, median three prior lines of therapy), including 15 patients with refractory solid tumors and one with non-Hodgkin lymphoma. The median number of treatment cycles received was 2 (range 2-6). The most common adverse event (AE) was hypertriglyceridemia (88%; 38% >= Grade 3), attributed to the fenretinide intralipid infusion vehicle. Other treatment-related AEs occurring in >= 20% of patients included anemia, hypocalcemia, hypoalbuminemia, and hyponatremia. At safingol dose 420 mg/m2, one patient had a dose-limiting toxicity of grade 3 troponinemia and grade 4 myocarditis. Due to limited safingol supply, enrollment was halted at this dose level. Fenretinide and safingol pharmacokinetic profiles resembled those observed in monotherapy trials. Best radiographic response was stable disease (n = 2). Conclusion(s): Combination fenretinide plus safingol commonly causes hypertriglyceridemia and may be associated with cardiac events at higher safingol levels. Minimal activity in refractory solid tumors was observed. Trial registration number: NCT01553071 (3.13.2012).Copyright © 2023, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Bourdel, N., et al. (2019). "Systematic review of quality of life measures in patients with endometriosis." PloS One 14(1): e0208464.
	Objectives Endometriosis and quality of life has been the subject of much research, however, there is little consensus on how best to evaluate quality of life in endometriosis, resulting in many and diverse scales being used. In our study, we aim to identify quality of life scales used in endometriosis, to review their strengths and weaknesses and to establish what would define an ideal scale in the evaluation of endometriosis-related quality of life. Materials and methods A search of the MEDLINE and EMBASE databases was carried out for publications in English and French for the period from 1980 to February 2017, using the words 'endometriosis' and 'quality of life'. Publications were selected if they reported on quality of life in patients with endometriosis and specified use of a quality of life scale. A quantitative and a qualitative analysis of each scale was performed in order to establish the strengths and weaknesses for each scale (systematic registration number: PROSPERO 2014: CRD42014014210). Results A total of 1538 articles publications were initially identified. After exclusion of duplicates and application of inclusion criteria, 201 studies were selected for analysis. The SF-36, a generic HRQoL measure, was found to be the most frequently used scale, followed by the EHP-30, a measure specific to endometriosis. Both perform well, when compared with other scales, with scale weaknesses offset by strengths. EHP-5 and EQ-5D also showed to be of good quality. All four were the only scales to report on MCID studied in endometriosis patients. Conclusion For clinical practice, routine evaluation of HRQOL in women with endometriosis is essential both for health-care providers and patients. Both SF-36 and EHP-30 perform better overall with regard to their strengths and weaknesses when compared to other scales.Copyright © 2019 Bourdel et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Bourdon, M., et al. (2024). "Impact of Endometriosis Surgery on In Vitro Fertilization/Intracytoplasmic Sperm Injection Outcomes: a Systematic Review and Meta-analysis." Reproductive sciences (Thousand Oaks, Calif.).
	Endometriosis-related infertility remains a therapeutic challenge. A burning issue in this field of research is determining whether pre-assisted reproductive technology (ART) surgery may be of some benefit in terms of reproductive outcomes. This systematic review and meta-analysis aimed at comparing ongoing pregnancy rates (OPR) and/or live birth rates (LBR) in patients who underwent endometriosis surgery before ART (IVF/ICSI) in comparison with patients who underwent first-line ART (IVF/ICSI). Searches were conducted from January 1990 to June 2021 on PubMed, Embase, and Cochrane Library using the following search terms: endometriosis, surgery, reproductive outcomes, and IVF/ICSI. The primary outcomes were OPR or LBR. A total of 19 studies were included in the meta-analysis. No statistically significant differences in LBR [0.91[0.63, 1.30]; I 2 = 66%; n = 11], OPR [1.28[0.66, 2.49]; I 2 = 60%; n = 3], and early pregnancy loss rate [0.88[0.62, 1.25]; I 2 = 0%; n = 7] per cycle were found when comparing patients who underwent endometriosis surgery before IVF/ICSI and those who did not. After the exclusion of the studies with high risks of bias, the LBR per cycle was significantly reduced in the case of surgical treatment before IVF/ICSI [0.53[0.33, 0.86]; I 2 = 30%; n = 4]. These data urge the clinician to carefully weigh the pros and cons before referring infertile patients with endometriosis to surgery before IVF, highlighting the key role of multidisciplinary referral centers. (© 2023. The Author(s), under exclusive licence to Society for Reproductive Investigation.)

Bourdon, M., et al. (2023). "The 'freeze-all' strategy seems to improve the chances of birth in adenomyosis affected women." Fertility and Sterility.
	OBJECTIVE: To compare assisted reproductive technologies(ART) outcomes between fresh versus freeze-all strategies in infertile women affected with adenomyosis. DESIGN: A single-center observational study SETTINGS: University hospital-based research center PATIENTS: Adenomyosis-affected women undergoing blastocyst embryo transfer following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) between 01/01/2018 and 31/11/2021. The diagnosis of adenomyosis was based on imaging criteria (i.e., transvaginal ultrasound and/or magnetic resonance imaging). INTERVENTION(S): Women who underwent a freeze-all strategy were compared to those who underwent a fresh embryo transfer (ET) strategy. MAIN OUTCOME MEASURE(S): cumulative live birth rate (LBR) RESULTS: A total of 306 women were included in the analysis: 111 in the fresh ET group and 195 in the freeze-all group. The adenomyosis phenotype (internal diffuse adenomyosis, external focal adenomyosis, and adenomyoma) was not significantly different between the two groups. The cumulative LBR [86 (44.1%) vs. 34 (30.6%), respectively; p = 0.020] and the cumulative ongoing pregnancy rate [88 (45.1%) versus 36 (32.4%), respectively; p = 0.029] were significantly higher in the freeze-all group compared to the fresh ET group. After multivariate logistic regression analysis, the freeze-all strategy in women with adenomyosis was associated with significantly higher odds of live birth compared to fresh ET (OR = 1.80; 95% CI = 1.02-3.16). CONCLUSION: The freeze-all strategy in women afflicted with adenomyosis undergoing ART was associated with significantly higher cumulative live birth rates. Our preliminary results suggest that the freeze-all strategy is an attractive option that increase ART success rates. Additional studies, with a randomized design, should be conducted to further test whether the freeze-all strategy enhances the pregnancy rate in adenomyosis-affected women.

Boutas, I., et al. (2021). "The expression of Galectin-3 in endometrial cancer: a systematic review of the literature." Molecular biology reports 48(7): 5699-5705.
	Background: Galectin-3 is part of a protein group called lectins and acts as a multifunctional glycoprotein due to its expression location. Galectin-3 is expressed by different human tissues. It plays a significant role in carcinogenesis and the selection of tumor-related physiological and pathological activities. Galectin-3 has been utilized through the years as a diagnostic and prognostic marker for various types of cancers.; Methods and Results: This review describes the outcomes of some studies on the matter that were selected appropriately through a review of the existing literature. These studies examined the levels of Galectin-3 expression in endometrial carcinomas, the outcomes, and the prognosis of these carcinomas. Two of the studies concluded that high expression of Galectin-3 is associated with a tumor's histological grade, type and depth. This enhanced nuclear Galectin-3 expression might assist in progression to atypia and neoplasia. The other three on the contrary concluded that malignant tumors had a decreased expression of Galectin-3 and that Galectin-3 played a suppressive role in tumor growth.; Conclusions: The part Galectin-3 might potentially have in metastasis of cancers and the offering of a better prognosis for patients is of high importance. To date, there is minimal literature regarding the effects of Galectin-3 and more research is required. (© 2021. The Author(s), under exclusive licence to Springer Nature B.V.)

Bouteaud, J., et al. (2022). "Impact of a 12-minute educational video prior to initial consultation in a Mature Women's Health and Menopause Clinic." Menopause 29(7): 856-860.
	Objectives: Assess acceptability of a 12-minute educational video before menopause clinic consultation and evaluate its impact on knowledge and treatment certainty. Method(s): This was a pre-post intervention study among new patients with vasomotor symptoms (VMS) referred to a menopause clinic in Toronto, Canada. Participants completed electronic questionnaires before and after viewing a 12-minute online video covering menopause facts and VMS treatments. Participants' demographic information and referring provider type were recorded. A 19-item true/false knowledge quiz and validated Decision Conflict Scale (DCS) were administered before and after viewing the video along with a validated Acceptability questionnaire after the video. Demographic information and acceptability were summarized descriptively and independent samples t tests compared knowledge and DCS total and subscores before and after viewing the education module. Multivariable analysis was used to identify factors associated with achieving treatment certainty. Result(s): Seventy-one participants completed pre- and postintervention questionnaires. Mean age was 51.4 +/- 6.0 years and most were White (58/71, 81.7%), had a university degree (24/71, 63.3%) and household income >$90,000 (53/71, 74.6%). After the video, there was significant increase in knowledge score (12.7 +/- 2.1 vs. 16.9 +/- 1.8, P < 0.001) and decrease in all DCS scores (total and five subscores) compared with preintervention scores (P < 0.001). Acceptability was high with 62/71 (87.3%) respondents indicating the tool was useful. Findings were independent of level of education, household income, and referring physician type. Conclusion(s): In a study of predominantly university-educated White women, a 12-minute education module on menopause and VMS treatment was acceptable, there was improved knowledge and decision certainty about VMS treatment.Copyright © 2022 by The North American Menopause Society.

Bowen, S. T., et al. (2021). "Defining mechanisms of recurrence following apical prolapse repair based on imaging criteria." American Journal of Obstetrics and Gynecology 225(5): 506.e501-506.e528.
	BACKGROUND: Prolapse recurrence after transvaginal surgical repair is common; however, its mechanisms are ill-defined. A thorough understanding of how and why prolapse repairs fail is needed to address their high rate of anatomic recurrence and to develop novel therapies to overcome defined deficiencies. OBJECTIVE: This study aimed to identify mechanisms and contributors of anatomic recurrence after vaginal hysterectomy with uterosacral ligament suspension (native tissue repair) vs transvaginal mesh (VM) hysteropexy surgery for uterovaginal prolapse. STUDY DESIGN: This multicenter study was conducted in a subset of participants in a randomized clinical trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Overall, 94 women with uterovaginal prolapse treated via native tissue repair (n=48) or VM hysteropexy (n=46) underwent pelvic magnetic resonance imaging at rest, maximal strain, and poststrain rest (recovery) 30 to 42 months after surgery. Participants who desired reoperation before 30 to 42 months were imaged earlier to assess the impact of the index surgery. Using a novel 3-dimensional pelvic coordinate system, coregistered midsagittal images were obtained to assess study outcomes. Magnetic resonance imaging-based anatomic recurrence (failure) was defined as prolapse beyond the hymen. The primary outcome was the mechanism of failure (apical descent vs anterior vaginal wall elongation), including the frequency and site of failure. Secondary outcomes included displacement of the vaginal apex and perineal body and change in the length of the anterior wall, posterior wall, vaginal perimeter, and introitus of the vagina from rest to strain and rest to recovery. Group differences in the mechanism, frequency, and site of failure were assessed using the Fisher exact tests, and secondary outcomes were compared using Wilcoxon rank-sum tests. RESULTS: Of the 88 participants analyzed, 37 (42%) had recurrent prolapse (VM hysteropexy, 13 of 45 [29%]; native tissue repair, 24 of 43 [56%]). The most common site of failure was the anterior compartment (VM hysteropexy, 38%; native tissue repair, 92%). The primary mechanism of recurrence was apical descent (VM hysteropexy, 85%; native tissue repair, 67%). From rest to strain, failures (vs successes) had greater inferior displacement of the vaginal apex (difference, -12 mm; 95% confidence interval, -19 to -6) and perineal body (difference, -7 mm; 95% confidence interval, -11 to -4) and elongation of the anterior vaginal wall (difference, 12 mm; 95% confidence interval, 8-16) and vaginal introitus (difference, 11 mm; 95% confidence interval, 7-15). CONCLUSION: The primary mechanism of prolapse recurrence following vaginal hysterectomy with uterosacral ligament suspension or VM hysteropexy was apical descent. In addition, greater inferior descent of the vaginal apex and perineal body, lengthening of the anterior vaginal wall, and increased size of the vaginal introitus with strain were associated with anatomic failure. Further studies are needed to provide additional insight into the mechanism by which these factors contribute to anatomic failure.

Boyd, B., et al. (2022). "Surgical Treatment of Stress Urinary Incontinence and Complications Stratified by Race and Ethnicity." International Urogynecology Journal 33(Supplement 2): S296-S297.
	Introduction: Midurethral sling (MUS) is the gold standard for the surgical treatment of stress urinary incontinence (SUI). Despite this, White and Hispanic women are more likely to undergo MUS than Black and Asian women. In the United States, White women undergo surgical treatment at a rate almost five times higher than Black women, however the perioperative complication rate for Black women is twice that of White women. This highlights our limited understanding of the racial and ethnic differences among treatment and outcomes of SUI, which has important implications for the provision of more equitable care. Objective(s): To evaluate racial and ethnic differences in the surgical treatment of SUI and associated complications. Method(s): This is a cross-sectional study of women undergoing surgical treatment for SUI between 2015 and 2020 using data from the American College of Surgeons National Surgical Quality Improvement Program. We included patients with SUI who underwent certain anti-incontinence procedures: open Marshall-Marchetti-Krantz procedure (MMK) or Burch urethropexy (CPT 51840, 51841), laparoscopic Burch urethropexy (CPT 51990, 51992) and sling (fascia and synthetic mesh CPT 57288). Complications were evaluated individually and with Clavien Dindo classification, and included mesh erosion, sling revision, blood transfusion, thrombosis, urinary tract infection and readmission within 30 days. Logistic regression models controlling for age, comorbidities and concurrent hysterectomy were used to assess associations between race/ethnicity and type of anti-incontinence procedure and 30-day postoperative complications. Result(s): A total of 23,193 eligible surgical cases were identified, including 223 (1.0%) open MMK/Burch urethropexy, 366 (1.6%) laparoscopic Burch urethropexy, and 22,604 (97.5%) slings. The population was 59.4% Non-Hispanic White, 11.7% Hispanic, 3.4% Non-Hispanic Black, 2.7% Asian, 0.6% Native Hawaiian or Pacific Islander, 0.6% American Indian or Alaska Native, and 21.6% Unknown. In bivariate analysis, American Indian or Alaska Native women were more likely to have an open MMK/Burch urethropexy compared to White women (2.2% vs 1.0%; p<.0001). Black women were more likely to have an open MMK/ Burch urethropexy compared to White women (1.5% vs 0.6%; p<.0001). Native Hawaiian or Pacific Islander women were more likely to have a laparoscopic Burch urethropexy compared to White women (4.7% vs 1.6%; p<.0001). In multivariate analysis, Black and Hispanic women had lower odds of receiving a sling than White women (OR=0.58 and 0.74; p=0.0068 and 0.0181 respectively). American Indian and Alaska Native women were two times more likely as White women to have surgical complications (OR 2.36, CI 1.29-4.31; p= 0.0052). Three percent of American Indian or Alaska Native women were readmitted compared to 1.4% of White women (p= 0.0528). Conclusion(s): In a large, national database, we describe racial and ethnic differences in the treatment of SUI and postoperative complications. Specifically, minority women were more likely to undergo open anti-incontinence procedures and were less likely to undergo sling procedures compared to White women. American Indian or Alaska Native women had higher risk of complications compared to White women. These racial/ethnic differences suggest potential areas of intervention for mitigating health disparities.

Boyd, B., et al. (2023). "TREATMENT FOR STRESS URINARY INCONTINENCE STRATIFIED BY RACE AND ETHNICITY." Neurourology and Urodynamics 42(Supplement 1): S50-S51.
	Introduction: Stress urinary incontinence (SUI) occurs in one in three women over age 45. The prevalence and treatment of SUI vary by race/ethnicity, however there are limitations in the literature. We aim to describe the treatment of SUI in a racially/ethnically diverse health maintenance organization. Method(s): This is a retrospective cohort study of patients with a new diagnosis of SUI (ICD-9 625.6 and ICD-10 N39.3) within Kaiser Permanente Southern California from 2008-2017. We then identified patients referred to Urogynecology or Urology and received treatment with pessary (CPT 57160, ICD-10 Z96.0), referral for pelvic floor physical therapy (PFPT) or surgery (CPT codes CPT 51715, 57288, 51992, 53500 51840, 51990). Logistic regression models examined the association between race/ethnicity and treatment. Result(s): A total of 67,187 patients with a new diagnosis of SUI were included: 36.7% were Non- Hispanic White, 5.6% Black, 47.5% Hispanic, 0.2% American Indian or Alaska Native, 7.6% Asian, 0.4% Native Hawaiian or Pacific Islander, 1.8% Unknown/ Multiple/Other. Within this cohort 9,074 patients were referred to Urogynecology (85.2%) or Urology (14.8%). Black, Hispanic, and Asian women were less likely to receive a pessary than White women (Table 1). Hispanic and Native Hawaiian or Pacific Islander women were more likely to be referred for PFPT (Table 1). All racial/ ethnic groups (except for American Indian/Alaska Native women) were less likely to receive a midurethral sling (MUS) compared to White women. Hispanic and Asian women were less likely to undergo urethropexy. When comparing no treatment to treatment, all racial/ethnic groups, except American Indian/Alaska Native, were less likely to receive treatment compared to White women. All racial/ethnic groups, except Hispanic and American Indian/Alaska Native, were more likely to receive conservative treatment (pessary and PFPT) compared to White women. Conclusion(s): We describe racial/ethnic differences in the treatment of SUI. Racial minority women were 50% less likely to undergo MUS, commonly posited as the gold standard treatment. Racial minority women were 40 - 100% more likely to receive conservative management, and less likely to receive any treatment, compared to White women. This supports prior studies that describe health disparities between racial/ethnic groups and has important implications for more equitable care. Funding(s): This research was supported by a grant from the Regional Research Committee of Kaiser Permanente Southern California, RRC grant number: KP-RRC-20211002..

Boyd, S. S., et al. (2021). "Pelvic Organ Prolapse Severity and Genital Hiatus Size With Long-Term Pessary Use." Female Pelvic Medicine & Reconstructive Surgery 27(2): e360-e362.
	OBJECTIVES: To evaluate the association between pessary use more than 1 year and change in prolapse severity. METHODS: This is a secondary analysis of a previously published randomized controlled trial of women undergoing office management of pessaries for management of symptomatic pelvic organ prolapse and incontinence. Primary outcome was change in pelvic organ prolapse quantification measurement genital hiatus (GH). Secondary outcomes included change in prolapse stage, type of pessary, size of pessary, number of pessary changes, and duration of use. Baseline data were collected from the earliest documented examination within the hospital record before pessary placement and compared with their final study visit. Demographics were analyzed using descriptive statistics. Student t test and Mann-Whitney tests were used for categorical comparisons. Pearson and Spearman correlation coefficients were used to evaluate change over time. RESULTS: The cohort was 132 predominantly non-Hispanic White (75%) women with symptomatic prolapse >stage 2 (70.5%). All were postmenopausal. Median duration of pessary use was 39.5 months (interquartile range, 17-64.5 months). Genital hiatus (P = 0.014) and prolapse stage (P = 0.001) decreased as duration of pessary use increased. Those with baseline stages ≥3 had a significant decrease in GH as duration of pessary use increased compared with stages <3 (-0.5 cm vs 0 cm, P < 0.001). There was no difference in change in GH when comparing women with baseline GH less than 3 to 3 cm or greater. CONCLUSIONS: Pessary use by women with pelvic organ prolapse causes a change in vaginal anatomy over time as seen by decreasing stage and point GH.

Boyle, B. R., et al. (2023). "The effect of weight loss interventions for obesity on fertility and pregnancy outcomes: A systematic review and meta-analysis." International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 161(2): 335-342.
	BACKGROUND: Weight loss could improve fertility, perhaps by reducing insulin resistance. OBJECTIVES: To assess the effect of weight loss interventions on fertility in women with obesity not recruited because of known infertility. SEARCH STRATEGY: Three databases during 1966-2020, trial registry. SELECTION CRITERIA: Randomized controlled trials (RCTs) with a follow-up of 1 year or more, with a mean cohort BMI of 30 kg/m2 or above. DATA COLLECTION AND ANALYSIS: A systematic review and meta-analysis was conducted. The primary outcome was pregnancy. The secondary outcome was weight change. MAIN RESULTS: A total of 27 RCTs (5938 women) were included. Weight loss interventions showed no statistically significant increase in pregnancies compared to control interventions (24 trials, 97 women with pregnancy; risk ratio [RR] 1.43, 95% confidence interval [CI] 0.91-2.23); weight change (mean difference [MD] -2.36 kg, 21 trials, 95% CI -3.17 to -1.55). Compared with low-fat diets, very-low-carbohydrate diets showed no statistically significant effect on women with pregnancy (three trials, 14 women with pregnancy; RR 1.37, 95% CI 0.49-3.84) or weight change (MD -0.32 kg, 95% CI -3.84 to 3.21). CONCLUSIONS: Diet-based weight loss interventions for women with obesity not recruited because of infertility were effective at producing long-term weight loss. The effects on fertility were not statistically significant, but few trials provided data. Weight loss trials should routinely collect fertility outcomes.

Boynukalin Fazilet, K., et al. (2022). "Subcutaneous progesterone administration provides a similar ongoing pregnancy rate compared with intramuscular progesterone administration in hormone replacement therapy frozen embryo transfer cycles." F&S reports 4(2): 165-172.
	Objective: To compare the ongoing pregnancy rates (OPRs) for subcutaneous progesterone (SC-P) to intramuscular progesterone (IM-P) in hormone replacement therapy used in frozen embryo transfer (FET) cycles.; Design: Prospective nonrandomized cohort study.; Setting: Private fertility clinic.; Patients: The study enrolled 224 patients scheduled for hormone replacement therapy (HRT)-FET cycles with SC-P (n = 133) or IM-P (n = 91). The route of P administration was decided according to the patient's preference and accessibility to the hospital. In the first FET cycle of a freeze-all cycle using single blastocyst transfers, a woman aged ≤35 was included.; Main Outcomes: Ongoing pregnancy (OP).; Results: The demographic, cycle, and embryologic characteristics were similar between groups. The clinical pregnancy rates (86/133[64.7%] vs. 57/91[62.6%]); miscarriage rates (21/86 [24.4%] vs. 10/57 [17.5%]), and OPR (65/133 [48.9%] vs. 47/91 [51.6%]) were comparable between the SC-P and IM-P groups. Binary logistic regression for OP as the dependent factor revealed that blastocyst morphology was found to be a significant independent prognosticator (for poor quality embryos adjusted odds ratio, 0.11; 95% confidence interval, 0.029-0.427) and progesterone route (SC-P vs. IM-P) was an insignificant prognosticator (adjusted odds ratio, 0.694; 95% confidence interval, 0.354-1.358).; Conclusions: The OPR for SC-P administration was similar to that for IM-P in HRT-FET cycles. The effect of ET-day P levels may vary regarding the administration route. Randomized controlled trials comparing different P administration routes are needed, and large-scale prospective trials are warranted to evaluate the ET-day P levels on pregnancy outcome. (© 2022 The Authors.)

Bozkurt, I. H., et al. (2022). "On-demand use of fesoterodine: a new paradigm for extended release antimuscarinics." International Urogynecology Journal 33(8): 2127‐2132.
	Introduction and hypothesis: We aimed to compare on‐demand and continuous use of fesoterodine 4 mg concerning efficacy and adverse effects. Methods: A total of 100 patients who were diagnosed with non‐neurogenic overactive bladder (OAB) syndrome were included in the study. All patients were evaluated with MMSE, ICIQ‐SF, SEAPI quality of health and OAB‐V8 questionnaires, at the beginning, 1st month and 4th month. Fesoterodine 4 mg was started for treatment. At the end of the 1st month, patients who obtained benefit from the treatment were 1:1 randomized into two groups. In group 1, fesoterodine 4 mg was given 1 × 1 in a standard manner whereas in group 2 patients took the pills on demand. Both groups were evaluated for efficacy and adverse events at 4 months. Results: Final analyses included 69 patients. At 4‐month follow‐up, OAB‐V8 scores were significantly improved compared to 1 month in both groups. Again at h months, no difference was detected between the two groups for MMSE, ICIQ‐SF and SEAPI scores. In continuous usage group, 4th month MMSE scores were significantly lower than 1st month scores. At 4 months, dry mouth and constipation were lower in the on‐demand group compared to continuous usage group. Conclusions: Compared to standard continuous usage, on‐demand usage of fesoterodine showed similar efficacy with fewer adverse events.

Boztaş, E., et al. (2022). "Comparison of the efficacy of pharmacological and nonpharmacological treatments in women with primary dysmenorrhea: randomized controlled parallel-group study." Ginekologia polska.
	Objectives: To compare the effectiveness of pharmacological (PT) and nonpharmacological treatments (NPT) in women with primary dysmenorrhea (PD) and determine the most effective treatment method.; Material and Methods: We enrolled 85 PD participants with PD who were randomly classified into five groups: pharmacological groups; naproxen sodium (NS) and micronized purified flavanoid fraction (MPFF), nonpharmacological groups; motor imagery focused pelvic floor exercise (MOPEXE) and acupressure, and no treatment group; control. Initial assessment was conducted in all groups on the first day of the menstrual cycle. After the end ofthe third menstrual cycle, the specialist physiotherapist and the obstetrician conducted a final evaluation. Intensity and nature of pain were evaluated with the Short-Form McGill Pain Questionnaire (SF-MPQ), and menstrual attitudes and behaviors were evaluated using the Menstruation Attitude Questionnaire (MAQ).; Results: In the total pain dimension scores, which are the sum of the affective dimension of pain and sensory dimension scores, the pre-post treatment difference was the highest in the mean of the total pain dimension. The highest was for MOPEXE (15.12 ± 4.44), followed by MPFF (7.53 ± 6.8); acupressure (7.47 ± 5.28) and NS (4.47 ± 4.91) showed more significant change than the control group (p = 0.001). The mean difference in visual analog scale (VAS) scores was highest in MOPEXE (4.53 ± 1.5), followed by acupressure (2.35 ± 1.66); MPFF (1.88 ± 1.73) and NS (1.65 ± 1.84) scores were more significant than the control group (p = 0.001). Regarding total pain intensity, the highest was MOPEXE (2.59 ± 0.94), followed by MPFF (1.18 ± 0.88); acupressure (1.06 ± 0.83) and NS (0.82 ± 1.01) scores were more significant compared to the control group (p = 0.001). There was no significant change in the pre-post difference values in the MAQ subparameters: menstruation as deliberate event, menstruating as bothersome event, menstruation as natural event, anticipation and prediction of the onset of menstruation, and denial of any effects of menstruation; menstruation as a natural event resulted in insignificant changes in parameters (p = 0.579, p = 0.074, p = 0.892, p = 0.056, p = 0. 377).; Conclusions: PT and NPT methods in the study were effective in coping with PD-associated pain. MPFF was more effective than the NS group in terms of relieving pain. In terms of pain, MOPEXE and acupressure groups were as effective as PT. The most effective of these treatment methods was the MOPEXE group created by the researcher.

Bradley, H., et al. (2022). "The prevalence of depression in women who experience pregnancy related pelvic girdle pain: A systematic review protocol."
	
Bradley, H. A., et al. (2022). "A NUTRITIONAL APPROACH TO TREATING SYMPTOMS OF ANTENATAL DEPRESSION AND ANXIETY. THE NUTRIMUM TRIAL: A DOUBLE-BLIND, RANDOMISED CONTROLLED TRIAL." Journal of Paediatrics and Child Health 58(SUPPL 2): 23.
	Background: Left untreated, antenatal depression and anxiety can have negative consequences for the mother, her baby and the rest of her family. The efficacy of a broad-spectrum multinutrient (minerals and vitamins) formula was investigated as a possible treatment for symptoms of depression and anxiety during pregnancy. Method(s): Between 13-24 weeks gestation, 88 participants scoring >=13 on the Edinburgh Postnatal Depression Scale (EPDS) were randomised to multinutrients (MN) or an active placebo (AP), containing iodine and riboflavin, for 12 weeks. Seventyone (81%) completed the trial with no group differences in dropouts. The Clinical Global Impression Scale of Improvement (CGII) and the EPDS were the primary outcomes analysed using mixed linear modelling. Result(s): Based on the CGI-I, the MN group demonstrated significantly greater improvement in symptoms over time, compared to the AP group (p < 0.001). Further, presence of personality difficulties reduced the placebo effect and increased the response to multinutrients based on CGI-I ratings. When personality difficulties were present, significantly more participants in the MN group (69%) were rated 'responders' to treatment at 12 weeks than the AP group (51%; OR = 6.667, p = 0.017). Participants rated themselves as 'responders' significantly more so in the MN group (69%) than in the AP group (39%; OR = 3.52, p = 0.011). There were no statistically significant differences between groups on the EPDS over time (p = 0.162) or of treatment-emergent adverse events and side effects. Conclusion(s): Broad-spectrum multinutrients may provide a safe, alternative treatment option for antenatal depression and anxiety and improve global functioning. Multinutrients may be of particular benefit to people with personality difficulties.

Bradley Linda, D., et al. (2019). "Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis of Prospective Studies." Journal of laparoendoscopic & advanced surgical techniques. Part A 29(12): 1507-1517.
	Background: Radiofrequency ablation (RFA) has emerged as a safe and effective treatment option for women with symptomatic uterine fibroids and can be delivered by laparoscopic, transvaginal, or transcervical approaches. The evidence regarding typical patient outcomes with RFA has not previously been examined in a comprehensive fashion. Materials and Methods: We performed a systematic review of prospective studies for treatment of uterine fibroids with RFA. Main outcomes were procedure time, patient recovery metrics, change in fibroid volume, symptom severity score (SSS), health-related quality of life (HRQL), and reinterventions. Data were analyzed with random effects meta-analysis and metaregression. Results: We identified 32 articles of 1283 unique patients (median age: 42 years) treated with laparoscopic RFA (19 articles), transvaginal RFA (8 articles), or transcervical fibroid ablation (5 articles). Mean procedure time was 49 minutes, time to discharge was 8.2 hours, time to normal activities was 5.2 days, and time to return to work was 5.1 days. At 12 months follow-up, fibroid volume decreased by 66%, HRQL increased by 39 points, and SSS decreased by 42 points (all P < .001 versus baseline). The annual cumulative rate of reinterventions due to fibroid-related symptoms was 4.2%, 8.2%, and 11.5% through 3 years. Conclusions: RFA of uterine fibroids significantly reduces fibroid volume, provides significant durable improvements in fibroid-related quality of life, and is associated with favorable reintervention rates.

Bradley Megan, S., et al. (2023). "Association Between Enlarged Genital Hiatus and Composite Surgical Failure After Vaginal Hysterectomy With Uterosacral Ligament Suspension." Urogynecology (Philadelphia, Pa.) 29(5): 479-488.
	Importance: The impact of a persistently enlarged genital hiatus (GH) after vaginal hysterectomy with uterosacral ligament suspension on prolapse outcomes is currently unclear.; Objectives: This secondary analysis of the Study of Uterine Prolapse Procedures Randomized trial was conducted among participants who underwent vaginal hysterectomy with uterosacral ligament suspension. We hypothesized that women with a persistently enlarged GH size would have a higher proportion of prolapse recurrence.; Study Design: Women who underwent vaginal hysterectomy with uterosacral ligament suspension as part of the Study of Uterine Prolapse Procedures Randomized trial (NCT01802281) were divided into 3 groups based on change in their preoperative to 4- to 6-week postoperative GH measurements: (1) persistently enlarged GH, 2) improved GH, or (3) stably normal GH. Baseline characteristics and 2-year surgical outcomes were compared across groups. A logistic regression model for composite surgical failure controlling for advanced anterior wall prolapse and GH group was fitted.; Results: This secondary analysis included 81 women. The proportion with composite surgical failure was significantly higher among those with a persistently enlarged GH (50%) compared with a stably normal GH (12%) with an unadjusted risk difference of 38% (95% confidence interval, 4%-68%). When adjusted for advanced prolapse in the anterior compartment at baseline, the odds of composite surgical failure was 6 times higher in the persistently enlarged GH group compared with the stably normal group (95% confidence interval, 1.0-37.5; P = 0.06).; Conclusion: A persistently enlarged GH after vaginal hysterectomy with uterosacral ligament suspension for pelvic organ prolapse may be a risk factor for recurrent prolapse.; Competing Interests: M.S.B. received research support from Hologic, Axonics. K.L.F. received grant support from Valencia Technologies and BlueWind Medical. A.G.V has stock ownership in Ninomed. M.G.G received research grant to RTI as the PFDN DCC from Boston Scientific. The remaining authors have declared they have no conflicts of interest. (Copyright © 2022 American Urogynecologic Society. All rights reserved.)

Bradley, W., et al. (2021). "Maintenance olaparib for patients with newly diagnosed, advanced ovarian cancer and a BRCA mutation: 5-year follow-up from SOLO1."  162: S25‐S26.
	Objectives: Newly diagnosed advanced ovarian cancer patients (pts) are at high risk of relapse and 5‐year survival is 30–50%. Delay of recurrence, prolonged survival and, for some pts, increased chance of cure are goals of treatment in this setting. In SOLO1 (NCT01844986; GOG‐3004) pts with advanced ovarian cancer and a BRCA1 and/or BRCA2 mutation (BRCAm) who were in response after first‐line platinum‐based chemotherapy derived significant progression‐free survival (PFS) benefit from maintenance olaparib vs placebo (median 41 months follow‐up; median not reached vs 13.8 months; hazard ratio 0.30; P<.001; Moore et al. NEJM 2018). We report analyses after 5‐years of follow‐up (data cut‐off [DCO]: March 5, 2020), performed to assess the long‐term efficacy and tolerability of maintenance olaparib for newly diagnosed advanced ovarian cancer. Methods: Pts received maintenance olaparib (tablets; 300 mg bid) or placebo for up to 2 years or until progression. PFS and recurrence‐free survival (RFS) were investigator‐assessed by modified RECIST v1.1. An exploratory subgroup analysis of PFS in higher‐risk (stage IV disease, stage III disease with residual disease following primary debulking surgery, inoperable stage III disease, or stage III disease and had undergone interval surgery) and lower‐risk (stage III disease without residual disease following primary debulking surgery) pts was carried out. For pts in complete response at baseline, RFS was defined post hoc as time from randomization to disease recurrence (new lesions by imaging) or death.[Formula presented] Results: A total of 260 pts were randomized to olaparib; 131 to placebo (median treatment duration 24.6 vs 13.9 months, respectively). After a median of 4.8 and 5.0 years of follow‐up, median PFS was 56 vs 14 months in the olaparib and placebo arms, respectively (Table). In the higher‐risk subgroup 42% of olaparib‐arm vs 17% of placebo‐arm pts were free from progression at 5 years; in the lower‐risk subgroup 56% vs 25% of pts, respectively, were progression free at this time point. Among pts in complete response at baseline, risk of disease recurrence or death was reduced by 63%. The safety profile of olaparib was consistent with previous observations. No new cases of myelodysplastic syndrome or acute myeloid leukaemia were reported (previous DCO: olaparib, 3/260 [1%]; placebo, 0/130), and incidence of new primary malignancies remained balanced between arms (olaparib, 7/260 [3%]; placebo, 5/130 [4%]). Conclusions: For pts with a BRCAm and newly diagnosed advanced ovarian cancer, the benefit derived from 2 years of maintenance olaparib was sustained beyond the end of treatment, and after 5 years, almost half of pts were progression free vs 20% with placebo. This benefit was consistent across higher‐ and lower‐risk pts. Over 50% of pts in complete response after first‐line platinum‐based chemotherapy remained free from relapse 5 years after randomization. A total of 5 years of follow‐up is the longest for any PARP inhibitor in this setting and no new safety signals were observed.

Bradley, W. H., et al. (2022). "An open label, nonrandomized, multisite phase II trial combining bevacizumab, atezolizumab, and rucaparib for the treatment of previously treated recurrent and progressive endometrial cancer." Journal of Clinical Oncology 40(16 Supplement 1).
	Background: Patients with metastatic recurrent endometrial cancer have limited effective therapies. Single agent pembrolizumab is utilized in mismatch repair deficient (MMRd) patients, while the combination of lenvatinib and pembrolizumab is now more commonly used in MMR intact patients who have progressed after chemotherapy combinations. This trial investigated a novel three drug regimen. Method(s): Patients with recurrent endometrial cancer not amenable to curative intent surgery or radiation after one or two lines of therapy were eligible regardless of histology. This study is a multicenter, open-label, nonrandomized phase II trial. All subjects initially received the three-drug combination of rucaparib, bevacizumab, and atezolizumab. The primary goal of this trial was to estimate the overall response rate in these patients, and secondarily to estimate the progression-free and overall survival of patients treated with this triplet combination. Total enrollment was 30, with the first six subjects participated in a safety lead-in. Treatments until progression, toxicity, or clinician choice. Subjects could continue past progression if, in the estimate of the treating clinician and subject, clinical benefit was being provided. Subjects were eligible for analysis if they received at least one cycle and had one postdose tumor assessment. The ORR assumption was 27% with a lower bound of 14%. Result(s): 30 subjects were enrolled between 07/2019 and 06/2021. Of these 26 were evaluable. Median follow up at cut off was 14.9 months. 23 subjects had clinical benefit, with 1 (4%) with CR, 9 (39%) with PR, and 13 (57%) with stable disease as best response. Overall median event-free (progression or death) was 5.3 (95% CI 2.7-7.9) months and overall survival 13.3 (95% CI NA) months at cut off. Median duration of therapy was 4.4 months (IQR 1.7-7.3), with 4 subjects remaining on study directed therapy at data cut off. Histology distribution was 50% serous, 20% endometrioid, and 13% carcinosarcoma. 19 pts were White, 8 African American, 2 identified as Asian, 1 unknown. In the MMR deficient patients, event-free probability was 11.9 months. Grade 3 or 4 treatment related adverse events occurred in 50% patients. Conclusion(s): To our knowledge, this trial represents the first use of a non-chemotherapybased triplet therapy for recurrent endometrial cancer. The combination of rucaparib, bevacizumab, and atezolizumab may safely be used to treat recurrent/persistent endometrial cancer. This combination demonstrates clinically meaningful improvement in response, with acceptable toxicity. Enhanced response to therapy was seen in MMR deficient subjects.

Bradshaw, A. and T. Sathyapalan (2022). "A clinical trial to see if LPRI-424 is safe and works for Polycystic Ovary Syndrome compared to a placebo for 9 months." ISRCTN registry.
	Plain English Summary Background and study aims The test medicine (LPRI-424) is being given to women with polycystic ovary syndrome (PCOS) to see if there is a change in hair growth when given for 9 months. This is being tested against a placebo and the hair growth is being measured by a tool called the Adapted Modified Ferriman-Gallwey (mFG) score. This score is used by Doctors to see how much hair growth there is for those suffering with polycystic ovary syndrome. Who can participate? Women aged 14 to 40 years diagnosed with PCOS. What does the study involve? Not provided at time of registration What are the possible benefits and risks of participating? Benefits: Improvement of PCOS symptoms in particular of hirsutism. Information learned from the trial may help other patients with hirsutism in the future. Risks: The main burden for subjects would be the E-Diary completion each day. The burden is minimised by taking less than 3 minutes to complete and the subjects being compensated for their time/compliance with the E-Diary. The amount of compensation will be given within the patient information sheet. Subjects will not be allowed any permanent hair removal during the trial, they can only use shaving as a method of hair removal. If the subject chooses to shave areas of their bodies, they must do so 15 days prior to the mFG score being tested to ensure the same standardised assessment of hair growth is done. This burden will be minimised by providing compensation to those patients who comply and complete the trial. Other risks and burdens include blood withdrawals, where the subject may get injection-site pain/discomfort. To mitigate this risk only a trained, experienced and delegated member of the study site team will perform blood withdrawals. The subjects will also have gynaecological examinations and intravaginal ultrasounds, this is an intrusive examination and the experience will be minimised by a trained and experienced member of the site team performing the assessments. Where is the study run from? Chemo Research S.L. (Spain) When is the study starting and how long is it expected to run for? September 2020 to November 2023 Who is funding the study? Chemo Research S.L. (Spain) Who is the main contact? Dr Thozhukat Sathyapalan, thozhukat.sathyapalan@hyms.ac.uk Study website

Braga, A., et al. (2022). "Urethral bulking agents for the treatment of recurrent stress urinary incontinence: A systematic review and meta-analysis." Maturitas 163: 28-37.
	Recurrent stress urinary incontinence (rSUI) represents a major challenge for most clinicians as there is little evidence in the literature on the best option after sling failure. The objective of this study is to summarise the findings on the use of urethral bulking agents (UBAs) in the management of rSUI after the failure of a mid-urethral sling (MUSs). We performed a systematic review and meta-analysis, according to PRISMA 2020 guidelines, and selected eleven publications for inclusion in the analysis. We found that the overall cure and improvement rate ranged from 64% to 85% in the included studies, with a pooled value of 75%, compared with pooled failure and re-operation rates of 32% (95% CI: 22%-43%) and 25% (95% CI: 17%-34%), respectively. The I2 test indicated significant statistical heterogeneity among the studies in relation to all the outcome measures; however, no risk of publication bias was found. To explore this heterogeneity in more depth, we performed a sub-group analysis of the two most commonly used bulking agents (Bulkamid and Macroplastique). The pooled values of the cure and improvement rate were 84% (95% CI: 77.0%-90.0%) and 80% (95% CI: 74.0%-85.0%) for Macroplastique and Bulkamid, respectively. We did not find significant heterogeneity or significant differences in the outcome measures in either group. For the first time in literature, our study provides an insight into the use of UBAs after failed MUSs. Although the results seem very promising, future studies with shared protocols are needed in order to recommend the use of UBAs in the treatment of recurrent cases.Copyright © 2022

Branco-Silva, M., et al. (2022). "Consolidation chemotherapy in postmolar low-risk gestational trophoblastic neoplasia: A systematic review protocol." BMJ Open 12(2): e059484.
	Introduction Current evidence remains insufficient to strongly demonstrate the benefits of consolidation chemotherapy to all women with low-risk gestational trophoblastic neoplasia (GTN). This protocol outlines a systematic review to investigate whether consolidation chemotherapy is necessary for all patients with postmolar low-risk GTN after human chorionic gonadotropin normalisation with first-line single-agent chemotherapy. Methods and analysis A search string will be used to search the PubMed (MEDLINE), EMBASE, Web of Sciences, Scopus, LILACS and Cochrane Central Register of Controlled Trials databases. Articles will be screened at the title and abstract level, and then at the full article level by two independent reviewers using inclusion/exclusion criteria. Randomised and non-randomised study designs will be included, while case studies, commentaries, editorials, review articles, animal studies, basic science studies and cross-sectional studies, as well as studies not reporting relapse/recurrence rates and/or whether consolidation chemotherapy was delivered will be excluded. There will be no restrictions on date of publication, geographical location, study setting, or language of publication. The primary outcome is rate of recurrence/relapse. The assessments of randomised controlled trials will be performed using the risk of bias tool from the Cochrane Collaboration. Non-randomised studies will be assessed using the Newcastle-Ottawa scale. The quality of evidence will be assessed using the Grading quality of evidence and strength of recommendations (Grades of Recommendations, Assessment, Development and Evaluation) guidelines. Ethics and dissemination No formal ethical approval is required as all data collected will be secondary data and analysed anonymously. Results will be disseminated through a peer-reviewed publication and at scientific events. PROSPERO registration number CRD42020164822.Copyright ©

Brand, S. R., et al. (2021). "A Randomized Phase 2 Study of VT-1161 for the Treatment of Acute Vulvovaginal Candidiasis." Clinical Infectious Diseases 73(7): e1518‐e1524.
	BACKGROUND: Acute vulvovaginal candidiasis (VVC) is common among women, but current azole antifungal treatments are often associated with safety and resistance issues. VT‐1161 (oteseconazole) is an oral agent with increased selectivity for fungal CYP51. In this phase 2 clinical study, we evaluated the efficacy and safety of VT‐1161 vs fluconazole in participants with moderate to severe acute VVC. METHODS: Participants presenting with an acute episode of VVC (n = 55) were randomized to receive VT‐1161 300 mg once daily (q.d.) for 3 days, 600 mg q.d. for 3 days, or 600 mg twice daily (b.i.d.) for 3 days or to receive a single dose of fluconazole 150 mg (FDA‐approved dose to treat acute VVC). Participants were followed for 6 months. The primary outcome was the proportion of participants with therapeutic (clinical and mycological) cure at day 28. RESULTS: A larger proportion of participants in the per‐protocol population experienced therapeutic cure in the VT‐1161 300 mg q.d. (75.0%), VT‐1161 600 mg q.d. (85.7%), and VT‐1161 600 mg b.i.d. (78.6%) groups vs the fluconazole group (62.5%); differences were not statistically significant. At 3 and 6 months, no participants in the VT‐1161 groups vs 28.5% and 46.1% in the fluconazole group, respectively, had evidence of mycological recurrence. No serious adverse events or treatment‐emergent adverse events leading to discontinuation were reported. CONCLUSIONS: The majority of participants across all treatment groups achieved therapeutic cure at day 28. VT‐1161 was well tolerated at all dose levels through 6 months of follow‐up. CLINICAL TRIALS REGISTRATION: NCT01891331.

Brandon, G., et al. (2021). "Efficacy of Neuromodulation in Treating Chronic Pelvic Pain: A Systematic Review."
	
Brandt, C. and E. C. J. van Vuuren (2022). "Postoperative Physiotherapy in Women Undergoing Pelvic Floor Reconstructive Surgery: A Randomized Controlled Clinical Trial." Physiotherapy Canada. Physiotherapie Canada 74(2): 126-138.
	Purpose: Postoperative physiotherapy in conjunction with pelvic organ prolapse (POP) surgery is still under-investigated and controversial. In this randomized controlled trial, pelvic floor muscle training (PFMT) and abdominal training were compared with a control condition (standard in-hospital treatment). Method: Eighty-one women were randomized to one of three groups. The Prolapse Quality of Life questionnaire, two-dimensional ultrasound, Pelvic Organ Prolapse Quantification System scale, the PERFECT (power, endurance, repetitions, fast contractions, every contraction timed) scheme, electromyography, Sahrmann scale, and pressure biofeedback unit (PBU) were used to measure quality of life (QOL), POP, and pelvic floor and abdominal muscle function. A mixed-model analysis of variance and the Kruskal-Wallis test was used for analysis. Results: Beneficial effects (p < 0.05) were found for the PFMT group - increased power, number of fast contractions, amount of movement, endurance, and Sahrmann and PBU measures - compared with the control group. Abdominal training led to a significant (p < 0.05) increase in bulging and discomfort, number of pelvic floor muscle contractions, and Sahrmann and PBU measures compared with the control condition; both groups showed significantly increased urinary frequency (p < 0.05). Conclusions: Postoperative physiotherapy did not have a beneficial effect on QOL or POP symptoms. PFMT and abdominal training had beneficial effects on pelvic floor muscle function and abdominal muscle measures. Additional abdominal training led to increased symptoms.

Brasoveanu, S., et al. (2023). "Laparoscopic Pectopexy versus Vaginal Sacrospinous Ligament Fixation in the Treatment of Apical Prolapse." Life (Basel, Switzerland) 13(10).
	Objectives: To compare the follow-up results of a sacrospinous ligament fixation (SSLF) technique for laparoscopic bilateral fixation of the vagina to the iliopectineal ligament via a PVDF-mesh (laparoscopic pectopexy technique, LP) in terms of cure rate and postoperative complications rate.; Material and Methods: This prospective study included 160 patients diagnosed with pelvic organ prolapse stage II-IV according to the POP-Q system. Eighty-two patients (51.25%) underwent vaginal sacrospinous ligament fixation and seventy-eight patients (48.75%) underwent the laparoscopic pectopexy procedure.; Results: The cure rate was high in both groups, 95.12% of the patients (78 out of 82) in the SSLF group and 93.59% of the patients (73 out of 78) in the LP group were cured post surgery, leading to an overall cure rate of 151 out of 160 patients. Pelvic pain was present in 5.00% of all patients, but was notably more frequent in the SSLF group (7, 8.54%) than in the LP group (1, 1.28%). Dyspareunia occurred in 4.37% of all patients, slightly more frequently in the SSLF group (6, 7.32%) than the LP group (1, 1.28%), but without significant difference.; Conclusions: The laparoscopic pectopexy procedure has comparably positive follow-up results with the conventional sacrospinous ligament fixation procedure. Both SSLF and LP are effective in the treatment of pelvic organ prolapse, with favorable anatomical and subjective results, a high cure rate and low rates of serious postoperative complications.

Brasoveanu, S., et al. (2023). "Evaluating Patient Preferences and Clinical Outcomes in Stress Urinary Incontinence Treatment: A Short-Term Follow-Up Study of the Transobturator Tape Procedure and Pubourethral Ligament Plication (a Minimally Invasive Technique)." Journal of Personalized Medicine 14(1).
	Objective: This study aims to provide an in-depth analysis of patient preferences and clinical outcomes associated with two surgical techniques for treating stress urinary incontinence (SUI): the transobturator suburethral sling (TOT) procedure and the pubourethral ligament plication (PUL) procedure. We evaluated the rates of postoperative complications, the duration of each procedure, hemoglobin loss, and days of hospitalization.; Materials and Methods: This prospective study included 80 patients who underwent surgery for SUI: 40 patients for the TOT procedure and 40 patients for the PUL procedure. Clinical data on patient characteristics, treatment efficacy, and post-surgical outcomes were analyzed to assess patient preferences and real-world clinical effectiveness.; Results: Regarding patient preferences, those who underwent TOT surgery were more likely to be older, had a higher average number of pregnancies, and were more often postmenopausal, in contrast to those who underwent PUL surgery ( p < 0.001 for each comparison). TOT patients had a hospital stay on average of 1.02 days, while PUL patients benefited from ambulatory stays only. In addition, the TOT group had a significantly longer average operating time (16.80 min) compared to the PUL group (9.90 min, p < 0.001). The study revealed notable outcomes in both groups, with high cure rates for both TOT (N 1 = 33, 82.5%) and PUL (N 2 = 28, 70%) procedures. Specifically, 76.25% of the patients (61 out of 80) were cured after the procedures. Chronic pelvic pain was present in 3.75% of all patients and was notably only observed in the TOT group, with 3 (7.5%) cases being noted. Similarly, vaginal erosion was experienced by 5% of all patients, with 10% of patients in the TOT group and none in the PUL group being affected. Dyspareunia occurred in 2.5% of all patients, with there being two (5%) cases in the TOT group and none in the PUL group.; Conclusions: This study highlights that while the PUL procedure achieves cure rates comparable to TOT, it offers a less invasive option with shorter operating times and no hospitalization required. These findings suggest that PUL could be a viable alternative for stress urinary incontinence (SUI) treatment, especially in contexts where avoiding mesh use is preferred. This adds significant value to patient-centered care in SUI management, offering tailored treatment options based on patient characteristics, preferences, and risk profiles.

Brassil, K. J., et al. (2023). "Trial in progress: Comprehensive outcomes for after cancer health (COACH), a randomized trial assessing health outcomes following primary cancer therapy." Cancer Research 83(7 Supplement).
	Purpose: This study evaluates feasibility and acceptability of a digital health coaching intervention for individuals who are within one year of completing primary cancer treatment of any modality, as well as its effect on health self-efficacy. Secondary endpoints evaluate trends in patient-reported outcomes (PRO), including financial toxicity, for which the Economic StraiN and Resilience in Cancer (ENRICh) tool is being validated. Additional endpoints explore associations between patientreported symptoms, wearable, biomarker, and clinical data. This study seeks to fill a critical knowledge gap as to how health behavioral changes prompted by health coaching may modulate symptoms and physical/psychosocial well-being through the longitudinal tracking of patient reported, clinical, and bioinformatic data. Method(s): This randomized, wait-list control trial is being conducted at geographically diverse National Cancer Institute-designated cancer centers. Per site enrollment is <150 participants, aged 18 and older, following completion of primary treatment for breast, ovarian, endometrial, lung, or gastric cancer or population specific (eg, >=65 years) cohorts. A 6-month coaching intervention utilizing phone calls coupled with supplemental digital content via text, email, or web-based application is delivered during months 1 through 6 (intervention) or months 7 through 12 (wait-list control). PROMIS and other validated questionnaires and activity data are collected over 12 months. Gut microbiome specimens and the Diet History Questionnaire (DHQ) III are collected at enrollment and 6 months. Feasibility (retention rate >=70%) and acceptability (<=20% scoring "not at all helpful"), are assessed with descriptive statistics. Summary Data: To date, 47 individuals have been enrolled at 3 study sites, Nebraska Medicine (36), Dana-Farber Cancer Institute (10), and The Ohio State University James Cancer Center (1). This includes 1 male and 46 female participants, with an average age of 63.62 (R 33-75), of whom 44 identify as White and 3 as Black or African American, and 47 identify as non-Hispanic. Among participants, 35 have a history of breast, 10 ovarian, 1 endometrial, and 1 gastric cancer. Two additional sites are planned to begin enrollment in 2023, one of which will primarily enroll participants identifying as Black and/or Hispanic. Conclusion(s): Enrollment is anticipated to complete by December 2023 with site-specific and composite results reported by December 2024. Novel outcomes related to the use of digital health coaching in the context of survivorship, as well as robust data assessing clinical, microbiome, dietary, patient-reported, and wearable data is expected to enhance existing evidence regarding outcomes in patients on both active surveillance and maintenance therapies for diverse tumor types.

Brau-Figueroa, H., et al. (2022). "Effectiveness of Concomitant Chemoradiotherapy with Gemcitabine in Locally Advanced Cervical Cancer Patients with Comorbidities." Cancer research and treatment 54(2): 554-562.
	Purpose: The standard treatment for locally advanced cervical cancer (LACC) is concomitant chemoradiotherapy with cisplatin (CDDP) followed by brachytherapy. The presence of comorbidities are risk factors for nephrotoxicity and are associated with lower survival. Gemcitabine is a radiosensitizing drug that has shown efficacy and safety in this context. The effectiveness of concomitant chemoradiotherapy with gemcitabine was evaluated versus cisplatin in LACC patients with comorbidities and preserved renal function.; Materials and Methods: An observational, longitudinal and paired study was carried out that included patients treated between February 2003 and December 2015. The primary objectives were to evaluate response rates, progression-free survival, and overall survival; the secondary objectives were to evaluate toxicity and renal function.; Results: Sixty-three patients treated with gemcitabine at 300 mg/m2 weekly and 126 patients treated with CDDP 40 mg/m2 weekly were included. There were no significant differences in response rates and survival rates. Treatment with cisplatin presented a higher frequency of hematological toxicities, while gemcitabine presented a higher frequency of gastrointestinal toxicities. A decrease in glomerular filtration rate (GFR; baseline vs. 1-year post-treatment) was observed in the cisplatin group (p=0.002), while not in the gemcitabine group (p=0.667). In a multivariate analysis, it is observed that only CDDP correlates with the decrease in GFR (hazard ratio, 2.42; p=0.012).; Conclusion: In LACC patients with comorbidities, gemcitabine and CDDP show the same efficacy, with different toxicity profiles. Treatment with cisplatin is associated with a significant decrease in GFR during follow-up, compared to treatment with gemcitabine that does not decrease it.

Brawijaya University, o. (2022). Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management.
	No Results Available Procedure: Superior Hypogastric Plexus Block|Procedure: Ganglion Impar Block Numerical rating scale (NRS)|Oswestry Disability Index (ODI)|Morphine equivalent daily dose (MEDD)|Adverse effect Female Not Applicable 36 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Supportive Care UB_WWN01 April 30, 2023

Brennen, R., et al. (2021). "Group-based pelvic floor muscle training for all women during pregnancy is more cost-effective than post-natal training for women with urinary incontinence: Cost-effectiveness analysis of a systematic review." Neurourology and Urodynamics 40(SUPPL 2): S86-S88.
	HYPOTHESIS / AIMS OF STUDY Despite evidence for pelvic floor muscle training (PFMT) to effectively prevent or treat postnatal urinary or faecal incontinence, (1, 2) there have been no studies evaluating the cost-effectiveness of different models-of-care to deliver PFMT in pregnancy or the postnatal period. Such an evaluation is needed to provide health services with relevant data to inform service planning. We therefore undertook this review to determine the costs and cost-effectiveness of different models-of-care delivered to provide PFMT in pregnancy or the postnatal period. STUDY DESIGN, MATERIALS AND METHODS Studies included in a recent Cochrane Systematic Review (1) on supervised PFMT during pregnancy or in the postnatal period for preventing or treating postnatal urinary incontinence and / or postnatal faecal incontinence were grouped according to model-of care and meta-analysis performed on these groupings. For models-of-care that showed a statistically significant impact on preventing or curing urinary and / or faecal incontinence, a cost-effectiveness analysis was undertaken. A base case for each model-of-care was generated based on the median number of sessions and duration of sessions and staffing levels of the reported interventions. Costs for each model-of-care were based on publicly available data on costs of consumables, room hire, staffing, and median wage of women of childbearing age. Sensitivity analysis was conducted for variables of the number of women attending group sessions, population employment levels and staffing hourly rates. RESULTS Seventeen studies were included for meta-analysis. Three models-of-care were clinically effective: individually-supervised PFMT during pregnancy to prevent urinary incontinence (Model 1), group-based PFMT during pregnancy to prevent or treat urinary incontinence (Model 2) and individually- supervised postnatal PFMT to treat urinary incontinence and prevent or treat faecal incontinence (Model 3). The health service costs per urinary incontinence case prevented or cured were $768 for Model 1, and $1,970 for Model 3. Model 2 generated a cost saving of $14 if there were 8 participants per session, with greater savings if more participants attend. The health service cost per faecal incontinence case prevented or cured was $2,784 (Model 3). Table 1 shows the costs for the different individually-supervised PFMT modelsof- care, while Figure 1 shows the cost per person according to number of attendees for group-based PFMT during pregnancy to prevent or treat urinary incontinence. INTERPRETATION OF RESULTS This was the first study to identify comparative cost-effectiveness of different modeal of care for preventing or treating postnatal incontinence. Individual PFMT delivery during pregnancy to prevent urinary incontinence was the most cost-effective model for overall costs. Group-based PFMT during pregnancy to prevent urinary incontinence was the most cost-effective model from a health service perspective, depending on the number of women attending the group-based intervention and the out-of-pocket costs charged. It is important to note that patients included in these studies did not have urinary incontinence at the start of treatment. For existing urinary incontinence, individual PFMT during pregnancy did not have a statistically significant clinical effect, although there was a trend towards positive outcomes in these analyses. One of the included studies provided minimal details about their intervention other than that there were only 1-2 treatment sessions. As supervision has been identified as a significant factor in achieving outcomes, (3) this may account for the lack of statistically significant clinical effect in both this individual study and the meta-analyses of this model. Most of the studies of postnatal PFMT focused on individual PFMT for treatment or for mixed prevention and treatment of urinary incontinence. Due to the lack of significant findings in the few studies that assessed group-based or mixed group and individual models, we did not analyse thes models for cost-effectiveness. Individual postnatal PFMT to treat urinary incontinence was both clinically significant and cost-effective. Based on our meta-analysis and cost-effectiveness analysis results: It is recommended that all continent pregnant women are provided with the opportunity to participate in urinary incontinence prevention services during pregnancy. It is more efficient for health service providers to provide group-based prevention services during pregnancy to continent pregnant women than provide individual treatment services to incontinent women postnatally if at least 4 women can attend the group sessions. Group-based prevention is preferable to individual prevention if: * At least 5 women can attend the group sessions and the service charges $10 per session * At least 8 women can attend the group sessions and the service charges $5 per session * At least 13 women can attend the group sessions and there is no charge per session We are unable to make any recommendations regarding early in-hospital postnatal PFMT or education sessions due to the lack of studies specific to the early postnatal period. We are unable to make a clear recommendation regarding whether it is better to provide prevention during pregnancy or treatment postnatally. While it is more efficient for health service providers to provide prevention services during pregnancy to continent pregnant women than to provide treatment services to women incontinent of urine postnatally, postnatal treatment has the additional benefit of preventing or treating faecal incontinence. If a health service is investing resources in prevention of urinary incontinence amongst pregnant women: * If at least 5 women can attend group PFMT, it is recommended that continent women are provided with the opportunity to participate in group PFMT during pregnancy for prevention of urinary incontinence. * If only 4 or fewer women can attend group PFMT, it is recommended that continent women are provided with the opportunity to participate in individual PFMT during pregnancy for prevention of urinary incontinence. CONCLUDING MESSAGE PFMT during pregnancy for prevention of postnatal urinary incontinence is a clinically effective and cost-effective treatment, with cost-effectiveness of group-based compared to individually supervised PFMT being dependent on the number of women who can attend a group and on whether the health service charges a co-payment for the service. Individually supervised PFMT for treatment of postnatal urinary incontinence is a clinically effective and cost-effective treatment that also provides effective prevention and treatment of faecal incontinence.

Brennen, R., et al. (2021). "Group-based pelvic floor muscle training for all women during pregnancy is more cost-effective than postnatal training for women with urinary incontinence: cost-effectiveness analysis of a systematic review." Journal of Physiotherapy 67(2): 105-114.
	QUESTION: What is the most cost-effective way of providing pelvic floor muscle training (PFMT) to prevent or treat postpartum incontinence? DESIGN: Meta-analysis and cost-effectiveness analysis of models of care included in a recent Cochrane systematic review. PARTICIPANTS: Pregnant and postnatal women. INTERVENTION: Supervised PFMT for preventing or treating urinary and/or faecal incontinence. OUTCOME MEASURES: Postpartum urinary or faecal incontinence. ANALYSIS: We examined the comparative incremental cost effectiveness of different approaches to successfully prevent or cure one case of incontinence. Costs were valued in Australian dollars using publicly available market rates and enterprise agreements as of 2019. Comparisons involving group-based treatment approaches were subject to sensitivity analyses where the numbers of patients attending each group were varied to identify thresholds where recommendations change. RESULT(S): Seventeen trials were included for meta-analysis. Three models of care were clinically effective: individually supervised PFMT during pregnancy to prevent urinary incontinence (Model 1), group-based PFMT during pregnancy to prevent or treat urinary incontinence (Model 2) and individually supervised postnatal PFMT to treat urinary incontinence and prevent or treat faecal incontinence (Model 3). The health service costs per urinary incontinence case prevented or cured were $768 for Model 1, and $1,970 for Model 3. However, Model 2 generated a cost saving of $14 if there were eight participants per session, with greater savings if more participants attend. The health service cost per faecal incontinence case prevented or cured was $2,784 (Model 3). CONCLUSION(S): Providing group-based PFMT for all women during pregnancy is likely more efficient than individual PFMT for incontinent women postnatally; however, providing PFMT for postnatal women with urinary incontinence should not be discounted because of the added known benefit for preventing and treating faecal incontinence.Copyright © 2021 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Brennen, R., et al. (2020). "The Effect of Pelvic Floor Muscle Interventions on Pelvic Floor Dysfunction After Gynecological Cancer Treatment: A Systematic Review." Physical Therapy 100(8): 1357-1371.
	Objective: The aim of this systematic review was to identify, evaluate, and synthesize the evidence from studies that have investigated the effect of nonsurgical, nonpharmacological, pelvic floor muscle interventions on any type of pelvic floor dysfunction or health-related quality of life in patients after any type of treatment for gynecological cancer.; Methods: Six electronic databases (Cochrane Library 2018, CINAHL 1982-2018, MEDLINE 1950-2018, EMBASE 1980-2018, PsycINFO 1806-2018, and EMCARE 1995-2018) were systematically searched in June 2018. Reference lists of identified articles were hand searched. Randomized controlled trials (RCTs), cohort studies, and case series were included if they investigated the effects of conservative treatments, including pelvic floor muscle training or dilator training, on bladder, bowel, or sexual function in patients who had received treatment for gynecological cancer. Risk of bias was assessed using the Physiotherapy Evidence Database scale for RCTs and the Newcastle-Ottawa scale for cohort studies.; Results: Five RCTs and 2 retrospective cohort studies were included (n = 886). The results provided moderate-level evidence that pelvic floor muscle training with counseling and yoga or core exercises were beneficial for sexual function (standardized mean difference = -0.96, 95% CI = -1.22 to -0.70, I2 = 0%) and health-related quality of life (standardized mean difference = 0.63, 95% CI = 0.38 to 0.88, I2 = 0%) in survivors of cervical cancer and very low-level evidence that dilator therapy reduced vaginal complications in survivors of cervical and uterine cancer (odds ratio = 0.37, 95% CI = 0.17 to 0.80, I2 = 54%). There were insufficient data for meta-analysis of bladder or bowel function.; Conclusion: Conservative pelvic floor muscle interventions may be beneficial for improving sexual function and health-related quality of life in survivors of gynecological cancer. Given the levels of evidence reported in this review, further high-quality studies are needed, especially to investigate effects on bladder and bowel function.; Impact: This review provides moderate-level evidence for the role of pelvic floor rehabilitation to improve health outcomes in the gynecological cancer survivorship journey. Clinicians and health service providers should consider how to provide cancer survivors the opportunity to participate in supervised pelvic floor rehabilitation programs. (© The Author(s) 2020. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Breschi, L., et al. (2023). "Development of an atlas-based segmentation tool for gynecological Interventional Radiation Therapy." Radiotherapy and Oncology 182(Supplement 1): S1965-S1966.
	Purpose or Objective Radiotherapy treatment involves several steps requiring accuracy and precision, performed by different professional figures. Physicians are responsible for the contouring activity, where they identify the tumor as the CTV structure and all the organs at risk (OARs). Despite this practice is regularized by international guidelines shared within the medical community, the inter- and intra-operator variability represents a limit to achieving the optimal results in terms of treatment success. This approach exploits the availability of a certain number of CT series, contoured by an expert physician. For interventional radiation therapy (IRT, brachytherapy) the contouring step is relevant and even more challenging than external beam radiotherapy (EBRT), because of the presence of applicators. The use of atlas-based segmentation in IRT, already tested for EBRT, may improve the treatment delivery in terms of time and repeatability. Materials and Methods CT images acquired on a Discovery CT590 RT CT scanner (GE Healthcare) were collected for 30 patients with cervical cancer and IRT prescription. They were reconstructed using a matrix of 512x512 and thickness of 0.62 mm. Bladder, bowel bag and rectum structures were defined as OARs and manually generated by an expert radiation oncologist on a dedicated treatment planning system (TPS Oncentra Masterplan v 4.6, Elekta). All the enrolled patients received intracavitary highdose- rate IRT with vaginal applicators of 3 cm diameter. MIM Maestro v.7.1.2 (MIM Software), installed on a workstation with Intel Core i7-7700 CPU and 16 GB RAM, was employed to build a CT atlas for female pelvis. A specific workflow for auto-segmentation of OARs for cervical cancer BT was created. Two algorithms for final contours creation, Majority Vote (MV) and STAPLE (Warfield et al. 2004) were compared, with two kinds of atlases: the first one masking the applicator in order to minimize its effect and the second one without masking the applicator. To evaluate the atlas performances, the Dice Coefficient (DC) and Mean Distance Agreement (MDA) were computed. Results The workflow gave the best results for DC and MDA in the case of the bladder (DC = 0.79 and MDA = 3.06 mm) corresponding to good reproducibility. Lower values were observed (DC = 0.61(0.54) and MDA = 3.54(6.77) mm) for rectum and bowel bag, respectively. The comparison between algorithms showed higher performances with STAPLE than MV (p < 0.05). No relevant differences were stated between atlases. Fig.1Bladder contour obtained with MIM. Conclusion This study analyzed performances of an atlas-based segmentation method with MIM MAESTRO. The best proposal of bowel bag, rectum and bladder contours in HDR interventional radiation therapy was obtained using the STAPLE algorithm. No difference was found between the two atlases, thus implying that masking the applicator is not necessary. Future steps will involve the increase of the number of atlas' subjects and the comparison with neural networks performances. [Figure presented]Copyright © 2023 Elsevier B.V.

Breuer, M., et al. (2022). "Warm and humidified insufflation gas during gynecologic laparoscopic surgery reduces postoperative pain in predisposed patients-a randomized, controlled multi-arm trial." Surgical Endoscopy 36(6): 4154-4170.
	Background: Postoperative pain remains a common problem in gynecologic laparoscopy, especially in head zone-related regions, triggered by intra-abdominal pressure during capnoperitoneum. Humidified and prewarmed insufflation gas may ameliorate pain and be beneficial.; Methods: This prospective randomized controlled parallel group multi-arm single-center study investigated the effects of temperature and humidity of insufflation gas on postoperative pain during gynecologic laparoscopy with a duration ≥ 60 min. Female participants (18-70 years) were blinded and randomly assigned-computer generated-to either insufflation with dry cold CO 2 with forced air warming blanket ("AIR"), humidified warm gas without forced air warming blanket ("HUMI"), or humidified warm gas with forced air warming blanket ("HUMI +"). We hypothesized that using humidified warm gas resulted in lower pain scores and less analgesic consumption. The primary endpoint postoperative pain was assessed for different pain localizations every 12 h during 7 days after surgery. Secondary endpoints were demand for painkillers and epidural anesthetics, length of stay in recovery room, and hospital stay. (Registration: ClinicalTrials.gov NCT02781194-completed).; Results: 150 participants were randomized. Compared to group "AIR" (n = 48), there was significantly less pain in group "HUMI +" (n = 48) in the recovery room (- 1.068; 95% CI - 2.08 to - 0.061), as well as significantly less ibuprofen use at day two (- 0.5871 g ± 0.258; p-value = 0.0471). Other variables did not change significantly. Stratification for presence of endometriosis or non-previous abdominal surgery in patient history revealed significantly less pain in both groups "HUMI" (n = 50) and "HUMI +" versus group "AIR." Related side effects were not noted.; Conclusion: In the overall population, the use of warm, humidified insufflation gas did not yield clinically relevant effects; however, in predisposed patients with endometriosis and who could otherwise expect high pain levels, warm and humidified gas may be beneficial. (© 2021. The Author(s).)

Brieger, K. K., et al. (2022). "High Prediagnosis Inflammation-Related Risk Score Associated with Decreased Ovarian Cancer Survival." Cancer Epidemiology Biomarkers and Prevention 31(2): 443-452.
	Background: There is suggestive evidence that inflammation is (IRRS) was developed, and its association with survival was related to ovarian cancer survival. However, more research is assessed using Cox proportional hazards models in the remaining needed to identify inflammation-related factors that are associated 50% of the data. with ovarian cancer survival and to determine their combined Results: There was a statistically significant trend of increasing effects. risk of death per quartile of the IRRS [HR 1/4 1.09; 95% confidence Methods: This analysis used pooled data on 8,147 women with interval (CI), 1.03-1.14]. Women in the upper quartile of the IRRS invasive epithelial ovarian cancer from the Ovarian Cancer had a 31% higher death rate compared with the lowest quartile (95% Association Consortium. The prediagnosis inflammation-related CI, 1.11-1.54). exposures of interest included alcohol use; aspirin use; other Conclusion(s): A higher prediagnosis IRRS was associated with an nonsteroidal anti-inflammatory drug use; body mass index; increased mortality risk after an ovarian cancer diagnosis. Further environmental tobacco smoke exposure; history of pelvic inflaminvestigation is warranted to evaluate whether postdiagnosis expomatory disease, polycystic ovarian syndrome, and endometriosis; sures are also associated with survival. menopausal hormone therapy use; physical inactivity; smoking Impact: Given that pre- and postdiagnosis exposures are often status; and talc use. Using Cox proportional hazards models, the correlated and many are modifiable, our study results can ultimately relationship between each exposure and survival was assessed in motivate the development of behavioral recommendations to 50% of the data. A weighted inflammation-related risk score enhance survival among patients with ovarian cancer.Copyright © 2022 American Association for Cancer Research

Brigham and W. s. Hospital (2024). Study on Allopregnanolone and Depression in Women Across the Menopause Transition.
	No Results Available Dietary Supplement: pregnenolone|Other: placebo Within-person change in score on the Ruminative Responses Scale Female Not Applicable 80 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Other 2024P000113 August 31, 2027

Brigham, et al. (2024). The Anabolic Effect of Testosterone on Pelvic Floor Muscles.
	No Results Available Drug: Testosterone cypionate|Drug: Placebo Change in pelvic floor muscle volume|Change in abdominal leak point pressure|Change in urine flow rate|Change in bladder pressure|Change in post void residual urine volume|Change in urinary symptoms|Change in quality of life Female Phase 2 30 Other|NIH Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 2023P002632|R01DK136904 July 2026

Bright, C. and Inc (2024). Safety and Efficacy of YB-1113 in Treatment of POI.
	No Results Available Drug: YB-1113 Incidence of treatment-emergent adverse events (AE)|Blood anti-Müllerian hormone (AMH) level|Follicle-stimulating hormone (FSH) and estradiol (E2) levels|Antral follicle counts (AFC) Female Phase 1 6 Industry Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment YB1113-POI August 30, 2025

Bright, K., et al. (2020). "Effectiveness of psychological interventions on mental health, quality of life and relationship satisfaction for individuals and/or couples undergoing fertility treatment: a systematic review and meta-analysis protocol." BMJ Open 10(7): e036030.
	INTRODUCTION: Infertility is a global public health problem affecting men, women and couples worldwide. The medical implications of infertility are often of primary focus in healthcare settings, but the experience of infertility also has a considerable social, emotional and psychological impact. Interventions aimed at alleviating psychological symptoms in individual and/or couples undergoing fertility treatment requires a systematic and comprehensive review of the literature to determine the efficacy of psychological interventions. The objective of this review is to evaluate the effectiveness, feasibility and acceptability of psychological interventions for individuals and/or couples seeking fertility to treat anxiety, depression, distress, quality of life and relationship satisfaction, as well as improve pregnancy rates. METHODS AND ANALYSIS: The search strategy will involve 11 databases, including MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily (Ovid), EMBASE (Ovid), PsycINFO (Ovid), Cochrane Central Register of Controlled Trials (OVID), The Cumulative Index to Nursing and Allied Health Literature (CINAHL) with Full Text (EBSCO), Social Work Abstracts (EBSCO), SocINDEX with Full Text (EBSCO), Academic Search Complete (EBSCO), Family & Society Studies Worldwide (EBSCO), Family Studies Abstracts (EBSCO) and Scopus. These databases will be searched from their inception to September 2019. Independent reviewers will search peer-reviewed published studies through electronic databases and additional sources, will extract the data and assess the methodological quality. Random-effects meta-analysis will be carried out by calculating effect sizes as Cohen's d indices. Heterogeneity will be examined by the I2 and the Q statistics. ETHICS AND DISSEMINATION: The current review does not require ethics approval. The results will be disseminated through publications in peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42019133757.

Bright Katherine, S., et al. (2020). "Interpersonal Psychotherapy to Reduce Psychological Distress in Perinatal Women: A Systematic Review." International Journal of Environmental Research and Public Health 17(22).
	Background: Interpersonal psychotherapy (IPT) is a psychological intervention with established efficacy in the prevention and treatment of depressive disorders. Previous systematic reviews have not evaluated the effectiveness of IPT on symptoms of stress, anxiety, depression, quality of life, relationship satisfaction/quality, social supports, and an improved psychological sense of wellbeing. There is limited information regarding moderating and mediating factors that impact the effectiveness of IPT such as the timing of the intervention or the mode of delivery of IPT intervention. The overall objective of this systematic review was to evaluate the effectiveness of IPT interventions to treat perinatal (from pregnancy up to 12 months postpartum) psychological distress.; Methods: MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily (Ovid), EMBASE (Ovid), PsycINFO (Ovid), Cochrane Central Register of Controlled Trials (OVID), CINAHL with Full Text (Ebsco), Social Work Abstracts (Ebsco), SocINDEX with Full Text (Ebsco), Academic Search Complete (Ebsco), Family & Society Studies Worldwide (Ebsco), Family Studies Abstracts (Ebsco), and Scopus databases were searched from inception until 31 January 2019. Two researchers independently screened articles for eligibility. Of the 685 screened articles, 43 met the inclusion criteria. The search was re-run on 11 May 2020. An additional 204 articles were screened and two met the inclusion criteria, resulting in a total of 45 studies included in this review. There were 25 Randomized Controlled Trials, 10 Quasi-experimental studies, eight Open Trials, and two Single Case Studies. All included studies were critically appraised for quality.; Results: In most studies (n = 24, 53%), the IPT intervention was delivered individually; in 17 (38%) studies IPT was delivered in a group setting and two (4%) studies delivered the intervention as a combination of group and individual IPT. Most interventions were initiated during pregnancy (n = 27, 60%), with the remaining 18 (40%) studies initiating interventions during the postpartum period.; Limitations: This review included only English-language articles and peer-reviewed literature. It excluded government reports, dissertations, conference papers, and reviews. This limited the access to grassroots or community-based recruitment and retention strategies that may have been used to target smaller or marginalized groups of perinatal women.; Conclusions: IPT is an effective intervention for the prevention and treatment of psychological distress in women during their pregnancy and postpartum period. As a treatment intervention, IPT is effective in significantly reducing symptoms of depression and anxiety as well as improving social support, relationship quality/satisfaction, and adjustment. Systematic Review Registration: PROSPERO CRD42019114292.

Brink, G. J., et al. (2022). "Response to Systemic Therapies in Ovarian Adult Granulosa Cell Tumors: A Literature Review." Cancers 14(12): 2998.
	For adult granulosa cell tumors (aGCTs), the preferred treatment modality is surgery. Chemotherapy and anti-hormonal therapy are also frequently used in patients with recurrent aGCT. We aimed to review the existing literature on the response to chemotherapy and anti-hor-monal therapy in patients with aGCT. Embase and MEDLINE were searched from inception to November 2021 for eligible studies. Objective response rate (ORR) was calculated as the total number of cases with a complete response (CR) or a partial response (PR). Disease control rate (DCR) was defined as the sum of cases with CR, PR or stable disease (SD). A total of 10 studies were included that reported on chemotherapy and 13 studies were included that reported on anti-hormonal ther-apy. The response rates of the 56 chemotherapy regimens that could be evaluated resulted in an ORR of 30% and DCR of 58%. For anti-hormonal therapy, the results of 73 regimens led to an ORR of 11% and a DCR of 66%. Evidence on systemic therapy in aGCT only is limited. For both chemotherapy and anti-hormonal therapy, the ORR is limited, but the response is considerably higher when patients achieving SD are included. New approaches are needed to provide more evidence and standardize treatment in aGCT.Copyright © 2022 by the authors. Licensee MDPI, Basel, Switzerland.

Broekman, K. E., et al. (2021). "Clinical benefit of systemic therapies for recurrent ovarian cancer-ESMO-MCBS scores." ESMO Open 6(4): 100229.
	Background: Licensed systemic treatment options for platinum-sensitive recurrent ovarian cancer are platinum-based chemotherapy and maintenance treatment with bevacizumab and poly (ADP-ribose) polymerase inhibitors. For platinum-resistant disease, several non-platinum options are available. We aimed to assess the clinical benefit of these treatments according to the European Society of Medical Oncology (ESMO)-Magnitude of Clinical Benefit Scale (MCBS).; Materials and Methods: A PubMed search was carried out including all studies evaluating systemic treatment of recurrent epithelial ovarian cancer, from 1990 onwards. Randomised trials with an adequate comparator and design showing a statistically significant benefit of the study arm were independently scored by two blinded observers using the ESMO-MCBS.; Results: A total of 1127 papers were identified, out of which 61 reported results of randomised trials of sufficient quality. Nineteen trials showed statistically significant results and the studied treatments were graded according to ESMO-MCBS. Only three treatments showed substantial benefit (score of 4 on a scale of 1-5) according to the ESMO-MCBS: platinum-based chemotherapy with paclitaxel in the platinum-sensitive setting and the addition of bevacizumab to chemotherapy in the platinum-resistant setting. The WEE1 inhibitor adavosertib (not licensed) also scores a 4, based on a recent small phase II study. Assessment of quality-of-life data and toxicity using the ESMO-MCBS showed to be complex, which should be taken into account in using this score for clinical decision making.; Conclusion: Only a few licensed systemic therapies for recurrent ovarian cancer show substantial clinical benefit based on ESMO-MCBS scores. Trials demonstrating overall survival benefit are sparse.; Competing Interests: Disclosure MJ serves on the advisory board of AstraZeneca and Merck, with funding to institution. The remaining authors have declared no conflicts of interest. (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Broi Michele Gomes, D., et al. (2021). "Screening of Variants in the Transcript Profile of Eutopic Endometrium from Infertile Women with Endometriosis during the Implantation Window." Rev. bras. ginecol. obstet 43(6): 457-466.
	Objective Abnormalities in the eutopic endometrium of women with endometriosis may be related to disease-associated infertility. Although previous RNA-sequencing analysis did not show differential expression in endometrial transcripts of endometriosis patients, other molecular alterations could impact protein synthesis and endometrial receptivity. Our aim was to screen for functional mutations in the transcripts of eutopic endometria of infertile women with endometriosis and controls during the implantation window. Methods Data from RNA-Sequencing of endometrial biopsies collected during the implantation window from 17 patients (6 infertile women with endometriosis, 6 infertile controls, 5 fertile controls) were analyzed for variant discovery and identification of functional mutations. A targeted study of the alterations found was performed to understand the data into disease's context. Results None of the variants identified was common to other samples within the same group, and no mutation was repeated among patients with endometriosis, infertile and fertile controls. In the endometriosis group, nine predicted deleterious mutations were identified, but only one was previously associated to a clinical condition with no endometrial impact. When crossing the mutated genes with the descriptors endometriosis and/or endometrium, the gene CMKLR1 was associated either with inflammatory response in endometriosis or with endometrial processes for pregnancy establishment. Conclusion Despite no pattern of mutation having been found, we ponder the small sample size and the analysis on RNA-sequencing data. Considering the purpose of the study of screening and the importance of the CMKLR1 gene on endometrial

Brown, N. (2021). "Cost-effectiveness of Interventional Radiology techniques in Australia: Towards sustainable, more affordable healthcare." Journal of Medical Imaging and Radiation Oncology 65(SUPPL 1): 82.
	Purpose: Interventional Radiology is an evolving clinical specialty that can improve patient outcomes, reduce treatment costs and strengthen the role of radiology within modern healthcare. This has the potential to position RANZCR as a leader in Value-Based Healthcare as minimally-invasive, image-guided IR and INR procedures are increasingly integrated into contemporary clinical algorithms. But to fulfil this potential and expand interventional radiology practise, high quality, comprehensive cost-effectiveness analyses will be required to prove the value of IR and INR to clinicians, managers, policy-makers and patients. This research develops cost-effectiveness models that can be applied across the spectrum of interventional radiology practise to determine the potential value of IR procedures to the Australian healthcare system. Methods and Materials: Markov models were developed to evaluate Quality-Adjusted Life Years (QALYs), lifetime cost burdens and incremental cost-effectiveness ratios (ICERs) for two common clinical presentations that can be treated with interventional radiology procedures or surgical alternatives. The initial comparisons were between percutaneous ablation of renal masses, partial nephrectomy and radical nephrectomy, and uterine fibroid embolization, myomectomy and hysterectomy. Data and assumptions on efficacy, re-treatment, complications, side-effects and quality of life were determined from a review of all relevant meta-analyses within the PubMed and Embase databases. Data on costs of treatment and subsequent healthcare were sourced from Medicare, public hospital and private hospital databases. Result(s): Interventional radiology procedures for the treatment of small renal masses and uterine fibroids are highly cost-effective and can result in improved patient outcomes. When compared to surgical interventions, IR procedures can yield higher quality adjusted life year values for patients and result in significant overall cost savings. Incremental cost-effectiveness ratios vary depending on costs of treatment in public or private hospitals. Medicare data indicate that these procedures are currently under-utilised. Conclusion(s): Percutaneous ablation of small renal masses and uterine fibroid embolization constitute high-value treatment options and should be more prominent in clinical algorithms. From a public health perspective, increased uptake of these procedures could save millions of dollars from both state and federal health budgets, improve the allocation of health resources, provide justification for increased IR training programs and expand patient access to essential services. These models can be applied to other IR and INR procedures, and additional cost-effectiveness analyses are now being undertaken to develop a comprehensive account of the true value of interventional radiology.

Bruce, P., et al. (2021). "Effects of different frozen embryo transfer regimens on abnormalities of fetal weight, large for gestational age, and macrosomia: a systematic review and meta-analysis."
	
Brule, K., et al. (2023). "A 6-month Lifestyle Intervention Program Improves Quality Of Life And Motivation In Women With Obesity And Infertility." Journal of the Endocrine Society 7(Supplement 1): A861.
	Introduction Infertility is the incapacity to conceive after 12 months of regular and unprotected sexual intercourse, affecting 11 to 16% of couples. Obesity affects fertility, increases fertility treatment costs, diminishes their efficacy, predisposes to many complications during pregnancy and presents risks for the offspring. To prevent those consequences, many organizations recommend that women with obesity be assisted in adopting healthy lifestyle habits before conception and maintain them during pregnancy. Also, women with infertility and those living with obesity score lower on the quality of life (QoL) scales. Therefore, our objective was to assess the impact of a lifestyle intervention on QoL and stages of change (based on the transtheoretical model) in women with obesity and seeking fertility treatments. Methods Women 18-40 years old with infertility and obesity (body mass index (BMI) >= 30 kg/m2 or BMI >= 27 kg/m2 for those with polycystic ovary syndrome), consulting at the fertility clinic of an academic center, were enrolled and randomized to usual fertility care (control group, CG) or the intervention program (lifestyle group, LSG) alone for 6 months and then combined to usual care. The lifestyle program focused on improving physical activity and nutrition and was based on motivational communication. It involved individual follow-ups with a nutritionist and a kinesiologist at weeks 0, 3, 6 and then every 6 weeks for 18 months. Also, participants needed to attend 12 group sessions, including workshops and physical activities. QoL scores from the SF-6D and FertiQol, levels of conviction (visual analog scales on 100), and stages of change were collected at baseline and at 6 months. Proportions were compared by Pearson chi-square tests and means by Student's t tests or ANCOVA (correcting for the baseline value of the result). Results Among 127 women, 85 had available data at 6 months (CG=43, LSG=42). After 6 months, and compared to the CG, women in the LSG improved more their SF-6D (+0.029 +/- 0.076 vs -0.017 +/- 0.082, p = 0.009, p ANCOVA <0.001) and FertiQoL total score (+0.35 +/- 6.85 vs -2.70 +/- 11.80, p = 0.18, p ANCOVA = 0.02). A higher proportion of women in LSG improved their stage of change by >=2 categories compared to CG (40.0% vs 13.2%, p=0.008). They better maintained their level of conviction about the need to improve their food habits (+4.0 +/- 13.4 vs -2.7 +/- 17.7, p ANCOVA=0.02) or their physical activity (+2.5 +/- 10.2 vs -5.1 +/- 13.8, p=0.006, p ANCOVA=0.01). Conclusion A lifestyle program targeting women with obesity and infertility significantly helped maintain or increase their QoL, levels of conviction for food habits and physical activity, and stages of change regarding lifestyle habits compared to usual fertility care. These results suggest that such lifestyle intervention can contribute to the well-being and maintenance of lifestyle changes in women with obesity who seek fertility treatments.

Brun, J. L., et al. (2022). "Management of women with abnormal uterine bleeding: Clinical practice guidelines of the French National College of Gynecologists and Obstetricians (CNGOF)." Gynecologie Obstetrique Fertilite et Senologie 50(5): 345-373.
	Objective: To provide French guidelines for the management of women with abnormal uterine bleeding (AUB). Design(s): A consensus committee of 26 experts was formed. A formal conflict-of-interest (COI) policy was developed at the beginning of the process and enforced throughout. The entire guidelines process was conducted independently of any industrial funding (i.e. pharmaceutical, or medical devices). The authors were advised to follow the rules of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized. Method(s): The last guidelines from the College national des gynecologues et obstetriciens francais (CNGOF) on the management of women with AUB was published in 2008. The literature seems now sufficient for an update. The committee studied questions within 7 fields (diagnosis; adolescent; idiopathic AUB; endometrial hyperplasia and polyps; fibroids type 0 to 2; fibroids type 3 and more; adenomyosis). Each question was formulated in a PICO (Patients, Intervention, Comparison, Outcome) format and the evidence profiles were produced. The literature review and recommendations were made according to the GRADE methodology. Result(s): The experts' synthesis work and the application of the GRADE method resulted in 36 recommendations. Among the formalized recommendations, 19 present a strong agreement and 17 a weak agreement. Fourteen questions did not find any response in the literature. We preferred to abstain from recommending instead of providing expert advice. Conclusion(s): The 36 recommendations made it possible to specify the diagnostic and therapeutic strategies of various clinical situations managed by the practitioner, from the simplest to the most complex.Copyright © 2022 Elsevier Masson SAS

Brunn, E., et al. (2022). "Virtual-Reality Effects on Acute Pain during Office Hysteroscopy: A Randomized Controlled Trial." Journal of Gynecologic Surgery 38(3): 214-220.
	Objective: The goal of this research was to evaluate the use of virtual reality (VR) as a noninvasive analgesic during office hysteroscopy. Material(s) and Method(s): The participants were 50 women undergoing office-based hysteroscopy at a single clinic in Washington DC randomized to VR or standard care from May to November 2020. The VR intervention consisted of guided meditation through an Oculus Go headset. Primary outcome measurement was peak pain score during the procedure based on a 100-mm visual analogue scale score. Secondary outcomes were changes in pain scores and changes in participants' heart rates (HRs). Result(s): No significant difference emerged in pain before, during, or after the procedure between the 2 groups. The peak pain score during the procedure for the VR group was 35 (15, 60) versus 30 (9, 54) for the standard hysteroscopy group (p = 0.317). VR had no significant effect on median HR change during the procedure (-4.6 [-0.5,11.1] versus +2.8 [0.1,7.7]; p = 0.327). Largely, participants in the VR group had positive experiences: 88% reported that the music was calming and 84% reported that meditation was helpful. Conclusion(s): This study showed no statistically significant difference in pain scores or change in HR prior to, during, or after hysteroscopic procedures with VR, compared to standard care. (J GYNECOL SURG 38:214)© Copyright 2022, Mary Ann Liebert, Inc., publishers 2022.

Bruno, V., et al. (2023). "Urological Complications in Radical Surgery for Cervical Cancer: A Comparative Meta-Analysis before and after LACC Trial." Journal of Clinical Medicine 12(17).
	Background: After the LACC trial publication in 2018, the minimally invasive approach (MIS) has severely decreased in favor of open surgery: MIS radical hysterectomy was associated with worse oncological outcomes than open surgery, but urological complications were never extensively explored in pre- versus post-LACC eras, even if they had a great impact on post-operative QoL. The purpose of this meta-analysis is to compare functional and organic urological complication rates before and after LACC trial.; Methods: An independent search of the literature was conducted 4 years before and after the LACC trial and 50 studies were included.; Results: The overall rate of urologic complications was higher in pre-LACC studies while no differences were found for organic urological complications. Conversely, the overall risk of dysfunctional urological complications showed a higher rate in the pre-LACC era. This is probably related to a sudden shift to open surgery, with potential lower thermal damage to the urinary tract autonomic nervous fibers.; Conclusions: This meta-analysis showed that the incidence of urological complications in radical cervical cancer surgery was higher before the LACC trial, potentially due to the shift to open surgery. Nevertheless, further studies are needed to shed light on the connection between minimally invasive surgery and urological damage.

Brusciano, L., et al. (2023). "EFFECTIVENESS OF PERINEAL PELVIS REHABILITATION COMBINED WITH BIOFEEDBACK AND RADIOFREQUENCY DIATHERMY (RDF) IN ANORECTAL FUNCTIONAL PAIN SYNDROMES ASSOCIATED WITH PARADOXICAL CONTRACTION OF THE LEVATOR ANI MUSCLES. A PROSPECTIVE STUDY." Arquivos de gastroenterologia 60(2): 201-207.
	•Anorectal functional pain syndrome is a very often disabling disease with a consequent significant negative impact on the patient's quality of life. Chronic proctalgia, in many patients, is secondary to the paradoxical contraction of the pelvic floor and associated with a dissynergy between the thorax-abdomen and the pelvic floor. •The use of radiofrequency diathermy with a system of static electrodes associated with biofeedback represents a valid rehabilitation option for those patients suffering from anorectal functional pain syndrome because it reduces pain and paradoxical contraction of the levator ani and improves quality of life of the patient. Background - Anorectal functional pain syndrome, also called chronic proctalgia, represents a neglected clinical entity and often confused with other syndromes such as vulvodynia or acute proctalgia. It is a very often disabling disease with a consequent significant negative impact on the patient's quality of life. Chronic proctalgia, in many patients, is secondary to the paradoxical contraction of the pelvic floor and associated with a dissynergy between the thorax-abdomen and the pelvic floor. To improve symptoms in functional anorectal pain syndromes, various rehabilitation techniques are used with the aim of promoting relaxation of the pelvic floor; however, to improve defecatory dynamics in patients with levator ani syndrome, only biofeedback has shown efficacy in a randomized study. The aim of this work is to evaluate whether a rehabilitation protocol with manometric biofeedback and radiofrequency diathermy (mt100 Fremslife emotion Tecar) reduces pain and paradoxical contraction of the levator ani and improves the quality of life in patients with anorectal pain syndromes. functional. Methods - This was a prospective study on 30 patients (20 women and 10 men) with anorectal functional pain syndrome and paradoxical contraction of the pelvic floor enrolled at the UOC of General, Minimally Invasive, Oncological and Obesity Surgery of the AOU "Luigi Vanvitelli" of Naples, Italy, from September 2021 to May 2022. All patients were evaluated with a coloproctological specialist visit followed by anorectal manometry and evaluation of altered clinical physiatric parameters (Brusciano Score). The protocol consisted of 10 rehabilitation sessions of the pelvic floor once a week and lasting approximately 45 minutes. During the sessions the patients were subjected to diathermy / radiofrequency treatment (10 minutes) with a static resistive electrode on the diaphragm, during which they were required to breathe diaphragmatically and to become aware of the perineal muscles, under the supervision of a physiotherapist; followed by application of diathermy with static capacitive (5 minutes) and resistive (10 minutes) electrode at the lumbar level. This was followed by the use of manometric biofeedback (15 minutes of tonic / phasic exercises) in order to instruct the patient on the reflex mechanism to obtain a voluntary relaxation of the external anal sphincter. The variables evaluated were Pain (VAS 0-10) and the questionnaire on the impact of colorectal and anal pathologies on the quality of life (CRAIQ-7) at the beginning, after 3 months and at the end of the treatment. Results - After 10 weeks, the rehabilitation treatment combined with diathermy and manometric biofeedback proved effective in the short term with a reduction in the scores of the Vas scale and CRAIQ-7 questionnaire and an increase in the percentage of release of the anal muscles on anorectal manometry. Conclusion - The use of radiofrequency diathermy with a system of static electrodes associated with biofeedback represents a valid rehabilitation option for those patients suffering from anorectal functional pain syndrome because it reduces pain and paradoxical contraction of the levator ani and improves quality of life of the patient.

Brussel Universitair, Z. (2021). Optimising Preconceptual Health in Subfertile PCOS Patients Using a Lifestyle Modification Program.
	No Results Available Behavioral: Lifestyle program body weight|body composition Female Not Applicable 226 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment LSPCOLMMDV October 31, 2024

Brussel Universitair, Z. (2024). Live Birth Rate After Sperm Selection Using ZyMōt Multi (850µL) Device for Intra Uterine Insemination.
	No Results Available Device: ZyMōt Multi (850µL)|Other: Density Gradient Centrifugation Cumulative live birth rate after 3 consecutive IUIs|Pregnancy rate|Miscarriages rate All Not Applicable 240 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment EC-2023-257 December 2027

Brzozowska, M. and A. Lewinski (2021). "Hormonal replacement therapy in women with a history of internal genital organ malignancy." Przeglad menopauzalny = Menopause review 20(1): 34-39.
	Sudden cessation of ovary activity as a result of bilateral oophorectomy or chemo- or radiotherapy in premenopausal women is linked with more serious consequences that bear no comparison to natural menopause - to name just a few: higher rate of mortality, higher rate of colorectal and lung cancer, circulatory system diseases, cognitive disorders, Parkinson's disease, psychological disorders, osteoporosis, and sexual disorders. The prolonged period of estrogens deficit in premenopausal age is connected with worsened quality of life. The progress in oncological care means that in many malignant diseases, also in the case of gynaecological malignancies, the percentage of survivors increases. This makes improving the quality of life more and more important. The purpose of this review is to establish, based on EBM data, the answer to whether replacement hormonal therapy, being the most effective treatment of menopause symptoms, can be recommended for women who have undergone bilateral oophorectomy because of gynaecological cancer. On the basis of collected data, derived from meta-analysis, and studies which have been published within the last 20 years, it seems that the use of the appropriate type of hormonal replacement therapy (HRT) in properly selected gynaecological cancer survivors (epithelial ovarian cancer - EOC, endometrial cancer, squamous cell carcinoma of the cervix) is safe and effective. It seems that benefits connected with better quality of life that stem from the use of appropriate HRT in gynaecological cancer survivors predominate the unfounded fear of disease recurrence in selected patients' groups.; Competing Interests: The authors report no conflict of interest. (Copyright © 2021 Termedia.)

Buchanan, A., et al. (2021). "Patient-reported outcomes of non-pharmacological interventions for endometrial cancer survivors: a systematic review." Journal of cancer survivorship : research and practice 15(4): 526-535.
	Purpose: The objective of this review was to assess the efficacy of non-pharmacological interventions on endometrial cancer (EC) survivors' QOL, and their use of patient-reported outcome measures (PROMs).; Methods: We conducted a systematic review of randomized controlled trials (RCTs) of non-pharmacological interventions that assessed the impact of intervention on EC survivors' general and domain-specific QOL (i.e., physical, psychological, and social well-being) using PROMs.; Results: Of the 3178 studies identified, 28 full-text articles were reviewed, and 10 were included in the review. Nine RCTs assessed at least one PROM as a primary outcome and six assessed a PROM as a secondary outcome, but few studies used validated PROMs. Significant improvements in general QOL were found in two studies, domain-specific QOL in three studies, and both general and domain-specific QOL in three studies; however, effect sizes ranged from small to large and no significant effects were found for social well-being and few were found for psychological well-being.; Conclusions: Few non-pharmacological interventions for EC survivors targeted QOL, even though QOL was assessed as either a primary or secondary outcome of the RCT. Despite this, findings suggest that non-pharmacological interventions for EC survivors hold promise for improving general and domain-specific QOL. Use of validated PROMs would greatly enhance outcome reporting and facilitate comparisons across studies. More interventions are also needed that address social and psychological functioning in this population.; Implications for Cancer Survivors: Our review highlights a need to (1) expand non-pharmacological RCTs for EC survivors, (2) increase the use of validated PROMs measuring QOL, and (3) address psychosocial domains of QOL when developing interventions for this population. (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)

Buckley, B. S., et al. (2019). "Conservative interventions for treating functional daytime urinary incontinence in children." Cochrane Database of Systematic Reviews 2019(9): CD012367.
	Background: In children, functional daytime urinary incontinence is the term used to describe any leakage of urine while awake that is not the result of a known underlying neurological or congenital anatomic cause (such as conditions or injuries that affect the nerves that control the bladder or problems with the way the urinary system is formed). It can result in practical difficulties for both the child and their family and can have detrimental effects on a child's well-being, education and social engagement. Objective(s): To assess the effects of conservative interventions for treating functional daytime urinary incontinence in children. Search Method(s): We searched the Cochrane Incontinence Specialised Register, which contains studies identified from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 11 September 2018). We also searched Chinese language bibliographic databases: Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), and Wanfang. No language restrictions were imposed. Selection Criteria: We included randomised controlled trials (RCTs), quasi-randomised, multi-arm studies, cross-over studies and cluster-randomised studies that included children aged between 5 and 18 years with functional daytime urinary incontinence. Data Collection and Analysis: Two review authors independently screened records and determined the eligibility of studies for inclusion according to predefined criteria. Where data from the study were not provided, we contacted the study authors to request further information. Two review authors assessed risk of bias and processed included study data as described in the Cochrane Handbook for Systematic Reviews of Interventions. Where meta-analysis was possible, we applied random-effects meta-analysis using the Mantel-Haenszel method for dichotomous outcomes. Main Result(s): The review included 27 RCTs involving 1803 children. Of these, six were multi-arm and one was also a cross-over study. Most studies were small, with numbers randomised ranging from 16 to 202. A total of 19 studies were at high risk of bias for at least one domain. Few studies reported data suitable for pooling due to heterogeneity in interventions, outcomes and measurements. Individual conservative interventions (lifestyle, behavioural or physical) versus no treatment. Transcutaneous electrical nerve stimulation (TENS) versus sham (placebo) TENS. More children receiving active TENS may achieve continence (risk ratio (RR) 4.89, 95% confidence interval (CI) 1.68 to 14.21; 3 studies; n = 93; low-certainty evidence). One individual conservative intervention versus another individual or combined conservative intervention. Pelvic floor muscle training (PFMT) with urotherapy versus urotherapy alone. We are uncertain whether more children receiving PFMT with urotherapy achieve continence (RR 2.36, 95% CI 0.65 to 8.53, 95% CI 25 to 100; 3 studies; n = 91; very low-certainty evidence). Voiding education with uroflowmetry feedback and urotherapy versus urotherapy alone. Slightly more children receiving voiding education with uroflow feedback and urotherapy may achieve continence (RR 1.13, 95% CI 0.87 to 1.45; 3 studies; n = 151; low-certainty evidence). Urotherapy with timer watch versus urotherapy alone. We are uncertain whether urotherapy plus timer watch increases the number of children achieving continence compared to urotherapy alone (RR 1.42, 95% CI 1.12 to 1.80; 1 study; n = 58; very low-certainty evidence). Combined conservative interventions versus other combined conservative interventions. TENS and standard urotherapy versus PFMT with electromyographic biofeedback and standard urotherapy. We are uncertain whether there is any evidence of a difference between treatment groups in the proportions of children achieving continence (RR 1.11, 95% CI 0.73 to 1.68; 1 study; n = 78; very low-certainty evidence). PFMT with electromyography biofeedback and standard urot erapy versus PFMT without feedback but with standard urotherapy. We are uncertain whether there is any evidence of a difference between treatment groups in the proportions of children achieving continence (RR 1.05, 95% CI 0.72 to 1.52; 1 study; n = 41; very low-certainty evidence). Individual conservative interventions versus non-conservative interventions (pharmacological or invasive, combined or not with any conservative interventions). PFMT versus anticholinergics. We are uncertain whether more children receiving PFMT than anticholinergics achieve continence (RR 1.92, 95% CI 1.17 to 3.15; equivalent to an increase from 33 to 64 per 100 children; 2 studies; n = 86; very low-certainty evidence). TENS versus anticholinergics. We are uncertain whether there was any evidence of a difference between treatment groups in the proportions of children achieving continence (RR 0.81, 95% CI 0.05 to 12.50; 2 studies; n = 72; very low-certainty evidence). Combined conservative interventions versus non-conservative interventions (pharmacological or invasive, combined or not with any conservative interventions). Voiding education with uroflowmetry feedback versus anticholinergics. We are uncertain whether there was any evidence of a difference between treatment groups in the proportion of children achieving continence (RR 1.02, 95% CI 0.58 to 1.78; 1 study; n = 64; very low-certainty evidence). Authors' conclusions: The review found little reliable evidence that can help affected children, their carers and the clinicians working with them to make evidence-based treatment decisions. In this scenario, the clinical experience of individual clinicians and the support of carers may be the most valuable resources. More well-designed research, with well-defined interventions and consistent outcome measurement, is needed.Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Buda, A., et al. (2022). "Neoadjuvant Chemotherapy Prior Fertility-Sparing Surgery in Women with FIGO 2018 Stage IB2 Cervical Cancer: A Systematic Review." Cancers 14(3).
	Nowadays, the optimal management of patients with cervical cancers measuring 2-4 cm desiring to maintain fertility is still uncertain. In this systematic review, we assessed the reliability of neoadjuvant chemotherapy (NACT) prior to fertility-sparing (FS) surgery in International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB2 cervical cancer, in terms of pathologic response, oncological and obstetric outcomes. The review of the literature was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data, using MEDLINE and PubMed, were searched for from 1 January 2005 up to 1 December 2020. We identified 20 articles and 114 women with IB2 disease, possible candidates for NACT prior to FS surgery. However, uterine conservation was achieved only in 76.7% of them. Patients reached optimal pathological response to NACT in 60.9% of cases and a TIP (cisplatin, ifosfamide and paclitaxel) regime was related to the best response. Suboptimal response to NACT appeared to be an independent negative prognostic factor. Up to 9.2% of patients recurred with a median 7.4-months DFS, and 4.6% of patients died of disease. Fifty percent of women tried to conceive after treatment and NACT prior to conization appeared to be the most promising alternative to upfront radical trachelectomy in terms of obstetric outcomes. In conclusion, NACT prior to FS surgery is an option, but the literature about this issue is still weak and FS should be carefully discussed with patients.

Budani, M. C., et al. (2020). "Efficacy and safety of follitropin alpha biosimilars compared to their reference product: a Meta-analysis." Gynecological Endocrinology: 1-9.
	Aim: Recently published multicentre, randomized phase III studies suggested the therapeutic equivalence of biosimilar follitropin alpha medicaments compared to the reference product. The aim of this meta-analysis is to pool the results of the three phase III trials in order to provide an overall analysis about the clinical bioequivalence between biosimilars and the originator. Method(s): The studies included in the analysis were pooled together in order to estimate the log odds ratio (OR) for binary outcomes and the weighted mean difference (WMD) for continuous outcomes along with the corresponding 95% confidence intervals (CI) by using a random effects model. The heterogeneity between the studies was evaluated with the Higgins and Chi-square tests. Result(s): No differences were found in term of number of oocytes retrieved at ovum pick-up, the primary endpoint recommended by the European Medicines Agency. No statistical differences were also found for biochemical pregnancy rate, take home baby rate, total follitropin alpha dose, duration of stimulation, and OHSS risk. A significantly higher clinical pregnancy rate (p =.03) was observed in the originator group in comparison to the biosimilar follitropin alpha. Conclusion(s): Biosimilar follitropin alpha medicaments resulted comparable in comparison to the reference product with respect to the number of oocytes retrieved, that is the primary endpoint recommended by the European Medicines Agency.Further study is needed to evaluate the therapeutic bioequivalence between follitropin alpha biosimilar and the reference medication with respect to secondary endpoints.Copyright © 2020, © 2020 Informa UK Limited, trading as Taylor & Francis Group.

Buechel, M. E., et al. (2021). "Correlation of imaging and plasma based biomarkers to predict response to bevacizumab in epithelial ovarian cancer (EOC)." Gynecologic Oncology 161(2): 382‐388.
	Purpose: Increasing measures of adiposity have been correlated with poor oncologic outcomes and a lack of response to anti‐angiogenic therapies. Limited data exists on the impact of subcutaneous fat density (SFD) and visceral fat density (VFD) on oncologic outcomes. This ancillary analysis of GOG‐218, evaluates whether imaging markers of adiposity were predictive biomarkers for bevacizumab (bev) use in epithelial ovarian cancer (EOC). Patients and methods: There were 1249 patients (67%) from GOG‐218 with imaging measurements. SFD and VFD were calculated utilizing Hounsfield units (HU). Proportional hazards models were used to assess the association between SFD and VFD with overall survival (OS). Results: Increased SFD and VFD showed an increased HR for death (HR per 1‐SD increase 1.12, 95% CI:1.05–1.19 p = 0.0009 and 1.13, 95% CI: 1.05–1.20 p = 0.0006 respectively). In the predictive analysis for response to bev, high VFD showed an increased hazard for death in the placebo group (HR per 1‐SD increase 1.22, 95% CI: 1.09–1.37; p = 0.025). However, in the bev group there was no effect seen (HR per 1‐SD increase: 1.01, 95% CI: 0.90–1.14) Median OS was 45 vs 47 months in the VFD low groups and 36 vs 42 months in the VFD high groups on placebo versus bev, respectively. Conclusion: High VFD and SFD have a negative prognostic impact on patients with EOC. High VFD appears to be a predictive marker of bev response and patients with high VFD may be more likely to benefit from initial treatment with bev.

Bugge, C., et al. (2020). "The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation." Trials 21(1): 836.
	Background: Process evaluations have become a valued component, alongside clinical trials, of the wider evaluation of complex health interventions. They support understanding of implementation, and fidelity, related to the intervention and provide valuable insights into what is effective in a practical setting by examining the context in which interventions are implemented. The TOPSY study consists of a large multi-centre randomised controlled trial comparing the effectiveness of pessary self-management with clinic-based care in improving women's condition-specific quality of life, and a nested process evaluation. The process evaluation aims to examine and maximise recruitment to the trial, describe intervention fidelity and explore participants' and healthcare professionals' experiences.; Methods: The trial will recruit 330 women from approximately 17 UK centres. The process evaluation uses a mixed-methods approach. Semi-structured interviews will be conducted with randomised women (18 per randomised group/n = 36), women who declined trial participation but agreed to interview (non-randomised women) (n = 20) and healthcare professionals recruiting to the trial (n ~ 17) and delivering self-management and clinic-based care (n ~ 17). The six internal pilot centres will be asked to record two to three recruitment discussions each (total n = 12-18). All participating centres will be asked to record one or two self-management teaching appointments (n = 30) and self-management 2-week follow-up telephone calls (n = 30). Process data (quantitative and qualitative) will be gathered in participant completed trial questionnaires. Interviews will be analysed thematically and recordings using an analytic grid to identify fidelity to the intervention. Quantitative analysis will be predefined within the process evaluation analysis plan.; Discussion: The wide variety of pessary care delivered across the UK for women with pelvic organ prolapse presents specific localised contexts in which the TOPSY interventions will be implemented. Understanding this contextual variance is central to understanding how and in what circumstances pessary self-management can be implemented (should it be effective). The inclusion of non-randomised women provides an innovative way of collecting indispensable information about eligible women who decline trial participation, allowing broader contextualisation and considerations of generalisability of trial findings. Methodological insights from examination of recruitment processes and mechanisms have the potential to inform recruitment mechanisms and future recruitment strategies and study designs.; Trial Registration: ISRCTN62510577 . Registered on 6 October 2017.

Buggio, L., et al. (2022). "Novel pharmacological therapies for the treatment of endometriosis." Expert review of clinical pharmacology 15(9): 1039-1052.
	Introduction: Endometriosis is a chronic, estrogen-dependent, inflammatory disease associated with pelvic pain, infertility, impaired sexual function, and psychological suffering. Therefore, tailored patient management appears of primary importance to address specific issues and identify the appropriate treatment for each woman. Over the years, abundant research has been carried out with the objective to find new therapeutic approaches for this multifaceted disease.; Areas Covered: This narrative review aims to present the latest advances in the pharmacological management of endometriosis. In particular, the potential role of GnRH antagonists, selective progesterone receptor modulators (SPRMs), and selective estrogen receptors modulators (SERMs) will be discussed. We performed a literature search in PubMed and Embase, and selected the best quality evidence, giving preference to the most recent and definitive original articles and reviews.; Expert Opinion: Medical therapy represents the cornerstone of endometriosis management, although few advances have been made in the last decade. Most studies have focused on the evaluation of the efficacy and safety of GnRH antagonists (plus add-back therapy in cases of prolonged treatment), which should be used as second-line treatment options in selected cases (i.e. non-responders to first-line treatments). Further studies are needed to identify the ideal treatment for women with endometriosis.

Buhl, B., et al. (2023). "Food & Fertility Study: study protocol for a Danish multicentre prospective cohort study investigating the association between food intake and semen quality, pregnancy and birth outcomes in infertile women and men." BMJ Open 13(7): e068354.
	Introduction: Worldwide infertility is highly prevalent, and lifestyle factors, such as food intake, could have an essential role in the success of a fertility treatment. The literature is not consistent and adequate for recommendations to the increasing number of women and men of reproductive age who ask for lifestyle guidance. Therefore, the aims of the Food & Fertility Study will be to investigate the possible association between food intake and semen quality in men, and pregnancy and live birth rates in women undergoing intrauterine insemination or assisted reproductive technology treatment.; Methods and Analysis: The Food & Fertility Study is a multicentre prospective cohort study which plans to enrol a total of 4000 women and men between 2022 and 2024. Data collection will take place in four fertility clinics through a web-based Food Frequency Questionnaire. Data on sperm quality and pregnancy and live birth rates will be obtained from medical records and national registers.; Ethics and Dissemination: The study is registered with and approved by the Danish Data Protection Agency, the North Denmark Region (j.nr: 2019-055298). Further, a Statement of Work and a Master Collaboration Agreement have been submitted and approved by the regional legal departments (AGR-2019-731-9667). Dissemination of the results will be through national and international conferences, in scientific environments, in the form of lectures to the broader public, and by peer-reviewed publications in international scientific journals.; Trial Registration Number: NCT05454046.; Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Bui, A., et al. (2022). "Clinical calculator redefines prognosis for high-risk early-stage ovarian cancers and potential to guide treatment in the adjuvant setting." Gynecologic Oncology 167(2): 205-212.
	Objective: To determine the utility of a clinical calculator to redefine prognosis and need for chemotherapy among patients with early-stage high-risk epithelial ovarian cancer.; Methods: Data were abstracted for stage I-II, high-risk ovarian cancer from the National Cancer Database from years 2005 to 2015. Based on demographic, pathologic, surgical, and laboratory characteristics, a clinical score was developed using Cox regression. Propensity score weighting was used to adjust for differences between patients who did and did not receive chemotherapy.; Results: Of 8188 patients with early-stage high-risk ovarian cancer, 6915 (84%) did and 1273 (16%) did not receive chemotherapy. A clinical calculator was created utilizing age, stage, histology, grade, tumor size, number of pelvic and paraaortic lymph nodes examined, the presence of malignant ascites, and CA125. The calculator divided patients into low, moderate, and high-risk groups with 5-year OS (overall survival) of 92%, 82%, and 66%, and 10-year OS of 85%, 67%, and 44%, respectively. Chemotherapy improved 5-year OS and 10-year OS in the high-risk group (56% to 73%; p < 0.001, 34% to 48%; p < 0.001). The moderate risk group had improved 5-year OS (80% to 85%; p = 0.01) but not 10-year OS (66% to 66%; p = 0.13). Chemotherapy did not improve 5-year or 10-year OS in low-risk patients (93% to 92%, p = 1.0, 86% to 84%, p = 0.99).; Conclusions: The prognosis among high-risk early-stage ovarian cancer patients is heterogeneous. This calculator may aid in patient-centered counseling regarding potential treatment benefits.; Competing Interests: Declaration of Competing Interest None of the authors have conflicts of interest as it relates to the submitted work. Outside of the submitted work, Dr. Ghamande has received compensation from GlaxoSmithKline for consulting and from Merck as part of their speaker bureau. Dr. Chan has received compensation from Astra Zeneca, Aravive, Clovis, Eisai, GlaxoSmithKline Merck, Myriad, Roche/GenentechSeagen. (Published by Elsevier Inc.)

Buisson, A., et al. (2023). "Retrospective blind assessment of SOPHiA DDM™ Dx HRD solution for evaluation of olaparib maintenance treatment efficacy in ovarian cancer patients from the randomized, phase III PAOLA-1 trial."  483: S55‐S56.
	Background &objectives: SOPHiA DDM™ Dx HRD Solution combines analysis of genomic instability and homologous recombination repair gene mutation status to predict homologous recombination deficiency (HRD) in ovarian cancer (OvCa). As part of the ENGOT HRD initiative, we present updated clinical relevance results. Methods: Using SOPHiA DDM™ Dx HRD Solution, DNA from a subcohort of 359 patients (pts) from the GINECO/ENGOT‐Ov25 PAOLA‐1 trial (NCT02477644) was re‐analysed in a multicentre study. We compared the results to those previously obtained using Myriad myChoice CDx. We investigated differences in progression‐free (PFS) and overall (OS) survival in the olaparib+bevacizumab and placebo+bevacizumab arms between HRD‐positive and HRD‐negative pts. Results: HRD status was determined in 98.9% of pts using SOPHiA DDM™ Dx HRD Solution. The overall concordance with Myriad myChoice CDx was 98.1% (95% confidence interval [CI], 96.0%‐ 99.1%) and highly reproducible across laboratories (r=0.987). In HRD‐positive pts, the PFS and OS time were 55.7 months and 75.2 months respectively in the olaparib+bevacizumab arm versus 18.7 and 56.4 months respectively in the placebo+bevacizumab arm (hazard ratio [HR] PFS, 0.32; 95% CI, 0.22‐0.45, p<0.001; HR OS, 0.49; 95% CI, 0.32‐0.77, p=0.002). No significant difference in PFS or OS was observed between treatment arms in pts with HRD‐negative test (HR PFS, 1.04; 95% CI, 0.71‐1.52; p=0.8; HR OS, 1.19; 95% CI, 0.78‐ 1.80; p=0.4). Conclusion: The analytical performance and the potential clinical relevance results of SOPHiA DDM™ Dx HRD Solution from PAOLA‐1 samples support the value of combining low‐pass whole genome and targeted sequencing in a unique workflow for reliable and decentralized HRD testing and future patient stratification.

Bukkems Leslie, J. H., et al. (2022). "The impact of para-aortic lymph node irradiation on disease-free survival in patients with cervical cancer: A systematic review and meta-analysis." Clinical and translational radiation oncology 35: 97-103.
	Background: Patients with locally advanced cervical cancer without para-aortic lymph node metastases (PAO-LNM) at diagnosis who undergo concurrent chemoradiotherapy are at 4-11% risk of developing PAO-LNM during follow-up. Some studies suggest a beneficial influence of elective para-aortic radiotherapy (PAO-RT) on disease-free survival (DFS) in these patients. The aim of this study was to systematically review and meta-analyse literature on the impact of PAO-RT on DFS in cervical cancer patients.; Methods: A systematic search of PubMed/MEDLINE and EMBASE databases was performed. The analysis included intervention studies that reported on DFS in patients with cervical cancer who received chemotherapy and pelvic radiotherapy with or without PAO-RT. From each included study, relevant study characteristics and outcome data including the hazard ratio (HR) adjusted for potential confounders were extracted. An overall pooled adjusted hazard ratio (aHR) for DFS after PAO-RT versus no PAO-RT was calculated using a random-effects model.; Results: A total of 2,016 articles were evaluated. Eleven articles were included in the systematic review, of which 3 were appropriate for quantitative meta-analysis. Pooling of these 3 cohorts (including 1,113 patients) demonstrated a statistically significant association between PAO-RT and DFS (pooled aHR 0.87, 95% confidence interval: 0.79-0.97). No significant heterogeneity among reported aHRs was observed (I 2 = 0.0%).; Conclusions: This meta-analysis suggests a modest but significant beneficial impact of elective para-aortic radiotherapy on DFS in patients with locally advanced cervical cancer who undergo concurrent chemoradiotherapy. This finding based on non-randomized studies provides an imperative for further investigation in prospective controlled trials.; Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2022 The Author(s).)

Bülow Nathalie, S., et al. (2022). "Co-treatment with letrozole during ovarian stimulation for IVF/ICSI: a systematic review and meta-analysis." Reproductive Biomedicine Online 44(4): 717-736.
	Letrozole reduces serum oestradiol by inhibiting the aromatase enzyme and has growing clinical indications in fertility. The available evidence of letrozole's role in ovarian stimulation for IVF and intracytoplasmic sperm injection (ICSI) and clinical outcomes was assessed. Medline, Cochrane, and ClinicalTrials.gov databases were systematically searched up until August 2021, including 31 studies (n = 16 randomized controlled trials [RCTs]; n = 15 observational studies). Live birth rate (LBR) in poor responders significantly increased by 7% (95% CI, 1% to 13%, P = 0.03) with letrozole co-treatment. Concomitantly, the gonadotrophin consumption was significantly reduced, without decreasing the number of retrieved oocytes. In normal responders, number of oocytes increased with 1.8 oocytes (95% CI 0.35 to 3.27, P = 0.01) with letrozole co-treatment. No significant effect on LBR, clinical pregnancy rate (CPR), or ovarian hyperstimulation syndrome rate was demonstrated. Only two studies reported on high responders and revealed no effect on LBR or CPR. Overall, the endometrium thickness was slightly affected, where as the, miscarriage rate and cancellation rate were unaffected by letrozole co-treatment. None of the included studies reported on neonatal outcomes. The quality of evidence was high or moderate in the RCTs and low in the observational studies. In conclusion, poor responders may benefit from co-treatment with letrozole during ovarian stimulation for IVF, whereas letrozole for normal and high responders requires further investigation with larger, high-quality studies. (Copyright © 2021 Reproductive Healthcare Ltd. All rights reserved.)

Buonomo, B., et al. (2021). "Ovarian transposition in patients with cervical cancer prior to pelvic radiotherapy: a systematic review." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 31(3): 360-370.
	Ovarian transposition aims to minimize ovarian exposure and damage during pelvic radiotherapy. One or both ovaries are separated from the uterus and mobilized away from the area where the radiation will be administered. A review of the available literature was conducted to evaluate the efficacy and safety of ovarian transposition among pre-menopausal women diagnosed with cervical cancer and eligible for pelvic radiotherapy. Outcomes evaluated were ovarian function preservation and complication rates. We also searched for information on pregnancy/live birth rates after ovarian transposition. Our search yielded a total of 635 manuscripts, of which 33 were considered eligible. A total of 28 full texts were selected for the current review, including 1377 patients who underwent ovarian transposition. The median or mean follow-up ranged between 7 and 87 months. Ovarian function preservation after ovarian transposition and pelvic radiotherapy, with or without chemotherapy, was 61.7% (431/699 patients), ranging from 16.6% to 100%. A total of 12 studies reported on 117 complications, accounting for 8.5%. Ovarian metastases were described in 5 (0.4%). Data about fertility preservation after ovarian transposition are scarce and definitive conclusions cannot be drawn. Based on the available data, ovarian transposition could be performed on young patients with tumors smaller than 4 cm, and it should be avoided in those with bulky tumors. A risk/benefit assessment should be carefully evaluated by a multidisciplinary team, and the decision regarding ovarian transposition should be always guided by the values and informed preferences of the patient.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Burbano, J., et al. (2021). "Neoadjuvant chemotherapy prior to fertility-sparing surgery in cervical tumors larger than 2 cm: a systematic review on fertility and oncologic outcomes." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 31(3): 387-398.
	Background: Management of cervical cancer tumors >2 cm has been a subject of controversy, with management often considered as either up-front radical trachelectomy or neoadjuvant chemotherapy before fertility-sparing surgery.; Methods: A systematic literature review was conducted following the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) checklist. This study was registered in the International Prospective Register of Systematic Reviews (PROSPERO). We searched Medline through PubMed, EMBASE, Cochrane Central Register of Controlled Trials, SCOPUS, and OVID between January 1985 and December 2020. Eligibility criteria for selecting studies were English language, randomized controlled trials, and observational studies including information on fertility and oncologic outcomes. All titles were managed in EndNote X7. Risk of bias was evaluated using the Joanna Briggs Institute (JBI) critical appraisal checklist for observational studies.; Results: Twenty-three studies with 205 patients who received neoadjuvant chemotherapy were included. The majority of patients (92.2%, n=189) had stage IB FIGO 2009 cervical cancer. The preferred regimen used was cisplatin in combination with paclitaxel or ifosfamide (80%, n=164). One hundred and eighty patients (87.8%) underwent fertility-sparing surgery; radical vaginal trachelectomy, abdominal trachelectomy, conization, and simple trachelectomy were performed in 62 (34.4%), 49 (27.2%), 34 (18.9%), and 26 (14.4%) women, respectively. In nine patients (5%) the type of procedure was not specified. The follow-up time reported in all studies ranged between 6 and 69 months. In 112 women who sought a pregnancy after surgery, 84.8% (n=95) achieved a gestation.The global recurrence and death rates were 12.8% and 2.8%, respectively.; Conclusion: Neoadjuvant chemotherapy followed by fertility-sparing surgery is a promising strategy that might allow fertility preservation in highly selected patients with cervical cancer with tumors >2 cm while providing acceptable oncologic outcomes. Results of prospective studies are required to validate its oncological safety.; Systematic Review Registration Number: PROSPERO CRD42020203789.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Burçin, Ö., et al. (2022). "The effectiveness of Yoga method for pelvic floor dysfunction."
	
Burden, S., et al. (2019). "Dietary interventions for adult cancer survivors." Cochrane Database of Systematic Reviews 2019(11): CD011287.
	Background: International dietary recommendations include guidance on healthy eating and weight management for people who have survived cancer; however dietary interventions are not provided routinely for people living beyond cancer. Objective(s): To assess the effects of dietary interventions for adult cancer survivors on morbidity and mortality, changes in dietary behaviour, body composition, health-related quality of life, and clinical measurements. Search Method(s): We ran searches on 18 September 2019 and searched the Cochrane Central Register of Controlled trials (CENTRAL), in the Cochrane Library; MEDLINE via Ovid; Embase via Ovid; the Allied and Complementary Medicine Database (AMED); the Cumulative Index to Nursing and Allied Health Literature (CINAHL); and the Database of Abstracts of Reviews of Effects (DARE). We searched other resources including reference lists of retrieved articles, other reviews on the topic, the International Trials Registry for ongoing trials, metaRegister, Physicians Data Query, and appropriate websites for ongoing trials. We searched conference abstracts and WorldCat for dissertations. Selection Criteria: We included randomised controlled trials (RCTs) that recruited people following a cancer diagnosis. The intervention was any dietary advice provided by any method including group sessions, telephone instruction, written materials, or a web-based approach. We included comparisons that could be usual care or written information, and outcomes measured included overall survival, morbidities, secondary malignancies, dietary changes, anthropometry, quality of life (QoL), and biochemistry. Data Collection and Analysis: We used standard Cochrane methodological procedures. Two people independently assessed titles and full-text articles, extracted data, and assessed risk of bias. For analysis, we used a random-effects statistical model for all meta-analyses, and the GRADE approach to rate the certainty of evidence, considering limitations, indirectness, inconsistencies, imprecision, and bias. Main Result(s): We included 25 RCTs involving 7259 participants including 977 (13.5%) men and 6282 (86.5%) women. Mean age reported ranged from 52.6 to 71 years, and range of age of included participants was 23 to 85 years. The trials reported 27 comparisons and included participants who had survived breast cancer (17 trials), colorectal cancer (2 trials), gynaecological cancer (1 trial), and cancer at mixed sites (5 trials). For overall survival, dietary intervention and control groups showed little or no difference in risk of mortality (hazard ratio (HR) 0.98, 95% confidence interval (CI) 0.77 to 1.23; 1 study; 3107 participants; low-certainty evidence). For secondary malignancies, dietary interventions versus control trials reported little or no difference (risk ratio (RR) 0.99, 95% CI 0.84 to 1.15; 1 study; 3107 participants; low-certainty evidence). Co-morbidities were not measured in any included trials. Subsequent outcomes reported after 12 months found that dietary interventions versus control probably make little or no difference in energy intake at 12 months (mean difference (MD) -59.13 kcal, 95% CI -159.05 to 37.79; 5 studies; 3283 participants; moderate-certainty evidence). Dietary interventions versus control probably led to slight increases in fruit and vegetable servings (MD 0.41 servings, 95% CI 0.10 to 0.71; 5 studies; 834 participants; moderate-certainty evidence); mixed results for fibre intake overall (MD 5.12 g, 95% CI 0.66 to 10.9; 2 studies; 3127 participants; very low-certainty evidence); and likely improvement in Diet Quality Index (MD 3.46, 95% CI 1.54 to 5.38; 747 participants; moderate-certainty evidence). For anthropometry, dietary intervention versus control probably led to a slightly decreased body mass index (BMI) (MD -0.79 kg/m2, 95% CI -1.50 to -0.07; 4 studies; 777 participants; moderate-certainty evidence). Dietary interventions versus control probably had little or no effect on waist-to-hip ratio (MD -0.01, 95% CI -0.04 to 0.02; 2 studies; 106 participants; low-ce tainty evidence). For QoL, there were mixed results; several different quality assessment tools were used and evidence was of low to very low-certainty. No adverse events were reported in any of the included studies. Authors' conclusions: Evidence demonstrated little effects of dietary interventions on overall mortality and secondary cancers. For comorbidities, no evidence was identified. For nutritional outcomes, there was probably little or no effect on energy intake, although probably a slight increase in fruit and vegetable intake and Diet Quality Index. Results were mixed for fibre. For anthropometry, there was probably a slight decrease in body mass index (BMI) but probably little or no effect on waist-to-hip ratio. For QoL, results were highly varied. Additional high-quality research is needed to examine the effects of dietary interventions for different cancer sites, and to evaluate important outcomes including comorbidities and body composition. Evidence on new technologies used to deliver dietary interventions was limited.Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Burg, L. C., et al. (2021). "A cost-effectiveness analysis of three approaches for lymph node assessment in patients with low- and intermediate-risk endometrial cancer." Gynecologic Oncology 161(1): 251-260.
	Objective: To assess the cost-effectiveness of sentinel lymph node mapping compared to risk factor assessment and routine full lymph node dissection for the assessment of lymph nodes in patients with low- and intermediate-risk endometrioid endometrial cancer. Method(s): A decision-analytic model was designed to compare three lymph node assessment strategies in terms of costs and effects: 1) sentinel lymph node mapping; 2) post-operative risk factor assessment (adjuvant therapy based on clinical and histological risk factors); 3) full lymph node dissection. Input data were derived from systematic literature searches and expert opinion. QALYs were used as measure of effectiveness. The model was built from a healthcare perspective and the impact of uncertainty was assessed with sensitivity analyses. Result(s): Base-case analysis showed that sentinel lymph node mapping was the most effective strategy for lymph node assessment in patients with low- and intermediate-risk endometrial cancer. Compared to risk factor assessment it was more costly, but the incremental cost effectiveness ratio stayed below a willingness-to-pay threshold of 20,000 with a maximum of 9637/QALY. Sentinel lymph node mapping was dominant compared to lymph node dissection since it was more effective and less costly. Sensitivity analyses showed that the outcome of the model was robust to changes in input values. With a willingness-to-pay threshold of 20,000 sentinel lymph node mapping remained cost-effective in at least 74.3% of the iterations. Conclusion(s): Sentinel lymph node mapping is the most cost-effective strategy to guide the need for adjuvant therapy in patients with low and intermediate risk endometrioid endometrial cancer.Copyright © 2021 The Authors

Burger, Z., et al. (2021). "Association of levonorgestrel intrauterine devices with stress reactivity, mental health, quality of life and sexual functioning: A systematic review." Frontiers in Neuroendocrinology 63: 100943.
	Levonorgestrel-intrauterine-devices (LNG-IUD) are one of the most used contraceptive methods worldwide. While several reviews exist on how LNG-IUDs impact physiology and gynaecological functions, this systematic review focuses on stress, mental health, quality of life, sexual functioning, and effects on brain architecture. While data on stress is scarce, results on mental health are ambiguous. More consistently, LNG-IUD use seems to improve quality of life and sexual functioning. No studies highlighting the consequences of LNG-IUD use on the brain were found. The reviewed studies are characterized by a substantial variation in approaches, participant groups, and study quality. More high-quality research assessing the effects of LNG-IUD on mental health, including response to stressors and brain function and structure, is needed to identify women vulnerable to adverse effects of LNG-IUD, also in comparison to oral contraceptives, and to empower women to make more informed choices concerning hormonal contraception.Copyright © 2021 Elsevier Inc.

Burghaus, S. and W. Beckmann Matthias (2021). "[Endometriosis: gynecological diagnosis and treatment : What should pain management specialists know?]." Schmerz (Berlin, Germany) 35(3): 172-178.
	Background: Endometriosis is one of the most common diseases in women of reproductive age. Despite characteristic symptoms such as dysmenorrhea, chronic abdominal pain, dysuria, dyschezia and dyspareunia, the average latency until diagnosis is around 10 years. In addition to the individual limitations, the disease also has economic and health policy relevance. The complaints are followed by reductions in working hours, cyclically recurring short-term sick leave or presenteeism with reduced performance.; Objective: An overview of the main recommendations of the S2k guideline on the diagnosis and treatment of endometriosis.; Material and Methods: For the S2k guideline "Diagnostics and therapy of endometriosis", a systematic literature search was conducted in PubMed and Cochrane according to a defined algorithm and over a period of more than 5 years, from 01.01.2014 to 31.12.2018. For the evaluation, 322 publications, including systematic reviews, meta-analyses and randomized controlled trials were considered and these were assessed by 41 mandate holders and representatives from 25 Association of the Scientific Medical Societies in Germany (AWMF) and non-AWMF professional societies, organizations, associations and working groups of the German Society for Gynecology and Obstetrics (DGGG), as well as two patient target groups.; Results: In a structured consensus process, 48 recommendations and 27 statements were formulated, which are presented in extracts in this paper.; Discussion: Interdisciplinary cooperation is essential in the treatment of patients with (suspected) endometriosis. This team should include all necessary disciplines in a cross-sectoral network. This is most likely to be achieved in a certified structure.

Burks, C., et al. (2021). "Excision versus Ablation for Management of Minimal to Mild Endometriosis: A Systematic Review and Meta-analysis." Journal of Minimally Invasive Gynecology 28(3): 587-597.
	Objective: The aim of this systematic review and meta-analysis was to perform an updated analysis of the literature in regard to the surgical management of minimal to mild endometriosis. This study evaluated women of reproductive age with superficial endometriosis to determine if the results of surgical excision compared with those of ablation in improved pain scores postoperatively.; Data Sources: The following databases were searched from inception to May 2020 for relevant studies: Cochrane Central Register of Controlled Trials, PubMed (MEDLINE), Ovid (MEDLINE), Scopus, and Web of Science.; Methods of Study Selection: From our literature search, a total of 2633 articles were identified and screened. Ultimately, 4 randomized controlled trials were selected and included in our systematic review. The combined total number of subjects was 346 from these 4 studies, with sample sizes ranging from 24 to 170 participants. Data from 3 of the included studies were able to be compared and analyzed for a meta-analysis. The primary outcome was reduction in the visual analog scale (VAS) score for endometriosis-associated pain (dysmenorrhea, dyschezia, and dyspareunia), with follow-up time ranging from 6 to 60 months postoperatively.; Tabulation, Integration, and Results: Data extracted from each study included the mean reduction in the VAS score from baseline. A random-effects model was used owing to significant heterogeneity across the studies. Statistical analyses were performed using Review Manager 5.3 software (Cochrane Collaboration, London, United Kingdom). The meta-analyses showed no significant differences between the excision and ablation groups in the mean reduction in VAS scores from baseline to 12 months postoperatively for dysmenorrhea (mean difference [MD] -0.03; 95% confidence interval [CI], -1.27 to 1.22; p = .97), dyschezia (MD 0.46; 95% CI, -1.09 to 2.02; p = .56), and dyspareunia (MD 0.10; 95% CI, -2.36 to 2.56; p = .94). In addition, there were no significant differences between the excision and ablation groups in mean VAS scores at the 12-month follow-up and beyond for dysmenorrhea (MD -0.11; 95% CI, -2.14 to 1.93; p = .92), dyschezia (MD 0.01; 95% CI, -0.70 to 0.72; p = .99), and dyspareunia (MD 0.34; 95% CI, -1.61 to 2.30; p = .73).; Conclusion: On the basis of the data from our systematic review and pooled meta-analysis, no significant difference between laparoscopic excision and ablation was noted in regard to improving pain from minimal to mild endometriosis. However, to make definitive conclusions on this topic, larger randomized controlled trials are needed with longer follow-up. (Copyright © 2020. Published by Elsevier Inc.)

Burt, L., et al. (2022). "SHORT COURSE ADJUVANT VAGINAL CUFF BRACHYTHERAPY IN EARLY ENDOMETRIAL CANCER: ADVERSE EVENTS AND EARLY PATIENT REPORTED OUTCOMES." International Journal of Gynecological Cancer 32(Supplement 3): A12.
	Objectives Adjuvant vaginal cuff brachytherapy (VCB) improves vaginal control rates in early stage endometrial cancer. We propose a shorter course of VCB would be non-inferior in safety, efficacy and quality of life metrics compared to standard course VCB. Methods This multi-institutional trial randomized early stage endometrial patients to adjuvant short course VCB (11 Gy x 2 fractions to the surface delivered a week apart) or the standard of care VCB (either 6 Gy x 5 fractions to the surface, 7 Gy x 3 fractions or 5-5.5 Gy x 4 fractions at 0.5 cm depth). All patients underwent hysterectomy with pathologically confirmed endometrioid adenocarcinoma, serous, clear cell or carcinosaroma histology. Eligible patients included all FIGO IB or II, FIGO 1A gr 2 -3 or FIGO 1A gr 1 with LVSI. Primary endpoint was health related quality of life (HRQOL) using the Global Health Score from the QLQ-C30 at 1 month. Results There were 108 patients enrolled from 5 institutions. At a median follow-up of 12.85 months, there have been no isolated vaginal recurrences. Table 1 shows the distribution of recurrences. Adverse events are shown in table 2. At the 1 month and 6 month time point, the QLQ-C30 scores in the experimental arm were non-inferior (P= p=0.00002). Conclusions This prospective randomized trial showed short course VCB is non-inferior to standard course VCB. While longer follow up data is necessary, short course VCB supports a growing literature in providing more options for women with early stage endometrial cancer.

Burton, J., et al. (2024). Effect of PreforPro® on Urinary and Vaginal Health.
	No Results Available Drug: Preforpro|Other: Placebo To change Nugent score in women with intermediate grade or BV|Determine whether the bacteriophage can translocate from the gastrointestinal system to genitourinary system.|Determine if the microbiota in the gut and urinary system change|Determine change in vaginal cell exfoliation.|Determine whether probiotics can translocate from the gastrointestinal system to genitourinary system.|Determine change in urogenital ATP levels. Female Phase 3 50 Other|Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment BVPFB2021 June 1, 2025

Busnelli, A., et al. (2022). "Impact of Thyroid Autoimmunity on Assisted Reproductive Technology Outcomes and Ovarian Reserve Markers: An Updated Systematic Review and Meta-Analysis." Thyroid : official journal of the American Thyroid Association 32(9): 1010-1028.
	Background: Thyroid autoimmunity (TAI) has a high prevalence among women of reproductive age. Investigating its possible impact on ovarian function and fertility is, thus, of utmost relevance. The aim of this systematic review and meta-analysis was to elucidate the effect of TAI on both assisted reproductive technology (ART) outcomes and ovarian reserve. Methods: This systematic review and meta-analysis was restricted to two groups of research articles investigating the association between TAI and: (1) autologous ART outcomes (i.e., fertilization rate [FR], implantation rate, clinical pregnancy rate [CPR], miscarriage rate, and live birth rate), (2) markers of ovarian reserve (i.e., anti-Müllerian hormone, basal follicle stimulating hormone, antral follicle count, and number of oocytes retrieved). Studies including women affected by overt hypo/hyperthyroidism were excluded. Relevant studies were identified by a systematic search in PubMed, MEDLINE, ClinicalTrials.gov, Embase, and Scopus, from database inception to May 1, 2022. Results: From a total of 432 identified publications, 22 studies were included in Group 1 and 26 studies in Group 2. The presence of TAI was associated with a higher risk of miscarriage (7606 participants, odds ratio [OR] 1.52, confidence interval [CI 1.14-2.01], p = 0.004, I 2 = 53%), lower chance of embryo implantation (7118 participants, OR 0.72, [CI 0.59-0.88], p = 0.001, I 2 = 36%), and live birth (11417 participants, OR 0.73, [CI 0.56-0.94], p = 0.02, I 2 = 71%). These associations were no longer observed in a subgroup analysis of patients who exclusively underwent intracytoplasmic sperm injection (ICSI). The FR and CPR as well as the mean values of surrogate markers of oocyte quantity appeared not to be affected by TAI. Conclusions: This data synthesis suggest a higher risk of adverse ART outcomes in women with positive TAI. However, the reliability of these findings is hampered by the relatively low quality of the evidence and significant heterogeneity in many of the meta-analyses. The possible protective effect of ICSI is promising but should be confirmed in controlled prospective clinical trials. PROSPERO Registration ID : CRD42021236529.

Busnelli, A., et al. (2021). "Thyroid function modifications in women undergoing controlled ovarian hyperstimulation for in vitro fertilization: a systematic review and meta-analysis." Fertility and Sterility 116(1): 218-231.
	Objective: To investigate the impact of controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF) on thyroid function.; Design: Systematic review and meta-analysis.; Setting: Not applicable.; Patient(s): Infertile women undergoing conventional IVF or intracytoplasmic sperm injection.; Intervention(s): Systematic search of PubMed, MEDLINE, Embase, Scopus, and Web of Science from inception until November 2020. Studies could be included only if they met the following criteria: subjects were classified as euthyroid or hypothyroid; serum thyroid-stimulating hormone (TSH) and/or free thyroxine (FT4) levels were evaluated before COH; and the same thyroid function test was reassessed after COH (i.e., at the time of trigger for final follicle maturation and/or at pregnancy test).; Main Outcome Measure(s): Mean difference (MD) between the serum TSH or FT4 levels assessed after COH and before COH.; Result(s): In euthyroid women, the serum TSH levels assessed at the time of trigger and at the time of pregnancy test were significantly higher than those at baseline (MD: 0.69 mIU/L, 95% confidence interval [CI]: 0.30-1.08, I 2 = 93% and MD: 0.67, 95% CI: 0.49-0.85, I 2 = 72%, respectively). The serum FT4 levels did not undergo significant changes. Subanalysis confirmed an increase in the TSH level after restricting the analysis to women treated with gonadotropin-releasing hormone agonist protocols and to those who achieved pregnancy. A pronounced increase in the TSH level was observed in women treated for hypothyroidism (MD: 1.50 mIU/L, 95% CI: 1.10-1.89, I 2 = 0%).; Conclusion(s): Pooling of the results showed a significant increase in serum TSH level in women undergoing COH for IVF. This change was particularly pronounced in women treated for hypothyroidism. New thyroid function screening strategies for women undergoing COH are warranted. (Copyright © 2021 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Butina, L. I., et al. (2022). "CLINICAL AND MORPHOLOGICAL FEATURES OF POST-CASTRATION SYNDROME IN WOMEN AFTER SURGICAL MENOPAUSE." Reproductive Endocrinology(63-64): 92-96.
	Research objective: to assess the clinical and morphological features of the course of post-castration syndrome (PS) in women after surgical menopause. Materials and methods. The main group (with surgical menopause) consisted of 67 women aged 45 to 55 years, who underwent surgical treatment with removal of the uterus with or without appendages. 30 women with natural menopause were included in the comparison group. The assessment of morphological changes in the reproductive organs in both groups was carried out according to the results of the histological examination of reproductive organs removed during the operation, and according to the results of the pathological examination of endometrium after curettage of uterine mucosa. Results. The leading indication for surgical treatment, which led to surgical menopause, was uterine leiomyoma in 71.1% of women. Extirpation of the uterus was performed in 64.2% of patients, complete exclusion of ovarian function was observed in 68.7%. There was a deficiency of estrogen in women with surgical menopause, even before the operation, as evidenced by the presence of morphological signs of hypoestrogenism in the form of endometrial atrophy in 41.8% of them, which is 6.2 times (p < 0.001) more often compared with women with natural menopause. The morphological signs of the inflammatory process in reproductive organs in more than half of women with surgical menopause (significantly more than in women with natural menopause, p < 0.001) increase the likelihood of depletion of the ovarian hormonal function and increase the intensity of PS symptoms. This is evidenced by a significant 2.8-fold increase in women with surgical menopause in the frequency of severe PS and the median of the modified Kupperman index compared with women with natural menopause (p < 0.001). The decrease in the ovarian hormonal function in women after surgical menopause increases the frequency of ovarian cysts by 12 times compared with women with natural menopause (p < 0.001). Conclusions. It is necessary to establish the significance of the investigated clinical and morphological features observed in women with surgical menopause to predict the severity of PS in them.Copyright © 2022 Trylyst. All rights reserved.

Butt Muhammad, S., et al. (2023). "Benefits of physical activity on reproductive health functions among polycystic ovarian syndrome women: a systematic review." BMC public health 23(1): 882.
	Background: Polycystic ovary syndrome (PCOS) is among the predominant endocrine disorders of reproductive-aged women. The prevalence of PCOS has been estimated at approximately 6-26%, affecting 105 million people worldwide. This systematic review aimed to synthesize the evidence on the effects of physical activity on reproductive health functions among PCOS women.; Methods: The systematic review includes randomization-controlled trials (RCTs) on physical exercise and reproductive functions among women with PCOS. Studies in the English language published between January 2010 and December 2022 were identified via PubMed. A combination of medical subject headings in terms of physical activity, exercise, menstrual cycle, hyperandrogenism, reproductive hormone, hirsutism, and PCOS was used.; Results: Overall, seven RCTs were included in this systematic review. The studies investigated interventions of physical activity of any intensity and volume and measured reproductive functions and hormonal and menstrual improvement. The inclusion of physical activity alone or in combination with other therapeutic interventions improved reproductive outcomes.; Conclusion: The reproductive functions of women with PCOS can be improved with physical activity. Furthermore, physical activity can also reduce infertility, as well as social and psychological stress among women.; Prospero Systematic Review Registration: CRD42020213732. (© 2023. The Author(s).)

Buultjens, M., et al. (2021). "The contribution of group prenatal care to maternal psychological health outcomes: A systematic review." Women and Birth 34(6): e631-e642.
	Problem: Poor mental health remains a significant cause of morbidity for childbearing women globally. Background(s): Group care has been shown to be effective in reducing select clinical outcomes, e.g., the rate of preterm birth, but less is known about the effect of Group Prenatal Care (GPC) on mental health outcomes of stress, depression and anxiety in pregnant women. Aim(s): To conduct a systematic review of the current evidence of the effect of group pregnancy care on mental health and wellbeing outcomes (i.e., stress, depression and/or anxiety) in childbearing women. Method(s): A comprehensive search of published studies in Medline, PsychInfo, CINAHL, ProQuest databases, ClinicalTrials.gov and Google Scholar. Databases were systematically searched without publication period restriction until Feb 2020. Inclusion criteria were randomized controlled trials (including quasi-experimental) and observational studies comparing group care with standard pregnancy care. Included were studies published in English, whose primary outcome measures were stress, depression and/or anxiety. Result(s): Nine studies met the inclusion criteria, five randomized controlled trials and four observational studies, involving 1585 women (39%) in GPC and 2456 women (61%) in standard (individual) pregnancy care. Although evidence is limited, where targeted education was integrated into the group pregnancy care model, significant reductions in depressive symptoms were observed. In addition, secondary analysis across several studies identified a subset of GPC women, i.e., higher risk for psychological symptoms, who reported a decrease in their depression, stress and anxiety symptoms, postpartum. Due to the diversity of group care structure and content and the lack of outcomes measures universally reported, a comprehensive meta-analysis could not be performed. Conclusion(s): The evidence suggests improvements in some markers of psychological health outcomes with group pregnancy care. Future research should involve larger well-designed studies encompassing cross-population data using a validated scale that is comparable across diverse childbearing populations and clinical settings to better understand the impact of group pregnancy care.Copyright © 2020 Australian College of Midwives

Buzzaccarini, G., et al. (2021). "Hyaluronic acid in vulvar and vaginal administration: evidence from a literature systematic review." Climacteric 24(6): 560-571.
	Vulvovaginal pathology impairs the quality of life of both women in menopause and those who are not. Different therapies have been proposed, mainly related to estrogen therapy in postmenopausal women. However, some contraindications limit its use, and different moisturizers or lubricants have been tested. Hyaluronic acid is a promising and widely used vaginal medical treatment with a moisturizing action and appears to provide a solution. For this reason, we performed a systematic review of the literature. We searched for original articles without date restriction until 30 April 2020. We included all clinical trials which administered local hyaluronic acid in the vulva or vagina. Only English studies and those performed in humans were eligible. Seventeen original studies were included in the review (from randomized controlled trials to longitudinal studies). Hyaluronic acid was generally found to be effective in improving vulvovaginal symptoms (dyspareunia, itching, burning, dryness) and signs (bleeding, atrophy, vaginal pH). In conclusion, hyaluronic acid has the properties to be an efficient moisturizer for women suffering from vulvovaginal atrophy who have contraindications for estrogen therapy and for vulvovaginal signs and symptoms affecting sexual well-being. However, a well-designed randomized controlled trial is needed in order to clarify its efficacy and safety profile.Copyright © 2021 International Menopause Society.

bvrzp, R. B. R. (2022). "Effect of Pilates compared to Pelvic Floor Muscle Training on urinary incontinence, pelvic floor muscle strength and respiratory in elderly women: a randomized clinical trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: E02.760.169.063.500.387.750 E02.779.474 G11.427.410.698 G11.427.410.698.277 This is a two‐arm, double‐blind, randomized controlled clinical trial. Experimental group: 17 elderly women with symptoms of stress urinary incontinence who will receive Mat Pilates sessions twice a week lasting 60 minutes each, for 3‐4 months. Control group: 17 elderly women with symptoms of stress urinary incontinence who will receive pelvic floor muscle training (PFM) sessions for 3‐4 months, twice a week, lasting 30 minutes. CONDITION: M01.060.116.100 Pelvic Floor; Urinary Incontinence PRIMARY OUTCOME: It is expected to find an improvement in respiratory muscle strength, represented by the increase in inspiratory and expiratory pressures measured in cmH2o and evaluated through manovacuometry, after the intervention period. It is expected to find an improvement in urinary leakage symptoms, represented by the decrease in the ICIQ‐SF score after the intervention period It is expected to find improvement in pelvic floor muscle strength, assessed through perineometry and represented by the increase in cmH2O values after the intervention period SECONDARY OUTCOME: Secondary outcomes are not expected INCLUSION CRITERIA: Being female; being between 60 – 79 years of age; presence of voluntary contraction of the pelvic floor muscles at least grade 2 defined as weak perineal contraction weak contraction on palpation; preserved cognitive function verified by the Mini Mental State Examination (MMSE) scored according to education level

Byatt, N., et al. (2022). "The PRogram in Support of Moms (PRISM): Results of A Cluster Randomized Controlled Trial of Two Active Interventions Addressing Perinatal Depression in Ambulatory Obstetric Settings." Journal of the Academy of Consultation-Liaison Psychiatry 63(Supplement 2): S232.
	2022 Dlin/Fischer Clinical Research Award Winner Abstract. Objective(s): We compared the effectiveness of two active interventions for perinatal depression. Method(s): We conducted a cluster randomized controlled trial. Ten Ob/Gyn practices were randomly assigned to receive (1) the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms, a state-wide, population-based program, and (2) the PRogram In Support of Moms (PRISM) which includes MCPAP for Moms plus a proactive, multifaceted, obstetric practice-level intervention with intensive implementation support. Patient participants (n=312) with Edinburgh Postnatal Depression Scale Scores (EPDS) >= 10 were recruited from participating practices and followed up to 11-13 months postpartum. Differences in depression symptomatology and treatment participation among patient participants were compared by intervention group. Generalized estimating equations were used to examine treatment initiation in MCPAP for Moms versus PRISM. Result(s): EPDS scores decreased by 4.5 in the MCPAP for Moms groups and 4.7 points in the PRISM group at 11-13 months postpartum as compared to baseline. Treatment initiation rates were 57% in the PRISM group and 50% MCPAP for Moms group. No statistically significant differences in depression symptomatology or treatment initiation were found between the groups. However, 32% of patient participants in the PRISM group sustained treatment compared with 22% in the MCPAP for Moms group. Conclusion(s): Both MCPAP for Moms and PRISM are effective in improving depression symptomology, and treatment initiation and sustainment rates. This finding is important because 1) 4-point decrease in EPDS is clinically significant, and 4) MCPAP for Moms was equally as effective as PRISM but is lower intensity and has greater population-based reach.Copyright © 2022

Byatt, N., et al. (2024). "Effectiveness of two systems-level interventions to address perinatal depression in obstetric settings (PRISM): an active-controlled cluster-randomised trial." The Lancet. Public health 9(1): e35-e46.
	BACKGROUND: Perinatal depression is a common and undertreated condition, with potential deleterious effects on maternal, obstetric, infant, and child outcomes. We aimed to compare the effectiveness of two systems-level interventions in the obstetric setting-the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms and the PRogram In Support of Moms (PRISM)-in improving depression symptoms and participation in mental health treatment among women with perinatal depression. METHODS: In this cluster-randomised, active-controlled trial, obstetric practices across Massachusetts (USA) were allocated (1:1) via covariate adaptive randomisation to either continue participating in the MCPAP for Moms intervention, a state-wide, population-based programme, or to participate in the PRISM intervention, which involved MCPAP for Moms plus a proactive, multifaceted, obstetric practice-level intervention with intensive implementation support. English-speaking women (aged ≥18 years) who screened positive for depression (Edinburgh Postnatal Depression Scale [EPDS] score ≥10) were recruited from the practices. Patients were followed up at 4-25 weeks of gestation, 32-40 weeks of gestation, 0-3 months postpartum, 5-7 months postpartum, and 11-13 months postpartum via telephone interview. Participants were masked to the intervention; investigators were not masked. The primary outcome was change in depression symptoms (EPDS score) between baseline assessment and 11-13 months postpartum. Analysis was done by intention to treat, fitting generalised linear mixed models adjusting for age, insurance status, education, and race, and accounting for clustering of patients within practices. This trial is registered with ClinicalTrials.gov, NCT02760004. FINDINGS: Between July 29, 2015, and Sept 20, 2021, ten obstetric practices were recruited and retained; five (50%) practices were randomly allocated to MCPAP for Moms and five (50%) to PRISM. 1265 participants were assessed for eligibility and 312 (24·7%) were recruited, of whom 162 (51·9%) were enrolled in MCPAP for Moms practices and 150 (48·1%) in PRISM practices. Comparing baseline to 11-13 months postpartum, EPDS scores decreased by 4·2 (SD 5·2; p<0·0001) among participants in MCPAP for Moms practices and by 4·3 (SD 4.5; p<0·0001) among those in PRISM practices (estimated difference between groups 0·1 [95% CI -1·2 to 1·4]; p=0·87). INTERPRETATION: Both the MCPAP for Moms and PRISM interventions were equally effective in improving depression symptoms. This finding is important because the 4-point decrease in EPDS score is clinically significant, and MCPAP for Moms has a lower intensity and greater population-based reach than does PRISM. FUNDING: US Centers for Disease Control and Prevention.

Byatt, N., et al. (2019). "Perinatal depression care pathway for obstetric settings." International Review of Psychiatry 31(3): 210-228.
	Perinatal depression is common and can have deleterious effects on mothers, infants, children, partners, and families. Despite this, few women who screen positive for depression receive psychiatric treatment. A comprehensive perinatal depression care pathway includes: (1) screening, (2) assessment, (3) triage and referral, (4) treatment access, (5) treatment initiation, (6) symptom monitoring, and (7) adaptation of treatment based on measurement until symptoms remit. This depression care pathway provides a scaffold on which to frame the challenges encountered when, and the opportunities that exist for, addressing depression in obstetric settings. Comprehensive interventions that address each step on the care pathway are needed to support obstetric practices in providing high-quality, evidence-based, effective treatment including pro-active follow-up for depression management. Despite recent attention being brought to, and significant progress in the field of maternal mental health, gaps in care persist. Ultimately, depression care needs to be fully integrated into obstetric care. Additionally, more targeted maternal mental health support and structure are needed for integration to occur and ultimately be optimized. Specific areas requiring more attention include consistency of screening, evaluation of patients with a positive depression screen for bipolar disorder, anxiety or substance use disorders, and monitoring of symptom improvement.Copyright © 2019, © 2019 Institute of Psychiatry and Johns Hopkins University.

Cabanas-Barja, A., et al. (2024). "Update on physiotherapy treatment in endometriosis: A systematic review." Clinica e Investigacion en Ginecologia y Obstetricia 51(1): 100929.
	Endometriosis is a chronic, inflammatory gynecological pathology characterized by the presence of endometrial tissue outside the uterus. Clinical manifestations include chronic pelvic pain, fatigue, dysmenorrhea, dyspareunia, infertility, dysuria and dyschezia. Physical therapy can be part of the symptomatic treatment of endometriosis; therefore, this review aims to analyze the scientific literature to evaluate the effect of physical therapy in endometriosis. A bibliographic search was carried out during the first two weeks of December 2022 in the databases PubMed, Medline, Scopus, Web of Science, PEDro, CINAHL and ENFISPO. The descriptors "Endometriosis" "Physical Therapy Modalities", "Physiotherapy", "Physiotherapist", "Physical therapy" and "Physical rehabilitation" were used. Results were limited to randomized clinical studies published in English or Spanish. A total of 943 results were obtained, of which 6 were selected after applying the eligibility criteria. The selected studies develop different physiotherapy interventions with techniques such as electrotherapy with TENS and high intensity pulsed laser, progressive muscle relaxation training, aerobic training, manual therapy, and therapeutic exercise through yoga. Physiotherapy appears to provide benefits in terms of reducing pelvic pain and improving quality of life in women with endometriosis.Copyright © 2023 Elsevier Espana, S.L.U.

Cacciamani Giovanni, E., et al. (2023). "Assessment and Reporting of Perioperative Adverse Events and Complications in Patients Undergoing Inguinal Lymphadenectomy for Melanoma, Vulvar Cancer, and Penile Cancer: A Systematic Review and Meta-analysis." World journal of surgery 47(4): 962-974.
	Background: Inguinal lymph node dissection (ILND) plays a crucial role in the oncological management of patients with melanoma, penile, and vulvar cancer. This study aims to systematically evaluate perioperative adverse events (AEs) in patients undergoing ILND and its reporting.; Methods: A systematic review was conducted according to PRISMA. PubMed, MEDLINE, Scopus, and Embase were queried to identify studies discussing perioperative AEs in patients with melanoma, penile, and vulvar cancer following ILND.; Results: Our search generated 3.469 publications, with 296 studies meeting the inclusion criteria. Details of 14.421 patients were analyzed. Of these studies, 58 (19.5%) described intraoperative AEs (iAEs) as an outcome of interest. Overall, 68 (2.9%) patients reported at least one iAE. Postoperative AEs were reported in 278 studies, combining data on 10.898 patients. Overall, 5.748 (52.7%) patients documented ≥1 postoperative AEs. The most reported ILND-related AEs were lymphatic AEs, with a total of 4.055 (38.8%) events. The pooled meta-analysis confirmed that high BMI (RR 1.09; p = 0.006), ≥1 comorbidities (RR 1.79; p = 0.01), and diabetes (RR 1.81; p = < 0.00001) are independent predictors for any AEs after ILND. When assessing the quality of the AEs reporting, we found 25% of studies reported at least 50% of the required criteria.; Conclusion: ILND performed in melanoma, penile, and vulvar cancer patients is a morbid procedure. The quality of the AEs reporting is suboptimal. A more standardized AEs reporting system is needed to produce comparable data across studies for furthering the development of strategies to decrease AEs. (© 2023. The Author(s) under exclusive licence to Société Internationale de Chirurgie.)

Cacciari, L. P., et al. (2019). "Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a cochrane systematic review abridged republication." Brazilian journal of physical therapy 23(2): 93-107.
	BACKGROUND: Pelvic floor muscle training is the most commonly used physical therapy treatment for women with urinary incontinence. OBJECTIVE(S): To assess the effects of Pelvic floor muscle training for women with urinary incontinence in comparison to a control treatment and to summarize relevant economic findings. METHOD(S): Cochrane Incontinence Group Specialized Register (February 12, 2018). SELECTION CRITERIA: Randomized or quasi-randomized trials in women with stress, urgency or mixed urinary incontinence (symptoms, signs, or urodynamic). DATA COLLECTION AND ANALYSIS: Trials were independently assessed by at least two reviewers authors and subgrouped by urinary incontinence type. Quality of evidence was assessed by adopting the Grading of Recommendations, Assessment, Development and Evaluation approach. RESULT(S): The review included thirty-one trials involving 1817 women from 14 countries. Overall, trials were small to moderate size, and many were at moderate risk of bias. There was considerable variation in the intervention's content and duration. Based on data available, we can be confident that Pelvic floor muscle training can cure or improve symptoms of stress and all other types of urinary incontinence. It may reduce the number of leakage episodes and the quantity of leakage, while improving reported symptoms and quality of life. Women were more satisfied with Pelvic floor muscle training, while those in control groups were more likely to seek further treatment. Long-term effectiveness and cost-effectiveness of Pelvic floor muscle training needs to be further researched. CONCLUSION(S): The addition of ten new trials did not change the essential findings of the earlier review, suggesting that Pelvic floor muscle training could be included in first-line conservative management of women with urinary incontinence.Copyright © 2019 Associacao Brasileira de Pesquisa e Pos-Graduacao em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Cacciari, L. P., et al. (2021). "Pelvic floor morphometrical and functional changes immediately after pelvic floor muscle training and at 1-year follow-up, in older incontinent women." Neurourology and Urodynamics 40(1): 245-255.
	AIMS: To compare the effects of group-based and individual physiotherapy for stress or mixed urinary incontinence (UI) on pelvic floor morphometry, pelvic floor muscle (PFM) function, and related self-efficacy, immediately after treatment and at 1 year. METHODS: This is a planned secondary analysis of the group rehabilitation or individual physiotherapy study, an assessor-blinded, randomized, noninferiority trial. Eligible participants included 362 community-dwelling older women with symptoms of stress/mixed UI. After learning how to contract PFMs, participants completed 12 weeks of PFM training, either individually (one-on-one) or as part of a group (eight women). Pelvic floor transperineal ultrasound volumes (morphometry), PFM intravaginal dynamometric data (function), and self-efficacy in performing PFM exercises were acquired at baseline, posttreatment, and at 1 year. RESULTS: Groups were comparable at all time points. Immediately posttreatment, both groups demonstrated significant changes in pelvic floor morphometry during coughs, and in PFM function during contractions and coughs. Participants also reported improved self-efficacy in performing PFM exercises. Results were sustained at 1 year. When participants coughed, pelvic floor structures were better supported (reflected by less caudal movement of the puborectalis sling and a smaller opening of the levator hiatus) in a pattern consistent with the "knack" strategy. Furthermore, both interventions resulted in stronger, faster, more coordinated, and more endurant PFMs. CONCLUSION: In older women with stress or mixed UI, both individual and group-based PFM training resulted in comparable improvements in overall PFM function, pelvic floor morphometry during coughs, and related self-efficacy in performing PFM exercises, which were sustained at 1 year.

Cadish, L. A., et al. (2023). "Projecting future prolapse outcomes with induction of labor at 39 weeks: a decision analysis." International Urogynecology Journal.
	Introduction and hypothesis: In 2018, the ARRIVE trial (A Randomized Trial of Induction Versus Expectant Management) concluded that routine induction of labor (IOL) at 39 weeks gestation decreases cesarean delivery risk, with slightly lighter birthweight infants. We debated whether routine IOL would improve, worsen, or not change POP risk compared with expectant management (EM). Methods: We constructed a decision analysis model with a lifetime horizon where nulliparous women reaching 39 weeks underwent IOL or EM. Subsequent vaginal versus cesarean delivery varied based on prior deliveries for up to four births. Subsequent delivery prior to 39 weeks and distribution of gestational age, birthweight, and delivery mode between 24 and 39 weeks was modeled from national data. We modeled increased POP risk with increasing vaginal parity, forceps delivery, and weight of largest infant delivered vaginally, accounting for differential infant weights in each strategy. Results: IOL and EM have similar population‐wide POP risk (15.9% and 15.7% respectively). Among women with only spontaneous vaginal deliveries that reached 39 weeks or beyond, the prevalence of POP was 20% after one delivery and 29% after four deliveries, with no difference between groups. The cesarean rate was lower with IOL (27.8% versus 29.8%). Sensitivity analysis revealed no meaningful thresholds among the variables, supporting model robustness. Conclusion: While routine induction of labor at 39 weeks results in a meaningfully higher vaginal delivery rate, there was no increase in POP, possibly due to the protective effect of lower birthweight.

Cadman, T., et al. (2024). "Urban environment in pregnancy and postpartum depression: An individual participant data meta-analysis of 12 European birth cohorts." Environment international 185: 108453.
	Background: Urban environmental exposures associate with adult depression, but it is unclear whether they are associated to postpartum depression (PPD).; Objectives: We investigated associations between urban environment exposures during pregnancy and PPD.; Methods: We included women with singleton deliveries to liveborn children from 12 European birth cohorts (N with minimum one exposure = 30,772, analysis N range 17,686-30,716 depending on exposure; representing 26-46 % of the 66,825 eligible women). We estimated maternal exposure during pregnancy to ambient air pollution with nitrogen dioxide (NO 2 ) and particulate matter (PM 2.5 and PM 10 ), road traffic noise (L den ), natural spaces (Normalised Difference Vegetation Index; NDVI, proximity to major green or blue spaces) and built environment (population density, facility richness and walkability). Maternal PPD was assessed 3-18 months after birth using self-completed questionnaires. We used adjusted logistic regression models to estimate cohort-specific associations between each exposure and PPD and combined results via meta-analysis using DataSHIELD.; Results: Of the 30,772 women included, 3,078 (10 %) reported having PPD. Exposure to PM 10 was associated with slightly increased odds of PPD (adjusted odd ratios (OR) of 1.08 [95 % Confidence Intervals (CI): 0.99, 1.17] per inter quartile range increment of PM 10 ) whilst associations for exposure to NO 2 and PM 2.5 were close to null. Exposure to high levels of road traffic noise (≥65 dB vs. < 65 dB) was associated with an OR of 1.12 [CI: 0.95, 1.32]. Associations between green spaces and PPD were close to null; whilst proximity to major blue spaces was associated with increased risk of PPD (OR 1.12, 95 %CI: 1.00, 1.26). All associations between built environment and PPD were close to null. Multiple exposure models showed similar results.; Discussion: The study findings suggest that exposure to PM 10, road traffic noise and blue spaces in pregnancy may increase PPD risk, however future studies should explore this causally.; Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Cadoo, K., et al. (2021). "Olaparib treatment in patients with platinum-sensitive relapsed ovarian cancer by BRCA mutation and homologous recombination deficiency status: secondary safety results from the phase II LIGHT study." Gynecologic Oncology 162(Supplement 1): S67-S68.
	Objectives: LIGHT (NCT02983799) evaluated olaparib treatment in patients with platinum-sensitive relapsed (PSR) ovarian cancer by BRCA mutation (BRCAm) and homologous recombination repair deficiency (HRD) status; the primary analysis demonstrated objective response rates (ORRs) of 69%, 64%, 29%, and 10% in cohorts of patients with a germline (g) BRCAm, with tumors with somatic (s) BRCAm, HRD-positive (non-BRCAm), and HRD-negative status, respectively (Cadoo K et al. ASCO 2020). Here, we report pre-specified secondary efficacy endpoints and subgroup analyses. Method(s): In this open-label, non-randomized study, patients with PSR ovarian cancer and >=1 prior line of platinum-based chemotherapy received olaparib monotherapy (300 mg bid). Patients were assigned to one of four cohorts based on whether they had a gBRCAm, tumors with sBRCAm, had HRD-positive (non-BRCAm) tumors, or HRD-negative tumors. Testing for gBRCAm was completed using Myriad BRACAnalysis CDx; sBRCAm testing was done with Myriad myChoice CDx. Genomic instability (GI) was assessed using the Myriad myChoice HRD test; tumors were deemed HRD-positive if they had a GI score >=42. Secondary efficacy endpoints included investigator-assessed progression-free survival (PFS; RECIST v1.1) and cancer antigen (CA)-125 response. Time to any progression (TTAP) was calculated from the date of the first dose of olaparib until the earliest date of RECIST v1.1 or CA-125 disease progression, or death. Result(s): The analysis was timed ~6 months after the last patient was enrolled (data cut-off, Aug 27, 2019). Of 271 enrolled patients who had received olaparib, 270 had measurable disease at baseline and were included in efficacy analyses (13 patients whose Myriad test result was failed or missing could not be assigned to a cohort; efficacy in these patients was analyzed separately). ORR and PFS by prior line of chemotherapy, CA-125 response, and TTAP are summarized in the Table. ORRs ~60-70% were observed in the gBRCAm and sBRCAm cohorts and ~30% in the HRD-positive (non-BRCAm) cohort, both in patients with 1 or >=2 prior lines of chemotherapy. Similarly, median PFS in patients was ~10-11 months in the BRCAm cohorts, and ~5-7 months in the HRD-positive (non-BRCAm) cohort, both in patients with 1 or >=2 prior lines of chemotherapy. In the BRCAm cohorts, a high proportion of patients achieved a CA-125 response and complete response (CR), with a CA-125 CR rate of 60% and 68% in the BRCAm cohorts and 29% in the HRD-positive non-BRCAm cohort. Median TTAP was ~11 months in the BRCAm cohorts, and 7.2 months in the HRD-positive (non-BRCAm) cohort.[Formula presented] Conclusion(s): Secondary efficacy data and subgroup analyses from the LIGHT study of olaparib monotherapy as treatment for PSR ovarian cancer support the primary analysis. Efficacy was observed in all cohorts, particularly in the gBRCAm and sBRCAm cohorts, where similar efficacy was observed. For patients without a BRCAm, greater efficacy was seen in the HRD-positive cohort.Copyright © 2021 Elsevier Inc.

Cadoo, K., et al. (2022). "Olaparib treatment for platinum-sensitive relapsed ovarian cancer by BRCA mutation and homologous recombination deficiency status: Phase II LIGHT study primary analysis." Gynecologic Oncology 166(3): 425-431.
	Objective: Olaparib treatment resulted in significant improvement in objective response rates (ORRs) and progression-free survival (PFS) over non‑platinum chemotherapy in patients with BRCA1/BRCA2-mutated (BRCAm) platinum-sensitive relapsed ovarian cancer (PSROC) and ≥2 prior lines of platinum-based chemotherapy in the phase III SOLO3 study. LIGHT (NCT02983799) prospectively evaluated olaparib treatment for patients with PSROC and known BRCAm and homologous recombination deficiency (HRD) status.; Methods: In this phase II open-label multicenter study, patients with PSROC and ≥1 prior line of platinum-based chemotherapy were assigned to cohorts by presence of germline BRCAm (gBRCAm), somatic BRCAm (sBRCAm), HRD-positive tumors without BRCAm, or HRD-negative tumors. The primary endpoint was investigator-assessed ORR. Secondary endpoints included disease control rate (DCR) and PFS. Tumors were analyzed using Myriad BRACAnalysis CDx and myChoice HRD assays; HRD-positive tumors were defined using a genomic instability score of ≥42.; Results: Of 272 enrolled patients, 271 received olaparib and 270 were included in efficacy analyses. At data cut-off, ORRs in the gBRCAm, sBRCAm, HRD-positive, and HRD-negative cohorts were 69.3%, 64.0%, 29.4%, and 10.1%, respectively. DCRs were 96.0%, 100.0%, 79.4%, and 75.3% in each cohort, respectively. Median PFS was 11.0, 10.8, 7.2, and 5.4 months, respectively. The most common (≥ 20%) treatment-emergent adverse events included nausea, fatigue/asthenia, vomiting, anemia, constipation, diarrhea, and decreased appetite.; Conclusions: Olaparib treatment demonstrated activity across all cohorts. The greatest efficacy was observed in the BRCAm cohorts, regardless of gBRCAm/sBRCAm. For patients without a BRCAm, greater efficacy was observed in the HRD-positive than the HRD-negative cohorts. The safety profile was consistent with that established in previous olaparib studies. (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Cagliari University, o., et al. (2021). Evaluation of Ovarian Reserve and Recurrence Rate After DWLS Diode Laser OMA Vaporization.
	No Results Available Procedure: laparoscopic endometrioma laser vaporization Evaluation of the ovarian reserve using AntiMullerian Hormone (AMH) assessment.|Evaluation of the ovarian reserve using Antral follicular Count (AFC)|Evaluation of the patients' symptoms|Evaluation of endometrioma recurrence rate|Evaluation of pregnancy rate Female Not Applicable 70 Other Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment OMA Diode Laser Vaporization September 1, 2023

Cagnacci, A., et al. (2022). "Polycarbophil vaginal moisturizing gel versus hyaluronic acid gel in women affected by vaginal dryness in late menopausal transition: A prospective randomized trial." European Journal of Obstetrics, Gynecology, and Reproductive Biology 270: 239-245.
	Objectives: During menopausal transition, women are frequently affected by vulvovaginal atrophy (VVA), due to the decline of estrogen levels. Resulting symptoms are itching, burning, dyspareunia, and vaginal dryness (reported in up to 85%). The aim of this trial was to verify if medical device polycarbophil vaginal (PCV) moisturizer gel is not less effective than hyaluronic acid (HA) gel in treating vaginal dryness.; Material and Methods: This was a multicenter, open label, randomized, parallel group, comparative study with non-inferiority design. Female included were ≥45 to ≤55 years in the menopausal transition, with subjective dryness, any objective sign of VVA, pH > 5, and body mass index of ≥18.5 to ≤36 kg/m 2 . Subjects were randomized to 1 g of PCV gel twice a week for 30 days or 3 g of HA vaginal gel every 3 days for 30 days.; Results: 53 subjects (mean age 49.45 ± 2.96 years) were analyzed. Vaginal health index showed an improvement (p < 0.001) in both groups (from 12.54 ± 1.37 to 16.36 ± 2.66 for PCV, from 12.00 ± 1.91 to 16.60 ± 2.50 for HA), but the difference between final means (95%CI: -1.66 to 1.18) evidenced that PCV is non-inferior to HA treatment. Similarly, an improvement was evidenced in vaginal maturation index (p = 0.005 for PCV, ns. for HA), female sexual function index (p < 0.001 for PCV, p < 0.001 for HA), and SF-12 (p < 0.001 for PCV, p < 0.001 for HA), with no difference between groups. Safety was optimal and no adverse events were reported.; Conclusions: The use of HA gel does not give additional benefits to those that are already provided by the moisturizing PCV. (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

Cai, P. (2021). "Discussion on the Value of Mifepristone and Misoprostol in the Treatment of Missed Abortion." 中外医学研究 19(26): 100‐102.
	Objective: To study the effect of mifepristone + misoprostol in patients with missed abortion. Methods: The samples were collected from 150 missed abortion patients admitted to the obstetrics and gynecology clinic and ward from January 2018 to December 2019. They were divided into the control group (direct uterine removal, n=75) and the observation group (mifediline) by random number table. ketone + misoprostol, n=75), and the two groups were compared in terms of clinical indicators, complications of uterine clearance, clinical efficacy and adverse reactions. Results: There was no significant difference in adverse reactions between the two groups (P>0.05); after treatment, compared with the control group, the observation group had shorter vaginal bleeding, menstrual rehydration time, less vaginal bleeding, and the observation group had a total effective rate ( 97.33%) was higher than that in the control group (86.67%), and the complication rate in the observation group (2.67%) was lower than that in the control group (16.00%), with a statistically significant difference (P<0.05). Conclusion: Combination medication in the treatment of missed abortion can improve the curative effect, reduce the occurrence of adverse reactions, and promote the recovery of the body, which is worthy of reference.

Cai, T., et al. (2022). "The efficacy and tolerability of pollen extract in combination with hyaluronic acid and vitamins in the management of patients affected by chronic prostatitis/chronic pelvic pain syndrome: a 26 weeks, randomized, controlled, single-blinded, phase III study." Minerva urology and nephrology 74(6): 780-788.
	Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) remains a challenging clinical condition to manage. Here, we evaluate the efficacy and tolerability of a new treatment option (suppositories) containing pollen extract in combination with hyaluronic acid and vitamins in the management of patients with CP/CPPS.; Methods: In this prospective, randomized, controlled, single-blinded, phase-III study we enrolled CP/CPPS patients between March and December 2019. Participants were randomized (1:1) to the following treatment groups: 1) pollen extract suppositories 1 daily for 10 days; or 2) ibuprofen 600 mg 1 tablet in the morning for 10 days. At the enrolment time and at the follow-up evaluations (3, 6 months), all patients completed baseline questionnaires ([National Institutes of Health Chronic Prostatitis Symptom Index [NIH-CPSI] and Quality of Well-Being [QoL]) and underwent urological examination and microbiological evaluation. The primary endpoint was the quality-of-life assessment with Patients' Reported Outcomes (PROs).; Results: One hundred and eighty-seven patients were screened. Finally, one hundred and twenty-four patients (mean age 34.6±3.9 years) were randomly allocated to the new pollen extract treatment (N.=63) or ibuprofen (N.=61) groups. At the end of follow-up examinations 56/63 group 1 patients (88.8%) showed a significant reduction of the NIH-CPSI total score, compared with 17/61 (27.8%) in group 2 (P<0.0001). Group 1 patients also reported a higher improvement in terms of PROs, when compared with the control group and group 1 patients reported a significant reduction of leucocyte count at the Meares-Stamey Test (-12; -4; P<0.001). Only mild adverse events were reported in the two groups and adverse events were less frequent in the pollen extract suppositories group.; Conclusions: The combination of pollen extract with hyaluronic acid and vitamins is more effective than ibuprofen in improving symptoms and Quality of Life in patients affected with CP/CPPS and has less side effects.

Caike Costa, F., et al. (2021). "Evaluation of transdermal testosterone use in postmenopause women with hypoactive sexual desire: A systematic Review."
	
Caiyun, W., et al. (2021). "Comparative efficacies of different immunotherapy regimens in recurrent implantation failures: A systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Calabrio Marcela, M., et al. (2019). "Transcutaneous nervous electric stimulation (TENS) in the treatment of localized provoked vulvodynia: systematic review." Femina 47(5): 302-306.
	
Calaf-Alsina, J., et al. (2023). "Sequential management of postmenopausal health and osteoporosis: An update." Maturitas 177: 107846.
	Increased life expectancy means that women are now in a hypoestrogenic state for approximately one-third of their lives. Overall health and specifically bone health during this period evolves in accordance with aging and successive exposure to various risk factors. In this review, we provide a summary of the approaches to the sequential management of osteoporosis within an integrative model of care to offer physicians a useful tool to facilitate therapeutic decision-making. Current evidence suggests that pharmacologic agents should be selected based on the risk of fractures, which does not always correlate with age. Due to their effect on bone turnover and on other hormone-regulated phenomena, such as hot flushes or breast cancer risk, we position hormone therapy and selective estrogen receptor modulators as an early postmenopause intervention for the management of postmenopausal osteoporosis. When the use of these agents is not possible, compelling evidence supports antiresorptive agents as first-line treatment of postmenopausal osteoporosis in many clinical scenarios, with digestive conditions, kidney function, readiness for compliance, or patient preferences playing a role in choosing between bisphosphonates or denosumab during this period. For patients at high risk of osteoporotic fracture, the "anabolic first" approach reduces that risk. The effect on bone health with these bone-forming agents or with denosumab should be consolidated with the subsequent use of antiresorptive agents. Regardless of the strategy, follow-up and treatment should be maintained indefinitely to help prevent fractures.Copyright © 2023

Caldwell, P. H. Y., et al. (2022). "An Alarm Watch for Daytime Urinary Incontinence: A Randomized Controlled Trial." Pediatrics 149(1): e2021053863.
	OBJECTIVES: Daytime urinary incontinence is disabling and occurs in 17% of school-aged children. Timed-voiding is part of standard therapy. Can an alarm watch to aid timed-voiding improve treatment response to standard therapy? METHODS: The WATCH (Watch with Alarm for Timed-Voiding in Children) study is a randomized controlled trial. Participants were randomly assigned (1:1) to a vibrating alarm or nonalarming watch for 3-months. The primary outcome was the proportion who achieved a complete response (14 consecutive dry days) after 3-months of treatment. Children aged 5 to 13 years who were prescribed timed-voiding for daytime urinary incontinence. RESULT(S): Overall, 243 children, with a mean age of 8 years, were enrolled, with 62% girls. At 3-months, the complete response rates were similar between the 2 groups (22% alarm versus 17% control; difference: 5%; 95% confidence interval (CI): 5% to 16%; P 5 .42). In the alarm group, treatment adherence was higher (40% vs 10%; difference: 30%; 95% CI: 20% to 40%; P < .001), frequency of incontinence was lower (25% dry; 40% had 1-3 wet days per week, 24% had 4-6 wet days per week, and 12% had daily wetting, compared with 19%, 30%, 35%, and 16%, respectively; P 5.05), and fewer had abnormal postvoid residual urine volumes (12% vs 24%; difference: 12%; 95% CI: 21% to 1%; P 5 .04) compared with the control group. Improvement was transient and did not persist 6 months beyond the treatment period. CONCLUSION(S): Alarm watches do not appear to lead to complete resolution of urinary incontinence in children but did promote treatment adherence, normalization of postvoid residual volumes, and reduction in incontinent episodes while being used.Copyright © 2022 by the American Academy of Pediatrics.

Calero Maria, J., et al. (2022). "Fertility and Pregnancy Outcomes in Patients With Adenomyosis: Is Adenomyosis Synonymous With Infertility?" Cureus 14(10): e30310.
	Adenomyosis is a disease related to the presence of endometrial glands and stromal cells within the uterine myometrium that used to be linked to females that are more than 40 years old and multiparous. Nowadays, females are delaying their pregnancies to their third or fourth decade, and as diagnostic approaches evolve, the disease has become a common problem for females who desire pregnancy. The aim of this study is to identify the physio-pathological factors by which adenomyosis causes infertility and pregnancy complications, as well as the possible results from infertility treatments and the most common pregnancy complications that females with adenomyosis face. A systematic review based on a systematic search from PubMed, Cochrane, and ScienceDirect databases from the past five years was done. Papers with free full text available were subject to the removal of duplicates, screening for relevant titles and abstracts, and a quality assessment to identify the risk of bias (RoB). A total of 10 papers were selected for this study; they include systematic reviews and meta-analyses, cohorts, literature review, and a case-control study. After the review of the data, we conclude that infertility may be due to several factors that impair adequate sperm mobility through the uterus and an impaired implantation of a product. After some fertility treatments were performed, females with adenomyosis had a lower rate of clinical pregnancy. The pregnancy complications such as preterm delivery and hypertension problems related to pregnancy had an increased risk for females with adenomyosis, while for others such as intrauterine fetal death and gestational diabetes, the information is still controversial. The main limitation of this study was the lack of information of physio-pathological-related information probably due to only including data from the past five years.; Competing Interests: The authors have declared that no competing interests exist. (Copyright © 2022, Calero et al.)

Calgary University, o., et al. (2022). Postoperative Return to Sexual Activity.
	No Results Available Other: Structured Counselling Tool Preparedness to return to sexual activity|Sexual Function|Postoperative Pain|Time to Return to Sexual Function Female Not Applicable 170 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Supportive Care 21-0749 November 2023

Callen, E., et al. (2023). "EE264 Immunotherapy for Advanced and Recurrent dMMR Endometrial Cancer: A Cost-Effectiveness Analysis." Value in Health 26(6 Supplement): S107.
	Objectives: Few treatment options exist for patients with advanced or recurrent endometrial cancer (EC) that has progressed after treatment with platinum-based therapy. Dostarlimab and pembrolizumab are approved for patients with advanced cancers that have not responded to prior therapy and are mismatch repair deficient (dMMR). This analysis aimed to add to the evidence on the cost-effectiveness of immunotherapy for advanced or recurrent dMMR EC. Method(s): Immunotherapy was compared to usual care (pegylated doxorubicin, PLD). A partitioned survival model was used to estimate probabilities of progression free survival, overall survival and death over a 25-year time horizon. Probabilities of being in each state were derived from survival curves in the published literature. Costs and utilities were derived from published literature and government estimates and discounted at 3 percent annually. Per-cycle costs of PLD, pembrolizumab, and dostarlimab were $1,680, $10,910, and $11,038, respectively. Model outputs were life-years gained, quality-adjusted life-years (QALYs) gained, costs, and incremental cost effectiveness ratios (ICERs). One-way sensitivity analysis was conducted to assess the impact of parameter uncertainties on modeled outcomes. Result(s): Compared to PLD, pembrolizumab resulted in 3.18 life-years and 2.20 QALYs gained, with an incremental cost of $612,125 and an ICER of $278,123 per QALY gained. Pembrolizumab was subject to extended dominance by dostarlimab, which yielded a gain of 3.84 life-years and 2.62 QALYs, with an incremental cost of $703,819 ($268,910 per QALY gained). Results were sensitive to cycles of therapy needed to attain maximum clinical benefit and per-cycle cost of progressed disease. Conclusion(s): Dostarlimab and pembrolizumab led to increases in life expectancy and quality of life compared to PLD, but these results suggest they may not currently be priced in line with expected clinical benefit at a willingness-to-pay threshold of $150,000/QALY. More work is needed to understand clinical trajectories following treatment with immunotherapy and cycles needed to attain maximum benefit.Copyright © 2023

Callens, C., et al. (2023). "Shallow whole genome sequencing approach to detect Homologous Recombination Deficiency in the PAOLA-1/ENGOT-OV25 phase-III trial." Oncogene 42(48): 3556-3563.
	The bevacizumab (bev)/olaparib (ola) maintenance regimen was approved for BRCA1/2-mutated (BRCAmut) and Homologous Recombination Deficient (HRD) high-grade Advanced Ovarian Cancer (AOC) first line setting, based on a significantly improved progression-free survival (PFS) compared to bev alone in the PAOLA-1/ENGOT-ov25 trial (NCT02477644), where HRD was detected by MyChoice CDx PLUS test. The academic shallowHRDv2 test was developed based on shallow whole-genome sequencing as an alternative to MyChoice. Analytical and clinical validities of shallowHRDv2 as compared to MyChoice on 449 PAOLA-1 tumor samples are presented. The overall agreement between shallowHRDv2 and MyChoice was 94% (369/394). Less non-contributive tests were observed with shallowHRDv2 (15/449; 3%) than with MyChoice (51/449; 11%). Patients with HRD tumors according to shallowHRDv2 (including BRCAmut) showed a significantly prolonged PFS with bev+ola versus bev (median PFS: 65.7 versus 20.3 months, hazard ratio (HR): 0.36 [95% CI: 0.24-0.53]). This benefit was significant also for BRCA1/2 wild-type tumors (40.8 versus 19.5 months, HR: 0.45 [95% CI: 0.26-0.76]). ShallowHRDv2 is a performant, clinically validated, and cost-effective test for HRD detection.Copyright © 2023, The Author(s).

Callens, C., et al. (2021). "Concordance Between Tumor and Germline BRCA Status in High-Grade Ovarian Carcinoma Patients in the Phase III PAOLA-1/ENGOT-ov25 Trial." Journal of the National Cancer Institute 113(7): 917‐923.
	BACKGROUND: PAOLA1 is a phase III study assessing olaparib maintenance therapy in advanced high‐grade ovarian carcinoma patients responding to first‐line platinum‐taxane‐based chemotherapy plus bevacizumab as standard of care. Randomization was stratified by treatment outcome and tumor BRCA1/2 status (tBRCA) at screening. METHODS: tBRCA was tested on formalin‐fixed, paraffin‐embedded tumor blocks on 5 French platforms using 2 next‐generation sequencing methods based either on hybrid capture or amplicon technology. One of the exploratory objectives was to assess the concordance between germline (gBRCA) and tBRCA testing in French patients. gBRCA testing was performed on blood samples on the same platforms. RESULTS: From May 2015 to July 2017, tBRCA tests were performed for 1176 screened patients. Only 52 (4.4%) tumor samples were noncontributive. The median interval between reception of the tumor sample and availability of the tBRCA status result was 37 days (range = 8‐260). A pathogenic variant was reported in 27.1% tumor samples (319 of 1176 screened patients). tBRCA and gBRCA testing were performed for 451 French patients with negative results for both tests in 306 patients (67.8%) and positive results for both tests in 85 patients (18.8%). Only 1 large genomic rearrangement of BRCA1 was detected, exclusively in the blood sample. Interestingly, tBRCA testing revealed 6.4% of pathogenic variant (29 of 451) not detected by gBRCA testing. CONCLUSIONS: tBRCA testing is an appropriate tool with an acceptable turnaround time for clinical practice and a low failure rate, ensuring reliable identification of patients likely to benefit from poly(ADP‐ribose) polymerase inhibitor therapy.

Calles, S., et al. (2023). "Complications of Pessaries Amenable to Surgical Correction: Two Case Reports and a Systematic Review of the Literature." Journal of Personalized Medicine 13(7).
	Background: Forty percent of women will experience prolapse in their lifetime. Vaginal pessaries are considered the first line of treatment in selected patients. Major complications of vaginal pessaries rarely occur.; Methods: PubMed and Embase were searched from 1961 to 2022 for major complications of vaginal pessaries using Medical Subject Headings (MeSH) and free-text terms. The keywords were pessary or pessaries and: vaginal discharge, incontinence, entrapment, urinary infections, fistula, complications, and vaginal infection. The exclusion criteria were other languages than English, pregnancy, complications without a prior history of pessary placement, pessaries unregistered for clinical practice (herbal pessaries), or male patients. The extracted data included symptoms, findings upon examination, infection, type of complication, extragenital symptoms, and treatment.; Results: We identified 1874 abstracts and full text articles; 54 were assessed for eligibility and 49 met the inclusion criteria. These 49 studies included data from 66 patients with pessary complications amenable to surgical correction. Clavien-Dindo classification was used to grade the complications. Most patients presented with vaginal symptoms such as bleeding, discharge, or ulceration. The most frequent complications were pessary incarceration and fistulas. Surgical treatment included removal of the pessary under local or general anesthesia, fistula repair, hysterectomy and vaginal repair, and the management of bleeding.; Conclusions: Pessaries are a reasonable and durable treatment for pelvic organ prolapse. Complications are rare. Routine follow-ups are necessary. The ideal patient candidate must be able to remove and reintroduce their pessary on a regular basis; if not, this must be performed by a healthcare worker at regular intervals.

Calvo, E., et al. (2022). "Phase I study of lurbinectedin in combination with weekly paclitaxel with or without bevacizumab in patients with advanced solid tumors." Investigational New Drugs 40(6): 1263-1273.
	Lurbinectedin and paclitaxel showed synergism in preclinical studies and have non-completely overlapping toxicity profiles. This phase I trial evaluated a combination of paclitaxel and lurbinectedin with/without bevacizumab in advanced tumors. This trial was divided into Group A, which evaluated weekly paclitaxel (60 or 80 mg) plus lurbinectedin (3.0-5.0 mg flat dose [FD] or 2.2 mg/m 2 ) every 3 weeks in advanced solid tumors; and Group B, which evaluated bevacizumab (BEV, 15 mg/kg) added to the recommended dose (RD) defined in Group A in advanced epithelial ovarian or non-small cell lung cancer (NSCLC). 67 patients (A, n = 55; B, n = 12) were treated. The RD was paclitaxel 80 mg/m 2 on Day (D)1,D8 plus lurbinectedin 2.2 mg/m 2 on D1. At this RD, myelotoxicity was reversible and manageable, and most non-hematological toxicities were mild/moderate. Adding BEV did not notably change tolerability. Twenty-five confirmed responses were observed: 20/51 evaluable patients in Group A (overall response rate [ORR] = 39% at all dose levels and at the RD), and 5/10 evaluable patients in Group B (ORR = 50%). Most responders had breast (n = 7/12 patients), small cell lung (SCLC) (n = 5/7), epithelial ovarian (n = 3/9) and endometrial cancer (n = 3/11) in Group A, and epithelial ovarian (n = 3/4) and NSCLC (n = 2/6) in Group B. Clinical benefit rate was 61% in Group A (58% at the RD), and 90% in Group B. No major pharmacokinetic drug-drug interactions were observed. Paclitaxel/lurbinectedin and paclitaxel/lurbinectedin/BEV are feasible combinations. Further development is warranted of paclitaxel/lurbinectedin in SCLC, breast, and endometrial cancer, and of paclitaxel/lurbinectedin/BEV in epithelial ovarian cancer. (© 2022. The Author(s).)

Camela, E., et al. (2022). "Giant basal cell carcinoma of the vulva successfully treated with Sonidegib." Dermatologic therapy 35(9): e15723.
	
Camilo Fabio, M., et al. (2023). "The Effects of Electrode Placement on Analgesia Using Transcutaneous Electrical Nerve Stimulation for Primary Dysmenorrhea: A Single-Blind Randomized Controlled Clinical Trial." Cureus 15(5): e39326.
	Background Primary dysmenorrhea (PD) refers to the occurrence of painful menstrual cramps without pathological involvement of the pelvic organs, with considerable morbidity and high prevalence among females of reproductive age. Objective The objective of this study is to present and test the efficacy of an innovative method of interactive transcutaneous electrical nerve stimulation (iTENS) for PD. Methods and materials This study is a single-blind controlled clinical trial. This was conducted at the outpatient clinic of the faculty of physical therapy. Females with PD (n=124) were divided into the treated group (transcutaneous electrical nerve stimulation {TENS} group {TG}, n=62) and the placebo group (PG, n=62). A single session of either iTENS or placebo intervention was used for 35 minutes. Pain, the duration of analgesia, and the use of pain medication were assessed before and after the intervention. Data from before and after the treatment were compared between groups (Student's t-test). The level of significance was set at 5%. Results A significant decrease in pain (p<0.001) was observed after the intervention for the TG, with a more long-lasting analgesia (p<0.001) and decreased need for pain medication (p<0.001). Conclusions The proposed method of transcutaneous electrical nerve stimulation (TENS) application showed positive results for pain management on females with PD, with no reported adverse effects. The new proposed TENS application takes into account the preferences of the patient regarding positioning and the number of channels needed to cause analgesia. This application was able to promote almost complete analgesia in females with primary dysmenorrhea, and the analgesia persisted for more than one menstrual cycle.; Competing Interests: The authors have declared that no competing interests exist. (Copyright © 2023, Camilo et al.)

Campagna, G., et al. (2022). "Laparoscopic uterosacral ligament suspension: a comprehensive, systematic literature review." European Journal of Obstetrics, Gynecology, and Reproductive Biology 277: 57-70.
	Objectives: Laparoscopic uterosacral ligament suspension (LUSLS) of the vaginal apex for the treatment of pelvic organ prolapse (POP) has gained popularity. The aim of this systematic review is to investigate perioperative outcomes and complications, subjective and objective success rates and recurrence rates in women undergoing this surgical procedure.; Study Design: A systematic literature search was performed in December 2021. The critical appraisal skills program (CASP) was used to assess the methodological quality of the selected studies. The Clavien-Dindo (CD) scale and the Satava scale were used to classify periprocedural complications. Continuous variables were described as means and standard deviations while categorical were expressed as percentages of the whole group. Statistical significance was set at p < 0.05.; Results: 26 articles were selected and analysed, with a total population of 1401 patients. Anatomical and subjective success rates after LUSLS ranged from 79% and 100% and from 76.2% to 100% respectively. The re-operation rate varied from 2% to 4.5% in the largest cohorts. The overall complication rate was 13.6%, however grade III CD complications occurred only in 1% of patients. Ureteral complications were described in only 2 cases.; Conclusions: LUSLS represent a safe and effective technique for vaginal apex resuspension in women with POP. Further larger prospective randomized studies are required to confirm these data.; Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2022 Elsevier B.V. All rights reserved.)

Campagna, G., et al. (2023). "Clinical, anatomical and perioperative outcomes of abdominal sacral colpopexy using autologous fascia: A systematic review of the literature." Journal of Gynecology Obstetrics and Human Reproduction 52(8): 102635.
	Objectives: Although sacral colpopexy is considered the gold standard for the treatment of advanced apical prolapse, several warnings and restrictions has been delivered to urogynecological surgeons in order to avoid the implants of prosthetics meshes. The purpose of this systematic review is to investigate the role of sacral colpopexy performed with autologous tissue in literature.; Methods: a systematic review according to PRISMA guidelines was performed in June 2022 through the Medline, Web of Science and Scopus databases. Quality assessment of each article was performed according to Critical Appraisal tool of Oxford center for EBM, LoE according to SORT standards, ROBINS-I tool for methodological assessment in non-randomized trials. From 236 screened records, 7 articles were considered eligible for this systematic review.; Results: Collected data showed objective cure rate ranging from 94.7% to 100% in medium term follow up. Subjective cure rate was specifically investigated in 2 studies with high satisfaction rates. Complication rate ranged from 0 to 36.8%, with 90.1% graded ≤2 according to Clavien-Dindo classification.; Conclusions: sacral colpopexy with autologous fascia shows satisfying outcomes in terms of safety and efficacy and may be taken in account in particular clinical situations.; Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare. (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)

Campagna, G., et al. (2021). "Laparoscopic lateral suspension for pelvic organ prolapse: A systematic literature review." European Journal of Obstetrics, Gynecology, and Reproductive Biology 264: 318-329.
	Background: Abdominal lateral suspension with mesh represents an alternative treatment to suspend the vaginal apex.; Objectives: The aim of this study was to summarize literature data regarding the anatomical and functional outcomes, and intra- and postoperative complications of this technique with minimally invasive approach (laparoscopic/robotic).; Search Strategy: Systematic literature search using MEDLINE/PubMed, SCOPUS, Web of Science.; Data Collection and Analysis: Two authors extracted data on baseline characteristics (age, BMI, prior pelvic reconstructive surgery, preoperative POP stage), perioperative outcomes (operative time, estimated blood loss, intraoperative and postoperative complications, admission time), objective and subjective success rate, surgical failure, time of follow-up. Data were presented descriptively.; Main Results: Thirteen studies were included in the review. The overall number of patients for our analysis was 1066. Patients referred for laparoscopic/robotic lateral suspension were most frequently postmenopausal, aged 50 to 65 years, BMI ≥ 25 kg/m2; 22.2% were already hysterectomized, while 17% had already a previous POP surgery. Operative time ranged from 78.4 ± 29.7 to 254 ± 45 min. The overall anatomic success was more than 90% in the apical compartment and more than 88% in the anterior compartment. Subjective cure rate varies from 78.4% to 100% in medium-term follow-up. Post-operative complication grade >= 3 according to Claiven-Dindo Scale was 1.03%. Mesh erosion rate varied between 0% and 13%.; Conclusions: Results coming from our systematic review suggest safety, efficacy and feasibility of minimally invasive lateral suspension with optimal anatomical and functional outcomes. Well-designed, randomized, controlled trials are required to confirm this data.; Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2021 Elsevier B.V. All rights reserved.)

Campitelli, M., et al. (2021). "Brachytherapy or external beam radiotherapy as a boost in locally advanced cervical cancer: A Gynaecology Study Group in the Italian Association of Radiation and Clinical Oncology (AIRO) review." International Journal of Gynecological Cancer 31(9): 1278-1286.
	This review analyzes the experience and trends in external beam radiotherapy for delivering a boost in locally advanced cervical cancer, identifying whether radiation therapy modalities impact clinical outcomes with the ultimate aim of evaluating alternatives to brachytherapy. Three independent Italian radiation oncologists conducted a literature search on different external beam radiotherapy boost modalities in locally advanced cervical cancer. The search yielded 30 studies. Eight dosimetric studies, evaluating target coverage and dose to organs at risk, and nine clinical investigations, reporting clinical outcomes, were analyzed. Dosimetric studies comparing external beam radiotherapy boost with brachytherapy produced divergent results, while clinical studies were limited by their retrospective nature, heterogeneous doses, radiation schedules, volumes and techniques, diverse follow-up times, and small cohorts of patients. Evidence emerged that high-tech external beam radiotherapy seemed no better than image-guided brachytherapy for delivering a boost in locally advanced cervical cancer. Prospective clinical studies comparing high-tech external beam radiotherapy and image-guided brachytherapy should be encouraged.Copyright ©

Campos, L. S., et al. (2021). "Survival after Laparoscopic versus Abdominal Radical Hysterectomy in Early Cervical Cancer: A Randomized Controlled Trial." Asian Pacific journal of cancer prevention : APJCP 22(1): 93-97.
	BACKGROUND: Previous studies have reported the safety of laparoscopic radical hysterectomy for treatment of early cervical cancer, as option to laparotomy. This study aims to compare overall survival between laparoscopic versus abdominal radical hysterectomy for early cervical cancer. METHODS: A single-center randomized controlled trial enrolled 30 patients with clinically staged IA2 cervical cancer and lymphovascular invasion, IB and IIA, who underwent laparoscopic radical hysterectomy (16) or abdominal radical hysterectomy (14). RESULT: The mean overall survival time was 74.74 months (CI 95%: 54.15-95.33) for LRH 91.67 months (CI 95%: 74.97-108.37) for ARH (log-rank test = 0.30). The mean disease-free survival time was 81.07 months (CI 95%: 60.95-101.19) for LRH and 95.82 months (CI 95%: 80.18-111.47) for ARH (log-rank test = 0.371). The overall survival hazard ratio was 2.05 (CI 95%: 0.51-8.24), and the disease-free hazard ratio was 2.13 (CI 95%: 0.39-11.7). CONCLUSION: Our study suggests a non-significant trend of worse outcomes for LRH. In light of recent controversy and need for prospective studies, further studies in different populations are required for definite conclusions and until then, patients should be aware of risks and benefits, survival data and quality of life outcomes related to both surgical techniques.

Campos, S., et al. (2022). "A randomized phase II trial of bevacizumab vs. bevacizumab and erlotinib as first-line consolidation after carboplatin, paclitaxel, and bevacizumab in newly diagnosed patients with mullerian tumors." International Journal of Clinical Oncology 27(12): 1881-1890.
	Background: The combination of paclitaxel to platinum remains the backbone of therapy in patients with advanced Mullerian tumors. In patients with newly diagnosed Mullerian tumors, we investigated the progression-free survival benefit of bevacizumab and bevacizumab and erlotinib as consolidation therapy post-induction therapy. Method(s): Sixty patients were enrolled in a phase II trial of carboplatin, paclitaxel, and bevacizumab (induction therapy). After the completion induction therapy, patients were stratified by response (>= SD) and then randomized (1:1) to either bevacizumab (A) or bevacizumab and erlotinib (AE.) The primary endpoint was PFS. Secondary endpoints included the response rate of induction and consolidation therapy and toxicity profile of each consolidative arm. Each consolidative arm was compared to the historical control GOG 111. Result(s): Forty-eight patients advanced to the consolidative phase of the trial. Twelve patients were removed in the induction phase, the majority for toxicity. The most common toxicity (grade >= 3) was diarrhea (20%: arm AE; 0%: arm A). One patient in the AE arm had a fatal cardiac arrest deemed unrelated to the study treatment. No gastrointestinal perforations were reported. The median PFS in the AE and A arm was 18.9 months (p < 0.0001) and 13.3 months (p: ns), respectively. The overall rate of grade 3/4 toxicities in the AE arm was 72% and in the A arm 30%. Six patients remain free of disease 10 years after enrollment. Conclusion(s): Combinatorial consolidation therapy with AE was associated with an improved progression-free survival in patients with Mullerian tumors.Copyright © 2022, The Author(s) under exclusive licence to Japan Society of Clinical Oncology.

Cancanelli, L., et al. (2022). "Evaluation of maintenance treatment with PARP inhibitors in ovarian carcinoma patients responding to platinum therapy: Use of restricted mean survival time as an index of efficacy." International journal of clinical pharmacology and therapeutics 60(1): 32-35.
	Background: Maintenance therapy using poly (ADP-ribose) polymerase inhibitors (PARPIs) is an important therapeutic option in advanced ovarian cancer after platinum-based chemotherapy.; Materials and Methods: We evaluated randomized studies (n = 5) describing the effect of maintenance therapy with PARPIs; they were obtained mainly by searching PubMed. Patient data for the analysis were derived from progression-free survival curves. Restricted mean survival time (RMST) and 95% confidence interval were estimated for individual arms of each trial.; Results: The three PARPIs used (olaparib, niraparib, rucaparib) all showed a higher effectiveness than placebo. The gains in progression-free survival were 6 - 8 months.; Conclusion: Maintenance therapy studies provide evidence that olaparib, niraparib, rucaparib are effective treatments for advanced ovarian cancer.

Cancer Queensland Centre for, G. and o. Queensland The University (2021). Sentinel Node Biopsy in Endometrial Cancer.
	No Results Available Procedure: TH BSO with SNB Note: If participants (≤45 years of age) wish to retain their ovaries a BSO may be omitted.|Procedure: TH BSO without retroperitoneal node dissection Note: If participants (≤45 years of age) wish to retain their ovaries a BSO may be omitted. Stage 1: Return to usual activities|Stage 2: Disease Free Survival|Cost Effectiveness using QALYs using EuroQoL-5D (EQ-5D) Questionnaire|Cost Effectiveness measuring Intervention costs|Cost Effectiveness measuring GP and specialist consultations|Cost Effectiveness measuring radiology and imaging requirements|Cost Effectiveness measuring prescriptions and over the counter medicine requirements|Cost Effectiveness measuring community and health service requirements and days off work and informal care required by family and friends using a combination of the Health Services Questionnaire and clinical files|Cost Effectiveness: direct costs using a bottom-up approach by recording the volume of resource use in both groups of the trial, and then applying a unit cost to each component|Perioperative Outcomes: Adverse Events|Perioperative Outcomes: Length of Surgery|Perioperative Outcomes: Blood Loss during Surgery|Perioperative Outcomes: Blood Transfusion Requirements during Surgery|Perioperative Outcomes: Length of Hospital Stay|Health Related Quality of Life and Fear of Recurrence|Incidence of Lymphedema|Adjuvant Treatment Requirements|Value of Molecular Biomarkers|Overall Survival|Patterns of Recurrence - date and localization of 1st recurrence|Impact of body composition (sarcopenia) on surgical complications, recovery and overall survival|Impact of frailty on surgical complications, recovery and overall survival|Follow-Up Strategies Female Phase 3 760 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ENDO-3 January 2031

Candiani, M., et al. (2022). "Fertility Sparing Procedure using Carbon Dioxide Fiber Laser Vaporization of Ovarian Endometrioma." Journal of visualized experiments : JoVE(185).
	The surgical management of endometrioma is still a matter of debate. Cystectomy, which is recognized as the standard technique, seems to be associated with a potential reduction in the ovarian reserve due to the inadvertent removal and thermal damage of healthy ovarian tissue. New ablative techniques with reduced tissue penetration depth and less thermal spread to the surrounding parenchyma may represent a viable alternative to cystectomy. For these reasons, the aim of this manuscript is to demonstrate the ablation of the endometrioma capsule using a CO2 fiber laser technique and discuss the clinical outcomes. Once the cyst has been drained and washed, a biopsy is taken. After cyst eversion, vaporization of the inner surface of the cyst is performed using a CO2 fiber laser. The technique is simple and reproducible as even young surgeons without any surgical experience were more confident in performing laser CO2 vaporization instead of cystectomy. The positive effects of CO2 technology are reported in a randomized controlled trial, where the postoperative changes in the antral follicular count (AFC) and antimullerian hormone (AMH) levels were compared between patients who had their endometrioma excised (cystectomy) and those who had undergone endometrioma vaporization with CO2 laser. The patients treated with CO2 laser showed significantly increased AFC without a reduction in serum AMH levels as compared to the cystectomy group, in which both parameters were significantly reduced. The postoperative pregnancy rate was also assessed, and comparable pregnancy rates were found after both treatments. On the contrary, patients treated with the CO2 fiber laser technique had more favorable in-vitro fertilization (IVF) outcomes compared to cystectomy. In conclusion, the CO2 fiber laser technique may represent a viable alternative to cystectomy in the surgical treatment of endometrioma in terms of ovarian preservation, pregnancy rates, and IVF outcomes. Moreover, it has the advantage of being independent of the surgeon's skills and personal experience.

Canfield, S. M. and K. E. Canada (2023). "Systematic Review of Online Interventions to Reduce Perinatal Mood and Anxiety Disorders in Underserved Populations." Journal of Perinatal and Neonatal Nursing 37(1): 14-26.
	Background: Online health interventions increase access to care, are acceptable to end users and effective for treating mental and physical health disorders. However, less is known about interventions to prevent and treat perinatal mood and anxiety disorders (PMADs). This review synthesizes existing research on PMAD prevention and treatment by exploring the treatment modalities and efficacy of online interventions and examining the inclusion of underserved populations in PMAD research. Method(s): Using PRISMA guidelines, authors conducted a systematic review of peer-reviewed literature published between 2008 and 2018 on online interventions aimed to prevent or treat PMADs. The authors also assessed quality. Eligible articles included perinatal women participating in preventive studies or those aimed to reduce symptoms of PMADs and utilized a Web-based, Internet, or smartphone technology requiring an online component. This study excluded telephone-based interventions that required one-on-one conversations or individualized, text-based responses without a Web-based aspect. Result(s): The initial search yielded 511 articles, and the final analysis included 23 articles reporting on 22 interventions. Most studies used an experimental design. However, no study achieved an excellent or good quality rating. Psychoeducation and cognitive-behavioral therapies (CBTs) were most common. Several interventions using CBT strategies significantly decreased depression or anxiety. Four studies recruited and enrolled mainly people identifying as low-income or of a racial or ethnic minority group. Attrition was generally high across studies. Discussion(s): More research using rigorous study designs to test PMAD interventions across all perinatal times is needed. Future research needs to engage diverse populations purposefully.Copyright © 2023 Lippincott Williams and Wilkins. All rights reserved.

Canlorbe, G., et al. (2021). "Fertility-Sparing Surgery for Ovarian Cancer." Journal of Clinical Medicine 10(18).
	(1) Background: although most patients with epithelial ovarian cancer (EOC) undergo radical surgery, patients with early-stage disease, borderline ovarian tumor (BOT) or a non-epithelial tumor could be offered fertility-sparing surgery (FSS) depending on histologic subtypes and prognostic factors. (2) Methods: we conducted a systematic review to assess the safety and fertility outcomes of FSS in the treatment of ovarian cancer. We queried the MEDLINE, PubMed, Cochrane Library, and Cochrane ("Cochrane Reviews") databases for articles published in English or French between 1985 and 15 January 2021. (3) Results: for patients with BOT, FSS should be offered to young women with a desire to conceive, even if peritoneal implants are discovered at the time of initial surgery. Women with mucinous BOT should undergo initial unilateral salpingo-oophorectomy, whereas cystectomy is an acceptable option for women with serous BOT. Assisted reproductive technology (ART) can be initiated in patients with stage I BOT if infertility persists after surgery. For patients with EOC, FSS should only be considered after staging for women with stage IA grade 1 (and probably 2, or low-grade in the current classification) serous, mucinous or endometrioid tumors. FSS could also be offered to patients with stage IC grade 1 (or low-grade) disease. For women with serous, mucinous or endometrioid high-grade stage IA or low-grade stage IC1 or IC2 EOC, bilateral salpingo-oophorectomy and uterine conservation could be offered to allow pregnancy by egg donation. Finally, FSS has a large role to play in patients with non- epithelial ovarian cancer, and particularly women with malignant ovarian germ cell tumors.

Canlorbe, G., et al. (2020). "Borderline Ovarian Tumours: CNGOF Guidelines for Clinical Practice - Therapeutic Management of Early Stages." Gynecologie Obstetrique Fertilite et Senologie 48(3): 287-303.
	Objectives: To provide guidelines for clinical practice from the French College of Obstetrics and Gynecology (CNGOF), based on the best evidence available, concerning early stage borderline ovarian tumors (BOT). Method(s): Bibliographical search in French and English languages by consultation of Pubmed, Cochrane, Embase, and international databases. Result(s): Considering management of early stage BOT, if surgery is possible without a risk of tumor rupture, the laparoscopic approach is recommended compared to laparotomy (Grade C). In BOT, it is recommended to take all the measures to avoid tumor rupture, including the peroperative decision of laparoconversion (Grade C). In BOT, extraction of the surgical specimen using an endoscopic bag is recommended (Grade C). In case of early stage, uni or bilateral BOT, suspected in preoperative imaging in a postmenopausal patient, bilateral adnexectomy is recommended (Grade B). In cases of bilateral BOT and desire of fertility preservation, a bilateral cystectomy is recommended (Grade B). In case of mucinous BOT and desire of fertility preservation, it is recommended to perform a unilateral adnexectomy (Grade C). In case of endometrioid BOT and desire of fertility preservation, it is not possible to establish a recommendation of treatment choice between cystectomy and unilateral adnexectomy. In case of mucinous BOT at definitive histological analysis in a woman of childbearing age who had an initial cystectomy, surgical revision for unilateral adnexectomy is recommended (Grade C). In the case of serous BOT with definitive histological analysis in a woman of childbearing age who has had an initial cystectomy, it is not recommended to repeat surgery for adnexectomy in the absence of residual suspicious lesion during initial surgery and/or on postoperative imaging (referent ultrasound or pelvic MRI) (Grade C). An omentectomy is recommended for complete initial surgical staging when BOT is diagnosed on extemporaneous analysis or suspected on preoperative radiological elements (Grade B). There is no data in the literature to recommend the type of omentectomy to be performed. If restaging surgery is decided for a presumed early stage BOT, an omentectomy is recommended (Grade B). Multiple peritoneal biopsies are recommended for complete initial surgical staging when BOT is diagnosed on extemporaneous or suspected on preoperative radiological elements (Grade C). In case of restaging surgery for a presumed early stage BOT, exploration of the abdominal cavity should be complete and peritoneal biopsies should be performed on suspicious areas or systematically (Grade C). A primary peritoneal cytology is recommended in order to achieve complete initial surgical staging when BOT is suspected on preoperative radiological elements (Grade C). In case of restaging surgery for presumed early stage BOT, a first peritoneal cytology is recommended (Grade C). For early serous or mucinous BOT, it is not recommended to perform a systematic hysterectomy (Grade C). For early stage endometrioid BOT, and in the absence of a desire to maintain fertility, hysterectomy is recommended for initial surgery or if restaging surgery is indicated (Grade C). For endometrioid-type early stage BOT, if there is a desire for fertility preservation, the uterus may be retained subject to good evaluation of the endometrium by imaging and endometrial sampling (Grade C). In case of surgery (initial or restaging if indicated) for early stage BOT, it is recommended to evaluate the macroscopic appearance of the appendix (Grade B). In case of surgery (initial or restaging if indicated) for early stage BOT, appendectomy is recommended only in case of macroscopically pathological appearance of the appendix (Grade C). Pelvic and lumbar aortic lymphadenectomy is not recommended for initial surgery or restaging surgery for early stage BOT regardless of histologic type (Grade C). In case of BOT diagnosed on definitive histology, the indication of restaging surgery should be discussed in Multidisciplinary Collaborative Meeting. For pre umed early stage BOT, it is recommended to use the laparoscopic approach to perform restaging surgery (Grade C). Restaging surgery is recommended for serous BOT with micropapillary appearance and unsatisfactory abdominal cavity inspection during initial surgery (Grade C). Restaging surgery is recommended in case of mucinous BOT if only a cystectomy has been performed or the appendix has not been visualized, then a unilateral adnexectomy will be performed (Grade C). If a restaging surgery is decided in the management of a presumed early stage BOT, the actions to be carried out are as follows: a peritoneal cytology (Grade C), an omentectomy (there is no data in the literature recommending the type of omentectomy to be performed) (Grade B), a complete exploration of the abdominal cavity with peritoneal biopsies on suspect areas or systematically (Grade C), visualization of the appendix +/- the appendectomy in case of pathological macroscopic appearance (Grade C), unilateral adnexectomy in case of mucinous TFO (Grade C).Copyright © 2020 Elsevier Masson SAS

Cano, A., et al. (2024). "Fezolinetant impact on health-related quality of life for vasomotor symptoms due to the menopause: Pooled data from SKYLIGHT 1 and SKYLIGHT 2 randomised controlled trials." BJOG: An International Journal of Obstetrics and Gynaecology.
	Objective: To assess the effect of fezolinetant treatment on health-related quality of life using pooled data from SKYLIGHT 1 and 2 studies. Design(s): Prespecified pooled analysis. Setting(s): USA, Canada, Europe; 2019-2021. Population: 1022 women aged >=40 to <=65 years with moderate-to-severe vasomotor symptoms (VMS; minimum average seven hot flushes/day), seeking treatment for VMS. Method(s): Women were randomised to 12-week double-blind treatment with once-daily placebo or fezolinetant 30 or 45 mg. Completers entered a 40-week, active extension (those receiving fezolinetant continued that dose; those receiving placebo re-randomised to fezolinetant received 30 or 45 mg). Main Outcome Measure(s): Mean changes from baseline to weeks 4 and 12 on Menopause-Specific Quality of Life (MENQoL) total and domain scores, Work Productivity and Activity Impairment questionnaire specific to VMS (WPAI-VMS) domain scores, Patient Global Impression of Change in VMS (PGI-C VMS); percentages achieving PGI-C VMS of 'much better' (PGI-C VMS responders). Mean reduction was estimated using mixed model repeated measures analysis of covariance. Result(s): Fezolinetant 45 mg mean reduction over placebo in MENQoL total score was -0.57 (95% confidence interval [CI] -0.75 to -0.39) at week 4 and -0.47 (95% CI -0.66 to -0.28) at week 12. Reductions were similar for 30 mg. MENQoL domain scores were also reduced and WPAI-VMS scores improved. Twice as many women receiving fezolinetant reported VMS were 'much better' than placebo based on PGI-C VMS assessment. Conclusion(s): Fezolinetant treatment was associated with improvement in overall QoL, measured by MENQoL, and work productivity, measured by WPAI-VMS. A high proportion receiving fezolinetant felt VMS were 'much better' based on PGI-C VMS responder analysis.Copyright © 2024 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.

Canon, C. M., et al. (2021). "SHOULD PATIENTS WITH ONLY TWO EMBRYOS ELIGBILE FOR BIOPSY AFTER A SINGLE CONTROLLED OVARIAN HYPERSTIMULATION CYCLE UTILIZE PGT-A PRIOR TO TRANSFER SELECTION? cycles without PGT-A." Fertility and Sterility 116(3): e246.
	Objective: Preimplantation genetic testing for aneuploidy (PGT‐A) is often utilized to enhance implantation rates by enabling the selection of a euploid embryo for transfer. Clinicians may question whether the use of PGT‐A is beneficial, especially for patients who produce low numbers of embryos after controlled ovarian hyperstimulation (COH).1 Our study aims to assess the potential benefit and/or risk of utilizing PGT‐A prior to embryo transfer in patients with only two available embryos compared to fresh or frozen ET cycles without PGT‐A. Materials and Methods: This study included patients who underwent an IVF cycle and had only two viable embryos available after COH from January 2003 to March 2021. Patients were separated into three groups: Group A: Patients who underwent subsequent single euploid blastocyst FET; Group B: Patients who underwent subsequent single blastocyst FET without the use of PGT‐A; Group C: Patients who underwent fresh double embryo transfer (DET) on day 3 or 5. Patients who utilized PGT‐A were included in the study if they had at least one euploid embryo available for transfer. Basic demographic and cycle characteristics were compared between groups. Statistical analysis was performed using ANOVA, chi‐square, and logistic regression. Results: Of the 949 patients included in this study, 772 underwent a single euploid blastocyst FET, 123 underwent a single FET w/o the use of PGT‐A, and 54 underwent a fresh DET,. All patients attempted at least one embryo transfer cycle, and 102 patients underwent two embryo transfer cycles. Patients who underwent FET with PGT‐A were more likely to become pregnant, and more likely to become pregnant after their first embryo transfer when compared with both FET without PGT‐A patients and Fresh DET (p <0.0001). Negative pregnancy outcomes as defined by a transfer resulting in a biochemical pregnancy, clinical pregnancy loss, or ectopic pregnancy were similar amongst all groups for both the first and second embryo transfer. On multivariate logistic regression, after adjusting for age, BMI, endometrial thickness, and embryo quality, there was a lower odds of pregnancy when undergoing single blastocyst FET without PGT‐A compared to single blastocyst FET with PGT‐A (OR 0.334 95% CI 0.139‐0.805). There was no difference in negative pregnancy outcomes between the groups. Conclusions: A decision must be made for patients with only two embryos available after COH whether to undergo fresh ET (with one or two embryos) or to cryopreserve the embryos with or without the use of PGT‐A. This study uses big data to develop a decision‐support tool to aid physicians in making this decision. Our study demonstrates that in patients who develop only two viable embryos, use of PGT‐A enhances the likelihood of achieving a successful pregnancy compared to patients who underwent a day 3 or 5 fresh DET or single blastocyst FET with untested embryos. Impact Statement: In patients with a low number of embryos per cycle, utilization of PGT‐A leads to higher odds of pregnancy and should be considered over transfer of unscreened embryos. References: 1. Lukassen HGM. Two cycles with single embryo transfer versus one cycle with double embryo transfer: a randomized controlled trial. Human reproduction. 2005;20(3):702‐708. doi:10.1093/humrep/deh672

Cao, A., et al. (2023). "Effect of exercise on body composition among women with ovarian cancer." Journal of cancer survivorship : research and practice 17(5): 1386-1396.
	Purpose: Obesity is associated with a higher risk of mortality in women with ovarian cancer. Exercise has improved body composition among cancer survivors, yet no randomized controlled trial has explored the effect of exercise on body composition in women with ovarian cancer. In this analysis, we examined the effect of a six-month aerobic exercise intervention on body composition among ovarian cancer survivors in the Women's Activity and Lifestyle Study in Connecticut (WALC).; Methods: Women with ovarian cancer (N = 144) were randomized in a 1:1 ratio to 6 months of an aerobic exercise intervention or attention-control, and body composition was measured as a secondary outcome at baseline and 6 months via dual-energy X-ray absorptiometry (DEXA). Women with at least one DEXA scan were included in the analysis (N = 103).; Results: On average, participants were 57.1 (± 8.7) years old and 1.6 (± 0.9) years since diagnosis. Women randomized to exercise maintained weight during the trial (- 0.11 kg, P = 0.82), while women in attention-control gained weight (+ 1.40 kg, P = 0.03); however, the between-group difference did not reach statistical significance (P = 0.09). We found no statistically significant differences by study arm for changes in body fat percentage, bone mineral density, or lean body mass.; Conclusions: Weight was maintained as a result of a 6-month aerobic exercise intervention among post-treatment ovarian cancer survivors. Future exercise and healthy eating interventions should consider additional measures (e.g., computer tomography scans, D 3 -creatinine) to more accurately assess changes in body composition.; Implications for Cancer Survivors: Moderate-intensity aerobic exercise may help ovarian cancer survivors maintain weight. (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Cao, L., et al. (2020). "Comparison of pregnancy outcomes and obstetric complications between frozen embryo transfer and fresh embryo transfer in women with polycystic ovary syndrome a meta-analysis." Journal of Reproductive Medicine 65(9-10): 277-285.
	OBJECTIVE: Frozen embryo transfer (FET) has been confirmed to be an alternative treatment for polycystic ovary syndrome (PCOS) patients. In FET cycles the pregnancy outcomes and obstetric complications are also of great concern. This meta-analysis study was aimed to evaluate pregnancy outcomes and obstetric complications between FET and fresh embryo transfer in women with PCOS. STUDY DESIGN: A literature search in PubMed, Embase, and the Cochrane Library was performed. We included 6 studies evaluating pregnancy outcomes and obstetric complications between FET and fresh embryo transfer in women with PCOS who received in vitro fertilization (IVF) treatment and intracytoplasmic sperm injection (ICSI) in this meta-analysis. The main outcome measures were clinical pregnancy rate, live birth rate, miscarriage rate, preterm birth rate, and mac-rosomia rate. RESULT(S): We included 6 studies, accounting for 3,290 frozen embryo cycles and 3,042 fresh embryo cycles in women with PCOS. Data analysis showed that the rate of miscarriage in the FET group was significantly lower than that of the fresh embryo transfer group. There were no significant differences between the two groups in the rates of clinical pregnancy, live birth, preterm birth, and macrosomia. CONCLUSION(S): Based on the above results, FET should ideally be performed as an appropriate treatment option for PCOS patients because of the lower rate of miscarriage in FET. (J Reprod Med 2020;65:277- 285).Copyright © Journal of Reproductive Medicine, Inc.

Cao, Q., et al. (2019). "Efficacy and safety of moxibustion in patients with chronic prostatitis/chronic pelvic pain syndrome: A systematic review protocol." Medicine 98(20): e15678.
	Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common urogenital disease. Moxibustion is a complementary treatment option for CP/CPPS. This systematic review will assess the efficacy and safety of moxibustion as a sole or add-on therapy for CP/CPPS.; Methods: We will retrieve randomized controlled trials (RCTs) of moxibustion for CP/CPPS from the following databases: PubMed, EMBASE, Cochrane Central Register of Controlled Trials, VIP, Chinese Biomedical Database, China National Knowledge Infrastructure Database, Wanfang Data, Chinese Medicine Database System, Google Scholar, Clinicaltrials.gov, and China Clinical Trial Registry from their inception to March 9, 2019, without language restrictions. RCTs comparing moxibustion with active drugs or moxibustion + drugs with these same drugs alone will be included. Primary outcomes will be the change in the total score of the National Institutes of Health's Chronic Prostatic Inflammatory States Index (NIH-CPSI) after moxibustion treatment. Secondary outcomes will include the scores of the individual NIH-CPSI domains, response to treatment of CP/CPPS, leucocyte and phosphatidylcholine corpuscle count in prostatic fluid, incidence of adverse events (AEs), and incidence of moxibustion-related AEs. The Cochrane risk of bias tool will be used for evaluating the risk of bias of individual trials. Heterogeneity will be detected by the Cochran Q test and I-square test. A random-effects model will be used to pool data in the meta-analysis. Risk ratio and weighted or standardized mean difference will be used as the effect measures. Three sets of subgroup analyses will be performed to explore the sources of heterogeneity. Where appropriate, we will assess the likelihood of publication bias based on funnel plots and quantitative tests.; Results: This study will produce the systematic review evidence regarding moxibustion for treating CP/CPPS based on current RCTs.; Conclusion: This study will provide a clear basis for understanding the efficacy and adverse reactions of moxibustion treatment for CP/CPPS.; Prospero Registration Number: CRD42019121338.

Cao, S.-Y., et al. (2023). "Recurrence and survival of patients with stage III endometrial cancer after radical surgery followed by adjuvant chemo- or chemoradiotherapy: a systematic review and meta-analysis." BMC Cancer 23(1): 31.
	Objective: To compare recurrence and survival in patients with stage III endometrial cancer after radical surgery, followed by either adjuvant chemoradiotherapy (ACR) or adjuvant chemotherapy (AC).; Methods: We searched for relevant studies in PubMed Central, Embase and the Cochrane Central Register of Controlled Trials. Data were pooled on rates of recurrence as well as rates of progression-free, disease-free and overall survival. Heterogeneity was evaluated using the I 2 test. Subgroup and sensitivity analyses were performed to identify potential sources of heterogeneity.; Results: Data from 18,375 patients in 15 retrospective studies and one randomized controlled trial were meta-analyzed. Compared to the AC group, the ACR showed significantly lower risk of local recurrence (OR 0.43, 95%CI 0.32-0.59) and total recurrence (OR 0.72, 95%CI 0.58-0.89). ACR was also associated with significantly better overall survival (HR 0.66, 95%CI 0.57-0.76), progression-free survival (HR 0.56, 95%CI 0.39-0.81) and disease-free survival (HR 0.66, 95%CI 0.53-0.83).; Conclusions: Adding adjuvant radiotherapy to adjuvant chemotherapy after radical surgery may significantly reduce risk of local and overall recurrence, while significantly improving survival of patients with stage III endometrial cancer. (© 2023. The Author(s).)

Cao, Y., et al. (2023). "Retroperitoneal drainage after radical gynecological malignancies: a systematic review and meta-analysis."
	
Cao, Y., et al. (2021). "Efficacy and safety of acupuncture for postpartum depression: A systematic review." Chinese Journal of Evidence-Based Medicine 21(8): 922-928.
	Objective To systematically review the efficacy and safety of acupuncture on postpartum depression (PPD). Methods PubMed, EMbase, The Cochrane Library, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy and safety of acupuncture in treatment of PPD from inception to February 2021. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Meta-analysis was then performed by using Stata16.0 software. Results A total of 13 RCTs involving 899 patients were included. The results of meta-analysis showed that there was no significant difference between hand acupuncture and fluoxetine hydrochloride in HAMD score (MD=0.45, 95%CI -0.52 to 1.41, P=0.36), clinical effective rate (RR=0.93, 95%CI 0.70 to 1.23, P=0.59), and clinical cure rate (RR=0.88, 95%CI 0.44 to 1.76, P=0.73). However, hand acupuncture was superior in safety to fluoxetine hydrochloride (RR=0.04, 95%CI 0.01 to 0.28, P<0.05). There was no significant difference in clinical effective rate (RR=1.08, 95%CI 0.87 to 1.36, P=0.49) and cure rate (RR=1.31, 95%CI 0.84 to 2.04, P=0.24) between both groups. Conclusions The current evidence shows that there are no differences between hand acupuncture and non-acupuncture in reducing HAMD score, improving the clinical effective rate and clinical cure rate. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusions.Copyright © 2021 West China University of Medical Science. All rights reserved.

Cao, Y. R., et al. (2020). "Effects of endometrial stimulation timings and techniques on pregnancy outcomes in patients without prior embryo transfer: A systematic review and meta-analysis." Reproductive and Developmental Medicine 4(3): 191-193.
	Objective: To investigate the effects of endometrial stimulation timings and techniques on pregnancy outcomes in patients without prior embryo transfer (ET). Method(s): We included a total of 10 studies related to the impact of endometrial stimulation on the pregnancy outcome of infertile patients with the first ET from 2010 to 2019. These studies were found by searching databases including China Science and Technology Journal Database (VIP), Chinese Biological Med (CBM), Chinese Medical Current Content (CMCC), China National Knowledge Internet (CNKI), WanFang Med Online, Cochrane Library, Web of Science, PubMed, Medline, ScienceDirect, and EMBASE. A total of 1,983 cycles were included, of which 725 were cycles with endometrial stimulation. Clinical outcomes included clinical pregnancy, implantation, abortion, multiple pregnancy, and live birth rate. Result(s): The implantation rate (IR) was higher in the fresh cycle endometrial stimulation group than in the control group (relative risk [RR] = 1.21, 95% confidence interval [CI] = 1.03-1.42; P = 0.02), but there were no significant between-group differences in the live birth rate (LBR) and abortion rate (AR). Subgroup analysis showed that whether follicular or luteal endometrial stimulation was performed before the ET cycle had no effect on the clinical pregnancy outcome, and endometrial stimulation on the day of oocyte retrieval reduced the clinical pregnancy rate (CPR) (RR = 0.37, 95% CI = 0.19-0.75; P = 0.005). Whether the technique involved the use of a curette or catheter, there was no significant between-group difference in CPR. Conclusion(s): Fresh cycle endometrial stimulation can improve the embryo IR in patients without prior ET, but it cannot increase CPR, LBR, or AR. Subgroup analysis showed that different endometrial stimulation timings and techniques did not significantly improve CPR and that endometrial stimulation on the day of oocyte retrieval reduced CPR.Copyright © 2020 Reproductive and Developmental Medicine Published by Wolters Kluwer - Medknow.

Capalbo, G., et al. (2023). "Laparoscopic Versus Abdominal Radical Hysterectomy." American Journal of Clinical Oncology: Cancer Clinical Trials 46(2): 85.
	
Capezzuoli, T., et al. (2022). "Gynaecologic and Systemic Comorbidities in Patients with Endometriosis: Impact on Quality of Life and Global Health." Clinical and Experimental Obstetrics and Gynecology 49(7): 157.
	Objectives: Endometriosis is an inflammatory disease characterized by a frequent association with gynecologic and systemic comorbidities. Our aim was to evaluate which gynecologic and systemic comorbidities occur in women affected by endometriosis and their impact on quality of life and global health. Mechanism: A literature search of the PubMed, Cochrane Library, Scopus and Web of Science databases was performed to identify the relevant studies published before December 31, 2021. We selected clinical studies, systematic reviews, and meta-analyses in English. Findings in Brief: Endometriosis is strongly associated with gynecologic (adenomyosis, uterine fibroids, polycystic ovarian syndrome-PCOS) and systemic (autoimmune, inflammatory, psychiatric and neurological disorders) comorbidities that impair women quality of life and global health through multiple mechanisms, influencing everyday life and work activities. Conclusion(s): Endometriosis is a chronic disease, impairing multiple functioning areas and affecting women's health and everyday life. Considering the co-existence of multiple both gynecological and non-gynecological disorders, endometrisois needs a multidisciplinary approach. Thus, specialized referral centres are warranted for a personalized management, focused on patient symptoms and comorbidities.Copyright © 2022 The Author(s).

Capobianco, G., et al. (2020). "Efficacy and effectiveness of bulking agents in the treatment of stress and mixed urinary incontinence: A systematic review and meta-analysis." Maturitas 133: 13-31.
	The objective of this systematic review and meta-analysis was to evaluate the efficacy and the effectiveness, as well as the safety and tolerability, of urethral bulking agents (UBAs) in women with mixed or stress urinary incontinence. PubMed, Scopus, and the Cochrane Central Register of Controlled Trials were used to identify relevant articles. In total, 3510 records were found. A total of 42 full texts were evaluated but only 21 (48.8 %) were selected for the qualitative and quantitative analysis. The pooled improvement rate in studies with a follow-up of <=1 and >1 year was 46.0 % (95 % CI: 37.0 %-57.0 %; I2: 88.9 %) and 57.0 % (95 % CI: 39.0 %-74.0 %; I2: 89.6 %), respectively. The outcome 'cure/dryness' ranged from 9.1 % to 56.7 %. The pooled cure rate was 26.0 % (95 % CI: 21.0 %-32.0 %; I2: 89.9 %) and 21.0 % (95 % CI: 16.0 %-27.0 %; I2: 34.2 %) in females with a follow-up of <=1 and >1 year, respectively. The treatment success rate ranged from 32.7 % to 93.3 % in 12 studies; it was objectively assessed with different tools (e.g., the Stamey scale in 5 studies). The pooled objective treatment success rate was 7.0 % (95 % CI: 59.0.0 %-75.0 %; I2: 82.4 %) and 46.0 % (95 % CI: 37.0 %-55.0 %; I2: 55.3 %) in women with a follow-up of <=12 and >12 months, respectively. The percentage of adverse events was 0.4 % (vaginal infection, irritation, lichen sclerosus, worsening urinary incontinence). However, the use of UBAs as the first-line therapy should be demonstrated in more comparative studies (randomized studies MUSs vs. UBAs). UBAs should be considered a first-line surgical therapy only for women with SUI and mixed UI with high anaesthesia risk, elderly patients, or patients reluctant to undergo surgery. Thus, UBAs should not be offered as first-line therapy for those women desiring a "one-time" durable solution for primary or recurrent SUI.Copyright © 2019 Elsevier B.V.

Capodaglio, P., et al. (2024). "Rehabilitation combined with dietary intervention improve urinary incontinence in women with obesity: A proof-of-principle study." Turkish Journal of Physical Medicine and Rehabilitation 70(1): 39-46.
	Objectives: This study aimed to assess the impact of add-on pelvic floor exercises on a weight management rehabilitation program. Patients and Methods: This proof of principle study was conducted between July 2019 and December 2019. Ninety-three adult female inpatients with obesity and diagnosis of urinary incontinence (UI) were assessed for inclusion, and the suitable patients were randomly assigned to the experimental group and the control group. Both groups underwent a weight management rehabilitation program, while the experimental group also performed pelvic floor exercises. The primary outcome was UI severity, assessed by the 1-h pad test. Secondary outcomes were urinary symptoms, assessed by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Patient Global Impression of Improvement (PGI-I), and Incontinence Quality of Life Questionnaire (I-QOL). Result(s): Sixty female inpatients were randomly assigned to the experimental group [n=30; median age: 64.50 (51.25 to 70.50) years] or the control group [n=30; median age: 67.50 (58.50 to 74.75) years]. The experimental group showed a statistically significant reduction in UI severity [pad test: 2.08 (1.21 to 8.85) g vs. 0.54 (0.24 to 1.13) g, p<0.01; ICIQ-SF: 14.00 (10.25 to 17.00) vs. 8.00 (6.25 to 11.75), p<0.01; I-QOL: 56.37 (42.28 to 73.64) vs. 78.64 (64.32 to 90.68), p<0.01]. Statistically significant differences were found in the between-groups analysis [pad test: 0.54 (0.24 to 1.13) g vs. 1.08 (0.83 to 3.86) g, p<0.01; ICIQ-SF: 8.00 (6.25 to 11.75) vs. 12.00 (10.00 to 16.00), p<0.01; I-QOL: 78.64 (64.32 to 90.68) vs. 68.18 (60.00 to 84.32), p<0.01]. Conclusion(s): Including pelvic floor exercises might provide additional benefits compared to standard rehabilitation in reducing UI symptoms in obese women.Copyright © 2024 Turkish Society of Physical Medicine and Rehabilitation. All rights reserved.

Capogrosso, P., et al. (2019). "Low-Intensity Shock Wave Therapy in Sexual Medicine-Clinical Recommendations from the European Society of Sexual Medicine (ESSM)." The Journal of Sexual Medicine 16(10): 1490-1505.
	Introduction: Low-intensity shockwave therapy (LISWT) has been investigated for the treatment of uroandrological disorders including erectile dysfunction (ED), Peyronie's disease (PD) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) with controversial findings.; Aim: To review the evidence on LISWT for ED, PD, and CP/CPPS and provide clinical recommendations on behalf of the European Society of Sexual Medicine.; Methods: Medline and Embase databases were searched for randomized clinical trials (RCTs), meta-analyses and open-label prospective or retrospective studies investigating the effect of LISWT on ED, PD, or CP/CPPS.; Outcomes: The panel provided statements on clinically relevant questions concerning LISWT: (i) treatment efficacy, (ii) treatment protocol, (iii) clinical indications, and (iv) safety. The level of evidence was provided according to the Oxford 2011 criteria and graded using the Oxford Centre for Evidence-Based Medicine recommendations.; Results: 11 RCTs and 5 meta-analyses investigated LISWT for ED. RCTs provided controversial results on the efficacy of LISWT and were affected by high heterogeneity and the small number of patients included. Pooled-data analysis showed an overall positive effect in terms of erectile function improvement but reported small estimates and included a largely heterogeneous cohort of patients. 4 RCTs and 1 meta-analysis assessed LISWT for PD. All trials showed positive findings in terms of pain relief but no effect on penile curvature and plaque size. Inclusion criteria vary widely among studies, and further investigation is needed. 5 RCTs investigated LISWT for CP/CPPS. Data showed a possible effect on pain relief, although there is no evidence supporting that pain relief was maintained or any improvement in pain over time.; Clinical Implications: LISWT needs to be further investigated in the context of sexual medicine and is almost but not yet ready for clinical practice.; Strengths and Limitations: All studies have been evaluated by a panel of experts providing recommendations for clinical practice.; Conclusions: LISWT is a safe and well-tolerated procedure but its efficacy for the treatment of ED is doubtful and deserves more investigation. Patients reporting pain associated with PD may benefit from LISWT, although no effect is expected on disease progression. LISWT is not a primary treatment for CP/CPPS, but it may be considered as an option to relieve pain. Capogrosso P, Frey A, Jensen CFS, et al. Low-Intensity Shock Wave Therapy in Sexual Medicine-Clinical Recommendations from the European Society of Sexual Medicine (ESSM). J Sex Med 2019;16:1490-1505. (Copyright © 2019 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Capote, S., et al. (2022). "Small Cell Carcinoma of the Vagina: First Systematic Review of Case Reports and Proposal of a Management Algorithm." Journal of Lower Genital Tract Disease.
	OBJECTIVES: Small cell carcinoma of the vagina (SmCCV) is an extremely rare disease. Evidence-based data and specific guidelines are lacking. We conducted the first systematic review of case reports to provide the most overall picture of SmCCV. MATERIALS AND METHODS: Literature search in PubMed and Scopus was performed using the terms "small cell carcinoma" and "vagina." English-language case reports of primary SmCCV up to January 2022 were included. RESULTS: Twenty-nine articles describing 44 cases met our inclusion criteria. We report a new case of our hospital. The global median overall survival (mOS) was 12.00 months (95% CI = 9.31-14.69). The mOS was not reached for stage I, and it was 12.00, 12.00, 9.00, and 8.00 months for stages II, III, IVA, and IVB, respectively (statistically significant differences between stage I and stages II, III, or IVA [log rank p = .003-.017]). Thirty-five cases received local treatments (77.8%). The mOS of patients treated with surgery ± complementary chemotherapy, radiotherapy ± complementary chemotherapy, chemoradiation ± complementary chemotherapy, and surgery + radiotherapy ± complementary chemotherapy were 11.00, 12.00, 17.00, and 29.00 months, respectively. The use of adjuvant or neoadjuvant chemotherapy (64.5%, mostly platinum + etoposide) showed longer mOS (77.00 vs 15.00 months). Four of 5 tested cases presented human papillomavirus infection, 3 of them presenting type 18. CONCLUSIONS: Small cell carcinoma of the vagina shows dismal prognosis. Multimodal local management plus complementary chemotherapy seems to achieve better outcomes. Human papillomavirus could be related to the development of SmCCV. A diagnostic-therapeutic algorithm is proposed.

Capozzi, V. A., et al. (2021). "The robotic single-port platform for gynecologic surgery: a systematic review of the literature and meta-analysis." Updates in surgery 73(3): 1155-1167.
	Since the first robotic single-site hysterectomy was performed, the research focused on the use of robotic single-site surgery (RSSS) for all gynecological conditions. This review aims to examine the studies available in the literature on RSSS in gynecology both for benign and malignant indications. The systematic review was carried out in agreement with the preferred reporting items for systematic reviews and meta-analyses statement (PRISMA). All the articles were grouped into three sets based on the surgical indication (Group 1, 2, and 3 for benign, malignant, and mixed diseases, respectively). Two hundred and fifty total studies were analyzed, and 27 articles were included in the review. A total of 1065 patients were included in the analysis. Of these, 605 patients were included in group 1, 260 in group 2, and 200 in group 3. Ten (1.7%) patients with benign pathology, 16 (6.2%) patients with malignant disease, and 5 (2.5%) patients with both diseases developed major complications. Two (0.3%) patients in group 1, 3 (1.2%) patients in group 2 and 5 (2.5%) in group 3 were converted to a different type of surgery. No significant differences were found between groups for BMI (p=0.235), operative time (p=0.723), estimated blood loss (EBL) (p=0.342), and hospital stay (p=0.146). The complications and conversions incidence through pooled analysis showed a higher general conversion rate (p=0.012) in group 3 (3.0%) and higher complications rate (p=0.001) in group 2 (5.3%) compared to the other groups. RSSS seems to be a feasible and safe procedure for all gynecological surgical procedures. A long-term analysis would be necessary before considering the RSSS oncologically safe for patients with malignant disease.

Capozzi, V. A., et al. (2020). "Endometrial stromal sarcoma: A review of rare mesenchymal uterine neoplasm." The Journal of Obstetrics and Gynaecology Research 46(11): 2221-2236.
	Objective: This review aims to analyze the pathological aspects, diagnosis and treatment of rare mesenchymal uterine tumors.; Methods: On August 2019, a systematic review of the literature was done on Pubmed, MEDLINE, Scopus, and Google Scholar search engines. The systematic review was carried out in agreement with the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes statement (PRISMA). The following words and key phrases have been searched: "endometrial stromal sarcoma", "low-grade endometrial stromal sarcoma", "high-grade endometrial stromal sarcoma", "uterine sarcoma", "mesenchymal uterine tumors" and "uterine stromal sarcoma". Across these platforms and research studies, five main aspects were analyzed: the biological characteristics of the neoplasms, the number of cases, the different therapeutic approaches used, the follow-up and the oncological outcomes.; Results: Of the 94 studies initially identified, 55 were chosen selecting articles focusing on endometrial stromal sarcoma. Of these fifty-five studies, 46 were retrospective in design, 7 were reviews and 2 randomized phases III trials.; Conclusion: Endometrial stromal sarcomas are rare mesenchymal uterine neoplasms and surgery represents the standard treatment. For uterus-limited disease, the remove en bloc with an intact resection of the tumor (without the use of morcellation) is strongly recommended. For advanced-stage disease, the standard surgical treatment is adequate cytoreduction with metastatectomy. Pelvic and para-aortic lymphadenectomy is not recommended in patients with Low-grade Endometrial Stromal Sarcoma (ESS), while is not clear whether cytoreduction of advanced tumors improves patient survival in High-grade ESS. Administration of adjuvant radiotherapy or chemotherapy is not routinely used and its role is still debated. (© 2020 Japan Society of Obstetrics and Gynecology.)

Capozzi Vito, A., et al. (2021). "Obstetrics outcomes after complete and partial molar pregnancy: Review of the literature and meta-analysis." European Journal of Obstetrics, Gynecology, and Reproductive Biology 259: 18-25.
	The hydatidiform mole is a rare gynecological disease rising from the trophoblastic. Post-molar pregnancies have an extremely variable course, varying from repeated abortions, stillbirths, preterm births, live births, or recurring in further molar pregnancies. Literature on obstetric outcomes following molar pregnancy is poor, often including monocentric studies, and with data collected from national databases. This review and meta-analysis aim to analyze the obstetric outcomes after conservative management of complete (CHM) and partial (PHM) molar pregnancies. The meta-analysis was performed following the Meta-analysis Of Observational Studies in Epidemiology (MOOSE) and the preferred reporting items for systematic reviews and meta-analyses statement (PRISMA). Six studies met the inclusion. Of the total 25,222 patients, 13,129 complete (52.1 %) and 12,093 partial (47.9 %) molar pregnancies were included. Live births rate after CHM was statistically higher (p = 0.002) compared to the live births after PHM (53.6 % vs. 51.0 %, 3266 vs. 1807 cases, respectively). Studies showed heterogeneity I 2 = 57.7 %, pooled proportion = 0.2 %, and 95 % Confidence Interval (CI) 0.6 to 0.9. No statistically significant difference was demonstrated for ectopic pregnancies (p = 0.633), miscarriage (p = 0.637), preterm birth (p = 0.865), stillbirth (p = 0.911), termination of pregnancy (p = 0.572), and complete molar recurrence (p = 0.580) after CHM and PHM. Partial molar recurrence occurred more frequently after PHM than CHM (0.4 % vs. 0.3 %, 52 vs. 37 cases, respectively, p = 0.002). Careful counseling on the obstetric subsequent pregnancies outcomes should be provided to patients eager for further pregnancy and further studies are needed to confirm these results.; Competing Interests: Declaration of Competing Interest The authors report no declarations of interest. (Copyright © 2021 Elsevier B.V. All rights reserved.)

Capozzi Vito, A., et al. (2021). "Peripherally Inserted Central Venous Catheters (PICC) versus totally implantable venous access device (PORT) for chemotherapy administration: a meta-analysis on gynecological cancer patients." Acta bio-medica : Atenei Parmensis 92(5): e2021257.
	Background and Aim: Ninety-four thousand gynecological cancer diagnoses are performed each year in the United States. The majority of these tumors require systemic adjuvant therapy. Sustained venous access was overcome by indwelling long-term central venous catheter (CVC). The best choice of which CVC to use is often arbitrary or dependent on physician confidence. This meta-analysis aims to compare PORT and peripherally inserted central catheter (PICC) outcomes during adjuvant treatment for gynecological cancer.; Methods: Meta-analysis Of Observational Studies in Epidemiology (MOOSE) and the preferred reporting items for systematic reviews and meta-analyses statement (PRISMA)were used to conduct the meta-analysis.; Results: 1320 patients were included, 794 belonging to the PORT group and 526 to the PICC group. Total complication rates were fewer in the PORT group, p = 0.05. CVC malfunction was less frequent in the PORT group than in the PICC group, p <0.01. Finally, thrombotic events were less expressed in the PORT group than in the PICC group, p = 0.02. No difference was found in operative complication, migration, malposition, extravasation, infection, and complication requiring catheter removal.; Conclusions: PORT had fewer thrombotic complications and fewer malfunction problems than PICC devices. Unless specific contraindications, PORTs can be preferred for systemic treatment in gynecological cancer patients.

Capozzi Vito, A., et al. (2022). "Update of Robotic Surgery in Benign Gynecological Pathology: Systematic Review." Medicina (Kaunas, Lithuania) 58(4).
	Background and Objectives : Since the Food and Drug Administration's (FDA) approval in 2005, the application of robotic surgery (RS) in gynecology has been adopted all over the world. This study aimed to provide an update on RS in benign gynecological pathology by reporting the scientific recommendations and high-value scientific literature available to date. Materials and Methods: A systematic review of the literature was performed. Prospective randomized clinical trials (RCT) and large retrospective trials were included in the present review. Results: Twenty-two studies were considered eligible for the review: eight studies regarding robotic myomectomy, five studies on robotic hysterectomy, five studies about RS in endometriosis treatment, and four studies on robotic pelvic organ prolapse (POP) treatment. Overall, 12 RCT and 10 retrospective studies were included in the analysis. In total 269,728 patients were enrolled, 1721 in the myomectomy group, 265,100 in the hysterectomy group, 1527 in the endometriosis surgical treatment group, and 1380 patients received treatment for POP. Conclusions: Currently, a minimally invasive approach is suggested in benign gynecological pathologies. According to the available evidence, RS has comparable clinical outcomes compared to laparoscopy (LPS). RS allowed a growing number of patients to gain access to MIS and benefit from a minimally invasive treatment, due to a flattened learning curve and enhanced dexterity and visualization.

Capozzi Vito, A., et al. (2023). "Optimal Management for Stage IVB Endometrial Cancer: A Systematic Review." Cancers 15(21).
	(1) Background: Endometrial cancer (EC) is a common gynecological malignancy, often diagnosed at an early stage with a high overall survival rate. Surgical treatment is the primary approach, guided by pathological and molecular characteristics. Stage IVB EC, characterized by intra and/or extra-abdominal metastasis, presents a significant challenge with no clear consensus on optimal management. (2) Methods: A systematic literature review was conducted from January to May 2023, covering studies from 2000 to 2023. Eligible studies included retrospective case series, prospective trials, and randomized clinical trials. (3) Results: Of 116 studies identified, 21 were deemed relevant: 7 on primary surgery, 10 on neoadjuvant chemotherapy (NACT), and 4 on adjuvant treatment. Notably, the impact of residual tumor after primary surgery was a critical factor affecting survival. The use of NACT followed by interval debulking surgery showed promise, particularly in cases deemed unresectable. Adjuvant treatment, combining radiotherapy and chemotherapy, demonstrated improved survival but lacked consensus regarding its role. (4) Conclusions: Stage IVB EC poses a complex challenge with limited evidence to guide management. Optimal cytoreduction remains crucial, and NACT should be considered for unresectable cases. Multimodality adjuvant therapy may benefit patients, even with disease spread beyond the pelvis. Future advances in molecular classification and targeted therapies are expected to enhance treatment strategies.

Capozzi Vito, A., et al. (2021). "Transperitoneal versus extraperitoneal laparoscopic aortic lymph nodal staging for locally advanced cervical cancer: A systematic review and meta-analysis." European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology 47(9): 2256-2264.
	Cervical cancer is the fourth most common neoplasm in women. In locally advanced cervical cancers, the international guidelines recommend nodal aortic assessment. Two techniques have been described to perform laparoscopic aortic lymphadenectomy: transperitoneal laparoscopic lymphadenectomy (TLL) and extraperitoneal laparoscopic lymphadenectomy (ELL). This meta-analysis aims to compare the surgical outcomes of TLL and ELL for staging purposes. The systematic review was carried out in agreement with the preferred reporting items for systematic reviews and meta-analyses statement (PRISMA). Two hundred and twenty studies were analyzed, and 19 studies were included in the review (7 for TLL and 12 for ELL group). 1112 patients were included in the analysis: 390 patients were included in group 1 and 722 patients in group 2.38 patients (9.7%) in the TLL group and 69 (9.5%) patients in the ELL group developed major complications. The analysis of all complications (intraoperative and postoperative) rate through pooled analysis did not show a significant difference between the two groups (p = 0.979), although a significantly higher intraoperative complication rate (p = 0.018) occurred in the TLL group compared to ELL. No significant differences were found between groups for BMI (p = 0.659), estimated blood loss (p = 0.889), length of stay (p = 0.932), intraoperative time (p = 0.932), conversion to laparotomy rate (p = 0.404), number of lymph node excised (p = 0.461) and postoperative complication (p = 0.291). TLL approach shows a higher rate of intraoperative complications, while no significant difference was found between the two techniques when postoperative complications were analyzed.; Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2021 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Carbajo-García María, C., et al. (2022). "Histone deacetylase inhibition by suberoylanilide hydroxamic acid: a therapeutic approach to treat human uterine leiomyoma." Fertility and Sterility 117(2): 433-443.
	Objective: To evaluate the effect of inhibition of histone deacetylases (HDACs) by suberoylanilide hydroxamic acid (SAHA) treatment of human uterine leiomyoma primary (HULP) cells in vitro on cell proliferation, cell cycle, extracellular matrix (ECM) formation, and transforming growth factor β3 (TGF-β3) signaling.; Design: Prospective study comparing uterine leiomyoma (UL) vs. adjacent myometrium (MM) tissue and cells with or without SAHA treatment.; Setting: Hospital and university laboratories.; Patient(s): Women with UL without any hormone treatment.; Intervention(s): Myomectomy or hysterectomy surgery in women for leiomyoma disease.; Main Outcome Measure(s): HDAC activity was assessed by enzyme-linked immunosorbent assay, and gene expression was assessed by quantitative real-time polymerase chain reaction. Effects of SAHA on HULP cells were analyzed by CellTiter (Promega, Madison, Wisconsin), Western blot, and quantitative real-time polymerase chain reaction.; Result(s): The expression of HDAC genes (HDAC1, fold change [FC] = 1.65; HDAC3, FC = 2.08; HDAC6, FC = 2.42) and activity (0.56 vs. 0.10 optical density [OD]/h/mg) was significantly increased in UL vs. MM tissue. SAHA decreased HDAC activity in HULP cells but not in MM cells. Cell viability significantly decreased in HULP cells (81.68% at 5 μM SAHA, 73.46% at 10 μM SAHA), but not in MM cells. Proliferating cell nuclear antigen expression was significantly inhibited in SAHA-treated HULP cells (5 μM SAHA, FC = 0.556; 10 μM SAHA, FC = 0.622). Cell cycle markers, including C-MYC (5 μM SAHA, FC = 0.828) and CCND1 (5 μM SAHA, FC = 0.583; 10 μM SAHA, FC = 0.482), were significantly down-regulated after SAHA treatment. SAHA significantly inhibited ECM protein expression, including FIBRONECTIN (5 μM SAHA, FC = 0.815; 10 μM SAHA, FC = 0.673) and COLLAGEN I (5 μM SAHA, FC = 0.599; 10 μM SAHA, FC = 0.635), in HULP cells. TGFβ3 and MMP9 gene expression was also significantly down-regulated by 10 μM SAHA (TGFβ3, FC = 0.596; MMP9, FC = 0.677).; Conclusion(s): SAHA treatment inhibits cell proliferation, cell cycle, ECM formation, and TGF-β3 signaling in HULP cells, suggesting that histone deacetylation may be useful for treatment of UL. (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Carcelén-Fraile María Del, C., et al. (2022). "Changes in satisfaction with female genital self-image and sexual function after a Qigong exercise intervention in Spanish postmenopausal women: a randomized-controlled trial." Menopause (New York, N.Y.) 29(6): 693-699.
	Objective: To analyze the effectiveness of a Qigong exercise program on satisfaction with female genital self-image and female sexual function in postmenopausal Spanish women.; Methods: A total of 49 women were randomly assigned to an experimental group (n = 22) that carried out training based on Qigong exercises for 12 weeks and a control group (n = 27) that did not carry out any type of intervention. Female genital self-image was measured through the Female Genital Self-Tmage Scale and female sexual function through the Female Sexual Function Tndex; both variables were measured before and just after the intervention.; Results: Results showed that women who participated in the Qigong exercise program showed significant improvements with respect to female genital self-image, as well as in the domains of desire, arousal, lubrication, satisfaction, and pain and the total score of the Female Sexual Function Index, but, on the contrary, were not found in the orgasm domain.; Conclusions: Our results suggest that Qigong has the potential to improve female genital self-image and female sexual function among postmenopausal Spanish women.; Competing Interests: Financial disclosure/conflicts of interest: None reported. (Copyright © 2022 by The North American Menopause Society.)

Carcelén-Fraile María Del, C., et al. (2022). "Qigong for mental health and sleep quality in postmenopausal women: A randomized controlled trial." Medicine 101(39): e30897.
	Background: Menopause is one of the stages in a woman's life that affects her psychological health, the most frequent being anxiety and depression. In addition, another problem related to this stage is the lack of sleep that causes a decrease in the quality of sleep. The purpose of this randomized controlled trial was to analyze the effectiveness of a Qigong exercise program on sleep quality, anxiety, and depression in Spanish postmenopausal women.; Methods: A total of 125 women were randomly assigned to an experimental group (EG) (n = 63) that carried out a Qigong exercise program for 12 weeks, or a control group (CG) (n = 62), which did not perform any type of intervention. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) and anxiety and depression using the Hospital Anxiety and Depression Scale (HADS).; Results: Women who underwent an intervention program experienced significant improvements for all measured variables, except for the use of sleeping medication and daytime dysfunctions that did not show any significant effect with respect to the group and group × time interaction.; Conclusions: After an intervention based on a BaDuanJin Qigong exercise program for 12 weeks, improvements were observed in sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, the total score of the PSQI, anxiety and depression in postmenopausal Spanish women.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Cardenas-Goicoechea, J., et al. (2019). "Minimally invasive interval cytoreductive surgery in ovarian cancer: systematic review and meta-analysis." Journal of Robotic Surgery 13(1): 23-33.
	The introduction of minimally invasive surgery in other gynecologic cancers has shown benefits with similar oncologic outcomes. However, the biology and complexity of surgery for ovarian cancer may preclude this approach for ovarian cancer patients. Our objective is to assess feasibility to achieve complete cytoreductive surgery after neoadjuvant chemotherapy for stage IIIC-IV ovarian cancer patients via minimally invasive surgery. Our data sources include PubMed, Embase, Scopus, Biosis, Clinicaltrials.gov, and the Cochrane Library. Meta-analysis was performed using the random-effects model with DerSimonian and Laird estimator for the amount of heterogeneity to estimate the pooled outcomes. A funnel plot and Egger's regression test were used to test publication bias. The Newcastle-Ottawa Quality Assessment Scale was used to assess the quality of the studies. There were 6 studies (3 prospective, 3 retrospective) that met the criteria for meta-analysis with a total of 3231 patients, 567 were in the minimally invasive group and 2664 in the laparotomy group. Both groups were similar in stage and serous histology. Complete cytoreductive surgery was achieved in 74.50% (95% CI 40.41-97.65%) and 53.10% (95% CI 4.88-97.75%) of patients in the minimally invasive and laparotomy groups, respectively. There was no statistical significant difference between these 2 pooled proportions (p = 0.52). Three studies compared minimally invasive surgery vs laparotomy. No significant difference was observed between the 2 groups in obtaining complete cytoreductive surgery [OR = 0.90 (95% CI 0.70-1.16; p = 0.43)]. A symmetrical funnel plot indicated no publication bias. The pooled proportion for grade > 2 postoperative complications was not significant among the laparoscopy group [3.11% (95% CI 0.00-10.24%; p = 0.15)]. Complete cytoreductive surgery appears feasible and safe with minimally invasive surgery in selected advanced ovarian cancer patients after neoadjuvant chemotherapy.

Cardenas-Trowers, O., et al. (2021). "Effect of bladder instillations with versus without triamcinolone acetonide on symptoms of interstitial cystitis/bladder pain syndrome in women: a randomized controlled trial." Neurourology and Urodynamics 40(SUPPL 1): S39‐S40.
	Introduction: Data on the efficacy of bladder instillation (BI) and use of steroids in BI for the treatment of interstitial cystitis/bladder pain syndrome (IC/ BPS) are limited. This study evaluated the utility of adding the steroid, triamcinolone acetonide, in BI for treatment of IC/BPS in women. Methods: Thiswas a single‐center, randomized, doubleblind, comparator‐controlled trial conducted from January 2019 to October 2020 that compared symptom response in women with IC/BPS who underwent 6 weekly BIs (containing heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL)) with or without intravesical triamcinolone acetonide (1 vial, 40 mg/1 mL). The primary outcome was the change in IC/BPS symptoms from baseline to the 6th BI based on the total score on the O'Leary Sant Questionnaire; range, 0 to 36 points with higher scores indicating worse symptoms; minimal clinically important difference, 4 points. Secondary outcomes included changes in the scores on the Pelvic Pain and Urgency/Frequency Questionnaire, Overactive Bladder Questionnaire, Pelvic Floor Distress Inventory, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (used to assess rates of sexual activity and dyspareunia), and visual analog pain scale from baseline to the 3rd and 6th BIs. A higher score on each of these instruments indicates worse symptoms. Results: Ninety women (n=45, BI without triamcinolone acetonide; n=45, BI with triamcinolone acetonide) were randomized (mean [SD] age, 42.0 years [14.4]) with 71 (79%) women providing data for the intention‐to‐treat analyses. Women in both treatment groups had improvement in their IC/BPS symptoms as indicated by a decrease in the total score on the O'Leary Sant Questionnaire from baseline to the 6th BI. This positive treatment response was not significantly different between the two groups. There was an improvement in all of the secondary outcomes, except for rates of sexual activity and dyspareunia, for both treatment groups from baseline to the 6th BI, but no significant between‐group differences. The adverse event rates for both groups were low. Conclusion: BI is a safe, effective treatment for women with IC/BPS. The addition of triamcinolone acetonide to a standard BI does not further improve treatment response.

Cardenas-Trowers, O. O., et al. (2021). "Bladder Instillations With Triamcinolone Acetonide for Interstitial Cystitis-Bladder Pain Syndrome: a Randomized Controlled Trial." Obstetrics and Gynecology 137(5): 810‐819.
	OBJECTIVE: To evaluate the utility of adding triamcinolone acetonide to a standard bladder instillation solution for treatment of interstitial cystitis‐bladder pain syndrome. METHODS: This was a single‐center, randomized, double‐blind trial that compared symptom response in women with interstitial cystitis‐bladder pain syndrome who underwent six bladder instillations with triamcinolone acetonide or six instillations without. All instillation solutions contained heparin, viscous lidocaine, sodium bicarbonate, and bupivacaine. The primary outcome was the change in interstitial cystitis‐bladder pain syndrome symptoms from the first to sixth bladder instillation between groups based on the total OLS (O'Leary‐Sant Questionnaire) score. Assuming a 4.03‐point or larger difference in the mean total OLS score from the first to sixth bladder instillation as compared between the groups, 64 participants were needed to show a significant difference with 80% power at the 0.05 significance level. RESULTS: From January 2019 to October 2020, 90 women were enrolled‐45 per group; 71 (79%) completed all six bladder instillations. Randomization resulted in groups with similar characteristics. There was no difference between groups in the primary outcome (bladder instillation with triamcinolone acetonide: mean OLS change ‐6.7 points, 95% CI 4.6‐8.8 and bladder instillation without triamcinolone acetonide: mean OLS change ‐5.8 points, 95% CI 3.4‐8.1; P=.31). Women in both groups had improvement in their interstitial cystitis‐bladder pain syndrome symptoms as indicated by a decrease in the total OLS score from the first to sixth bladder instillation. CONCLUSION: The addition of triamcinolone acetonide to a standard bladder instillation solution does not improve symptoms associated with interstitial cystitis‐bladder pain syndrome. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03463915.

Cardim Hilton Jose, P., et al. (2023). "EFFICACY AND SAFETY OF OVARIAN STEM CELL TRANSPLANTATION IN PATIENTS WITH PRIMARY OVARIAN INSUFFICIENCY AND POOR OVARIAN RESPONSE: A SYSTEMATIC REVIEW." International Journal of Health Science 3(15).
	a maior editora de publicação científica do Brasil

Cardoso, B. R., et al. (2024). "Nut Consumption and Fertility: a Systematic Review and Meta-Analysis." Advances in nutrition (Bethesda, Md.) 15(1): 100153.
	The high concentration of omega-3 polyunsaturated fats, dietary fibers, vitamins, minerals, and polyphenols found in nuts suggest their regular consumption may be a simple strategy for improving reproductive health. This systematic review and meta-analysis aimed to present up-to-date evidence regarding the association between nut intake and fertility outcomes in males and females. Ovid MEDLINE, Embase, CINAHL, and Scopus were searched from inception to 30 June 2023. Eligible articles were interventional or observational studies in human subjects of reproductive age (18-49 y) that assessed the effects (or association) of dietary nut consumption (for a minimum of 3 mo) on fertility-related outcomes. Random-effects meta-analyses were completed to produce a pooled effect estimate of nut consumption on sperm total motility, vitality, morphology, and concentration in healthy males. Four studies involving 875 participants (646 males, 229 females) were included in this review. Meta-analysis of 2 RCTs involving 223 healthy males indicated consumption of >= 60g nuts/d increased sperm motility, vitality, and morphology in comparison to controls but had no effect on sperm concentration. Nonrandomized studies reported no association between dietary nut intake and conventional sperm parameters in males, embryo implantation, clinical pregnancy or live birth in males and females undergoing ART. Our meta-analysis shows that including at least 2 servings of nuts daily as part of a Western-style diet in healthy males improves sperm parameters, which are predictors of male fertility. Due to their nutritional profile, nuts were found to have potential to promote successful reproductive outcomes. This trial was registered at PROSPERO (CRD42020204586).Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Carducci, B., et al. (2021). "Zinc supplementation for improving pregnancy and infant outcome." Cochrane Database of Systematic Reviews(3).
	- Background It has been suggested that low serum zinc levels may be associated with suboptimal outcomes of pregnancy, such as prolonged labour, atonic postpartum haemorrhage, pregnancy‐induced hypertension, preterm labour and post‐term pregnancies, although these associations have not yet been established. This is an update of a review first published in 1997 and subsequently updated in 2007, 2012 and 2015. Objectives 1. To compare the effects on maternal, fetal, neonatal and infant outcomes in healthy pregnant women receiving zinc supplementation versus no zinc supplementation, or placebo.
2. To assess the above outcomes in a subgroup analysis reviewing studies performed in women who are, or are likely to be, zinc‐deficient. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (3 July 2020), and reference lists of retrieved studies. Selection criteria Randomised trials of zinc supplementation versus no zinc supplementation or placebo administration during pregnancy, earlier than 27 weeks' gestation. We excluded quasi‐randomised controlled trials. We intended to include studies presented only as abstracts, if they provided enough information or, if necessary, by contacting authors to analyse them against our criteria; we did not find any such studies. Data collection and analysis Three review authors applied the study selection criteria, assessed trial quality and extracted data. When necessary, we contacted study authors for additional information. We assessed the certainty of the evidence using GRADE. Main results For this update, we included 25 randomised controlled trials (RCTs) involving over 18,000 women and their babies. The overall risk of bias was low in half of the studies. The evidence suggests that zinc supplementation may result in little or no difference in reducing preterm births (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.74 to 1.03; 21 studies, 9851 participants; low‐certainty evidence). Further, zinc supplementation may make little or no difference in reducing the risk of stillbirth (RR 1.22, 95% CI 0.80 to 1.88; 7 studies, 3295 participants; low‐certainty evidence), or perinatal deaths (RR 1.10, 95% CI 0.81 to 1.51; 2 studies, 2489 participants; low‐certainty evidence). It is unclear whether zinc supplementation reduces neonatal death, because the certainty of the evidence is very low. Finally, for other birth outcomes, zinc supplementation may make little or no difference to mean birthweight (MD 13.83, 95% CI ‐15.81 to 43.46; 22 studies, 7977 participants; low‐certainty evidence), and probably makes little or no difference in reducing the risk of low birthweight (RR 0.94, 95% CI 0.79 to 1.13; 17 studies, 7399 participants; moderate‐certainty evidence) and small‐for‐gestational age babies when compared to placebo or no zinc supplementation (RR 1.02, 95% CI 0.92 to 1.12; 9 studies, 5330 participants; moderate‐certainty evidence). We did not conduct subgroup analyses, as very few studies used normal zinc populations. Authors' conclusions There is not enough evidence that zinc supplementation during pregnancy results in improvements in maternal or neonatal outcomes. Future research to address ways of improving the overall nutritional status of pregnant women, particularly in low‐income regions, and not looking at zinc in isolation, should be an urgent priority. Plain language summary Zinc supplementation for improving pregnancy and infant outcome What is the issue? In low‐ and middle‐income countries, many women have poor diets and are deficient in key micronutrients that are required for good health. This is especially concerning during pregnancy, when energy and nutrient needs are greater for both the mother and the growing baby. Zinc plays a critical role in normal growth and development. Deficiency in zinc could lead to adverse health outcomes, such as being born too soon or too small. This is an update of a r view first published in 1997 and subsequently updated in 2007, 2012 and 2015. Why is this important? Although severe zinc deficiency is rare, it is estimated that mild‐to‐moderate deficiency is common in several regions of the world. Studies of human pregnancy and zinc supplementation, including those from low‐ and middle‐income countries, have failed to document a consistent beneficial effect on fetal growth, length of gestation, and early newborn survival. What evidence did we find? We searched for studies in July 2020. This updated review now includes 25 randomised controlled trials, involving over 18,000 women and their babies. We found that zinc supplementation in pregnancy may make little to no difference in reducing the risk of preterm births, stillbirths, or deaths around the time of birth, when compared to no zinc supplementation or placebo. Zinc supplementation may make little or no difference to the birthweight of babies, and probably makes little or no difference to the number of babies born either with a low birthweight or small for their gestational age, when compared with no zinc supplementation, or with giving a placebo. We cannot be sure whether zinc supplementation reduces death in newborns, because the certainty of the evidence is very low. What does this mean? There is not enough evidence that zinc supplementation during pregnancy results in better outcomes for women and their babies. Finding ways to improve women's overall nutritional status, particularly in low‐income areas, will do more to improve the health of mothers and babies than supplementing pregnant women with zinc alone. This should be an urgent research priority for the future.

Caresia-Aróztegui, A. P., et al. (2019). "18 F-FDG PET/CT in locally advanced cervical cancer: A review." Revista espanola de medicina nuclear e imagen molecular 38(1): 59-68.
	Cervical cancer is the second most common gynecological cancer worldwide. In locally advanced cervical cancer, 18 F-FDG PET/CT has become important in the initial staging, particularly in the detection of nodal and distant metastasis, aspects with treatment implications and prognostic value. The aims of this study were to review the role of 18 F-FDG PET/CT in uterine cervical cancer, according to the guidelines of the main scientific institutions (FIGO, NCCN, SEGO, SEOM, ESGO, and ESMO) and its diagnostic accuracy compared to conventional radiological techniques, as well as to review the acquisition protocol and its utility in radiotherapy planning, response assessment and detection of recurrence. (Copyright © 2018 Sociedad Española de Medicina Nuclear e Imagen Molecular. Publicado por Elsevier España, S.L.U. All rights reserved.)

Carey Erin, T., et al. (2022). "Rationale and design of a multicenter randomized clinical trial of vestibulodynia: understanding pathophysiology and determining appropriate treatments (vestibulodynia: UPDATe)." Annals of medicine 54(1): 2885-2897.
	Background: Limited data are available to establish evidence-based management protocols for vestibulodynia (VBD), a chronic vulvar pain condition that affects approximately 14 million women in the U.S. For the purposes of the study, our group subdivided VBD subtypes that may benefit from different types of treatment: 1) VBD peripheral (VBD-p), characterized by pain localized to the vulvar vestibule and 2) VBD central (VBD-c), characterized by VBD alongside one or more other chronic overlapping pain conditions (e.g. irritable bowel syndrome, temporomandibular disorder, and fibromyalgia syndrome) that affect remote body regions. Here, we describe the rationale and design of an NIH-funded multicenter clinical trial comparing the effectiveness of topical and/or systemic medication for alleviating pain and normalizing pain- relevant biomarkers among women with VBD-p and VBD-c.; Methods: Participants will be randomly assigned to one of four parallel arms: peripheral treatment with 5% lidocaine + 0.5 mg/ml 0.02% oestradiol compound cream + oral placebo pill, 2) central treatment with the tricyclic antidepressant nortriptyline + placebo cream, 3) combined peripheral cream and central pill treatments, or 4) placebo cream and placebo pill. The treatment phase will last 16 weeks, with outcome measures and biomarkers assessed at 4 time points (0, 8, 16, and 24 weeks). First, we will compare the efficacy of treatments in alleviating pain using standardized tampon insertion with a numeric rating scale and self-reported pain on the short form McGill Pain Questionnaire. Next, we will compare the efficacy of treatments in improving perceived physical, mental, and sexual health using standardized questionnaires. Finally, we will measure cytokines and microRNAs in local vaginal and circulating blood samples using multiplex assays and RNA sequencing, and determine the ability of these biomarkers to predict treatment response.; Conclusion: This is the first multicenter randomized controlled trial to evaluate the efficacy of peripherally and centrally acting medications currently used in clinical practice for treating unique VBD subtypes based on distinct clinical and biological signatures.; Administrative Information: Vestibulodynia UPDATe is a multi-centre, two-by-two factorial designed randomized, double-blind, placebo-controlled trial registered at clinical trials.gov (NCT03844412). This work is supported by the R01 HD096331 awarded to Drs. Nackley, Rapkin, Geller and Carey by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).Key messagesPeripheral lidocaine and oestradiol and centrally-targeted nortriptyline medications are used for the treatment of pain in women with VBD, but there is a lack of data from well-powered RCTs.This two-by-two factorial RCT will test the efficacy of these medications in VBD subtypes characterized by distinct clinical characteristics and biomarker profiles.We hope that results will provide clinicians with scientific evidence of therapeutic efficacy in distinct VBD subtypes in an effort to direct and optimize treatment approaches.

Carlo, R. and P. Francesca (2022). "Mininvasive Cytoreduction Surgery plus HIPEC for Epithelial Ovarian Cancer: A Systematic Review."
	
Carmichael Samuel, P., et al. (2022). "Regenerative Medicine Therapies for Prevention of Abdominal Adhesions: A Scoping Review." The Journal of surgical research 275: 252-264.
	Introduction: Globally, abdominal adhesions constitute a significant burden of morbidity and mortality. They represent the commonest complication of abdominal operations with a lifelong risk of multiple pathologies, including adhesive small bowel obstruction, female infertility, and chronic pain. Adhesions represent a problem of the entire abdomen, forming at the time of injury and progressing through multiple complex pathways. Clinically available preventative strategies are limited to barrier technologies. Significant knowledge gaps persist in the characterization and mitigation of the involved molecular pathways underlying adhesion formation. Thus, the objectives of this scoping review are to describe the known molecular pathophysiology implicated in abdominal adhesion formation and summarize novel preclinical regenerative medicine preventative strategies for potential future clinical investigation.; Methods: A literature review was performed in accordance with the Preferred Reporting Items for Systematic Reviews Extension for Scoping Reviews. Included peer-reviewed publications were published within the last 5 y and contained in vivo preclinical experimental studies of postoperative adhesions with the assessment of underlying mechanisms of adhesion formation and successful therapy for adhesion prevention. Studies not involving regenerative medicine strategies were excluded. Data were qualitatively synthesized.; Results: A total of 1762 articles were identified. Of these, 1001 records were excluded by the described screening criteria. Sixty-eight full-text articles were evaluated for eligibility, and 11 studies were included for review.; Conclusions: Novel and reliable preventative strategies are urgently needed. Recent experimental data propose novel regenerative medicine targets for adhesion prevention. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Carneiro, L., et al. (2023). "Improving the well-being of cancer hospitalized patients: SENTIR meditation program." Confinia Cephalalgica et Neurologica 33(2): e2023010.
	Background and aim: The present work aims to develop, implement, and evaluate the effectiveness of a health/wellness promotion program, based on mindfulness meditation, sensory stimulation and virtual reality, with oncology patients in hospitals. Method(s): We developed an intervention study, with pre and post-test quantitative assessment, complemented with qualitative data. The intervention included six personalized sessions combining guided meditation, sensory stimulation, and virtual reality. Twelve cancer patients participated (83.3% female) with a mean age of 33.7 years (SD= +/-13.0) receiving treatment at a Cancer Treatment Hospital. Physiological (heart rate, blood pressure and oxygen saturation), and psychological parameters (DASS21) were used. Result(s): The comparison of the physiological parameters, before and after the sessions, revealed a statistically significant increase in oxygen saturation (p=0.03) after the first session. Regarding the levels of anxiety, stress, and depression, they significantly decreased (p<0.01) after the intervention. Qualitative data reinforced these positive results. Conclusion(s): The implemented intervention proved to be effective in reducing psychological vulnerability and partially effective in physiological measures. It is concluded that the program promotes the well-being of cancer patients in a hospitalized situation, favoring better coping with the disease.Copyright © Mattioli 1885.

Carnero, K. G. and P. W. Gundling (2021). "Effect of home pelvic floor muscle training using mobile app in Primipara with stress incontinence." European journal of integrative medicine 48.
	Introduction: Stress incontinence (SUI) is a common disease among women. It is the most frequent pelvic floor dysfunction, defined involuntary loss of urine during effort or exertion. Epidemiological studies imply that especially the first pregnancy and parturition are associated with a higher risk of developing stress incontinence. Conservative first‐line treatment includes pelvic floor muscle training (PFMT), the long‐term effectiveness of which is apparently associated with lifelong exercise. eHealth, the use of mobile information and communication technology for health issues, is being discussed to improve adherence and facilitate the implementation of exercise programs in everyday life, which should lead to an improved quality of life. The aim of this study is to evaluate the effect of app‐supported home based PFMT on the quality of life and adherence of women. Method: Randomized controlled trial with two groups of six women each with home based PFMT for six weeks. One group with and one without app support. Data from both groups were evaluated at the beginning and end of the training weeks using validated questionnaires for improvement in the severity of symptoms (ICIQ‐UI SF questionnaire), for changes in quality of life (ICIQ‐LUTSqol questionnaire) and to measure the subjective benefit and satisfaction with treatment as well as willingness (BSW). Results: At follow‐up, the group that trained with the app, reported a statistically significant reduction in symptom severity (MRang = 4.5), z = ‐ 2.207, p = 0.03, r = 0.6, and their quality of life scores captured a relevant improvement, (MRang = 15.), z = ‐ 2.232, p = 0.03, r = 0.6. The groups were significantly different for both outcome measures. Women in the control group also had a significant increase in condition‐specific quality of life but no decrease in the severity of their symptoms. Conclusion: Home‐based PFMT using a mobile app program seems to have a positive effect on the symptoms and quality of life of women with stress incontinence after vaginal delivery and may have an impact on the adherence of the training program. Keywords: pelvic floor muscle training, ehealth, stress incontinence, primipara, adherence, quality of life

Carolin, S., et al. (2023). "Does menopausal hormone therapy have a preventive impact on menopausal depression? A systematic review."
	
Caroline Cristine, A., et al. (2022). "The Effects of Polyphenol on Insulin Resistance and Hormonal Parameters on Women With Polycystic Ovary Syndrome: a Systematic Review and Meta - Analysis of Randomized Controlled Trials." PROSPERO International prospective register of systematic reviews.
	
Carolyn, E., et al. (2022). "Anti-obesity medications for Polycystic Ovary Syndrome."
	
Carosso, A. R., et al. (2022). "Expectant Management Before In vitro Fertilization in Women Aged 39 or Above and Unexplained Infertility Does Not Decrease Live Birth Rates Compared to Immediate Treatment." Reproductive Sciences 29(4): 1232-1240.
	Unexplained infertile couples can have further expectant management before starting assisted reproductive treatments. However, ovarian reserve and in vitro fertilization (IVF) outcomes rapidly decline after 39 years or more. It is thus important to clarify whether a waiting policy is also appropriate for women of advanced age. Couples who had access to a waiting list for approximately 1 year before receiving reimbursed public IVF were compared with those paying for access to immediate treatment. To allow for comparisons between these two strategies, we followed up couples who opted to pay for 1 year after the last embryo transfer from their first cycle. We calculated the proportion of live births in both groups and compared these using logistic regression models and a two-sample Z test for equality of proportions. Six hundred thirty-five couples were evaluated. Out of 359 couples in the immediate group, 70 (19.5%) had a live birth of which 11 after natural conception and 59 after IVF. Out of 276 couples in the waiting group, 57 (20.7%) had a live birth of which 37 after natural conception and 20 after IVF. There was no statistically significant difference between the two strategies in terms of the crude cumulative live birth rate (cLBR). The adjusted odds ratio of 0.69 (95%CI:0.39-1.22) did not change this conclusion as our sensitivity analyses. The cLBR for the 'waiting before IVF' and the 'immediate' strategies were similar. Further studies are needed to better characterize couples affected by unexplained infertility in order to individualize treatment strategies.Copyright © 2021, Society for Reproductive Investigation.

Carpenter Janet, S., et al. (2021). "A Menopause Strategies-Finding Lasting Answers for Symptoms and Health (MsFLASH) investigation of self-reported menopausal palpitation distress." Journal of Women's Health 30(4): 533-538.
	Background: Study to describe the degree of menopausal palpitation distress and its demographic, clinical, symptom, and quality-of-life (QOL) correlates. Analysis of existing, baseline, data from peri- and postmenopausal women, 42 to 62 years of age, who participated in the Menopause Strategies-Finding Lasting Answers for Symptoms and Health (MsFLASH) clinical trials testing interventions for vasomotor symptoms (n = 759). Up to 46.8% of menopausal women report having palpitations, yet the symptom is relatively understudied. Little is known about palpitation distress or its correlates. Materials and Methods: Degree of distress from "heart racing or pounding" was self-reported over the past two weeks as "not at all," "a little bit," "moderately," "quite a bit," or "extremely." Other measures included self-report forms, clinic-verified body mass index (BMI), vasomotor symptom diaries, and validated symptom and QOL tools. Results: The percentage who reported palpitation distress was 19.6%, 25.2%, and 33.5% in the three trials or 25.0% overall. In multivariate analysis, the odds of reporting palpitation distress was lower in past smokers (odds ratio [OR] = 0.59 [95% confidence interval (CI) 0.38-0.90]) and current smokers (OR = 0.48 [0.27-0.87]) relative to never-smokers and lower with every 5 kg/m2 higher BMI (OR = 0.82 [0.69-0.98]).The odds of reporting palpitation distress was higher with every five point more severe insomnia (OR = 1.28 [1.05-1.54]), five point worse depressive symptoms (OR = 1.47 [1.11-1.95]), five point worse perceived stress (OR = 1.19 [1.01-1.39]), and one point worse menopausal QOL (OR = 1.29 [1.06-1.57]). Conclusions: Menopausal palpitation distress is common and associated with demographic, clinical, symptom, and QOL factors. Findings can be used for screening in clinical practice and to justify additional research on this understudied symptom. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

Carpenter, J. S., et al. (2022). "MsFLASH analysis of diurnal salivary cortisol and palpitations in peri- and postmenopausal women." Menopause 29(2): 144-150.
	Objective:To evaluate the relationship between diurnal salivary cortisol patterns and distress from heart palpitations in midlife women. Method(s):We analyzed baseline data from 293 women who were eligible for a 3 x 2 factorial trial of exercise or yoga versus routine activity, and omega-3 fish oil versus placebo for vasomotor symptoms. Women self-collected salivary cortisol using swabs at four time points over 2 consecutive days and reported distress from heart racing or pounding during the past 2 weeks using a single item. Sample description and covariate data included demographics, clinical data, vasomotor symptom frequency from daily diaries, medication use, and validated questionnaires on depression, stress, and insomnia (Patient Health Questionnaire-8, Perceived Stress Scale, and Insomnia Severity index). Data were analyzed using descriptive statistics, chi-square and t tests, and repeated measure linear regression models. Result(s):Participants were on average 54.6 (SD = 3.6) years old, most were White (67%) postmenopausal (84%), and 26% reported distress related to palpitations. In adjusted models, the morning (wake plus 30-min) geometric mean daily salivary cortisol concentrations were significantly more blunted in those with distress from palpitations compared with those without distress (P <= 0.03). When all covariates were controlled, distress from palpitations was the sole significant predictor of wake plus 30-minute cortisol (-0.25 [-0.45 to -0.04], P = 0.02). Conclusion(s):Palpitations among midlife women may be associated with blunted morning cortisol, and this relationship is not explained by demographics, clinical variables, vasomotor symptoms, medications, depression, stress, or insomnia.Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The North American Menopause Society.

Carralero-Martínez, A., et al. (2021). "Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: study protocol for a randomized controlled trial." Trials 22(1): 356.
	Background: Chronic pelvic pain syndrome (CPPS) is a multifactorial disorder that affects 5.7% to 26.6% of women and 2.2% to 9.7% of men, characterized by hypersensitivity of the central and peripheral nervous system affecting bladder and genital function. People with CPPS have much higher rates of psychological disorders (anxiety, depression, and catastrophizing) that increase the severity of chronic pain and worsen quality of life. Myofascial therapy, manual therapy, and treatment of trigger points are proven therapeutic options for this syndrome. This study aims to evaluate the efficacy of capacitive resistive monopolar radiofrequency (CRMRF) at 448 kHz as an adjunct treatment to other physiotherapeutic techniques for reducing pain and improving the quality of life of patients with CPPS.; Methods: This triple-blind (1:1) randomized controlled trial will include 80 women and men with CPPS. Participants will be randomized into a CRMRF activated group or a CRMRF deactivated group and receive physiotherapeutic techniques and pain education. The groups will undergo treatment for 10 consecutive weeks. At the beginning of the trial there will be an evaluation of pain intensity (using VAS), quality of life (using the SF-12), kinesiophobia (using the TSK-11), and catastrophism (using the PCS), as well as at the sixth and tenth sessions.; Discussion: The results of this study will show that CRMRF benefits the treatment of patients with CPPS, together with physiotherapeutic techniques and pain education. These results could offer an alternative conservative treatment option for these patients.; Trial Registration: ClinicalTrials.gov NCT03797911 . Registered on 8 January 2019.

Carralero-Martínez, A., et al. (2022). "Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: A randomized controlled trial." Neurourology and Urodynamics 41(4): 962-972.
	Aim: To evaluate the efficacy of adjuvant, capacitive resistive monopolar radiofrequency (CRMRF, INDIBA) treatment at 448 kHz together with physiotherapeutic techniques compared to a sham treatment with the same techniques, for pain reduction and quality of life (QoL) improvements in patients with chronic pelvic pain syndrome (CPPS).; Methods: A triple-blind, randomized controlled trial (RCT) including patients with CPPS randomly allocated (1:1) to a CRMRF-activated group (intervention) or a CRMRF-deactivated one (control). Both groups received physiotherapeutic techniques and pain education weekly for 10 consecutive weeks. Data from a visual analogical scale and the SF-12 questionnaire were collected at trial commencement and repeated at the 5th and 10th sessions. Pain intensity was considered the main outcome. For the comparisons between variables, the χ 2 and Student's t test were used. Superiority was analyzed by estimating the mean change (95% confidence interval). Analysis was performed for the per-protocol and the intention-to-treat populations. The statistical significance level was set at p < 0.05.; Results: Eighty-one patients were included (67.9% women) with a mean age of 43.6 years (SD 12.9). CRMRF lessened pain scores by more than 2 points and improved QoL by 5 points. There were no relevant side effects and overall adherence to the treatment was 86.4%.; Conclusions: This is the first RCT that evaluates the efficacy of CRMRF (INDIBA) compared to a sham treatment, and demonstrates its superiority in decreasing pain and improving QoL. Such results may lead to greater prescribing of CRMRF when treating CPPS patients. (© 2022 Wiley Periodicals LLC.)

Carrera, M., et al. (2022). "Hysteroscopic metroplasty for the treatment of the dysmorphic uterus: A SWOT analysis." Frontiers in surgery 9: 1097248.
	INTRODUCTION: Dysmorphic uterus or T-shaped uterus is an increasingly frequent diagnosis among the infertile population that has been associated to worse reproductive results. Hysteroscopic metroplasty is a safe and simple procedure that can improve the reproductive outcomes in this group of patients, although the benefits of this procedure remains controversial due to the lack of adequate scientific evidence. OBJECTIVE: To analyze the hysteroscopic metroplasty using the SWOT (Strengths, Weaknesses, Opportunities and Threats) methodology. DATA SOURCES: An electronic search from inception each database up to December 2021 including the following databases was conducted: PubMed-MEDLINE, EMBASE, Web of Science, The Cochrane Library, and Google Scholar. METHODS OF STUDY SELECTION: Studies reporting outcomes of patients undergoing hysteroscopic metroplasty were included. TABULATION: Not applicable. INTEGRATION AND RESULTS: Clinical evidence from the included studies suggests an improvement in reproductive results after performing hysteroscopic metroplasty especially in women with recurrent pregnancy loss and previous infertility, but all of them have relevant methodological limitations. For this reason, benefits, risks and alternatives of this intervention should be considered with caution. CONCLUSIONS: Evidence from published data shows a probable association between dysmorphic uterus and poor reproductive outcomes. Hysteroscopic metroplasty in patients with dysmorphic uterus could improve pregnancy outcomes, but there is need of properly designed prospective controlled studies to determine the benefits of this technique.

Carrera, M., et al. (2022). "Effect of Hysteroscopic Metroplasty on Reproductive Outcomes in Women with Septate Uterus: Systematic Review and Meta-Analysis." Journal of Minimally Invasive Gynecology 29(4): 465-475.
	Objective: The aim of this systematic review with meta-analysis is to evaluate the impact of hysteroscopic metroplasty on adverse reproductive outcomes such as miscarriage, preterm birth, and fetal malpresentation in patients with history of infertility or previous poor obstetrical outcomes.; Data Sources: A systematic electronic search from inception each database up to April 2021 including the following databases was conducted: PubMed-MEDLINE, EMBASE, Web of Science, The Cochrane Library, the CGF Specialized Register of Controlled Trials, Google Scholar, and trial registries. A combination of the following keywords was used: uterine septum, septate uterus, congenital uterine malformation, class 2 uterus, class V uterus, metroplasty, hysteroscopic, pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, live birth, preterm birth, cesarean section, 'cesarean delivery, and fetal malpresentation.; Methods of Study Selection: Studies comparing reproductive outcomes between women undergoing hysteroscopic resection of the uterine septum and those with expectant management were included. Eligible population consisted of infertile women, women with poor obstetrical history, or women without previous pregnancy failures and a diagnosis of septate uterus.; Tabulation, Integration, and Results: The systematic electronic search retrieved 1076 studies; after elimination of duplicates, 688 titles and abstracts were screened, and 55 were assessed for eligibility. Eleven studies were included in the quantitative synthesis: one randomized controlled trial and 10 observational studies involving reproductive outcomes from 1589 patients with either complete or partial uterine septum. The pooled OR for miscarriage was 0.45, (95% CI, 0.22-0.90). When the analysis was performed considering subgroups according to the type of septum, pooled OR in complete septum subgroup was 0.16 (95% CI, 0.03-0.78), OR = 0.36 (95% CI, 0.19-0.71) in the partial septum subgroup and 0.58 (95% CI, 0.20-1.67) in those studies not differentiating between complete or partial septum. No significant differences were found between the 2 groups in OR of clinical pregnancy, term live birth, or risk of cesarean delivery. There was a significant decrease in the frequency of preterm birth in patients who underwent partial septum resection (OR = 0.30, 95% CI, 0.11-0.79). This difference was detected neither in patients with complete septum nor in studies not differentiating between partial or complete septum. The risk of fetal malpresentation was also significantly reduced (OR = 0.32, 95% CI, 0.16-0.65).; Conclusion: The results of the present meta-analysis support that hysteroscopic metroplasty is effective in reducing the risk of miscarriage in patients with complete or partial uterine septum, although these data should be confirmed with a well-designed randomized controlled trial. (Copyright © 2021 AAGL. Published by Elsevier Inc. All rights reserved.)

Carrillo, T., et al. (2023). "Impact of Continuous Estroprogestin Treatment on Circulating Microparticle Levels in Deep Endometriosis Patients." International Journal of Molecular Sciences 24(14).
	There has been increasing interest in the study of new pathogenic mechanisms in endometriosis (END), including the coagulation/fibrinolysis system and its link with inflammation and tissue remodeling. It has been suggested that END patients, especially with deep-infiltrating (DE) forms, could present a hypercoagulable state revealing higher levels of proinflammatory and procoagulant markers, such as total circulating microparticles (cMPs) and cMP-TF (tissue factor), released by cells in response to damage, activation, or apoptosis. However, no previous study has assessed the effect of END hormonal treatments on cMP and cMP-TF levels. Therefore, the aim of this study was to evaluate the impact of these treatments on cMP and cMP-TF levels in DE patients. Three groups were compared: DE patients receiving a continuous combined oral contraceptive regimen (CCOCR) (n = 41), DE patients without CCOCR (n = 45), and a control group (n = 43). cMP and cMP-TF levels were evaluated in platelet-free plasma. A significant decrease in the total cMP levels was found in the DE group with CCOCR versus the group without CCOCR, reflecting a higher chronic inflammatory status in DE patients that decreased with the treatment. cMP-TF levels were higher in DE patients receiving CCOCR versus those not receiving CCOCR, suggesting that treatments containing estrogens play a predominant role in suppressing the inhibitory pathway of TF.

Carter, F., et al. (2023). "Hypocaloric Dietary Intervention Reduces Excessive Follicle Recruitment In Women With PCOS." Journal of the Endocrine Society 7(Supplement 1): A865.
	Introduction: Disordered antral follicle development in polycystic ovary syndrome (PCOS) is characterized by excessive recruitment, early or absence of follicle selection and decreased incidence of dominance and ovulation. Whether lifestyle interventions aimed at weight loss improve defects in antral folliculogenesis to promote ovulation in women with PCOS and comorbid obesity is unknown. Objective(s): To test the hypothesis that a hypocaloric dietary intervention improves antral follicle development in a subset of women with PCOS and obesity as evidenced by decreased recruitment, and increased selection, dominance, and ovulation. Method(s): Preliminary analysis of women with PCOS and obesity (7 out of 20) who participated in a hypocaloric dietary intervention was conducted. The study protocol consisted of every-other-day visits to a clinical research center for ovarian ultrasonography and venipuncture over a 4-week baseline period (pre-intervention), followed by a 12-week commercial hypocaloric dietary meal plan intervention aimed at achieving 1-2 lbs of weight loss per week. Anthropometry, DEXA, hirsutism scoring, and oral glucose tolerance testing were conducted at baseline and during the final month of the intervention in the follicular phase. The number and diameter of all follicles >= 2 mm at each visit were recorded offline, and individual follicles >= 7 mm were tracked using the Identity Method throughout the 16-weeks. Clinical, morphologic, and endocrine markers were compared using paired t-tests pre- vs. post-intervention, and linear mixed models assessed changes in recruitment, selection, dominance, and ovulation. Result(s): The hypocaloric dietary intervention resulted in mean weight loss of 8.8 +/- 2.9% and significant reductions in waist (-13 +/- 9 cm) and hips (-10 +/- 3 cm) circumference, body mass index (-3.4 +/- 1.4 kg/m2 ), and percent total body fat (-1.5 +/- 1.3%; all p<0.02). Glucoregulatory status, menstrual cycle lengths, reproductive hormone (LH, FSH, E2, P4, TT, AMH) concentrations, and hirsutism scores did not differ pre- vs. post-intervention. The number of follicle recruitment events decreased with percent weight loss during the intervention (p=0.01), as did the average number of follicles recruited per cohort (p=0.01). By contrast, the frequency of follicle selection, dominance, and ovulation did not change with weight loss (p>0.05). Higher pre-intervention LH was associated with fewer follicles recruited per cohort during the intervention (p=0.03). No other metabolic or endocrine marker was correlated with changes in follicular events. Conclusion(s): Clinically meaningful weight loss induced by a hypocaloric dietary intervention resulted in improvements in early stages of antral follicle development in women with PCOS, albeit these changes did not affect ovulatory follicle dynamics or the frequency of ovulation.

Carter, J., et al. (2021). "GOG 244 - The Lymphedema and Gynecologic cancer (LeG) study: The impact of lower-extremity lymphedema on quality of life, psychological adjustment, physical disability, and function." Gynecologic Oncology 160(1): 244-251.
	OBJECTIVE: To assess quality of life (QOL) in patients who developed lower-extremity lymphedema (LLE) after radical gynecologic cancer surgery on prospective clinical trial GOG 244. METHODS: The prospective, national, cooperative group trial GOG-0244 determined the incidence of LLE and risk factors for LLE development, as well as associated impacts on QOL, in newly diagnosed patients undergoing surgery for endometrial, cervical, or vulvar cancer from 6/4/2012-11/17/2014. Patient-reported outcome (PRO) measures of QOL (by the Functional Assessment of Cancer Therapy [FACT]), body image, sexual and vaginal function, limb function, and cancer distress were recorded at baseline (within 14 days before surgery), and at 6, 12, 18, and 24 months after surgery. Assessments of LLE symptoms and disability were completed at the time of lower limb volume measurement. A linear mixed model was applied to examine the association of PROs/QOL with a Gynecologic Cancer Lymphedema Questionnaire (GCLQ) total score incremental change ≥4 (indicative of increased LLE symptoms) from baseline, a formal diagnosis of LLE (per the GCLQ), and limb volume change (LVC) ≥10%. RESULTS: In 768 evaluable patients, those with a GCLQ score change ≥4 from baseline had significantly worse QOL (p < 0.001), body image (p < 0.001), sexual and vaginal function (p < 0.001), limb function (p < 0.001), and cancer distress (p < 0.001). There were no significant differences in sexual activity rates between those with and without LLE symptoms. CONCLUSIONS: LLE is significantly detrimental to QOL, daily function, and body image. Clinical intervention trials to prevent and manage this chronic condition after gynecologic cancer surgery are needed.

Carter, P., et al. (2020). "Management of mesh complications following surgery for stress urinary incontinence or pelvic organ prolapse: a systematic review." BJOG : an international journal of obstetrics and gynaecology 127(1): 28-35.
	Background: Mesh surgery for stress urinary incontinence or pelvic organ prolapse can result in complications such as mesh exposure, mesh extrusion, voiding dysfunction, dyspareunia, and pain. There is limited knowledge or guidance on the effective management for mesh-related complications.; Objective: To determine the best management of mesh complications; a systematic review was conducted as part of the national clinical guideline 'Urinary incontinence (update) and pelvic organ prolapse in women: management'.; Search Strategy: Search strategies were developed for each indication for referral.; Selection Criteria: Relevant interventions included complete or partial mesh removal, mesh division, and non-surgical treatments such as vaginal estrogen.; Data Collection and Analysis: Characteristics and outcome data were extracted, and as a result of the heterogeneous nature of the data a narrative synthesis was conducted.; Main Results: Twenty-four studies were included; five provided comparative data and four studies stated the indication for referral. Reported outcomes (including pain, dyspareunia, satisfaction, quality of life, incontinence, mesh exposure, and recurrence) and the reported incidences of these varied widely.; Conclusions: The current evidence base is limited in quantity and quality and does not permit firm recommendations to be made on the most effective management for mesh-related complications. Robust data are needed so that mesh complications can be managed effectively in the future.; Tweetable Abstract: Systematic review demonstrates that the outcomes following mesh revision surgery are highly variable. (© 2019 Royal College of Obstetricians and Gynaecologists.)

Carter, T., et al. (2019). "The effectiveness of exercise-based interventions for preventing or treating postpartum depression: a systematic review and meta-analysis." Archives of Women's Mental Health 22(1): 37-53.
	Postpartum depression can have detrimental effects on both a mother's physical and mental health and on her child's growth and emotional development. The aim of this study is to assess the effectiveness of exercise/physical activity-based interventions in preventing and treating postpartum depressive symptoms in primiparous and multiparous women to the end of the postnatal period at 52 weeks postpartum. Electronic databases were searched for published and unpublished randomised controlled trials of exercise/physical activity-based interventions in preventing and treating depressive symptoms and increasing health-related quality of life in women from 4 to 52 weeks postpartum. The results of the studies were meta-analysed and effect sizes with confidence intervals were calculated. The Grading of Recommendations Assessment and Development and Evaluation (GRADE) system was used to determine the confidence in the effect estimates. Eighteen trials conducted across a range of countries met the inclusion criteria. Most of the exercise interventions were aerobic and coaching compared to usual care, non-intervention and active controls. Small effect sizes of exercise-based interventions in reducing depressive symptoms were observed collectively and the quality of evidence was low across the individual studies. Although exercise-based interventions could create an alternative therapeutic approach for preventing major depression in postpartum women who experience subthreshold elevated depressive symptoms, the clinical effectiveness and the cost-effectiveness of exercise-based and physical activity interventions need to be better established. There is a need for further more rigorous testing of such interventions in high-quality randomised controlled trials against active control conditions before large-scale roll-out of these interventions in clinical practice is proposed.

Caruso, G., et al. (2023). "Vulvar Paget's Disease: A Systematic Review of the MITO Rare Cancer Group." Cancers 15(6).
	Vulvar Paget's disease (VPD) is a rare form of cutaneous adenocarcinoma of the vulva, which accounts for about 1-2% of all vulvar neoplasms and mainly affects post-menopausal women. The clinical presentation is usually non-specific and mimics chronic erythematous skin lesions; therefore, the diagnosis is often difficult and delayed. Although VPD is typically diagnosed at a locally advanced stage and has a high recurrence rate, the prognosis is overall favorable with a 5-year survival of nearly 90%. Due to the limited and poor-quality evidence, there is no global consensus on optimal management. Therefore, we performed a systematic review of the literature through the main electronic databases to deepen the current knowledge of this rare disease and discuss the available treatment strategies. Wide surgical excision is recommended as the standard-of-care treatment and should be tailored to the tumor position/extension and the patient's performance status. The goal is to completely remove the tumor and achieve clear margins, thus reducing the rate of local recurrences. Non-surgical treatments, such as radiotherapy, chemotherapy, and topical approaches, can be considered, especially in the case of unresectable and recurrent disease. In the absence of clear recommendations, the decision-making process should be individualized, also considering the new emerging molecular targets, such as HER2 and PD-L1, which might pave the way for future targeted therapies. The current review aims to raise awareness of this rare disease and encourage international collaboration to collect larger-scale, high-quality evidence and standardize treatment.

Caruso, G., et al. (2023). "Dose-dense neoadjuvant chemotherapy before radical surgery in cervical cancer: a retrospective cohort study and systematic literature review." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society.
	Objective: To evaluate the role of dose-dense neoadjuvant chemotherapy followed by radical hysterectomy in reducing adjuvant radiotherapy in International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB1-IB2/IIA1 cervical cancer with disrupted stromal ring and as an alternative to concurrent chemoradiotherapy in FIGO 2018 stages IB3/IIA2.; Methods: This was a retrospective cohort study including patients with FIGO 2018 stage IB1-IIA2 cervical cancer undergoing dose-dense neoadjuvant chemotherapy at the European Institute of Oncology in Milan, Italy between July 2014 and December 2022. Weekly carboplatin (AUC2 or AUC2.7) plus paclitaxel (80 or 60 mg/m 2 , respectively) was administered for six to nine cycles. Radiological response was assessed by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria. The optimal pathological response was defined as residual tumor ≤3 mm. Kaplan-Meier curves were used to estimate survival rates. A systematic literature review on dose-dense neoadjuvant chemotherapy before surgery for cervical cancer was also performed.; Results: A total of 63 patients with a median age of 42.8 years (IQR 35.3-47.9) were included: 39.7% stage IB-IB2/IIA1 and 60.3% stage IB3/IIA2. The radiological response was as follows: 81% objective response rate (17.5% complete and 63.5% partial), 17.5% stable disease, and 1.6% progressive disease. The operability rate was 92.1%. The optimal pathological response rate was 27.6%. Adjuvant radiotherapy was administered in 25.8% of cases. The median follow-up for patients who underwent radical hysterectomy was 49.7 months (IQR 16.8-67.7). The 5-year progression-free survival and overall survival were 79% (95% CI 0.63 to 0.88) and 92% (95% CI 0.80 to 0.97), respectively. Fifteen studies including 697 patients met the eligibility criteria for the systematic review. The objective response rate, operability rate, and adjuvant radiotherapy rate across studies ranged between 52.6% and 100%, 64% and 100%, and 4% and 70.6%, respectively.; Conclusions: Dose-dense neoadjuvant chemotherapy before radical surgery could be a valid strategy to avoid radiotherapy in stage IB1-IIA2 cervical cancer, especially in young patients desiring to preserve overall quality of life. Prospective research is warranted to provide robust, high-quality evidence.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Caruso, G., et al. (2022). "Systematic lymph node dissection during interval debulking surgery for advanced epithelial ovarian cancer: a systematic review and meta-analysis." Journal of Gynecologic Oncology 33(5): e69.
	Objective: To evaluate the efficacy and safety of systematic lymph node dissection (SyLND) at the time of interval debulking surgery (IDS) for advanced epithelial ovarian cancer (AEOC).; Methods: Systematic literature review of studies including AEOC patients undergoing SyLND versus selective lymph node dissection (SeLND) or no lymph node dissection (NoLND) after neoadjuvant chemotherapy (NACT). Primary endpoints included progression-free survival (PFS) and overall survival (OS). Secondary endpoints included severe postoperative complications, lymphocele, lymphedema, blood loss, blood transfusions, operative time, and hospital stay.; Results: Nine retrospective studies met the eligibility criteria, involving a total of 1,660 patients: 827 (49.8%) SyLND, 490 (29.5%) SeLND, and 343 (20.7%) NoLND. The pooled estimated hazard ratios (HR) for PFS and OS were, respectively, 0.88 (95% confidence interval [CI]=0.65-1.20; p=0.43) and 0.80 (95% CI=0.50-1.30; p=0.37). The pooled estimated odds ratios (ORs) for severe postoperative complications, lymphocele, lymphedema, and blood transfusions were, respectively, 1.83 (95% CI=1.19-2.82; p=0.006), 3.38 (95% CI=1.71-6.70; p<0.001), 7.23 (95% CI=3.40-15.36; p<0.0001), and 1.22 (95% CI=0.50-2.96; p=0.67).; Conclusion: Despite the heterogeneity in the study designs, SyLND after NACT failed to demonstrate a significant improvement in PFS and OS and resulted in a higher risk of severe postoperative complications.; Trial Registration: PROSPERO Identifier: CRD42022303577.; Competing Interests: No potential conflict of interest relevant to this article was reported. (© 2022. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.)

Caruso, S., et al. (2023). "Vaginal health and quality of sexual life of postmenopausal women on hyaluronic acid and Biosaccharide Gum-1 vaginal gel." Taiwanese Journal of Obstetrics & Gynecology 62(5): 702-708.
	Objective: To evaluate the efficacy of daily vaginal gel containing hyaluronic acid (HA) and Biosaccharide Gum-1 (BG-1) on vulvovaginal atrophy (VVA) and on sexual function and quality of life (QoL).; Materials and Methods: One hundred-four postmenopausal women with VVA were enrolled in the nonrandomized comparison cohort study. Of them, 50 women on HA/BG-1 participated in the study group and 54 women on lubricants/moisturizers on-demand as a control group. The primary endpoint was the efficacy of the vaginal gel on VVA evaluated by the Vaginal Health Index (VHI) score. Secondary endpoints included sexual behavior by the self-administered female sexual function index (FSFI) questionnaire, and quality of life (QoL), by the Short Form-36 questionnaire (SF-36).; Results: All symptoms of AVV improved after 12 weeks of treatment in women on HA/BG-1. The VMI, although improved at the 12-week follow-up compared to baseline, it connoted a low estrogenic stimulation value. Sexual function improved significantly in women on HA/BG-1. Moreover, women reported a significant improvement in the somatic aspects of QoL. No benefits were obtained by the women in the control group.; Conclusions: Treatment with HA/BG-1 could have used in postmenopausal women who complain of vaginal dryness. The amelioration of VVA-related signs could improve sexual function and QoL.; Competing Interests: Declaration of competing interest None. (Copyright © 2023. Published by Elsevier B.V.)

Carvalho, V., et al. (2023). "Sex steroid hormones and epilepsy: Effects of hormonal replacement therapy on seizure frequency of postmenopausal women with epilepsy-A systematic review." European journal of neurology 30(9): 2884-2898.
	Background and Purpose: Hormonal replacement therapy (HRT) is used for symptomatic treatment of menopause. Some evidence suggests a proconvulsant effect of estrogen and an anticonvulsant role of progesterone. Thus, the use of exogenous sex steroid hormones might influence the course of epilepsy in peri- and postmenopausal women with epilepsy (WWE). We conducted a systematic review on the impact of HRT on the frequency of seizures of WWE.; Methods: PubMed and Scopus were searched for articles published from inception until August 2022. Abstracts from the past 5 years from the European Academy of Neurology and European Epilepsy Congresses were also reviewed. Article reference lists were screened, and relevant articles were retrieved for consultation. Interventional and observational studies on WWE and animal models of estrogen deficiency were included. Critical appraisal was performed using the revised Cochrane risk-of-bias tool for randomized trials and ROBINS-E tool.; Results: Of 497 articles screened, 13 studies were included, including three human studies. One cross-sectional study showed a decrease in seizure frequency in WWE using combined HRT, a case-control study showed an increase in comparison with controls, and a randomized clinical trial found a dose-dependent increase in seizure frequency in women with focal epilepsy taking combined HRT. Ten studies addressing the impact of HRT in rat models were also included, which showed conflicting results.; Conclusions: There is scarce evidence of the impact of HRT in WWE. Further studies should evaluate the harmful potential, and prospective registries are needed for monitoring this population. (© 2023 European Academy of Neurology.)

Casado-Adam, A., et al. (2022). "The Role of Intraperitoneal Intraoperative Chemotherapy with Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis from Ovarian Cancer-Hyperthermia versus Normothermia: A Randomized Controlled Trial." Journal of Clinical Medicine 11(19).
	Background: The treatment of ovarian carcinomatosis with cytoreductive surgery and HIPEC is still controversial. The effect and pharmacokinetics of the chemotherapeutics used (especially taxanes) are currently under consideration.; Methods: A phase II, simple blind and randomized controlled trial (NTC02739698) was performed. The trial included 32 patients with primary or recurrent ovarian carcinomatosis undergoing cytoreductive surgery (CRS) and intraoperative intraperitoneal chemotherapy with paclitaxel (PTX): 16 in hyperthermic (42-43 °C) and 16 in normothermic (37 °C) conditions. Tissue, serum and plasma samples were taken in every patient before and after intraperitoneal chemotherapy to measure the concentration of PTX. To analyze the immunohistochemical profile of p53, p27, p21, ki67, PCNA and caspase-3 and the pathological response, a scale of intensity and percentage of expression and a grouped Miller and Payne system were used, respectively. Perioperative characteristics and morbi-mortality were also analyzed.; Results: The main characteristics of patients, surgical morbidity, hemotoxicity and nephrotoxicity were similar in both groups. The concentration of paclitaxel in the tissue was higher than that observed in plasma and serum, although no statistically significant differences were found between the two groups. No statistically significant association regarding pathological response and apoptosis (caspase-3) between both groups was proved. There were no statistically significant differences between the normothermic and the hyperthermic group for pathological response and apoptosis.; Conclusions: The use of intraperitoneal PTX has proven adequate pharmacokinetics with reduction of cell cycle and proliferation markers globally without finding statistically significant differences between its administration under hyperthermia versus normothermia conditions.

Casalderrey-Rodriguez, M., et al. (2022). "Effectiveness of physiotherapy for pain management in primary dysmenorrhoea." Clinica e Investigacion en Ginecologia y Obstetricia 49(3): 100757.
	The aim of this study is to evaluate the efficacy of different physical therapy modalities for the treatment of primary dysmenorrhoea. Method(s): A review of the current scientific literature was conducted by searching during January and February 2021 the databases: PubMed, SPORTDiscus, Medline, CINAHL, and Web of Science. The MeSH descriptors used were: "Dysmenorrhea", "Exercise Therapy" and "Physical Therapy Modalities". Result(s): Thirteen studies were included and analysed, and were grouped for better analysis according to the type of intervention: therapeutic exercise, transcutaneous electrostimulation and thermotherapy, kinesiotape, connective tissue massage, dry needling, and acupuncture. The common variable in all the studies was the evaluation of the intensity of menstrual pain, which reduced when the different physical therapy modalities were applied. Conclusion(s): The physical therapy techniques proposed in the review seem to be an effective tool in the treatment of women with primary dysmenorrhoea. However, more studies are needed to analyse the long-term effects., El objetivo en este estudio es evaluar la eficacia de las diferentes modalidades de fisioterapia para el tratamiento de la dismenorrea primaria. Metodos: Se ha llevado a cabo una revision de la literatura cientifica actual mediante una busqueda durante enero y febrero de 2021 en las bases de datos: PubMed, SPORTDiscus, Medline, CINAHL y Web of Science. Los descriptores MeSH utilizados fueron: <>, <> y < >. Resultados: Se han incluido y analizado 13 estudios, que fueron agrupados para un mejor analisis segun el tipo de intervencion: ejercicio terapeutico, electroestimulacion transcutanea y termoterapia, kinesiotape, masaje de tejido conectivo, puncion seca y acupuntura. La variable comun en todos los estudios fue la evaluacion de la intensidad del dolor menstrual, el cual se redujo al aplicar las distintas modalidades de fisioterapia. Conclusion: Las tecnicas de fisioterapia planteadas en la revision parecen ser una herramienta efectiva en el tratamiento de mujeres con dismenorrea primaria. Sin embargo, se necesitan mas estudios que analicen los efectos a largo plazo.Copyright © 2022 Elsevier Espana, S.L.U.

Casarin, J., et al. (2021). "Music Therapy for Preoperative Anxiety Reduction in Women Undergoing Total Laparoscopic Hysterectomy: a Randomized Controlled Trial." Journal of Minimally Invasive Gynecology 28(9): 1618‐1624.e1611.
	Study Objective: To assess the superiority of a music therapy intervention (Music) vs usual care (Control) in reducing the preoperative anxiety of patients undergoing total laparoscopic hysterectomy (TLH) with nononcologic indications. Design: This was a 1:2 (Music vs Control) randomized controlled study. Setting: A teaching hospital. Patients: One hundred patients were available for the analysis: 30 and 70 in the Music and Control arms, respectively. Interventions: Perioperative music therapy pathway in patients undergoing TLH for benign disease. Measurements and Main Results: Anxiety was evaluated with the State‐Trait Anxiety Inventory Y Form (STAI‐Y) at different time points: at baseline and during preoperative, early postoperative, and late postoperative periods. Pathologic anxiety was defined as STAI‐Y state >45. Postoperative pain was registered using the visual analog scale. Women in the Music arm experienced lower anxiety levels (median STAI‐Y scores 38.0 vs 41.0; p = .002) during the preoperative period. STAI‐Y scores did not vary significantly by intervention at each subsequent time point. A significant difference between the groups (Music vs Control) was found in the proportion of women with pathologic anxiety during the preoperative (16.7% vs 37.2%; p = .04) and early postoperative periods (0% vs 12.9%; p = .04), whereas no significant difference between the groups was registered during the late postoperative period (6.6% vs 7.1%; p = .93). Postoperative pain intensity did not significantly differ between the groups at 1, 3, and 6 hours after surgery. Conclusions: Music therapy might be a viable complementary modality to usual surgical care in the gynecologic setting for its ability to significantly decrease preoperative anxiety in women undergoing TLH for benign conditions.

Casarin, J., et al. (2020). "Surgical treatment of large adnexal masses: a retrospective analysis of 330 consecutive cases." Minimally Invasive Therapy and Allied Technologies 29(6): 366-374.
	Introduction: In the present study, perioperative outcomes of laparoscopy (LPS) were compared to open surgery (OS) for the treatment of large adnexal masses (AM). Material(s) and Method(s): Retrospective observational cohort study. Data of consecutive patients who underwent ovarian cystectomy or salpingo-oophorectomy for large AM (diameter >=10 cm) at a referral minimally invasive gynecologic center were analyzed. Propensity score match (PSM) analysis was used to minimize covariate imbalances between the two groups. Result(s): Overall 330 patients, 285 (86.4%) LPSs and 45 (13.6%) OSs were included. PSM showed LPS (vs. OS) to be associated with less intraoperative blood loss (mL: 131.1 +/- 52.6 vs. 545.5 +/- 101.2; p =.007), shorter operative time (min: 84.8 +/- 77.9 vs. 123.7 +/- 70.1; p <.001), but higher rate of spillage (54.5% vs. 12.1%; p <.001). Among the LPS group, a positive correlation between AM size and both conversion to open surgery and need for mini-laparotomy was found (p <.05). Conclusion(s): An accurate patient selection, a dedicated workup, and an appropriate counselling are mandatory before LPS for large AM. The increased risks of intraoperative spillage associated with the minimally invasive approach should be acknowledged.Copyright © 2019 Society of Medical Innovation and Technology.

Casarramona, G., et al. (2022). "The efficacy and safety of luteal phase support with progesterone following ovarian stimulation and intrauterine insemination: A systematic review and meta-analysis." Frontiers in Endocrinology 13: 960393.
	The aim of this systematic review and meta-analysis was to update the current evidence for the efficacy and safety of progesterone luteal phase support (LPS) following ovarian stimulation and intrauterine insemination treatment (OS-IUI) for unexplained or mild male infertility. Four additional studies were identified compared to the previous review in 2017. Twelve RCTs (2631 patients, 3262 cycles) met full inclusion criteria. Results from quantitative synthesis suggest that progesterone LPS after OS-IUI leads to higher live birth (RR 1.38, 95%CI [1.09, 1.74]; 7 RCTs, n=1748) and clinical pregnancy rates (RR 1.38, 95% CI [1.21, 1.59]; 11 RCTs, n=2163) than no LPS or placebo. This effect is specifically present in protocols using gonadotropins for OS-IUI (RR 1.41, 95%CI [1.17, 1.71]; 7 RCTs, n=1114), and unclear in protocols involving clomiphene citrate (RR 1.01, 95% CI [0.05, 18.94]; 2 RCTs, n=138). We found no effect of progesterone LPS on multiple pregnancy or miscarriage rates. No correlation between drug-dosage or duration of treatment and effect size was seen. Though our results suggest both benefit and safety of progesterone LPS in OS-IUI, evidence is of low to moderate quality and additional well-powered trials are still mandatory to confirm our findings and justify implementation in daily practice.; Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display&#95;record.php?RecordID=292325, identifier CRD42021292325.; Competing Interests: FB is a Member of the external advisory board for Merck Serono and Ferring BV has received grants and personal fees outside the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Casarramona, Lalmahomed, Lemmen, Eijkemans, Broekmans, Cantineau and Drechsel.)

Casiano, E., et al. (2023). "Nonestrogen Therapies for Treatment of Genitourinary Syndrome of Menopause: A Systematic Review." Obstetrics and Gynecology 142(3): 555-570.
	Objective: To systematically review the literature and provide clinical practice guidelines regarding various nonestrogen therapies for treatment of genitourinary syndrome of menopause (GSM).; Data Sources: MEDLINE, EMBASE, ClinicalTrials.gov , and Cochrane databases were searched from inception to July 2021. We included comparative and noncomparative studies. Interventions and comparators were limited to seven products that are commercially available and currently in use (vaginal dehydroepiandrosterone [DHEA], ospemifene, laser or energy-based therapies, polycarbophil-based vaginal moisturizer, Tibolone, vaginal hyaluronic acid, testosterone). Topical estrogen, placebo, other nonestrogen products, as well as no treatment were considered as comparators.; Methods of Study Selection: We double-screened 9,131 abstracts and identified 136 studies that met our criteria. Studies were assessed for quality and strength of evidence by the systematic review group.; Tabulation, Integration, and Results: Information regarding the participants, details on the intervention and comparator and outcomes were extracted from the eligible studies. Alternative therapies were similar or superior to estrogen or placebo with minimal increase in adverse events. Dose response was noted with vaginal DHEA and testosterone. Vaginal DHEA, ospemifene, erbium and fractional carbon dioxide (CO 2 ) laser, polycarbophil-based vaginal moisturizer, tibolone, hyaluronic acid, and testosterone all improved subjective and objective signs of atrophy. Vaginal DHEA, ospemifene, tibolone, fractional CO 2 laser, polycarbophil-based vaginal moisturizer, and testosterone improved sexual function.; Conclusion: Most nonestrogen therapies are effective treatments for the various symptoms of GSM. There are insufficient data to compare nonestrogen options to each other.; Competing Interests: Financial Disclosure Alexandriah Alas reports receiving payment for expert testimony. Ethan Balk reports receiving funding from SGS for methodology consultation. Alexis A. Dieter reports that she received payment as an expert witness and research grants were paid to her institution. David R. Rahn received the grant support from the National Institutes of Health R01 AG047290; Bridge Award from American Association of Obstetricians and Gynecologists Foundation and American Board of Obstetrics and Gynecology; and the Patient-Centered Outcomes Research Institute. He also received an investigator-initiated award from Pfizer for provision of study drug (Premarin vaginal cream). The other authors did not report any potential conflicts of interest. (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Casiraghi, A., et al. (2023). "Long-term clinical and histological safety and efficacy of the CO2 laser for treatment of genitourinary syndrome of menopause: an original study." Climacteric 26(6): 605-612.
	Objective: This study aimed to evaluate histological modifications of the vaginal mucosa after repeated microablative fractional CO2 laser treatments. As secondary objectives we evaluated the clinical effects associated with repeated microablative fractional CO2 laser treatments using validated questionnaires. Method(s): A prospective intervention study was performed in the Division of Gynecology and Obstetrics, Urogynecology Unit, IRCCS San Raffaele Scientific Institute with 15 postmenopausal women complaining of genitourinary syndrome of menopause symptoms. The cohort of patients was submitted to at least two previous laser treatment cycles in the past years. The Vaginal Health Index (VHI), visual analog scale (VAS), Female Sexual Function Index (FSFI), Urinary Distress Inventory-6 (UDI-6), International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI) and 5-point Likert scale were used. Moreover, histological examinations were carried out on all samples. Result(s): At 4 weeks after the last treatment, the VHI score and all FSFI items were significantly increased compared with baseline. We observed a statistically significant decrease in both frequency and severity for all urinary symptoms after the follow-up. We observed a statistically significant increase in the number of epithelial cell layers with a consequent increase in epithelial thickness, in the number of glycogen-filled cells and in the number of papillae after the laser treatment. No signs of fibrosis were observed as neovascularization was observed in each woman. Conclusion(s): This is the first study demonstrating the histological persistency of efficacy in repeated annually laser treatment cycles, with tissue changes always leading to regenerative results without any sign of fibrosis. Clinical Trial Registration: ClinicalTrials.gov ID: NCT04868812 (release date: 27 April 2021).Copyright © 2023 International Menopause Society.

Cassani, C., et al. (2021). "Oral contraception use in BRCA gene mutation carriers: information for counselling in routine clinical practice." European Journal of Gynaecological Oncology 42(3): 441-449.
	The objective of this narrative review is to put risks and benefits for the use of oral contraception (OC) into perspective in counselling high-risk carriers of BRCA1 or BRCA2 gene mutations. We searched PubMed, Embase, and the Cochrane Library for studies that evaluated associations between OC use and breast or ovarian cancer among women who are carriers of BRCA1/2 mutations. All studies concordantly demonstrated an inverse correlation between OC and ovarian cancer risk in BRCA mutated women. Regarding breast cancer risk, results are conflicting with some studies reporting a slightly increased risk associated with OC use, whereas others reveal no evidence of a significant association in carriers. Numerous potential cancer risk modifiers and the modern evolution of OC can partly explain these results. OC use may also reduce the risk of extra-ovarian cancers such as those of the colon and endometrium, as observed in the general population. BRCA1/2 carriers should always receive a sensible and patient-centered contraceptive counselling because current evidence does not support recommendation against OC use, taking into account the individual profile.Copyright ©2021 The Author(s). Published by IMR Press.

Castanon, E., et al. (2022). "Bayesian interpretation of immunotherapy trials with dynamic treatment effects." European Journal of Cancer 161: 79-89.
	Introduction: The mechanism of action of immune checkpoints inhibitors hinders the writing of rational statistical analysis plans for phase III randomised clinical trials (RCTs) because of their unpredictable dynamic effects. The purpose is to illustrate the advantages of Bayesian reporting of treatment efficacy analysis in immunotherapy RCTs, in contrast to frequentist reporting. Method(s): Fourteen RCTs (one with two pairwise comparisons) that failed to achieve their primary objective (overall survival, OS) were selected. These RCTs were reanalysed using Bayesian Cox models with dynamic covariate coefficients and time-invariant models. Result(s): The RCTs that met inclusion criteria were 7 lung cancer trials, various other tumours, with antiPD1, antiPDL1 or antiCTLA4 therapies. The minimum detectable effect (deltaS) was superior to the true benefit observed in all cases, in conditions of non-proportional hazards. Schoenfeld tests indicated the existence of PH assumption violations (p<0.05) in 6/15 cases. The Bayesian Cox models revealed a probability of benefit >79% in all the RCTs, with the therapeutic equivalence hypothesis unlikely. The OS curves diverged after a median of 9.1 months. Since the divergency, no non-proportionality was evinced in 13/15, while the Wald tests achieved p<0.05 in 12/15 datasets. In all cases, the Bayesian Cox models with dynamic coefficients detected fluctuations of the hazard ratio, and increased 2-year OS was the most likely hypothesis. Conclusion(s): We recommend progressively implementing Bayesian and dynamic analyses in all RCTs of immunotherapy to interpret and assess the credibility of frequentist results.Copyright © 2021 Elsevier Ltd

Castelo-Branco, C., et al. (2021). "Review & meta-analysis: isopropanolic black cohosh extract iCR for menopausal symptoms - an update on the evidence." Climacteric : the journal of the International Menopause Society 24(2): 109-119.
	A systematic literature search revealed 35 clinical studies and one meta-analysis comprising 43,759 women, of which 13,096 were treated with isopropanolic Cimicifuga racemosa extract (iCR). Compared to placebo, iCR was significantly superior for treating neurovegetative and psychological menopausal symptoms, with a standardized mean difference of -0.694 in favor of iCR ( p < 0.0001). Effect sizes were larger when higher dosages of iCR as monotherapy or in combination with St. John's wort ( Hypericum perforatum [HP]) were given (-1.020 and -0.999, respectively), suggesting a dose-dependency. For psychological symptoms, the iCR+HP combination was superior to iCR monotherapy. Efficacy of iCR was comparable to low-dose transdermal estradiol or tibolone. Yet, due to its better tolerability, iCR had a significantly better benefit-risk profile than tibolone. Treatment with iCR/iCR+HP was well tolerated with few minor adverse events, with a frequency comparable to placebo. The clinical data did not reveal any evidence of hepatotoxicity. Hormone levels remained unchanged and estrogen-sensitive tissues (e.g. breast, endometrium) were unaffected by iCR treatment. As benefits clearly outweigh risks, iCR/iCR+HP should be recommended as an evidence-based treatment option for natural climacteric symptoms. With its good safety profile in general and at estrogen-sensitive organs, iCR as a non-hormonal herbal therapy can also be used in patients with hormone-dependent diseases who suffer from iatrogenic climacteric symptoms.

Castelo-Branco, C., et al. (2022). "Black cohosh efficacy and safety for menopausal symptoms. The Spanish Menopause Society statement." Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology 38(5): 379-384.
	Objective: The increasing interest in Western countries regarding phytotherapy use to treat menopause-related symptoms has led the Spanish Menopause Society (AEEM) to update its position statement performed in 2009 on the role of black cohosh ( Cimicifuga racemosa ) for the treatment of menopausal symptoms.; Material and Methods: A panel of experts from both clinical and research backgrounds were assembled to investigate the best available evidence. Selected studies were obtained by an electronic search, including the Internet search engines MEDLINE-Pubmed (1997-December 2021) and the Cochrane Controlled Trials Register.; Results: Most of the well-designed studies published in recent years have been conducted with the isopropanolic extract of black cohosh/ C. racemosa . The most common dose is 40 mg/day capable of achieving a significant reduction in hot flushes (particularly in women with intense hot flushes) and an improvement in mood. Used at the recommended doses, C. racemose produces no significant adverse reactions.; Conclusion: Black cohosh is an effective and safe treatment option for the relieving of vasomotor symptoms. Finally, further clinical trials with sufficient patient enrollment and longer study follow-up are needed.

Castro, R. A., et al. (2021). "Vaginal Sacrospinous Ligament Fixation Using Tissue Anchoring System Versus a Traditional Technique for Women With Apical Vaginal Prolapse: A Randomized Controlled Trial." Female Pelvic Medicine & Reconstructive Surgery 27(1): e215-e222.
	OBJECTIVE: The aim of the study was to compare the efficacy and safety of the tissue anchoring system (TAS) kit versus the traditional technique for sacrospinous ligament fixation (SSLF) to treat apical vaginal wall prolapse. METHODS: A prospective randomized controlled multicenter study of noninferiority involving women with apical prolapse (C-point≥+1). Primary outcome is surgical success as C-point≤-4 at the 1-year follow-up. Secondary outcomes are success according to the composite criteria as C-point≤-4, Ba-point ≤0, and Bp-point ≤0; POP-Q measures of the vaginal compartments; intraoperative findings, complications; reoperation rate; hospital stay; and quality of life and sexual functioning (PISQ-12). It was estimated that 50 individuals per group would yield an 80% power for a noninferiority margin of 15%. RESULTS: Ninety-nine women were randomized: TAS (n = 55) and traditional SSLF (n = 44). The groups' preoperative data were similar. Drop-out rate was 11% for 12-month follow-up. Success rates were 90% for TAS and 80% for traditional SSLF (P = 0.0006; absolute difference, 9.8%; 90% confidence interval, -5.2 to 24.8) with the sensivity analyses per-protocol considering only the subjects that completed the 12-month follow-up and 80% versus 73%, respectively (P = 0.0048; absolute difference, 7.3%; 90% confidence interval, -9.6 to 24.2) by sensivity analyses considering the total number of participants randomized and treated with drop-out cases as failure. We detected shorter intraoperative time to dissect and reach the SSL, shorter length of hospitalization, lower rates of urinary tract infection, and lower pain scores in the first 30 days postoperative in the TAS compared with the traditional SSLF groups (P < 0.05). There was an improvement in women's quality of life that did not differ between groups. CONCLUSIONS: The modified technique of SSLF using the TAS kit is noninferior to the traditional technique for the treatment of apical compartment in 12-month follow-up.

Catana, A. M., et al. (2023). "Strong relationships between the CA-125 KELIM score and the tumor biological effects after neo-adjuvant chemotherapy in advanced ovarian cancer patients: CHIVA trial (GINECO)." Annals of Oncology 34(Supplement 2): S532.
	Background: The modeled CA-125 longitudinal kinetic parameter KELIMTM during 1st-line chemotherapy is as a pragmatic indicator of the tumor primary chemosensivitiy. However, the links between KELIMTM and the beneath chemotherapy-induced tumor biological effects had to be explored. We studied the links between KELIMTM values and pathological response, and changes in TILs, in ovarian cancer patients treated with neo-adjuvant chemotherapy (NACT) +/- interval debulking surgery (IDS). Method(s): In the randomized phase II trial CHIVA (NCT01583322), 188 patients were treated with NACT carboplatin-paclitaxel +/- nintedanib, +/- IDS. Patient KELIMs were previously calculated. The pathological response was assessed with the Chemotherapy Response Score on the omentum (CRS 1-3), and with an enriched pathological response pR score based on the available tumor tissue block when omentum was lacking (pRS 1-3), obtained after NACT. Changes in stromal TILs (sTILs, % of the stromal surface on lymphocytes) and intra-epithelial TILs (ieTILs, qualitative appreciation, 0-2) in baseline tissue and after NACT were analyzed. Result(s): A strong association was found between patient KELIMTM value and the omentum CRS after NACT (n=67; median KELIMTM, 0.71 for CRS-1; 1.26 for CRS-2; 1.66 for CRS-3; P<0.01). Consistent, a correlation was observed between KELIM and tumor pRS (n=103; median KELIMTM, 0.73 for pRS-1; 1.25 for pRS-2; 1.61 for pRS-3; P <0.01). At baseline before NACT, no relationships between KELIMTM and TILs were found. After NACT, a significant association was observed between higher patient KELIMTM values and higher intra-epithelial TILs infiltrate after NACT (n=99; median KELIM, 0.88 for ieTILs score 0-1; vs 1.26 for ieTILs score 2; P = 0.03). Conclusion(s): High consistency was found between patients KELIMTM and the pathological response after neo-adjuvant chemotherapy, assessed with the omentum CRS score, or the larger tumor pRS score. Omentum may not necessarily needed to assess the pathological response. Intra-epithelial TILs change after NACT was strongly associated with KELIMTM-assessed chemosensitivity, thereby opening hypotheses about mechanisms of platinum-sensitivity. Clinical trial identification: NCT01583322. Legal entity responsible for the study: ARCAGY-GINECO (Paris, France). Funding(s): Hospital de la Timone (Marseille, France) and Universite Claude Bernard Lyon 1 (Lyon, France). Disclosure: G. Ferron: Financial Interests, Advisory Board: Olympus, AstraZeneca, MSD, Clovis Oncology, Rand-biotech; Financial Interests, Other, Honoraria: Olympus, AstraZeneca, MSD, Roche, Clovis Oncology, EISAI, GSK Tesaro, RanD Biotech; Financial Interests, Other, R&D contract: Olympus; Financial Interests, Other, Educational courses: Olympus, Rand-biotech; Financial Interests, Funding, Congress Funding: AstraZeneca, MSD, Roche, PharmaMar, EISAI, GSK Tesaro. I.L. Ray-Coquard: Financial Interests, Personal, Advisory Board: Roche, GSK, AstraZeneca, Mersana, Deciphera, Amgen, Oxnea, Merck Sereno, Agenus, Novartis, Macrogenics, Clovis, EQRX, Adaptimmune, Eisai, SUTRO, BMS, Adaptimmune, Daiichi Sankyo; Financial Interests, Institutional, Other, COLIBRI translational research: BMS; Financial Interests, Institutional, Advisory Board, translational research NEOPREMBROV trial: MSD; Non-Financial Interests, Principal Investigator: PAOLA1; Non-Financial Interests, Other, President: GINECO. P. Combe: Financial Interests, Advisory Board: AstraZeneca, BMS, MSD, EISAI, SANOFI, Novartis, Daiichi Sankyo, Clovis Oncology, GSK, Amgen; Financial Interests, Other, Investigator in clinical trial: MSD, Novartis, AstraZeneca, BMS. F. Joly Lobbedez: Financial Interests, Personal, Advisory Board: GSK, AstraZeneca, MSD, Janssen, Ipsen, BMS, Bayer, Eisai; Financial Interests, Personal, Invited Speaker: GSK, AstraZeneca, MSD, Janssen, Ipsen, Amgen, Astellas; Financial Interests, Institutional, Coordinating PI: GSK, AstraZeneca; Financial Interests, Institutional, Research Grant: BMS; Other, Travel: MSD, GSK. C. Lebreton: Financial Interests, Personal, Advisory B ard: GSK, MSD, Eisai, Clovis Oncology. J. Alexandre: Financial Interests, Personal, Advisory Board: Eisai, MSD, GSK, Janssen, Pfizer; Financial Interests, Personal, Invited Speaker: Eisai, MSD, AstraZeneca, GSK, Novartis; Financial Interests, Institutional, Research Grant: Janssen, GSK, MSD; Financial Interests, Institutional, Local PI: MSD, Eisai, Agenus, GSK, Immunogen, Incyte. P. Follana: Financial Interests, Personal, Invited Speaker: GSK, Eisai, MSD; Financial Interests, Personal, Advisory Board: Clovis, AZ, Novartis; Financial Interests, Personal, Other, Congress invitation: Gilead. B. You: Financial Interests, Personal, Advisory Board: AZ, MSD, Roche, GSK, Eisai, Seagen, Bayer, Novartis, Amgen, Clovis, BMS, Myriad, Menarini, Gilead. All other authors have declared no conflicts of interest.Copyright © 2023 European Society for Medical Oncology

Catarina, S. and M. Mariana (2023). "The effect of manual therapy on pain and fertility in women with endometriosis: a systematic review."
	
Cava, R. and Y. Orlin (2022). "Home-based transcutaneous tibial nerve stimulation for overactive bladder syndrome: a randomized, controlled study." International Urology and Nephrology 54(8): 1825-1835.
	Purpose: Transcutaneous posterior tibial nerve stimulation (TPTNS) for the treatment of overactive bladder syndrome (OAB), with or without urge urinary incontinence (UUI) using electrodes imbedded in the fabric of a conventional sock and an attachable battery-operated stimulation device (ZIDA-Exodus Innovations, Sufa, Israel), was compared for effectiveness and safety to a sham procedure in a prospective, blinded, randomized, controlled trial. Method(s): Forty patients with diagnosed with OAB were recruited from a single site. There were two groups: a treatment group (21 patients, mean age 64), which used an active ZIDA activation device (ZIDA) and a sham control group (SCG, 19 patients, mean age 72) randomized in a 1:1 ratio. After individual fitting of the sock and face-to-face instruction in the use of the device, patients in both groups self-administered the treatment once weekly for 30 min at home for a duration of 12 weeks. Prior to randomization and in Week 12, patients completed two 3-day bladder diaries and a quality-of-life (QOL) survey. Treatment success was defined as at least a 50% reduction in urgency voids with or without incontinence or at least a 30% reduction in 24-h frequency from baseline to Week 12. The key secondary endpoint was change in QOL from baseline to Week 12. Result(s): The success rate for the primary endpoint in the ZIDA group was 80% (n = 16/20) versus 39% (n = 7/18) in the SCG (p = 0.02). For QOL, the least squares mean difference in change from baseline to Week 12 between the ZIDA and sham control arms total score was - 12.7 (95% CI - 20.2 to - 5.1). No significant adverse effects were observed. Conclusion(s): TPTNS using the ZIDA home-based stimulation device offers a safe and effective treatment for patients with OAB syndrome and improves QOL. Trial regestration: TRN: NCT04470765.Copyright © 2022, The Author(s), under exclusive licence to Springer Nature B.V.

Cavalcante Marcelo, B., et al. (2023). "Peripheral blood natural killer cell cytotoxicity in recurrent miscarriage: a systematic review and meta-analysis." Journal of Reproductive Immunology 158: 103956.
	Dysregulated natural killer (NK) cells have been associated with recurrent miscarriages (RM). Studies have suggested that high peripheral blood NK cell cytotoxicities (pNKCs) are associated with an increased risk of RM. The aim of this systematic review (SR) and meta-analysis (MAs) is to investigate the difference in pNKC between nonpregnant and pregnant women with RM and controls and determine whether pNKC is reduced by immunotherapy. We searched the PubMed/Medline, Embase, and Web of Science databases. The MAs were conducted to compare pNKCs between women with and without RM before and during pregnancy as well as pre- and post-immunotherapy. Risk of bias in nonrandomized studies was assessed by the Newcastle-Ottawa Scale. Statistical analysis was performed using the Review Manager software. A total of 19 studies were included in the SR and 14 studies in the MAs. The MAs revealed higher pNKCs among nonpregnant women with RM compared to controls (MD, 7.99 95 %CI 6.40-9.58; p < 0.00001). pNKCs were also higher in pregnant women with RM than in pregnant controls (MD, 8.21 95 %CI 6.08-10.34; p < 0.00001). Women with RM showed significantly decreased pNKCs after the immunotherapy compared to before (MD, -8.20 95 %CI -10.20 - -6.19; p < 0, 00001). Additionally, there is an association between high pNKCs and the risk of pregnancy loss in women with RM. However, included studies showed substantial heterogeneities regarding the inclusion criteria of patients, techniques measuring pNKC, and types of immunotherapies. More studies are needed to evaluate the clinical efficiency of pNKCs in managing RM.; Competing Interests: Declaration of Competing Interest The authors have no relevant interests to declare. (Copyright © 2023 Elsevier B.V. All rights reserved.)

Cavalcante Marcelo, B., et al. (2021). "Lymphocyte immunotherapy in recurrent miscarriage and recurrent implantation failure." American journal of reproductive immunology (New York, N.Y. : 1989) 85(4): e13408.
	Problem: Lymphocyte immunotherapy (LIT) emerged in the early 1980s as a new therapeutic proposal for couples with a history of recurrent miscarriages (RM). However, in the early 2000s, the effectiveness of LIT was questioned. Recently, meta-analyses have observed the effectiveness and safety of LIT in treating couples with RM. Some studies evaluated the use of LIT in recurrent implantation failure (RIF) in in vitro fertilization cycles.; Methods: This systematic and narrative review evaluated the data available in the literature regarding the efficacy and safety of the use of LIT. Searches in PubMed/Medline, Embase, and Cochrane Library databases were conducted, using the following keywords: "recurrent miscarriage," "lymphocyte immunotherapy," and "recurrent implantation failure".; Results: This review describes the historical aspects of LIT and discusses its protocols, mechanisms of action, side effects, complications, and current evidence of the effectiveness in cases of reproductive failure. It also discusses the use of LIT during the COVID-19 pandemic and new immunological therapies.; Conclusion: In the vast majority of studies, the use of LIT for RM couples has shown an improvement in pregnancy outcomes. The most of the current studies that support the evidence are quasi-experimental, with few randomized, double-blind studies (Level of evidence III). However, the current evidence are not convincing for the use of LIT in RIF patients. (© 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Cavalcante Marcelo, B., et al. (2023). "Calcineurin inhibitors in the management of recurrent miscarriage and recurrent implantation failure: Systematic review and meta-analysis." Journal of Reproductive Immunology 160: 104157.
	Recurrent miscarriage (RM) affects up to 2.5% of couples of reproductive age. Up to 10% of couples using assisted reproductive technology experience recurrent implantation failure (RIF). Immunosuppressive drugs, such as calcineurin inhibitors (CNIs), has been proposed for RM and RIF management. This systematic review and meta-analysis (SRMA) aimed to evaluate the efficacy and safety of CNIs in RM and RIF treatment. We searched in the three databases. Review Manager 5.4.1 was used for statistical analysis. This review included 8 studies involving 1042 women (485 women in the CNIs group and 557 women in the control group). CNI treatment (cyclosporine [CsA] and tacrolimus [TAC]) increases live birth rate (LBR, odds ratio [OR]: 2.52; 95% confidence interval [CI]: 1.93-3.28, p < 0.00001) and clinical pregnancy rate (OR: 2.25; 95% CI: 1.54-4.40, p < 0.0001) and decreases miscarriage rate (OR: 0.45 95% CI: 0.32-0.63, p < 0.00001) when compared to the control. Side effects and obstetric and neonatal complications was similar in both groups. In conclusion, CNIs increased LBR in women with RM and RIF but there is a moderate risk of bias. Subgroup analysis revealed that CNIs improved LBR in women with RM with a low risk of bias. However, in women with RIF, with moderate to high risk of bias. The use of CsA and TAC, in low doses and for a short period, for managing reproductive failures in women seems to be safe, not causing serious side effects nor increasing the risk of obstetric and neonatal complications.; Competing Interests: Declaration of Competing Interest The authors declare that there is no conflict of interest. (Copyright © 2023 Elsevier B.V. All rights reserved.)

Cavalcante, M. B., et al. (2020). "Intrauterine perfusion immunotherapies in recurrent implantation failures: Systematic review." American Journal of Reproductive Immunology 83(6): e13242.
	Studies have investigated the gestational outcomes of new immunological therapies in the treatment of patients with recurrent implantation failure (RIF) in assisted reproductive technology (ART). The objective of this article is to assess the current state of evidence available in the literature on intrauterine perfusion immunotherapies in women undergoing ART treatments. By considering the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA), the authors performed systematic review by searching the databases of PubMed/MEDLINE and Scopus using the following key words: "recurrent implantation failure," "intrauterine infusion," "Platelet-Rich Plasma (PRP)," "Peripheral Blood Mononuclear Cells (PBMC)," "Granulocyte Colony-Stimulating Factor (G-CSF)," and "Human Chorionic Gonadotropin (hCG)." The authors analyzed the indications and the impact of new immunological therapies with intrauterine infusions on the pregnancy outcomes of patients undergoing ART. PRP, PBMC, G-CSF, and hCG were the four most used immunological therapies with intrauterine infusion. These new therapies appear to improve the results of ART treatments in cases of RIF. However, the small number of studies does not allow definitive conclusions about the effectiveness of these therapies.Copyright © 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Cayir, G. and B. Kizilkaya (2022). "The effect of a counseling and training program on the treatment of women with overactive bladder." Psychology, health & medicine 27(8): 1726-1738.
	Anticholinergic drugs and behavioral interventions are effective methods for the treatment of OAB and UUI. This randomized controlled, prospective, and quasi-experimental study determined the effect of healthy lifestyle behavior training, based on the Health Promotion Model (HPM), on the treatment of women with Overactive Bladder (OAB). The study sample included intervention and control groups with a sample size of 100 women diagnosed with OAB who received pharmacological treatment and agreed to participate in the study. The data were collected using an Introductory Information Form, Urinary Diary, OAB Questionnaire (OAB-V8), King's Health Questionnaire (KHQ), Healthy Life Style Behavior Scale II (HLSB II), Brief Symptom Inventory (BSI), and 24-hour Pad Test. The intervention group was administered a 45-minute training program based on Pender's HPM. There was a statistically significantly higher level of decrease in urgency (z = -3,259;p = 0,001), nocturia (z = -3,691;p < 0,001), urge urinary incontinence (z = -2,391;p = 0,017), and urinary frequency (chi2 = 17,420;p < 0,001) in the intervention group during the posttest period. The study found a significant decrease in the total posttest scores of the women in the intervention group on the OAB-V8 (t = -6.955;p < 0.001), KHQ (t = -5.354;p < 0.001), and BSI (t = -6.463;p < 0.001) scales whereas a statistically significant increase was found in their total score on the HLSB II (t = 9.139;p < 0.001) scale. The study concluded that HLSB training, which was prepared based on HPM, reduced OAB symptoms among women, improved the quality of their lives, changed their HLSBs, and positively affected their psychological symptoms.

Ceccaroni, M., et al. (2021). "Dienogest vs GnRH agonists as postoperative therapy after laparoscopic eradication of deep infiltrating endometriosis with bowel and parametrial surgery: a randomized controlled trial." Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology 37(10): 930-933.
	BACKGROUND: The recurrence of deep infiltrating endometriosis (DIE) after its surgical excision is a big problem: postoperative treatment is crucial. OBJECTIVE: To compare two postoperative treatments: Dienogest and GnRH agonists. DESIGN: Prospective Randomized Controlled Trial (RCT). PATIENTS: 146 women submitted to laparoscopic eradication of DIE with bowel and parametrial surgery. INTERVENTIONS: Patients were randomized into two groups. Group A (n = 81) received Triptorelin or Leuprorelin 3.75 mg every 4 weeks for 6 months. Group B (n = 65) received Dienogest 2 mg/day for at least 6 months. A first interview made after six months valued compliance to therapy, treatment tolerability, pain improvement, and side effects. A second interview at 30 ± 6 months valued pain relapse, imaging relapse, and pregnancy rate. MAIN OUTCOMES: The primary outcome was to demonstrate the non-inferiority of Dienogest about the reduction in pain recurrence. Secondary outcomes were differences in terms of treatment tolerability, side effects, imaging relapse rate, and pregnancy rate. RESULTS: Both Dienogest and GnRH agonists were associated with a highly significant reduction of pain at 6 and 30 months, without any significant difference (p < .001). About treatment tolerability, a more satisfactory profile was reported with Dienogest (p = .026). No difference in terms of clinical relapse, imaging relapse, and live births was found. CONCLUSIONS: Dienogest has proven to be as effective as GnRH agonists in preventing recurrence of DIE and associated pelvic pain after surgery. Also, it is better tolerated by patients.

Cecere Sabrina, C., et al. (2023). "Safety of PARP inhibitors as maintenance therapy in ovarian cancer." Expert Opinion on Drug Safety 22(10): 897-908.
	Introduction: Antiangiogenic agents and poly(ADP-ribose) polymerase inhibitors (PARP-Is) have improved the outcome of patients suffering from ovarian cancer. However, as they are associated with many adverse events (AEs), it is important to be aware of their safety and toxicity profiles.; Areas Covered: We reviewed PARP-I therapeutical indications, mechanism of action, metabolism, and interactions. We reported on all major and minor AEs that have emerged from clinical trials (SOLO1, PRIMA, PAOLA1, ATHENA, SOLO2, NOVA, ARIEL3, NORA), their follow-ups, meta-analyses, and real-world studies, particularly hematologic toxicities and their management, and secondary malignancies (myelodysplastic syndrome and acute myeloid leukemia). We also addressed gastrointestinal, neurological, respiratory, hepatic, and renal toxicity and the use of PARP-Is in older, pregnant, and lactating patients. No specific research strategy in terms of keywords, inclusive dates and databases was used.; Expert Opinion: PARP-Is benefits largely outweigh the risks associated with potential AEs. Randomized controlled trials produced strong good, quality data, but they enrolled a selected population and failed to capture rare events. More pharmacovigilance data and real-life studies on a larger and more heterogeneous sample are needed to understand PARP-Is differences and to clarify the incidence of late AEs to balance the risk/benefit ratio.

Celik, O., et al. (2022). "Receptivity-based uterine fibroid surgery: an updated systematic review of the evidence." Clinical and Experimental Obstetrics and Gynecology 49(5): 114.
	Background: Analyzing expression patterns of receptivity genes is a minimally invasive diagnostic method to identify the underlying cause of subfertility in women with uterine fibroid with a history of implantation failure or recurrent pregnancy loss. This updated systematic review was designed to determine the molecular and genetic changes in the endometrium of women with fibroid and how myomctomy affect the outcome of spontaneous or assisted conception treatment. We also discussed the extent to which we should consider the effects of fibroids on endometrial receptivity when deciding whether or not to perform myomectomy. Method(s): A total of 184 articles reached as a result of PubMed research and meeting the selection criteria, were evaluated. Of these, 28 full text articles on uterine leiomyoma and endometrium, leiomyoma and receptivity, fibroid and implantation, myomectomy and implantation, fibroid and genes, fibroid surgery and receptivity, fibroid and uterine peristalsis, fibroid and immune cell were evaluated. Result(s): The endometrium of subfertile women with fibroid appears to have a disease specific pattern according to the type of the fibroid. The response of the endometrium to a fibroid may vary depending on whether the fibroid is close or far from it. Leiomyomas that contribute to subfertility must be near to or in contact with the endometrium, as is the case for Types 0, 1 and 2 leiomyomas. The proximity to the endometrial cavity makes the effect of fibroid on the endometrium more pronounced. While Type 3 fibroid causes subfertility similar to submucosal fibroids, the subfertility-producing effects of Type 4 fibroids have not been clearly clarified. However, the fact that the fibroid is far from the cavity should not mean that it has no effect on the endometrium. The mechanical stress created by a Type 4 fibroid that is not connected to the endometrium may be converted into biological signal and disrupt receptivity. Data on whether myomectomy restores impaired receptivity are mostly based on clinical observations, and studies evaluating endometrial receptivity before and after myomectomy are very few. Conclusion(s): Analysis of receptivity genes in subfertile women with fibroid may assist the clinician in deciding whether or not to perform myomectomy. If it is determined whether fibroids affect receptivity other than their mechanical effects, the indications for myomectomy may expand or narrow.Copyright © 2022 S.O.G. CANADA Inc.. All rights reserved.

Celiksoy, H. Y., et al. (2022). "Low Dose of Gonadotropin with Letrozole Versus High Dose of Gonadotropin in Patients with Poor Ovarian Response Undergoing Ivf: a Randomised, Single-Blind, Prospective Trial." Zeynep kamil tip bulteni 51(4): 221‐225.
	Objective: The ideal controlled ovarian stimulation protocol for patients with poor ovarian response (POR) is not clear yet, and is the subject of many studies. Aromatase inhibitors have been introduced as a new treatment modality in controlled ovarian stimulation as they were found to elevate follicular sensitivity to gonadotropins (Gn). The aim of this study was to evaluate whether it is possible to reduce the required Gn dose by adding letrozole to the treatment without compromising success. Material and Methods: Patients who underwent in vitro fertilization treatment between 2014 and 2015 in our department and who were classified as poor responder patients according to Bologna criteria were recruited and randomized. In the first group, 33 patients were treated with 150 IU Gn in combination with letrozole 5 mg /day for the first five days of the stimulation. In the second group, 27 patients were treated with 300 IU Gn. Results: Amoung the groups there were no statistically significant difference in duration of ovulation stimulation, duration of antagonist use, number of retrieved oocytes, number of transferred embryos, implantation, cycle cancelation, chemical, clinical and ongoing pregnancy rates (all p>0.05). Gn use was significantly higher in 300 IU Gn alone group compared to 150 IU Gn in combination with letrozole group (1354 ± 468 IU versus 2555 ± 725 IU, p<0.05). Conclusion: The addition of letrozole yields comparable pregnancy outcomes with significantly low doses of Gn, so may be regarded as an effective adjuvant agent in POR patients.

Cellier, M., et al. (2024). "Endometrial biopsy performed before the first in vitro fertilization does not impact the early pregnancy rate." Scientific Reports 14(1): 1153.
	Endometrial biopsy (EB) has been showed to increase the rate of clinical pregnancy in patients who underwent in vitro fertilization (IVF) failures. The purpose of this work was to assess the impact of an EB performed before the first in IVF on the early pregnancy rate. Be One study is a prospective, single-centre, randomized, open-label study. In this parallel study, patients were evenly split into two groups. In one group, patients underwent an EB between days 17 and 22 of the menstrual cycle that precedes the ovarian stimulation. In the other group (control), no EB was performed. The hCG-positive rate (early pregnancy rate) was evaluated on day 14 after the ovarian puncture. In total, 157 patients were randomized in the EB group and 154 patients were in the control group. The early pregnancy rate was 33.1% (52/157) in the EB group and 29.9% (46/154) in the control group (p=0.54). Other parameters, including perforation, endometritis, or pain level were reassuring. An EB performed during the luteal phase of the menstrual cycle preceding the stimulation of the first IVF did not increase early pregnancy rate.Copyright © 2024. The Author(s).

Cengiz, H., et al. (2021). "Vaginal-assisted Laparoscopic Sacrohysteropexy and Vaginal Hysterectomy with Vaginal Vault Suspension for Advanced Uterine Prolapse: 12-month Preliminary Results of a Randomized Controlled Study." Gynecology and Minimally Invasive Therapy 10(1): 30-36.
	OBJECTIVE: Vaginal-assisted laparoscopic sacrohysteropexy (VALH) is a new modified form of uterine-sparing prolapse surgery using a combined vaginal and laparoscopic approach. We aimed to compare 1 year efficacy and safety of VALH and vaginal hysterectomy with vaginal vault suspension (VH + VVS) in the surgical treatment of apical pelvic organ prolapse (POP). MATERIALS AND METHODS: Women who requested surgical treatment for stage 2-4 symptomatic uterine prolapse were recommended to participate in one year-long randomized study between July 2017 and January 2019. POP Quantification (POP-Q) examination and validated questionnaires such as International Consultation on Incontinence Questionnaire Vaginal Symptoms (IVIQ-VS) survey, Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire Short Form (IIQ-7), and Patient Global Impression of Improvement (PGI-I) were recorded at baseline and 12 months after surgery. The main primary outcome measure was apical prolapse recurrence. Secondary results were duration of surgery, pain score, blood loss, postoperative hospital stay, and quality of life scores related to prolapse. RESULTS: There were 15 women in VALH and 19 women in the VH + VVS group. ICIQ-VS score, ICIQ-QOL, UDI-6, and IIQ-7 scores were improved for both groups. According to the PGI-I scores, 80% of subjects in the VALH group, and 100% in the VH + VVS group, were "very much better" or "much better" with their prolapse symptoms at their 1-year follow-up. There was no reoperation or operation-related complication in both groups. CONCLUSION: VALH and VH + VVS have similar 1-year cure rates and patient satisfaction.

Center Asan, M. (2023). Patient Blood Mangement (PBM) Using IV Iron in Patients With Gynecologic Cancer.
	No Results Available Drug: Ferric Carboxymaltose 50Mg/Ml Inj 20Ml|Drug: RBC transfusion rate|hemoglobin differences|Frequency of anemia|Frequency and delay period of treatment|The costs that patients actually pay for treatment (Cost-effectiveness)|Quality of life of patients EORTC QLQ-C30|Adverse events|Quality of life of patients HINT-8 Female Not Applicable 334 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care 2022-1674 December 2025

Center City of Hope, M. and C. Institute National (2023). Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers.
	No Results Available Procedure: Biospecimen Collection|Other: Informational Intervention|Other: Quality-of-Life Assessment|Other: Questionnaire Administration|Behavioral: Short-Term Fasting Cumulative double strand deoxyribonucleic acid (dsDNA) damage of normal tissue|Percentage of patients completing 4 weeks of time-restricted eating during RT|Rates of objective clinical adverse events (AEs)|Quality of life (QoL) indices - PR25|Quality of life (QoL) indices - CR29|Accumulated gH2ax foci|Oxidative DNA damage All Phase 2 60 Other|NIH Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care 21709|NCI-2023-00238|P30CA033572 January 1, 2027

Center Dubai, F. (2022). Immediate Ambulation Versus Short-time Bed Rest in Sub-fertile Women Undergoing Embryo Transfer.
	No Results Available Procedure: embryo transfer Percentage of participants who received or did not receive bed rest after embryo transfer who carried a viable pregnancy beyond 10 weeks' gestation|Percentage of participants who received or did not receive bed rest after embryo transfer who carried a viable pregnancy beyond 6 weeks' gestation|Percentage of participants who received or did not receive bed rest after embryo transfer who aborted before 12 weeks' gestation Female Not Applicable 156 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Other Bed rest after embryo transfer August 1, 2024

Center Erasmus, M. and W. Foundation (2024). Online Brief CBT Intervention for Women With PCOS.
	No Results Available Behavioral: online brief CBT intervention Depression|Anxiety|QoL|Coping Female Not Applicable 158 Other Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Treatment How2deal December 1, 2025

Center Fred Hutchinson, C. and N. Research National Institute of (2021). An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis.
	No Results Available Other: AHEI diet Pain Measurement|Quality of Life Questionnaire|Quality of Life Survey|Inflammatory Markers|Protein Measurement|Tumor Necrosis Factor Measurement|Tumor Necrosis Factor Measurement #2|inflammatory Markers Female Not Applicable 100 Other|NIH Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment RG1004314|8772|R01NR017951 January 31, 2025

Center Leiden University, M., et al. (2024). Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages.
	No Results Available Drug: Prednisolone|Drug: Placebo Live birth rate|Ongoing pregnancy|Congenital abnormalities|Gestational age|Survival at 28 days of neonatal life|Adverse events|Pregnancy complications|Direct and indirect costs|Anxiety and depression|Quality of life (Health state)|Birthweight|Productivity costs due to condition|Medical consumption Female Phase 2 490 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment LUMC-PREMI July 29, 2027

Center Leiden University, M., et al. (2021). Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features.
	No Results Available Drug: Olaparib|Radiation: Pelvic external beam radiotherapy|Drug: Chemotherapy|Drug: Durvalumab|Drug: Medroxyprogesterone Acetate|Drug: Megestrol Acetate|Radiation: Vaginal brachytherapy|Other: Observation p53abn-RED trial|MMRd-GREEN trial|NSMP-ORANGE trial|POLEmut-BLUE trial|Recurrence-free survival|Pelvic recurrence-free survival|Vaginal recurrence-free survival|Endometrial cancer-specific survival|Overall survival|Treatment-related toxicity - according to CTCAE v5.0|Health-related quality of life - Assessed using the EORTC QLQ-C30 questionnaire|Health-related quality of life - Assessed using the EORTC QLQ-EN24 questionnaire Female Phase 2|Phase 3 1615 Other|Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment RAINBO|ENGOT-en14-1,2,3,4|CCTG EN.10 TAPER arm A POLE January 1, 2031

Center, M. D. A. C. (2021). IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors.
	No Results Available Biological: Bevacizumab|Drug: Glutaminase-1 Inhibitor IACS-6274|Drug: Paclitaxel|Drug: Capivasertib Incidence of adverse events (AEs) All Phase 1 54 Other Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2021-0265|NCI-2021-09063 May 29, 2026

Center Milton, S. H. M. (2024). Feasibility of a Mindfulness Intervention for Endometriosis Surgery.
	No Results Available Behavioral: pain education|Behavioral: mindfulness of pain introduction and intervention Use of opioid medication|Pain intensity|Sleep quality (sleep duration, awakenings, efficiency)|Sleep report|Emotional functioning|Patient global impression of change|Pain catastrophizing|Treatment satisfaction Female Not Applicable 20 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Health Services Research 23397 February 28, 2025

Center Ohio State University Comprehensive, C. (2022). Hyperthermic Intraperitoneal Chemotherapy With Cisplatin During Surgery or Cisplatin Before Surgery for the Treatment of Stage III or IV Ovarian, Fallopian Tube or Peritoneal Cancer.
	No Results Available Drug: Carboplatin|Drug: Cisplatin|Procedure: Cytoreductive Surgery|Drug: Hyperthermic Intraperitoneal Chemotherapy|Drug: Paclitaxel|Other: Quality-of-Life Assessment|Other: Questionnaire Administration Incidence of chemotherapy-related adverse events|Feasibility of chemotherapy immediately perioperatively|Percentage of patients in Arm C with a treatment free interval of < 8 weeks|Recurrence free survival|Tumor response|Quality of life (QOL) assessment EORTC QLQ-C30 All Early Phase 1 45 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment OSU-20277|NCI-2021-06207 December 31, 2024

Center Shaare Zedek, M. (2023). Acupuncture With/Without Self-acupressure for Post-oophorectomy Hot Flashes in BRCA Carriers.
	The present study will examine the effectiveness of acupuncture, with/without self-acupressure, on 200 post- RRSO patients who suffer from at least 5 hot flashes per day, including those treated with HRT. All participants will receive 8 weekly treatments with acupuncture, and then randomly assigned to receive (or not) self-administered acupressure, to be performed daily at home. The response to the study interventions will be assessed using daily Hot Flash Scores, the Menopause Specific Quality of Life (MenQoL) and Measure Yourself Concerns and Wellbeing (MYCAW) questionnaires (at baseline; at the end of the 8-week intervention; and at 16 weeks). The safety of the study treatments will be assessed throughout.

Center Texas, F. and O. Fertility (2022). Prospective, Randomized Trial Comparing ICSI to Insemination for Non-Male Factor Patients Undergoing PGT-A.
	No Results Available Procedure: ICSI Rate of karyotypically normal blastocysts|Rate of blastocyst development|Fertilization rate All Not Applicable 500 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment ICSI November 1, 2023

Center University Hospitals Cleveland, M., et al. (2021). Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse.
	No Results Available Procedure: Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP)|Procedure: Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) Treatment failure|Postoperative pain medication use|Change in surgical pain using VAS|Postoperative anti-emetic use|Change in nausea using VAS|Change in fatigue using MAF|Change in bladder function using UDI-6|Change in bladder function using IIQ-7|Change in bowel function using CRAD-8|Change in sexual function using PISQ-12|Change in sexual function using FSFI|Change in body image using BIPOP|Change in quality of life using P-QOL|Change in satisfaction with care using PGI-I|Rate of Grade I-V DINDO complications in each surgical arm Female Not Applicable 320 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 20210871 April 30, 2030

Center University of Texas Southwestern, M. and R. Institute Patient-Centered Outcomes (2024). IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine.
	The purpose of this study is to compare two complex, multi-component evidence-based postpartum interventions in underserved populations of lower socioeconomic status in an effort to reduce maternal morbidity and mortality. This large, multi-center randomized controlled trial will compare two multi-component postpartum care models via hybrid type 1 design conducted in two phases. An initial phase (phase 1) will collect baseline data and ensure patient input into final study. In phase 2, women will be randomized. Comparators are evidenced- based approaches: (1) an intensive in-person education with virtual education via push notifications using an electronic health record web portal; (2) a telehealth model using serial encounters. The "push" approach using notifications directly contrasts with the "pull" approach using telehealth visits. Both models include home visit programs. The study population includes patients delivering in two urban, inner-city health systems: Parkland (Dallas, TX) and Grady Memorial (Atlanta, GA). The primary outcome is time from hospital discharge to diagnosis and treatment of a composite of complications in the first 6 weeks. Based upon pilot data, 2349 women will demonstrate a 40% reduction (9 to 5.4 days) with 80% power and two-sided alpha of 0.05. 3500 women will be enrolled (1000 in phase 1; 2500 in phase 2) with anticipated <5% attrition at 6 weeks. Inclusion will be women who deliver liveborn infants. Secondary outcomes include mental health disorders, emergency room visits, hospital admissions, patient knowledge, quality of life and satisfaction, provider satisfaction, and social determinants of health. Women will be followed for one year postpartum.

Center Walter Reed National Military, M. (2021). BOTOX® at the Time of Prolapse Surgery for OAB.
	No Results Available Drug: OnabotulinumtoxinA 100 UNT|Other: Injectable saline Change from baseline to postoperative weeks 6 to 12 in Overactive Bladder bother short form (OAB-q SF) questionnaire looking for a decrease of 10 points, which is the minimally important difference.|Change from baseline to postoperative weeks 6 to 12 in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12).|Change from baseline to postoperative weeks 6 to 12 in Patient Global Impression of Severity Scale (PGI-S).|Patient Global Impression of Improvement Scale (PGI-I) at 6 to 12 weeks postoperatively.|Urinary tract infection|Urinary retention Female Phase 4 138 U.S. Fed Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment 3-2021 June 2023

Center Walter Reed National Military, M. (2024). New Approaches to Nerve Stimulation Therapy for Bladder Pain Syndrome.
	No Results Available Procedure: Pulsed radiofrequency ablation|Procedure: Sham ablation VAS Pain Score|O' Leary-Sant Voiding and Pain Indices|Average number of daytime voids over the prior week|Average number of daytime episodes of urinary incontinence over the prior week|Patient Health Questionnaire - 9 (PHQ-9)|Number of treatments currently taking for BPS|Patient Global Impression of Severity (PGI-S)|Patient Global Impression of Improvement (PGI-I) Female Not Applicable 38 U.S. Fed Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment WRNMMC-2023-0433 May 2026

Center Wolfson, M. (2022). Biweekly Follow-Up and At-Home Ultrasound Reduce Anxiety in Women With Recurrent Pregnancy Loss.
	No Results Available Device: PulseNmore ES™|Device: Standard Ultrasound Anxiety levels Female Not Applicable 50 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care WOMC-0130-22 April 1, 2025

Central, T. and O. Group Eastern European Gynecologic (2022). Intermediate Risk Cervical Cancer: Radical Surgery +/- Adjuvant Radiotherapy.
	No Results Available Radiation: No adjuvant therapy|Radiation: Adjuvant radiotherapy Disease-free survival|Overall survival|Pelvic disease-free survival|Health-related quality of life based questionnaire|Treatment-related adverse events based on Common Terminology Criteria for Adverse Events v5.0 Female Phase 3 514 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ENGOT-cx16/CEEGOG/CERVANTES December 2032

Centre Universiti Kebangsaan Malaysia, M. (2021). Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis.
	No Results Available Other: Vaginal hygiene wash|Other: placebo wash Bacterial vaginosis cure rate|Visual analog scale of symptoms before treatment|Visual analog scale of symptoms after treatment|Microbial profile of vaginal flora before treatment|Microbial profile of vaginal flora after treatment|Cytokines concentration before treatment|Cytokines concentration after treatment|Recurrence of symptoms 1 month after completed treatment|Microbial analysis of vaginal flora 1 month after completed treatment Female Not Applicable 56 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment FF-2021-031 January 2022

Ceriani, C. E. J. and S. D. Silberstein (2023). "Current and emerging pharmacotherapy for menstrual migraine: a narrative review." Expert Opinion on Pharmacotherapy 24(5): 617-627.
	Introduction: In this article, we discuss menstrual migraine (MM), which can be categorized as menstrually related migraine (MRM) or pure menstrual migraine (PMM). MM attacks are often longer, more severe, and harder to treat than other migraine attacks. Appropriate treatment strategies include acute treatment, short term preventive treatment, and daily preventive treatment, depending on the patient's pattern of migraine and occurrence of migraine outside the menstrual period. Areas covered: A PubMed, Cochrane Library, Medline, and Ovid search from inception to October 2022 provided articles relating to MM pathophysiology and treatment. Expert opinion: In patients for whom standard acute therapy is inadequate, short term or daily preventive treatment should be considered. Patients with PMM may be adequately managed with short term preventive treatment started 2 days prior to the onset of migraine and continued for 5-6 days. Frovatriptan is the mainstay of short-term prevention. Patients who experience additional attacks outside the menstrual period may benefit from daily preventive treatment. Estrogen-containing contraceptive treatment may be effective in appropriately selected patients. Emerging research on the pathophysiology of MM indicates that oxytocin agonists and CGRP antagonists may prove to be effective treatment options.Copyright © 2023 Informa UK Limited, trading as Taylor & Francis Group.

Čerina, D., et al. (2022). "Is There a Place for Adjuvant Chemotherapy in the Treatment of Locally Advanced Cervical Cancer?" Current oncology (Toronto, Ont.) 29(8): 5223-5237.
	Findings on the efficacy of adjuvant chemotherapy (ACT) of locally advanced cervical cancer (LACC) after the concurrent chemoradiation (CCRT) therapy were inconsistent, and the OUTBACK trial was expected to shed some light regarding the topic. Its results on ACT in LACC were negative, with the conclusion of not to use it. The objective of this review was to present the inconsistencies of previous studies, along with the OUTBACK trial in more detail, and to rethink whether its results provide an unambiguous and definite answer to the optimal position of ACT in the treatment of LACC. To critically appraise the OUTBACK trial and understand the consequences of its results, we used only randomized controlled studies (RCTs) on ACT in LACC that have been included in high-quality systematic reviews and meta-analyses. We calculated the pooled prediction intervals using a random effects meta-analysis of all published randomized studies including the OUTBACK trial. After combining the OUTBACK trial with the results of four previous randomized trials, the pooled hazard ratio for overall survival benefit of CCRT + ACT was 0.95 (95% CI 0.75; 1.20). The pooled hazard ratio of the four previous trials was 1.00 (95% CI 0.69; 1.44). The OUTBACK trial improved the precision of the pooled estimate, but the clinical heterogeneity and the consequent prediction intervals are still very wide, and with 95% reliability, we can expect that if the new study, using a similar approach to the ACT, on a randomly selected patient population from the presented five trials is conducted, its hazard ratio for overall survival after ACT would be between 0.47 and 1.93. In conclusion, there is an absolute need for further research in order to optimally define the position of ACT in the treatment of LACC.

Cerrahpasa Istanbul, U. (2022). The Effect of Digital Literacy Education Given to Postmenopausal Women on Health Literacy and Quality of Life.
	No Results Available Behavioral: digital literacy education specific to menopause digital literacy education increases the digital literacy level of women|digital literacy education increases women's health literacy level|digital literacy education improves women's menopause-specific quality of life Female Not Applicable 100 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Supportive Care E-74555795-050.01.04-519850 March 2023

Cerrahpasa Istanbul, U. (2023). The Effect of Baby Massage Training Given to Pregnant Women on Maternal Attachment and Postpartum Depression.
	No Results Available Behavioral: Baby massage the Maternal Attachment Scale (mother-baby bonding scale)|The Edinburgh Postpartum Depression Scale Female Not Applicable 54 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Prevention 2023/132 July 30, 2024

Cerrahpasa Istanbul, U. and M. University Ondokuz (2023). Kegel and Abdominal Exercises on Urinary Incontinence Severity, Quality of Life, and Sleep Quality in Menopausal Women.
	No Results Available Behavioral: Experimental Group: Kegel exercises and abdominal exercises|Behavioral: Control Group: Kegel exercises Urinary Incontinence Severity|Quality of life of women with urinary incontinence will be evaluated|Sleep Quality Female Not Applicable 70 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Supportive Care B.30.2.ODM.0.20/60-164 November 20, 2023

Certelli, C., et al. (2020). "Electrochemotherapy in vulvar cancer: A systematic review." Italian Journal of Gynaecology and Obstetrics 32(1): 34-43.
	There are some problems about the optimal treatment modality of vulvar cancer (VC): unfeasible surgery in elderly women with several comorbidities and the absence of treatments applicable in recurrent disease. For these reasons, Electrochemotherapy (ECT) may have an important role in the management of these patients. The aim of this systematic review is to evaluate ECT in VC in terms of clinical response, adverse events and quality of life (QoL). We conducted a search on the electronic database PubMed/MED-LINE. All the studies in English language published from 2006 and August 2019 were considered eligible. The 4 studies included in the systematic review reported an overall objective response rate (complete and partial response) was 74.3%. No treatment-related serious adverse events were reported in any of the studies. An improvement in the QoL was reported. In conclusion, ECT is an easy, quick to perform, less invasive and repeatable procedure, which have shown a positive clinical response, a reduction in symptoms and an improvement in QoL. Since the survival for advanced and metastatic diseases has been, fortunately, increased, it is also important to focus our efforts on the QoL and on the local control of the disease.Copyright © 2020 Global Research Online. All rights reserved.

Cetin, B. and O. Gumusay (2023). "PD-1 and PD-L1 Blockade plus Chemotherapy in Endometrial Cancer." The New England Journal of Medicine 389(9): 866-867.
	
Ceyhan, T., et al. (2023). "Repeated application of luteal phase oestradiol/GnRH antagonist priming increases IVF success for poor ovarian reserve patients." Journal of Obstetrics and Gynaecology 43(2): 2211664.
	We aimed to compare repeated LPP (luteal phase oestradiol LPP/GnRH antagonists protocol) treatment with different protocol results with poor ovarian response (POR) patients. Two hundred and ninety-three cycles with poor ovarian reserve who underwent LPP, microdose flare up protocol and antagonist protocol were included in the study. Of these, 38 patients were applied LPP in the first cycle and LPP in the second cycle. After the microdose or antagonist protocol applied in the first cycle, LPP was applied to 29 patients in the second cycle. There are 128 patients who received LPP only once and 31 patients who received microdose flare up only once. The clinical pregnancy rate was monitored higher in LPP application group in the second cycle than the patients who received only LPP and patients who received LPP after different protocols (p = .035). b-hCG positivity per embryo and clinical pregnancy rate were found to be significantly higher with the LPP application in the second protocol (p = .000, p = .001). Repeated LPP may be the first choice protocol for low ovarian reserve patients.Copyright © 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Cezar, C., et al. (2021). "Can uterine artery embolization be an alternative to plastic and reconstructive uterus operation by minimally invasive surgery?" GMS Interdisciplinary plastic and reconstructive surgery DGPW 10: Doc07.
	Introduction: Plastic and reconstructive minimally invasive surgery has been established as gold standard in myomectomy. Therapy failure eventually leads to future surgical interventions or hysterectomy: surgeons and patients should be aware of the risks and benefits. We conducted a systematic review to analyse the evidence on the therapeutic indications and adverse events associated with uterine artery embolization and thereby evaluating if this method could be a valid alternative therapy. Methods: In concordance with PRISMA guidelines, literature research was made in PubMed, Cochrane Library, UpToDate, Amboss and Medline databases. Clinical trials, reviews and case reports published in English between January 2010 and June 2020 were included. Results: 44 articles were included out of 838 papers identified at initial search. Regarding uterine fibroids, three original papers and one Cochrane review reported the benefits of the procedure as an alternative to surgery, even in large and giant fibroids. Furthermore, several studies discussed the use of embolization for postpartum haemorrhage to decrease rates of hysterectomy after other haemostatic methods were exhausted, because of the potential risk of abnormal placentation in a future pregnancy. The procedure can also be successfully used as prophylactic method in different obstetrical procedures. Conclusions: The use of embolization in different uterine pathologies is a minimally invasive procedure as an alternative to surgery, especially in women who desire to preserve their uterus. Its related complications are described and can be avoided by a stringent indication of the procedure. More evidence regarding fertility after UAE, use of the procedure prophylactically in obstetrical haemorrhage or in adenomyosis is needed.; Competing Interests: The authors declare that they have no competing interests. (Copyright © 2021 Cezar et al.)

Cha, D. S., et al. (2024). "The efficacy of zuranolone in postpartum depression and major depressive disorder: a review & number needed to treat (NNT) analysis." Expert Opinion on Pharmacotherapy 25(1): 5-14.
	Introduction: Major depressive disorder (MDD) is a common and debilitating mental illness. Postpartum depression (PPD) impacts women globally and is one of the most common complications of childbirth that is underdiagnosed and undertreated, adversely impacting the mental health of women, children, and partners. Available antidepressant medications require weeks to months before showing effect. In this setting, zuranolone, an oral neuroactive steroid and a positive allosteric modulator of GABAA receptors, is an attractive alternative as a rapid-acting antidepressant treatment. Areas covered: This article reviews zuranolone (SAGE217), focusing on available clinical studies in individuals with PPD and MDD. This paper adds to the extant literature by presenting the efficacy data as Number Needed to Treat (NNT) to facilitate indirect comparisons with other antidepressants. Expert opinion: Zuranolone is a novel rapid-acting (i.e. two week course) oral antidepressant for the treatment of adults with PPD with ongoing clinical trials evaluating its efficacy in adults with MDD. Zuranolone is well tolerated with no significant safety concerns in any clinical trials completed to date. Zuranolone will be scheduled by the Drug Enforcement Agency (DEA).Copyright © 2024 Informa UK Limited, trading as Taylor & Francis Group.

Chae Su, H., et al. (2019). "Effect of adjuvant therapy on the risk of recurrence in early-stage leiomyosarcoma: A meta-analysis." Gynecologic Oncology 154(3): 638-650.
	Objectives: To assess the effect of adjuvant chemotherapy (AC) or radiotherapy (AR) on the risk of recurrence in surgically treated patients with early-stage uterine leiomyosarcoma (uLMS).; Methods: We searched the PubMed, EMBASE, and MEDLINE, and Cochrane databases for publications up to March 2019, which compared patients with early-stage uLMS who received AC or AR with those who did not. The primary endpoint was recurrence rate. Random- or fixed-effects models were used for pooled estimates of the effect of adjuvant treatments on recurrence rates. Subgroup analyses were conducted based on study design, surgical staging, AC regimen (gemcitabine/docetaxel regimen), and type of AR.; Results: Three randomized trials and 9 observational studies (9 studies for AC vs. observation, n = 496; 9 studies for AR vs. observation, n = 425) were included. The meta-analysis indicated that AC did not decrease the risk of recurrence compared with observation (odds ratio [OR] = 0.65, 95% confidence interval [CI] = 0.37-1.15, P = 0.14; P = 0.09 and I 2 = 42.1). Similarly, AR did not decrease the risk of recurrence compared with observation (OR = 1.11, 95% CI = 0.56-2.21, P = 0.76; P = 0.10 and I 2 = 40.4). Meta-regression analyses revealed no significant association between median follow-up time and recurrence. In subgroup analyses (study design, surgical staging, gemcitabine/docetaxel regimen, type of AR), neither AC nor AR decreased the risk of recurrence significantly.; Conclusion: AC, including gemcitabine/docetaxel regimen, or AR did not reduce the recurrence rate in patients with early-stage uLMS. (Copyright © 2019 Elsevier Inc. All rights reserved.)

Chae-Kim, J., et al. (2021). "Outcomes of women treated with progestin and metformin for atypical endometrial hyperplasia and early endometrial cancer: a systematic review and meta-analysis." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 31(12): 1499-1505.
	Objective: Progestin therapy is the recommended fertility-sparing management of atypical endometrial hyperplasia or early-stage endometrial cancer in reproductive-aged women. Our objective was to evaluate disease relapse after progestin and metformin versus progestin therapy alone in patients with endometrial hyperplasia or cancer. Our secondary outcomes were disease remission, clinical pregnancy and live birth rate.; Methods: A systematic review of the literature was conducted (MEDLINE, Web of Science, Cochrane Library, CINAHL, LILACS, clinicaltrials.gov) from inception to April 2021. Studies of reproductive-aged women with atypical endometrial hyperplasia or early endometrial cancer who received progestin and metformin or progestin alone for fertility-sparing management, were included in the review. Early endometrial cancer was defined as grade 1, stage 1 disease. Exclusion criteria included women with higher grade endometrial cancer and when conservative management was not for fertility-sparing purposes. Data are presented as odds ratios (ORs) and 95% confidence intervals (CIs) with fixed or random effects meta-analysis. Quality scoring was based on the Newcastle-Ottawa and Jadad scales.; Results: In total, 271 reports were identified and six studies met the inclusion criteria. These studies included 621 women; 241 (38.8%) patients received combined therapy and 380 (61.2%) received progestin therapy alone. Relapse rates were lower for progestin and metformin than for progestin therapy alone (pooled OR 0.46, 95% CI 0.24 to 0.91, p=0.03). The remission rates were not different (pooled OR 1.35, 95% CI 0.91 to 2.00, p=0.14). Women who received progestin and metformin achieved pregnancy and live birth rates similar to those who received progestin therapy only (pooled OR 1.01, 95% CI 0.44 to 2.35, p=0.98; pooled OR 0.46, 95% CI 0.21 to 1.03, p=0.06).; Conclusion: For reproductive-aged women with atypical endometrial hyperplasia or early endometrial cancer, progestin and metformin therapy compared with progestin therapy alone is associated with lower relapse rates, and similar remission, clinical pregnancy and live birth rates.; Prospero Registration Number: CRD42020179069.disease remission.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Chaemsaithong, P., et al. (2020). "Does low-dose aspirin initiated before 11 weeks' gestation reduce the rate of preeclampsia?" American Journal of Obstetrics and Gynecology 222(5): 437-450.
	Objective Data: Preconception or early administration of low-dose aspirin might improve endometrial growth, placental vascularization, and organogenesis. Most studies have evaluated the potential benefit of preconception or early administration of low-dose aspirin in women with a history of recurrent pregnancy loss, women who have undergone in vitro fertilization, or women with thrombophilia or antiphospholipid syndrome. These women are at an increased risk of placenta-associated complications of pregnancy, including preeclampsia, preterm delivery, and fetal growth restriction.; Study Outcomes: We performed a systematic review and meta-analysis to evaluate the effect of low-dose aspirin initiated at <11 weeks' gestation on the risk of preeclampsia, gestational hypertension, or any hypertensive disorder of pregnancy. Secondary outcomes included preterm delivery at <37 weeks' gestation and fetal growth restriction.; Study Appraisal and Synthesis Methods: We searched in MEDLINE via PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform from 1985 to November 2018. Entry criteria were randomized controlled trials evaluating the effect of aspirin administered at <11 weeks' gestation in preventing preeclampsia and/or hypertensive disorders in pregnancy or improving pregnancy outcomes in women with recurrent miscarriage as compared with placebo or no treatment and outcome data available or provided by authors for >85% of the study population. Relative risks with 95% confidence intervals were calculated for each study and pooled for global analysis as the effect measure. We assessed statistical heterogeneity in each meta-analysis using the χ 2 statistics, I 2 , and Tau 2 . Heterogeneity was considered substantial if an I 2 was greater than 50% and either the Tau 2 was greater than zero or there was a low P value (<0.10) in the χ 2 test for heterogeneity. Random-effects meta-analysis, weighted by the size of the studies, was performed to produce an overall summary on aspirin effect for each outcome. Sensitivity analysis by sequential omission of each individual study and by fixed-effects model was performed. Publication bias was not assessed because of the small number of included studies. Statistical analysis was performed using Stata release 14.0 (StataCorp).; Results: The entry criteria were fulfilled by 8 randomized controlled trials on a combined total of 1426 participants. Low-dose aspirin initiated at <11 weeks' gestation was associated with a nonsignificant reduction in the risk of preeclampsia (relative risk, 0.52; 95% confidence interval, 0.23-1.17, P = .115), gestational hypertension (relative risk, 0.49; 95% confidence interval, 0.20-1.21; P = .121), and any hypertensive disorder of pregnancy (relative risk, 0.59; 95% confidence interval, 0.33-1.04, P = .067). Early administration of low-dose aspirin reduced the risk of preterm delivery (relative risk, 0.52; 95% confidence interval, 0.27-0.97, P = .040) but had no impact on the risk of fetal growth restriction (relative risk, 1.10; 95% confidence interval, 0.58-2.07, P = .775). Except for preterm delivery and any hypertensive disorder of pregnancy, sensitivity analysis demonstrated similar observations, therefore confirming the robustness of the analysis.; Conclusion: The administration of low-dose aspirin at <11 weeks' gestation in women at high risk does not decrease the risk of preeclampsia, gestational hypertension, any hypertensive disorder of pregnancy, and fetal growth restriction. However, it might reduce the risk of preterm delivery. Larger randomized controlled trials will be required to substantiate the findings. (Copyright © 2019. Published by Elsevier Inc.)

Chaisson, N. and M. Schafer Katherine (2023). "Streamlining the Use of Mifepristone for Early Pregnancy Loss Across a Large Health Care System Sets the Stage for Rapid Expansion of Medication Abortion Access in a Post-Roe Environment." Annals of Family Medicine 21(5): 469.
	
Chakraborty, P., et al. (2022). "Significance of Hyperhomocysteinemia in Immediate As Well As Long-Term Health Risk/s in Women with Polycystic Ovary Syndrome: a Probabilistic Model Using Dynamic Bayesian Network Analysis." Reproductive sciences (Thousand Oaks, Calif.).
	Polycystic ovary syndrome (PCOS) is a heterogeneous entity comprising broad spectra of ovarian disorders with trademark features of metabolic syndrome like insulin resistance, obesity, and dyslipidaemia to name a few. Hyperhomocysteinemia, an independent risk factor of metabolic syndrome, has been suggested as a causative factor in spontaneous miscarriage in PCOS. However, it is yet to be resolved whether hyperhomocysteinemia has a contributory role in the pathogenesis or could direct long-term sequences of the syndrome. A total of 2355 women with history of one or more first trimester abortions were screened and 1539 were selected for the study. Selected patients were initially divided by the presence or absence of PCOS, while subsequent stratification was based on hyperhomocysteinemia, insulin resistance, and/or obesity. The miscarriage population/s was mostly represented by hyperhomocysteinemia in both the cohorts (PCOS: 69.08% vs. non-PCOS: 56.68%). ROC-AUC values suggest increased predisposition of hyperhomocysteinemia-mediated miscarriage (hyperhomocysteinemia: 0.778; insulin resistance: 0.601; BMI: 0.548). A probabilistic causal model was designed using dynamic Bayesian network to evaluate the time-series data points before, during, and after pregnancy which revealed a possibility of 32.24% (n = 79) of PCOS cohort developing hypertension, 26.94% (n = 66) of onset of diabetes and 4.49% cardiovascular disease 3 years following pregnancy. We conclude hyperhomocysteinemia may possibly contribute to spontaneous miscarriage and related to metabolic derailments later in life.

Chalkidou, A., et al. (2023). "The Comparative Study of the Administration of the Combination Preparation of Isoflavones and Hyaluronic Acid in Menopausal Women for the Treatment of the Symptoms of Menopause, Urogenital Atrophy and Oteoporosis in Relation to Existing Hormone Replacement Therapies." Materia socio-medica 35(3): 206-214.
	Background: Menopause is characterized by a series of symptoms and effects from the various systems and organs, for which, the decline in estrogen production from the ovaries is considered responsible.; Objective: The aim of this study was to make comparative study of the administration of the combination preparation of isoflavones and hyaluronic acid in menopausal women for the treatment of the symptoms of menopause, urogenital atrophy and osteoporosis in relation to existing hormone replacement therapies.; Methods: In this five-year, double-blind, placebo-controlled clinical study, a total of 274 postmenopausal women were enrolled and classified into three groups. Participants in group A, were 96 women who did not receive Hormone Replacement Therapy (HRT), in the second group, 92 received daily treatment with tibolone (2.5 mg) as monotherapy, and in the third group, 86 received treatment with a pharmaceutical formulation of hyaluronic acid 120 mg and isoflavones. MF11RCE 80 mg.; Results: In the postmenopausal women of our study, a significant reduction of postmenopausal symptoms was found in both groups B and C of participants who received hormone replacement preparations compared to group A who did not receive HRT. Furthermore, no difference in efficacy was observed between the administered preparations of isoflavones and tibolone.; Conclusion: The combination of isoflavones and hyaluronic acid has the same efficacy as tibolone in menopausal symptoms.; Competing Interests: There are no conflicts of interest. (© 2023 Anna Chalkidou, Efthimios Oikonomou,, Dimitrios Lambrinos, Anastasia Bothou, Dimitrios Kyriakou, Konstantinos Nikolettos, Georgios Marinos. Georgios Iatrakis, Stefanos Zervoudis, Nikolaos Nikolettos. Panagiotis Tsikouras.)

Chambers, L. M., et al. (2021). "Impact of treatment modality on overall survival in women with advanced endometrial cancer: A National Cancer Database analysis." Gynecologic Oncology 160(2): 405-412.
	OBJECTIVE: To evaluate overall survival (OS) in women with advanced endometrial cancer (EC) following chemotherapy alone (CT), neoadjuvant chemotherapy and interval debulking surgery (NACT + IDS) or primary cytoreductive surgery and chemotherapy (PCS + CT). METHODS: The National Cancer Database (NCDB) was queried for patients with stage III/IV EC from 2004 to 2015. Univariable and multivariable Cox proportional hazards analyses assessed the impact of treatment modality upon OS. RESULTS: Of 48,179 women identified, 5531 received CT (11.5%), 2614 NACT + IDS (5.4%) and 40,034 PCS + CT (83.1%). Median OS was 11.1 months for CT, 25.1 months for NACT + IDS and 60.9 months for PCS + CT (p < 0.001). On multivariate analysis, NACT + IDS (HR 0.44 (0.40, 0.49); p < 0.001) and PCS + CT (HR 0.32 (0.30, 0.35); p < 0.001) were associated with improved OS vs. CT alone. Age, African American race, income, higher Charlson comorbidity index and grade were predictors of worse OS (p < 0.001). On subgroup analysis by stage (III/IV) and histology (Type I/II), PCS + CT improved OS for all patients, compared to NACT + IDS (p < 0.001) and CT (p < 0.001). NACT + IDS was associated with improved OS vs. CT in stage III type I (HR 0.50; 95% CI 0.38, 0.67; p < 0.001), stage IV type I (HR 0.43; 95% CI 0.35, 0.52; p < 0.001), and stage IV type II EC (HR 0.43; 95% CI 0.36, 0.51; p < 0.001), but not stage III type II EC (HR 0.76; 95% CI 0.56, 1.03; p = 0.08). CONCLUSIONS: In women with advanced EC, PCS + CT is associated with improved OS compared to NACT + IDS or CT alone, regardless of stage or histology. Additionally, NACT + IDS is associated with superior OS in stage III type I and all stage IV EC compared to CT alone. Where feasible, surgery should be incorporated into treatment planning in women with advanced EC.

Chan Michelle, C., et al. (2022). "Rhesus isoimmunisation in unsensitised RhD-negative individuals seeking abortion at less than 12 weeks' gestation: a systematic review." BMJ Sexual & Reproductive Health 48(3): 163-168.
	Aim: The aim of this review was to systematically review the outcome of routine anti-D administration among unsensitised rhesus (RhD)-negative individuals who have an abortion. This review is registered with Prospero.; Methods: A search for all published and ongoing studies, without restrictions on language or publication status, was performed using the following databases from their inception: EBM Reviews Ovid - Cochrane Central Register of Controlled Trials, MEDLINE Ovid (Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily), Embase.com, Popline and Google Scholar. Study types included: randomised controlled trials, controlled trials, cohort and case-control studies from 1971 onwards. The population included women who undergo an abortion (induced, incomplete, spontaneous or septic abortion), medical or surgical <12 weeks, and isoimmunisation in a subsequent pregnancy. The primary outcomes were: (1) development of a positive Kleihauer-Betke test and (2) development of Rh alloimmunisation in a subsequent pregnancy.; Results: A total of 2652 studies were screened with 105 accessed for full-text review. Two studies have been included with high bias appreciated. Both studies found few women to be sensitised in forming antibodies after an abortion. The limited studies available and heterogeneity prevent the conduction of a meta-analysis.; Conclusions: Rh immunoglobulin has well-documented safety. However, it is not without risks and costs, is a possible barrier to delivering efficient services, and may have limited availability in some countries. The evidence base and quality of studies are currently limited. There is unclear benefit from the recommendation for Rh testing and immunoglobulin administration in early pregnancy. More research is needed as clinical practice guidelines are varied, based on expert opinions and moving away from testing and administration at time of abortion.; Implications: There is limited evidence surrounding medical benefit of Rh testing and immunoglobulin administration in early pregnancy. Further research is needed to define alloimmunisation and immunoglobulin benefit to update standards of care. Additionally, other factors should be considered in forming clinical policies and guidelines such as costs, feasibility and impact on access to care for patients.; Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Chan, S. Y., et al. (2023). "Time-to-conception and clinical pregnancy rate with a myo-inositol, probiotics, and micronutrient supplement: secondary outcomes of the NiPPeR randomized trial." Fertility and Sterility 119(6): 1031-1042.
	Objective: To determine whether a combined myo-inositol, probiotics and micronutrient nutritional supplement impacts time-to-natural-conception and clinical pregnancy rates. Design(s): Secondary outcomes of a double-blind randomized controlled trial. Setting(s): Community recruitment. Patient(s): Women aged 18 to 38 years planning to conceive in the United Kingdom, Singapore, and New Zealand, excluding those with diabetes mellitus or receiving fertility treatment. Intervention(s): A standard (control) supplement (folic acid, iron, calcium, iodine, beta-carotene), compared with an intervention additionally containing myo-inositol, probiotics, and other micronutrients (vitamins B2, B6, B12, D, zinc). Main Outcome Measure(s): Number of days between randomization and estimated date of natural conception of a clinical pregnancy, as well as cumulative pregnancy rates at 3, 6, and 12 months. Result(s): Of 1729 women randomized, 1437 (83%; intervention, n=736; control, n=701) provided data. Kaplan-Meier curves of conception were similar between intervention and control groups; the time at which 20% achieved natural conception was 90.5 days (95% confidence interval: 80.7, 103.5) in the intervention group compared with 92.0 days (76.0, 105.1) in the control group. Cox's proportional hazard ratios (HRs) comparing intervention against control for cumulative achievement of pregnancy (adjusted for site, ethnicity, age, body mass index, and gravidity) were similar at 3, 6, and 12 months. Among both study groups combined, overall time-to-conception lengthened with higher preconception body mass index, and was longer in non-White than in White women. Among women who were overweight the intervention shortened time-to-conception compared with control regardless of ethnicity (12-month HR=1.47 [1.07, 2.02], P=.016; 20% conceived by 84.5 vs. 117.0 days) and improved it to that comparable to nonoverweight/nonobese women (20% conceived by 82.1 days). In contrast, among women with obesity, time-to-conception was lengthened with intervention compared with control (12-month HR=0.69 [0.47, 1.00]; P=.053; 20% conceived by 132.7 vs. 108.5 days); an effect predominantly observed in non-White women with obesity. Conclusion(s): Time-to-natural-conception and clinical pregnancy rates within a year were overall similar in women receiving the intervention supplement compared with control. Overweight women had a longer time-to-conception but there was suggestion that the supplement may shorten their time-to-conception to that comparable to the nonoverweight/nonobese women. Further studies are required to confirm this. Clinical Trial Registration Number: clinicaltrials.gov (NCT02509988)Copyright © 2023 The Authors

Chancellor, M. B., et al. (2021). "An evaluation of women with persistent or recurrent stress urinary incontinence (SUI) following surgery in a double-blind, randomized, controlled trial comparing safety and efficacy of autologous muscle derived cells for urinary sphincter repair (AMDC-USR) with placebo (PBO)." Journal of urology 206(SUPPL 3): e99‐e100.
	INTRODUCTION AND OBJECTIVE: Women with persistent or recurrent SUI following prior surgical intervention have an unmet medical need with symptoms which substantially impact daily functioning and quality of life (QOL). METHODS: Data provided are a stratified subset from a Phase 3 study (NCT01893138). 75 women with average 19.8±11.3 stress leaks over 3 days were randomized 2:1 (150 x 106 AMDC‐USR:vehicle PBO) at 22 sites. AMDC‐USR was manufactured from skeletal muscle tissue harvested from the vastus lateralis via outpatient biopsy and injected into the urinary sphincter during a subsequent outpatient procedure. SUI was monitored by 3‐day diaries of stress incontinence episode frequency (SIEF) and QOL questionnaires during blinded follow‐up through 12 months. RESULTS: All women completed 12‐month visits (50 AMDCUSR; 25 PBO). Treatment effect at ≥75% SIEF reduction was robust and significant. SIEF reduction in AMDC‐USR correlated with improvement in all QOL scores at 12 months (p 0.002) and exceeded clinically meaningful levels of ≥ 10‐point improvement in I‐QOL score at ≥75% reduction in SIEF. There were significant differences in QOL changes between responders and non‐responders in the AMDC‐USR group only. There were no AMDC‐USR‐related serious adverse reactions. CONCLUSIONS: Women with chronic SUI symptoms (average > 12 years) sought treatment despite undergoing as many as five prior surgeries at the time of enrollment. A single injection of AMDCUSR may be a safe and effective treatment in this challenging refractory population. Based in part on this evidence to address unmet medical need and the recognized seriousness of the condition, AMDC‐USR has been granted the expedited Regenerative Medicine Advanced Therapy (RMAT) designation by the United States Food and Drug Administration for this population.

Chang, C., et al. (2021). "The Impact of Bariatric Surgery Compared to Metformin Therapy on Pregnancy Outcomes in Patients with Polycystic Ovarian Syndrome: a Systematic Review and Meta-analysis." Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract 25(2): 378-386.
	Background: Polycystic ovarian syndrome (PCOS) is a leading cause of infertility among women of reproductive age. The interplay between hyperinsulinemia and obesity results in many of the reproductive and hormonal changes seen in PCOS including abnormal menses, infertility, and pregnancy loss. While bariatric surgery has been found to be an effective treatment strategy for morbid obesity, its role in the management of PCOS-related infertility compared to standard therapy (metformin) is less clear.; Aims: To assess the impact of bariatric surgery on pregnancy outcomes in women with PCOS compared to metformin therapy in a systematic review and meta-analysis.; Methods: MEDLINE, EMBASE, PubMed, and Google Scholar were searched from inception to August 2019. Studies that reported quantitative data on pregnancy outcomes on women of reproductive age with PCOS with at least a 3-month follow-up and a minimum of 5 or more sample size were included. The primary outcome was pregnancy rate, expressed as an event rate and 95% confidence interval (95% CI).; Results: Ten studies with a total of 587 patients were included in the final analyses (Metformin: 5 studies, n = 192; Bariatric surgery (BS): 5 studies (2 Roux-en-Y gastric bypass, 2 sleeve gastrectomy, 1 Roux-en-Y gastric bypass + sleeve gastrectomy), n = 186). The average time to follow-up was 18.25 months (range 3-36) with a shorter time to follow-up in the metformin group compared to the bariatric surgery group (Metformin: 11.2 vs BS: 24.5 months). While metformin increased the likelihood of pregnancy compared to placebo or non-surgical interventions (OR = 3.08, 95% CI 1.29-7.37, p = 0.01), the pregnancy rate after bariatric surgery was greater than metformin (34.9%, 95% CI 0.20-0.53 vs 17.1%, 95% CI 0.12-0.23, p = 0.026 for the difference). Additionally, there was a trend to a greater improvement in menstrual irregularity in the bariatric group compared to the metformin group with a reduction of 92% in the bariatric cohort compared to a reduction of 54% in the metformin cohort, but the data was limited.; Conclusion: Bariatric surgery appears to be a more effective treatment strategy for patients with PCOS and class 3 obesity compared to metformin alone. Women with PCOS and infertility should consider bariatric surgery for weight loss and improvement in pregnancy outcomes.

Chang, C.-L., et al. (2022). "Comparing the outcomes and effectiveness of robotic-assisted sacrocolpopexy and laparoscopic sacrocolpopexy in the treatment of pelvic organ prolapse." International Urogynecology Journal 33(2): 297-308.
	Introduction and Hypothesis: Abdominal sacrocolpopexy is regarded as the gold standard for management of pelvic organ prolapse (POP). Nowadays, minimally invasive surgeries are preferred, and sacrocolpopexy can be performed using either a laparoscopic or robotic-assisted approach. The aim of the current study was to compare the efficacy and safety of robotic-assisted sacrocolpopexy (RASC) and laparoscopic sacrocolpopexy (LSC) through an updated systematic review and meta-analysis.; Methods: We performed a systematic literature review of different databases and related references from their inception until July 2020 without language restrictions. All randomized control trials and comparative studies that compared RASC and LSC for the management of POP were included.; Results: A total of 13 studies including 2115 participants were included for the pooled analysis. The pooled results revealed that RASC was associated with a significantly longer operative time (weighted mean difference, 29.53 min; 95% confidence interval [CI], 12.88 to 46.18 min, P = 0.0005), significantly less estimated blood loss (weighted mean difference, -86.52 ml; 95% CI -130.26 to -42.79 ml, P = 0.0001), significantly fewer overall intraoperative complications (odds ratio [OR] 0.6; 95% CI 0.40 to 0.91; P = 0.01) and significantly lower conversion rate (OR 0.39; 95% CI 0.19 to 0.82; P = 0.01) compared with LSC. There were no significant differences between the length of hospital stays, overall postoperative complications, postoperative stress incontinence, mesh erosion and effectiveness between the two groups.; Conclusion: The current study showed comparable efficacy between RASC and LSC. Though RASC was associated with less blood loss and a lower conversion rate, the differences were not clinically significant. The choice of surgical procedure with either RASC or LSC is according to surgeon discretion and patient preferences. (© 2021. The International Urogynecological Association.)

Chang, C. S., et al. (2023). "Comparison of Minimally Invasive and Open Surgery for the Treatment of Endometrial Cancer with a High Risk of Recurrence: A Propensity Score Matching Study in Korea and Taiwan." Annals of Surgical Oncology 30(11): 6855-6864.
	Background: This study compared oncologic outcomes between minimally invasive surgery (MIS) and open surgery for the treatment of endometrial cancer with a high risk of recurrence. Method(s): This study included patients with endometrial cancer who underwent primary surgery at two tertiary centers in Korea and Taiwan. Low-grade advanced-stage endometrial cancer (endometrioid grade 1 or 2) or endometrial cancer with aggressive histology (endometrioid grade 3 or non-endometrioid) at any stage was considered to have a high risk of recurrence. We conducted 1:1 propensity score matching between the MIS and open surgery groups to adjust for the baseline characteristics. Result(s): Of the total of 582 patients, 284 patients were included in analysis after matching. Compared with open surgery, MIS did not show a difference in disease-free survival [hazard ratio (HR) 1.09; 95% confidence interval (CI) 0.67-1.77, P = 0.717] or overall survival (HR 0.67; 95% CI 0.36-1.24, P = 0.198). In the multivariate analysis, non-endometrioid histology, tumor size, tumor cytology, depth of invasion, and lymphovascular space invasion were risk factors for recurrence. There was no association between the surgical approach and either recurrence or mortality in the subgroup analysis according to stage and histology. Conclusion(s): MIS did not compromise survival outcomes for patients with endometrial cancer with a high risk of recurrence when compared with open surgery.Copyright © 2023, Society of Surgical Oncology.

Chang, E. S., et al. (2022). "Postprocedural Pain Associated With 5 Versus 20 Intradetrusor Injections of onabotulinumtoxinA for Treatment of Overactive Bladder: a Multicenter Randomized Clinical Trial." Urogynecology (Philadelphia, Pa.) 28(8): 518‐525.
	IMPORTANCE: Intradetrusor injection of onabotulinumtoxinA is performed via varying injection paradigms but no studies have studied the various effects of these paradigms on patient experience with the procedure. OBJECTIVES: This randomized clinical trial aims to compare pain and procedure time between patients receiving a 100‐unit dose of onabotulinumtoxinA in 5 injections compared to 20 injections for the treatment of idiopathic overactive bladder or urgency urinary incontinence. STUDY DESIGN: Patients presenting with refractory overactive bladder or urgency urinary incontinence at 2 clinical sites were identified and randomized to undergo onabotulinumtoxinA treatment with 5 injections versus 20 injections. Patients rated their pain level on a 10‐point visual analog scale at procedure completion. The procedure duration was recorded with a stopwatch. Patients were followed up 6 weeks postprocedure, at which time they completed a Global Response Assessment to determine subjective efficacy of treatment. Participants were additionally monitored for incidence of adverse events in the follow‐up period. RESULTS: The average pain score was not statistically significant between groups (2; interquartile range, 1‐4 for the 5 injection group vs 3; interquartile range, 2‐4 for the 20 injection group; P = 0.27). Patients who received 5 injections experienced significantly shorter mean procedure time as compared with patients who received 20 injections (76 seconds vs 176 seconds; P < 0.001). There were no differences in subjective efficacy or adverse events between groups. CONCLUSIONS: Perceived pain, efficacy, and postprocedure complications did not significantly differ between patients receiving 5 injections and 20 injections, but procedure time was significantly shorter.

Chang, N. (2022). "Effects of Fuyuan Yishen Huoxue decoction combined with conventional western medicine in treatment of irregular menstruation after induced abortion." China Minkang Medicine / 中国民康医学 34(14): 107‐109,113.
	Objective: To observe the effect of Fu Yishen Huoxue Decoction combined with conventional western medicine in the treatment of patients with irregular menstruation after induced abortion. Methods: From January 2018 to January 2020, 80 patients with irregular menstruation after induced abortion were selected for prospective study, and they were divided into the control group and the observation group with 40 cases in each group according to the random number table method. The control group was treated with conventional western medicine (estradiol valerate tablets + progesterone capsules), and the observation group was treated with Fufu Yishen Huoxue Decoction on the basis of the control group. Thickness, menstrual period, estrogen levels [estradiol (E_(2)), progesterone (P)], and incidence of adverse reactions. Results: The total effective rate of the observation group was 95.00% (38/40), which was higher than 75.00% (30/40) of the control group, and the difference was statistically significant (P<0.05). Conclusion: Fu Yishen Huoxue Decoction combined with conventional western medicine in the treatment of patients with irregular menstruation after induced abortion can improve the total effective rate of treatment, estrogen level, promote endometrial hyperplasia, and restore menstrual cycle, and its effect is better than conventional western medicine treatment.

Chang, O. H., et al. (2021). "03 Surgical correction of the genital hiatus at the time of sacrocolpopexy - are concurrent posterior repairs cost-effective?" American Journal of Obstetrics and Gynecology 224(6 Supplement): S726-S727.
	Objectives: Correcting the genital hiatus with posterior repair (PR) during sacrocolpopexy reduces prolapse recurrence, but may result in complications or dyspareunia requiring subsequent treatment. Our objective was to perform a cost-effectiveness analysis of posterior repair performed at the time of laparoscopic sacrocolpopexy. Material(s) and Method(s): We used TreeAge Pro to construct a decision model comparing sacrocolpopexy with and without concurrent posterior repair (SCP and SCP + PR). Using a time horizon of 1 year, we modeled prolapse recurrence, prolapse retreatment, and complications including rectal injury, rectovaginal hematoma requiring OR take-back, and postoperative dyspareunia. Costs included index surgery, surgical retreatment, and complications. Costs, probabilities, and utilities were gathered from Medicare reimbursement data, published literature, and institutional billings department (Table 1). We modeled effectiveness as quality-adjusted-life years (QALY). Cost-effectiveness was defined as an incremental cost-effectiveness ratio (ICER) and willingness to pay (WTP) of $100,000/QALY. Base-case, tornado plots, sensitivity analyses were performed. Result(s): In the base case scenario, SCP was the dominant strategy with lower cost and higher effectiveness. Tornado plots showed CEA results were most influenced by the cost of SCP, cost of SCP + PR, and probability of dyspareunia after SCP. In one-way sensitivity analyses, the model outcome would change only if the cost of SCP was greater than SCP + PR or if the probability of dyspareunia was 80.8% after SCP. SCP + PR costs more than SCP, but we analyzed what would happen if costs were equal. In this hypothetical scenario, SCP + PR still only became the optimal strategy if the recurrence rate after SCP was >20% (base case 9.2%) while at the same time dyspareunia after SCP + PR was <10% (base case 29%). These unlikely scenarios further support the strength of our model. Similarly, when the probability of prolapse recurrence after SCP was increased to 30%, SCP + PR only became the optimal strategy if every patient undergoes prolapse retreatment after SCP and SCP + PR. Conclusion(s): In this cost-effectiveness analysis, SCP without concurrent PR was the dominant strategy. SCP + PR costs more with lower effectiveness than SCP alone due to higher surgical cost of SCP + PR and higher probability of dyspareunia after SCP + PR. [Formula presented]Copyright © 2021

Chang, O. H., et al. (2021). "Hysterectomy Versus Hysteropexy at the Time of Native Tissue Pelvic Organ Prolapse Repair: A Cost-Effectiveness Analysis." Female Pelvic Medicine and Reconstructive Surgery 27(2): E277-E281.
	Objective The aim of the study was to determine whether a hysterectomy at the time of native tissue pelvic organ prolapse repair is cost-effective for the prevention of endometrial cancer. Methods We created a decision analysis model using TreeAge Pro. We modeled prolapse recurrence after total vaginal hysterectomy with uterosacral ligament suspension (TVH-USLS) versus sacrospinous ligament fixation hysteropexy (SSLF-HPXY). We modeled incidence and diagnostic evaluation of postmenopausal bleeding, including risk of endometrial pathology and diagnosis or death from endometrial cancer. Modeled costs included those associated with the index procedure, subsequent prolapse repair, endometrial biopsy, pelvic ultrasound, hysteroscopy, dilation and curettage, and treatment of endometrial cancer. Results TVH-USLS costs US $587.61 more than SSLF-HPXY per case of prolapse. TVH-USLS prevents 1.1% of women from experiencing postmenopausal bleeding and its diagnostic workup. It prevents 0.95% of women from undergoing subsequent major surgery for the treatment of either prolapse recurrence or suspected endometrial cancer. Using our model, it costs US $2,698,677 to prevent one cancer death by performing TVH-USLS. As this is lower than the value of a statistical life, it is cost-effective to perform TVH-USLS for cancer prevention. Multiple 1-way sensitivity analyses showed that changes to input variables would not significantly change outcomes. Conclusions TVH-USLS increased costs but reduced postmenopausal bleeding and subsequent major surgery compared with SSLF-HPXY. Accounting for these differences, TVH-USLS was a cost-effective approach for the prevention of endometrial cancer. Uterine preservation/removal at the time of prolapse repair should be based on the woman's history and treatment priorities, but cancer prevention should be one aspect of this decision.Copyright © American Urogynecologic Society. All rights reserved.

Chang, O. H., et al. (2021). "Reply: Hysterectomy Versus Hysteropexy at the Time of Native-Tissue Pelvic Organ Prolapse Repair: A Cost-Effectiveness Analysis." Female Pelvic Medicine & Reconstructive Surgery 27(12): e716.
	
Chang, O. H., et al. (2022). "Surgical correction of the genital hiatus at the time of sacrocolpopexy - a 7-year markov analysis." American Journal of Obstetrics and Gynecology 226(3 Supplement): S1291.
	Objectives: Narrowing the genital hiatus with a posterior repair at the time of sacrocolpopexy may reduce the odds of prolapse recurrence but increases the risk of surgical complications or dyspareunia. Our objective was to perform a cost-effectiveness analysis of concurrent posterior repair performed at the time of laparoscopic hysterectomy with sacrocolpopexy over a 7-year time period. Material(s) and Method(s): We used TreeAge Pro to construct a decision model comparing sacrocolpopexy with and without concurrent posterior repair (SCP and SCP+PR) over a time horizon of 7 years. A Markov model was embedded in the decision model to simulate prolapse recurrence, prolapse retreatment, and complications including rectal injury, rectovaginal hematoma requiring operative take-back, and postoperative dyspareunia. Costs included index surgery, surgical retreatment and complications. Costs, probabilities, and utilities were gathered from Medicare reimbursement data, published literature, and institutional billings department (Table 1). We modeled effectiveness as quality-adjusted-life years (QALY). Cost-effectiveness was defined as an incremental cost-effectiveness ratio (ICER) calculated as costs / effectiveness and the willingness to pay (WTP) was set at $100,000/QALY. Sensitivity analyses were performed by varying input variables across a wide range to identify thresholds where our conclusions could change. Result(s): Our model showed that SCP was the dominant strategy with lower costs (-$ 9699.02) and higher effectiveness (+0.10) compared to SCP+PR over the 7-year period. Tornado plots showed that the analysis was most influenced by the cost of SCP and cost of SCP+PR. In one-way sensitivity analyses, the model outcome would change only if the cost of SCP was greater than SCP+PR which is not reasonable with the longer operative time and associated surgical complications. In two-way sensitivity analyses, we varied the probability of prolapse recurrence after both strategies. Our conclusions would only change if the probability of recurrence after SCP was 49.5% higher than after SCP+PR. When varying the probabilities of dyspareunia for both strategies, SCP+PR only became the dominant strategy if the probability of dyspareunia for SCP+PR were 9.9% less than the rate associated with SCP alone. None of the scenarios above were reasonable. Conclusion(s): In this 7-year Markov cost-effectiveness analysis, SCP without concurrent PR was the dominant strategy. SCP+PR costs more with lower effectiveness than SCP alone due to higher surgical cost of SCP+PR and higher probability of dyspareunia after SCP+PR. [Formula presented]Copyright © 2022

Chang, W. Y. and H. Y. Li (2020). "Anesthetic efficacy of propofol combined butorphanol in laparoscopic surgery for ectopic pregnancy: A protocol of systematic review and meta-Analysis." Medicine (United States) 99(20): e20289.
	Background:Recent studies have suggested that propofol combined butorphanol (PB) has anesthetic effect in laparoscopic surgery (LS) for ectopic pregnancy (EP). But investigations of its potential effects are inconsistent. We will explore the current literature examining PB in LS for EP. Method(s):We will perform a comprehensive search from MEDLINE, Embase, Cochrane Library, PsycINFO, Global Health, Web of Science, Allied and Complementary Medicine Database, and China National Knowledge Infrastructure from inception to the present. Other literatures, such as conference abstracts, references to the relevant reviews will also be checked. Two authors will check the titles, abstracts, and full texts independently. They will also independently carry out data collection and study quality assessment. We will conduct statistical analysis using RevMan 5.3 software. Result(s):This study will provide accurate results on the anesthetic effect and safety of PB in LS for EP. Conclusion(s):This study will establish high-quality evidence of the anesthetic effect and safety of PB in LS for EP to facilitate the clinical practice and guideline development.Study registration number:INPLASY202040044.Copyright © 2020 Lippincott Williams and Wilkins. All rights reserved.

Chang, Y., et al. (2022). "Association of embryo transfer type with infertility in endometriosis: a systematic review and meta-analysis." Journal of Assisted Reproduction and Genetics 39(5): 1033-1043.
	Purpose: The study aims to evaluate whether frozen embryo transfer can restore optimal receptivity leading to better assisted reproductive technology outcomes in women with endometriosis.; Methods: This systematic review and meta-analysis, conducted from January 10, 2021 to July 1, 2021, searched the Cochrane Library, PubMed, Embase, Web of Science, OVID, and Clinicaltrials.gov databases from inception to January 10, 2021. The search strategy combined search terms as follows: ("endometriosis" OR "deep endometriosis" OR "endometrioma") AND ("frozen-thawed embryo transfer" OR "frozen embryo transfer" OR "freeze-all strategy") AND ("pregnancy outcome" OR "live birth rate" OR "clinical pregnancy rate" OR "miscarriage rate"). No publication time or language limits were set during the searches. In addition, references of the related articles were searched by hand. Patients were included if they had a history of endometriosis and had received fresh or frozen embryo transfer. Only the first transfer cycle was included. Odds ratios (ORs) and 95% confidence intervals (CIs) were used to express outcomes, and data synthesis was conducted using RevMan, version 5.4 software.; Results: A total of six studies with moderate methodologic quality were retrieved in the meta-analysis. The studies included 3010 women with endometriosis who wanted to conceive; 1777 (59.0%) had frozen embryo transfer, and 1233 (41.0%) had fresh embryo transfer. There was a significantly higher frequency of live births in the frozen embryo group than in the fresh embryo group (OR, 1.53; 95% CI, 1.13-2.08; P = .007). Despite a similar clinical pregnancy rate in the two groups (OR, 1.26; 95% CI, 0.95-1.69; P = .11), the difference in miscarriage rate was significant (OR, 0.70; 95% CI, 0.50-0.97; P = .03). Evidence quality was considered moderate.; Conclusion: Cryopreserved embryo transfer has resulted in preferable reproduction outcomes when compared with fresh embryo transfer in patients with endometriosis, but the evidence is not yet abundant. More strictly designed research is needed to evaluate whether frozen embryo transfer leads to better reproductive outcomes in women with endometriosis compared with those receiving fresh embryo transfer.; Registration Number: PROSPERO CRD42021248313. (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Chang, Y. S., et al. (2023). "Associations between breastfeeding intention, breastfeeding practices and post-natal depression during the COVID-19 pandemic: A multi-country cross-sectional study." Maternal & child nutrition 19(1): e13450.
	Associations between breastfeeding intention, duration and post-natal depression (PND) have been shown in pre-COVID-19 studies. However, studies during COVID-19 have not examined the associations between breastfeeding intention, breastfeeding practices, and PND in an international sample of post-natal women, taking into consideration COVID-19 related factors. This is the first study to address this gap as both PND and breastfeeding may be affected by COVID-19, and have important long-term effects on women's and infant's health. A cross-sectional internet-based survey was conducted with 3253 post-natal women from five countries: Brazil, South Korea, Taiwan, Thailand, and the United Kingdom from July to November 2021. The results showed that women who intended to breastfeed during pregnancy had lower odds of having PND than women who did not intend to. Women who had no breastfeeding intention but actually breastfed had greater odds (AOR 1.75) of having PND than women who intended to breastfeed and actually breastfed. While there was no statistical significance in expressed breast milk feeding in multivariable logistic regression models, women who had shorter duration of breastfeeding directly on breast than they planned had greater odds (AOR 1.58) of having PND than those who breastfed longer than they planned even after adjusting for covariates including COVID-19-related variables. These findings suggested the importance of working with women on their breastfeeding intention. Tailored support is required to ensure women's breastfeeding needs are met and at the same time care for maternal mental health during and beyond the pandemic.

Chao, Y.-S. and S. McCormack (2019). "HPV Self-Sampling for Primary Cervical Cancer Screening: A Review of Diagnostic Test Accuracy and Clinical Evidence – An Update." CADTH Rapid Response Reports.
	The introduction of cervical cancer screening and timely intervention is associated with the recent decrease in cervical cancer incidence. 1 There are several options to screen cervical cancer. Two of the methods commonly used in Canada are cytology and human papillomavirus (HPV) tests. 2 Cytology requires clinicians to obtain samples from the cervix for further examination. 2 HPV tests that detect the infection of HPV also requires samples from the cervix. 2 The HPV tests that detect certain types of carcinogenic HPV genotypes, especially genotypes 16 and 18, are called high-risk HPV tests. 3 The samples can be obtained via brushes or swabs or other devices not only by clinicians, but also by screening participants. 3 Clinician-sampled HPV tests are used in screening program in several countries, such as Italy 4 and Denmark. 5 Self-sampled HPV tests have been tested in the capital region in Denmark but have not replaced clinician-sampled tests. 5 With feasibility to conduct at home and potentially better acceptability to participants, self-sampled HPV tests have been used to reach individuals that are unscreened or under-screened for cervical cancer. 4 In a previous CADTH report, there was some evidence to show similar diagnostic test accuracy between self- and clinician-sampled HPV tests. 6 For example, the diagnostic test accuracy of GP5+/6+ polymerase chain reaction (PCR) HPV tests using samples taken with brushes is similar for self- and clinician-collected samples. 7 In several primary studies, fair to high agreement between self- and clinician-sampled HPV tests has been found. 6 Since the previous CADTH review, there have been primary studies comparing self- and clinician-sampled HPV tests published 8 , 9 and a systematic review has been updated. 3 This report updates the previous review on the difference in the diagnostic test accuracy of self-sampled HPV tests and the agreement between self- and clinician-sampled HPV tests. (Copyright © 2019 Canadian Agency for Drugs and Technologies in Health.)

Chaowawanit, W., et al. (2021). "Comparison between laparoscopic and robotic surgery for sentinel lymph node mapping in endometrial cancer using indocyanine green and near infra-red fluorescence imaging." Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology 41(4): 642-646.
	Indocyanine green (ICG) and near infra-red fluorescence imaging in minimally invasive surgery is an option to map sentinel lymph nodes (SLN). The aim of this study was to compare the outcomes of SLN mapping between laparoscopic and robotic surgery. One-hundred-and-forty women with histologically confirmed endometrial cancer, were treated with a minimally invasive hysterectomy, bilateral salpingo-oophorectomy and SLN mapping. After anaesthetic induction, ICG was superficially injected into cervical submucosa and deeply injected into the cervical stroma at the 3 and 9 o'clock positions (1.25 mg/site). Eleven cases were abandoned after ICG injection (laparoscopic surgery seven cases and robotic surgery four cases) because of obesity, technical difficulty and peritoneal disease. One-hundred-and-eleven patients were analysed. Seventy-six patients had a laparoscopic procedure and 33 patients had robotic surgery. The overall and bilateral detection rates were 97% and 83% for laparoscopic surgery and 88% and 73% for robotic surgery. Laparoscopic surgery was superior to robotic surgery in terms of overall detection (p-value .046). There was no significant difference in the intra-operative SLN identification time or SLN dissection time between laparoscopy and robotic surgery (p-value .247 and .145, respectively). Further research is required to compare laparoscopy and robotic surgery in terms of SLN detection.Impact StatementWhat is already known on this subject? Sentinel lymph node (SLN) mapping aims to avoid complications and provide useful staging information for endometrial cancer. ICG has been shown to improve the detection rate and NPV compared with other tracers (blue dye and technetium 99). No data exists comparing SLN mapping rates using ICG in laparoscopy and robotic surgery.What do the results of this study add? The overall and bilateral detection rates were 97% and 83% for laparoscopic surgery and 88% and 73% for robotic surgery. Laparoscopic surgery was superior to robotic surgery in terms of overall detection. There was no significant difference in the intra-operative SLN identification time or SLN dissection time between laparoscopy and robotic surgery.What are the implications of these findings for clinical practice and/or further research?: This study confirms that laparoscopy and robotic surgery are not different in terms of bilateral detection rate and SLN operating time; the study population is small.

Chapman, G. C., et al. (2021). "Tamsulosin vs placebo to prevent postoperative urinary retention following female pelvic reconstructive surgery: a multicenter randomized controlled trial." American Journal of Obstetrics and Gynecology 225(3): 274.e271-274.e211.
	BACKGROUND: Postoperative urinary retention is common after female pelvic reconstructive surgery. Alpha receptor antagonists can improve dysfunctional voiding by relaxing the bladder outlet and may be effective in reducing the risk of postoperative urinary retention. OBJECTIVE: This study aimed to determine whether tamsulosin is effective in preventing postoperative urinary retention in women undergoing surgery for pelvic organ prolapse. STUDY DESIGN: This was a multicenter, double-blind, randomized controlled trial between August 2018 and June 2020, including women undergoing surgery for pelvic organ prolapse. Patients were excluded from recruitment if they had elevated preoperative postvoid residual volume, history of postoperative urinary retention, or a contraindication to tamsulosin. Those who experienced cystotomy were excluded from analysis. Participants were randomized to a 10-day perioperative course of tamsulosin 0.4 mg vs placebo, beginning 3 days before surgery. A standardized voiding trial was performed on postoperative day 1. The primary outcome was the development of postoperative urinary retention, as defined by the failure of the voiding trial or subsequent need for catheterization to empty the bladder. Secondary outcomes included the rate of urinary tract infection and the impact on lower urinary tract symptoms as measured by the American Urological Association Symptom Index. RESULTS: Of 119 patients, 57 received tamsulosin and 62 received placebo. Groups were similar in regard to demographics, preoperative prolapse and voiding characteristics, and surgical details. Tamsulosin was associated with a lower rate of postoperative urinary retention than placebo (5 patients [8.8%] vs 16 patients [25.8%]; odds ratio, 0.28; 95% confidence interval, 0.09-81; P=.02). The number needed to treat to prevent 1 case of postoperative urinary retention was 5.9 patients. The rate of urinary tract infection did not differ between groups. American Urological Association Symptom Index scores significantly improved after surgery in both groups (median total score, 14 vs 7; P<.01). Scores related to urinary stream improved more in the tamsulosin group than in placebo (P=.03). CONCLUSION: In this placebo-controlled trial, tamsulosin use was associated with a reduced risk of postoperative urinary retention in women undergoing surgery for pelvic organ prolapse.

Chaput Kathleen, H., et al. (2023). "Effect of Remote Peer-Counsellor- delivered Behavioral Activation and Peer-support for Antenatal Depression on Gestational Age at Delivery: a single-blind, randomized control trial." Trials 24(1): 240.
	Background: Antenatal depression (AD) is the most common complication of pregnancy in developed countries and increases the risk of preterm birth (PTB). Many pregnant individuals with AD do not obtain treatment due in part to risks associated with antidepressant medications, the expense and wait times for psychological services, and perceived stigma. Accessible and timely treatment of antenatal depression is crucial to minimize foetal impacts and associated long-term child health outcomes. Previous studies show that behavioural activation and peer support are promising avenues of treatment for perinatal depression. Additionally, remote and paraprofessional counselling interventions show promise as more accessible, sustainable, and cost-effective treatment avenues than traditional psychological services. The primary aim of this trial is to test the effectiveness of a remote, behavioural activation and peer support intervention, administered by trained peer para-professionals, for increasing gestational age at delivery among those with antenatal depression. The secondary aims are to evaluate the effectiveness for treating AD prior to delivery, with persistence into the postpartum; improving anxiety symptoms; and improving parenting self-efficacy compared to controls.; Methods: A two-arm, single-blinded, parallel groups randomized controlled trial (RCT) with repeated measures will be conducted. Participants scoring >10 on the Edinburgh Postnatal Depression Scale will be recruited from the larger P3 cohort and invited to enroll. Assessments will be conducted prior to 27 weeks' gestation at trial intake (T1), post-intervention, prior to delivery (T2), 5-6 months postpartum (T3), and 11-12 months postpartum (T4) and will include self-report questionnaires and linked medical records.; Discussion: Our remote, peer paraprofessional-delivered behavioural activation plus peer support intervention has the potential to successfully reduce symptoms of AD, which may in turn decrease the risk of PTB and subsequent health impacts. The current trial builds on previous findings and uses a patient-oriented approach to address priorities for patient care and to provide a cost-effective, accessible, and evidence-based treatment to pregnant individuals with AD.; Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) registry (ISRCTN51098220) ISRCTN51098220. Registered on April 7, 2022. (© 2023. The Author(s).)

Charbonneau-Lefebvre, V., et al. (2022). "Attachment and Childhood Maltreatment as Moderators of Treatment Outcome in a Randomized Clinical Trial for Provoked Vestibulodynia." The Journal of Sexual Medicine 19(3): 479-495.
	Background: Although distal developmental factors, such as attachment and childhood maltreatment (CM), are associated with the occurrence, severity, and adjustment to provoked vestibulodynia (PVD)-the most prevalent form of vulvodynia-no studies to date have examined whether these variables are related to treatment efficacy in the context of PVD. Attachment and CM may act as moderating variables when examining different treatment modalities, whereby individuals with more insecure attachment orientations (anxiety/avoidance) or a history of CM may benefit less from treatments with higher interpersonal contexts, such as sex and couple therapy-a recommended treatment for PVD.; Aim: The present randomized clinical trial (RCT) examined attachment and CM as predictors and moderators of sexual satisfaction, distress, and function at post-treatment and 6-month follow-up while comparing 2 treatments for PVD: Topical lidocaine, and a novel cognitive behavioral couple therapy focused on women's pain and partners' sexuality.; Methods: One hundred eight women with PVD were randomized to a 12-week treatment of either lidocaine or couple therapy. Women completed questionnaires at pretreatment, post-treatment, and at a 6-month follow-up.; Outcomes: (1) Global Measure of Sexual Satisfaction; (2) Female Sexual Distress Scale-Revised; (3) Female Sexual Function Index.; Results: Both attachment and CM were significant moderators of treatment outcomes. At either post-treatment or 6-month follow-up, in the couple therapy condition, women with greater attachment avoidance had poorer outcomes on sexual distress, satisfaction and function, whereas women with higher levels of CM had poorer outcomes on sexual satisfaction and sexual function, compared to women in the lidocaine condition.; Clinical Implications: Although these novel findings need further replication, they highlight the importance for clinicians to take into account distal factors, for instance, attachment and CM, when treating sexual difficulties such as PVD, as these variables may affect more interpersonal dimensions of treatment (eg, trust, compliance, etc.) and ultimately, treatment progress.; Strengths & Limitations: Using a rigorous RCT study design and statistical approach, this study is the first to examine attachment and CM as moderators in the treatment of sexual difficulties. It is however limited by the use of self-report measures, and further studies are necessary to validate the generalizability of current results to other sexual difficulties.; Conclusion: Findings support the role of interpersonal factors in the treatment of PVD and indicate that short-term psychological interventions, such as couple therapy, may be less beneficial for women with antecedents of CM and attachment insecurity. V Charbonneau-Lefebvre, M-P Vaillancourt-Morel, NO Rosen, et al. Attachment and Childhood Maltreatment as Moderators of Treatment Outcome in a Randomized Clinical Trial for Provoked Vestibulodynia. J Sex Med 2022;19:479-495. (Copyright © 2022 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Charite, U., et al. (2021). Transcranial Direct Current Stimulation to Reduce Chronic Pelvic Pain in Endometriosis.
	No Results Available Device: tDCS : Transcranial direct current stimulation Pelvic pain via pressure pain threshold Female Phase 2 40 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment EA1/174/19 January 2023

Charite, U., et al. (2021). Effects of Fasting on Success Rates of Assisted Reproductive Techologies.
	No Results Available Behavioral: Fasting Fertilisation rate|glucose in culture medium of oocytes|lactate in culture medium of oocytes|pyruvate in culture medium of oocytes|pregnancy rate|rate of mature oocytes|rate of life births|rate of implantable embryos|Course of IVF/ICSI preparation and pregnancy|WHO-5 questionnaire|changes in diet|mindfulness|anxiety and depression|current mood|experienced stress|physical fitness|quality of relationship|psychological stress caused by the unfulfilled desire to have children|gratitude|self-efficacy|abdominal sonography Female Not Applicable 1 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment KiWuC December 12, 2022

Charles, U. and R. Czech (2022). Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS.
	No Results Available Procedure: Transobturator cystocele repair|Procedure: Anterior colporrhaphy Anatomic failure|Composite surgery failure|2-year composite surgery failure|2-year anatomic failure|Complication rate|Pain after the surgery|Subjective perception of improvement|2-year subjective perception of improvement|Patient satisfaction|De novo stress urinary incontinence (SUI)|De novo overactive bladder (OAB)|Change in quality of life - urinary incontience|Change in quality of life - prolapse bother|Change in quality of life - anorectal problems|Change in quality of sexual life|Change in severity of urinary incontinence Female Not Applicable 592 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment STARS November 1, 2025

Charlotte, M., et al. (2024). "Implementation of robotic ups (unilateral pectineal suspension) for the correction of apical prolapse in a high volume laparoscopy center." European Journal of Obstetrics and Gynecology and Reproductive Biology 293: 40.
	Introduction and aims: Pelvic organ prolapse (POP) is a common disorder. Conservative treatment can be addressed; if unsuccessful, surgery is indicated. Surgical treatments such as vaginal hysterectomy (with anterior and posterior repair), sacrospinous fixation and laparoscopic sacrocolpopexy are broadly used as standard surgical procedures. Performing a hysterectomy does not increase the success rate. In addition, the use of synthetic meshes is under debate because of possible postoperative complications. The study aims to describe the implementation of UPS as a minimal invasive mesh-free apical fixation in a high volume laparoscopy center. Method(s): Robotic UPS is a standardized technique of 5 steps to restore the natural anatomical position of the uterus or vaginal cuff. After identifying the cranial part of the pectineal ligament, a non-absorbable suture is placed for lateral fixation. By manipulation of the uterus or cuff intraoperatively, the ideal anatomical reconstruction is simulated. After dissecting the bladder, the medial fixation of the suture is placed, followed by a tension free suspension to restore the physiological anatomy. Prolapse was measured by POP-Q. Result(s): In comparison to the standard surgical techniques for POP, UPS provides several advantages. The medial tension-free apical placement combined with normal pelvic floor mobility and the restoration of the vaginal axis allows for normal vaginal function. The technique provides maximum safety, significant reduction of operative time and avoidance of ureter, bowel and hypogastric nerve dissection. This procedure can be performed in a same day discharge setting (SDS). Conclusion(s): UPS was first designed, described and performed at the University Pelvic Floor Center of Klinikum Nuernberg, Germany. UPS is a highly efficient minimal-invasive mesh-free surgery, avoiding the need of a hysterectomy. Reliable level one support is achieved, respecting the natural anatomy. This technique can easily be implemented, resulting in efficient and innovative surgical POP treatment.Copyright © 2023

Charo Lindsey, M., et al. (2022). "Real-World Data From a Molecular Tumor Board: Improved Outcomes in Breast and Gynecologic Cancers Patients With Precision Medicine." JCO precision oncology 6: e2000508.
	Purpose: Next-generation sequencing is increasingly used in gynecologic and breast cancers. Multidisciplinary Molecular Tumor Board (MTB) may guide matched therapy; however, outcome data are limited. We evaluate the effect of the degree of matching of tumors to treatment as well as compliance to MTB recommendations on outcomes.; Methods: Overall, 164 patients with consecutive gynecologic and breast cancers presented at MTB were assessed for clinicopathologic data, next-generation sequencing results, MTB recommendations, therapy received, and outcomes. Matching score (MS), defined as percentage of alterations targeted by treatment over total pathogenic alterations, and compliance to MTB recommendations were analyzed in context of oncologic outcomes.; Results: Altogether, 113 women were evaluable for treatment after MTB; 54% received matched therapy. Patients with MS ≥ 40% had higher overall response rate (30.8% v 7.1%; P = .001), progression-free survival (PFS; hazard ratio [HR] 0.51; 95% CI, 0.31 to 0.85; P = .002), and a trend toward improved overall survival (HR 0.64; 95% CI, 0.34 to 1.25; P = .082) in univariate analysis. The PFS advantage remained significant in multivariate analysis (HR 0.5; 95% CI, 0.3 to 0.8; P = .006). Higher MTB recommendation compliance was significantly associated with improved median PFS (9.0 months for complete; 6.0 months for partial; 4.0 months for no compliance; P = .004) and overall survival (17.1 months complete; 17.8 months partial; 10.8 months none; P = .046). Completely MTB-compliant patients had higher MS ( P < .001). In multivariate analysis comparing all versus none MTB compliance, overall response (HR 9.5; 95% CI, 2.6 to 35.0; P = .001) and clinical benefit (HR 8.8; 95% CI, 2.4 to 33.2; P = .001) rates were significantly improved with higher compliance.; Conclusion: Compliance to MTB recommendations resulted in higher degrees of matched therapy and correlates with improved outcomes in patients with gynecologic and breast cancers.; Competing Interests: Ramez N. EskanderConsulting or Advisory Role: Pfizer, Clovis Oncology, AstraZeneca/MedImmune, Tesaro, Merck, Eisai, Agenus, Myriad Genetics, Daiichi Sankyo/LillySpeakers' Bureau: AstraZeneca/MedImmune, Myriad GeneticsTravel, Accommodations, Expense: AstraZeneca/MedImmune, Merck, Eisai Jason SicklickStock and Other Ownership Interests: PersonalisConsulting or Advisory Role: DecipheraSpeakers' Bureau: QED Therapeutics, Foundation Medicine, Roche, Deciphera, MJH Life SciencesResearch Funding: Foundation Medicine, Amgen Richard SchwabLeadership: Procend IncStock and Other Ownership Interests: Samumed (I)Patents, Royalties, Other Intellectual Property: The patent covers sialylated glycans and antibodies that specifically bind to them for early detection and diagnosis of cancer (Inst) Rebecca ShatskyHonoraria: SOTERIA Precision Medicine, Horizon CME, OncoSec, Relevate Health Group, The Dedham GroupConsulting or Advisory Role: SOTERIA Precision Medicine, OncoSec, The Dedham GroupSpeakers' Bureau: Horizon CMEResearch Funding: Oncternal Therapeutics (Inst), Phoenix Molecular Designs (Inst), Genentech (Inst), OncoSec (Inst), CytomX Therapeutics (Inst), Merck (Inst) Steven PlaxeStock and Other Ownership Interests: Pfizer, Merck, Zimmer BioMet, GlaxoSmithKline, AstraZeneca, Bristol Myers Squibb/Pfizer, Johnson & Johnson/JanssenResearch Funding: Endocyte (Inst), Incyte (Inst), MedImmune (Inst), Novartis (Inst), Pfizer (Inst), Janssen Oncology (Inst), BIND Therapeutics (Inst), PharmaMar (Inst), AstraZeneca (Inst), Kevelt (Inst), Millennium (Inst), Tesaro (Inst) Shumei KatoHonoraria: RocheConsulting or Advisory Role: Foundation Medicine, Pfizer/EMD SeronoResearch Funding: ACT Genomics, Sysmex, Konica Minolta, OmniSeq Razelle KurzrockLeadership: CureMatch, CureMetrix IncStock and Other Ownership Interests: CureMatch, IDbyDNAHonoraria: Roche, EUSA Pharma, NeoGenomics Laboratories, Biocom, NeoMed Therapeutics, Advanced Therapeutics, LEK, AACR, Chugai Pharma USA, Wiley, Merck, Pfizer, Meyer Consulting, Foundation Medicine, Turning Point Therap utics, BicaraConsulting or Advisory Role: Actuate Therapeutics, Loxo, XBiotech, Neo-Med, Roche, Gaido Soluventis, Pfizer, Merck, Turning Point Therapeutics, TD2/Volastra, Bicara Therapeutics IncSpeakers' Bureau: RocheResearch Funding: Guardant Health (Inst), Sequenom (Inst), Merck Serono (Inst), Genentech (Inst), Pfizer (Inst), Foundation Medicine (Inst), Incyte (Inst), Konica Minolta (Inst), Grifols (Inst), OmniSeq (Inst), Debiopharm Group (Inst), Boerhinger Ingelheim (Inst), Top Alliance BioScience (Inst), Takeda (Inst), MedImmune (Inst)Travel, Accommodations, Expenses: Roche, EUSA Pharma, NeoGenomics Laboratories, Biocom, NeoMed Therapeutics, Advanced Therapeutics, LEK, AACR, Chugai Pharma USA, WileyNo other potential conflicts of interest were reported.

Charoenkwan, K., et al. (2024). "Alterations in mitochondria isolated from peripheral blood mononuclear cells and tumors of patients with epithelial ovarian cancers." Scientific Reports 14(1): 15.
	Metabolic alterations play an essential role in ovarian carcinogenesis. The flexibility of mitochondrial functions facilitates cellular adaptation to the tough environment associated with carcinogenesis. An understanding of the differences in mitochondrial functions in normal ovaries and cancers could provide a basis for further exploration of future mitochondria-based screening, diagnosis, prognostic prediction, and targeted therapy for epithelial ovarian cancers. The main objective of this study was to assess mitochondrial function profiles measured from PBMCs and ovarian tissues of epithelial ovarian cancers in comparison with normal ovaries. A total of 36 patients were recruited for the study, all of whom underwent primary surgical treatment for malignant epithelial ovarian neoplasm. Of these, 20 patients were in the early stage and 16 patients were in the advanced stage. Additionally, 21 patients who had pelvic surgery for benign gynecologic conditions, with normal ovaries incidentally removed, were recruited as controls. At the time of surgery, a blood sample was collected from each participant for PBMC isolation, and ovarian tissue was retained for molecular studies. These studies included the examination of oxidative stress, mitochondrial mass, mitochondrial respiration, mitochondrial reactive oxygen species (ROS), mitochondrial membrane potential (MMP) changes, and mitochondrial swelling. Clinical and histopathological data were also collected and compared between different stages of epithelial ovarian cancers: early-stage (group 1), advanced-stage (group 2), and normal ovaries (group 3). The levels of cellular oxidative stress, mitochondrial mass, and mitochondrial biogenesis in the peripheral blood mononuclear cells (PBMCs) of participants with ovarian cancer were significantly lower than those of the control group. However, the mitochondrial respiratory parameters measured from the PBMCs were similar across all three groups. Furthermore, mitochondrial membrane depolarization and mitochondrial swelling were observed in ovarian tissues of both early-stage and advanced-stage cancer groups. We demonstrated the dynamic nature of mitochondrial ROS production, biogenesis, and respiratory function in response to epithelial ovarian carcinogenesis. The flexibility of mitochondrial functions under diverse conditions may make it a challenging therapeutic target for ovarian cancer.Copyright © 2024. The Author(s).

Charra-Brunaud, C., et al. (2022). "[Dose optimization in 3D pulsed dose rate brachytherapy for patients with locally advanced cervical cancer: A French multicenter phase II trial]." Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique 26(3): 474-480.
	Purpose: We present the results of the PHRC Tridicol, a prospective French phase II study whose objective was to increase the dose delivered to the target volume during brachytherapy for locally advanced cervical cancers.; Material and Methods: Eight centers included 48 patients, treated with concomitant radiochemotherapy, then uterovaginal brachytherapy.; Results: The median follow-up was 63 months. The dose of brachytherapy delivered in biological equivalent dose (EQD2) to 90% of the High Risk CTV (D90 CTV HR) was 80Gy in median dose. The 5-year local control rate (LC) was 84%, close to the hypothesis of 86.7%. The rate of severe complications (grade 3-4) was 23% at 5 years. The rectal dose was correlated with the risk of severe complications.; Conclusion: HR CTV dose was below the target (85Gy) due to low use of parametrial interstitial needles, as the centers did not always have an adequate applicator, or were at the time at the beginning of their learning curve. The 5-year LC rate was improved compared to that of the comparable STIC PDR group (78%) but lower than the retroEMBRACE cohort of GEC ESTRO (89%). The complication rate was higher than in the comparable group of STIC PDR but close to that of retroEMBRACE. Training brachytherapy teams in interstitial implantation or referring patients to referral centers should help improve the therapeutic index of cervical cancer. (Copyright © 2021 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.)

Charrie, M. and S. Billecocq (2021). "Knowledge of pelvic floor disorders in peripartum women: A systematic review." Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie 31(4): 204-214.
	
Chase, D., et al. (2020). "Patient-reported outcomes at discontinuation of anti-angiogenesis therapy in the randomized trial of chemotherapy with bevacizumab for advanced cervical cancer: an NRG Oncology Group study." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 30(5): 596-601.
	Introduction: To describe patient-reported outcomes and toxicities at time of treatment discontinuation secondary to progression or toxicities in advanced/recurrent cervical cancer patients receiving chemotherapy with bevacizumab.; Methods: Summarize toxicity, grade, and health-related quality of life within 1 month of treatment discontinuation for women receiving chemotherapy with bevacizumab in GOG240.; Results: Of the 227 patients who received chemotherapy with bevacizumab, 148 discontinued study protocol treatment (90 for disease progression and 58 for toxicity). The median survival time from treatment discontinuation to death was 7.9 months (95% CI 5.0 to 9.0) for those who progressed versus 12.1 months (95% CI 8.9 to 23.2) for those who discontinued therapy due to toxicities. The most common grade 3 or higher toxicities included hematologic, gastrointestinal, and pain. Some 57% (84/148) of patients completed quality of life assessment within 1 month of treatment discontinuation. Those patients who discontinued treatment due to progression had a mean decline in the FACT-Cx TOI of 3.2 points versus 2.2 in patients who discontinued therapy due to toxicity. This was a 9.9 point greater decline in the FACT-Cx TOI scores than those who discontinued treatment due to progression (95% CI 2.8 to 17.0, p=0.007). The decline in quality of life was due to worsening physical and functional well-being. Those who discontinued treatment due to toxicities had worse neurotoxicity and pain.; Discussion: Patients who discontinued chemotherapy with bevacizumab for toxicity experienced longer post-protocol survival but significantly greater declination in quality of life than those with progression. Future trial design should include supportive care interventions that optimize physiologic function and performance status for salvage therapies.; Competing Interests: Competing interests: DC reports personal fees received from AstraZeneca, Clovis, Roche/Genentech, and Tesaro, outside of the submitted work. BJM reports personal fees received from Roche/Genentech, outside of the submitted work. RTP reports serving on a Scientific Advisory Board for Genentech/Roche. AO reports serving on advisory boards for Roche, AstraZeneca, PharmaMar, Clovis Oncology, and Tesaro and received support for travel/accommodation from Roche, AstraZeneca, and PharmaMar. WKH reports receiving personal fees as consultant for Antiva, PathoVax, and Li-Cor, outside of the submitted work. DR reports serving on the Advisory Board for Genentech and Ipsen and received personal fees, outside of the submitted report. RS reports serving on the Speaker Bureau for Genentech as well as serving on Advisory Boards for Tesaro, Clovis, AstraZeneca, and Ethicon, outside of the submitted work. KST reports serving on the Speaker’s Bureau, Advisory Board for Roche/Genentech. (© IGCS and ESGO 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Chase, D. M., et al. (2021). "Impact of disease progression on healthrelated quality of life of advanced ovarian cancer (AOC) patients-pooled analysis from the prima trial." International Journal of Gynecological Cancer 31(SUPPL 1): A284.
	Introduction/Background∗ Clinical trials consistently demonstrate the detrimental impact of progressive disease (PD) on patients' health‐related quality of life (HRQoL). Progressionfree survival (PFS) is an established regulatory endpoint. However, PFS is often excluded as an efficacy endpoint on the basis that ‐ PFS is not patient relevant ‐ in early benefit assessment by select EU health technology agencies. The PRIMA/ENGOT‐OV26/GOG‐3012 (NCT02655016) Phase 3 trial showed niraparib significantly prolongs median PFS vs placebo in patients with AOC responsive to 1L platinum (Pt)‐ based chemotherapy, (CT), regardless of biomarker status. This post‐hoc analysis of PRIMA is the first study to examine the relationship between HRQoL and PD in a broad frontline AOC maintenance treatment setting. Methodology In PRIMA, patients with AOC responsive to 1L Pt CT were randomised 2:1 to once‐daily, maintenance niraparib or placebo. Impact of PD on patient HRQoL, irrespective of treatment, was evaluated within the pooled ITT population by comparing HRQoL at the last on‐treatment (pre‐progression) visit with HRQoL at end of treatment (EOT), +4 weeks, +8w, +12w, and +24w. Assessments included FOSI, EORTC QLQ‐C30, EQ‐5D‐VAS, and EORTC QLQ‐OV28 abdominal/GI symptom scale. ANCOVA was applied with treatment as a fixed effect and HRQoL at last on‐treatment visit as a continuous covariate. Mixed models for repeated measurements (MMRM) evaluated cumulative HRQoL changes. Result(s)∗ Significant reductions in HRQoL from pre‐ to postprogression were observed across all measures. Compared with pre‐progression, FOSI scores (Least‐squares mean [95% CI]) were lower at EOT+4w (‐2.2 [‐2.8, ‐1.6]) and EOT+24w (‐ 1.7 [‐2.3, ‐1.1]); each p<0.0001. Similarly, at these timepoints EORTC‐QLQ‐C30 scores were lower by ‐10.2 (‐12.4, ‐8.0) and ‐10.7 (13.2, ‐8.2) points, respectively, and EQ‐5D‐VAS by ‐8.2 (‐10.4, ‐6.0) and ‐6.2 (‐8.2, ‐4.2) points, respectively; each p<0.0001. EORTC QLQ‐OV28 scores were significantly worse at EOT+4w (6.6 [4.3, 8.9]) and EOT+24w (5.0 [2.8, 7.2]); each p<0.0001. Similar changes were seen on MMRM analysis. Conclusion∗ These findings demonstrate HRQoL is negatively impacted by PD in AOC. Preservation of HRQoL, an important therapy goal in the maintenance setting particularly for asymptomatic patients, can be achieved with PFS prolongation. PFS is of significant relevance and clinically important for AOC patients.

Chau, J. P. C., et al. (2022). "Perioperative enhanced recovery programmes for women with gynaecological cancers." Cochrane Database of Systematic Reviews 2022(3): CD008239.
	Background: Gynaecological cancers account for 15% of newly diagnosed cancer cases in women worldwide. In recent years, increasing evidence demonstrates that traditional approaches in perioperative care practice may be unnecessary or even harmful. The enhanced recovery after surgery (ERAS) programme has therefore been gradually introduced to replace traditional approaches in perioperative care. There is an emerging body of evidence outside of gynaecological cancer which has identified that perioperative ERAS programmes decrease length of postoperative hospital stay and reduce medical expenditure without increasing complication rates, mortality, and readmission rates. However, evidence-based decisions on perioperative care practice for major surgery in gynaecological cancer are limited. This is an updated version of the original Cochrane Review published in Issue 3, 2015. Objective(s): To evaluate the beneficial and harmful effects of perioperative enhanced recovery after surgery (ERAS) programmes in gynaecological cancer care on length of postoperative hospital stay, postoperative complications, mortality, readmission, bowel functions, quality of life, participant satisfaction, and economic outcomes. Search Method(s): We searched the following electronic databases for the literature published from inception until October 2020: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PubMed, AMED (Allied and Complementary Medicine), CINAHL (Cumulative Index to Nursing and Allied Health Literature), Scopus, and four Chinese databases including the China Biomedical Literature Database (CBM), WanFang Data, China National Knowledge Infrastructure (CNKI), and Weipu Database. We also searched four trial registration platforms and grey literature databases for ongoing and unpublished trials, and handsearched the reference lists of included trials and accessible reviews for relevant references. Selection Criteria: We included randomised controlled trials (RCTs) that compared ERAS programmes for perioperative care in women with gynaecological cancer to traditional care strategies. Data Collection and Analysis: Two review authors independently screened studies for inclusion, extracted the data and assessed methodological quality for each included study using the Cochrane risk of bias tool 2 (RoB 2) for RCTs. Using Review Manager 5.4, we pooled the data and calculated the measures of treatment effect with the mean difference (MD), standardised mean difference (SMD), and risk ratio (RR) with a 95% confidence interval (CI) to reflect the summary estimates and uncertainty. Main Result(s): We included seven RCTs with 747 participants. All studies compared ERAS programmes with traditional care strategies for women with gynaecological cancer. We had substantial concerns regarding the methodological quality of the included studies since the included RCTs had moderate to high risk of bias in domains including randomisation process, deviations from intended interventions, and measurement of outcomes. ERAS programmes may reduce length of postoperative hospital stay (MD -1.71 days, 95% CI -2.59 to -0.84; I2 = 86%; 6 studies, 638 participants; low-certainty evidence). ERAS programmes may result in no difference in overall complication rates (RR 0.71, 95% CI 0.48 to 1.05; I2 = 42%; 5 studies, 537 participants; low-certainty evidence). The certainty of evidence was very low regarding the effect of ERAS programmes on all-cause mortality within 30 days of discharge (RR 0.98, 95% CI 0.14 to 6.68; 1 study, 99 participants). ERAS programmes may reduce readmission rates within 30 days of operation (RR 0.45, 95% CI 0.22 to 0.90; I2 = 0%; 3 studies, 385 participants; low-certainty evidence). ERAS programmes may reduce the time to first flatus (MD -0.82 days, 95% CI -1.00 to -0.63; I2 = 35%; 4 studies, 432 participants; low-certainty evidence) and the time to first defaecation (MD -0.96 days, 95% CI -1.47 to -0.44; I2 = 0%; 2 studies, 228 participants; low-certainty evidence). The studies did not report the effects of ERAS programm s on quality of life. The evidence on the effects of ERAS programmes on participant satisfaction was very uncertain due to the limited number of studies. The adoption of ERAS strategies may not increase medical expenditure, though the evidence was of very low certainty (SMD -0.22, 95% CI -0.68 to 0.25; I2 = 54%; 2 studies, 167 participants). Authors' conclusions: Low-certainty evidence suggests that ERAS programmes may shorten length of postoperative hospital stay, reduce readmissions, and facilitate postoperative bowel function recovery without compromising participant safety. Further well-conducted studies are required in order to validate the certainty of these findings.Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Chekerov, R., et al. (2023). "Pazopanib with Topotecan weekly for patients with platinum-resistant or intermediate-sensitive recurrent ovarian cancer: results of a multicentre, open label phase I/II study (TOPAZ)." Journal of Cancer Research and Clinical Oncology 149(10): 7637-7649.
	Purpose: Pazopanib has promising antiangiogenetic activity in solid cancers. The investigator-initiated phase I/II trial evaluated the combination of Topotecan with Pazopanib in platinum-resistant or intermediate-sensitive recurrent ovarian cancer (ROC).; Methods: Patients (≥ 18 years) with first or second recurrence were enrolled in this multicentre open-label trial. Phase I analysed Topotecan 4 mg/m 2 (day 1, 8, 15, ever 28 days) for six cycles to identify the maximum tolerated dose (MTD) of Pazopanib added in a dose-escalating scheme with 400 mg starting dose. The phase II analysed safety and efficacy aspects. For all patients with clinical remission a maintenance with Pazopanib until progression was allowed. This trial is registered with ClinicalTrials.gov, number NCT01600573.; Results: Between June 2012 and February 2017, 11 patients were enrolled in the phase I, and 50 patients in the phase II study. The MTD of Pazopanib was determined by 400 mg/daily. Haematological and liver toxicities determined the dose limiting toxicities (DLT) and the most common grade 3-4 adverse events: leucopenia (25%), neutropenia (22%), thrombocytopenia (19%), accumulation of cholestatic (20%) and hepatocellular damage (15%), which often caused dose modifications, but no new life-threatening events. Overall response was 16% and clinical benefit rate 68%. Median progression-free survival (PFS) was 3.5 months (95% CI 2.0-5.0). Due to early progression only 20% of the patients were able to start with maintenance treatment.; Conclusion: The combination of pazopanib and weekly topotecan is feasible, resulting in a manageable haematological and liver toxicity, but despite its encouraging response rate, was not associated with a significant survival benefit. (© 2023. The Author(s).)

Chekerov, R., et al. (2022). "COMPARISON OF QUALITY OF LIFE IN PATIENTS WITH PLATINUM-SENSITIVE RECURRENT OVARIAN, FALLOPIAN TUBE AND PERITONEAL CANCER TREATED WITH TRABECTEDIN PLUS PEGYLATED LIPOSOMAL DOXORUBICIN (PLD) OR STANDARD PLATINUM-BASED THERAPY: DATA LOOK OF THE NOGGO S16/ COMPASS TRIAL." International Journal of Gynecological Cancer 32(Supplement 2): A252-A253.
	Introduction/Background Despite recent progress regarding surgical and medical management of primary ovarian cancer, relapses are still frequent and one of the most critical challenges in the clinical routine. There is a broad consensus that quality of life (QoL) should be one of the most relevant goals of any therapy in relapsed ovarian cancer. Methodology We report the results of a data look of the multicentre, randomized (1:1), active-controlled, open-label phase IV NOGGO-S16/COMPASS trial performed in patients with recurrent, platinum-sensitive, ovarian, peritoneal or fallopian tube cancer. The scope of this trial is to evaluate QoL with EORTC QLQ-C30 and QLQ-OV28 questionnaires during/after chemotherapy either with platinum/taxane-free combination of trabectedin (Yondelis) plus PLD or with standard platinumbased chemotherapy comprising combination of carboplatin with PLD, gemcitabine or paclitaxel. The current data look serves to characterise the included patient population. Results Data from 76 patients screened have been analysed. Patients have a median age of 63 years (range: 21-82), the performance status score of 0/1 was recorded in 75 patients (98.7%), and most are BRCA-negative (77.4%). They are diagnosed with primary ovarian carcinoma (83.6%), primary peritoneal carcinoma (9.6%) and fallopian carcinoma (6.8%), and 79% of patients have a grade 3 histopathological staging. Poly (ADP-ribose) polymerase inhibitors or bevacizumab were given as prior maintenance therapy to 15.3% and 76.4% of patients, respectively. Overall, 60% of patients had a platinum- free interval of >12 months before randomization and 45.8% of patients finished COMPASS trial as per protocol. The main reasons for withdrawal were progression under treatment (18.6%), toxicity (15.3%), death (13.6%) and patient wish (6.8%). Post-protocol maintenance therapy was given to 23.8% of patients. No differences in patient characteristics were observed. Conclusion Based on this data look no significant signal for a non-inferiority of the study arms have been observed. Study is ongoing and open for recruitment.

Chelariu-Raicu, A., et al. (2021). "A multicenter open-label randomized phase II trial of paclitaxel plus EP-100, a novel LHRH receptor-targeted, membrane-disrupting peptide, versus paclitaxel alone for refractory or recurrent ovarian cancer." Gynecologic Oncology 160(2): 418-426.
	OBJECTIVE: This randomized open-label phase II study evaluated the safety and clinical activity of EP-100 plus weekly paclitaxel in patients with recurrent ovarian cancer expressing positive LHRH receptor. METHODS: In a limited "run-in" dose escalation phase for EP-100, six patients were treated with ascending dose levels (13 mg/m2, 20 mg/m2, 30 mg/m2). In the randomized phase, patients received weekly paclitaxel (80 mg/m2 intravenously) plus twice weekly EP-100 (30 mg/m2 intravenously; combination arm) or weekly paclitaxel alone (80 mg/m2 intravenously; paclitaxel arm). The primary study endpoint was overall response rate (ORR). RESULTS: Forty-four patients were then randomized to either the experimental combination arm (n = 23) or the standard of care paclitaxel monotherapy arm (n = 21). The ORR was 35% (95%CI 16%-57%) for the combination arm and 33% (95% CI 15%-57%) for the paclitaxel arm. An interesting observation from an unplanned analysis was that a subset of patients with target liver lesions showed a greater overall response rate to the combination (69%) compared to paclitaxel alone (16%). The frequency of treatment-related grade 3-4 adverse events was similar between treatment arms: 48% vs 43% for the combination and paclitaxel arms, respectively. CONCLUSIONS: ORR in the EP-100 combination arm was similar to that in the group treated with paclitaxel alone; however, a subset of patients with liver metastases appeared to benefit from the combination. The addition of EP-100 did not appear to augment the adverse event profile of paclitaxel and was well tolerated.

Chen, B., et al. (2020). "The Effect of Neoadjuvant Chemotherapy on Lymph Node Metastasis of FIGO Stage IB1-IIB Cervical Cancer: A Systematic Review and Meta-Analysis." Frontiers in Oncology 10: 570258.
	Objectives: This study aimed to assess the effect of neoadjuvant chemotherapy (NACT) on the rate of lymph node metastasis (LNM) in FIGO stage IB1-IIB cervical cancer patients and compare the LNM between NACT plus surgery and surgery only.; Methods: We identified 34 eligible studies in PubMed, Web of Science, Cochrane Library, and EMBASE from inception to July 27, 2019. Data analyses were performed by Stata (version 13) and Revman (version 5.3).; Results: In these 34 included studies, the pooled incidence of LNM was estimated as 23% (95% CI, 0.20-0.26; I 2 = 79.6%, P <0.001). In the subgroup analysis, we identified five factors, including study type, year of publication, continents from which patients came, histological type and the FIGO stage. When taking FIGO stage into consideration, the LNM rate was 13% in stage IB (95% CI: 0.10-0.15; I 2 = 5.5%, P =0.385), 23% in stage IIA (95% CI: 0.18-0.28; I 2 = 0%, P =0.622), and 27% in stage IIB (95% CI: 0.20-0.33; I 2 = 0%, P =0.898), respectively. Through the comparison between NACT plus surgery and surgery only based on the six randomized controlled trials, the incidence of positive lymph nodes was lower in patients receiving NACT plus surgery than surgery only (RR=0.57, 95% CI: 0.39-0.83; I 2 = 60.5%, P =0.027). The 5-year OS was higher in the NACT + surgery group than surgery-only group (RR=1.13, 95% CI: 1.03-1.23; I 2 = 0.0%, P =0.842).; Conclusions: Among cervical cancer in stage IB1-IIB, the preoperative NACT plus radical surgery resulted in a 23% probability of LNM, which was lower than those receiving radical surgery only. In stage IIA and IIB, the effect of NACT to reduce LNM was more obvious. (Copyright © 2020 Chen, Wang, Ren, Shen, Ding, Zhu, Mao and Wang.)

Chen, C., et al. (2023). "Effectiveness of digital psychological interventions in reducing perinatal depression: a systematic review of meta-analyses." Archives of Women's Mental Health 26(4): 423-439.
	Digital psychological interventions have been widely used clinically in recent years, but the methodological quality and quality of evidence of related studies are unclear, thus interfering with the translation of practice outcomes and the application of clinical decisions. We searched for meta-analyses of randomized controlled trials in the PubMed, Web of Science, Embase, Cochrane Library, JBI Database, CINAHL, and PsycINFO databases as well as some databases containing gray literature up to 27 April 2022 using a combination of keywords. After two researchers independently screened and extracted data from the literature, the methodological quality of the included literature was evaluated by the AMSTAR 2 scale, and the evidence quality of the outcome index was graded by the Grading of Recommendations, Assessment, Development, and Evaluation system. A total of 12 meta-analyses reporting the positive impact of digital psychological interventions in the prevention and/or treatment of depressive symptoms in perinatal women were included, but the methodological quality and evidence level of the included studies were low. Digital psychological interventions are effective in reducing perinatal depression, but the methodological quality and reliability of outcome indicators are mostly low. Improving study designs, using higher-quality clinical evidence, conducting systematic evaluation studies strictly following the procedures, and standardizing the reporting of study results are recommended.

Chen, D., et al. (2020). "Pregnancy Outcomes Following Letrozole Use in Frozen-thawed Embryo Transfer Cycles: A Systematic Review and Meta-analysis." Geburtshilfe und Frauenheilkunde 80(8): 820-833.
	While widely used for ovulation induction in assisted reproductive technology, the clinical efficacy of letrozole for endometrial preparation prior to frozen-thawed embryo transfer (FET) cycles remains yet to be elucidated. We performed a meta-analysis to compare pregnancy outcomes after letrozole use with those of other endometrial preparation protocols in patients undergoing FET. PubMed, Scopus, Embase and the Cochrane Library were searched for eligible studies. Clinical pregnancy rate (CPR), live birth rate (LBR) and birth defect rate (BDR) were analysed using odds ratio (OR) and 95% confidence interval (CI). A total of 10 studies representing 75 968 FET cycles were included. Comparable CPR and LBR were observed when comparing letrozole administration with natural cycle (OR 1.24, 95% CI: 0.69 - 2.24; OR 1.18, 95% CI: 0.60 - 2.32), artificial cycle (OR 1.46, 95% CI: 0.87 - 2.44; OR 1.39, 95% CI: 0.77 - 2.52), and artificial cycle with gonadotropin-releasing hormone agonist suppression (OR 1.11, 95% CI: 0.78 - 1.59; OR 1.18, 95% CI: 0.82 - 1.68). Pooled results of the limited studies comparing letrozole with human menopausal gonadotropin demonstrated a similar CPR between groups (OR 1.46, 95% CI: 0.29 - 7.21, two studies), but the letrozole group had a statistically lower LBR (OR 0.67, 95% CI: 0.52 - 0.86, one study). No increased BDR was observed in the letrozole group compared to natural cycles or artificial cycles (OR 0.98, 95% CI: 0.60 - 1.61; OR 1.39, 95% CI; 0.84 - 2.28). This pooled analysis supports the use of letrozole as an efficacious and safe alternative to mainstream regimens for endometrial preparation in FET cycles.; Competing Interests: Conflict of Interest The authors declare that they have no conflict of interest.

Chen, F., et al. (2021). "Evaluation of the Efficacy of Sex Hormone-Binding Globulin in Insulin Resistance Assessment Based on HOMA-IR in Patients with PCOS." Reproductive sciences (Thousand Oaks, Calif.) 28(9): 2504-2513.
	This study aimed to evaluate the efficacy of SHBG in predicting insulin resistance (IR) in newly diagnosed, untreated patients with polycystic ovary syndrome (PCOS). Hundred newly diagnosed, untreated patients with PCOS and 61 subjects without PCOS (41 healthy volunteers with normal BMI and 20 subjects with overweight/obese) were included in the study. Receiver-operating characteristic (ROC) analysis was used to assess the effectiveness of SHBG in predicting IR in overweight/obese and non-overweight PCOS patients and the optimal cut-off values of SHBG. The results showed negative correlations between log-SHBG and log-I0 (r = - 0.372, P < 0.001) and log-SHBG and log-Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) (r = - 0.393, P < 0.001) after adjusting for blood pressure, serum lipid, age, and body mass index (BMI) in all of the PCOS patients. In patients with IR (defined as HOMA-IR ≥2.29), the area under the ROC curves (AUCs) of the SHBG for ROC analysis in the non-overweight group, overweight/obese group, and all PCOS patients were 0.774 (P = 0.0001), 0.922 (P = 0.0001), and 0.885 (P = 0.0001), respectively. The optimal cut-off value of SHBG was 37 nmol/L with a sensitivity of 97.62% and specificity of 80.85% in the overweight group. In patients with IR (HOMA-IR ≥2.5), the AUCs of SHBG for ROC analysis in the non-overweight group, overweight/obese group, and all PCOS patients were 0.741 (P = 0.0003), 0.928 (P = 0.0001), and 0.880 (P = 0.0001), respectively. The optimal cut-off value of SHBG was 30.2 nmol/L with a sensitivity of 97.44% and specificity of 82.69% in the overweight/obese group. In conclusion, this study observed a negative correlation between SHBG and HOMA-IR in PCOS patients after adjustment of confounding factors. SHBG was an independent influential factor of HOMA-IR and can be used as a positive predictive marker for IR in PCOS patients, especially in those who are overweight/obese.

Chen, F., et al. (2022). "Multicentre, prospective, randomised controlled trial to evaluate hexaminolevulinate photodynamic therapy (Cevira) as a novel treatment in patients with high-grade squamous intraepithelial lesion: APRICITY phase 3 study protocol." BMJ Open 12(6): e061740.
	Introduction: High-risk human papilloma virus (HPV)-associated cervical cancer is the fourth most common cancer in women worldwide. Current treatments of high-grade squamous intraepithelial lesion (HSIL) of the cervix are based on invasive surgical interventions, compromising cervical competence and functionality. APRICITY is a multicentre, prospective, double-blind, randomised controlled phase 3 study further evaluating the efficacy and safety of Cevira, an integrated drug-delivery and light-delivery device for hexaminolevulinate photodynamic therapy, which shows promise as a novel, non-invasive outpatient therapy for women with HSIL.; Methods and Analysis: Patients with biopsy-confirmed HSIL histology are invited to participate in the study planned to be conducted at 47 sites in China and 25 sites in Ukraine, Russia and the European Union. The aim is to include at least 384 patients, which will be randomised to either Cevira or placebo group (2:1). All patients will be assessed 3 months after first treatment and a second treatment will be administered in patients who are HPV positive or have at least low-grade squamous intraepithelial lesion. Primary endpoint is the proportion of the responders 6 months after first treatment. Secondary efficacy and safety endpoints will be assessed at 6 months, and data for secondary performance endpoints of the Cevira device will be collected at 3 months and 6 months, in case second treatment was administered. All patients in the Cevira group will be enrolled in an open, long-term extension study for 6 months to collect additional efficacy and safety data (study extension endpoints).; Ethics and Dissemination: The study was approved by the ethics committee of the Peking Union Medical College Hospital and Hannover Medical University, Germany. Findings will be disseminated through peer review publications and conference presentations.; Trial Registration Number: NCT04484415; clinicaltrials.gov.; Competing Interests: Competing interests: CD received consulting fees from MSD, GSK, Tesaro and Clovis Oncology and honoraria from MSD and GSK. LH is an employee of Asieris Pharmaceuticals (Shanghai) Co., Ltd. FC, ZN, CM, LS, YZ, ZY, JL and PH have nothing to declare. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Chen, F., et al. (2021). "A multicentre, prospective, randomised controlled trial to evaluate hexaminolevulinate photodynamic therapy (Cevira) as a novel treatment in patients with high grade squamous intraepithelial lesion: APRICITY Phase 3 study protocol." MedRxiv.
	Introduction: High-risk human papilloma virus (HPV)-associated cervical cancer is the fourth most common cancer in women worldwide. Current treatments of high grade squamous intraepithelial lesion (HSIL) of the cervix are based on invasive surgical interventions, compromising cervical competence and functionality. Objective(s): APRICITY is a multicentre, prospective, double-blind, randomised controlled Phase 3 study further evaluating the efficacy and safety of Cevira, an integrated drug- and light-delivery device for hexaminolevulinate photodynamic therapy, which shows promise as a novel, non-invasive therapy for women with HSIL. Methods and analysis: Patients with biopsy-confirmed HSIL histology are invited to participate in the study currently being conducted at 47 sites in China and 25 sites in Ukraine, Russia and European Union. The aim is to include at least 384 patients which will be randomised to either Cevira or placebo group (2:1). All patients will be assessed 3 months after first treatment and a second treatment will be administered in patients who are HPV positive or have at least low grade squamous intraepithelial lesion (LSIL). Primary endpoint is the proportion of the responders at 6 months after first treatment. Secondary efficacy endpoints and safety endpoints will be assessed at 6 months, and data for secondary performance endpoints for Cevira device will be collected at 3 months and 6 months, in case second treatment was administered. All patients in the Cevira group will be enrolled in an open, long-term extension study following patients for further 6 months to collect additional efficacy and safety data (study extension endpoints). Conclusion(s): Due to its non-invasiveness and convenient application, Cevira may be a favourable alternative to surgical methods in treatment of patients with HSIL. Ethics and dissemination: The study was approved by the ethics committee of the Peking Union Medical College Hospital and Hannover Medical University, Germany. Findings will be disseminated through peer review publications and conference presentations.Copyright © , CC BY-NC.

Chen, F. Y., et al. (2019). "New therapeutic approaches for endometriosis besides hormonal therapy." Chinese Medical Journal 132(24): 2984-2993.
	Objective:Endometriosis is a common gynecologic disease that frequently leading to chronic pelvic pain, severe dysmenorrhea, and subfertility. As first-line hormonal treatment can interfere with ovulation and may cause recurrent pelvic pain, exploration of new non-hormonal therapeutic approaches becomes increasingly necessary. This review aimed to evaluate the pre-clinical and clinical efficacy and safety of non-hormonal treatment for endometriosisData sources:Databases including PubMed, Embase, Cochrane Library, SINOMED, ClinicalTrials.gov, and Google Scholar were searched up to October 2019, using search terms "endometriosis" and "non-hormonal therapy."Study selection:Twenty-four articles were reviewed for analysis, including nine animal studies and 15 human trials; all were published in English. Result(s):Twenty-four articles were identified, including 15 human trials with 861 patients and nine animal studies. Some agents have been evaluated clinically with significant efficacy in endometriosis-related pelvic pain and subfertility, such as rofecoxib, etanercept, pentoxifylline, N-palmitoylethanolamine, resveratrol, everolimus, cabergoline (Cb2), and simvastatin. Other drugs with similar pharmacological properties, like parecoxib, celecoxib, endostatin, rapamycin, quinagolide, and atorvastatin, have only been tested in animal studies. Conclusion(s):Clinical data about most of the non-hormonal agents are not sufficient to support them as options for replacement therapy for endometriosis. In spite of this, a few drugs like pentoxifylline showed strong potential for real clinical application.Copyright © 2019 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license. Copyright © 2019 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license.

Chen, H. (2023). "Study on the efficacy of organic corrosion inhibitor in acid medium as complex in thetreatment of systemic diseases in patients with gynecological tumors." European Journal of Gynaecological Oncology 44(2): 129-130.
	Objectives: Common gynecological tumors are vulva skin tumor, cervical tumor, and uterine fibroids, etc. At present, there is still no uniform standard for the causes of cancer and the mechanism of recurrence and metastasis. If the treatment of gynecological tumor patients is not timely, it is easy to cause cancer. But there will be a variety of diseases, the mortality rate is high. Although traditional chemotherapy can reduce the relevant symptoms of patients, there are often adverse reactions and recurrence and metastasis after surgery. How to effectively prevent tumor metastasis and recurrence is one of the key research directions of anti-tumor. Therefore, in this study, organic corrosion inhibitors in acidic media were used as complexes to implant into the organ section after tumor resection to ensure tumor metastasis and recurrence. Method(s): 83 patients with gynecological tumors in a hospital from September 2021 to April 2022 were selected as the research objects. After screening the inclusion criteria, 70 patients were selected for the control experiment. In the control experiment, the average course of gynecological cancer patients was 5 years, and the average tumor diameter was (20 +/- 13) mm. 70 patients were divided into two groups, 35 patients in each group. The first group was the control group for routine treatment, and the second group was the experimental group for implantation of organic corrosion inhibitor complex for treatment after surgery. The data were analyzed by SPSS22.0 software. The statistical method was t-test, and p < 0.05 was the difference with statistical significance. Result(s): During the study, 70 patients were subject to a control experiment. In the control experiment, the adverse reactions and recurrence rate in the control group were higher than those in the experimental group, and the adverse reactions in the control group reached 17 cases, accounting for 48.58%. There were 8 cases of recurrence, accounting for 22.86%. There were only 9 cases of adverse reactions in the experimental group, accounting for 25.70%. 2 cases recurred, accounting for 6.66%. Specific data are shown in Table 1. In the comparison of serum indicators, the control group's Alanine Aminotransferase (ALT) is 51.4 +/- 16, and Aspartate Aminotransferase (AST) is 36 +/- 12.1. The ALT and AST of the experimental group were 53 +/- 18 and 42 +/- 16. There is a significant difference between the two groups in the level of indicators. The specific results are shown in Fig. 1. Conclusion(s): This study demonstrated that a new organic corrosion inhibitor with appropriate cost was applied to gynecological tumor patients as a complex. The experimental results showed that the complex effectively changed the clinical serum indexes of patients. The rate of adverse reactions was lower, and the rate of tumor recurrence and metastasis was lower than that of traditional chemotherapy. It is a safe treatment method with wide clinical application..

Chen, H., et al. (2021). "Efficacy and Safety of Bevacizumab-Combined Chemotherapy for Advanced and Recurrent Endometrial Cancer: A Systematic Review and Meta-analysis." Balkan Medical Journal 38(1): 7-12.
	Background: Bevacizumab-combined chemotherapy is a new regimen for advanced/recurrent endometrial cancer.; Aims: To evaluate the efficacy and safety of bevacizumab-combined chemotherapy in advanced/recurrent endometrial cancer.; Study Design: Systematic review and meta-analysis.; Methods: Eligible studies were retrieved from Embase, PubMed, and Cochrane Library. The data of primary outcomes including progression-free survival and overall survival and secondary outcomes including overall survival, response rate, and adverse events (grade ≥2) were extracted, pooled, and used for the meta-analysis to compare the efficacy and safety of bevacizumab-combined chemotherapy with other treatments in patients with advanced/recurrent endometrial cancer.; Results: Notably, 2 randomized-controlled and 5 single-arm trials of bevacizumab-combined chemotherapy or bevacizumab single-agent therapy for endometrial cancer were included. Meta-analysis indicated that bevacizumab-combined chemotherapy significantly increased the progression-free survival rate (hazard ratio=0.82, 95% confidence interval=0.70, 0.97) and overall survival rate (hazard ratio=0.83, 95% confidence interval=0.70, 0.98) compared with chemotherapy alone. The rates of overall, complete, and partial response to bevacizumab-combined chemotherapy were 76%, 22%, and 21%, respectively. The 6 and 12-month disease-free progression rates after bevacizumab-combined chemotherapy were 79% and 62%, respectively. Anemia (23%), leukopenia (46%), neutropenia (51%), hypertension (16%), and fatigue (24%) were the general adverse events after bevacizumab-combined chemotherapy.; Conclusion: Bevacizumab-combined chemotherapy may have a higher efficacy in improving the overall and progression-free survival in patients with advanced/recurrent endometrial cancers compared with chemotherapy alone.

Chen, J., et al. (2021). "Systematic review on efficacy and safety of Bushen Tiaojing therapy in treatment of polycystic ovary syndrome infertility." Chinese Traditional and Herbal Drugs 52(10): 3037-3050.
	Objective: To systematicly evaluate the efficacy and safety of Bushen Tiaojing Recipes combined with ovulation-induction drugs in the treatment of polycystic ovary syndrome (PCOS) infertility. Method(s): Databases including CNKI, VIP, Wan Fang, PubMed, Cochrane Library, Embase and Clinical Trials were searched from the establishment of the database to November, 2020. According to the inclusion and exclusion criteria, the randomized controlled trials (RCTs) of Bushen Tiaojing Recipes combined with ovulation-induction drugs in the treatment of PCOS infertility were collected, the data were extracted, and the quality of each study was evaluated with the "Cochrane bias risk assessment tool". The Meta analysis of the final indicators was analyzed by the Review Manager 5.3 software and the quality of evidence of the outcome indicators were evaluated according to the GRADE standard. Result(s): A total of 28 RCTs with 2659 patients and 1337 cases in the treatment group and 1322 cases in the control group were enrolled. Systematic review results showed that: compared with single ovulation-induction drugs, Bushen Tiaojing Recipes combined with ovulation-induction drugs had significant effects on improving ovulation rate, pregnancy rate and androgen (T), luteinizing hormone (LH), reducing the incidence of adverse reactions and ovarian volume and increasing endometrial thickness (P < 0.01). There was no significant difference in increasing estradiol (E2) and follicle stimulating hormone (FSH) between the two groups (P > 0.05). The funnel plot of ovulation rate and pregnancy rate showed that each research point was asymmetric, suggesting that there might be publication bias. According to the GRADE method, the quality of evidence was low in ovulation rate and pregnancy rate and very low in other aspects. Conclusion(s): Under the guidance of Bushen Tiaojing method, Bushen Tiaojing Recipes combined with ovulation induction drugs has fine clinical efficacy and good safety. However, due to the low quality of the included studies, clinical use still needs to be cautious.Copyright © 2021, Editorial Office of Chinese Traditional and Herbal Drugs. All right reserved.

Chen, J.-M., et al. (2022). "Clinical Evaluation of Autologous and Allogeneic Stem Cell Therapy for Intrauterine Adhesions: A Systematic Review and Meta-Analysis." Frontiers in Immunology 13: 899666.
	Objective: Intrauterine adhesions (IUAs) are a major cause of female infertility. Stem cells can be used to restore endometrial function owing to their regenerative abilities. We compared the safety and efficacy of autologous and allogeneic stem cell treatments in patients with recurrent IUA after conventional therapy based on a systematic review of the related literature.; Methods: The PubMed, Embase, and Cochrane databases were systematically searched. All analysis were performed using Review Manager 5.4. We compared improvements in endometrial thickness, pregnancy rates, menstruation, and side effects after autologous and allogeneic stem cell therapy. The study was registered with PROSPERO, CRD 42022322870.; Results: Our search returned 154 reports, 10 of which met the inclusion criteria, representing 116 patients. Of these, 44 patients in two studies were treated with allogeneic stem cells and 72 patients in eight studies were treated with autologous stem cells. Improvements in endometrial thickness and pregnancy rates after intrauterine device treatment were compared between the autologous and allogeneic stem cell groups. Endometrial thickness increased more after autologous stem cell IUA treatment (mean difference, 1.68; 95% confidence interval [CI]: 1.30-2.07; P < 0.00001), and the pregnancy rate was also improved (relative risk, 1.55; 95% CI: 1.19-2.02, P < 0. 001). No obvious and serious adverse reactions were observed during stem cell therapy in either group.; Conclusions: This meta-analysis and systematic review of the results of randomized trials of autologous and allogeneic stem cell treatments for IUA suggests that autologous stem cells have a better effect in improving the endometrium thickness and pregnancy rate.; Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42022322870.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Chen, Huang, Chen, Lin and Shi.)

Chen, J. S. and K. A. Kho (2021). "22 Randomized trial of laparoscopic versus abdominal hysterectomy for benign indications and impact on surgical success." American Journal of Obstetrics and Gynecology 224(6): S741.
	Objectives: To examine the differences in patient‐centered goals in individuals undergoing laparoscopic versus abdominal hysterectomy for benign indications. Materials and Methods: This abstract is a sub‐analysis of a prospective, randomized controlled trial examining the impact of laparoscopic versus abdominal hysterectomy on patient‐centered outcomes including quality of life, pain, and productivity. At each pre‐operative visit, each participant reported top three patient‐centered goals they hoped to achieve prior to undergoing a hysterectomy. In addition, participants rated their subjective achievement of goals from 1 to 10, with 1 (goal not achieved) and 8 to 10 (goal achieved). The subjects were then randomized to total laparoscopic (TLH) or total abdominal hysterectomy (TAH). Following surgery, repeat assessment of goal achievement was obtained within each group on post‐operative day 1, at 6 weeks, 6 months than 12 months post‐operatively. In addition, the length of time to successful goal achievement (scores of 8 or higher during any post‐operative period) was recorded in all participants. Power analysis was based on differences in the primary outcome of the initial study: Quality of Life as scored by the SF‐36 form. With a clinically significant differences of 15 points in the SF‐36 required a sample size of 29 patients in each group for a power of 80% with a two‐sided significance level of 0.05. With that, differences in goal achievement rates and the length of time to goal achievement were examined between TLH and TAH groups using the calculated sample size of the initial study. Results: A total of 91 participants undergoing benign hysterectomy were enrolled and randomized. Three patients were lost to follow‐up, with 88 subjects available for final analysis. The top three goals listed respectively were: “Abnormal Uterine Bleeding,” (AUB) “Pelvic Pain,” (PP) and “Quality of Life.” (QOL). Overall, there were no significant differences in the percentage of goal achievement between TLH and TAH groups for QOL (69% vs 67%, P = 0.88), for AUB (67% vs 51%, P = 0.14), and PP (53% vs 49%, P = 0.67), though it appears that participants who listed QOL as their top goal were more likely to achieve the goal. The mode of hysterectomy did not appear to alter differences in goal achievement. In addition, there were no significant differences in the length of time to goal achievement between TLH and TAH groups for QOL (156 days vs 159 days, P = 0.99), for AUB (96 vs 116, P = 0.25), and PP (146 vs 143, P = 0.80). Conclusion: In conclusion, there were no significant differences in goal achievement rates between TLH versus TAH groups regardless of the desired patient‐centered goals, though the majority of participants achieved their respective goals in both groups. In addition, there were no differences in length of time to goal achievement between the two groups. This study suggests that a hysterectomy itself may have a therapeutic effect on patient‐centered outcomes irrespective of the route of surgery.

Chen, K., et al. (2023). "Efficacy and safety of Gushen Antai Pills combined with dydrogesterone in the treatment of threatened miscarriage: a systematic review and meta-analysis." Frontiers in Pharmacology 14: 1138968.
	Background: Despite some progress has been made in the pathogenesis and treatment of threatened miscarriage (TM), conventional treatment remains suboptimal. Thus, complementary medicine gradually become a new treatment option for treating threatened miscarriage. Gushen Antai Pills ( GAP), a classic prescription of Traditional Chinese medicine (TCM), has became a popular complementary therapy to conventional western medicine (dydrogesterone) in treating threatened miscarriage in recent years. However, a systematic summary and analysis for its therapeutic effects is lacking. This meta-analysis aimed to systematically evaluate the effectiveness and safety of Gushen Antai Pills combined with dydrogesterone in the treatment of threatened miscarriage. Methods: A systematic search across seven electronic databases was conducted from inception to 17 September 2022. Studies were included if they were randomized controlled trials (RCTs) evaluating the effect of integrating Gushen Antai Pills and dydrogesterone in patients with threatened miscarriage, and reported the outcomes of interest. All statistical analyses were conducted using the Revman5.3 and Stata 13 software. The GRADE system was used to evaluate the quality of evidence. Results: Ten eligible randomized controlled trials involving 950 participants were contained in this meta-analysis. The pooled analysis showed that Gushen Antai Pills combined with dydrogesterone can significantly reduce the incidence of early pregnancy loss (RR: 0.29; 95% CI: 0.19-0.42; p < 0 . 00001) and alleviate clinical symptoms (RR: 1.39; 95% CI: 1.22-1.59; p < 0 . 00001), compared with treatment of dydrogesterone alone. Also, meta-analysis indicated that integrating Gushen Antai Pills and dydrogesterone is more effective than using dydrogesterone alone in improving hormone levels (serum levels of progesterone, β -HCG and estradiol) for women with threatened miscarriage (all p < 0 . 00001). Meanwhile, the combined effects with significant heterogeneity also showed favorable consistency in the sensitivity analyses, indicating a good stability of present results. Moreover, no significant differences between Gushen Antai Pills combined with dydrogesterone and control group on adverse events was identified. The overall GRADE qualities were low to moderate. Conclusion: The overall available evidence suggested that Gushen Antai Pills combined with dydrogesterone had significant effects in improving pregnancy success rate, clinical symptoms and hormone levels for women with threatened miscarriage, with considerable safety and reliability. However, due to the partial heterogeneity, suboptimal quality and high risk of bias of some included studies, further rigorously designed randomized controlled trials are required. Systematic Review Registration: identifier https://INPLASY2022120035, https://inplasy.com/inplasy-2022-12-0035/.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2023 Chen, Liu, Meng, Li, Yang and Wang.)

Chen, L., et al. (2023). "The effects of weight loss-related amenorrhea on women's health and the therapeutic approaches: a narrative review." Annals of Translational Medicine 11(2): 132.
	Background and Objective: Weight loss-related amenorrhea is defined as the reversible functional inhibition of the hypothalamic-pituitary-ovarian (HPO) axis associated with weight loss or low body weight, which occurs mostly in adolescents and women of reproductive age. The specific pathological mechanisms of this disease have not yet been elucidated, and the optimal evidence-based guidelines for its clinical assessment and management are limited. This review summarizes its adverse effects on female health, and the individualized, emerging, and multidisciplinary therapeutic approaches used to treat it. Method(s): We searched the PubMed, Web of Science, and China National Knowledge Infrastructure (CNKI) databases for Chinese and English literature on functional hypothalamic amenorrhea (FHA), and retrieved original articles (on basic and clinical research) and reviews published up to December 2022. Key Content and Findings: We reviewed the findings on the unfavorable effects of weight loss-related amenorrhea with a focus on reproduction, the skeletal and cardiovascular system, other endocrine effects, and mental health. Lifestyle changes and hormonal replacement have been shown to alleviate the underlying causes and lead to the recovery of menstruation. However, the efficacy of treatments is affected by many factors, such as psychological stress and heterogeneity. Conclusion(s): Weight loss-related amenorrhea, which is an important type of FHA, is manifested by anovulation and hypoestrogenism, and has both short- and long-term adverse effects on women's overall health. It is difficult to alleviate its underlying causes. Individualized treatments need to be optimized and emerging or multidisciplinary therapeutic approaches need to be explored that aim to recover normal menstruation and ovulation, eliminate the undesirable effects of prolonged hypoestrogenism and alleviate psychological disorders.Copyright © Annals of Translational Medicine. All rights reserved.

Chen, L., et al. (2023). "Efficacy and safety of different low-molecular-weight heparins in improving pregnancy outcomes in patients with recurrent abortion: a network meta-analysis." Chinese Journal of Evidence-Based Medicine 23(7): 790-796.
	Objective To systematically evaluate the efficacy and safety of different low-molecular-weight heparins (LMWHs) in improving pregnancy outcomes in patients with recurrent abortion. Methods The PubMed, EMbase, Cochrane Library, CBM, CNKI, VIP and WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) related to the objectives from inception to July 2022. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was then performed by using Stata 16.0 software. Results A total of 25 RCTs involving 4 631 patients were included. Enoxaparin, dalteparin, nadroparin, and tinzaparin were included. The results of network meta-analysis showed that the live birth rate of the tinzaparin was higher than that of enoxaparin and dalteparin. The live birth rate in nadroparin was higher than that in enoxaparin and dalteparin. The cumulative sorting probability showed that tinzaparin ranked best for improving the live birth rate, nadroparin ranked best for reducing the miscarriage rate, and enoxaparin ranked best for reducing the preterm birth rate. Conclusion Current evidence suggests that tinzaparin and nadroparin may be the best choice for improving pregnancy outcomes in patients with recurrent abortion. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.Copyright © 2023 West China University of Medical Science. All rights reserved.

Chen, L., et al. (2022). "A PHASE 1, FIRST IN HUMAN, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY OF TST005 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS." Journal for Immunotherapy of Cancer 10(Supplement 2): A801.
	Background Anti-programmed death 1/ligand 1 (PD-1/PD-L1) therapies have been established as standard treatment for multiple tumor types. However, the key challenge of these therapies is resistance caused by immunosuppressive factors in the tumor microenvironment (TME). TGF-b is a multi-functional cytokine that is involved in the tight regulation of either antitumor immunity or tumor immunosuppression. TGF-b promotes an immune exclusion TME thus renders PD-L1 blockade ineffective. Therefore, dual targeting PD-L1 and TGF-b represents a rational synergistic strategy to enhance clinical outcome relative to each agent alone. TST005 is a novel bi-functional fusion protein combining a high affinity PD-L1 monoclonal antibody (mAb) in a fragment crystallizable (Fc) silenced immunoglobulin G1 (IgG1) backbone and a differentiated transforming growth factor beta (TGF-b) trap with improved stability. This study will investigate TST005's safety, tolerability and preliminary anti-tumor activity in solid tumors. Methods This Phase 1, first in human (FIH) study is an openlabel, multicenter trial that consists of a dose escalation phase in patients with advanced solid tumors who has failed prior therapy followed by a dose expansion phase in human papillomavirus (HPV) related malignancies that is not amenable to surgeryand have received prior standard therapy(ies). The primary objectives are to evaluate the safety and tolerability and determine the maximum tolerated dose or recommended Phase 2 dose(s) of TST005. Secondary objectives include pharmacokinetic, pharmacodynamic and preliminary anti-tumor activity of TST005. The dose escalation phase comprises five dose cohorts: accelerated titration of 1 subject in the starting dose cohort (1 mg/kg), and then four dose cohorts (3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg) following classic 3+3 design. No more than one prior immune checkpoint inhibitor (ICI) treatment is allowed for eligible subjects. In the dose expansion phase, up to 30 patients with locally advanced or metastatic HPV+ malignancies, including cervical cancers, P16+ Oropharyngeal cancers, and other tumors that are known HPV+, and who are ICI treatment naive will be enrolled. Subjects will receive TST005 intravenous infusion every 3 weeks (Q3W) until disease progression per RECIST v1.1 and/ or immune RECIST or unacceptable toxicity. Subjects may continue to receive TST005 beyond RECIST v1.1 defined progression at the discretion of the Investigator. This study is ongoing at 4 sites in the US and China. As of the 30 June, 2022, the first two dose cohorts evaluation has been completed and no DLT was observed.

Chen, L.-R., et al. (2019). "Isoflavone Supplements for Menopausal Women: A Systematic Review." Nutrients 11(11).
	Isoflavones have gained popularity as an alternative treatment for menopausal symptoms for people who cannot or are unwilling to take hormone replacement therapy. However, there is still no consensus on the effects of isoflavones despite over two decades of vigorous research. This systematic review aims to summarize the current literature on isoflavone supplements, focusing on the active ingredients daidzein, genistein, and S-equol, and provide a framework to guide future research. We performed a literature search in Ovid Medline using the search terms "isoflavone" and "menopause", which yielded 95 abstracts and 68 full-text articles. We found that isoflavones reduce hot flashes even accounting for placebo effect, attenuate lumbar spine bone mineral density (BMD) loss, show beneficial effects on systolic blood pressure during early menopause, and improve glycemic control in vitro. There are currently no conclusive benefits of isoflavones on urogenital symptoms and cognition. Due to the lack of standardized research protocols including isoflavone component and dosage, outcomes, and trial duration, it is difficult to reach a conclusion at this point in time. Despite these limitations, the evidence thus far favors the use of isoflavones due to their safety profile and benefit to overall health.

Chen, P., et al. (2020). "Effect of melatonin for the management of endometriosis: A protocol of systematic review and meta-analysis." Medicine 99(22): e20353.
	Background: This study aims to explore the effect of melatonin for the management of endometriosis.; Methods: We will search electronic databases (Cochrane Library, MEDLINE, EMBASE, CINAHL, Web of Science, Scopus, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure) from their inceptions to the February 29, 2020 without language and publication time limitations. The study identification, study quality assessment, and data extraction will be undertaken by two separate researchers. We will also appraise evidence quality of main outcomes by Grading of Recommendations Assessment Development and Evaluation, and statistical analysis performance by RevMan 5.3 Software.; Results: This study will summarize up-to-date clinical evidence to investigate the effect of melatonin for the management of endometriosis.; Conclusion: This study may provide helpful evidence of melatonin for the management of endometriosis.; Systematic Review Registration: INPLASY202040093.

Chen, Q., et al. (2022). "Systematic Review of Olaparib in the Treatment of Recurrent Platinum Sensitive Ovarian Cancer." Frontiers in Oncology 12: 858826.
	Objective: To systematically evaluate the efficacy and safety of olaparib in the treatment of recurrent platinum-sensitive ovarian cancer.; Methods: The Cochrane Library, PubMed, Chinese Biomedical Literature Database, CNKI, VIP Database, Wanfang Science and Technology Database were searched for randomized controlled trials (RCTs) of olaparib in the treatment of recurrent platinum-sensitive ovarian cancer from the establishment of each database to January 2022. Two reviewers independently evaluated the quality of the literature, extracted the data, and cross-checked the methodological quality. Meta-analysis was performed using RevMan 5.4 software.; Results: A total of 7 RCTs were included, including 2406 patients, There were 1497 patients in treatment groups and 909 patients in the control group. Meta-analysis results showed that in terms of effectiveness, the overall survival time of patients in the olaparib group [HR=1.24, 95%CI(1.06, 1.45), P=0.006]; in terms of safety, for all grades of adverse events (including nausea, fatigue, vomiting, diarrhea, abdominal pain, and headache), [HR=1.54, 95%CI(1.38, 1.71), P=0.0002], for grade 3 or higher adverse events (including nausea, fatigue, vomiting, diarrhea, abdominal pain, and headache), [HR=2.13, 95%CI(1.61, 2.81), P=0.003], there were significant differences compared with the control group, suggesting that the risk of adverse reactions in the experimental group was higher than that in the control group. Subgroup analysis showed that only abdominal pain, headache and vomiting were not statistically significant, and other adverse reactions were statistically significant.; Conclusion: Based on the existing clinical evidence, olaparib in the treatment of recurrent platinum-sensitive ovarian cancer has a longer overall survival than the control group. It is an ideal regimen, but the incidence of adverse reactions is high.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Chen, Li, Zhang and Wu.)

Chen, R., et al. (2020). "The effects and costs of laparoscopic versus abdominal myomectomy in patients with uterine fibroids: a systematic review and meta-analysis." BMC surgery 20(1): 55.
	Background: Abdominal myomectomy (AM) and laparoscopic myomectomy (LM) are commonly see surgery for the uterine fibroids, several randomized controlled trials (RCTs) have compared the role of AM and LM, the results remained inconsistent. Therefore, we attempted this meta-analysis to analyze the role of LM versus AM in patients with uterine fibroids.; Methods: We searched PubMed et al. databases from inception date to July 31, 2019 for RCTs that compared LM versus AM in patients with uterine fibroids. Two authors independently screened the studies and extracted data from the published articles. Summary odd ratios(OR) or mean differences(MD) with 95% confidence intervals(CI) were calculated for each outcome by means of fixed- or random-effects model.; Results: Twelve RCTs with a total of 1783 patients were identified, with 887 patients for and 897 patients for AM. Compared with AM, LM could significantly decrease the blood loss (OR = - 29.78, 95% CI -57.62- - 0.95), shorten the duration of postoperative ileus (OR = - 10.91, 95% CI -18.72- - 3.11), reduce the length of hospital stay (OR = - 1.57, 95% CI -2.05- - 1.08), but LM was associated with longer duration of operation (OR = 16.10, 95% CI 6.52-25.67) and higher medical cost (OR = 17.61, 95% CI 7.34-27.88).; Conclusions: LM seems to be a better choice for patients with uterine fibroids, more related studies are needed to identify the role of LM and AM for the treatment of uterine fibroids.

Chen, S., et al. (2022). "Retinoids in cancer chemoprevention and therapy: Meta-analysis of randomized controlled trials." Frontiers in genetics 13: 1065320.
	Retinoids, natural and synthetic derivatives of vitamin A, have many regulatory functions in human body, including regulating cellular proliferation, differentiation, apoptosis. Moreover, retinoids have been used successfully for the treatment of certain malignancies, especially acute promyelocytic leukemia (APL) in adults and neuroblastoma in children. However, retinoids have not yet been translated into effective systemic treatments for most solid cancers. Some recent studies have shown that retinoids promote tumorigenesis. Therefore, we performed this meta-analysis to systematically evaluate the efficacy of retinoids in the chemoprevention and treatment of cancers. We performed literature search of several electronic databases, including PubMed, Embase and Cochrane Library from 2000 January to 2021 November. Various outcomes were applied to investigate the potential of retinoids for prevention and treatment of cancers. The primary outcomes in this study were disease recurrence and clinical response. The secondary outcomes included overall survival (OS), cancer development, disease progression and event-free survival. We identified 39 randomized controlled trials with 15,627 patients in this study. Our results showed that lower recurrence rate and better clinical response were obtained in retinoids treated patients with cancer or premalignancy as compared with control. The differences were statistically significant (RR = 0.85, 95% CI = 0.74-0.96, p = 0.01; RR = 1.24, 95% CI = 1.03-1.49, p = 0.02, respectively). Retinoids treatment was not associated with improvement in overall survival, cancer development, disease progression or event-free survival. Subgroup analysis conducted based on cancer type showed that patients benefited from retinoids treatment in APL, renal cell carcinoma, hepatocellular carcinoma, lung cancer, Kaposi sarcoma, and complete hydatidiform mole. No significant therapeutic effect was noted in head and neck cancer, acute myeloid leukemia (AML), melanoma, breast cancer, bladder cancer, cervical intraepithelial neoplasia (CIN) or cervical carcinoma. Subgroup analysis based on tumor classification demonstrated that retinoids group obtained a lower recurrence rate and better clinical response than control group in solid cancers. In conclusion, clinical application of retinoids was associated with reduction in disease recurrence and improvement in clinical response, illustrating that retinoids play a key role in cancer prevention and therapy. Further research is needed to broaden the utility of retinoids in other types of cancers. Systematic Review Registration: PROSPERO, identifier CRD42022296706.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Chen, Hu, Tao, Xia, Wu, Cheng and Wang.)

Chen, S., et al. (2022). "LNG-IUS vs. medical treatments for women with heavy menstrual bleeding: A systematic review and meta-analysis." Frontiers in Medicine 9: 948709.
	Introduction: To compare efficacy and safety of the levonorgestrel-releasing intrauterine system (LNG-IUS) with medical treatments for women with heavy menstrual bleeding.; Materials and Methods: We searched PubMed, Embase, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure (CNKI), and Wanfang databases for relevant randomized controlled trials (RCTs) in November 2021. All meta-analyses were performed using the random-effects model. PROSPERO registration number: CRD42021295379.; Results: A total of trials (with 14 references) reporting on 1,677 women were included in this systematic review. The majority of the included RCTs were rated with low-to-unclear risk of bias in selection, detection, attrition, reporting, and other bias. All RCTs were rated as high risk in performance bias because blinding was difficult to ensure in the compared groups. Results of meta-analyses revealed that the number of clinical responders was greater in the LNG-IUS group than that in the medical treatments group at both 6-month (steroidal: five RCTs; n = 490; risk ratio [RR]: 1.72 [1.13, 2.62]; I 2 = 92%; nonsteroidal: one RCT; n = 42; RR: 2.34 [1.31, 4.19]) and 12-month (steroidal: three RCTs; n = 261; RR: 1.31 [1.01, 1.71]; I 2 = 74%) endpoints, with no clear differences on number of dropouts, and the incidence of adverse events.; Conclusion: Evidence indicates that LNG-IUS is superior to the medical treatments in short-term and medium-term clinical responses, blood loss control, compliance, and satisfaction. Meanwhile, frequency of adverse events related to LNG-IUS is acceptable.; Systematic Review Registration: PROSPERO, identifier CRD42021259335, https://www.crd.york.ac.uk/prospero/display&#95;record.php?ID=CRD42021295379.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Chen, Liu, Peng and Zheng.)

Chen, S., et al. (2023). "Comparative study of absorbable suture and permanent suture in sacrocolpopexy: a meta-analysis and systematic review." International Urogynecology Journal 34(5): 993-1000.
	Introduction and Hypothesis: The aim of this study was to compare the surgical results and the complications of absorbable suture (AS) versus permanent suture (PS) in sacrocolpopexy (SCP).; Methods: We systematically searched PubMed, Embase, ClinicalTrials.gov, and the Cochrane Library Central Register of Controlled Trials for articles in which researchers compared AS with PS in SCP. The primary outcomes were the surgical success rate and suture-related complications (suture exposure/erosion, mesh erosion, and suture removal). All analyses were performed with Review Manager 5.3.; Results: Four articles involving 689 patients were ultimately included. Our findings demonstrated that AS had similar surgical success rates to those of PS (OR=1.34; 95% CI, 0.60-2.96) and no significant differences in failure rates were noted between the two groups (OR=0.75; 95% CI, 0.34-1.66). Subgroup analyses in patients with anatomical failure revealed no significant differences in recurrent posterior prolapse (OR=0.33; 95% CI, 0.05-2.10) or in recurrent apical (OR=0.64; 95% CI, 0.03-13.66) or anterior prolapse (OR=0.45; 95% CI, 0.13-1.57). However, the AS group were at a lower risk of suture exposure/erosion (OR=0.18; 95% CI, 0.06-0.58) and a lower suture removal rate (OR=0.14; 95% CI, 0.03-0.61) and retreatment (OR=0.36; 95% CI, 0.16-0.82), but the mesh erosion was not significantly different (OR=1.00; 95% CI, 0.49-2.08).; Conclusions: The data showed that AS had a similar success rate, less exposure/erosion, and were less likely to be removed and require retreatment than PS, which supported the notion that AS is as effective as PS but safer. (© 2023. The International Urogynecological Association.)

Chen, X., et al. (2021). "Effects of metformin on body weight in polycystic ovary syndrome patients: model-based meta-analysis." Expert review of clinical pharmacology 14(1): 121-130.
	Objectives: The present study aimed to investigate the effects of metformin on body weight in polycystic ovary syndrome (PCOS) patients by model-based meta-analysis (MBMA).; Methods: Randomized controlled trial (RCT) studies of metformin in treatment of PCOS patients were collected and efficacy indicators were the body mass index (BMI) change rates from baseline.; Results: 28 RCT studies, 1631 PCOS patients were included for analysis. Model of metformin monotherapy, and model of metformin combination therapy were established, respectively. After deducting control group effects, the E max of metformin on BMI were -5.88% and -11.8% in metformin monotherapy and metformin combination therapy, respectively. In order to play better curative effects, for metformin monotherapy, 1000 mg/day metformin needs for at least 25.5 weeks; For metformin combination therapy, 1000 mg/day metformin needs for at least 58.6 weeks.; Conclusion: It was the first time to quantify the effects of metformin on body weight and recommend dose and duration for metformin monotherapy and metformin combination therapy in PCOS patients.

Chen, X., et al. (2022). "Acupuncture combined with metformin versus metformin alone to improve pregnancy rate in polycystic ovary syndrome: A systematic review and meta-analysis." Frontiers in Endocrinology 13: 978280.
	Objective: The aim of this study was to evaluate the comparison between acupuncture combined with metformin versus metformin alone in improving the pregnancy rate of people with polycystic ovary syndrome (PCOS).; Methods: A literature search of eight databases resulted in nine randomized controlled trials (RCTs) that assessed the effect of acupuncture combined with metformin on pregnancy rate in PCOS patients compared with metformin alone. Subsequently, data extraction and analysis were conducted to evaluate the quality and risk of bias of the methodological design of the study, and meta-analysis was conducted on the RCT data.; Results: Nine RCTs and 1,159 women were included. Acupuncture can improve pregnancy rate. It was analyzed according to the diagnostic criteria of PCOS [ Z = 2.72, p = 0.007, relative risk (RR) 1.31, 95% CI 1.08 to 1.60, p = 0.15, I 2 = 41%]. Analysis was performed according to different diagnostic criteria of pregnancy ( Z = 3.22, p = 0.001, RR 1.35, 95% CI 1.13 to 1.63, p = 0.12, I 2 = 42%). Acupuncture can improve ovulation rate. Subgroup analysis was performed according to the number of ovulation patients ( Z = 2.67, p = 0.008, RR 1.31, 95% CI 1.07 to 1.59, p = 0.04, I 2 = 63%) and ovulation cycle ( Z = 3.57; p = 0.0004, RR 1.18, 95% CI 1.08 to 1.29, p = 0.57, I 2 = 0%). Statistical analysis also showed that acupuncture combined with metformin could improve homeostatic model assessment of insulin resistance (HOMA-IR) [mean difference (MD) -0.68, 95% CI -1.01 to -0.35, p = 0.003, I 2 = 83%].; Conclusions: Based on the results of this study, compared with metformin alone, acupuncture combined with metformin has a positive effect on pregnancy rate, ovulation rate, and insulin resistance in PCOS. However, due to the limitations regarding the number and quality of the included studies, the above conclusions need to be verified by further high-quality studies.; Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/#myprospero.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Chen, Lan, Yang, Liu, Li, Zhu, Zhao, Long, Wang, Xie, Li and Wu.)

Chen, X., et al. (2022). "Systematic Review and Meta-Analysis of Complications after Laparoscopic Surgery and Open Surgery in the Treatment of Pelvic Abscess." BioMed Research International 2022: 3650213.
	Background. Pelvic abscess surgery consists mostly of open laparotomy and laparoscopic surgery. Open surgery is regarded as a classic procedure. With the rise and promotion of laparoscopic indications in recent years, comparative studies of the two's postoperative effectiveness have been limited. Objective. To compare the clinical effects of laparoscopic exploratory surgery and open surgery in the treatment of pelvic abscess. Methods. Through computer searches of PubMed, EMBASE, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang, and Weipu databases, we found publicly available case-control research on laparoscopic surgery and open surgery for treating pelvic abscess. The papers that met the evaluation criteria were screened, and meta-analysis was used to look at 8 papers on laparoscopic surgery and open surgery for treating pelvic abscess from 2010 to 2021. Results. The results of this study showed that compared with the open laparotomy group, the incidence of laparoscopic group in the incision infection rate (RR=0.29, 95% CI (0.20, 0.41), and P<0.00001), the incidence of intestinal injury (RR=0.08, 95% CI (0.04, 0.14), and P<0.00001), incidence of intestinal obstruction (RR=0.26, 95% CI (0.08, 0.90), and P=0.03<0.05), and postoperative pelvic abscess recurrence rate (RR=0.34, 95% CI (0.13, 0.86), and P=0.02<0.05) are lower than open surgery, and the difference of these four items is statistically significant. There was no difference in the risk of urinary tract injury between laparoscopic surgery and open surgery (RR=0.92, 95% CI (0.27, 3.17), and P=0.89>0.05). Conclusion. In terms of incision infection, intestinal damage, intestinal obstruction, and recurrence of pelvic abscess, the laparoscopic group clearly outperforms the open group, and it merits clinical promotion and use.Copyright © 2022 Xiaolu Chen et al.

Chen, X., et al. (2022). "Meta-analysis of therapeutic efficacy and effects of integrated traditional Chinese and Western medicine on coagulation and fibrinolysis system in patients with threatened abortion and polycystic ovary syndrome." American journal of translational research 14(5): 2768-2778.
	Background: Polycystic ovary syndrome (PCOS) patients are prone to early pregnancy loss. Studies have found that the blood fibrinolytic activity of PCOS patients is closely related to the high abortion rate. At present, it is considered that the combination of traditional Chinese and Western medicine in the treatment of PCOS with threatened abortion has a good effect on fetal protection. Therefore, the clinical efficacy of the combination of traditional Chinese and Western medicine in the treatment of PCOS with threatened abortion was systematically evaluated, and the effect of traditional Chinese medicine on the blood fibrinolytic status of patients was also evaluated.; Methods: The clinical randomized controlled trials (RCTs) of integrated traditional Chinese and Western medicine in the treatment of PCOS with threatened abortion were reviewed from four Chinese databases (CNKI, WANFANG, VIP, and SINOMED) and two English databases (PubMed, EMBASE) from their time of establishment to May 2021. According to the inclusive and exclusive criteria, tests were selected, data were extracted and evaluated, the systematic review was carried out by description analysis, and the meta-analysis was conducted using RevMan 5.3 software from Cochrane Collaboration. Begg's and Egger's tests were performed for assessing symmetries of funnel plot by the software Stata 16.0.; Results: 6 RCTs involving 361 participants were included. Meta-analysis results showed that integrated traditional Chinese and Western medicine can increase the total efficacy compared with the control groups [RR=1.22, 95% CI (1.10, 1.35), P=0.0002]. Meanwhile, the improvement of TCM syndrome integral [MD=-2.11, 95% CI (-2.56, -1.66), P<0.00001], D-II [MD=-0.29, 95% CI (-0.49, -0.09), P=0.004], Hcy [MD=-3.02, 95% CI (-3.64, -2.39, P=0.00001], PAI-I [SMD=-2.38, 95% CI (-2.82, -1.73), P<0.00001] were better than a single Western medicine treatment. And it can increase the level of β-HCG [SMD=3.44, 95% CI (1.87, 5.01), P<0.0001], P [MD=7.70, 95% CI (7.10, 8.31), P<0.00001], E2 [MD=205.36, 95% CI (140.93, 269.80), P<0.00001]. The funnel plot, Egger's test (P=0.210), and Begge's test (P=0.573) suggested that there was no evidence of substantial publication bias.; Conclusions: The effect of integrated traditional Chinese and Western medicine is better than that of Western medicine alone in the treatment of PCOS with threatened abortion, and it has certain advantages in improving the fibrinolytic status of patients. However, due to the limitation of the quality and quantity of the included literature, more rigorous and larger sample studies are needed to confirm these conclusions in the future.; Competing Interests: None. (AJTR Copyright © 2022.)

Chen, X.-T., et al. (2023). "Does endometrial compaction before embryo transfer affect pregnancy outcomes? a systematic review and meta-analysis." Frontiers in Endocrinology 14: 1264608.
	Objective: There is no clear evidence of clinical significance of endometrial compaction, which can be measured by a reduction in endometrial thickness (EMT) during the follicular-luteal transition before the day of embryo transfer. In this study, we aim to determine whether endometrial compaction has an effect on in vitro fertilization (IVF) success.; Methods: We searched PubMed, Cochrane, Embase, and Web of Science electronic databases for studies published in English up to March 2023. Heterogeneity between studies was assessed using the I 2 statistic. The random effects model and fixed effects model was used to pool the risk ratio (RR) with a corresponding 95% confidence interval (CI). A subgroup analysis was performed based on different methods of ultrasonic measurement and different endometrial compaction rates (ECR). Stata 17.0 software was used for meta-analysis. Pregnancy outcomes, which included clinical pregnancy rate, ongoing pregnancy rate, live birth rate, and spontaneous abortion rate, were evaluated.; Results: In this study, 18 cohort studies were included, involving 16,164 embryo transfer cycles. Pooled results indicated that there was no significant difference between the endometrial compaction group and the non-compaction group in terms of clinical pregnancy rate (RR [95% CI]=0.98 [0.90,1.08]; I 2 = 69.76%), ongoing pregnancy rate (RR [95% CI]=1.18 [0.95,1.47]; I 2 = 78.77%), live birth rate (RR [95% CI]= 0.97 [0.92,1.02]; I 2 = 0.00%) or spontaneous abortion rate (RR [95% CI]= 1.07[0.97,1.26]; I 2 = 0.00%). According to the subgroup analysis of ultrasonic measurement methods, in the transvaginal ultrasound (TVUS) combined with abdominal ultrasonography (AUS) cycles of the endometrial compaction group, the rate of ongoing pregnancy (RR [95% CI] = 1.69 [1.26, 2.26]; I 2 = 29.27%) and live birth (RR [95% CI] = 1.27 [1.00,1.61]; I 2 = 62.28%) was significantly higher than that of the non-compaction group. Additionally, subgroup analysis based on ECR revealed a significantly higher rate of ongoing pregnancy when ECR ≥ 15% (RR [95% CI] = 1.99 [1.61, 2.47]; I 2 = 0.00%).; Conclusion: Endometrial compaction has no adverse effect on clinical pregnancy rate, ongoing pregnancy rate, live birth rate, or spontaneous abortion rate. A possible explanation for the contradictory findings of previous studies lies in the method by which the EMT is measured.; Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display&#95;record.php?ID=CRD42023430511, identifier CRD42023430511.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2023 Chen, Sun and Song.)

Chen, Y., et al. (2022). "Association between statin use and the risk, prognosis of gynecologic cancer: A meta-analysis." European Journal of Obstetrics, Gynecology, and Reproductive Biology 268: 74-81.
	Background: Recent evidence has demonstrated that the salutary effect of statins on the prevention and prognosis of cancers, including gynecologic cancers. However, due to the heterogeneity of tumors, the results from related studies regarding the association between statin therapy and gynecologic cancers are conflicting. Thus, we conducted this meta-analysis to better understand the relationship between statins use and gynecologic cancers.; Methods: We searched for articles published before July 2021 in the databases: PubMed, Web of Science, Medline, EMBASE and Google Scholar. We computed odds ratio (OR)/relative risk (RR) or hazard ratio (HR) and 95% confidence intervals (CI) regarding the association between statin use and the risk or prognosis of gynecologic cancers by using STATA 12.0 software.; Results: The present meta-analysis showed that statin use was associated with a lower risk of gynecologic cancer (OR/RR = 0.89, 95% CI 0.83 to 0.96, I 2 = 60.6%, p < 0.001). Statin use was associated with lower risks of endometrial cancer and ovarian cancer (endometrial cancer: OR/RR = 0.81, 95% CI 0.70 to 0.94, I 2 = 62.3%, p = 0.001; ovarian cancer: OR/RR = 0.92, 95% CI 0.85 to 1.00, I 2 = 42.1%, p = 0.077). The present meta-analysis showed that statin use was associated with a lower mortality of gynecologic cancer (HR = 0.73, 95% CI 0.67 to 0.80, I 2 = 39.0%, p = 0.03). Statin use was associated with lower mortalities of endometrial cancer and ovarian cancer (endometrial cancer: HR = 0.71, 95% CI 0.64 to 0.80, I 2 = 31.9%, p = 0.144; ovarian cancer: HR = 0.78, 95% CI 0.73 to 0.83, I 2 = 43.9%, p = 0.051).; Conclusion: Statins use was inversely associated with the risk and mortality of gynecologic cancers. Meanwhile, we need more well-designed and high-quality studies with strong evidence for definite conclusions that determine clinical practice.; Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2021. Published by Elsevier B.V.)

Chen, Y., et al. (2023). "Systematic review and meta-analysis of reproductive outcomes after high-intensity focused ultrasound (HIFU) treatment of adenomyosis." Best practice & research. Clinical obstetrics & gynaecology 92: 102433.
	High-intensity focused ultrasound (HIFU) has emerged as a promising uterus-sparing and possibly fertility-sparing treatment modality for women with adenomyosis, especially those who desire to conceive. We conducted this systematic review and performed a meta-analysis on clinical studies aimed to improve reproduction in women with adenomyosis. After extensive search of PubMed and CNKI, we identified 10 studies published in English and Chinese involving a total of 557 patients with adenomyosis who desired to conceive after HIFU treatment. We found a pooled estimate of pregnancy rate of 53.4% and of the live birth rate of 35.2%, and there was a substantial heterogeneity among these studies. While there is a potential for HIFU treatment to improve fertility for patients with adenomyosis who desired to conceive, such evidence is very weak as of now. Comparative studies with much higher methodological rigor, preferably randomized clinical trials, are badly needed to further illuminate this issue.

Chen, Y., et al. (2019). "Efficacy of ten interventions for endometriosis: A network meta-analysis." Journal of cellular biochemistry 120(8): 13076-13084.
	Objective: Clinical trials comparing the efficacy of different interventions for endometriosis are limited and controversial. The aim of the present study is to perform a network meta-analysis on the efficacy of various interventions for endometriosis.; Methods: We searched PubMed and Ovid EMBASE through 1 June, 2018, for trials reporting the pain score and 1-year pregnancy rate of patients including at least one pair of direct control group. The mean difference of pain score, odds ratio of 1-year pregnancy rate, and their associated 95% credible intervals (CrI) were used to describe efficacy. The surface under the cumulative ranking curve (SUCRA) was calculated to illustrate the rank probability of various treatments for different outcomes, on the basis of network meta-analysis.; Results: Our meta-analysis enrolled six studies for the evaluation of reducing pain and 10 studies for the 1-year pregnancy rate. All involved trials were sufficiently powered with a low risk of bias. Expectant management (EM), progesterone (PR), and gonadotropin-releasing hormone (GnRH)-agonist (GN) were significantly effective to reduce pain when compared with the placebo; EM ranked the highest on the SUCRA curve. For the 1-year pregnancy rate, no significant difference between the interventions was evident. Ablation ranked the highest with a SUCRA value of 0.6328. The rank of EM was acceptable with a SUCRA value of 0.4452. Our experimental results need to be verified by more high-quality randomized controlled trial articles.; Conclusion: Limited available evidence showed that EM, PR, and GN were significantly effective to reduce pain when compared with the placebo. Due to a lack of convincing evidence favoring surgery or medication, we recommend considering EM. (© 2019 Wiley Periodicals, Inc.)

Chen, Y., et al. (2020). "Fuke Qianjin Combined with Antibiotic Therapy for Pelvic Inflammatory Disease: A Systematic Review and Meta-Analysis." Evidence-based complementary and alternative medicine : eCAM 2020: 5372839.
	Background: Pelvic inflammatory disease (PID) without timely and proper treatment can cause long-term sequelae; meanwhile, patients will be confronted with the antimicrobial resistance and side effects. Chinese patent medicine as a supplement is used to treat PID with satisfactory clinical efficacy. This study evaluated the efficacy and safety of Fuke Qianjin (FKQJ) combined with antibiotics in the treatment of PID.; Methods: Eight electronic databases and other resources were searched to make a collection of the randomized controlled trials (RCTs) from 1990 to 2019. The RCTs contrasting the effect of FKQJ combined with antibiotics regimens and antibiotics alone in reproductive women with PID were included. The antibiotics regimens are all recommended by the guidelines. Two reviewers independently screened the studies, extracted the data, and assessed the methodological quality of the included studies. Then, the meta-analyses were performed by RevMan 5. 3 software if appropriate.; Results: Twenty-three RCTs (2527 women) were included in this review. The evidence showed that FKQJ combined with antibiotics improved the markedly effective rate compared to antibiotics alone group (RR = 1.38, 95% CI 1.27 to 1.49, I 2 = 42%), shortened the improvement time of low abdominal pain (MD = -1.11, 95% CI -1.39 to -0.84, I 2 = 38%), and increased the rate of lower abdominal pain improvement (RR = 1.35, 95% CI 1.19 to 1.55, I 2 = 0). The implementation of adjuvant reduced the recurrent rate compared with antibiotics alone (RR = 0.27, 95% CI 0.13 to 0.56, I 2 = 0%).; Conclusions: Based on available evidence, FKQJ combined with antibiotics therapy have certain outcomes on increasing the markedly effective rate, decreasing the recurrent rate compared with antibiotics alone group. This therapy appears to improve lower abdominal pain and curtail the relief time. Due to the low quality and the risk of bias, any high-quality evidence or longer follow-up period should be advisable and necessary in the future.; Competing Interests: The authors declare that they have no conflicts of interest. (Copyright © 2020 Yu Chen et al.)

Chen, Z., et al. (2022). "The effect of mindfulness-based stress reduction therapy on maternal anxiety, depression, and sleep quality: A protocol for systematic review and meta-analysis." Medicine (United States) 101(8): 28849.
	Background:Depression and anxiety are common in the prenatal and postnatal periods, which significantly influence pregnant women and their unborn babies. Pharmacological interventions can negatively affect maternal and infant health outcomes, while psychotherapy can avoid adverse events of medication and improve maternal depression and anxiety. Whether mindfulness-based stress reduction (MBSR) can alleviate maternal anxiety and depression and improve sleep quality is still controversial. Therefore, we aim to conduct a meta-analysis by collecting randomized controlled trials (RCTs) reporting the effects of MBSR on maternal anxiety, depression, and sleep quality, thus providing evidence-based medical evidence for non-pharmacological interventions. Method(s):RCTs reporting the effect of MBSR on maternal anxiety, depression, and sleep quality versus conventional obstetric care will be searched in online databases, including the Cochrane Central Register of Controlled Trials Repositories, PubMed, Embase, Web of Science, Chinese Science Citation Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese Scientific Journal Database, and Wan Fang Database. Literature selection, data extraction, risk of bias assessment, and meta-analyses will be independently completed by 2 researchers. Meta-analysis will be performed by using RevMan5.4. Result(s):The results of this meta-analysis will be submitted to a peer-reviewed journal for publication. Conclusion(s):This study will provide reliable evidence-based evidences for the effects of MBSR on improving maternal anxiety, depression, and sleep quality.Copyright © 2022 Lippincott Williams and Wilkins. All rights reserved.

Chen, Z., et al. (2021). "Effect of antibiotics on urine leakage in women with refractory detrusor overactivity: a phase IIb randomized trial." Neurourology and Urodynamics 40(1): 158‐167.
	Aim: Because bacterial cystitis is common in women with refractory detrusor overactivity, the aim was to compare the efficacy of 6 weeks of rotating antibiotics versus placebo, in conjunction with an anticholinergic, in controlling the symptoms of urge incontinence. Methods: In a multicenter phase IIb double‐blinded randomized placebo‐controlled trial, women with urodynamically proven refractory detrusor overactivity were randomized in a 2:1 ratio of antibiotics versus placebo for 6 weeks, in addition to darifenacin for 6 months. Any woman with disabling cystitis symptoms was given appropriate antibiotics (“clinical override”). The primary outcome was the degree of urge incontinence change at 6 weeks and 6 months on 24‐h pad test. Secondary outcomes were changes in leaks and voids per day measured on 3‐day bladder diary and quality of life measures. Microbiological data were collected at all visits. Results: Although 278 women were screened, only 36 were randomized and 33 (91.7%) completed the trial. Leakage on 24‐h pad test decreased at 6 months by 75 g in patients receiving antibiotics versus 35 g in placebo. Cure of urge incontinence occurred at 6 months in 10/21 (48%) of antibiotics versus 2/12 (17%) of placebo. Clinical override, necessitating treatment of cystitis, occurred in 41.6% of placebo versus 16.7% of the antibiotic group by 6 months. Conclusion: Despite the small sample size, the study showed a significant reduction in pad leakage and leaks per day over 24 h in the active treatment group over a 6‐month period. Nearly half of patients on placebo had disabling urinary tract infection symptoms that required clinical override treatment.

Chen, Z., et al. (2022). "Effectiveness and Safety of the Traditional Chinese Medicine Treatment ( HuoxueHuayu Therapy) for Malignant Tumors: A Systematic Review and Meta-Analysis." Evidence-based complementary and alternative medicine : eCAM 2022: 7944063.
	Background: A malignant tumor is one of the refractory diseases that threaten human life and health. HuoxueHuayu therapy (one of the Traditional Chinese Medicine therapies to promote blood circulation and remove blood stasis) is widely used as an antitumor supplementary method. However, its efficacy and safety are still controversial. Therefore, the objective of this study was to provide evidence-based evidence for HuoxueHuayu therapy in the treatment of malignant tumors and confirm its safety and effectiveness.; Methods: A systematic search in 8 electronic databases targeted randomized clinical studies evaluating HuoxueHuayu therapy for response evaluation, tumor progression rate, quality of life (QoL), peripheral hemogram, performance status, immunologic function, tumor marker, and blood coagulation function in cancer patients, published from the establishment of the database to December 31, 2020. Risk ratio (RR) was used for counting data, mean difference (MD) or standardized mean difference (SMD) was used for measurement data, and 95% confidence interval (CI) was used as efficacy analysis statistics.; Results: Our search identified 69 studies, evaluating 4402 patients in total. Randomized controlled trials (RCTs) evaluated gastric ( n = 14), lung ( n = 18), pancreatic ( n = 2), colorectal ( n = 10), liver ( n = 14), breast ( n = 2), ovarian ( n = 2), gallbladder ( n = 1), esophagus ( n = 1), and combined ( n = 14) cancers and hematological malignancies ( n = 2). The duration of HuoxueHuayu therapy ranged from 3 to 48 weeks. Methodological bias was low in 64 studies and high in 5 studies. HuoxueHuayu therapy was associated with significant improvement in response evaluation (Response Evaluation Criteria in Solid Tumor (RECIST): RR: 1.44, 95% CI: 1.27 to 1.63, I 2 = 0%, n = 33 studies; World Health Organization Criteria in Solid Tumors (WHOCIST): RR: 1.40, 95% CI: 1.23 to 1.59, I 2 = 0%, n = 26 studies), recurrence rate (RR: 0.85, 95% CI: 0.72 to 0.99, I 2 = 0%, n = 2 studies), quality of life, performance status (MD: 5.60, 95% CI: 5.04 to 6.15, p < 0.001), immunologic function (CD3: SMD: 1.23, 95% CI: 0.79 to 1.66, p < 0.001; CD4: SMD: 1.25, 95% CI: 0.77 to 1.74, p < 0.001; CD4/CD8: SMD: 1.05, 95% CI: 0.69 to 1.42, p < 0.001; natural killer cell (NK): SMD: 0.74, 95% CI: 0.32 to 1.15, p < 0.001), tumor marker, and blood coagulation function (D-dimer (D-D); fibrinogen (FIB)). In addition, HuoxueHuayu therapy could reduce toxicity caused by chemotherapy and radiotherapy without risks of liver and kidney injury or bleeding, although the effect on tumor metastasis was uncertain.; Conclusions: The present update of our systematic review and meta-analyses provided essential evidence for the beneficial effect of HuoxueHuayu therapy to show promise in cancer treatment, improving quality of life, addressing cancer-related symptoms, and reducing toxicity in a secure way.; Competing Interests: The authors declare that they have no conflicts of interest in this paper. (Copyright © 2022 Zehui Chen et al.)

Cheng, H., et al. (2019). "Oncological Outcomes and Safety of Ovarian Preservation for Early Stage Adenocarcinoma of Cervix: A Systematic Review and Meta-Analysis." Frontiers in Oncology 9: 777.
	Objectives: To evaluate the oncological outcomes and safety of ovarian preservation, and to review the prognostic factors for ovarian metastases in early stage cervical adenocarcinoma. Methods: PubMed, Embase, and Cochrane databases were searched for publications up to January 2019. Two investigators independently screened the studies for eligibility and extracted specific data. The primary outcomes were overall survival (OS) and progression-free survival (PFS). Pooled odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using STATA statistical software version 19.0. Results: A total of 68 unique manuscripts were identified through the search strategy, and 10 studies were included in the meta-analysis of the safety of ovarian preservation. Fixed-effects model was used because of moderate heterogeneity. Pooled results of the included studies showed that ovarian preservation is not associated with a statistically significant OS (OR 1.00, 95% CI 0.64-1.56, I 2 = 25.7%) or PFS (OR 0.98, 95% CI 0.57-1.66, I 2 = 0%) in early stage cervical adenocarcinoma. In addition, 19 studies were included in the review of prognostic factors for cervical adenocarcinoma and risk factors for ovarian metastases. The incidence of ovarian metastases was 0% in stage IA, 2.8% in stage IB, 3.4% in stage IIA, and 11.8% in stage IIB cervical adenocarcinoma. International Federation of Gynecology and Obstetrics (FIGO) stage, tumor size, deep stromal invasion (DSI), lymph node metastasis (LNM), and vaginal invasion were significantly related to poor prognosis. Risk factors associated with ovarian metastases included age, FIGO stage, tumor size, DSI, parametrial invasion, corpus uteri invasion, LNM, vaginal invasion, and blood vessel invasion. Conclusions: Ovarian preservation in young patients with early stage cervical adenocarcinoma is safe and has no significant effect on OS or PFS. Preserving ovaries in patients with FIGO stage IIB seems not reasonable because of the high rate of ovarian metastasis.

Cheng, M., et al. (2020). "Efficacy of Applying Hyaluronic Acid Gels in the Primary Prevention of Intrauterine Adhesion after Hysteroscopic Myomectomy: A Meta-Analysis of Randomized Controlled Trials." Life (Basel, Switzerland) 10(11).
	Intrauterine adhesion (IUA), which mainly occurs after intrauterine surgery or an inflammatory process, is an important but often neglected condition in women of reproductive age. The presentation of IUA varies greatly, ranging from symptom-free to severe, with amenorrhea or infertility. With much advanced development of intrauterine instruments, more intrauterine diseases can be successfully cured by hysteroscopic surgery. Among these, submucosal myoma is one of the best examples. Submucosal myomas are often related to abnormal bleeding, anemia, and possible infertility or miscarriage. However, submucosal myoma after hysteroscopic myomectomy may be complicated by IUA in various grades of severity, and its incidence and prevalence might be nearly one-quarter to one-third of patients, suggesting an urgent need for efforts to decrease the risk of developing IUA after hysteroscopic myomectomy. Many strategies have been reported to be useful for this purpose, and intrauterine application of anti-adhesive gels, such as polyethylene oxide-sodium carboxymethylcellulose (PEO-NaCMC) or auto-crosslinked hyaluronic acid (ACHA), has become increasingly popular in routine clinical practice. This meta-analysis is aimed at investigating the effect of ACHA on the primary prevention of IUA formation after hysteroscopic myomectomy. A pooled analysis of three studies (hysteroscopic surgeries for fibroids, polyps, and septum) including 242 women showed that using PEO-NaCMC or ACHA gel decreased the IUA rate with an odds ratio (OR) of 0.364 (95% confidence interval (CI) 0.189-0.703, p = 0.03). Pooled analysis of two studies that limited the use of ACHA in 119 women showed that the application of ACHA gel for the primary prevention of IUA in patients after hysteroscopic myomectomy led to a statistically significant reduction of the development of IUA postoperatively (OR 0.285, 95% CI 0.116-0.701, p = 0.006). All of this suggests that the use of ACHA gel in patients after hysteroscopic myomectomy could significantly reduce de novo IUA, although more evidence is needed.

Cheng, P., et al. (2020). "The acupuncture-related therapy for post-stroke urinary incontinence: A protocol for systematic review and network meta-analysis." Medicine (United States) 99(44): E22865.
	Background:With the rising incidences stroke, the Post-Stroke Urinary Incontinence (PSUI) has become one of the common clinical sequelae. PSUI not only lowers the quality of life of patients, but also impacts tremendously to mental health. As a treasure of Chinese medicine, acupuncture and its related therapies have been widely accepted in clinical treatment of PSUI. Recently, there have been many clinical studies on the treatment of PSUI with acupuncture and related therapies, but the best way to treat PSUI is controversial. Therefore, the purpose of this paper is to provide an optimal ranking regarding acupuncture and its related therapies for PSUI. Method(s):The five domestic and foreign databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, Wanfang Database will be systematically searched. The time range of the literature search is from the date of establishment to August 31, 2020. The main evaluation outcome was the number of patients after treatment, and the frequency of urinary incontinence. The secondary evaluation outcome was International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Barthel Activities of Daily Living Index (Barthel ADL Index) and the incidence rate of adverse events. The methodological quality of the article will evaluated by Cochrane Collaboration's Tool and the quality of evidence will evaluated through Grading of Recommendations Assessment, Development and Evaluation (GRADE) instrument. The Network Meta-Analysis (NMA) will be completed using Stata statistical software. Result(s):The final results of this study will be published in a peer-reviewed journal. Conclusion(s):This network meta-analysis will compare the efficacy and safety of different acupuncture therapies in the treatment of PSUI and summarize the best treatment options, which will help patients and doctors to choose effective acupuncture methods in time.Copyright © 2020 Lippincott Williams and Wilkins. All rights reserved.

Cheng, P., et al. (2021). "Role of Arts Therapy in Patients with Breast and Gynecological Cancers: A Systematic Review and Meta-Analysis." Journal of Palliative Medicine 24(3): 443-452.
	Background: Women with breast and gynecological cancers often experience adverse symptoms such as anxiety, depression, pain, and fatigue. Objective(s): The purpose of this meta-analysis was to clarify the role of arts therapy (based on music, painting, and dance) in quality of life and reported symptoms among women with breast and gynecological cancers. Method(s): Articles on arts therapy were retrieved from relevant electronic databases through to May 2020. The outcomes (quality of life and symptoms such as anxiety, depression, pain, and fatigue) were estimated according to standard or validated scales that assessed psychological status and activities of daily living. The effect sizes for arts therapy were combined to show the standardized mean difference (SMD) and corresponding confidence interval (CI), and a random-effects model was used for computation. Result(s): In total, 19 randomized controlled studies were included in this meta-analysis. The pooled SMDs for arts therapy were statistically significant for quality of life (0.58; 95% CI: 0.02-1.13; p = 0.04), anxiety (-1.10; 95% CI: -1.88 to -0.32), depression (-0.71; 95% CI: -1.19 to -0.23), pain (-1.01; 95% CI; -1.97 to -0.08), and fatigue (-0.59; 95% CI: -1.18 to -0.00). However, the summary SMDs for arts therapy was not significant for sleep disturbance, anger, vigor, tension, confusion, and stress. Conclusion(s): This meta-analysis shows that arts therapy has favorable effects on improving quality of life and depression among patients with breast and gynecological cancers. Arts therapy also has positive effects on improving anxiety, pain, and fatigue symptoms among patients with breast cancer. Further studies are required to confirm the effect of arts therapy on anxiety, pain, and fatigue in patients with gynecological cancer.© Copyright 2021, Mary Ann Liebert, Inc., publishers 2021.

Cheng, P. and X. H. Yang (2022). "Preservation of the fallopian tube in ectopic tubal pregnancy. An analysis of the outcome of two laparoscopic surgical approaches." Annali italiani di chirurgia 93: 241-247.
	INTRODUCTION: The application of laparoscopic partial tubal resection with end-to-end anastomosis can reduce the incidence of persistent ectopic pregnancy. AIM: We aim to compare the therapeutic effects of laparoscopic fenestration and laparoscopic partial tubal resection with end-to-end anastomosis in the treatment of tubal ectopic pregnancy. MATERIAL AND METHODS: The patients were randomly divided into the observation group (the group treated with laparoscopic partial tubal resection with end-to-end anastomosis, n=238) and the control group (the group treated with laparoscopic fenestration, n=213). The average operation time, intraoperative blood loss, postoperative exhaust time and hospital stay were observed to evaluate the clinical effect. In addition, the time required for the beta-HCG to drop to normal level, the patency of the fallopian tubes and the ovarian function were observed in the two groups after the operation. RESULT(S): There was no significant difference between observation group operation time, intraoperative hemorrhagic amount, blood beta-HCG recovery time and hospital time and control group (P > 0.05). The postoperative fallopian tube patency rate in the observation group was 67.58%, significantly higher than the control group (P < 0.05). In addition, there was no significant difference in ovarian function between the two groups. CONCLUSION(S): The method of laparoscopic partial tubal resection with end-to-end anastomosis is more effective in the treatment of tubal ectopic pregnancy, and has less impact on ovarian function, which can effectively improve the probability of normal pregnancy after the operation. KEY WORD: Fallopian tube, Ectopic pregnancy, Laparoscopic fenestration, Laparoscopic partial tubal resection with end-to-end anastomosis.

Cheng, Q., et al. (2022). "Effectiveness of psychoeducational interventions among caregivers of patients with cancer: A systematic review and meta-analysis." International journal of nursing studies 127: 104162.
	BACKGROUND: Many of the needs of caregivers of patients with cancer are unmet, particularly their informational and psychological needs. Psychoeducational interventions that focus on providing caregivers with information, and on meeting their emotional and psychosocial needs, may therefore be effective. OBJECTIVE: To evaluate the effectiveness of psychoeducational interventions on the outcomes of caregivers of patients with cancer and identify characteristics of effective psychoeducational interventions. DESIGN: A systematic review and meta-analysis of randomised controlled trials. DATA SOURCES: The databases of PubMed, Embase, the Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature Complete, the British Nursing Index, PsycINFO, Ovid Emcare, Scopus, Chinese Journal Net, and Wan Fang Data were searched in December 2020. Clinical trial registers, related websites and reference lists of included studies were also examined. REVIEW METHODS: The Cochrane Risk of Bias Tool was used to appraise the quality of included studies. Meta-analysis was conducted, and narrative syntheses were performed where meta-analysis was inappropriate. RESULTS: Fourteen articles describing 12 studies were included. The results of the meta-analysis showed that psychoeducational interventions have short-term (immediately post-intervention) positive effects on relieving anxiety [SMD: -0.50, 95%CI: (-0.97, -0.02), p = 0.04], depression [SMD: -0.54, 95%CI: (-0.76, -0.32), p < 0.00001] and caregiver burden [SMD: -0.57, 95%CI: (-0.87, -0.27), p = 0.0002] and improving their quality of life [SMD: 0.42, 95%CI: (0.23, 0.62), p < 0.0001) and self-efficacy [SMD: 0.31, 95%CI: (0.09, 0.53), p = 0.006] in the caregivers of patients with cancer. They also showed long-term (at least 3 months post-intervention) positive effects on improving physical health [SMD: 0.26, 95%CI: (0.05, 0.47), p = 0.02]. The types of psychoeducational interventions varied in the 12 studies. However, the main contents of effective psychoeducational interventions included tasks related to health care provisions for patients, caregiver self-care and stress management, and relationship and coping skills. In general, most studies had short follow-up periods and involved caregivers of older patients with cancer (>40 years old). CONCLUSIONS: Psychoeducational interventions may have short-term desirable effects on caregivers' anxiety, depression, quality of life, burden and self-efficacy and long-term desirable effects on physical health. Individual psychoeducational intervention varied in contents, delivery mode, dosage and format. Research is needed to further specify the optimal combination of contents. Further high-quality RCTs are warranted, with longer follow-up periods, for caregivers of patients with cancer, especially caregivers of younger patients with cancer.

Cheng, X., et al. (2022). "Does antibiotic therapy for chronic endometritis improve clinical outcomes of patients with recurrent implantation failure in subsequent IVF cycles? A systematic review and meta-analysis." Journal of Assisted Reproduction and Genetics 39(8): 1797-1813.
	Purpose: This study aims to assess whether antibiotic therapy for chronic endometritis (CE) could improve subsequent IVF outcomes in patients with recurrent implantation failure (RIF).; Methods: Studies that explore CE treatment in patients with RIF were retrieved from PubMed, EMBASE, Wanfang, and Google Scholar up to Jan 31, 2022. All retrieved studies were selected according to the inclusion and exclusion criteria. The main outcome measures include implantation rate (IR), clinical pregnancy rate (CPR), ongoing pregnancy rate/live birth rate (OPR/LBR), and miscarriage rate (MR). Odds ratios (ORs) were analyzed for pregnancy outcomes with a 95% confidence interval (CI).; Results: Nine articles were enrolled in this study. Patients receiving oral antibiotic administration (OAA) did not show any advantage over patients without CE with regard to IR, OPR/LBR, and MR, but they showed a higher CPR. Patients with cured CE after OAA therapy had significantly higher CPR, IR, and OPR/LBR compared with patients without CE. Patients with persistent CE after OAA therapy had significantly lower IR, CPR, and OPR/LBR compared with patients without CE. Patients with cured CE had significantly higher IR, CPR, and OPR/LBR compared with persistent CE patients.; Conclusions: Antibiotic treatment may improve the pregnancy outcomes of RIF patients in subsequent IVF cycles only if the condition of CE is confirmed cured in a control biopsy afterwards. Otherwise, no sufficient evidence has shown improvements in clinical outcomes in RIF patients with persistent CE. (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Cheng-Chun, Y. and L. Jyun-Yan (2021). "Prophylactic intraoperative uterine artery embolization during cesarean section or cesarean hysterectomy for patients with abnormal placentation."
	
Chengyang, J., et al. (2021). "Pelvic floor muscle training for women with urinary incontinence after stroke: a systematic review."
	
Chen-Li, D., et al. (2022). "Ketamine as potential treatment for postpartum depression: A narrative review." Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists 34(4): 264-274.
	Background: Postpartum depression (PPD) is a severe, debilitating mood disorder with consequences for both mothers and children, highlighting the need for rapid-acting and effective treatments for PPD. The aim of this narrative review is to synthesize the available literature on the administration of ketamine for PPD and propose ketamine as a viable and advantageous treatment.; Methods: A search was conducted on MEDLINE/PubMed, PsycInfo, and Embase databases from inception to October 10, 2021 for preclinical studies, interventional studies (ie, open-label and randomized controlled trials), as well as systematic reviews and meta-analyses evaluating the use of ketamine in postpartum populations. Completed and ongoing clinical trials were identified on ClinicalTrials.gov.; Results: Four clinical trials were identified. Results from this review support additional investigation into ketamine as a potential treatment for PPD.; Conclusions: Ketamine may be a favorable option for treating PPD due to its antidepressive and analgesic effects, short infusion time, and rapid clearance from the maternal bloodstream. However, there is insufficient evidence to support its use in this population, underscoring the importance of additional clinical research investigating ketamine for PPD.

Chermansky, C. J., et al. (2022). "Intravesical Instillation of OnabotulinumtoxinA in the Treatment of Refractory Overactive Bladder in Participants with Urinary Incontinence." Journal of urology 208(4): 855-862.
	Purpose:Intradetrusor injections of onabotulinumtoxinA are efficacious for the treatment of overactive bladder with urgency urinary incontinence in adults refractory to or intolerant of anticholinergics. Delivery of onabotulinumtoxinA via instillation would reduce the need for intradetrusor injections. The objective of this trial was to assess the efficacy and safety of intravesical instillation of an onabotulinumtoxinA + hydrogel admixture.Materials and Methods:After review of a stage 1 safety phase by an independent committee, participants were recruited into stage 2 and randomized to either onabotulinumtoxinA 100, 300, 400, or 500 U, or placebo, all with hydrogel admixture. End points included change from baseline to week 12 in the number of urinary incontinence episodes (primary); micturition, urgency urinary, and nocturia episodes/day; volume voided per micturition; proportion of participants with a >=50% decrease from baseline in urinary incontinence episodes/day; and Overactive Bladder Questionnaire total score. Adverse events were reported. Result(s):Change from baseline to week 12 in number of urinary incontinence episodes was -2.72 with placebo and ranged from -0.89 to -1.85 in the onabotulinumtoxinA + hydrogel treatment groups. No difference from placebo was observed for any efficacy end point. The proportions of participants with treatment-emergent adverse events were similar among all groups, with asymptomatic bacteriuria the highest reported (6.7%-15.5%). There were no reports of urinary retention or elevated post-void residual volume. Conclusion(s):Intravesical instillation of an onabotulinumtoxinA + hydrogel admixture for the treatment of refractory overactive bladder was well tolerated, but it showed no improvement over placebo.Copyright © 2022 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc.

Chernukha, G. E., et al. (2022). "NEW PERSPECTIVES ON OVULATION INDUCTION WITH LETROZOLE IN WOMEN WITH POLYCYSTIC OVARY SYNDROME." Akusherstvo i Ginekologiya (Russian Federation) 2022(12): 107-114.
	Objective: To compare the efficacy and adverse event rates of letrozole in a stair-step and standard ovulation induction (01) protocols in women with polycystic ovary syndrome (PCOS) and anovulatory infertility. Material(s) and Method(s): The study included 194 patients aged 28.7 (25;33), body mass index 21.5 (21;26) kg/m2. Of them, 106/194 (54.6%) women did not respond to the initial stimulation with 2.5 mg letrozole. They were divided into group 1 (n=52) and group 2 (n=54) undergoing stair-step protocol and standard protocol, respectively. During 01, the patients underwent ultrasound monitoring of ovarian and endometrial status. Furthermore, the clinical evaluation included estimated time of ovulation and ovulation and pregnancy rates. Result(s): The ovulation rates were equally high in both groups and was 92.3% on the stair-step protocol and 85.2% on the standard protocol (p=0.25). The time to ovulation was statistically significantly shorter in the stair-step protocol [33.9 (3.23) versus 59.5 (11.96) days; p<0.001J. The mean M echo was larger in the same group [0.2 (2.2) mm versus 9.3 (2.2) mm; p=0.01[. There was no statistical difference in pregnancy and live birth rates between the stair-step and standard protocols [17/52 (32.7%) versus 12/54 (22.2%); p=0.23 and 15/52(28.8%) versus 11/54 (20.4%);p=0.31[. None of the patients developed ovarian hyperstimulation syndrome (OHSS). The incidence of multiple pregnancies in group 1 was 1/17(5.9%) (p=0.31). Conclusion(s): The stair-step protocol with letrozole allows repeated stimulation without inducing a menstrual-like response and can be considered an effective treatment of anovulatory infertility in PCOS. It reduces the time to ovulation approximately twofold without increasing the risk of OHSS and multiple pregnancies, thus improving patients' quality of life.Copyright © A group of authors, 2022.

Chernyavskaya, M. A. and I. A. Narkevich (2020). "Biological effects of phytoestrogens: Clinical effectiveness and potential application in the treatment of climacteric syndrome." Farmakoekonomika 13(2): 164-169.
	Aim. To review scientific publications on clinical effectiveness and potential application of phytoestrogens (PE) in the treatment of climacteric syndrome. Materials and methods. The PRISMA approach was used. The systematic search was performed in three electronic scientific databases: Cochrane library, PubMed/MEDLINE, and eLIBRARY.ru. The publications were also manually searched for in the reference lists of the relevant articles. Results. The filters were used to select 79 publications; 26 of them were included in the final review. The main method of treatment for the manifestations of the climacteric syndrome is menopausal hormonal therapy (MHT). One of the alternative methods for the control of its symptoms is the application of phytoestrogens (PE), primarily, isoflavones, lignans, and coumestans. Active metabolites of PE are expressed under the influence of gut microflora that is different in various groups of women, which can determine the differences in the effectiveness. Taking into account multidirectional character of the studies as well as numerous publications of low quality, it is still impossible to come to the final conclusion on the effectiveness of PE-containing food supplements (FS) when it comes to a decrease in the occurrence rate and expression of such symptoms as hot flushes, night sweats, and cognitive deterioration. The conclusions on the prevention of cardio-vascular diseases are not definite either. Conclusions. The review showed that scientists could not come to the conclusion on the effectiveness and safety of PE-containing FS. Probably, the most prospective means of the control of climacteric syndrome are FS that contain isoflavones of red clover and soy in the maximum effective concentration. Considering free access to such FS on the market, they must meet high safety requirements.Copyright © 2020, Farmakoekonomika. All rights reserved.

Chi, C. (2022). "Comparison of application of remifentanil and propofol combined anesthesia in painless induced abortion under the monitoring of different anesthesia depth index." Medical Theory and Practice / 医学理论与实践 35(2): 281‐283.
	Objective: To compare the application effect of remifentanil and propofol combined anesthesia in painless induced abortion under the monitoring of different anesthesia depth index (NTI). Methods: A total of 114 patients who underwent painless abortion in our hospital from September 2019 to September 2020 were selected and divided into three groups according to the random number table method. The depth of anesthesia was monitored with Narcotrend. The depth of anesthesia in group A was at the level of D1 (NTI was 47‐56 points), group B was at the level of D2 (NTI was 37‐46 points), and group C was at the level of E0 (NTI was 27‐36 points). The anesthesia effects and adverse reactions were compared, and the levels of serum cortisol and epinephrine were measured and compared before anesthesia and 30 minutes after recovery from anesthesia. Results: The excellent and good rate of anesthesia in group B was significantly higher than that in groups A and C (P<0.05). The recovery time in group B was shorter than that in group C (P<0.05), and the incidence of adverse reactions in group B was lower than that in groups A and C (P<0.05). The levels of serum cortisol and epinephrine in the three groups at 30 min after anesthesia were higher than those before anesthesia (P<0.05), but lower in group B than in groups A and C (P<0.05). Conclusion: When using propofol and remifentanil for compound anesthesia in painless abortion, the depth of anesthesia is optimal at D2 level, which can better meet the needs of surgery, reduce the stress level, speed up the resuscitation process, and have less adverse reactions. few.

Chi, Y., et al. (2022). "Laser treatment vs vaginal estrogen on genitourinary syndrome of menopause in women." PROSPERO International prospective register of systematic reviews.
	
Chiaffarino, F., et al. (2022). "Prevalence of polycystic ovary syndrome in European countries and USA: A systematic review and meta-analysis." European Journal of Obstetrics and Gynecology and Reproductive Biology 279: 159-170.
	We conducted a systematic review and meta-analyses of the prevalence of Polycystic Ovary Syndrome (PCOS) and the frequency of its phenotypes in Europe and the USA, also focusing on temporal trends of the condition, to compare the PCOS prevalence among populations with a similar level of diagnostic resources availability and attitudes toward health problems, to improve comparability of estimates. We considered Europe and USA, two high-income areas with these characteristics. The overall PCOS prevalence according to the NIH1990, ESHRE/ASRM 2003, AES-PCOS diagnostic criteria was respectively 6.2 % (95%CI 5.3-7.0), 19.5 % (95%CI 17.3-21.6), and 15.0 % (95%CI 12.9-17.1), with no appreciable heterogeneity across geographic areas. Phenotype A, the "complete PCOS", showed higher prevalence in all areas (44.8%, 95%CI 40.3-49.3), followed by phenotype D, called "non-hyperandrogenic PCOS" (19.5%), phenotype C termed as "ovulatory PCOS" (16.2%), and phenotype B, presenting as phenotype A but without polycystic ovarian morphology (14.9%). In all the studies analysing temporal trends of PCOS, an increase in prevalence of PCOS was reported, due, at least in part, to changing diagnostic criteria. The prevalence of PCOS is similar in European countries and the USA. Interestingly, some differences in the frequency of PCOS phenotypes emerged between the two areas with a higher frequency of phenotype A and a lower one of phenotype C in the USA. Recognizing the factors which explain these differences would lead to a better understanding of the etiopathogenesis and the clinical expression of PCOS.Copyright © 2022

Chiavarini, M., et al. (2022). "Postmenopausal exogenous hormone therapy and Melanoma risk in women: A systematic review and time-response meta-analysis." Pharmacological research 176: 106054.
	
Chicago University, o. and H. M. S. Gmb (2022). Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL).
	No Results Available Drug: Myfembree Oral Product Fibroid recurrence on ultrasound after myomectomy.|Participants' quality of life assessed by the Quality of Life Questionnaire.|Work Productivity and Activity Impairment assessed by Work Productivity and Activity Impairment Questionnaire.|Female Sexual Function Impairment assessed by Female Sexual Function Index Questionnaire.|Heavy menses recurrence after myomectomy with score ≥ 120 on Pictorial Bleeding Assessment Chart (PBAC).|Pelvic pain recurrence after myomectomy with Numerical Rating Scale (NRS) ≥ 4 at baseline.|The need for surgical/non-surgical reintervention for recurrent symptoms after myomectomy reported by the participant and based on her provider's decision. Female Phase 4 136 Other|Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IRB22-0282 April 2026

Chicago University of Illinois, a. (2023). Time Restricted Eating for the Treatment of PCOS.
	No Results Available Other: 6-h Time restricted eating (TRE)|Other: Calorie restriction (CR)|Other: Control Change in body weight|Change in fat mass, lean mass, visceral fat mass|Change in bone mineral density|Change in waist circumference|Change in Insulin sensitivity|Change in Fasting glucose|Change in Fasting insulin|Change in HbA1c|Change in Blood pressure|Change in heart rate|Change in Plasma lipids (LDL cholesterol, HDL cholesterol, triglycerides)|Change in inflammatory markers (TNF-apha, IL-6, IL-10, IL-B, hs-CRP)|Change in oxidative stress (8-isoprostane)|Change in reproductive hormones (testosterone, DHEA, SHBG, androstenedione)|Change in energy and nutrient intake|Change in physical activity (steps/d)|Change in mood|Change in appetite Female Not Applicable 300 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 2022-1500 January 1, 2028

Chicago University of Illinois, a. and C. Health (2022). Caria: Digital Intervention for Menopause Symptom.
	No Results Available Behavioral: Caria app|Behavioral: Menopause Education Hot Flush Rating Scale|Women's Health Questionnaire Female Not Applicable 150 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2021-0282 December 15, 2022

Chichevatov, D. A., et al. (2023). "TREATMENT OF CERVICAL ESOPHAGEAL CARCINOMA: SYSTEMATIC REVIEW AND META-ANALYSIS." Siberian Journal of Oncology 22(4): 101-108.
	Objectives. Up to date managing a cervical esophageal carcinoma (CEC) has remained a controversial challenge. The choice of treatment is still uncertain. In the present review we attempted to assess eligibility of surgery in treatment of CEC. Material and Methods. We have enquired particular publication databases and the enquiries yielded 24 contributions matching study selection criteria such as (1) original articles published from 2000 to 2022, (2) primary tumor localization in the cervical esophagus, (3) squamous cell carcinoma, (4) available characteristics of studied groups (age, sex, T, N, M, stage), (5) detailed description of curative procedures (radiation therapy, chemotherapy, surgery), (6) information about overall survival. These publications represented two arms of 14 surgical and 17 non-surgical subgroups to analyze. Individual patient dataand parameter estimates have been renewed on the basis of original Kaplan-Meier curves plotted. Results.The analysis revealed a highly heterogeneous (I2=83.76 %; 95 % CI, 71.40-92.16) random effects model. Including a surgical option into treatment of CEC did not affect 3-year overall survival (p=0.665); 46.4 % (95 % CI, 37.4-55.6) vs 43.7 % (95 % CI, 35.3-51.6), respectively. Possibilities of surgical and non-surgical modalitiesemployment were discussed. Conclusion. In treatment of CEC CRT and surgery are non-inferior to each other. These modalities are evenly associated with posterior side effects and complications, which adversely affect functional outcomes and survival. The choice of a treatment mode may depend on tumor response to induction therapy. The latter demands further investigations.Copyright © 2023, Tomsk National Research Medical Center of the Russian Academy of Sciences. All rights reserved.

ChiCtr (2021). "Clinical study of the effects of metformin combined with different dietary intervention patterns on pregnancy and endocrine metabolism in overweight/obese patients with polycystic ovary syndrome." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: A group:The first phase of the intervention required lifestyle guidance based on caloric restriction and a low carbohydrate diet accompanied by a 1000mg BID regimen with metformin.Outpatient visits were performed at the 4th, 8th and 12th weeks respectively.;B group:Metformin 1000mg BID was required for a normal structured diet based on caloric restriction.Outpatient visits were performed at the 4th, 8th and 12th weeks respectively.In the second phase of the intervention (12 to 36 weeks), caloric restriction and a normal structured diet with metformin were continued.; CONDITION: E28.200 Polycystic ovary syndrome PRIMARY OUTCOME: pregnancy rate;pregnancy outcome; SECONDARY OUTCOME: weight;Body mess index;waistline;glycometabolism;change in blood fat;change in the function of islets;change in sex hormones;inflammatory indications;change in blood pressure;change in adipokines;change in intestinal flora; INCLUSION CRITERIA: 1. Aged >= 20 years, but <= 40 years; 2. Patients with hyperandrogenemia and meeting the diagnostic criteria for PCOS may be diagnosed with 2 of the following 3 criteria, as amended by the Rotterdam Working Group of the American Society for Reproductive Medicine (ASRM): (1) anovulation or irregular ovulation; (2) evidence of clinical or biochemical changes with elevated androgen levels (such as hirsutis, acne); (3) Ovarian enlargement, at least 12 small follicles with a diameter of 2 9mml on each side and/or unilateral or bilateral ovarian volume >= 10ml.Congenital adrenal hyperplasia and other ovarian tumors secreting testosterone were excluded.3. Body mass index (BMI) >= 24kg/m2; 4. Women who have not used contraception for more than 2 years and have not become pregnant; women who need to become pregnant but have agreed to use non‐drug contraception for the last 3 months; 5. Agree to regular postnatal examinations during pregnancy and acc

ChiCtr (2022). "Clinical efficacy of blastocyst culture supernatant transfer in hormone replacement frozen-thawed embryo transfer cycle: a prospective double-blind randomized controlled study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: experimental group:blastocyst culture supernatant transfer;control group:conventional culture medium transfer; CONDITION: female infertility PRIMARY OUTCOME: Live birth rate; SECONDARY OUTCOME: Clinical pregnancy rate;Early abortion rate; INCLUSION CRITERIA: 1. The first frozen embryo transfer; 2. Aged 20‐40 years; 3. Basic endocrine FSH<=10IU/L, BMI<=30; 4. At least one high‐quality blastocyst and blastocyst culture supernatant with D5 grade and above B3BB should be frozen; 5. Endometrial thickness >= 7mm and progesterone <= 1.0ng/ml on the day of secretory transformation.

ChiCtr (2022). "Clinical study of low intensity focused ultrasound in promoting endometrial repair after abortion." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: control group :The control group received no treatment;Drug group:In the drug group, subjects were treated with Euthyrene‐drospirenone ethinylestradiol tablets, one tablet per day (3mg/0.02mg) after surgery, for 3 months. ;Low intensity focused ultrasound intervention group:Intra‐regional mobile therapy was carried out within 5cm of the symphysis pubis center at a speed of 1‐2cm/s, with the intervention time of 15 minutes each time, once a day, for a total of 7 treatments (once a day in the first three days after surgery, with treatment gear 3‐5; After 3 d;Electrical stimulation group:After surgery, the electrode was pasted on the uterine area, and the analgesic mode was adopted. The intervention lasted for 30 minutes, and the treatment lasted for 3 consecutive days. Then, the patients were treated twice a week for two weeks. The uterine rejuvenation mode was adopted, and the el; CONDITION: Clinical study of low intensity focused ultrasound in promoting endometrial repair after abortion PRIMARY OUTCOME: 1) Endometrial thickness examination [15] : Transvaginal ultrasonography was performed 3 weeks after surgery to evaluate the endometrial thickness of each group. 2) Hemodynamic indexes of endometrium: Transvaginal ultrasonography was performed 3 weeks after surgery to check the endometrial blood flow and subendometrial&#; SECONDARY OUTCOME: 1) Endometrial type and volume: Transvaginal ultrasonography was performed 3 weeks after surgery to evaluate the endometrial type ABC in each group, analyze the proportion of each type in each group, and calculate the endometrial volume by THREE‐DIMENSIONAL ultrasonography. 2) VAS pain score: pain score was&#; INCLUSION CRITERIA: 1. Ultrasound examination showed intrauterine pregnancy, live fetus, anterior uterus, 6‐10 weeks of gestation; 2. 18‐35 years old, less than 3 times of qing Dynasty; 3. Menstrual regularity within 3 months before pregnancy; 4. Voluntarily give up pregnancy and accept induced abortion.

ChiCtr (2022). "A clinical study on application of ciprofol and propfol in general anesthesia of painless abortion." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Ciprofol group:Intravenous bolus injection of cyclopofol 0.4 mg/kg;Propofol group:Propofol injection 2.0mg/kg; CONDITION: N/A PRIMARY OUTCOME: Success rate of anesthesia induction; SECONDARY OUTCOME: Effects on respiratory and circulatory systems;Time of anesthesia induction;Recovery time after anesthesia;Time required to leave the hospital after anesthesia;Frequency and dose of ciprofol and propofol injection; INCLUSION CRITERIA: 1. Aged 18‐35 years; 2. American Anesthesiologist Classification (ASA) I‐II; 3. Outpatient patients undergoing elective general anesthesia induced abortion; 4. Pregnancy time is 6 to 10 weeks; 5. Body mass inde X(BMI) 18‐30kg/m^2; 6. Vital signs: respiratory rate >=10 and <=24 times/min; blood oxygen saturation (SpO2) >=95% when breathing air; systolic blood pressure (SBP) >=90mmHg and <=160mmHg; diastolic blood pressure (DBP) >=60mmHg and <=100mmHg; heart rate >=55 and <=100 beats/min; 7. Be able to understand the research process and method, and voluntarily participate in this research.

ChiCtr (2022). "The ED 95 of Esketamine in Outpatient-Induced Abortion Compared to Equivalent Sufentanil: a randomized controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group one:esketamine;Group two:sufentanil;Group three:propofol; CONDITION: early pregnancy PRIMARY OUTCOME: dose of propofol; SECONDARY OUTCOME: time of operation;awakening time;heart rate;mean arterial pressure;pluse oxygen saturation;Ramsay sedation scores;visual analogue scale scores;Beck Depression Scale score;adverse effect; INCLUSION CRITERIA: 1. Women in the first trimester (7‐10 weeks) who planned to undergo painless abortion; 2. Women aged between 18 and 45; 3. BMI =18‐25kg/m2; 4. ASA classification was I‐II; 5. Voluntary participation in the study.

ChiCtr (2022). "Effect of local PRP injection on ovarian reserve and assisted reproductive outcomes: a randomized controlled study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention group:Injection of PRP;Control group:None; CONDITION: Diminished Ovarian Reserve PRIMARY OUTCOME: live birth rate; SECONDARY OUTCOME: number of eggs retrieved;2PN fertilization rate;available embryo rate;biochemical pregnancy rate;clinical pregnancy rate;ongoing pregnancy rate;miscarriage rate;embryo implantation rate;cycle cancellation rate; INCLUSION CRITERIA: 1. AFC < 5, AMH < 1.2ng/ml; 2. No pregnancy >=6 months without contraception; 3. The number of oocytes obtained by the previous standard regimen (antagonist and long regimen) was <=3; 4. The patient or his legal representative signed the informed consent form.

ChiCtr (2022). "Effect of routine hysteroscopy before IUI on live birth rate in infertile women with normal uterine cavity by ultrasound: a multicenter randomized clinical trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group A:Perform hysteroscopy;Group B:Hysteroscopy not performed; CONDITION: Endometrial Diseases PRIMARY OUTCOME: live birth rate; SECONDARY OUTCOME: Complications of hysteroscopy and surgery ;Comfort tolerance after operation;miscarriage rate;Ectopic pregnancy rate ;Incidence of maternal complications during pregnanc;Incidence of neonatal complications;Cost of hysteroscopy ;Cost of IUI treatment ; INCLUSION CRITERIA: ?Infertility; ?IVF/ICSI assisted fertility treatment is planned for the first time; ?Aged 20 to 38 years; ?Accept and adhere to treatment and follow‐up.

ChiCtr (2022). "Effect of routine hysteroscopy before IVF/ICSI on live birth rate in infertile women with normal uterine cavity by ultrasound: a multicenter randomized clinical trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group A :Perform Hysteroscopy;Group B:Without Hysteroscopy; CONDITION: Endometrial Diseases PRIMARY OUTCOME: live birth rate; SECONDARY OUTCOME: Complications of hysteroscopy and surgery;Pain score of operation;Comfort tolerance after operation;miscarriage rate;Ectopic pregnancy rate;Incidence of maternal complications during pregnancy;Incidence of neonatal complications;Cost of hysteroscopy;Cost of in vitro fertilization (IVF) treatment; INCLUSION CRITERIA: 1. Infertility; 2. IVF/ICSI assisted fertility treatment is planned for the first time; 3. Aged 20‐38 years; 4. Accept and adhere to treatment and follow‐up.

ChiCtr (2022). "Effect of Zhuyun Pill combined with dydrogesterone on early pregnancy outcome in threatened abortion: a single- center randomized controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: The experimental group:Zhuyun Pill + Dydrogesterone;The control group:Zhuyun Pill placebo + Dydrogesterone; CONDITION: threatened abortion PRIMARY OUTCOME: Early pregnancy embryo survival rate; SECONDARY OUTCOME: Blood ß‐hCG;progesterone;estradiol; INCLUSION CRITERIA: 1. Age between 25 and 40 years. 2. Positive urine pregnancy test or blood HCG test. 3. Early pregnancy (5‐8 weeks/35‐56 days) with vaginal bleeding, cervical os closure with or without abdominal pain and diagnostic ultrasound confirmation of intrauterine embryo or fetal survival. 4. The diagnosis of fetal leakage or fetal disturbance is consistent with the TCM diagnosis of renal deficiency type / spleen and kidney deficiency type. 5. No treatment was received for this preterm abortion. 6. The subject and her spouse are competent and willing to sign informed consent. 7. The subject will be randomised and will take the medication until the 10th week (70 days) of pregnancy as specified in the study protocol.

ChiCtr (2022). "Effect of Zishen Yufei wan in women with unexplained recurrent abortion: a randomized controlled double-blind clinical study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Control:Dydrogesterone + placebo;Intervention group:Dydrogesterone + Zishen Yufei wan; CONDITION: unexplained recurrent abortion PRIMARY OUTCOME: live birth rate; INCLUSION CRITERIA: 1. Aged 20‐40 years; 2. Spontaneous abortion >= 2 consecutive times with the same partner; 3. Patients and their family members fully understood the content of the study and voluntarily signed informed consent; 4. Gestational age < 8 weeks.

ChiCtr (2022). "The efficacy and safety of cyclosporine in improving pregnancy outcome of patients with repeated embryo implantation failure: an open, randomized, controlled study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: control group:Freezing embryo transfer (FET);experimental group:Freezing embryo transfer (FET)+cyclosporin A 50mg bid; CONDITION: repeated embryo implantation failure(RIF) PRIMARY OUTCOME: clinical pregnancy rate; SECONDARY OUTCOME: Embryo implantation rate;live birth rate;abortion rate;Blood ß‐HCG;pregnancy complication;Neonatal score and neonatal basic situation;immunological indexes; INCLUSION CRITERIA: 1.No clinical pregnancy was obtained after 2 or more transplants; 2.Hysteroscopy showed normal size and endometrium. 3.4 embryos at cleavage stage or 2 embryos at blastocyst stage were transplanted; 4.22‐35 years old; 5.The chromosome karyotype of both husband and wife has no obvious abnormality; 6.Semen examination of the male was normal; 7.Healthy four (TORCH) tests and no infectious diseases; 8.Subjects have clear consciousness and can cooperate with the experiment, complete medical records and sign informed consent;

ChiCtr (2022). "Efficacy of Pre-Treatment with Remimazolam on Prevention of Propofol-Induced Injection Pain in Patients Undergoing abortion." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group 1 :remimazolam;Group 2:normal saline; CONDITION: propofol‐induced injection pain PRIMARY OUTCOME: Incidence of propofol injection pain;Adverse reactions; SECONDARY OUTCOME: Propofol injection pain intensity;vital signs;surgery time;recovery time; INCLUSION CRITERIA: 140 patients underwent elective painless abortion examination under general anesthesia, ASA grade I ‐II; Age is 18‐65 years old; BMI is 18‐28 kg/m2.

ChiCtr (2022). "Evaluation of efficacy and safety of granulocyte colony-stimulating factor in the treatment of patients with low ovarian reserve: a multicenter, randomized, double-blind, placebo-controlled clinical trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Experimental group:G‐CSF;Control group:Normal saline; CONDITION: Diminished ovarian reserve PRIMARY OUTCOME: Optimal embryo rate; SECONDARY OUTCOME: Oocyte acquisition rate;Transplantable embryo rate;MII oocyte rate; INCLUSION CRITERIA: 1. Voluntary participation, understanding and signing of informed consent; 2. In line with IVF/ICSI indications; 3. Conform to one of the three can be: (1) 1.10 <= FSH <= 20; (2) Antral follicles <= 7; (3) AMH <= 2.0; 4. Aged 20‐40 years; 5. PPOS program to promote ovulation.

ChiCtr (2022). "Frozen-warmed embryo transfer after 6 or 7 days of progesterone administration for day 6 blastocysts in hormone replacement therapy cycles: a randomized controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group A:Embryos are transferred after 6 days of progesterone supplementation;Group B:Embryos are transferred after 7 days of progesterone supplementation; CONDITION: Female infertility PRIMARY OUTCOME: Live birth rate; SECONDARY OUTCOME: Biochemical pregnancy rate;Clinical pregnancy rate;Early miscarriage rate;Ectopic pregnancy rate;Multiple pregnancy rate;Neonatal outcome;Perinatal complications; INCLUSION CRITERIA: 1. Age at the time of oocyte retrieval between 20 and 40 years; 2. Having single frozen‐thawed blastocyst transfer in HRT cycles; 3. Both husband and wife fully understand and voluntarily participate in the study.

ChiCtr (2022). "Growth hormone improves the clinical outcome of in vitro fertilization and embryo transfer in elderly patients: a multicenter, open label, randomized controlled study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group N1:Patients receiving GH are going to be administered 18 IU/week sc on Day2 or Day3 of the previous menstrual cycle before IVF. After about 6 administrations, patients can receive 4 IU/day GH sc until HCG injection.;Group N2:Patients in Group N2 will start controlled ovarian hyperstimulation after being grouped without preliminary GH administration.; CONDITION: Ovarian dysfunction PRIMARY OUTCOME: Cumulative live birth rates; SECONDARY OUTCOME: Number of retrieved oocytes;Number of mature eggs;Number of fertilized eggs;Number of cleaved embryos;Number of high‐quality embryos;Endometrial thickness on hCG day;Implantation rate;Mild to severe OHSS;Viable intrauterine pregnancy;Ectopic pregnancy;Abortion;Stillbirth;Terminal pregnancy;Live birth;Gestational age at birth;Birth weight;Neonatal mortality;Important congenital malformations;cleavage rate;high‐quality embryo rate;clinical pregnancy rate;ongoing pregnancy rate;cycle cancellation rate;Ectopic pregnancy rate;miscarriage rate;live birth rate;risk of low birth weight;preterm birth rate;OHSS incidence; INCLUSION CRITERIA: 1.Infertile women planning IVF / ICSI for the first time 2.Age: 35‐42 years old 3.GH has not been used in the past 2 months

ChiCtr (2022). "Intervention of Rational Emotional Behavior Therapy (REBT) for Psychological Distress among Patients with Early Threatened Miscarriage after Invitro Fertilization-Embryo Transfer (IVF-ET)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention group:Rational emotional behavior therapy + routine nursing;Control group:Routine nursing; CONDITION: infertility PRIMARY OUTCOME: anxiety;depression; INCLUSION CRITERIA: 1. Patients who met the diagnostic criteria for early threatened abortion before 12 weeks of gestation after IVF‐ET surgery; 2. Self‐rating anxiety scale score >=50 points (standard score); 3. Have certain audiovisual, speaking, reading and writing ability, can cooperate with research; 4. Sign informed consent; 5. Volunteer to participate in the study.

ChiCtr (2022). "A multicenter, randomized, double-blind study on the efficacy and safety of Gongxuening capsules in reducing postoperative bleeding after induced abortion." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Experimental group:Gongxuening Capsule;Control group:Placebo capsule; CONDITION: postoperative bleeding after induced abortion PRIMARY OUTCOME: Vaginal bleeding volume; SECONDARY OUTCOME: Bleeding time;Menstrual rehydration time;Endometrial repair;Complication;Safety index; INCLUSION CRITERIA: 1. 20 years old <= age <= 40 years old; 2. Intrauterine pregnancy <= 10 weeks (note: preoperative ultrasound fetal sac < 1 cm and fetal bud < 3 cm), women who require abortion without contraindications; 3. Regular menstrual cycle in the past si Xmonths, no recent (si Xmonths) history of induced abortion; 4. The subjects voluntarily signed the informed consent.

ChiCtr (2022). "A multicenter, randomized, double-blind, dose-parallel control exploratory phase IIa clinical trial to evaluate the efficacy and safety of Zishen Yutai Pills in the treatment of diminished ovarian reserve (spleen and kidney deficiency syndrome)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: high dose group:Zishen Yutai Pills ;low dose group:Zishen Yutai Pills ;Placebo group:Placebo; CONDITION: diminished ovarian reserve PRIMARY OUTCOME: anti‐mullerian hormone; SECONDARY OUTCOME: Antral follicle count;FSH normalization rate;FSH/LH ratio;five se Xhormones (FSH, LH, E2, PRL, T);ovarian volume;serum inhibin B;Normalization rate of menstrual cycle (rate of patients with menstrual cycle of 28‐25 days);menstrual score;TCM syndrome score and curative effect;progesterone;endometrial status;adverse events;vital signs;physical examination;blood routine examination;routine urine and urine sediment microscopy;routine stool+occult blood examination;liver function;renal function;12‐lead ECG examination;Breast ultrasound; INCLUSION CRITERIA: 1. Conform to the diagnosis of diminished ovarian reserve; 2. TCM syndrome differentiation is spleen and kidney deficiency syndrome; 3. Females aged < 40 years with a history of sexual life; 4. The patient voluntarily participates in this clinical trial, gives informed consent and signs a written informed consent form.

ChiCtr (2022). "Natural cycle frozen-thawed embryo transfer: luteal support or not? A multi-center, non-inferiority, randomized controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Luteal support group:Patients receive vaginal progesterone extended‐release gel and intramuscular progesterone from the first day after ovulation;No luteal support group:None; CONDITION: Natural cycle frozen‐thawed embryo transfer PRIMARY OUTCOME: Ongoing pregnancy rate; SECONDARY OUTCOME: Positive pregnancy rate;Embryo implantation rate;Incidence of threatened abortion;Pregnancy loss rate;Ectopic pregnancy rate;Multiple pregnancy rate;Live birth rate;Pregnancy‐related complications;Obstetric complications; INCLUSION CRITERIA: 1. Ovulation regularity; 2. At least one embryo is available for transfer.

ChiCtr (2022). "A randomized controlled trial of acupuncture in the treatment of ovarian reserve dysfunction." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Experimental group:The two acupoints were used alternately;Control group:Superficial puncture of 2‐3mm on all acupoints; CONDITION: Diminished ovarian reserve (DOR) PRIMARY OUTCOME: Antral follicle count; SECONDARY OUTCOME: Follicle stimulating hormone;Luteinizing hormone;Estradiol;Progesterone;Arterial resistance index;Systolic / diastolic blood flow velocity ratio;Peak systolic blood flow velocity;Anti‐mullerian hormone;Self‐Rating Anxiety Scale;Clinical pregnancy rate;Available embryo rate;Egg number;High‐quality embryo rate;Embryo implantation rate;Biochemical pregnancy rate;Early pregnancy loss rate;Sustained pregnancy rate; INCLUSION CRITERIA: 1. Aged >=20 and <40 years; 2. Meet the diagnostic criteria of DOR; 3. Volunteer to participate in the trial and sign the informed consent.

ChiCtr (2023). "Alleviating Postoperative Pain after Laparoscopic Myomectomy: the Role of Dexamethasone and Ropivacaine in Superior Hypogastric Plexus Block." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Control Group:10ml: 100mg ropivacaine 20ml in the SHP area;Treatment Group:10ml: 100mg ropivacaine 19ml + 1ml: 5mg dexamethasone 1ml in the SHP area; CONDITION: Postoperative Pain after Laparoscopic Myomectomy PRIMARY OUTCOME: VAS score; SECONDARY OUTCOME: cumulative consumption of non‐steroidal anti‐inflammatory drugs or opioids within 48 hours postoperatively;postoperative adverse reactions;intraoperative fluid volume, urine output, and blood loss;first postoperative exhaust time;first postoperative ambulation; INCLUSION CRITERIA: 1.Patients undergoing elective laparoscopic myomectomy for uterine fibroids. 2.Number of fibroids not exceeding 10. 3.ASA grade of I‐III. 4.Age between 18 to 55 years. 5.Willingness to participate in the study and provide signed informed consent. 6.Not currently participating in other clinical trials.

ChiCtr (2023). "Analysis of pregnancy outcomes in patients with polycystic ovary syndrome after clinical intervention with human assisted reproductive technology." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Treatment group:Pharmacological intervention;Control group:N/A; CONDITION: Polycystic ovary syndrome PRIMARY OUTCOME: Clinical pregnancy rate;Abortion rate;Oocyte tetrieval rate;High quality embryo number; INCLUSION CRITERIA: PCOS can be defined if at least 2 of the following 3 criteria are present: ? Watery ovulation or chronic anovulation (OA); ? Clinical manifestations of hyperandrogenemia or hyperandrogenism (HA); ? Ultrasonic monitoring of polycystic ovarian changes (PCO)

ChiCtr (2023). "Application of dural puncture epidural technique for elderly orthopedic surgery of lower limbs." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Epidural group:Anesthesia method: epidural block; Anesthetic drugs: 0.5% ropivacaine +1% lidocaine 8‐12ml.;Combined spinal epidural anesthesia group:Methods of anesthesia: combined spinal‐epidural block; Anesthesia: 0.5% ropivacaine + sterile water for injection 2‐2.4ml.;Dural puncture epidural block group:Anesthesia method: dural puncture epidural block; Anesthetic drugs: 0.5% ropivacaine +1% lidocaine 8‐12ml.; CONDITION: elderly orthopedic surgery of lower limbs PRIMARY OUTCOME: Time from sensory block plane to T10; SECONDARY OUTCOME: Highest level of anesthesia;Blood pressure;Heart rate;Sedation score;Pain score;Effect of anesthesia;The amount of local anesthetic used;Adverse reactions; INCLUSION CRITERIA: (1)All patients were American Society of Anesthesiologists physical status 1‐?, aged =60 years, undergoing lower extremity orthopedic surgery. (2) There were no contraindications of operation and spinal anesthesia; (3) Complete clinical data and signed informed consent.

ChiCtr (2023). "Application of sacrococcygeal ice compress based on posterior acoustic pathway damage decrease on focused ultrasound ablation (FUAS): a randomized controlled study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: sacrococcygeal ice compress:Intraoperative and postoperative ice compress on sacrococcygeal region;blank control:none; CONDITION: Uterine leiomyoma PRIMARY OUTCOME: visual analogue scale,VAS; SECONDARY OUTCOME: Postoperative pelvic magnetic resonance imaging; INCLUSION CRITERIA: Patients with uterine leiomyomas diagnosed by pelvic color Doppler ultrasound and pelvic magnetic resonance, agree to receive FUAS and sacrococcygeal ice compress, no severe systemic diseases, understand the VAS system, informed consent.

ChiCtr (2023). "Application of ultrasound-guided pudendal nerve block in transvaginal pelvic floor reconstruction." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: experimental group:ultrasound‐guided pudendal nerve block;control group:general anesthesia; CONDITION: Perioperative pain in transvaginal pelvic floor reconstruction PRIMARY OUTCOME: Number of PCA;Number of flurbiprofen axetil for rescue analgesia; SECONDARY OUTCOME: pain score;Consumption of remifentanil;Consumption of propofol;catheter‐related bladder discomfort(CRBD);Incidence of adverse reactions;Leaving bed time;Length of postoperative hospital stay;Postoperative analgesia satisfaction; INCLUSION CRITERIA: 1. ASA I‐II 2. Over 60 years old 3. BMI<30kg/m2 4. Patients with pelvic organ prolapse who intend to undergo transvaginal hysterectomy and/or anterior/posterior vaginal wall repair under general anesthesia

ChiCtr (2023). "Application research on improvement of voiding dysfunction after radical operation of cervical cancer based on the original new method of core muscle strength training." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: core muscle strength training group:In the core muscle training group, the subject was placed in a supine position with knees bent at 90° and feet shoulder‐width apart. An elastic band was placed at the proximal end of the knee joint, and the patient was asked to do the hip abduction and external rotation exercise first, maintaining the resistance of the elastic band at 1.5‐2 kg. Slowly, the abdominal contraction, chest inhibition, and anal lift after exhalation were implemented to promote the contraction of transverse abdominal muscles and pelvic floor muscles at the same time, maintaining 5 seconds for one time, 20 times for one group, and two groups were implemented each time.;Regular rehabilitation training group:The conventional rehabilitation training group performed plyometric intervention at a load that could be repeatedly completed 8‐12 times (approximately equal to 60‐70% 1RM:1 repetition maximum), and 2 sets of each of the 9 resistance exercises were performed 8 to 12 times, respectively. The duration of each intervention was 15 minutes, and the intervention was performed 5 times per week for 12 weeks of treatment.; CONDITION: Application research on improvement of voiding dysfunction after radical operation of cervical cancer based on the original new method of core muscle strength training PRIMARY OUTCOME: Urinary function indicators;Postoperative urinary catheter replacement rate in patients undergoing radical cervical cancer surgery;Mesure deHandicap Urinaire; SECONDARY OUTCOME: Imaging indicators of the transversus abdominis muscle; INCLUSION CRITERIA: ?. Age 18 to 65 years old; ?. Meet the relevant diagnostic criteria in the Guidelines for the diagnosis and treatment of cervical cancer (4th edition) [26]; ?. Radical cervical cancer surgery with postoperative catheterization; ?. No contraindications to surgery; ?. Complete clinical information; ?. Voluntary participation and signed informed consent.

ChiCtr (2023). "Clinical effect of ultrasound-guided paracervical nerve block in the treatment of cervical cancer patients with painless postimplantation." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Control Group:Bilateral paracervical nerve block was not performed;Group:Bilateral paracervical nerve block was performed ; CONDITION: cervical cancer PRIMARY OUTCOME: VAS score;Incidence of hypoxemia;WHO Pain scale;Nausea and vomiting occur;Physical activity condition;the satisfaction of patients;Surgeon satisfaction; SECONDARY OUTCOME: Circulatory adverse events;heart rate;mean arterial pressure;operative time; INCLUSION CRITERIA: ASA ? ‐ ? level;Patients receiving painless post‐implantation therapy for cervical cancer;Aged 18‐75 years;They agreed to participate in the study and signed the informed consent form

ChiCtr (2023). "Clinical efficacy of diaphragmatic breathing training combined with biofeedback electrical stimulation therapy for postpartum stress urinary incontinence." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Vaginal delivery experimental group:biofeedback electric stimulation therapy combine with diaphragmatic breathing training ;Vaginal delivery control group:biofeedback electric stimulation therapy;Caesarean section experimental group:biofeedback electric stimulation therapy combine with diaphragmatic breathing training ;Caesarean section control group:biofeedback electric stimulation therapy; CONDITION: Postpartum stress urinary incontinence PRIMARY OUTCOME: Digital assessment of pelvic floor muscle strength;pelvic organ prolapse quantification;pelvic floor muscle bioelectrical activity; SECONDARY OUTCOME: pelvic floor distress inventory‐short form 20; INCLUSION CRITERIA: ?Newborn mothers who have given birth for more than 3 months. ?Age 22 to 35 years. ?Lochia drains. ?Full‐term delivery, singleton. ?Newborn baby weighing 2500‐3500g. ?Prenatal Body Mass Inde Xof between 18.5 and 23.9. ?Simple mild or moderate stress urinary incontinence or a diagnosis of pelvic. ?prolapse I‐II using pelvic organ ?prolapse quantification (POP‐Q) in women. ?No previous history of pelvic surgery or coexisting pelvic infections, no combined heart disease, diabetes, hypertension during pregnancy, no postpartum dysfunctional disorders prior to pregnancy.

ChiCtr (2023). "Clinical observation of functional magnetic stimulation of pelvic floor in treatment of stress urinary incontinence." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: control group:Perform pelvic floor muscle training according to the pelvic floor muscle training recommended by the urinary incontine.;observation group:On the basis of pelvic floor muscle training, pelvic floor functional magnetic stimulation (sacral nerve magnetic stimulation). ; CONDITION: stress urinary incontinence PRIMARY OUTCOME: International Consultation on Incontinence Questionnaires; SECONDARY OUTCOME: one hour urine pad test;Pelvic floor surface electromyography; INCLUSION CRITERIA: ? Postpartum stress urinary incontinence, in line with the relevant diagnostic criteria; ? After =1 month (simple drug treatment or simple pelvic floor muscle function training) conservative effect is not significant; ? Agree not to receive any other treatment outside the program during the period of participation in the program.

ChiCtr (2023). "Clinical Observation on Auricular Acupressure for Primary Dysmenorrhea." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Treatment group:Auricular acupressure;Control group:Placebo auricular acupressure; CONDITION: Primary Dysmenorrhea PRIMARY OUTCOME: visual analogue scale, VAS; SECONDARY OUTCOME: Menstrual Distress Questionnaire;usage rate of analgesics;blind assessment;safety evaluation;Onset time of analgesic effect;Duration of pain; INCLUSION CRITERIA: (1) Patients who meet the diagnostic criteria for PD; (2) Between the ages of 18 and 30; (3) With regular menstrual cycle of 28±7 days, menstrual period of 3‐7 days, and the pain starting on the first day of the cycle; (4) Haven't received treatment for PD within a month prior to enrollment; (5) VAS score =4; (6) Voluntarily participate in the study and sign the informed consent.

ChiCtr (2023). "Clinical study of antibiotics combined with antioxidants in the treatment of infertility patients with chronic endometritis after repeated transplantation failure." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group A :doxycycline 100 mg Bid + metronidazole 400 mg Bid + cefdinir 100 mg tid for 14 days;Group B:doxycycline 100 mg Bid + metronidazole 400 mg Bid + cefdinir 100 mg tid + vitamin E 500 mg Bid + vitamin C 500 mg Bid for 14 days; CONDITION: Reproductive endocrine PRIMARY OUTCOME: live birth rate; SECONDARY OUTCOME: ongoing pregnancy rate;positive hCG rate;implantation rate;early miscarriage rate;clinical pregnancy rate; INCLUSION CRITERIA: 1. Transplantation cycle =2; 2. Patients with endometritis

ChiCtr (2023). "Clinical study of Bushen Huoxue Prescription on treatment mechanism and progeny of unexplained recurrent abortion." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Bushen Huoxue prescription combined with aspirin group:Bushen Huoxue prescription combined with aspirin for 3 months;Bushen Huoxue formula combined with aspirin placebo group:Bushen Huoxue prescription combined with aspirin placebo treatment for 3 months;Bushen Huoxue formula placebo combined with aspirin group:Bushen Huoxue prescription placebo combined with aspirin;Bushen Huoxue prescription placebo combined with aspirin placebo group:Bushen Huoxue prescription placebo combined with aspirin placebo was administered for 3 months; CONDITION: Unexplained Recurrent Spontaneous Abortion PRIMARY OUTCOME: Factors associated with angiogenesis;Factors associated with iron death; SECONDARY OUTCOME: Coagulation index;Uterine arterial blood perfusion;Safety index; INCLUSION CRITERIA: (1) Women of childbearing age, aged 20‐40 years; (2) Normal menstrual cycle (28 30 days); (3) Urine pregnancy test is negative, blood ß‐HCG < 5IU/L, consent to use contraceptives during the medication; (4) The diagnostic criteria of URSA Western medicine and syndrome of kidney deficiency and blood stasis of slippery fetus were met; (5) Sign informed consent.

ChiCtr (2023). "Clinical study on perioperative analgesia of butorphanol in patients with ovarian cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: 1:Sufentanil 0.04 µg·kg‐1·h‐1;2:Butorphanol 3.0ug·kg‐1·h‐1;3:Butorphanol 3.5ug·kg‐1·h‐1;4:Butorphanol 4.0ug·kg‐1·h‐1; CONDITION: ovarian cancer PRIMARY OUTCOME: Visual Analogue Scale/Score,; SECONDARY OUTCOME: adverse reactions;rescue analgesia;CD4+;CD8+;CA‐125;HE4;Inflammatory factor; INCLUSION CRITERIA: ?ASA grade?‐?; (2) Patient compliance was good; (3) Postoperative pathological examination confirmed ovarian cancer. (4) No history of drug allergy; ?FIGO Grade I‐III; patients aged 18‐65.

ChiCtr (2023). "Clinical study on the efficacy and safety of remazolam besylate for induction and maintenance of general anesthesia in gynecological laparoscopic surgery." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Experimental group:Remazolam sedation;Control group:Propofol sedation; CONDITION: Gynecological uterine and adnexal diseases PRIMARY OUTCOME: Incidence of intraoperative hypotension; SECONDARY OUTCOME: Vital signs;Anesthesia wake time;Adverse reactions; INCLUSION CRITERIA: 1. Patients undergoing gynecological laparoscopic general anesthesia surgery (except for patients with malignant tumors); 2. Age 18‐60 years; 3 Body mass inde X(BMI): 18.5‐30 kg/m^2; 4 American Society of Anesthesiologists Grading (ASA) Grades I‐III; 5. Subjects voluntarily participate in the trial and sign the informed consent form of the trial.

ChiCtr (2023). "Clinical study on the immediate analgesic effect of acupuncture in the treatment of acute dysmenorrhea." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group A:acupuncture;Group B:Sham‐acupuncture; CONDITION: dysmenorrhea PRIMARY OUTCOME: Analgesic efficiency at 10 minutes; SECONDARY OUTCOME: Analgesic efficiency at0‐1?2, 4, 6, 8min time points;Visual Analog Score(VAS);Blind evaluation;Evaluation of compliance; INCLUSION CRITERIA: (1)Meet the diagnostic criteria for primary dysmenorrhea and are experiencing acute attacks of dysmenorrhea; (2)Age 14‐35 years; (3)Visual analog score (VAS) >= 4; (4)Have not been treated with acupuncture and taken analgesic medication; (5)Voluntarily participated in this study and signed the informed consent, family informed consent is required for those under 18 years of age. Note: Patients who meet the above 5 items at the same time may be included in this study.

ChiCtr (2023). "A clinical study on the prevention and treatment of vulvovaginal candidiasis in women with Azmasol." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Treatment group 1:Oral fluconazole 150mg once a day for 1 day and vaginal miconazole 400mg once a night for 3 days;;Treatment group 2:Oral fluconazole 150mg, once a day for 1 day; vaginal miconazole 400mg, once a night for 3 days; oral Azmasol , 2 pills twice a day for 6 days; if symptoms are effectively controlled after 7 days from the first treatment, continue oral Azmasol 1 pill daily for 12 weeks for consolidation.;Treatment group 3:Vaginal miconazole suppositories 400mg once a night for 3 days and oral Azmasol, 2 sticks twice a day for 6 days;; CONDITION: vulvovaginal candidiasis PRIMARY OUTCOME: Clinical cure rate;Compound cure rate; SECONDARY OUTCOME: Clinical improvement;Microbial clearance; INCLUSION CRITERIA: 1. Healthy women who are sexually active; 2. 18 years of age or older; 3. Have not consumed cranberry juice, polyphenols or antioxidant supplements within the past 2 weeks; 4. = 2 recurrent episodes of vulvovaginal candidiasis in the past 6 months; or 5. = 3 episodes of recurrent vulvovaginal candidiasis in the past 12 months.

ChiCtr (2023). "Comparative study on the effectiveness of two surgical methods for early cervical cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: TARH:TARH;Laparoscopic surgery based on the open stateGasless TLRH:Laparoscopic surgery based on the open state; CONDITION: Early Stage Cervical Cancer PRIMARY OUTCOME: Disease free survival;Length of stay; SECONDARY OUTCOME: Recurrence rates;Postoperative pain ;The Quality of Life;Operation time;Estimated blood loss;operative complications;The levels of CD4 + T lymphocytes, NK cells and CD4 + CD25 high CD127 low Treg;Hemodynamic parameters;MAP;SV;Costs; INCLUSION CRITERIA: Patients at least 18 years of age with adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the cervix, ECOG performance status of 0‐1, and FIGO (2018) clinical stage IA1 disease with lymphovascular space invasion, IA2 disease, or IB1 disease (<2 cm and limited to the cervix) were randomized 1:1 to open or minimally invasive radical hysterectomy. Patients could undergo either a type II or a type III radical hysterectomy (Piver classification) and pelvic lymphadenectomy. Postoperative adjuvant radiation therapy was recommended according to the Sedlis criteria, which are widely accepted.

ChiCtr (2023). "Comparison of the clinical outcomes in PCOS patients with letrozole resistance undergoing ovulation induction using letrozole "stair-step"protocol versus traditional gonadotropin protocol." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: study group:letrozole;control group:Gn protocol; CONDITION: polycystic ovarian syndrome PRIMARY OUTCOME: Multifollicular development rate; SECONDARY OUTCOME: monofollicular development rate; ovulation rate;cancellation rate;OHSS ;clinical pregnancy rate; INCLUSION CRITERIA: aged younger than 40 years old;PCOS patients with letrozole resistance

ChiCtr (2023). "Construction of a prevention plan for lower limb lymphedema in patients with gynecological malignant tumors after surgery and a multicenter clinical application study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: experimental group:To implement the established prevention program of lower limb lymphedema for gynecological malignant tumor patients after operation ;Control group:Routine postoperative care and treatment; CONDITION: Gynecology malignant tumor PRIMARY OUTCOME: Incidence of lower limb lymphedema;Stage of lower limb lymphedema; SECONDARY OUTCOME: Self‐reported symptoms;Life quality;Brief fatigue scale score; INCLUSION CRITERIA: Histopathological diagnosis of cervical cancer, endometrial cancer, vulvar cancer, ovarian cancer; Surgical treatment with pelvic or inguinal or aortic lymphadenectomy; =18 years of age; Volunteer.

ChiCtr (2023). "Effect and clinical efficacy evaluation of Tiao Shen Ning Xin Acupuncture on insomnia and anxiety comorbidity in patients with gynecological tumor chemotherapy." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Treatment Group:Electroacupuncture combined with cognitive behavioral therapy for insomnia;Control group:Sham electroacupuncture combined with cognitive behavioral therapy for insomnia; CONDITION: Insomnia‐anxiety comorbidity PRIMARY OUTCOME: pittsburgh sleep quality inde,PSQI ; Athens Insomnia Scale,AIS;;Hamilton Anxiety Rating Scale,HAMA; SECONDARY OUTCOME: Sleep monitoring bracelet (heart rate, deep sleep time, light sleep time, REM time); INCLUSION CRITERIA: (1) Patients diagnosed with gynecological tumors (ovarian cancer, cervical cancer, endometrial cancer, vulvar malignancy, vaginal malignancy, uterine sarcoma, gestational trophoblastic tumor, etc.) requiring chemotherapy, insomnia and anxiety according to pathology; (2) Aged between 20 and 70 years old (including 20 and 70 years old); (3) Subject agrees and signs informed consent.

ChiCtr (2023). "The effect of corrective pelvic training in conjunction with biofeedback electrical stimulation on postpartum stress urinary incontinence in accordance with the regional dependency theory through a randomised controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: control group:Biofeedback electrical stimulation ;Experimental group 1:Combined biofeedback electrical stimulation in neutral pelvic position;Experimental group 2:Corrective pelvic position training combined with neutral pelvic position and biofeedback electrical stimulation; CONDITION: Postpartum stress urinary incontinence PRIMARY OUTCOME: Pelvic floor electromyography Glazer assessment test; SECONDARY OUTCOME: pelvic floor distress inventory‐short form 20, PFDI‐20;International Consultation on Incontinence Questionnaire‐Urinary Incontinence Short Form , ICI‐Q‐SF; INCLUSION CRITERIA: ?Patients were all primiparous women who returned 42 days after vaginal delivery and all had a single full‐term normal birth; ?were assessed by the postural assessment system as having anterior/posterior pelvic tilt, lateral pelvic tilt and pelvic rotation; ? were diagnosed with pelvic floor dysfunction with stress urinary incontinence; accepted the treatment offered by the hospital with complete data on the subject; ?and had normal cognitive abilities and could communicate normally.

ChiCtr (2023). "Effect of dexamethasone combined with different drugs as adjuvant of local anesthetic on TAP nerve block." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group D:At the end of the operation, dexamethasone 10mg was given intravenously, followed by bilateral TAPB and unilateral 0.375% ropivacaine 20ml under ultrasound guidance.;Group DD:At the end of the operation, dexamethasone 10mg was given intravenously, followed by bilateral TAPB and unilateral 0.375% ropivacaine+dexmedetomidine 30ug, 20ml under ultrasound guidance.;Group DE:At the end of the operation, dexamethasone 10mg was given intravenously, followed by bilateral TAPB and unilateral 0.375% ropivacaine+magnesium sulfate 200mg, 20ml under ultrasound guidance.;Group DM:At the end of the operation, dexamethasone 10mg was given intravenously, followed by ultrasound‐guided bilateral TAPB, unilateral 0.375% ropivacaine+dexmedetomidine 30ug+ magnesium sulfate 200mg, 20ml.; CONDITION: Tubal ovarian abscess; Gynecological tumor; Pain after laparoscopic surgery (gynecology, gastrointestinal surgery) PRIMARY OUTCOME: The completion time of nerve block from the first time the patient presses the analgesia pump.; SECONDARY OUTCOME: Sleep score;Opioid dosage;Pain score;Analgesic pump pressing times;Sedation score; INCLUSION CRITERIA: Patients undergoing minimally invasive lower abdominal surgery (gynecology, colorectal). INCLUSION CRITERIA: (1) 18‐65 years old; (2) BMI 18‐30; (3) ASA level 1‐3; (4) No diabetes or diabetes regularity; (5) No history of chronic pain, alcohol abuse or drug abuse; (6)Those who voluntarily accept postoperative intravenous analgesia.(7)Once agreed to accept this study.

ChiCtr (2023). "Effect of dexmedetomidine as an adjuvant in transversus abdominis plane block on postoperative recovery in gynecological patients undergoing laparoscopic surgery." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group A:TAPB with dexmedetomidine and ropivacaine before skin incision;Group B:Ropivacaine in TAPB before peeling;Group C:Ropivacaine in TAPB after sewing;Group D:TAPB free; CONDITION: Ovarian cyst, uterine fibroid, cervical cancer PRIMARY OUTCOME: Pain scores;Restore quality; SECONDARY OUTCOME: Infection index;hemodynamics;Narcotic drug usage;Postoperative recovery;Postoperative analgesic effect;Side effects and adverse reactions;Early recovery index;Incidence of POCD; INCLUSION CRITERIA: (1) Age range from 18 to 80 years old; (2) Patients who are conscious, voluntarily participate in this study and sign informed consent; (3) American Society of Anesthesiologists (ASA) Class I to III; (4) Operation duration >=60min; (5) patients without serious cardiovascular and cerebrovascular diseases and respiratory and circulatory system diseases; (6) Patients without obvious contraindications to anesthesia.

ChiCtr (2023). "The effect of different doses of esketamine on the incidence and quality of recovery in patients with cervical cancer: a double-blind, randomized controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Saline group(Group N):Single intravenous injection of 10ml of saline was given 10min before skin cutting;Eesketamine 0.1 mg / kg group(Group A):Single intravenous injection of esketamine 0.1 mg / kg (diluted to 10ml) 10min before skin cutting;Eesketamine 0.2 mg / kg group(Group B):Single intravenous injection of esketamine 0.2 mg / kg (diluted to 10ml) 10min before skin cutting;Eesketamine 0.4 mg / kg group(Group C):Single intravenous injection of esketamine 0.4 mg / kg (diluted to 10ml) 10min before skin cutting; CONDITION: Cervical cancer PRIMARY OUTCOME: Prevalence of depression within 7 days after surgery; SECONDARY OUTCOME: Self‐rating Scale (SDS) at 1d, 3d, 5d and 7d;Recovery quality scale score at 1d, 3d, 5d and 7d (QoR‐15);Sleep quality score on the 1d, 3d, 5d and 7d after operation;Postoperative drug withdrawal‐extubation time;In‐out PACU time;Time of first rescue analgesia after operation;The amount of remedial analgesic drugs at 1d, 3d, 5d and 7d;Length of postoperative hospitalization;Intraoperative remifentanil dosage;Intraoperative propofol dosage;Intraoperative mean arterial pressure; INCLUSION CRITERIA: 1. Age: 30 65 years old; 2. ASA grades I to II; 3. Cervical cancer stage III and below; 4.BMI 18 28 kg/m²; 5. Be able to complete the questionnaire independently and voluntarily sign the informed consent form to participate in this trial study.

ChiCtr (2023). "Effect of Esketamine on depression and perioperative neuropsychiatric disorders in patients with malignant tumors." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: group E :After anesthesia induction, group E was given 0.5mg/kg Esketamine (esketamine diluted to 10mg/ml) and 100ml postoperative analgesic pump, and the analgesic formula was Esketamine 2mg/kg(Esketamine diluted to 10mg/ml) + Sufentanil 2.5µg/kg+ flurbiprofen ester 2mg/kg+ tolanisetron 10mg+ normal saline;group C :After anesthesia induction, group C was given 0.05ml/kg normal saline and 100ml postoperative analgesic pump. The analgesic formula was Sufentanil 2.5µg/kg+ flurbiprofen ester 2mg/kg+ toranisetron 10mg+ normal saline; CONDITION: Perioperative neurocognitive dysfunction PRIMARY OUTCOME: Incidence of postoperative delirium;Neuropsychological testing;The occurrence of postoperative depression; SECONDARY OUTCOME: Scores on telephone interview for cognitive status‐modified;Numeric rating scale score;PCA press times;Intraoperative anesthetic dosage;Use of vasoactive drugs;Intraoperative fluid entry and exit volume;Duration of operation and anesthesia;Postoperative adverse reaction;All‐cause mortality, readmission rate and secondary operation rate 30 days after surgery;Rate of tumor recurrence and metastasis within 3 months after surgery;Postoperative recovery quality; INCLUSION CRITERIA: 1. From February 1, 2021 to August 31, 2022, patients aged over 60 years with malignant tumors were selected for surgery in Guangxi Medical University Cancer Hospital (gynecological tumors, gastrointestinal tumors, thoracic surgery, urological surgery), no gender limit; 2. ASA ? ‐?, BMI 18‐25kg/m^2; 3. Years of education >=6 years; 4. Pathological report diagnosed cancer; 5. Expected operation time >=2 hours and postoperative hospital stay > 7 days.

ChiCtr (2023). "Effect of hydroxychloroquine sulfate on pregnancy outcomes in patients with repeated implantation failure and ANA positive: a double-blind, randomized, placebo-controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Hydroxychloroquine sulfate group:Hydroxychloroquine sulfate;Placebo group :Placebo; CONDITION: patients with repeated implantation failure and ANA positive PRIMARY OUTCOME: clinicalpregnancy; SECONDARY OUTCOME: hCG positive rate;Early abortion rate;Sustained pregnancy rate; INCLUSION CRITERIA: 1. Patients who failed to obtain clinical pregnancy after at least 2 fresh or freeze‐thaw embryo transfer cycles and at least 2 high‐quality cleavage embryos or 1 high‐quality blastula each time 2. ANA titer >= 1:80 was detected by indirect immunofluorescence at least 4 weeks interval >=2 times; 3. IVF treatment was performed at the reproductive center for the second pregnancy.

ChiCtr (2023). "Effect of intravenous dexamethasone on sleep quality after open gynecological surgery." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: treatment group:intravenous dexamethasone 8mg;control group :intravenous saline; CONDITION: Postoperative sleep disturbance PRIMARY OUTCOME: Sleep Quality ; SECONDARY OUTCOME: Depression and Anxiety Scale;pain score;Consumption of opioid analgesics (sufentanil);Blood glucose values; INCLUSION CRITERIA: 18‐70 years old, ASA grade I‐III, open gynecological tumor surgery, BMI < 35

ChiCtr (2023). "Effect of intravenous lidocaine on propofol Schnider mode TCI inhibition of cervical dilatation during induced abortion." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: lidocaine group:Intravenous injection of lidocaine 1mg/kg;Control group:Physiological saline; CONDITION: Anesthesia for patients undergoing painless induced abortion PRIMARY OUTCOME: Propofol's EC50; SECONDARY OUTCOME: Vital signs;Wake up of time;The operation time;Pain of propofol injection;VAS pain score; INCLUSION CRITERIA: Patients with primary induced abortion, 6‐9 weeks gestation, age =35 years old, body mass inde X18‐25 kg/m2, ASA grade I‐? were selected.

ChiCtr (2023). "Effect of Kuntai Capsule on intestinal microecology and insulin resistance in patients with polycystic ovary syndrome: a multicenter, randomized and parallel controlled clinical study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Al group:Orally take Kuntai capsule, 4 pills / time, 3 times / day, for three months, non‐stop during menstrual time.;A2 group:Orally take Kuntai capsule, 4 pills / time, 3 times / day, for three months, non‐stop during menstrual time.;B group:no; CONDITION: PCOS PRIMARY OUTCOME: flora analysis in stool samples;blood fat ; SECONDARY OUTCOME: se Xhormone;Serum glucose;Fasting serum insulin;OGTT;BMI;WHR ;Menstruation scores;acne scores;hirsutism scores; INCLUSION CRITERIA: 1Patients meet the diagnostic criteria of the 2003 European Society for Human Reproductive and Embryology in Rotterdam and the American Society of Reproductive Medicine (ESHRE / ASRM), which requires any 2 of the following 3 items: 1) rare ovulation and / or anovulation; 2) clinical manifestations and / or excessive androgens; or 3) ultrasound detection of ovarian polycystic changes: with =12 follicles of 2‐9mm in diameter in one /both ovaries,ovarian volume= 10 ml in one /both ovaries;2. Patients are evaluated by the steady‐state model insulin resistance inde X(homeostasis model assessment‐insulin resistance index, HOMA‐IR), HOMA‐IR= 2.69 is regarded as IR, otherwise not IR;3. Women aged between the ages of 18 and 40 years;4. 18=BMI=35 kg/m2;5.Patients have no family planning in recent 3 months;6. Patients are ability to follow the protocol for treatment, examination, and follow‐up;7.Patients are consent, voluntary to be tested.

ChiCtr (2023). "Effect of low-dose esketamine on postoperative quality of recovery in gynecological laparoscopic patients." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Experimental group (Esketamine group ):Esketamine is administered an 0.25mg/kg prior to deemectomy after anesthesia and then maintained at 0.1mg/kg/h.The drug was discontinued about 15minutes before the end of surgery.;Control group :Normal saline was administered an 0.25mg/kg prior to deemectomy after of anesthesia and then maintained at 0.1mg/kg/h.The drug is discontinued about 15minutes before the end of surgery.; CONDITION: Gynecopathy PRIMARY OUTCOME: The global score Quality of Recovery‐40 Scale(QoR‐40) at 24 hours after surgery); SECONDARY OUTCOME: Dosage of sedative analgesic drugs during operative;Acute pain score at immediately,6,12,and 24 hours after surgery;Dosage of postoperative analgesics;Consumption of vasoactive agents;postoperative nausea and vommiting score;duration of anesthesia and surgery;Awakening time; INCLUSION CRITERIA: 1.Age 18‐65 years ,2.ASA physical status I‐?,3.18.5=BMI=30,4.Schduled for laparoscopic surgery under general anesthesia,including laparoscopic total hysterectomy,myomectomy,double adnexectomy,and ovarian cyst removel(except for patients with malignant tumors),5.inforemed consent can be signed.

ChiCtr (2023). "Effect of myomectomy on pregnancy outcome of frozen embryo transfer cycle in infertile patients with FIGO 4-6 uterine fibroids: a multicenter randomized controlled clinical study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group A:Perform hysteromyomectomy;Group B:Hysteromyomectomy not performed; CONDITION: FIGO 4‐6 uterine fibroids PRIMARY OUTCOME: live birth rate; SECONDARY OUTCOME: miscarriage rate;Ectopic pregnancy rate ;premature birth rate;clinical pregnancy rate;Cumulative live birth rate;Size changes of Uterine fibroid;Incidence of maternal complications during pregnanc;Incidence of neonatal complications;operative time;Complications of hysteromyomectomy;Cost of hysteromyomectomy;Cumulative clinical pregnancy rate; INCLUSION CRITERIA: 1. Aged 20 to 40 years; 2. Infertility patients planning to undergo IVF/ICSI; 3. MRI diagnosis shows that only single FIGO type 4‐6 fibroid with a diameter of 3‐7cm or combined no more than five FIGO type 4‐6 fibroids with a diameter of less than 2cm.

ChiCtr (2023). "The effect of N-acetylcysteine supplementation on ovulation induction in PCOS patients: a pragmatic, randomized, parallel-controlled, non-inferior study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: NAC group: During routine letrozole +uFSH ovulation stimulation, orally administrate NAC 1.8g/d daily (Usage: 0.6g, po, tid);Control group:Only routine letrozole +uFSH was administered to induce ovulation; CONDITION: polycystic ovarian syndrome PRIMARY OUTCOME: clinical pregnancy rate; SECONDARY OUTCOME: Ovulation rate per cycle;the incidence rate of OHSS;early pregnancy loss rate; INCLUSION CRITERIA: 1.the age of female partners were between 21 38 years old; 2. The cause of infertility in both spouses was diagnosed as ovulation disorder related to the woman's PCOS; 3. Previous ovulation induction treatment =2 cycles; 4. BMI=18.5, < 24. 5.. The semen examination of the male partner met the following requirements: semen volume =1.5ml, liquefaction time < 30min, concentration > 15×106/ml, PR=32%, NR+NP: =40%.

ChiCtr (2023). "Effect of perioperative esketamine bunching management on postoperative pain and gastrointestinal function of cervical cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Control group:Normal saline was pumped,PCIA (sufentanil 3µ g/kg);Intervention group 1: Esketamine group1(Preoperative: 0.25 mg/kg, maintained at 0.15 mg · kg‐1 · h‐1, PCIA (sufentanil 2 µ g/kg+esketamine 1.5 mg/kg);Intervention group 2: Esketamine group2 ((Preoperative: 0.125mg/kg, maintained at 0.075 mg · kg‐1 · h‐1, PCIA (sufentanil 2 µ g/kg+Esketamine 0.75mg/kg)); CONDITION: Postoperative gastrointestinal dysfunction PRIMARY OUTCOME: The incidence of postoperative gastrointestinal dysfunction; SECONDARY OUTCOME: Daily I‐FEED score for 7 days after surgery;Daily visual analogue scale (VAS) rest and exercise scores, as well as number of analgesic pump presses, 7 days after surgery;;The dosage of opioid drugs and the dosage of esketamine;;Rehabilitation progress indicators: first exhaust, defecation time, first oral intake time, and first time out of bed activity time;;The incidence of respiratory depression, hypotension, vomiting, nausea, and itching within 24 and 48 hours after surgery.;The incidence of multiple dreams, nightmares, hallucinations, mental disorders, restlessness, difficulty in orientation, blurred vision, tachycardia, and salivation within 24 and 48 hours after surgery.; INCLUSION CRITERIA: ? Age 25‐65 ?American Society of Anesthesiologists grading I and II ?Body Mass Inde X18‐30kg/m2 ? Planned open surgery for cervical cancer patients under general anesthesia ? Surgical duration 2.5‐4.5 hours ? Patient is willing to use patient controlled intravenous analgesia ? Sign informed consent form

ChiCtr (2023). "Effect of phospropofol disodium and sevoflurane anesthesia on immune cell expression profiling in gynecologic malignancy surgery: a prospective, double-blind, randomized controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Phosphopofol disodium group:Midazolam 0.2 mg, fopropofol disodium 20‐30 mg/kg, sufentanil 0.2‐0.4 µg/kg, cis‐atracurium 0.2 mg/kg intravenously in the fopropofol disodium group, and the patient's jaw was relaxed and inserted into the endotracheal tube through the mouth. ;Sevoflurane group:Under the monitoring of BIS, the sevoflurane group inhaled 8% sevoflurane by tidal volume, causing the patient's consciousness to disappear, adjusted the concentration of inhaled sevoflurane to 3 4% and reduced the fresh air flow to 2 3L/min, and maintained the BIS value between 45 55. Sufentanil 0.2 to 0.4 micrograms/kg was injected intravenously, cis‐atracurium 0.2 mg/kg, and the patient's jaw was relaxed and inserted into the endotracheal tube through the mouth.; CONDITION: Gynecological malignant tumors PRIMARY OUTCOME: Levels of circulating natural killer T cells, type 1 and type 17 helper T cells, and cytotoxic T cells in peripheral venous blood.; SECONDARY OUTCOME: The proportion of CD4 and CD25 expression in circulating regulatory T cells, and the proportion of circulating neutrophils, lymphocytes, and monocytes; INCLUSION CRITERIA: 1. Age greater than 20 years old and less than 70 years old 2. Surgical surgery for gynecological malignant tumors (cervical cancer, ovarian cancer and endometrial cancer) under general anesthesia 3. ASA grade I. III 4. Sign the informed consent form

ChiCtr (2023). "Effect of target-controlled infusion of remazolam on postoperative quality of patients with gynecologic malignant tumor after laparoscopic surgery." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group P:Propofol;Group R:Remazolam; CONDITION: gynecologic malignant tumor PRIMARY OUTCOME: Qor‐15 score; SECONDARY OUTCOME: Intraoperative vital signs;Partial pressure of end‐respiratory carbon dioxide;Frequency of use of vasoactive drugs;Incidence of adverse events in the anesthesia recovery room;The dwell time of the PACU;Recovery time;Extubation time;Length of hospital stay; INCLUSION CRITERIA: ?Age 18‐65 years ?the American Society of Anesthesiologists (ASA) grade I‐II Grade ? was able to conduct the Recovery Quality Rating Questionnaire

ChiCtr (2023). "Effect of time-restricted feeding in combination with short -cating oral contraceptives on PCOS: a prospective randomized controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention group (Group TRF):Subjects in the TRF group were instructed to adhere to a strict 8 hour time‐restricted eating for 12 weeks, while also regularly taking drospirenone and ethinylestradiol II. ;Control group (Group COC):Regularly taking drospirenone and ethinylestradiol II for 12 weeks; CONDITION: Polycystic Ovary Syndrome PRIMARY OUTCOME: Spontaneous ovulation; SECONDARY OUTCOME: Serum glucose;Serum insulin;Triglyceride;Cholesterol;High‐density lipoprotein;Low‐density lipoprotein;Estradiol;Progesterone;Follicle stimulating hormone;Luteinizing hormone;Total testosterone;Prolactin;Uric Acid;Creatinine;Weight;Waist‐hip ratio; INCLUSION CRITERIA: [1] Female aged 18‐45 [2] Women diagnosed with PCOS according to Rotterdam criteria [3] Sign the informed consent voluntarily and be willing to participate in this study

ChiCtr (2023). "Effect of ultrasound-guided stellate ganglion block on postoperative pain, nausea and vomiting in patients undergoing gynecological laparoscopic surgery." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group S:Stellate ganglion block;Group C:control group; CONDITION: Laparoscopic gynecological surgery PRIMARY OUTCOME: Postoperative pain;Postoperative nausea and vomiting; SECONDARY OUTCOME: MAP, HR, SP02, BIS;Intraoperative anesthetic dosage, intraoperative volume, operation time, recovery time, extubation time, Richimond restlessness and sedation score after recovery, PACU stay time, alderete score before returning to the ward;Postoperative hospital stay and EQ‐5D were used to evaluate the quality of early recovery, sleep quality before and after surgery, pain threshold, anxiety and depression scores were determined by Von Frey fiber.;Postoperative time of getting out of bed, feeding time, exhaust time, discharge time, surgery‐related complications, MMSE scale score; INCLUSION CRITERIA: 1. Gynecological laparoscopic surgery patients (including laparoscopic uterine surgery, laparoscopic adnexal surgery, laparoscopic myomectomy, fallopian tube plastic surgery, etc.); 2. Age >=18 years; 3.BMI < 18.5‐30 kg/m^2; 4. ASA I III level.

ChiCtr (2023). "The effect of Vitamin D3 supplementation on ovulation induction in PCOS patients: a pragmatic, randomized, parallel-controlled, non-inferior study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Vitamin D supplementation group:During routine letrozole +uFSH ovulation stimulation, 4000IU of vitamin D is taken orally daily ;Control group:Only routine letrozole +uFSH was administered to induce ovulation; CONDITION: polycystic ovarian syndrome PRIMARY OUTCOME: clinical pregnancy rate; SECONDARY OUTCOME: Ovulation rate per cycle;the incidence of OHSS;early pregnancy loss rate; INCLUSION CRITERIA: 1.the age of female partners were between 21 38 years old; 2. The cause of infertility in both spouses was diagnosed as ovulation disorder related to the woman's PCOS; 3. Previous ovulation induction treatment =2 cycles; 4. BMI=18.5, < 24; 5. Vitamin D deficiency (serum vitamin D less than 20ng/ml).

ChiCtr (2023). "Effect of vitamin D supplementation on the clinical outcome of assisted reproductive technology in infertile patients with endometriosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: experimental group:Oral vitamin D;control group:None; CONDITION: Endometriosis PRIMARY OUTCOME: Carbohydrate antigen CA‐125;Serum vitamin D levels;B ultrasound;Clinical pregnancy rate;Biochemical pregnancy rate;Cytokines; SECONDARY OUTCOME: Height;Weight;Reactive oxygen species;Malondialdehyde, MDA;Glutathione peroxidase, GSH‐PX;Superoxide dismutase, SOD; INCLUSION CRITERIA: 1. Aged 20‐40 years; 2. A patient with endotropism diagnosed laparoscopically.

ChiCtr (2023). "The effectiveness, safety and health economic evaluation of progestogen treatment for endometrial hyperplasia without atypia: a prospective randomized controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Experimental group of therapeutic intervention:Levonorgestrel‐releasing intrauterine system;Controlled group of therapeutic intervention:Dydrogesterone;Experimental group of preventive intervention:Levonorgestrel‐releasing intrauterine system;Controlled group of preventive intervention:Dydrogesterone; CONDITION: Endometrial hyperplasia (EH) PRIMARY OUTCOME: Complete remission rate after 6 months treatement; SECONDARY OUTCOME: Recurrence rate of patient who achieved complete remission;The total costs of treatment and follow‐up; INCLUSION CRITERIA: 1. Premenopausal female between 30‐50 years old. 2. Patients with pathological diagnosis of endometrial hyperplasia. 3. Willing to receive progestogen treatment. 4. Without previous diagnosis of EH. 5. Patients should return for regular follow‐up and pathological examinations. 6. Patients should sign the informed consent before inclusion.

ChiCtr (2023). "Effects Analysis of HIFU Combined with Dienogest in the Treatment of Adenomyosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Control Group:Oral dienogest, once daily, one capsule each time for 6 month;Experimental Group:HIFU treatment, oral dienogest the next day after HIFU, once daily, one capsule each time for 6 month; CONDITION: Adnomyosis PRIMARY OUTCOME: Uterine volume; SECONDARY OUTCOME: Visual Analogue Scale ;carbohydrate antigen 125 (CA125); INCLUSION CRITERIA: Women of childbearing age, 25‐50 years old; Adenomyosis was diagnosed according to clinical symptoms, gynecological B‐ultrasound or pelvic plain scan + enhanced magnetic resonance imaging (MRI) ; Willing to receive high‐intensity focused ultrasound therapy or oral dienogest therapy; All patients and their family members were informed of the study and signed informed consent voluntarily.

ChiCtr (2023). "Effects of Lactobacillus acidophilus on insulin resistance in obese patients with polycystic ovary syndrome: a randomized controlled clinical study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention group:Lactobacillus acidophilus‐JYLA‐191+melbine (DMBG);Control group:Melbine (DMBG); CONDITION: 5A80.1 Polycystic ovarian syndrome PRIMARY OUTCOME: Insulin resistance;Six items of sexual hormones; SECONDARY OUTCOME: Liver function;Menstrual cycle;Height and weight; INCLUSION CRITERIA: (1)Patients with PCOS with obesity (BMI=28kg/?) and insulin resistance inde X(HOMA‐IR) greater than or equal to 2.69 (2)Women of childbearing age, aged 18‐40 years (3)No drugs affecting menstruation (such as contraceptives, hormones or other drugs affecting insulin, blood sugar, se Xhormones and lipid metabolism) were taken within 3 months, and no related treatment was used, and no induced abortion was recorded; (4) Gynecological examination and auxiliary examination: there are no organic lesions in the internal and external genitalia, and there are no other primary diseases; (5) Those who have signed an informed consent form.

ChiCtr (2023). "Effects of perioperative oxycodone as the sole opioid on immune function in patients undergoing gynecologic malignancy surgery based on multimodal analgesia." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group O:During anesthesia induction, oxycodone 0.3 mg/kg was injected intravenously.Intraoperative injection of oxycodone 0.03 mg/kg on demand to maintain analgesia;Postoperative PCIA: Oxycodone 50 mg diluted to 100 ml;Group C:During anesthesia induction, sufentanil was injected 0.3 µg/kg;Intraoperative continuous infusion of remifentanil 0.1‐0.3 µg/kg/min to maintain analgesia;Postoperative PCIA: Sufentanil 50 µg diluted to 100 ml; CONDITION: patients undergoing gynecologic malignancy surgery PRIMARY OUTCOME: CD4+/CD8+ at 24 hours after surgery; SECONDARY OUTCOME: Degree of pain scored by visual analogue scale (VAS);Catheter‐related bladder discomfort; INCLUSION CRITERIA: aged 18 to 64 years, American Society of Anesthesiologists (ASA) grade =?, scheduled for laparoscopic gynecological malignancy surgery under general anesthesia.

ChiCtr (2023). "Efficacy and safety of minocycline versus doxycycline in the treatment of chronic endometritis: a single-center, randomized, open-label, non-inferiority trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Experimental group and control group:Oral doxycycline;Experimental group and control group:Oral minocycline; CONDITION: chronic endometritis PRIMARY OUTCOME: Immunohistochemical examination of endometrial tissue shows a negative conversion rate of CD138+cells; SECONDARY OUTCOME: Immunohistochemical examination of endometrial tissue shows a negative conversion rate of CD56/57+cells;TBNK lymphocytes;Th1 and Th2 cytokines;live birth rate; INCLUSION CRITERIA: ? Premenopausal women who still need to have children; ?CD138 immunohistochemical staining showed more than 1 plasma cell per 10HPF. ? No endometrial hyperplasia or malignant or structural pathological features of the uterus; (4) Consent to perform a second endometrial biopsy approximately 4 to 6 weeks after the first endometrial biopsy; ? Obtain informed consent from patients and their families, and sign informed consent.

ChiCtr (2023). "Efficacy and Safety of Recombinant Human Granulocyte Colony-Stimulating Factor in Patients with Unexplained Recurrent Pregnancy Loss: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention group:rhG‐CSF+aspirin+progesterone;Control group:placebo+aspirin+progesterone; CONDITION: unexplained recurrent pregnancy loss PRIMARY OUTCOME: 24 weeks live birth rate; SECONDARY OUTCOME: early pregnancy loss rate;clinically confirmed pregnancy rate;ongoing pregnancy rate(to 10 weeks);ongoing pregnancy rate(to 12 weeks);28 weeks live birth rate;ectopic pregnancy rate;stillbirth rate;incidence rate of pregnancy complications;neonatal weigh;neonatal Apgar score;neonatal birth defect rate;incidence rate of adverse effect; INCLUSION CRITERIA: (1)Age of 20 to 37 years old (the reason for setting the upper age limit of 37 years old is that abortion caused by chromosomal aberrations has a higher incidence in advanced maternal age, and cannot be prevented by immunological regulation);(2)Body mass inde X(BMI) between 15 to 29 at screening(Mean±SD of out‐patients from two centers in the past 2 years);(3)Menstrual cycle within 21‐35 days,and the difference between the longest cycle and the shortest cycle only in 1 year is no more than 7 days;(4)History of recurrent pregnancy loss, defined as two or more fetal losses before 24 weeks of gestation (including biochemical pregnancy);(5)Willingness to conceive spontaneously and signing of informed consent form.

ChiCtr (2023). "Efficacy and safety of vitamin D supplementation in the treatment of pediatric overactive bladder syndrome: a prospective, randomized, controlled, single-center clinical study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Vitamin D supplementation group:Supplementation with oral vitamin D preparations;Tolterodine group:Take tolterodine;Standard urotherapy group:Dietary instruction, behavioral training, bladder training; CONDITION: Overactive Bladder Syndrome PRIMARY OUTCOME: pediatric lower urinary tract symptom score;Overall symptom improvement score;bladder diary;Urinary frequency, urinary urgency, urinary incontinence, maximum urinary output;Maximum urinary urgency score;urinary urgency score;Drug‐related adverse reactions;Serum vitamin D levels; INCLUSION CRITERIA: (1) Children older than 4 years of age with a diagnosis of OAB seen at the outpatient urology clinic of the Children's Hospital of Chongqing Medical University (diagnosis follows the latest ICCS recommendations). (2) Children with a serum vitamin D level of less than 35 ng/ml as indicated by the laboratory results of our hospital. (3) The child's guardian has been informed of the nature of the study, understands the provisions in the protocol, can ensure compliance, and has signed an informed consent form.

ChiCtr (2023). "Efficacy of polyethylene glycol recombinant human growth hormone on pregnancy outcomes for patients with thin endometrium undergoing frozen embryo transfer: a pilot study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention group:Pretreatment with long‐acting growth hormone before FET;Control group:Routine HRT+FET; CONDITION: Thin endometrium PRIMARY OUTCOME: Ongoing pregnancy rate; SECONDARY OUTCOME: Chemical pregnancy rate;Clinical pregnancy rate;Pregnancy loss rate;Ectopic pregnancy rate;Endometrial Thickness on progestogen initiate day;Endometrial morphology on progestogen initiate day;Endometrial blood flow indicators on progestogen initiate day; INCLUSION CRITERIA: (1) Females aged 20‐39; (2) Endometrial thickness<7 mm in trigger day of conventional ovulation protocol or progestogen conversion day 2 or more times previously; (3) BMI: 18‐30kg/m2 (included); (4) patients who will planing to perform freeze‐thaw single blastocyst transplantation (including IVF, ICSI, and PGT‐A cycles); (5) At least 1 blastocyst in IVF/ICSI cycles or at least 1 euploid embryo in PGT‐A cycles left for transfer, with a Gardner morphological score of = 4BC (D5 or D6); (6) Be capable of giving informed consent.

ChiCtr (2023). "Erzhitiangui granule in improving the outcomes of IVF/ICSI-ET in elderly patients with DOR: a prospective randomized, controlled, double-blind trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Experimental Group:Erzhitiangui‐Decoction;Control Group:placebo; CONDITION: diminished ovarian reserve PRIMARY OUTCOME: Cumulative clinical pregnancy rate; SECONDARY OUTCOME: TCM syndrome score of kidney Yin deficiency syndrome;Serum E2 and P4 levels on trigger day;2PN fertilization number;Number of embryos available; INCLUSION CRITERIA: ? Meet the diagnostic criteria of diminished ovarian reserve: AFC=5 or AMH=1.2ng/ml; ? Conforming to the syndrome differentiation standard of kidney Yin deficiency syndrome of TCM; ? Age of 35‐42 years old; ? Sign the informed consent.

ChiCtr (2023). "Evidence-based study and clinical application of aromatherapy on postpartum depression/anxiety." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: experimental group:Inhalation with sweet orange essential oil;control group:Inhalation with jojoba oil; CONDITION: Postpartum Depression PRIMARY OUTCOME: postpartum depression;postpartum anxiety;serum estradiol;Serum 5‐hydroxytryptamine; SECONDARY OUTCOME: Postpartum sleep quality; INCLUSION CRITERIA: 1. Aged >= 18 years; 2. Edinburgh Postnatal Depression score >= 9 or State‐Trait Anxiety Inventory > 40; 3. Singleton full‐term delivery; 4. Cooperate with the examination, understand and agree to the study.

ChiCtr (2023). "An exploratory clinical trial on the efficacy and safety of recombinant human follicle stimulating hormone+recombinant luteinizing hormone (r-hFSH+r-hLH) in young patients with diminished ovarian reserve (DOR) (POSEIDON Group 3)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group A:From the 3rd day of menstrual cycle, a fixed dose of r‐hFSH 300IU (Gonal‐F, product of Merck, Germany)+r‐hLH 150IU (Luveris, product of Merck, Germany) was injected for ovarian stimulation.;Group B:From the 3rd day of menstrual cycle, a fixed dose of r‐hFSH 300IU (Gonal‐F, a product of Merck, Germany) was injected for ovarian stimulation.; CONDITION: Infertility PRIMARY OUTCOME: Ongoing pregnancy rate; SECONDARY OUTCOME: Follicular Output Rate;Follicle‐To‐Oocyte Index;fertilization rate;implantation rate;Biochemical pregnancy rate;Clinical pregnancy rate;Live birth rate;Number of oocytes retrieved;number of MII oocytes;Number of transferrable embryos;Number of high‐quality embryos;Number of fresh embryo transfers;Serum LH?estradiol and progesterone Level on HCG Day;Endometrial thickness on embryo transfer day;pregnancy loss;ectopic pregnancy;pregnancy complications; INCLUSION CRITERIA: Subjects meeting Poseidon Group 3 criteria: (1) Age < 35 years old; (2)AFC < 5 or AMH < 1.2 µg /L

ChiCtr (2023). "Explore the mechanism of acupuncture intervention on metabolism and reproductive function of PCOS-IR patients based on ß-endorphin-insulin pathway." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: control group:Basic treatment+metformin;treatment group:Basic treatment + acupuncture; CONDITION: 5A80.1 Polycystic Ovary Syndrome PRIMARY OUTCOME: Detection of sex hormones and related indexes of glucose and lipid metabolism;pregnancy rate, abortion rate; SECONDARY OUTCOME: Follicle development was monitored by ultrasound;Detection of ß‐endorphin, gonadotropin releasing hormone and insulin signaling factor; INCLUSION CRITERIA: 1.The diagnostic criteria for both PCOS and insulin resistance were met; 2. Between 20 and 40 years old; 3. Voluntary signing of informed consent.

ChiCtr (2023). "-Hybrid effectiveness-implementation of task-sharing in prevention of rural perinatal depression: a cluster randomized trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: intervention group:Task‐sharing App‐based Intervention ;Control group:Self‐help App‐based Intervention; CONDITION: perinatal depression PRIMARY OUTCOME: depressive status;negative emotion symptom;sleep quality;parenting competence;social support;reach;adoption;implementation;maintenance; SECONDARY OUTCOME: barriers and facilitators of implementation; INCLUSION CRITERIA: 1) = 18 years old; 2) have established a pregnancy health care record at township health centers; 3) 6‐13 weeks of pregnancy; 4) Edinburgh Postnatal Depression Scale: EPDS < 13; 5) informed consent.

ChiCtr (2023). "An Intervention Reminder Model for Female Stress Urinary Incontinence: a Multi-centered, Random Controlled Clinical Study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group with assistance reminder:daily reminder from smartphone APP;Control group:general education; CONDITION: Stress urinary incontinence PRIMARY OUTCOME: modified Oxford Grading Scale;1h pad test;Glazer assessment; SECONDARY OUTCOME: IIQ‐7;SF‐12;I‐QOL;PISQ‐12; INCLUSION CRITERIA: 1) Adult female, normal cognition, primary school education/academic ability, can use mobile phones; 2) symptoms consistent with stress urinary incontinence; 3) Voluntarily participate in this trial and give written informed consent.

ChiCtr (2023). "A multicenter clinical study on floating needle pre intervention for primary dysmenorrhea in young women." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Treatment group:Floating needle pre intervention;Waiting for the backup group:Maintain original lifestyle habits without intervention; CONDITION: Primary dysmenorrhea PRIMARY OUTCOME: Response rate to VAS score decrease in dysmenorrhea after treatment (3rd menstrual cycle) (proportion of patients with VAS score decrease of 50% or VAS score decrease of = 3 points); SECONDARY OUTCOME: 1. Response rate of dysmenorrhea relief during menstrual cycles 1,2, 4, 5, and 6;VAS score at peak pain intensity per cycle;Duration of dysmenorrhea per cycle (cumulative, degree, h);CO XMenstrual Symptom Scale (CMSS);Beck Anxiety Scale, Beck Depression Scale;The demand for painkillers;Patient self‐evaluation;Adverse event occurrence rate; INCLUSION CRITERIA: (1) Women aged 18 to 30 who have not given birth; (2) Conforming to PD diagnostic criteria: spasmodic pain in the lower abdomen that occurs before or during menstruation without other diseases such as endometriosis; (3) The basic pattern of the cycle is (28 ± 7) d; (4) The visual analogue scale (VAS) score for pain in at least three consecutive menstrual cycles is = 40mm.

ChiCtr (2023). "A multicenter randomized controlled study about Levonorgestrel-releasing intrauterine device suture in the treatment of adenomyosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: LNG‐IUS suture fixation:Hysteroscopic fixation of Manyule ring;simple placement of LNG‐IUS:Simple Manyue Music Ring Placement; CONDITION: adenomyosis PRIMARY OUTCOME: LNG‐IUS expulsion rate; SECONDARY OUTCOME: algomenorrhea;Menstrual volume;side effects;CA125; INCLUSION CRITERIA: 1:She had menorrhagia or dysmenorrhea and met the diagnosis of "adenomyosis"; 2:She had a strong desire to preserve the uterus; 3:She had no fertility requirements in the short term.

ChiCtr (2023). "A multi-center randomized controlled trial study on the effects of Tiepi Fengdou Granules on nutrition and menopausal-related symptoms in menopausal women." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Control group:Bujiale 1mg + Dydrogesterone 5mg/day, continuous administration for 90 days;Experimental group 1:Tiepi Fengdou Granules (3g/pack), 2 packs/time, 3 times a day, for 90 days;Experimental group 2:Tiepi Fengdou Granules (3g/pack), 2 packs/time, 3 times a day, combined with Bujiale 1mg + Dydrogesterone 5mg/day, taken continuously for 90 days; CONDITION: menopausal syndrome PRIMARY OUTCOME: Sex hormone test;Liver and kidney function tests;Thyroid function test;Ultrasound of uterus and breast;Vaginal microecology examination; INCLUSION CRITERIA: 1. Female aged 40‐65 years old; 2. Menopause for more than 12 months and pregnancy excluded, follicle‐stimulating hormone >40U/L and estradiol <10‐20pg/ml; 3. Have a uterus and at least one ovary; 4. Accompanied by vasomotor symptoms such as hot flashes or symptoms of autonomic nervous system dysfunction such as palpitations, dizziness, headache, insomnia, tinnitus, or psychiatric and neurological symptoms such as agitation, anxiety, low mood, depression, or vaginal dryness, dyspareunia, Women with recurrent vaginal infections, difficulty urinating, frequent urination, urgency and other urogenital symptoms, or osteoporosis; 5. Voluntarily participate and sign the consent form to enter clinical research.

ChiCtr (2023). "Multicenter study of the safety and efficacy of ultrasound-guided aspiration and sclerotherapy with polidocanol for benign ovarian cyst." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Test group:Polidocanol injection;Control group:Lauromacrogol injection; CONDITION: Endometriosis PRIMARY OUTCOME: Reduction rate of cyst volume; SECONDARY OUTCOME: Cyst recurrence rate;Visual analogue scales;Quality of life;Medical costs;Duration of sclerotherapy;Total amount of sclerosing agents; INCLUSION CRITERIA: 1. At least 18 years old; 2. According to the comprehensive judgment of clinical, imaging and laboratory examination, it was diagnosed as ovarian endometriosis with a diameter of 4‐10 cm; 3. Ultrasonography revealed a single cyst in one or both ovaries with unspaced unilocular cysts; 4. Serum carbohydrate antigen 125 (CA‐125) < 200 U/mL; 5. No hormones and gonadotropin‐releasing hormone analogues (GnRH‐a) were taken in the past three months; 6. No other gynecological diseases, serious heart and lung diseases; 7. For females of childbearing potential, pregnancy test results were negative at screening/baseline; 8. Sign informed consent voluntarily and follow protocol requirements.

ChiCtr (2023). "A multi-center, randomized, double-blind and positive parallel control clinical study of the efficacy and safety of Levornidazole Disodium Phosphate for Injection in the treatment of pelvic anaerobic infections." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Test Group 1:Levornidazole Disodium Phosphate for Injection, intravenous drip, each 1g (4 tubes) of the test drug will bedissolved in 100mL of 0.9% sodium chloride injection. The first daily administration of the test drug is given once a day, 2 g each time, a total of 200 mL; the second administration is given with 100mL of 0.9% sodium chloride injection, each bottle drip time of 30‐60 minutes, continuous administration for 7 days, each two infusions interval of 12 hours. (q24h Dosing group);Test Group 2:Levornidazole Disodium Phosphate for Injection, intravenous drip, dissolved in 100mL of 0.9% sodium chloride injection per 1g (4 tubes) of the test drug. The first daily administration of the test drug is given once a day, that is, 1g (dissolved in 100mL of 0.9% sodium chloride injection), the additional 100mL of 0.9% sodium chloride injection is given once; the second administration of 4 vials (dissolved in 100mL of 0.9% sodium chloride injection), each bottle drip time of 30‐60 minutes, continuous administration for 7 days, each two infusions interval of 12 h. (q12h, dosing group);Control group:Levornidazole and Sodium Chloride Injection, intravenous drip, the first daily administration of 0.5g (100mL) is given, and another 100mL of 0.9% sodium chloride injection is given once to make the total liquid volume of each administration reach 200mL; the second administration is given 0.5 g (100 mL) with a drip time of 30‐60 minutes per vial for 7 consecutive days with an interval of 12 hours.; CONDITION: Gynecological pelvic inflammatory diseases (including endometritis, salpingitis, salpingo‐oophoritis, tubo‐ovarian abscess, pelvic peritonitis, parauterine connective tissue inflammation and others) PRIMARY OUTCOME: Clinical efficacy after 14 days of treatment; SECONDARY OUTCOME: Microbiological efficacy and comprehensive efficacy after 14 days of treatment;Clinical efficacy, microbiological efficacy, and comprehensive efficacy of 7‐day treatment; INCLUSION CRITERIA: 1)Female patients aged 18 to 65 (including patients aged 18 and 65); 2)Participants have not used effective anti‐anaerobic drugs 72 hours before enrollment 3)Patients with gynecological pelvic infections caused by anaerobic bacteria that the investigators believe need to be treated with injection: sexually active women and STI (sexually transmitted infections) patients who meet the following conditions and have no other causes: a) uterine tenderness or adnexal tenderness or cervical motion tenderness; b) At least one of the following additional conditions is met: body temperature (axillary temperature) = 37.8°C, purulent cervical or vaginal discharge, leukocytosis detected by microscopic examination of vaginal discharge (15 per high‐power white blood cell count =), Complete Blood Count white blood cell count = 10X10^9/L; C‐reactive protein is elevated. 4) The subjects volunteered to be tested and signed the informed consent form, and the process of si

ChiCtr (2023). "A multi-center, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of vaginal use of quadruple Live Lactobacillus capsule in the treatment of postmenopausal atrophic vaginitis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Experimental group:Lactobacillus quad live capsule in vaginal use;Control group:placebo; CONDITION: postmenopausal atrophic vaginitis PRIMARY OUTCOME: vaginal microecology; SECONDARY OUTCOME: TCT (lateral vaginal wall);subjective symptoms;Vaginal sign score; INCLUSION CRITERIA: 1. Sign the informed consent voluntarily, and be able to follow the requirements of the program procedures; 2. Women with a sexual history, aged =45 years and =70 years at the time of informed consent; 3. At the time of screening, the chief complaint was natural menopause =12 months or medical records showed bilateral ovariectomy =6 months, or follicle‐stimulating hormone (FSH) =40 IU/L and estradiol (E2) =20 pg/mL. 4. Moderate to severe vaginal dryness, or moderate to severe dyspareunia for sexually active persons (stable partners and having or attempting to have vaginal intercourse =1 times per month) within 3 months before screening; Note: Vaginal dryness: moderate, most of the time feel vaginal dryness and discomfort, but does not affect daily life; Severe, has been feeling vaginal dryness discomfort, affecting daily life. Pain during intercourse: moderate, most of the time there is pain during intercourse, intercourse brings little satisfaction

ChiCtr (2023). "A Multicenter, Randomized, Investigator-Blind, Positive Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy of Recombinant Human Follicle-Stimulating Hormone Injection (LZ-B-01) and Gonal-f in Controlled Ovarian Hyperstimulation in Assisted Reproductive Technology." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Experimental group:Recombinant Human Follicle‐Stimulating Hormone Injection;Control group:Gonal‐f; CONDITION: 1.Women with anovulation (including polycystic ovary syndrome [PCOS]) who are unresponsive to clomiphene citrate treatment. 2.Women undergoing controlled ovarian hyperstimulation in assisted reproductive technology (ART) such as in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), and zygote intrafallopian transfer (ZIFT) to stimulate the development of multiple follicles. Patients with severe deficiency of luteinizing hormone (LH) and follicle‐stimulating hormone (FSH). PRIMARY OUTCOME: Compare the number of oocytes retrieved in two groups. Note: Follicles with a diameter =10 mm must be punctured. Total oocyte count: Defined as the average number of oocytes obtained per subject 36±2 hours after trigger administration.; SECONDARY OUTCOME: Total dosage of experimental drug;Duration of experimental drug stimulation in the trial (number of days);Hormone levels (LH, E2, P) and their changes after experimental drug administration in the trial.;Serum E2 level on the trigger day;The levels and changes of hormones [luteinizing hormone (LH), estradiol (E2), progesterone (P) measured in the central laboratory] after administration of experimental drugs;The percentage of follicles with a diameter =10mm on the 6th day of ovarian stimulation (number of follicles with a diameter =10mm divided by the total number of follicles).;The percentage of follicles with a diameter =14mm on trigger day (number of follicles with a diameter =14mm divided by the total number of follicles).;The proportion of MII (metaphase II) oocytes to the total number of oocytes retrieved on the day of egg retrieval, specifically for intracytoplasmic sperm injection (ICSI) only.;The normal fertilization rate refers to the percentage of embryos showing both pronuclei (PN) and polar bodies (PB) after in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).;The usable embryo rate on the 3rd day after egg retrieval ;The embryo transfer rate (on the 3rd to 5th day after egg retrieval);The serum hCG/ß‐hCG positive rate (12‐14 days after embryo transfer);The clinical pregnancy rate (4‐7 weeks after embryo transfer) ; INCLUSION CRITERIA: In order to be eligible for participation in this study, subjects must meet all of the following INCLUSION CRITERIA: 1)Couples voluntarily participating in the clinical trial, meeting the requirements of relevant national regulations for assisted reproductive technology, and signing an informed consent form (ICF). 2)Female infertility patients aged 20 to 38 years (including the boundary values). 3)Regular natural menstrual cycles within the range of 24 to 35 days (including the boundary values). 4)Body mass inde X(BMI), calculated as BMI = weight (kg)/height^2 (m^2), within the range of 18.5 to 28.0 kg/m^2 (including the boundary values). 5)Diagnosed with tubal infertility, unexplained infertility, or male factor infertility in females. 6)The examination results conducted within the 60 days prior to randomization confirmed the following: a.Serum levels of follicle‐stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), estradiol (

ChiCtr (2023). "Nintedanib in Prevention of Pulmonary Fibrosis in Malignant Ovarian Germ Cell Tumor Patients Receiving Bleomycin: a randomized, double-blind, controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: nintedanib group (experimental group):standard BEP regimen chemotherapy with nintedanib 150mg bid po till the end of treatment;placebo group (control group):standard BEP regimen chemotherapy with plabeco 150mg bid po till the end of treatment; CONDITION: Malignant Ovarian Germ Cell Tumor PRIMARY OUTCOME: Absolute decline value in forced vital capacity (ml);Percent decline in predicted forced vital capacity (ml);Carbon monoxide dispersion (DLCO) decline rate (%); SECONDARY OUTCOME: The safety and adverse effects of nintedanib in the treatment of malignant ovarian germ cell tumors;Onlogical outcomes of patients between two groups;Fertility outcomes of patients between two groups;Quality of life patients between two groups; INCLUSION CRITERIA: 1. Women with malignant germ cell tumor and patients treated with chemotherapy regimen containing bleomycin; 2. Aged >= 14 years; 3. Can complete lung function examination; 4. FVC is greater than 45% of the normal predicted value and DLCO is greater than 60% of the normal predicted value; 5. Informed consent and signed informed consent; 6. Good compliance.

ChiCtr (2023). "NOX index guidied administration of remifentanil in gynecological laparoscopic surgery: a randomized controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention group:Nox‐guided remifentanil in laparoscopic surgery:;standard of care:Remifentanil was used according to clinical experience; CONDITION: gynecological laparoscopic surgery PRIMARY OUTCOME: The consumption of remifentanil during the surgery; SECONDARY OUTCOME: The number of patients with hemodynamic instability;Plasma ACTH and serum cortisol concentrations before anesthesia induction, at the end of suture, at extubation, and after leaving PACU; INCLUSION CRITERIA: (1) Age above 18 and below 65 (2)ASA grade I to III (3) Patients undergoing elective laparoscopic adnexal and (or) hysterectomy procedures (4) Expected operation duration > 1 hour (5) Sign informed consent

ChiCtr (2023). "Pregnancy outcomes following a letrozole ovulation induction cycle vs. a hormone replacement cycle with GnRH-a pretreatment for frozen-thawed embryo transfer in women with endometriosis: a randomized controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: LE :letrozole ovulation induction protocol for frozen‐thawed embryo transfer;GnRH‐a+HRT:hormone replacement therapy with GnRH‐a pretreatment protocol for frozen‐thawed embryo transfer; CONDITION: Infertility PRIMARY OUTCOME: Live birth rate; SECONDARY OUTCOME: Clinical pregnancy rate;Biochemical pregnancy rate;miscarriage rate;Incidence of obstetric and perinatal complications;Incidence of neonatal complications; INCLUSION CRITERIA: 1. Age between 20 and 40 years; 2. Patients diagnosed with endometriosis by laparoscopy or laparotomy, or meeting all of the following criteria: (1) Cyclical and non‐cyclical signs and symptoms (dysmenorrhea, dyspareunia, dyschezia, etc.) (2) Palpable nodularities in the pouch of Douglas found on bimanual pelvic examination (3) Endometrioma found by TVS 3. Previous embryo transfer failure cycle is = 2, and previous ovulation cycle is = 2; 4. Performing frozen‐thawed single blastocyst transfer, and the blastocyst was morphologically graded as 4BC or better using Gardner grading criteria.

ChiCtr (2023). "pre-menstrual acupuncture at sensitized points in the treatment of primary dysmenorrhea: a randomized controlled trail." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: acupuncture group:acupuncture;Ibuprofen sustained‐release capsules can be taken when abdominal pain is unbearable (VAS=7) in both groups.;blank control group:follow up;Ibuprofen sustained‐release capsules can be taken when abdominal pain is unbearable (VAS=7) in both groups.; CONDITION: primary dysmenorrhea PRIMARY OUTCOME: menstrual pain visual analogue scale score;Incidence of dysmenorrhea; SECONDARY OUTCOME: symptom duration and severity measured by the Co XMenstrual Symptom Scale, CMSS;Usage of ibuprofen during menstruation; INCLUSION CRITERIA: A ) The diagnostic criteria were in line with the ' 2017 SOGC clinical practice guidelines : primary dysmenorrhea ( No.345 ) ' and the diagnostic criteria for primary dysmenorrhea in the 9th edition of the textbook ' Obstetrics and Gynecology ' of People 's Health Publishing House ( Xie Xing, Kong Beihua, Duan Tao ) ; tCM syndrome differentiation is based on ' evidence‐based acupuncture clinical practice guidelines‐primary dysmenorrhea ', which is differentiated as qi stagnation and blood stasis syndrome. b ) 18‐30 years of age ; c ) The course of disease was more than 6 menstrual cycles, and the average VAS pain score was = 4 points for 3 consecutive months ; d ) No other treatment was taken or combined within 2 weeks before enrollment ; e ) Regular menstrual cycle, cycle in 28 ± 7 days ; ( f ) To sign the informed consent.

ChiCtr (2023). "A prospective, randomized, controlled, and multicenter clinical study on Shenluo Tiaojing pills and Shenluo Yuchun pills in treatment of polycystic ovary syndrome of kidney-yang deficiency and phlegm obstruction type and kidney-yin deficiency and phlegm-blood stasis type." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Treatment group (Kidney‐yang deficiency and phlegm obstruction type):Shenluo Tiaojing pills 12 g/dose, twice daily, taken with warm water at half an hour after meal for 6 months in total ;Control group (Kidney‐yang deficiency and phlegm obstruction type):Drospirenone and ethinylestradioltablets, from the fifth day of menstruation, one tablet at the same time every day for 21 consecutive days;Treatment group (Kidney‐yin deficiency and phlegm‐stasis type):Shenluo Yunchun pills 15 g/dose, twice daily, taken with warm water at half an hour after meal for 6 months in total ;Control group (Kidney‐yin deficiency and phlegm‐stasis type):Metformin hydrochloride tablets, taken orally with meals starting from the first day of menstruation, 500mg/dose, three times a day, for 6 cycles in total; CONDITION: Polycystic Ovary Syndrome PRIMARY OUTCOME: Basal Body Temperature;Ultrasound follicle monitoring; SECONDARY OUTCOME: BMI;WHR;Acne score;Melanosis (pseudoacanthosis nigricans) score;Determination of sexual hormone levels;OGTT;Insulin release test;Blood lipid; INCLUSION CRITERIA: 1) Patients aged 16 40 (included); 2) Those conforming to PCOS diagnostic criteria, with duration of disease =6 months 3) Those with PCOS of kidney‐yang deficiency and phlegm obstruction type or kidney‐yin deficiency and phlegm‐stasis type in TCM syndrome differentiation; 4) Those who have not received medication or those who have taken medication but stopped it for more than 3 months; 5) Those who have ability to cooperate in observing efficacy and adverse events, as well as recording in the subject diary; 6) Those who voluntarily participate in this clinical study and sign relevant informed consent forms.

ChiCtr (2023). "QuikClear hysteroscopic tissue resection system versus hysteroscopic electroresection in the treatment of submucous fibroids: a single-center prospective randomized controlled study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Control group:Hysteroscopic resection.;Experimental group:QuikClear hysteroscopic tissue resection system group; CONDITION: submucous fibroids PRIMARY OUTCOME: Effectiveness; SECONDARY OUTCOME: Security;Postoperative pregnancy;Satisfaction evaluation;Clinical performance; INCLUSION CRITERIA: 1) Patients who voluntarily sign informed consent to participate in the clinical trial on the basis of full understanding after fully explaining the purpose and content of the clinical trial, including the subject's compliance. 2) Age 20‐45 years old 3) Patients with benign uterine lesions were diagnosed after hysteroscopy. 4) Patients with diagnostic curettage or blunt dissociation are difficult to remove. 5) Type 0, type 1 or type 2 uterine submucous fibroids (diameter = 4 cm). 6) Sexual life history.

ChiCtr (2023). "A randomised, double-blind, placebo-control study evaluating the efficacy and safety of hyaluronic acid gel in the treatment of genitourinary syndrome of menopause." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: intervention group:vaginal application of one tube of sodium hyaluronate gel, once every day for the first two weeks and once every 3 days for the following two weeks, with four weeks in total.;placebo control group:vaginal application of one tube of placebo, once every day for the first two weeks and once every 3 days for the following two weeks, with four weeks in total.; CONDITION: genitourinary syndrome of menopause PRIMARY OUTCOME: improvement of symptoms; SECONDARY OUTCOME: improvement of vaginal atrophy symptoms questionnaire, vaginal health inde Xscore, vaginal pH, vaginal maturation inde Xand female sexual function inde Xcompared to baseline;vital signs and physical examination; INCLUSION CRITERIA: 1. aged between 45‐70 (with boundary included) 2. menopause women (with or without hysterectomy) with at least one of following criteria met: a. amenorrhea over 12 months if no hysterectomy was done b. serum FSH level above 40IU/L if currently undergoing amenorrhea between 6‐12 months, or underwent hysterectomy before menopause c. underwent bilateral oophorectomy over 6 months ahead of baseline visit 3. vaginal discharge pH>5.0 4. underwent at least one of the following symptoms and degree of symptoms evaluated as moderate or severe using the VASQ rating scale a. vaginal dryness at least once a week b. vulvovaginal itching at least once a week c. sensation of stimulation at least once a week d. feeling of pain in vulvovaginal area at least once a week e. coital pain at least once a week 5. participants could voluntarily avoid the use of either antibiotics, pre/probiotics, drugs containing estrogen unless permitted. 6. participa

ChiCtr (2023). "A Randomized clinical trial of Postoperative adjuvant therapy with Toripalimab versus cervical lymphadenectomy alone for Residual recurrent nasopharyngeal carcinoma in cervical lymph nodes." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Test group:Cervical lymphadenectomy + Toripalimab;Control group:Cervical lymphadenectomy; CONDITION: Nasopharyngeal carcinoma PRIMARY OUTCOME: failure‐free survival, FFS; SECONDARY OUTCOME: overall survival, OS;distant metastases‐free survival, DMFS;local recurrence‐free survival, LRFS;Safety index;Quality of life; INCLUSION CRITERIA: 1) Age: 18‐70 years. 2) Histologically and/or cytologically confirmed recurrent nasopharyngeal carcinoma non‐keratinizing carcinoma (differentiated or undifferentiated, WHO type II or III; 3) Primary nasopharyngeal and cervical lymph node lesions have been treated with radical dose radiotherapy; 4) Imaging findings of residual or recurrent cervical lymph nodes alone, clinical stage rT0N1‐3M0, no distant metastasis; 5) KPS score = 70; 6) Patients have signed informed consent and are willing and able to comply with the study plan visit, treatment plan, laboratory tests and other study procedures.

ChiCtr (2023). "Randomized controlled study on the effect of acupuncture on ovulation disorders in polycystic ovary syndrome." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: A:Acunpuncture;C:Shallow needling of non meridian and non acupoint control points; CONDITION: PCOS PRIMARY OUTCOME: ovulation rate;Menstrual frequency; SECONDARY OUTCOME: Serum se Xhormone levels;Number of cystic follicles;BMI;Waist to Hip Ratio;Medical Outcomes Study,SF‐36; INCLUSION CRITERIA: ? Conforming to PCOS diagnostic standards; ? Age 18‐40 years old; ? Infrequent menstruation (Menstrual cycle>35 days or less than 8 menstruations in the last 12 months) or amenorrhea (menopause time exceeds 90 days); ? The patient voluntarily participates in clinical trials and signs an informed consent form.

ChiCtr (2023). "A randomized controlled trial of the treatment of stress urinary incontinence in women by acupuncture at the ZhongJi point under CT location." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Treatment Group 1:Acupuncture was applied to Zhongji point to the anterior bladder space.;Treatment Group 2:Acupuncture was applied at Zhongji point to 1cm below the abdominal wall.;Control group:Acupuncture was applied to Zhongji point to the fat layer.; CONDITION: SUI PRIMARY OUTCOME: 1h pad test;International Advisory Committee on Incontinence Urinary Incontinence Questionnaire‐short form; INCLUSION CRITERIA: (1) in accordance with the fourth international incontinence recommendations (4 th Edition 2009). ? Symptoms: when the abdominal pressure increases in various degrees, such as sneezing, coughing, laughing, strenuous exercise or walking, urine leakage is involuntary. When the abdominal pressure is stopped, urine flow is stopped. ? Signs: involuntary urine leakage when abdominal pressure increased, or weight gain >1g in pad test; ? No accompanying symptoms such as urgency and frequency of urination. (2) the age is greater than 35 years old and less than 65 years old; (3) signed informed consent and were willing to participate in the study.

ChiCtr (2023). "A randomized controlled, open clinical study comparing the safety and efficacy of transvaginal natural orifice transluminal endoscopic surgery (VNOTES) and single-port transumbilical total laparoscopic hysterectomy." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: VNOTES group:Total hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (VNOTES);LESS group:Total hysterectomy by single‐port transumbilical total laparoscopic hysterectomy (LESS); CONDITION: ? Adenomyosis/endometriosis; ? Uterine fibroids; ? cervical intraepithelial lesions; ? Atypical endometrial hyperplasia; ? Other conditions requiring hysterectomy. PRIMARY OUTCOME: Intraoperative and postoperative complications; SECONDARY OUTCOME: Hemoglobin before and after surgery;Pain intensity;Satisfaction; INCLUSION CRITERIA: INCLUSION CRITERIA: =18 years old, < 75 years old, female patients with indications of hysterectomy due to benign diseases according to clinical guidelines, the surgical indications included: ? adenomyopathy/endometriosis; ? Uterine fibroids; ? cervical intraepithelial lesions; ? Atypical endometrial hyperplasia; ? Other conditions requiring hysterectomy.

ChiCtr (2023). "A randomized, double-blind, placebo-controlled, multicenter clinical trial of the efficacy and safety of Ejiao Composite Syrup in the treatment of diminished ovarian reserve (deficiency of qi and blood syndrome)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Treatment Group:Ejiao Composite Syrup;Control Group:Ejiao Composite Syrup Mimetic Agent; CONDITION: Diminished ovarian reserve (deficiency of qi and blood syndrome) PRIMARY OUTCOME: Follicle stimulating hormone; SECONDARY OUTCOME: Pictorial Blood Loss Assessment Chart;Luteinizing Hormone;Prolactin;Progesterone;Estradiol;Testosterone;Anti‐Müllerian Hormone;Antral Follicle Count;Pittsburgh Sleep Quality Index;TCM syndrome curative effect; INCLUSION CRITERIA: 1) Age: 25‐39 years old (including boundary value) female; 2) Meet the diagnostic criteria of diminished ovarian reserve; 3) In accordance with the diagnostic criteria of less menstrual period of TCM; The TCM syndrome differentiation type was "deficiency of qi and blood syndrome". 4) Auxiliary examination: the results of 2 tests within 3 months met the following criteria: 10Miu/mL= Follicle stimulating hormone (FSH) < 25 miU /ml; 5) Menstrual cycle regularity,:21 < menstrual cycle < 35 days,1 day = menstrual period =7 days; 6) No history of intrauterine operation or systemic hormone therapy within 3 months before treatment; 7) Voluntarily sign the informed consent form of the subjects.

ChiCtr (2023). "A randomized, open, positive controlled clinical study to evaluate the efficacy and safety of Baofukang Shuan in the treatment of bacterial vaginosis (BV)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: test group :Baofukangshuan;Control group:Metronidazole vaginal gel; CONDITION: Bacterial vaginosis PRIMARY OUTCOME: Cure rate of BV after 3 to 5 days of discontinuation.; SECONDARY OUTCOME: Cure rate of BV after 28 +/‐ 3 days of discontinuation;Relapse rate of BV after 28 +/‐ 3 days of discontinuation;Improvements in vaginal microecology; INCLUSION CRITERIA: 1. Women aged over 18 years are sexually active; 2. Bacterial vaginosis (BV) was diagnosed; 3. Informed consent and voluntary participation in this study, and signed informed consent.

ChiCtr (2023). "Randomized, open-label, two-treatment, two-cycle, crossover design bioequivalence study of a single oral dose of dienogest tablets in healthy subjects under fed conditions." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Test preparation‐Reference preparation group:cycle 1 the test product was taken orally; cycle 2 reference preparation was taken orally;Reference preparation‐ Test preparation group:cycle 1 reference preparation was taken orally; cycle 2 the test product was taken orally; CONDITION: Endometriosis PRIMARY OUTCOME: Cmax;Tmax;AUC0‐t;AUC0‐8;?z;t1/2;F; INCLUSION CRITERIA: 1)Subjects are fully informed of the purpose of the trial, its content, procedure, and possible adverse effects, volunteered as subjects, and signed an informed consent form prior to the start of any procedure. 2)Healthy female subjects aged 18‐45 years old (inclusive). 3)Subjects should weigh no less than 45 kg. Body mass inde Xwas in the range of 19 to 26 kg/m2 (inclusive). Body mass inde X(BMI) = weight (kg)/height2 (m2). 4)Vital signs, physical examination (skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, bones/muscles, nervous system, etc.), 12‐lead electrocardiogram, gynecologic ultrasound (routine color ultrasound of gynecologic organs), laboratory tests (including routine blood, blood biochemistry, blood pregnancy, coagulation function, routine urine, immune tetralogy) with normal test results or those judged by the clinician to be abnormal without clinical significance. 5)Subjects must have regular menstruation (menstrual cyc

ChiCtr (2023). "Recombinant luteinizing hormone supplementation based on FSH/LH values will improve clinical outcomes with antagonist protocol: a prospective, single-center, single-blind, randomized controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Experimental group:Administer gene recombinant follicle‐stimulating hormone (r‐FSH) 150‐225u + gene recombinant luteinizing hormone (r‐LH) 75u, inject once a day, for 5 consecutive days, the sixth day of stimulation (the sixth day of stimulation) according to adjust the dosage of r‐LH according to the FSH/LH value (if >= 5r‐LH, increase to 150 u/d, if < 5r‐L1, the dosage remains unchanged) until the night needle day.;Control group:From the start date, r‐FSH (150‐225u) was injected once a day for 5 consecutive days, and 75u r‐LH was added on the 6th day according to the current clinical routine until the night acupuncture day.; CONDITION: Infertility PRIMARY OUTCOME: good‐quality cleavage embryos; SECONDARY OUTCOME: follicle export rate;MII oocyte rate;fertility rate;available embryo rate;good embryo rate;Clinical pregnancy rate;Pregnancy loss rate; INCLUSION CRITERIA: 1. The age of the woman is 20‐40 years old, and the menstrual cycle is normal; 2. Both husband and wife have normal chromosomes; 3. Without adenomyosis and endometriosis; 4. No intramural fibroids > 4 cm, intrauterine adhesions or untreated endometrial polyps.

ChiCtr (2023). "Remimazolam versus propofol sedation on the quality of recovery in patients with painless induced abortion : a randomized non-inferiority trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Remimazolam group:Sufentanil combined with Remazolam for sedation;Propofol group:Sufentanil combined with propofol for sedation; CONDITION: NA PRIMARY OUTCOME: Postoperative quality of recovery‐15; SECONDARY OUTCOME: Incidence of nausea and vomiting after awakening;Injection pain;Time to discharge;Incidence of hypoxemia;Incidence of hypotension;The number and frequency of additional sedative drugs;Recovery time; INCLUSION CRITERIA: (1) Patients undergoing elective, painless induced abortion surgery (2) Age 18‐45 years; (3)BMI18 28kg/m2 (4) Gestation time, 50‐75 days; (5) Blood routine, coagulation routine, urine routine, white ribbon routine, liver and kidney function test results were unremarkable; (6) American Society of anesthesiologists (ASA) class I to II; (7) Informed of the experimental procedure and risks of anaesthesia, volunteered to participate in this study and signed consent for anaesthesia.

ChiCtr (2023). "Research for the Treatment of Female Stress Urinary Incontinence Using Transcutaneous Acupoint Electrical Stimulation Combined with Vaginal Biofeedback Electrical Stimulation." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Control group:Biofeedback Electrical Stimulation Therapy via Vaginal Canal;Observation group:TEAS treatment was performed simultaneously with Biofeedback Electrical Stimulation Therapy via Vaginal Canal; CONDITION: N39.300 female stress urinary incontinence PRIMARY OUTCOME: One‐hour pad test;Modified Oxford Muscle Grading Scale;Short Form of International Consultation on Incontinence Questionnaire (ICIQ‐SF); SECONDARY OUTCOME: Pelvic floor muscle electromyography assessment;Short Form of Incontinence Impact Questionnaire (IIQ‐7);Incontinence Quality of Life Scale ( I‐QOL); INCLUSION CRITERIA: Patients with mild to moderate stress urinary incontinence who meet the following criteria: female, aged 20‐40, with clear thinking ability and able to follow verbal or written instructions, who have not received any relevant treatments in the month prior to participation in the study, voluntarily agree to participate in this study, and sign an informed consent form.

ChiCtr (2023). "Safety and efficacy of ultrasound-guided superior hypogastric plexus block combined with conscious sedation in ambulatory patients undergoing percutaneous microwave ablation of uterine myomas: a single-center, double-blinded, randomized controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: the intervention group:ultrasound‐guided superior hypogastric plexus block (SHPB) combined with conscious sedation;the control group:local anesthesia combined with conscious sedation; CONDITION: uterine myomas PRIMARY OUTCOME: the success rate of anesthesia; SECONDARY OUTCOME: vasoactive drug consumption;acetaminophen consumption;sleep quality;the Uterine Fibroid Symptom and Quality of Life Score (UFS‐QOL); INCLUSION CRITERIA: a. Patients with a body mass inde X(BMI) of less than 30.0 kg·m‐2. b. Patients aged 18 to 45 years. c. Patients with American Society of Anesthesiologists (ASA) physical status classes ? and ?. d Ultrasound guided PMWA surgery for uterine fibroids.

ChiCtr (2023). "Sentinel lymph node biopsy in early cervical cancer: a prospective randomized controlled study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: sentinel lymph node biopsy group:sentinel lymph node biopsy;pelvic lymphadenectomy group:pelvic lymphadenectomy; CONDITION: cervical cancer PRIMARY OUTCOME: Recurrence rate; SECONDARY OUTCOME: lymphatic leakage and lymphatic retention cyst;lower limb edema;Intraoperative blood loss and operative time;Postoperative pelvic drainage;Number of pathological lymph node positive cases;Number of cases of postoperative adjuvant chemoradiotherapy;Postoperative quality of life; INCLUSION CRITERIA: (1) Stage IA2‐IB1 was first diagnosed according to the 2018 FIGO clinical staging criteria and no treatment was given; ? Cervical pathological biopsy was diagnosed as cervical squamous cell carcinoma or adenocarcinoma. ? Preoperative MRI and other imaging data showed no lymph node metastasis. (4) Voluntarily participated in the experiment and signed the informed consent

ChiCtr (2023). "A Study of Fluzoparib Maintenance Treatment in Participants With HRD Positive Initially Treated Advanced Ovarian Cancer Following Response on Front-Line Short Cycle Platinum-Based Chemotherapy." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Cohort 1:After 4 cycles of platinum‐containing chemotherapy, the patient achieved complete clinical remission and began to take fluzopril.;Cohort 2:After 6 cycles of platinum‐containing chemotherapy, the patient achieved complete clinical remission and began to take fluzopril.; CONDITION: Ovarian Cancer PRIMARY OUTCOME: Progression Free Survival Rate at 12 months; SECONDARY OUTCOME: Progression‐free survival;Progression Free Survival Rate at 24 months;Overall survival; INCLUSION CRITERIA: 1.The patients voluntarily participated in this study and signed the informed consentincluding undergoing treatment and scheduled visits and examinations 2.Patients must be female 18‐75 years of age 3.Newly diagnosed ovarian cancer, fallopian‐tube cancer, or primary peritoneal cancer, that is stage III or IV according to International Federation of Gynecology and Obstetrics [FIGO] 4.Patients with histologically confirmed, high grade serous or high grade endometrioid ovarian cancer, fallopian‐tube cancer or primary peritoneal cancer. 5.Satisfactory primary debulking surgeryno visible residual tumor or residual tumor=1cm(R0/R1) 6.After surgery, complete response ( CR ) was achieved after platinum‐based chemotherapy, and screening should be completed within 8 weeks after the last dose of chemotherapy ; according to the RECIST1.1 standard, the disease was completely relieved ( CR ), and CA‐125 was within the upper limit of normal ( ULN ) or not incre

ChiCtr (2023). "Study on psychological status of young patients with induced abortion by multimodal health education." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Experimental group:Multi mode health education;control group:reguar post abortion care; CONDITION: induced abortion PRIMARY OUTCOME: Anxiety Scale;Depression Scale; INCLUSION CRITERIA: 1. Patients aged 14‐19 years; 2. The gestational age is within 12 weeks; 3. The patient and guardian voluntarily participated in the study and signed the informed consent form.

ChiCtr (2023). "A study on the application of a mental health promotion program for women with polycystic ovary syndrome." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention group :Mindfulness integrated cognitive‐behavioral therapy + lifestyle ;Intervention group:lifestyle ;control group :waiting in the list; CONDITION: Polycystic ovary syndrome PRIMARY OUTCOME: depression;anxiety; SECONDARY OUTCOME: body image distress;subjective well‐being;Body Mass Inde X(BMI); INCLUSION CRITERIA: (1) Meet the diagnostic criteria in "Diagnosis of Polycystic Ovary Syndrome: Health Industry Standards of the People's Republic of China" approved in 2011; (2) Age = 18 years old; (3) PHQ‐9 = 5 or GAD‐7 = 5 or both PHQ‐9 and GAD‐7 = 5; (4) Voluntarily participate in this study

ChiCtr (2023). "Study on the Effect of Huolong Cupping Comprehensive Moxibustion Therapy on Preventing VTE Formation in Patients Undergoing Gynecological Laparoscopic Surgery." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: control group:Routine perioperative care;Test group:Intervention was conducted on the day before surgery and the first, third, and fifth days after surgery, with a total of 4 treatments. Hand contact with the skin first and then drop the jar, using a combination of pushing, scraping, and moxibustion for operation. Moxibustion and scraping were performed in the order of Taixi, Sanyinjiao, Fenglong, Zusanli, Chengshan, Yanglingquan, Weizhong, Xuehai, Futu, and Yinmen, while moxibustion was performed on Yongquan acupoint with Ai box. Hold the jar with one hand, first test the temperature, then lower the jar. After lowering the jar, use wrist force to rotate the warm moxibustion and push the jar on the corresponding acupoints with the patient s tolerable strength, to avoid the appearance of fever. Moxibustion and scraping at each acupoint will take about 1 minute, and the entire operation will take about 20 minutes.; CONDITION: venous thromboembolism PRIMARY OUTCOME: Incidence of VTE;Fibrinolysis 2 items; SECONDARY OUTCOME: Caprini Thrombosis Risk Factor Assessment Form;Comfort Rating Scale;coagulation; INCLUSION CRITERIA: (1) Patients undergoing laparoscopic surgery for benign and malignant gynecological tumors; (2) Those with complete clinical data; (3) Between the ages of 18 and 60; (4) Informed consent and voluntary participation in this study; (5) Able to withstand ultrasound examination; (6) Conscious, without mental illness or cognitive impairment, able to communicate effectively, and able to complete the assessment scale;

ChiCtr (2023). "Study on the effect of TCM TEAS on the prevention and treatment of PONV after gynecological laparoscopic surgery." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: TEAS group:30min before anesthesia, the percutaneous acupuncture points were continuously given to the acupuncture points of Jinghegu, Neiguan, Zusanli and Sanyin until the end of the operation.;Control group:The patient was given a sham acupuncture 30min before anesthesia (1cm to take the acupoint next to Hegu, Neiguan, Zusanli and Sanyinjiao, connected to the stimulator, and no electrical stimulation) until the end of the operation.; CONDITION: Nausea and vomiting after general anesthesia PRIMARY OUTCOME: Postoperative nausea and vomiting; SECONDARY OUTCOME: C‐reactive protein;Interleukin‐6;Interleukin ‐10 ;Tumor necrosis factor‐a;creatine kinase; INCLUSION CRITERIA: Patients undergoing elective gynecological laparoscopic surgery under general anesthesia (1) Patients hospitalized for laparoscopic gynecological surgery; (2) Preoperative general condition can be, ASA grade I III; Age 18‐65 years old (3) patients can communicate normally, there are no obvious contraindications to acupuncture; (4) The skin of the limbs is intact, suitable for acupuncture; (5) The patient and family sign the informed consent form.

ChiCtr (2023). "Study on the efficacy and safety of esketamine combined with remazolam in anesthesia for daytime abortion surgery." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: group RM1:Anesthesia was induced with esketamine combined with remimazolam 0.2mg/kg, and to determine the half effective dose of esketamine combined with different doses of remazolam to inhibit the body response of patients undergoing daytime painless abortion during cervical dilation .;group RM2:Anesthesia was induced with esketamine combined with remimazolam 0.3mg/kg, and to determine the half effective dose of esketamine combined with different doses of remazolam to inhibit the body response of patients undergoing daytime painless abortion during cervical dilation ;group RM3:Anesthesia was induced with esketamine combined with remimazolam 0.4mg/kg, and to determine the half effective dose of esketamine combined with different doses of remazolam to inhibit the body response of patients undergoing daytime painless abortion during cervical dilation .; CONDITION: daytime painless abortion surgery PRIMARY OUTCOME: median effective dose;body movement response;adverse events;non‐invasive blood pressure;heart rate;SPO2;sedation;drug use;vital signs; SECONDARY OUTCOME: Narcotrend index;visual analogue scale;BPS score;time of anesthesia induction;time of operation;time of awakening;time of leaveing the operating room;Modified MOAA/S score;Modified alderete score; INCLUSION CRITERIA: (1) Age: 18‐50 years old (2) BMI:18kg/?‐30kg/? (3) ASA : I‐II (4) Patients with 4‐10 weeks of pregnancy and surgical indications for outpatient day‐time painless abortion (5) The patient has informed consent to the surgical protocol and experimental protocol

ChiCtr (2023). "Study on the Improvement of Polycystic Ovarian Syndrome patients with overweight / obesity by standardizing medical nutrition management and probiotic treatment." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: A(PCOS):None;B:Standardized nutrition management and placebo;C:Standardized nutrition management and probiotic;D(healthy control):None; CONDITION: Polycystic Ovarian Syndrome PRIMARY OUTCOME: Fasting blood glucose ;Insulin;Total cholesterol;Triglyceride;High‐density lipoprotein cholesterol;Low‐Density Lipoprotein Cholesterol;body weight;waist;Body fat percentage;Body Mass Index; SECONDARY OUTCOME: gut microbiota; INCLUSION CRITERIA: Control group: (1) age:18 40, 18.5=BMI<23.9kg/m^2 (2) No history of gastrointestinal diseases such as diarrhea within 4 weeks, and no anomaly in stool exam. (3) No history of allergic diseases such as asthma and allergic cough. (4) No treatment of probiotic, prebiotic, postbiotic or antibiotic within 2 weeks PCOS group: (1)2003 Rotterdam Standard Diagnosis of PCOS (2)BMI =24 kg/m^2 (3) age:18 40

ChiCtr (2023). "Study on therapeutic effect of acupuncture myofascial trigger point combined with abdominal stretch on primary dysmenorrhea in athletes." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: MTrPs alone acupuncture group:MTrPs alone acupuncture ;MTRPS combined with abdominal stretch therapy group:MTRPS combined with abdominal stretch therapy;Traditional microwave TDP combined with stretching therapy group:Traditional microwave TDP combined with stretching therapy; CONDITION: Primary dysmenorrhea PRIMARY OUTCOME: Pain condition;Functional assessment;Physical indicators;Sports Performance; INCLUSION CRITERIA: (1) met the diagnostic criteria for primary dysmenorrhea; (2) female athletes aged 18‐35 years; (3) premenstrual pain intensity =4 points (0‐10 VAS scores) ; (4) had premenstrual pain symptoms for at least 6 months; (5) not pregnant or not planning to become pregnant during the study period; (6) no serious heart, liver, kidney, nervous system, endocrine system diseases; (7) has not used analgesics or other drugs or methods for the treatment of PDM in the past 4 weeks; (8) is willing to follow the study protocol and sign an informed consent form.

ChiCtr (2023). "The Therapeutic Effect of Transcutaneous Electrical Acupoint Stimulation on Primary Dysmenorrhea." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention group:Transcutaneous electrical acupoint stimulation;Control group:Sham‐Transcutaneous electrical acupoint stimulation; CONDITION: Primary dysmenorrhea PRIMARY OUTCOME: Pain;Total effect rate;Uterine artery hemodynamics; SECONDARY OUTCOME: Mental health;Quality of life; INCLUSION CRITERIA: 1) Ultrasound examination shows no organic lesions in the reproductive organs; 2) Age 18‐40 years old; 3) Menstrual cycle regularity: 28 ± 7 days; 4) VAS score = 4 cm (moderate or above pain) at the baseline; 5) Willing to complete the corresponding questionnaire check and sign the informed consent form.

ChiCtr (2023). "To investigate the effect of ultrasound-guided TAP block on neutrophil/platelet to lymphocyte ratio in patients undergoing radical resection of endometrial cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: TAPB+GA group:Transversus abdominis plane block combined with general anesthesia;GA group:general anesthesia; CONDITION: Endometrial Cancer PRIMARY OUTCOME: Neutrophil to lymphocyte ratio; SECONDARY OUTCOME: Platelet to lymphocyte ratio;VAS score;Nausea and vomiting; INCLUSION CRITERIA: ? Age 20‐70 years old; ? All patients were diagnosed as endometrial cancer for the first time without any systemic treatment, and confirmed as endometrial cancer by postoperative pathology; ?ASA grade I‐III; ? No distant metastasis of other sites occurred; ? The operation was performed by the same group of surgeons.

ChiCtr (2023). "To investigate whether probiotics can delay the development of paraneoplastic thrombocythemia in patients with ovarian cancer through their effects on intestinal flora." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group1:Bifidobacterium longum;Group2:Placebo; CONDITION: Ovarian Cancer PRIMARY OUTCOME: platelets;Fecal flora; SECONDARY OUTCOME: CA125;HE4;Coagulation function; INCLUSION CRITERIA: 1. Ovarian cancer patients with PLT count greater than 300 X10^9/L; 2. Epithelial ovarian cancer (serous adenocarcinoma, mucous adenocarcinoma, endometrioid adenocarcinoma, etc.) was confirmed by puncture pathology or highly suspected ovarian cancer was confirmed by postoperative pathology; 3. The patient was generally in good condition, aged 18‐75 years, and did not have serious heart, lung, kidney, liver dysfunction or metabolic diseases.; 4. 6 courses of TC chemotherapy were received after surgery; Fresh, meso‐posterior, and internal fecal samples of 10 g were collected and quickly stored at ‐80 degree C. Fecal DNA extraction and 16S rRNA gene sequencing were performed for intestinal flora detection; 5. No antibiotics or other drugs were used in the first 3 months after the completion of treatment.

ChiCtr (2023). "Ultrasound-Guided erector spinae plane block for postoperative analgesia in patients undergoing posterior cervical spine surgery: a randomized controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Experimental group:erector spinae plane block;Control group:local infiltration analgesia; CONDITION: Cervical spondylosis combined with spinal stenosis, spinal tumors, and cervical instability PRIMARY OUTCOME: Dosage of morphine within 24 h after surgery; SECONDARY OUTCOME: Intraoperative consumption of opioids;Postoperative Visual Analogue Scale Score;Times of sleep interruption due to pain on the night of surgery;Time until the first walkout of bed after surgery;Time to hospital discharge; The total cost of hospitalization;Total morphine consumption during hospitalization;postoperative adverse events; INCLUSION CRITERIA: (1) PCSS are indicated for patients with cervical spondylosis with posterior longitudinal ligament calcification, cervical spondylosis with spinal canal stenosis, cervical spondylosis with arachnoiditis, spinal canal tumor, and cervical instability; (2) Ages of 18‐60 years with gender restriction; (3) The preoperative American Society of anesthesiologists (ASA) anesthesia risk assessment grade is I to II; (4) Patients who signed informed consent.

ChiCtr (2024). "Impact of three endothelial preparation protocols on clinical outcomes of first transfer of frozen-thawed embryos in patients with PCOS: a prospective randomized controlled study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: HRT:Endothelial preparation using a hormone replacement program;GnRH‐a HRT:Endothelial preparation using a GnRH‐a hormone replacement program;LE:Endothelial preparation with letrozole; CONDITION: PCOS PRIMARY OUTCOME: Clinical pregnancy rate; SECONDARY OUTCOME: pregnancy outcome;neonatal outcome;Safety indicators; INCLUSION CRITERIA: (1) <38 years of age; (2) Diagnosis of PCOS after exclusion of other endocrine disorders and fulfillment of 2 of the Rotterdam criteria: polycystic changes of the ovaries (PCOM); clinical manifestations of hyperandrogenism and/or hyperandrogenemia; and menstrual abnormalities such as sporadic ovulation or anovulation; (3) Patients with indications for IVF/ICSI‐FET procedure; (4) Hysteroscopy within 12 months did not show significant abnormalities; (5) Patients and their families voluntarily participated in this study, understood the related rights and risks, and signed an informed consent form.

ChiCtr (2024). "A multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of Zishen Yutai Pill on IVF outcomes in young women with expected ovarian hyporesponsiveness (Poseidon Group 3) and explore the mechanism of follicular fluid metabolism." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: intervention:Zishen Yutai Pill treatment+GnRH antagonist protocol;control:GnRH antagonist protocol; CONDITION: infertility PRIMARY OUTCOME: number of oocytes retrieved; SECONDARY OUTCOME: Duration of use of exogenous gonadotropins;total exogenous gonadotropin dose;average daily dose of exogenous gonadotropins;Serum E2 (pg/ml) and P (ng/ml) levels on the trigger day;fertilization number;Number of transferable embryos;Number of top quality embryos (TQE);Mature oocyte rate (M ? oocyte rate);Cycle cancellation rate;positive pregnancy test;implantation rate;clinical pregnancy;Early spontaneous abortion ;threatened abortion;ectopic pregnancy;Multiple pregnancy ;Persistent pregnancy; INCLUSION CRITERIA: (1) Women aged = 20 years old,<35 years old, married and diagnosed as infertile; (2) Planned IVF/ICSI treatment; (3) Low ovarian reserve (anti Mullerian hormone (AMH) levels<1.2 ng/ml and/or antral follicle count (AFC)<5).

ChiCtr (2024). "RCT study on pregnancy outcomes of different timing of thawing and transfer in frozen-thawed single blastocyst transfer cycles." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Control group :LH surge + 7 days thawing transplantation group ;test group:Thawed transplantation 12 hours earlier.; CONDITION: Infertility PRIMARY OUTCOME: Blastocyst implantation rate per transfer cycle; SECONDARY OUTCOME: Ectopic pregnancy rate;HCG positive rate;Clinical pregnancy rate; INCLUSION CRITERIA: (1) Age < 40 years; (2) frozen‐thawed embryo transfer cycles; (3) endometrial preparation protocol for natural cycles or microstimulation cycles; (4) D5/D6 high‐quality single blastocyst transfer cycles without C.

Chidambaram, V., et al. (2022). "A randomised comparative study of sublingual and vaginal misoprostol for cervical priming before minor gynaecological procedures." Journal of Obstetrics and Gynaecology 42(6): 2297-2301.
	This study aimed to compare the effect of misoprostol using vaginal or sublingual routes on the non-pregnant uterine cervix prior to minor gynaecological procedures. One hundred and forty women were randomised 1:1 into two groups: A and B. Group A received misoprostol 400 mcg vaginally and pyridoxine 40 mg sublingually and Group B received misoprostol 400 mcg sublingually and pyridoxine 40 mg vaginally 4 h prior to procedure. The outcomes studied were maximum size of Hegar's dilator that could be inserted into the cervix without any resistance, ease of dilatation, need and time required for further dilatation, side effects and complications. Baseline cervical dilatation was significantly more in Group A than Group B. Need for further dilatation and time required for further dilatation were also significantly less in Group A than Group B. Thus, we conclude that vaginal misoprostol is more effective than sublingual misoprostol in cervical priming before minor gynaecological procedures. Clinical Trial Registration Number:www.ctri.nic.in; CTRI/2018/07/015080 IMPACT STATEMENTWhat is already known on this subject? Cervical priming has been shown to result in shorter operative time, easier mechanical dilatation, reduced incidence of complications and blood loss when used prior to surgical abortion and has been recommended as a standard practice in various national and international guidelines for safe abortion practices. Misoprostol has many advantages over other ripening agents like osmotic dilators, other prostaglandins and mifepristone. Misoprostol can be given through oral, sublingual, vaginal, buccal and rectal routes. Use of misoprostol has been found to improve cervical dilatation, reduce need of further dilatation and ease of dilatation without many complications when compared to placebo for cervical priming of non-pregnant cervix. Studies comparing vaginal and sublingual routes have shown no significant difference for cervical ripening in pregnant women. What the results of this study add? We found that vaginal misoprostol for cervical priming was more effective than sublingual misoprostol in reaching a higher baseline cervical dilatation, with reduced need and time required for further dilatation before minor gynaecological procedures, although the ease of dilatation was similar in both groups. This effect of vaginal misoprostol was more marked in premenopausal women. What the implications are of these findings for clinical practice and/or further research? The results of our study are at variance with other studies done on use of misoprostol via the vaginal or sublingual routes, and hence it is imperative that large multi-center studies be performed to bring about consensus on the topic.Copyright © 2022 Informa UK Limited, trading as Taylor & Francis Group.

Chien, T. J., et al. (2024). "Head-to-Head Comparison of Electroacupuncture and Laser Acupuncture Effects on Autonomic Regulation and Clinical Effects in Dysmenorrhea: A Randomized Crossover Clinical Trial." Journal of Integrative and Complementary Medicine.
	Introduction: Electroacupuncture (EA) has been applied in dysmenorrhea and has shown good efficacy. The mechanisms of EA are associated with autonomic nervous system adjustments and neuroendocrine regulation. Laser acupuncture (LA), however, has been widely investigated for its noninvasiveness. However, it remains uncertain whether LA is as effective as EA. This study aimed to compare EA and LA head to head in dysmenorrhea. Method(s): A crossover, randomized clinical trial was conducted. EA or LA was applied to selected acupuncture points. Participants were randomized into two sequence treatment groups who received either EA or LA twice per week in luteal phase for 3 months followed by 2-month washout, then shifted to other groups (sequence 1: EA > LA; sequence 2: LA > EA). Outcome measures were heart rate variability (HRV), prostaglandins (PGs), pain, and quality-of-life (QoL) assessment (QoL-SF12). We also compared the effect of EA and LA in low and high LF/HF (low frequency/high frequency) status. Result(s): Totally, 43 participants completed all treatments. Both EA and LA significantly improved HRV activity and were effective in reducing pain (Visual Analog Scale [VAS]; EA: p < 0.001 and LA: p = 0.010) and improving QoL (SF12: EA: p < 0.001, LA, p = 0.017); although without intergroup difference. EA reduced PGs significantly (p < 0.001; d p = 0.068). In low LF/HF, EA had stronger effects than LA in increasing parasympathetic tone in respect of percentage of successive RR intervals that differ by more than 50 ms (pNN50; p = 0.053) and very low-frequency band (VLF; p = 0.035). Conclusion(s): There is no significant difference between EA and LA in improving autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea. EA is prominent in PGs changing and preserving vagus tone in low LF/HF; yet LA is noninvasive for those who have needle phobia. Whether LA is equivalent with EA and the mechanism warrants further study. Clinical trial identification number: NCT04178226.Copyright © Mary Ann Liebert, Inc.

Chien, Y., et al. (2021). "Effects of curcuminoids in the treatment of polycystic ovary syndrome: a meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Chien, Y.-J., et al. (2021). "Effects of Curcumin on Glycemic Control and Lipid Profile in Polycystic Ovary Syndrome: Systematic Review with Meta-Analysis and Trial Sequential Analysis." Nutrients 13(2).
	The therapeutic effects of curcumin for polycystic ovary syndrome (PCOS) remain inconclusive. The present study aims to evaluate the effects of curcumin on glycemic control and lipid profile in patients with PCOS. PubMed, Embase, Scopus, Web of Science, and Cochrane Library were searched from the inception through 28 November 2020. Randomized control trials (RCTs), which enrolled adult patients with PCOS, compared curcumin with placebo regarding the glycemic control and lipid profile, and reported sufficient information for performing meta-analysis, were included. Three RCTs were included. Curcumin significantly improves fasting glucose (mean difference (MD): -2.77, 95% confidence interval (CI): -4.16 to -1.38), fasting insulin (MD: -1.33, 95% CI: -2.18 to -0.49), Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) (MD: -0.32, 95% CI: -0.52 to -0.12), and quantitative insulin sensitivity check index (QUICKI) (MD: 0.010, 95% CI: 0.003-0.018). It also significantly improves high-density lipoprotein (MD: 1.92, 95% CI: 0.33-3.51) and total cholesterol (MD: -12.45, 95% CI: -22.05 to -2.85). In contrast, there is no statistically significant difference in the improvement in low-density lipoprotein (MD: -6.02, 95% CI: -26.66 to 14.62) and triglyceride (MD: 8.22, 95% CI: -26.10 to 42.53) between curcumin and placebo. The results of the fasting glucose, fasting insulin, HOMA-IR, QUICKI, and total cholesterol are conclusive as indicated by the trial sequential analysis. Curcumin may improve glycemic control and lipid metabolism in patients with PCOS and metabolic abnormality without significant adverse effects. Further studies are advocated to investigate the potential effects of curcumin on hyperandrogenism.

Chiengthong, K., et al. (2022). "Effect of vaginal estrogen in postmenopausal women using vaginal pessary for pelvic organ prolapse treatment: a randomized controlled trial." International Urogynecology Journal 33(7): 1833-1838.
	Introduction and Hypothesis: Evidence and recommendations for the use of intravaginal estrogen for prevention of bacterial vaginosis and pessary-related complications are limited and controversial. We hypothesized that adding intravaginal estrogen to pessary use would decrease the incidence of bacterial vaginosis and other pessary-related complications.; Methods: A single-center, open-label, randomized, parallel study was conducted between April 2018 and August 2020. Participants were randomized to either receive intravaginal estriol 0.03 mg plus Lactobacillus acidophilus 100 million viable cell vaginal tablets or have no treatment. The Amsel criteria, normal flora index, visual analog scale, Thai version of the ICIQ-VS (International Consultation on Incontinence Questionnaire-Vaginal symptoms) questionnaire, vaginal abrasions and vaginal bleeding were evaluated at entry and at 2- and 14-week follow-up.; Results: Seventy-eight women were included and randomized to two groups (39 women per group). At 2-week follow-up, one participant in the intervention group and two participants in the control group were diagnosed with bacterial vaginosis (2.7% vs. 5.7%, p = 0.609). At 14-week follow-up, two participants in the intervention group and two participants in the control group were diagnosed with bacterial vaginosis (5.7% vs. 6.2%, p = 0.926). Normal flora index was significantly different at 2-week follow-up [8 (6.3) vs. 5 (6.0), p = 0.032]. There was no significant difference in the visual analog scale, Thai version of the ICIQ-VS, vaginal abrasions and vaginal bleeding between the 2- and 14-week follow-ups.; Conclusions: This study shows no benefit of intravaginal estrogen in reducing bacterial vaginosis, vaginal abrasions, vaginal bleeding and pain in postmenopausal women using a vaginal pessary for pelvic organ prolapse treatment. (© 2021. The International Urogynecological Association.)

Chihara, D., et al. (2022). "Early drug development in solid tumours: analysis of National Cancer Institute-sponsored phase 1 trials." Lancet (London, England) 400(10351): 512-521.
	Background: The low expectation of clinical benefit from phase 1 cancer therapeutics trials might negatively affect patient and physician participation, study reimbursement, and slow the progress of oncology research. Advances in cancer drug development, meanwhile, might have favourably improved treatment responses; however, little comprehensive data exist describing the response and toxicity associated with phase 1 trials across solid tumours. The aim of the study is to evaluate the trend of toxicity and response in phase 1 trials for solid tumours over time.; Methods: We analysed patient-level data from the Cancer Therapy Evaluation Program of the National Cancer Institute-sponsored investigator-initiated phase 1 trials for solid tumours, from Jan 1, 2000, to May 31, 2019. We assessed risks of treatment-related death (grade 5 toxicity ratings possibly, probably, or definitely attributable to treatment), all on-treatment deaths (deaths during protocol treatment regardless of attribution), grade 3-4 toxicity, and proportion of overall response (complete response and partial response) and complete response rate in the study periods of 2000-05, 2006-12, and 2013-2019, and evaluated their trends over time. We also analysed cancer type-specific and investigational agent-specific response, and analysed the trend of response in each cancer type over time. Univariate associations of overall response rates with patients' baseline characteristics (age, sex, performance status, BMI, albumin concentration, and haemoglobin concentration), enrolment period, investigational agents, and trial design were assessed using risk ratio based on the modified Poisson regression model.; Findings: We analysed 465 protocols that enrolled 13 847 patients using 261 agents. 144 (31%) trials used a monotherapy and 321 (69%) used combination therapies. The overall treatment-related death rate was 0·7% (95% CI 0·5-0·8) across all periods. Risks of treatment-related deaths did not change over time (p=0·52). All on-treatment death risk during the study period was 8·0% (95% CI 7·6-8·5). The most common grade 3-4 adverse events were haematological; grade 3-4 neutropenia occurred in 2336 (16·9%) of 13 847 patients, lymphopenia in 1230 (8·9%), anaemia in 894 (6·5%), and thrombocytopenia in 979 (7·1%). The overall response rate for all trials during the study period was 12·2% (95% CI 11·5-12·8; 1133 of 9325 patients) and complete response rate was 2·7% (2·4-3·0; 249 of 9325). Overall response increased from 9·6% (95% CI 8·7-10·6) in 2000-05 to 18·0% (15·7-20·5) in 2013-19, and complete response rates from 2·5% (2·0-3·0) to 4·3% (3·2-5·7). Overall response rates for combination therapy were substantially higher than for monotherapy (15·8% [15·0-16·8] vs 3·5% [2·8-4·2]). The overall response by class of agents differed across diseases. Anti-angiogenesis agents were associated with higher overall response rate for bladder, colon, kidney and ovarian cancer. DNA repair inhibitors were associated with higher overall response rate in ovarian and pancreatic cancer. The rates of overall response over time differed markedly by disease; there were notable improvements in bladder, breast, and kidney cancer and melanoma, but no change in the low response of pancreatic and colon cancer.; Interpretation: During the past 20 years, the response rate in phase 1 trials nearly doubled without an increase in the treatment-related death rate. However, there is significant heterogeneity in overall response by various factors such as cancer type, investigational agent, and trial design. Therefore, informed decision making is crucial for patients before participating in phase 1 trials. This study provides updated encouraging outcomes of modern phase 1 trials in solid tumours.; Funding: National Cancer Institute.; Competing Interests: Declaration of interests RL has served as a consultant for Monte Rosa Therapeutics. CRF has served as a consultant for AbbVie, AstraZeneca, Bayer, BeiGene, Bristol Meyers Sqibb/Celgene, Denovo Biopharma, Genen ech/Roche Pharma, Genmab, Gilead Sciences, Karyopharm Therapeutics, Morphosys, Pharmacyclics/Janssen, Seagen, and Spectrum Pharmaceuticals; and has received research funding paid to the institution from 4D, AbbVie, Acerta Pharma, Adaptimmune, Allogene Therapeutics, Amgen, Bayer, Celgene, Cellectis, EMD, Gilead Sciences, Genentech/Roche, Guardant, Iovance Biotherapeutics, Janssen, Kite Pharma, MorphoSys, Nektar Therapeutics, Novartis, Pfizer, Pharmacyclics, Sanofi, Takeda, TG Therapeutics, Xencor, Ziopharm, Burroughs Wellcome Fund, Eastern Cooperative Oncology Group, National Cancer Institute, V Foundation for Cancer Research, and the Cancer Prevention and Research Institute of Texas where he is a CPRIT Scholar in Cancer Research. LJN has received research support from BMS/Celgene, Caribou Biosciences, Epizyme, Genentech, Gilead/Kite, IGM Biosciences, Janssen, Novartis, Takeda, and TG Therapeutics; and has served as consultant for ADC Therapeutics, Bayer, BMS/Celgene, Epizyme, Genentech, Gilead/Kite, Janssen, Morphosys, Novartis, Takeda, and TG Therapeutics. All other authors declare no competing interests. (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Child, T. J., et al. (2021). "A RANDOMISED CONTROLLED BLINDED TRIAL ASSESSING THE EFFECTIVENESS OF EMBRYOGLUE AS AN EMBRYO TRANSFER MEDIUM IN IVF CYCLES." Fertility and Sterility 116(3): e4.
	Objective: To assess if the use of a hyaluronin‐enriched embryo transfer medium [EmbryoGlue (Vitrolife, Sweden)] results in higher live birth rates in IVF cycles compared to standard transfer medium. Materials and Methods: A single centre randomised controlled blinded study recruiting patients between 2017 and 2019. The study included women aged 18 ‐ 45 years having fresh or frozen transfer of 1‐2 cleavage stage embryos or blastocysts. Sample size: Based on the unit’s average live birth rate per embryo transfer in all patients of 32%, to show an increase in the live birth rate to 42% with power of 80% and significance at 5%, 730 patients were required. 10% live birth increase based on published RCT data. Fresh IVF patients had a long agonist or short antagonist protocol. Ovarian stimulation achieved with Gonal‐F or Menopur. IVF or ICSI used as required and embryos cultured individually in Sydney IVF sequential media (COOK Medical, Sydney) overlaid with SAGE Oil (Origio, Denmark). For frozen transfers endometrial preparation was achieved with a natural or medicated (estrogen and GnRH antagonist plus vaginal progesterone) regime. Up to two cleavage stage embryos or blastocysts transferred trans‐cervically using a Wallace Sureview catheter under abdominal ultrasound scan guidance. After consent, patients were randomised using sealed, numbered opaque envelopes. The patient, and the clinician performing the ET were blinded as to study group. Unblinding could occur when the cycle outcome was known (live birth or failed cycle). For statistical analysis, the Chi‐square, Fisher's exact, and Student T tests were used as appropriate. For patients randomised to EmbryoGlue the manufacturer’s instructions were followed with embryos placed in warmed and pre‐equilibrated EmbryoGlue for 10 to 30 minutes before transfer. For patients randomised to the control group embryos were placed in warmed, pre‐equilibrated COOK culture media. Dishes were not overlayed with oil. Results: 731 women were randomised to Group A (standard media) or Group B (EmbryoGlue). There were no differences in patient characteristics between the two groups. Following randomisation, 50 patients did not have ET mostly due to development of OHSS symptoms requiring freeze‐all in a fresh cycle. On an ITT basis the live birth rate per cycle was 37.5% (137/365) vs 35.7% (131/366) (p=NS) and on a per‐protocol (ie actually having ET) 40.5% (137/338) vs 38.2% (131/343) (p=NS) in Groups A and B respectively. There was no statistical difference in live birth rate between the standard or EmbryoGlue culture groups when comparing fresh vs frozen, and cleavage or blastocyst stage transfers. There was no difference in implantation, miscarriage, ectopic or multiple pregnancy rates between the study groups. Conclusions: There is no improvement in live birth rate with the use of a hyaluronin‐enriched embryo transfer medium such as EmbryoGlue during IVF treatment cycles. Impact Statement: In a randomised, controlled, blinded and suitably powered study performed in an academic IVF unit the use of a hyaluronin‐enriched embryo transfer medium (EmbryGlue) did not improve IVF outcome.

Chilimoniuk, Z., et al. (2022). "Molecular methods for increasing the effectiveness of ovarian cancer treatment: a systematic review." Future oncology (London, England) 18(13): 1627-1650.
	Background: The aim of the current study is to analyze and summarize the latest research on improving therapy in ovarian cancer. Materials & methods: Data analysis was based on a review of publications from 2011 to 2021 in the PubMed database with use of the search terms including 'EGFR ovarian cancer', 'folate receptor inhibitors ovarian cancer', 'VEGF ovarian cancer', 'PDGF ovarian cancer' and 'CTLA-4 ovarian cancer'. Results: 6643 articles were found; 238 clinical trials and randomized control trials were analyzed; 122 studies were rejected due to inconsistency with the topic of the work. Conclusion: Extensive research on the treatment of ovarian cancer increases the chance of developing the most effective therapy suited to the individual needs of the patient.

Chin, C. and S. Damast (2022). "Radiation therapy in the definitive management of medically inoperable endometrial cancer." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 32(3): 323-331.
	The incidence of endometrial cancer continues to increase worldwide with growing life expectancy and rates of obesity. While endometrial cancer is primarily a surgical disease managed with hysterectomy, a small proportion of patients are deemed to be poor surgical candidates due to their co-morbidities. These medically inoperable patients should be considered for curative treatment with definitive radiation therapy, and brachytherapy is an integral component of their care. Referral to a high-volume center early on in the care of potentially inoperable patients is crucial to optimize their management. These patients should be evaluated by a high-risk surgical and anesthesia team to confirm their medical inoperability. For inoperable patients, use of image-guided brachytherapy is encouraged. Brachytherapy applicator selection is determined based on a patient's anatomy, uterine size, and extent of tumor. Advances in anatomic and functional imaging including multiparametric magnetic resonance imaging (MRI) have improved clinical staging of these patients and have also allowed for the delivery of three-dimensional image-guided brachytherapy with improved accuracy. With recent consensus guidelines to guide local computed tomography and/or MRI volume-based delineation of targets and organs-at-risk, local outcomes have improved and treatments are delivered with less acute and late morbidity. Ongoing trials are looking at novel systemic agents, such as immunotherapy, to induce a systemic anti-tumor immune response and improve outcomes in these patients.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Ching, H., et al. (2023). "The effectiveness of technology-based cognitive behavioral therapy on perinatal depression and anxiety: A systematic review and meta-analysis." Worldviews on Evidence-based Nursing 20(5): 451-464.
	BACKGROUND: Extensive literature has shown the effectiveness of cognitive behavioral therapy in treating perinatal depression, but little is known about the effectiveness of its technology-based version. AIM: The aim of this review was to examine the effectiveness of technology-based cognitive behavioral therapy in reducing depressive and anxiety symptoms in women suffering from or at risk of experiencing perinatal depression. METHOD(S): Six electronic databases were searched until February 2023 for articles published in English. Random-effect meta-analyses were conducted. Heterogeneity was assessed using the I2 statistics and Cochran's Q chi-squared test. Sensitivity analyses and subgroup analyses were also performed, and quality appraisals at the study and outcome levels were conducted. RESULT(S): A total of 16 randomized controlled trials were included in the review. Results from meta-analyses suggest that technology-based cognitive behavioral therapy has a medium effect in reducing perinatal depressive symptoms and a small effect in reducing perinatal anxiety symptoms. Overall, women suffering from or at risk of perinatal depression may benefit from technology-based cognitive behavioral therapy. LINKING EVIDENCE TO ACTION: Future interventions can be improved by addressing both perinatal depression and anxiety, paying more attention to antenatal women to prevent postnatal mental health issues, and using self-guided mobile applications for accessibility.Copyright © 2023 Sigma Theta Tau International.

Chinthakanan, O., et al. (2022). "Rate of postoperative urinary retention after anterior compartment prolapse surgery, comparing early versus conventional transurethral catheter removal: a randomized controlled trial." International Urogynecology Journal 33(Supplement 1): S61-S62.
	Introduction: Indwelling transurethral catheter is required to prevent postoperative urinary retention after prolapse surgery. To minimize risk of urinary retention and patient's discomfort, the catheter should be removed as soon as possible. Objective(s): The objective was to compare the rate of postoperative urinary retention (POUR) after anterior prolapse surgery in an early transurethral catheter removal (24 hours post-operative) and our standard practice of postoperative day 3. Method(s): A randomized controlled study was conducted, patients undergoing anterior compartment prolapse surgery between March of 2020 and February of 2021 in a university hospital. Women were randomized into two groups. In an early and conventional group transurethral catheter was removed on 24 hours post-operative and 3 postoperative days, respectively. After removal, if the second void residual urine volume exceeded 150 ml, POUR was diagnosed and intermittent catheterization was performed (Figure 1 and 2). The primary outcome was the rate of POUR. The secondary outcomes included urinary tract infection (UTI), asymptomatic bacteriuria (AB), time to ambulation, time to spontaneous void, length of hospitalization and patient satisfaction using Patient Global Impression Scale of Improvement (PGI-I). Result(s): A total of 68 women consented. Groups had similar baseline characteristics. The average age was 66.7+/-9.94 years old. There were no statistically significant differences in baseline characteristic (Table 1). Majority of patients underwent anterior colporrhaphy or colpocleisis. There were no differences in terms of intraoperative blood loss, operative time, anesthetic modalities, opioid use, and complications (Table 2). Intention-to-treat analysis (n=68), the overall POUR rate was 31.2%. The POUR rate of the conventional group was 18.2% higher than the early removal group; however, it was not statistically significant. (32.4% vs. 26.5%, RR = 0.82; 95% CI:0.39-1.72). There was no significant difference between groups in terms of postoperative AB rate (14.7 vs 0%, p = 0.05). There was no postoperative UTI developed. In the early removal group, there are shorter lengths of hospital stay (1 day vs. 3 days) and 3.8hours earlier in time to ambulation (p = 0.2), without significant differences in postoperative patient satisfaction. The mean PGI-I were similar in both groups,(p = 0.58), mostly reported "much better"(Table 3). Even though patients experienced POUR, they were still satisfied with the outcome ( 80% vs 87.5% in POUR and non-POUR patients; p = 0.465, respectively). Conclusion(s): Among patients undergoing anterior compartment prolapse surgery with or without concomitant surgery, the early removal group is comparable in POUR rate to conventional group. There is a lesser chance of development of urinary tract infection and shorter length of hospitalization. Therefore, early transurethral catheter removal is preferable following anterior compartment prolapse surgery.

Chiofalo, B., et al. (2019). "Primary debulking surgery vs. interval debulking surgery for advanced ovarian cancer: review of the literature and meta-analysis." Minerva Medica 110(4): 330-340.
	Introduction: Epithelial ovarian cancer (EOC) is the seventh most common cancer among women in the world and the leading cause of death from gynecological malignancies. The standard treatment for advanced EOC consists of optimal primary debulking surgery (PDS) associated with an adjuvant chemotherapy. Neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS) have been proposed in the management of advanced EOC to increase the rate of complete citoreductive surgery and to reduce morbidity and mortality. This systematic review and meta-analysis is conducted to compare the oncologic and postoperative outcomes of NACT and IDS with PDS followed by chemotherapy in patients with ovarian cancer.; Evidence Acquisition: We conducted a search on the electronic databases PubMed/Medline, Cochrane and Scopus. All randomized controlled trials, cohort and case-control studies comparing PDS and IDS in ovarian cancer published in English until 28 February 2019 were considered eligible.; Evidence Synthesis: Twenty studies were included in the systematic review. As regards the meta-analysis, only studies that allowed the data we needed to be extracted were included: five were included for the evaluation of overall survival (OS) and PFS and 9 for the evaluation of major postoperative complications and days of hospital stay.; Conclusions: From the meta-analysis of the current available literature, none of the two investigated procedures has proven to be superior in terms of OS and PFS in the treatment of advanced ovarian cancer. However surgical complexity and postoperative complications are reduced in the IDS group.

Chiou, Y., et al. (2023). "Effect of Perioperative Immunonutrition Intervention Among Gynecological Cancer Patients: A Systematic Review."
	
Chiu, C.-C., et al. (2022). "Maintenance Therapy for Preventing Endometrioma Recurrence after Endometriosis Resection Surgery - A Systematic Review and Network Meta-analysis." Journal of Minimally Invasive Gynecology 29(5): 602-612.
	Objective: To evaluate the efficacy of different hormone therapies in preventing postoperative endometrioma recurrence.; Data Sources: The MEDLINE, COCHRANE, and Embase electronic databases were searched from inception to 30 April 2021.; Methods of Study Selection: Randomized controlled trials (RCTs) or cohort studies including reproductive age women with endometriosis undergoing ovarian cystectomy or excision of endometriotic lesions compared the effects of postoperative adjuvant therapy (gonadotropin-releasing hormone agonist [GnRHa]) and postoperative maintenance hormone interventions for more than 1 year (i.e., oral contraceptive pills [OCPs], dienogest [DNG], levonorgestrel-releasing intrauterine system [LNGIUS]) on endometrioma recurrence.; Tabulation, Integration, and Results: Data collection and analysis of the data were independently performed 2 two reviewers. A total of 11 studies were included, of which 2 were RCTs, and 9 were cohort studies. There were 2394 patients with 6 interventions (cases: 1665, 69.6%) and expectant management (cases: 729, 30.4%). Relative treatment effects were estimated using network meta-analysis and ranked in descending order. The clinical effectiveness of these drugs (vs expectant management) was as follows: GnRHa plus DNG (odds ratio [OR], 0.04; 95% confidence interval [CI], 0.01-0.27), surface under the cumulative ranking (SUCRA) = 94.0; DNG (OR, 0.11; 95% CI, 0.04-0.32), SUCRA = 69.7; GnRHa plus OCP (OR, 0.12; 95% CI, 0.02-0.64), SUCRA = 63.4; GnRHa plus LNGIUS (OR, 0.13; 95% CI, 0.03-0.66), SUCRA = 59.4; and OCP (OR, 0.21; 95% CI, 0.13-0.36), SUCRA = 43.6. The effectiveness of GnRHa (OR, 0.47; 95% CI, 0.12-1.89), SUCRA = 17.3 was not significantly different from that of controls.; Conclusion: In network meta-analysis, combined postoperative adjuvant therapy and longer maintenance hormone treatment are better than a single agent in preventing postoperative endometrioma recurrence. GnRHa plus DNG maintenance treatment might be the most effective intervention. Large-scale RCTs of these agents are still required. (Copyright © 2022 AAGL. Published by Elsevier Inc. All rights reserved.)

Chiyoda, T., et al. (2020). "Lymphadenectomy for primary ovarian cancer: a systematic review and meta-analysis." Journal of Gynecologic Oncology 31(5): e67.
	Objective: To assess the effectiveness of lymphadenectomy at primary debulking surgery (PDS) on the survival of patients with epithelial ovarian cancer (EOC).; Methods: We searched PubMed, Ichushi, and the Cochrane Library. Randomized controlled trials (RCTs) and retrospective cohort studies comparing survival of women with EOC undergoing lymphadenectomy at PDS with that of women without lymphadenectomy were included. We performed a meta-analysis of overall survival (OS), progression-free survival (PFS), and adverse events.; Results: For advanced-stage EOC, 2 RCTs including 1,074 women and 7 cohort studies comprising 3,161 women were evaluated. Meta-analysis revealed that lymphadenectomy was associated with improved OS (hazard ratio [HR]=0.80; 95% confidence interval [CI]=0.70-0.90). However, meta-analysis of 2 RCTs revealed no significant difference in OS between the lymphadenectomy and no-lymphadenectomy groups (OS: HR=1.02; 95% CI=0.85-1.22). For early-stage EOC, 1 RCT comprising 268 women and 4 cohort studies comprising 14,228 women were evaluated. Meta-analysis showed that lymphadenectomy was associated with improved OS (HR=0.75; 95% CI=0.68-0.82). A RCT of early-stage EOC reported that lymphadenectomy was not associated with improved OS (HR=0.85; 95% CI=0.49-1.47). Surgery-related deaths were similar in both groups (risk ratio [RR]=1.00; 95% CI=0.99-1.01); however, blood transfusion was required less frequently in the no-lymphadenectomy group (RR=0.74; 95% CI=0.63-0.86).; Conclusions: Meta-analysis of RCTs and observational studies suggest that lymphadenectomy was associated with improved OS in advanced- and early-stage EOC. However, results from RCTs demonstrate that lymphadenectomy was not associated with improved OS in advanced- and early-stage EOC.; Competing Interests: No potential conflict of interest relevant to this article was reported. (Copyright © 2020. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology.)

Chiyoda, T., et al. (2022). "Sentinel node navigation surgery in cervical cancer: a systematic review and metaanalysis." International Journal of Clinical Oncology 27(8): 1247-1255.
	Sentinel node navigation surgery (SNNS) is used in clinical practice for the treatment of cervical cancer. This study aimed to elucidate the appropriate sentinel lymph node (SLN) mapping method and assess the safety and benefits of SNNS. We searched the PubMed, Ichushi, and Cochrane Library databases for randomized controlled trials (RCT) and studies on SLN in cervical cancer from January 2012 to December 2020. Two authors independently assessed study quality and extracted data. We quantitatively analyzed the detection rate, sensitivity/specificity, and complications and reviewed information, including the survival data of SLN biopsy (SLNB) without pelvic lymphadenectomy (PLND). The detection rate of SLN mapping in the unilateral pelvis was median 95.7% and 100% and in the bilateral pelvis was median 80.4% and 90% for technetium-99 m (Tc) with/without blue dye (Tc w/wo BD) and indocyanine green (ICG) alone, respectively. The sensitivity and specificity of each tracer were high; the area under the curve of each tracer was 0.988 (Tc w/wo BD), 0.931 (BD w/wo Tc), 0.966 (ICG), and 0.977 (carbon nanoparticle). Morbidities including lymphedema, neurological symptoms and blood loss were associated with PLND. One RCT and five studies all showed SNNS without systematic PLND does not impair recurrence or survival in early-stage cervical cancer with a tumor size ≤ 2-4 cm. Both Tc w/wo BD and ICG are appropriate SLN tracers. SNNS can reduce the morbidities associated with PLND without affecting disease progression in early-stage cervical cancer. (© 2022. The Author(s) under exclusive licence to Japan Society of Clinical Oncology.)

Chloe, S., et al. (2023). "A systematic review and meta-analysis investigating the efficacy of intravenous immunoglobulin therapy in the treatment of secondary recurrent miscarriage."
	
Cho, J. S., et al. (2021). "Effects of Perioperative Dexmedetomidine on Immunomodulation in Uterine Cancer Surgery: A Randomized, Controlled Trial." Frontiers in Oncology 11: 749003.
	OBJECTIVE: Dexmedetomidine has sympatholytic, anti-inflammatory, and analgesic effects and may exert anti-tumor effect by acting on α2A adrenoreceptor. We investigated whether perioperative dexmedetomidine preserves immune function in patients undergoing uterine cancer surgery. METHODS: One hundred patients were randomly assigned to the control or dexmedetomidine groups (50 patients each). Dexmedetomidine was infused at rates of 0.4 μg/kg/h intraoperatively and 0.15 μg/kg/h during the first 24 h postoperatively. The primary outcome was natural killer (NK) cell activity, which was measured preoperatively and 1, 3, and 5 days postoperatively. The inflammatory response was measured by interleukin-6, interferon-γ, and neutrophil/lymphocyte ratio, and pain scores and opioid consumption were assessed. Cancer recurrence or metastasis and death were evaluated 2 years postoperatively. RESULTS: NK cell activity decreased postoperatively in both groups and changes over time were not different between groups (P=0.496). Interferon-γ increased postoperatively in the dexmedetomidine group, whereas it maintained at the baseline value in the control group. Change in interferon-γ differed significantly between groups (P=0.003). Changes in interleukin-6 and neutrophil-lymphocyte ratio were comparable between groups. Both pain score with activity during the first 1 h and opioid consumption during the first 1-24 h postoperatively were lower in the dexmedetomidine group. Rates of cancer recurrence/metastasis (16.3% vs. 8.7%, P=0.227) and death within 2 years postoperatively (6.7% vs. 2.2%, P=0.318) were not different between groups. CONCLUSIONS: Perioperative dexmedetomidine had no favorable impacts on NK cell activity, inflammatory responses, or prognosis, whereas it increased interferon-γ and reduced early postoperative pain severity and opioid consumption in uterine cancer surgery patients.

Cho, K. and M. Kim (2023). "Effects of aromatherapy on depression: A meta-analysis of randomized controlled trials." General Hospital Psychiatry 84: 215-225.
	Objective: Non-pharmacological interventions, such as aromatherapy, have been utilized for treating depression. This systematic review and meta-analysis aimed to investigate the effects of aromatherapy on depressive symptoms.; Method: The databases of PubMed, MEDLINE, CINAHL, EMBASE, Web of Science, and the Cochrane Library were searched from May 5, 2023, to May 20, 2023. Only randomized controlled trials that implemented aromatherapy in adults aged ≥18 years were included. The standardized mean difference (SMD) was calculated, and subgroup analysis, meta-ANOVA, and meta-regression were performed for the moderator variables.; Results: Thirty-two clinical trials (27 studies) were included in the final analysis. Aromatherapy demonstrated a moderate effect size for reducing depressive symptoms (SMD = -0.56, 95% CI: -0.69 to -0.43). Inhalation was the most effective method of delivery and blended essential oils were more effective than lavender or other single essential oils. Aromatherapy demonstrated a moderate effect size for reducing depressive symptoms among menopausal women, patients with heart disease (coronary artery disease or acute coronary syndrome), and psychological illnesses. However, it demonstrated no effect on postpartum or pregnant women. Mean age was a significant moderator variable.; Conclusions: Reliable evidence is present for the application of aromatherapy to reduce depressive symptoms, and it can be utilized effectively to decrease depressive symptoms.; Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Choi, S.-J. and D.-I. Kim (2019). "To evaluate the efficacy and safety of PLC in perimenopausal or postmenopausal women with Hot Flashes: study protocol for a randomized controlled trial." Trials 20(1): 415.
	Background: Hot flashes are the most frequent symptoms of the menopause, with 10-20% of all postmenopausal women reporting nearly intolerable occurrences. Although pharmacopuncture with hominis placenta extract is one of the new acupuncture therapies popular in East Asian medicine with a known efficacy in treating facial flushing, there has been little research on the efficacy and safety of this extract. This study, therefore, aims to evaluate the efficacy and safety of pharmacopuncture with hominis placenta extract (PLC) compared to injections of normal saline, in perimenopausal and postmenopausal women in Korea.; Methods/design: This study is a randomized placebo-controlled single-blind multi-center parallel-design trial. In total, 128 perimenopausal or postmenopausal women who meet the inclusion criteria will be recruited. The treatment group will receive PLC pharmacopuncture twice a week, for a total of 18 sessions over 9 weeks. The control group will receive injections of normal saline at the same acupoints during the same period. The post-treatment follow-up assessment will occur 4 weeks after the participant has completed the treatment.; Discussion: We believe that this trial will provide evidence for the efficacy and safety of PLC pharmacopuncture as a treatment for hot flashes in perimenopausal and postmenopausal women.; Trial Registration: Clinical Research Information Service (CRIS), Republic of Korea, ID: KCT0003533 , Registered on 20 February 2019.

Choi, W., et al. (2023). "Phase 1 trial of 4-1BB-based adoptive T-cell therapy targeting human telomerase reverse transcriptase in patients with advanced refractory solid tumors." Cytotherapy 25(11): 1236-1241.
	Background aims: Human telomerase reverse transcriptase (hTERT) is an attractive target for anti-cancer therapies. We developed an effective method for generating hTERT-specific CD8+ T cells (hTERT-induced natural T cells [TERTiNTs]) using peripheral blood mononuclear cells (PBMCs) from patients with solid cancers and investigated their feasibility and safety. Method(s): This was a single-center phase 1 trial using a 3 + 3 dose escalation design to evaluate six dose levels of TERTiNTs. PBMCs from each patient were screened using an hTERT peptide panel to select those that stimulated CD8+ T cells. The four most stimulatory peptides were used to produce autologous CD8+ T cells from patients refractory or intolerant to standard therapies. Eligible patients received a single intravenous infusion of TERTiNTs at different dose levels (4 x 108 cells/m2, 8 x 108 cells/m2 and 16 x 108 cells/m2). Pre-conditioning chemotherapy, including cyclophosphamide alone or in combination with fludarabine, was administered to induce lymphodepletion. Result(s): From January 2014 to October 2019, a total of 24 patients with a median of three prior lines of therapy were enrolled. The most common adverse events were lymphopenia (79.2%), nausea (58.3%) and neutropenia (54.2%), mostly caused by pre-conditioning chemotherapy. The TERTiNT infusion was well tolerated, and dose-limiting toxicities were not observed. None of the patients showed objective responses. Seven patients (30.4%) achieved stable disease with a median progression-free survival of 3.9 months (range, 3.2-11.3). At the highest dose level (16 x 108 cells/m2), four of five patients showed disease stabilization. Conclusion(s): The generation of TERTiNTs was feasible and safe and provided an interesting disease control rate in heavily pre-treated cancer patients.Copyright © 2023 International Society for Cell & Gene Therapy

Chopra, S., et al. (2021). "Late Toxicity After Adjuvant Conventional Radiation Versus Image-Guided Intensity-Modulated Radiotherapy for Cervical Cancer (PARCER): A Randomized Controlled Trial." Journal of clinical oncology : official journal of the American Society of Clinical Oncology 39(33): 3682-3692.
	PURPOSE: Postoperative Adjuvant Radiation in Cervical Cancer (PARCER), a phase III randomized trial, compared late toxicity after image-guided intensity-modulated radiotherapy (IG-IMRT) with three-dimensional conformal radiation therapy (3D-CRT) in women with cervical cancer undergoing postoperative radiation. METHODS: Patients were randomly assigned to receive either IG-IMRT or 3D-CRT after stratification for the type of hysterectomy and use of concurrent chemotherapy. The primary end point was 3-year grade ≥ 2 late GI toxicity assessed using Common Toxicity Criteria for Adverse Events v 3.0 and estimated using time-to-event, intention-to-treat analysis, with a study level type I error of 0.05 and a nominal α of .047 after accounting for one interim analysis. Secondary end points included acute toxicity, health-related quality of life, and pelvic relapse-free, disease-free, and overall survival. RESULTS: Between 2011 and 2019, 300 patients were randomly assigned (IG-IMRT 151 and 3D-CRT 149). At a median follow-up of 46 (interquartile range, 20-72) months, the 3-year cumulative incidence of grade ≥ 2 late GI toxicity in the IG-IMRT and 3D-CRT arms were 21.1% versus 42.4% (hazard ratio [HR] 0.46; 95% CI, 0.29 to 0.73; P < .001). The cumulative incidence of grade ≥ 2 any late toxicity was 28.1% versus 48.9% (HR 0.50; 95% CI, 0.33 to 0.76; P < .001), respectively. Patients reported reduced diarrhea (P = .04), improved appetite (P = .008), and lesser bowel symptoms (P = .002) with IG-IMRT. However, no difference was observed in the time by treatment interaction. The 3-year pelvic relapse-free survival and disease-free survival in the IG-IMRT versus the 3D-CRT arm were 81.8% versus 84% (HR 1.17; 95% CI, 0.68 to 1.99; P = .55) and 76.9% versus 81.2% (HR 1.03; 95% CI, 0.62 to 1.71; P = .89), respectively. CONCLUSION: IG-IMRT results in reduced toxicity with no difference in disease outcomes.

Chou, H. H., et al. (2021). "Postoperative adjuvant dose-dense chemotherapy with bevacizumab and maintenance bevacizumab after neoadjuvant chemotherapy for advanced ovarian cancer: a phase II AGOG/TGOG trial." European Journal of Obstetrics, Gynecology, and Reproductive Biology 262: 13‐20.
	OBJECTIVE: The objective of this study is to evaluate the safety and efficacy of adding bevacizumab to dose‐dense adjuvant chemotherapy with bevacizumab maintenance after neoadjuvant chemotherapy (NAC) and interval debulking surgery (IDS) for stage III/IV ovarian, tubal, and primary peritoneal cancer. STUDY DESIGN: This phase II clinical trial using Simon's minimax two‐stage design was conducted. At the first stage, 13 subjects were enrolled, and the trial would proceed to second stage if ≤3 subjects discontinued treatment for study‐defined significant adverse events (AEs). Patients with stage III/IV ovarian, tubal, and primary peritoneal cancer deemed not feasible for primary cytoreductive surgery were enrolled after 3‐4 cycles of NAC and IDS without disease progression. NAC could be either weekly paclitaxel (80 mg/m2) (dose‐dense) plus 3‐weekly carboplatin (AUC5‐6) or 3‐weekly conventional schedule. After IDS, postoperative dose‐dense adjuvant chemotherapy for 3 cycles at least (best to 6 cycles), and 3‐weekly bevacizumab 15 mg/kg was given since postoperative cycle 2. Further 3‐weekly maintenance bevacizumab 15 mg/kg was given intravenously for 17 cycles. RESULTS: Of the 22 enrolled subjects, 13 (59.1 %) had no gross lesion after IDS. Of the 13 subjects enrolled on the 1 st stage, one study‐defined significant AE occurred, therefore the trial proceeded to the 2nd stage (n = 9). The median progression‐free survival (PFS) was 22.1 months (95 % confidence interval [CI], 13.7‐30.5), and the median overall survival (OS) was 49.2 months (95 % CI, 33.8‐64.6). Peritoneal Cancer Index score at entering abdomen during IDS was significant for PFS (>12 vs ≤ 12: p = 0.003). One of the 22 subjects did not receive any study treatment. In the safety analysis (n = 21), grade 3/4 AEs included thrombocytopenia of 38.1 %, neutropenia 71.4 %, and anemia 28.6 %. Study‐defined significant AEs of bowel perforation, poor‐healing wound, and hypertension were found in 1 case each, respectively. CONCLUSION: This phase II trial demonstrated adding bevacizumab to dose‐dense adjuvant chemotherapy with bevacizumab maintenance after NAC was feasible with tolerable toxicity and comparable PFS/OS as compared to other studies using bevacizumab in the NAC phase or dose‐dense scheduling throughout.

Choudhary, N., et al. (2022). "Hypericin and its anticancer effects: From mechanism of action to potential therapeutic application." Phytomedicine : international journal of phytotherapy and phytopharmacology 105: 154356.
	Background: Emerging studies indicate that hypericin has diverse pharmacological actions and exhibits potential for treatment of various types of cancer.; Purpose: The current review evaluates the pharmacological activity, associated molecular mechanism, and therapeutic application of hypericin as an anticancer agent according to the most recent state of knowledge with special emphasis on clinical trials and safety profile.; Method: This review follows The Preferred Reporting Items for Systematic Reviews criteria. Various databases, including PubMed, Scopus and Science Direct, were used to search and collect relevant literature. The major keywords used included the following: cancer, distribution, property, signaling pathway, pharmacological effect, treatment, prevention, in vitro and in vivo studies, toxicity, bioavailability, and clinical trials.; Results: One hundred three articles met the established inclusion and exclusion criteria. Hypericin has shown anticancer activity against the expansion of several cell types including breast cancer, cervical cancer, colorectal cancer, colon cancer, hepatocellular carcinoma, stomach carcinoma, leukemia, lung cancer, melanoma, and glioblastoma cancer. Hypericin exerts its anticancer activity by inhibiting pro-inflammatory mediators, endothelial growth factor, fibroblast growth factor, cell adhesion, angiogenesis, and mitochondrial thioredoxin. It has also been shown to cause an increase in the levels of caspase-3 and caspase-4, arrest the cell cycle at metaphase leading to cancer cell apoptosis, and affect various protein and gene expression patterns.; Conclusion: Hypericin exhibits significant inhibitory activity against various types of in vitro and in vivo cancer models. However, well-designed, high quality, large-scale and multi-center randomized clinical studies are required to establish the safety and clinical utility of hypericin in cancer patients. (Copyright © 2022. Published by Elsevier GmbH.)

Chow, B., et al. (2019). "Radiobiological dose calculation parameters for cervix cancer brachytherapy: A systematic review." Brachytherapy 18(4): 546-558.
	The GEC-ESTRO recommendation in cervical cancer treatment planning, including external beam radiotherapy and brachytherapy boosts, is to use radiobiological dose calculations. Such calculations utilize the linear-quadratic model to estimate the effect of multiple cellular response factors and dose delivery parameters. The radiobiological parameters utilized in these calculations are literature values estimated based on clinical and experimental results. However, the impact of the uncertainties associated with these parameters is often not fully appreciated. This review includes a summary of the radiobiological dose calculation (for both high-dose-rate and pulsed-dose-rate brachytherapy boost treatments) for cervical cancer and a compilation of the reported values of the associated parameters. As discrepancies exist between conventionally recommended and published values, equivalencies between current brachytherapy boosts may be imprecise and could create underappreciated uncertainties in the radiobiological dose calculations. This review highlights these uncertainties by calculating the radiobiological dose delivered by the brachytherapy boost when assuming different radiobiological parameter values (within the range reported by previous research). Furthermore, conventional treatment planning does not consider the effects of proliferation of the tumor over the treatment time, which can significantly decrease its radiobiological dose and can introduce an additional variance of over 7 Gy 10 . Further investigation of uncertainties in parameter values and modifications of current dose models could improve the accuracy of radiobiological dose calculation. (Copyright © 2019 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Chow, H., et al. (2024). "A systematic review of community pharmacy interventions to improve peri- and post-menopausal health." Post Reproductive Health.
	Menopause is defined as the permanent cessation of menstruation due to loss of ovarian follicular function. Symptoms include mood disorders, vaginal atrophy, hot flashes and night sweats and can emerge during a gradual transition period called perimenopause. Community pharmacies are well placed to deliver a wide range of healthcare services, including supporting and educating menopausal women; however, to date, no systematic review has assessed the effectiveness of community pharmacy-led interventions in improving peri- and post-menopausal health. In accordance with PRISMA guidelines we evaluated community pharmacy-led interventions that targeted women in peri- or post-menopause. Electronic searches in EMBASE, MEDLINE, CINAHL and Cochrane Library were conducted on 13th February 2023. Additionally, we examined the included studies references and citation lists using Google Scholar. A total of 915 articles were identified and screened against the inclusion criteria. Two studies were included; one identified post-menopausal women at risk of developing osteoporosis (OP), and one evaluated the outcomes of a community pharmacy-based menopause education programme. Study one found 11 (11%) post-menopausal women were at risk of developing OP based on quantitative ultrasound screening offered by community pharmacists and referred to their physician. Study two reported that women had access to adequate personalised menopause counselling and increased knowledge of menopause topics because of the educational programme within community pharmacies. Both studies were of low quality. The lack of included studies reflects the need for high-quality research to determine whether community pharmacy-led interventions are feasible, effective and acceptable, to improve health outcomes of peri- or post-menopausal women.Copyright © The Author(s) 2024.

Chow Ka, M., et al. (2022). "A nurse-led sexual rehabilitation programme for rebuilding sexuality and intimacy after treatment for gynaecological cancer: Study protocol for a randomized controlled trial." Journal of Advanced Nursing 78(5): 1503-1512.
	Aim: To implement a nurse-led sexual rehabilitation programme for gynaecological cancer (GC) survivors and to evaluate its effects on their sexual functioning, sexual distress and marital satisfaction.; Design: An assessor-blinded, randomized controlled trial.; Methods: The development of the nurse-led sexual rehabilitation intervention was guided by the concept of sexual health, as stated in the Neotheoretical Framework of Sexuality; the explicit permission giving, limited information, specific suggestions and intensive therapy model; and evidence-based nursing interventions for sexuality. Four intervention sessions will be delivered along the treatment trajectory. Women newly diagnosed (within 3 months) with GC will be recruited from the gynaecological units of three hospitals in Hong Kong. The participants (N = 172) will be randomly assigned to the intervention group to receive the nurse-led sexual rehabilitation programme, or to an attention control group to receive attention on four occasions during the same period when the intervention group receives the intervention. Sexual functioning, sexual distress and marital quality will be measured at baseline, 1 month after the completion of cancer treatment, after completion of the sexual rehabilitation programme and 12 months after cancer treatment. Semi-structured interviews will be conducted with the participants in the intervention group to explore their experiences with and feelings towards the programme. The study was funded in March 2019 and ethics approval was obtained in January 2019.; Discussion: Positive outcomes of the nurse-led sexual rehabilitation programme will contribute to scientific and practical knowledge about nursing interventions to help GC survivors and their partners to resume a satisfying intimate relationship and adapt to changes in sexuality after treatment.; Impact: This study will contribute to the evidence for and advance research on the effectiveness of nurse-led sexuality rehabilitation interventions to support women and their partners to rebuild sexuality and intimacy after treatment for GC. (© 2022 John Wiley & Sons Ltd.)

Chowdhury, M. H., et al. (2020). "Effect of supplementary omega-3 fatty acids on pregnant women with complications and pregnancy outcomes: review from literature." Journal of Maternal-Fetal and Neonatal Medicine: 1-17.
	Numerous benefits have been associated with omega-3 fatty acid consumption during pregnancy and the postpartum period, whether it is consumed in the diet with seafood or via supplements such as fish oil. This review primarily aimed to assess the current situation of the impact of omega-3 long-chain Poly Unsaturated Fatty Acid (PUFA) supplementation on the outcomes of pregnancy. The electronic search of Medline, PubMed, Public Library of Science (PLOS) and Google Scholar databases was carried out for papers from 01 February 1995 to 01 March 2017 using keywords such as "pregnancy," "supplement," "long-chain polyunsaturated fatty acids," "omega 3 fatty acids," and "clinical trials." Out of twenty-six studies, both observational and interventional, fourteen studies found the influence of omega 3 fatty acids during pregnancy or the early postpartum period on the duration of gestation and infant size at birth, preeclampsia, depression, and infant visual function and neurodevelopment have been reported. Omega 3 fatty acid intakes (both in terms of absolute amounts of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) and the ratio of these 2 fatty acids) varied widely in these studies, however, and no clear consensus exists regarding the effects of omega 3 fatty acids on any of these outcomes. Because of the potential importance of these fatty acids for pregnant or lactating women, fetus, and newborn infants and the limited data from clinical trials assessing the effect of these fatty acids on pregnancy and infant outcomes, additional research is required to better define optimal intakes of specific omega 3 fatty acids during these critical periods.Copyright © 2020, © 2020 Informa UK Limited, trading as Taylor & Francis Group.

Chowdhury, M. L., et al. (2019). "Urethral Pain Syndrome: A Systematic Review." Current Bladder Dysfunction Reports 14(2): 75-82.
	Purpose of Review: Urethral pain syndrome (UPS) is defined as pain localized to the urethra with an unpleasant sensation, dysuria often accompanied by urinary frequency and urgency present greater than 6 months in the absence of an identifiable cause. A paucity of information exists on the subject as it is often combined with conditions such as interstitial cystitis or prostatitis. The aim is to provide and explain different definitions and diagnostic work-up and discuss treatment options for providers. Recent Findings: Few recent studies exist addressing urethral pain syndrome. Most literature is decades old. Thirty-five full-text articles were included in the review. This syndrome occurs most commonly in females of childbearing age. Patients must be evaluated thoroughly with full history and physical. Etiologies proposed include sensory dysfunction, pelvic floor dysfunction, psychogenic factors (depression and anxiety), diet, obstruction, infections, and hypoestrogen status. Treatment strategies include behavioral management of stress management, diet modification, pelvic floor treatments, local estrogen, anesthetic with or without cooling, oral medications for related lower urinary tract symptoms, or anxiolytics/antidepressants. Psychological support is recommended for these patients. Summary: UPS can have multiple etiologies and a multimodal therapy should be applied to these patients. Therapy should be individualized, oftentimes including concurrent therapy for overlapping conditions. Serious pathology should be ruled out and a stepwise approach to treatment should be utilized after setting treatment expectations with the patient.Copyright © 2019, Springer Science+Business Media, LLC, part of Springer Nature.

Christelle, K., et al. (2020). "The effects of evening-primrose oil on menopausal symptoms: A systematic review and meta-analysis of randomized controlled trials." Current Women's Health Reviews 16(4): 265-276.
	Background: Evening primrose oil (EPO) has been a treatment option for reducing menopausal symptoms, but evidence for its use is inadequate. Objective(s): The study aimed to determine the effectiveness of EPO in treating menopausal symptoms among peri and postmenopausal women. Study Design: This is a systematic review with meta-analyses of randomised clinical trials (RCTs). Method(s): We searched CENTRAL, Medline, Embase and trial registries for relevant RCTs. The methodology and reporting were carried out grounded on references from the Cochrane collaboration and the preferred reporting items for systematic reviews and meta-analyses statement. Review Manager version 5.3.5 was used to perform all the statistical analyses. Result(s): Five RCTs, recruiting a total of 402 peri and postmenopausal women were identified. EPO did not reduce the frequency of daily vasomotor symptoms (MD 0.01 episodes, 95% CI-0.54 to 0.57, P=0.960), frequency of daytime hot flash episodes (MD-0.51 episodes, 95% CI-2.05 to 1.03, P=0.510), frequency of night sweat episodes (MD 0.33 episodes, 95% CI-0.48 to 1.13, P=0.430) and severity of vasomotor symptoms (SMD-0.45, 95% CI-1.56 to 0.66, P=0.420) in comparison to control. EPO was associated with a minimal reduction in the severity of overall menopausal symptoms in comparison to control (SMD-1.18; 95% CI-2.18 to-0.18, P=0.02). There were insufficient data to pool results for musculoskeletal symptoms, mood, sexuality, sleeping disorders and quality of life. Conclusion(s): EPO may reduce the severity of overall menopausal symptoms but is not effective to reduce the frequency and severity of vasomotor symptoms. The evidence quality ranged from very low to moderate. Further research is needed to enhance related evidence. PROSPERO Registration Number: CRD42019142821.Copyright © 2020 Bentham Science Publishers.

Christiansen Mille, G., et al. (2022). "SystematiC nurse-led cONsultations based oN Electronic patient-reported outcome among women with ovarian- or endometrial Cancer during chemoTherapy - protocol for the CONNECT study." Acta oncologica (Stockholm, Sweden) 61(5): 602-607.
	
Christiansen Ole, B., et al. (2019). "Treatment with intravenous immunoglobulin in patients with recurrent pregnancy loss: An update." Journal of Reproductive Immunology 133: 37-42.
	Intravenous immunoglobulin (IVIg) has a documented clinical effect in many autoimmune diseases and has so far been tested in >10 randomised controlled trials (RCTs) in women with recurrent pregnancy loss (RPL). The results of the RCTs have, however, been very divergent. In meta-analyses of all trials, no significant impact on live birth rate has been reported. In contrast, in sensitivity analyses, IVIg significantly increased live birth rates when initiated prior to conception and it had a borderline significant therapeutic effect in women with secondary RPL. Higher dosages of IVIg and serological signs of autoimmunity in the treated patients tended to increase the success rate after treatment. A follow-up study of patients from our recent RCT also supports a significant therapeutic effect in patients who had received IVIg before conception. The lessons learned from the published trials and meta-analyses should be incorporated in the design of future RCTs of IVIg in the treatment of RPL. (Copyright © 2019 Elsevier B.V. All rights reserved.)

Christine, L., et al. (2021). "Behavioural interventions for peri and postmenopausal sleep disruption and insomnia: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Christmas Monica, M., et al. (2023). "Menopause hormone therapy and urinary symptoms: a systematic review." Menopause (New York, N.Y.) 30(6): 672-685.
	Importance: Urogenital changes associated with menopause are now classified as genitourinary syndrome of menopause (GSM), which includes symptoms of urgency, frequency, dysuria, and recurrent urinary tract infections for which the recommended treatment is estrogen. However, the association between menopause and urinary symptoms and the efficacy of hormone therapy for these symptoms is uncertain.; Objective: Our objective was to define the relationship between menopause and urinary symptoms including dysuria, urgency, frequency, recurrent urinary tract infections (UTIs), and urge and stress incontinence by conducting a systematic review of the effects of hormone therapy (HT) for urinary symptoms in perimenopausal and postmenopausal women.; Evidence Review: Eligible studies included randomized control trials with perimenopausal and postmenopausal women with a primary or secondary outcome of the following urinary symptoms: dysuria, frequent UTI, urgency, frequency, and incontinence, included at least one treatment arm of estrogen therapy, and were in English. Animal trials, cancer studies and pharmacokinetic studies, secondary analyses, and conference abstracts were excluded. PubMed, Scopus, and the Cochrane Central Register of Controlled Trials were searched until April 2022. Two authors reviewed each article with discrepancies resolved through whole group consensus. Data extracted included the following: publication date, country, setting, subject number, follow-up, duration, age, race/ethnicity, study design, inclusion criteria, and main findings.; Findings: There is insufficient evidence to confirm that menopause is associated with urinary symptoms. The effect of HT on urinary symptoms depends on type. Systemic HT may cause urinary incontinence or worsen existing urinary symptoms. Vaginal estrogen improves dysuria, frequency, urge and stress incontinence, and recurrent UTI in menopausal women.; Conclusions and Relevance: Vaginal estrogen improves urinary symptoms and decreases the risk of recurrent UTI in postmenopausal women.; Competing Interests: Financial disclosure/conflicts of interest: M.M.C. reports Board of Trustees for The North American Menopause Society (NAMS), NAMS Scientific Program Committee, NAMS Editorial Board, and FDA Bone, Reproductive and Urologic Division (BRUDAC) Committee. M.M.C. developed a menopause lecture series for AllianceChicago and wrote a white paper on GSM for Materna Medical, but did not receive any financial compensation. J.L. is a consultant for Haitec Medical, Inc. The other authors have nothing to disclose. (Copyright © 2023 by The North American Menopause Society.)

Christoffel, L., et al. (2021). "Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results." Medical devices (Auckland, N.Z.) 14: 77-84.
	Background: Transcervical fibroid ablation (TFA) is a minimally invasive, effective treatment of symptomatic uterine fibroids that utilizes intrauterine ultrasound for imaging and radiofrequency energy for ablation. Outcomes reported with TFA have been positive, with significant reductions in fibroid volume, improvements in symptom severity and health-related quality of life, and low complication and surgical reintervention rates. The SAGE registry characterizes the long-term (5-year) outcomes of TFA when used to treat symptomatic uterine fibroids in real-world usage.; Methods/design: SAGE is an ongoing postmarket global registry involving up to 50 sites and up to 500 women who select TFA with the Sonata system for treatment of symptomatic uterine fibroids. Patients are followed for 5 years. Main outcomes include symptom severity score and health-related quality of life subscales of the UFS-QoL, general health status on the EQ-5D, perceived treatment benefit, treatment satisfaction, work and activity patterns, overall patient treatment outcome, adverse events, pregnancy incidence and outcomes, and surgical reinterventions for heavy menstrual bleeding.; Discussion: The SAGE registry represents the largest known study of TFA for uterine fibroids and will generate up to 2500 patient-years of outcome data. Preliminary results from the first 160 treated women suggest broad applicability of TFA to a wide range of fibroid types and sizes and an excellent safety profile, with a device-related adverse event rate of 0.6% and a serious procedure-related adverse event rate of 0.6%. Of the 241 fibroids treated, 10% were submucous, 52% transmural, 28% intramural, and 10% subserous. Ablated fibroid diameters ranged from <1 cm to >10 cm, with 27% of fibroids having maximum diameters >5 cm. The real-world experience from SAGE will strengthen the existing evidence on the durability of TFA in providing meaningful relief from uterine fibroid symptoms and will have important clinical and economic implications for patients, physicians, and healthcare payers.; Trial Registration: https://clinicaltrials.gov, NCT03118037. Registered on 18 April 2017.; Competing Interests: The authors report no competing interests. (© 2021 Christoffel et al.)

Christopoulou, A., et al. (2022). "Prophylaxis of cancer-associated venous thromboembolism with low-molecular-weight heparin-tinzaparin: Real world evidence." Oncology Letters 23(4): 115.
	Thromboprophylaxis, as a preventive measure for cancer-associated thrombosis (CAT), may be beneficial for patients with active cancer and high-risk for thrombosis. The present post hoc analysis include a total of 407 patients enrolled in the Greek Management of Thrombosis study, who received thromboprophylaxis with tinzaparin. The objectives of the present analysis were: i) To obtain sufficient evidence for the administration of prophylaxis in patients with active cancer, irrespective of Khorana risk assessment model score; ii) to identify the selection criteria for both dose and duration of tinzaparin; and iii) to evaluate the efficacy and safety of tinzaparin administered for CAT prophylaxis. The main tumor types for the patients included in the present study were as follows: Lung (25.1%), pancreatic (14.3%), breast (9.1%), stomach (8.4%), colorectal (7.9%) and ovarian (7.6%). Furthermore, metastatic disease was observed in 69.5% of the patients. High thrombotic burden agents (HTBAs) were administered to 66.3% of the patients, and 17.4% received erythropoietin. A total of 43.7% of the patients exhibited a Khorana score <2. The results of the present study demonstrated that both the presence of metastatic disease and the use of HTBAs seemed to influence oncologists' decisions for the use of thromboprophylaxis in patients with active cancer, regardless of Khorana score. Tinzaparin, in dose expressed in the standard notation for heparins, i.e., anti-Xa factor international units (Anti-Xa IU), was administered at an intermediate dose (InterD; 8,000-12,000 Anti-Xa IU; once daily) to 52.4% of patients, while the remaining patients received a prophylactic dose (ProD; ≤4,500 Anti-Xa IU; once daily). The average duration of thromoprophylaxis was 5 months. Furthermore, a total of 14 (3.4%) thrombotic events and 6 (1.5%) minor bleeding events were recorded. A total of four thrombotic events were observed following an InterD treatment of tinzaparin, while 10 thrombotic events were observed following ProD treatment. The present study also demonstrated that an InterD of tinzaparin was administered more frequently to patients with a body mass index >30 kg/m 2 , a history of smoking and a history of metastatic disease, along with administration of erythropoietin. InterD tinzaparin treatment was found to be potentially more efficacious and without safety concerns. The present study is a registered clinical trial (ClinicalTrials.gov code, NCT03292107; registration date, September 25, 2017).; Competing Interests: The authors declare that they have no competing interests. (Copyright: © Christopoulou et al.)

Chrysanthopoulos, I., et al. (2023). "Detection of GSTM1 -null Genotype in Women Undergoing IVF Treatment." Journal of Clinical Medicine 12(23).
	Background: Glutathione S-transferase (GST) M1 belongs to a family of detoxification enzymes and deficiency in enzyme activity is due to a homozygous deletion of the GSTM1 gene. Several studies reveal a possible correlation between female infertility and GSTM1 polymorphisms. The aim of this study is to investigate the effect of the GSTM1 -null polymorphism in female infertility as well as in IVF parameters.; Methods: In the study group 125 women were classified as infertile according to WHO and 49 women with at least one successful pregnancy and no miscarriages, as control group. Genomic DNA from blood samples was isolated and PCR amplification was applied to determine the presence of GSTM1 -null genotype.; Results: Data analysis demonstrated a statistically significant higher presence of GSTM1 -null variant in the infertile group compared to the control group. In a subgroup analysis of the infertile group, the estradiol levels, the number of fertilized oocytes as well as the number and the quality of the cumulus-oocyte complex, were statistically significant higher in women detected with the wildtype of GSTM1 gene compared to those who had the GSTM1 null genotype (deletion).; Conclusions: Our study results propose a possible involvement of GMST1 in female infertility and may help elucidate possible interactions between the microenvironment of oocytes and the oxidative stress.

Chu, Z., et al. (2024). "Effects of different treatment methods on clinical efficacy and fertility outcomes of patients with adenomyosis." Journal of Ovarian Research 17(1): 16.
	Objective: This trial was to investigate the effect of different treatment methods on the clinical efficacy and fertility outcome of patients with adenomyosis. Method(s): In total, 140 patients with adenomyosis were evenly and randomly allocated into group A (laparoscopic surgery), group B (laparoscopic surgery combined with gonadotropin-releasing hormone analogs [GnRH-a]), group C (ultrasound-guided percutaneous radiofrequency ablation), and group D (ultrasound-guided percutaneous radiofrequency ablation combined with GnRH-a). On the 3rd day after surgery, patients in group B and group D were subcutaneously injected with GnRH-a (Leuprorelin Acetate SR for Injection) at 3.75 mg/time, once every 4 weeks, for a total of 3 months. The therapeutic effects of the 4 groups were compared, including menstrual volume, dysmenorrhea score, uterine volume, clinical efficacy, luteinizing hormone (LH), estradiol (E2), and follicle-stimulating hormone (FSH) levels, CA125 levels, recurrence, pregnancy status, and pregnancy outcomes. Result(s): After treatment, the menstrual volume of 4 groups was lowered, dysmenorrhea, Visual Analog Scale (VAS) score, LH, FSH, E2, and CA125 levels were reduced, and uterine volume was decreased. The menstrual volume, VAS score, levels of LH, FSH, E2, and CA125, and uterine volume were reduced in groups B, C, and D compared with group A, and the decrease was more significant in group D. The total effective rate of group D was 100.00%, which was higher than that of group A (71.43%), group B (80.00%), and group C (82.86%). After one year of drug withdrawal, the recurrence of hypermenorrhea, dysmenorrhea, uterine enlargement, and excessive CA125 in group D was significantly lower than that in groups A, B and C, and the recurrence in groups B and C was significantly lower than that in group A (P < 0.05). Compared with groups A, B, and C, group D had a higher pregnancy rate, natural pregnancy rate, and lower in vitro fertilization-embryo transfer rate (P < 0.05), but showed no significant difference in pregnancy outcomes. Conclusion(s): Ultrasound-guided percutaneous radiofrequency ablation combined with Leuprorelin Acetate is effective in the treatment of adenomyosis, which can effectively relieve clinical symptoms, protect postoperative ovarian function, reduce recurrence rate, alleviate pain, and improve quality of life.Copyright © 2024, The Author(s).

Chua, V. H., et al. (2022). "Quality of Life among Survivors of Locally Advanced Cervical Cancer Treated with Definitive Chemoradiotherapy in a Decade of Transition." Asian Journal of Oncology 8(2): 81-91.
	Introduction The standard treatment for locally advanced cervical cancer (LACC) is concurrent chemoradiotherapy (CRT). External beam radiotherapy (EBRT) and brachytherapy (BRT) advances in the last decade have resulted in improved local control and survival. There is a lack of data on quality of life (QoL) among survivors. Objective This systematic review aimed to synthesize published data on QoL among LACC survivors treated with CRT and determine clinical factors of QoL. Methods Systematic literature search was conducted in PubMed, EBSCO, and ScienceDirect for relevant articles published in 2010 to 2020. Eligible studies on LACC survivors aged 18 years and above, who reported QoL after CRT, were included. Screening and data extraction were done by two pairs of independent reviewers. Results Five cohort studies, three cross sectional studies, and one clinical trial were included. Reported temporal evolution of QoL varied: two studies reported improvement of overall QoL, while four reported worsening of symptoms. Gastrointestinal, genitourinary, sexual, and psychosocial domains showed significant impairment. Age, stage, and baseline distress and physical condition were clinical determinants of body image, sexual activity, menopausal symptoms, distress, and dyspnea. Peripheral neuropathy, lymphedema, and dyspnea were reported, while grade 3 to 4 gastrointestinal, genitourinary, and musculoskeletal toxicities were rare. Conclusion Use of advanced EBRT and BRT techniques is associated with improving QoL in the first 3 years from treatment completion. Gastrointestinal, genitourinary, sexual, and psychosocial functions remain impaired on the long-term. Other late toxicities worth noting include peripheral neuropathy, lower limb edema, and insufficiency fractures.Copyright © 2022. Spring Hope Cancer Foundation & Young Oncologist Group of Asia. All rights reserved.

Chudzicka-Strugała, I., et al. (2021). "Effects of Synbiotic Supplementation and Lifestyle Modifications on Women With Polycystic Ovary Syndrome." The Journal of Clinical Endocrinology and Metabolism 106(9): 2566-2573.
	CONTEXT: Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age. OBJECTIVE: This study was designed to evaluate effects of lifestyle modifications and synbiotic supplementation on PCOS. DESIGN: A randomized (1:1) double-blind, placebo-controlled trial. SETTING: Academic hospital. PATIENTS OR OTHER PARTICIPANTS: Overweight and obese women with PCOS were identified according to the Rotterdam criteria. Evaluations were performed at baseline and repeated after 3 months of treatment. INTERVENTION: Lifestyle modifications in combination with synbiotic supplementation or placebo. MAIN OUTCOME MEASURES: Change in body mass index (BMI) and testosterone level. RESULTS: In the placebo group, a 5% decrease in BMI was accompanied by significant decreases of the waist, hip, and thigh circumferences. The synbiotic group experienced an 8% decrease in BMI, which was significantly greater than that in the control group (P = 0.03) and was accompanied by decreases in the waist, hip, and thigh circumferences. Testosterone did not decrease significantly in the placebo group (decrease of 6%), whereas in the synbiotic group it decreased by 32% (P < 0.0001). The decrease of testosterone was significantly greater in the synbiotic group than in the placebo group (P = 0.016). CONCLUSIONS: Synbiotic supplementation potentiated effects of lifestyle modifications on weight loss and led to significant reduction of serum testosterone.

Chui, C., et al. (2021). "Maintenance Therapy for Preventing Endometrioma Recurrence after Endometriosis Resection Surgery– A Systematic Review and Network Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Chung Jacqueline Pui, W., et al. (2022). "Hyoscine butylbromide in pain reduction associated with ultrasound-guided manual vacuum aspiration: a randomized placebo-controlled trial." Reproductive Biomedicine Online 44(2): 295-303.
	Research Question: What is the effect of adding an anti-spasmodic drug to an existing ultrasound-guided manual vacuum aspiration (USG-MVA) protocol to alleviate immediate post-procedure abdominal cramping pain in women treated for early pregnancy loss?; Design: Double-blind, placebo-controlled, randomized controlled trial conducted between February 2018 and January 2020. Participants were assigned to receive a 1-ml intravenous injection containing 20-mg hyoscine butylbromide (HBB) (n=55) or saline (n =56) as a control immediately before USG-MVA. Primary outcome was reduced abdominal pain after adding a 20-mg dose of HBB to the current pain control regimen. Secondary outcomes were vaginal pain, complications and side-effects, women's pre- and post-procedure psychological state, physiological stress (saliva alpha-amylase) and procedure pain control satisfaction. Two-way mixed ANOVA was used to evaluate the main effects and interactions.; Results: VAS abdominal pain scores in the HBB group were 16% lower immediately after and 21% lower 2 h after surgery (not statistically significant). Two-way ANOVA indicated that time (F[ 1108 ] = 83.41, P < 0.001) was the only significant main effect for reduced abdominal pain after the procedure and vaginal pain score (F[1108] = 180.1, P < 0.0001) but not drug received. No adverse events were reported. No significant difference was found for psychological state, physiological stress and procedure pain control satisfaction between the two groups.; Conclusions: Anti-spasmodic drugs can help to reduce abdominal cramping pain associated with USG-MVA; HBB produced an insignificant decrease in abdominal pain score. Further studies with longer acting or larger doses of anti-spasmodic drugs are warranted. (Copyright © 2021 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Chung, J. P. W., et al. (2021). "Ovarian reserve and recurrence 1 year post-operatively after using haemostatic sealant and bipolar diathermy for haemostasis during laparoscopic ovarian cystectomy." Reproductive Biomedicine Online 43(2): 310-318.
	RESEARCH QUESTION: Is there a difference in the ovarian reserve 1 year post-operatively in those who used a haemostatic sealant or bipolar diathermy for haemostasis during laparoscopic ovarian cystectomy for ovarian endometriomas? DESIGN: This was an extended follow-up observational study of a previous randomized controlled trial where women aged 18 to 40 years with 3-8 cm unilateral or bilateral endometriomas were randomized to receive haemostasis by a haemostatic sealant or bipolar diathermy following ovarian cystectomy. The primary outcome was the ovarian reserve as assessed by antral follicle count (AFC) 1 year post-operatively. Secondary outcomes included the recurrence rate of ovarian endometrioma, the change in anti-Müllerian hormone (AMH) and FSH concentrations, and reproductive outcomes. RESULTS: The significant increase in AFC at 3 months after initial surgery (P = 0.025) in the haemostatic sealant group compared with the diathermy group was sustained at 1 year (P = 0.024) but there was no difference in AMH or FSH concentrations between the groups throughout the follow-up period. The recurrence rate in the FloSeal group was 7.7% (n = 3/39) compared with 22.2% (n = 8/36) in the diathermy group (P = 0.060). The recurrence rate in women who had bilateral lesions was significantly higher than those with unilateral lesions (risk ratio 5.33, interquartile range 1.55-18.38). No difference in reproductive outcomes was found between the two groups. CONCLUSIONS: Applying haemostatic sealant after laparoscopic cystectomy of ovarian endometriomas produces a significantly greater improvement in AFC, which was apparent at 3-month follow-up, and was sustained at 1-year follow-up without compromising the recurrence rate.

Chun-Xi, Z., et al. (2021). "Does the addition of a low-quality embryo as part of double embryo transfer improve pregnancy outcome? a systematic review and network meta-analysis."
	
Cianci, S., et al. (2021). "Robotic Pelvic Exenteration for Gynecologic Malignancies, Anatomic Landmarks, and Surgical Steps: A Systematic Review." Frontiers in surgery 8: 790152.
	Pelvic exenteration represents the last resort procedure for patients with advanced primary or recurrent gynecological malignancy. Pelvic exenteration can be divided into different subgroup based on anatomical extension of the procedures. The growing application of the minimally invasive surgical approach unlocked new perspectives for gynecologic oncology surgery. Minimally invasive surgery may offer significant advantages in terms of perioperative outcomes. Since 2009, several Robotic Assisted Laparoscopic Pelvic Exenteration experiences have been described in literature. The advent of robotic surgery resulted in a new spur to the worldwide spread of minimally invasive pelvic exenteration. We present a review of the literature on robotic-assisted pelvic exenteration. The search was conducted using electronic databases from inception of each database through June 2021. 13 articles including 53 patients were included in this review. Anterior exenteration was pursued in 42 patients (79.2%), 2 patients underwent posterior exenteration (3.8%), while 9 patients (17%) were subjected to total exenteration. The most common urinary reconstruction was non-continent urinary diversion (90.2%). Among the 11 women who underwent to total or posterior exenteration, 8 (72.7%) received a terminal colostomy. Conversion to laparotomy was required in two cases due to intraoperative vascular injury. Complications' report was available for 51 patients. Fifteen Dindo Grade 2 complications occurred in 11 patients (21.6%), and 14 grade 3 complications were registered in 13 patients (25.5%). Only grade 4 complications were reported (2%). In 88% of women, the resection margins were negative. Pelvic exenteration represents a salvage procedure in patients with recurrent or persistent gynecological cancers often after radiotherapy. A careful patient selection remains the milestone of such a mutilating surgery. The introduction of the minimally invasive approach has led to advantages in terms of perioperative outcomes compared to classic open surgery. This review shows the feasibility of robotic pelvic exenteration. An important step forward should be to investigate the potential equivalence between robotic approaches and the laparotomic one, in terms of long-term oncological outcomes.

Cianci, S., et al. (2022). "Surgical outcomes of diaphragmatic resection during cytoreductive surgery for advanced gynecological ovarian neoplasia: A randomized single center clinical trial - DRAGON." Gynecologic Oncology 164(2): 271-277.
	Introduction: Ovarian cancer (OC) represent nearly 4% of gynecologic malignancies and it is often diagnosed at advanced stage. Diaphragmatic surgery, a fundamental step of advanced stage ovarian cancer (ASOC) debulking surgery, is associated with a high post-operative complication incidence, which is supposedly reduced with thoracostomy tube placement. We assessed the role of intra-operative thoracostomy tube placement, as a prevention measure for post-operative complications, after diaphragmatic resection.; Methods: This was a single center prospective randomized trial. Ovarian cancer patients, who underwent mono-lateral diaphragmatic resection, were randomized 1:1 into two arms. Arm A included patients receiving intra-operative thoracostomy tube placement (TP); Arm B patients did not receive thoracostomy tube placement (NTP). After surgery, all patients underwent seriate chest x-ray and ultrasound to record thoracic complications. Statistical analysis included uni- and multivariable logistic regression model (proportional odds model).; Results: Three hundred seventy-one patients were screened and 88 patients were enrolled: 44 in arm A and B, respectively. No statistically significant differences for intra-operative (p = 0.291) and any grade of post-operative complication (p = 0.072) were detected, while 6.8% of patients in arm A and 22.7% in arm B experienced severe respiratory symptoms (p = 0.035); 18.2% of patients in arm A had a moderate/large pleural effusion versus 65.9% in arm B (p < 0.0001). At multivariable analysis, results confirmed that the NTP-group had a higher risk to receive post-operative thoracostomy tube placement due to pleural effusion than the TP-group (odds ratio [95% Confidence Interval] = 14.5 [3.7-57.4]).; Conclusions: Thoracostomy intra-operative tube placement after diaphragmatic resection is effective to prevent post-operative thoracic complications. The extension of resection does not influence outcomes and the risk of post-operative thoracentesis or TP remain elevated.; Competing Interests: Declaration of Competing Interest Authors declare to have nothing to disclose. (Copyright © 2021 Elsevier Inc. All rights reserved.)

Cianci, S., et al. (2023). "Exploring Surgical Strategies for Uterine Fibroid Treatment: A Comprehensive Review of Literature on Open and Minimally Invasive Approaches." Medicina (Kaunas, Lithuania) 60(1).
	Background and Objectives: Uterine myomas represent one of the most prevalent pathologies affecting the female population. These benign neoplasms originate from the smooth muscular cells of the uterus, and they can be either single or multiple. Often associated with debilitating symptoms such as pelvic heaviness, pain, constipation, and urinary dysfunctions, the surgical management of myomectomy exhibits considerable variability. This diversity in approaches is influenced by factors such as the number and size of myomas, the patient's age, and overall clinical conditions. This study aims to elucidate and compare the advantages and disadvantages of different surgical approaches, specifically endoscopic procedures versus open surgery, providing valuable insights for clinical decision making. Materials and Methods: A comprehensive bibliographic search spanning from 2013 to 2023 was systematically conducted across databases including Medline, Embase, the Cochrane Database of Systematic Reviews, and ClinicalTrials.gov. The search utilized keywords such as "myomectomy laparoscopic and open", "myomectomy open and minimally invasive", "myomectomy open and laparoscopic", and "myomectomy open vs. laparoscopic." The research methodology, along with predetermined inclusion and exclusion criteria, was established prior to the search, ensuring a systematic and rigorous approach. Subsequently, data analysis was carried out. Results: Following the study selection process, 25 articles met the eligibility criteria for inclusion in this analysis. The average numbers of myomas were 3.7 (ranging from 1 to 13.7) and 5.4 (ranging from 1 to 13.5) for the minimally invasive surgery and open surgery groups, respectively. In terms of myoma size, the total averages across studies were 7 cm (ranging from 4.8 to 14) for the minimally invasive group and 8 cm (ranging from 3.9 to 11.2) for the open surgery group. The average pregnancy and delivery rates were 29.7% (ranging from 1.8 to 100) for the minimally invasive group and 28.5% (ranging from 1.8 to 100) for the open surgery group. Regarding complications, the average rate was 14.2% (ranging from 0 to 50) for the endoscopic group and 22.3% (ranging from 0 to 60.3) for the laparotomic group. Conclusions: In conclusion, a critical factor influencing the choice of surgical approach is primarily the size and quantity of fibroids. The mini-laparotomic approach emerges as a viable alternative to endoscopy, demonstrating favorable surgical outcomes and aesthetic results. Interestingly, the type of surgical procedure appears to have no significant impact on the pregnancy rate.; Competing Interests: All authors declare no conflicts of interest.

Cianci, S., et al. (2021). "Percutaneous-assisted vs mini-laparoscopic hysterectomy: comparison of ultra-minimally invasive approaches." Updates in surgery 73(6): 2347-2354.
	To assess the feasibility and the safety of the ultra-minimally invasive (U-MIS) approaches in gynecology, we compared our experience in percutaneous assisted hysterectomy (PSS-H) with a series of 3 mm mini-laparoscopy hysterectomy (m-LPS-H). 126 patients affected by benign and malignant gynecological conditions were considered eligible for minimally invasive hysterectomy: 80 patients received PSS approach and 46 m-LPS approach. For both groups, we evaluated intra and perioperative outcomes, post-operative pain and cosmetic outcomes. The baseline characteristics were comparable between the two study groups. As well, no differences were reported in the clinical indications for hysterectomy, principally fibroids/adenomyosis, endometrial hyperplasia and early stage endometrial cancer. The median operative time was 88.5 (40-190) minutes for PSS-H group and 95.0 (42-231) minutes in m-LPS-H group (p=0.131). No differences were detected in median estimated blood loss (p=0.104) as well, in the uterine manipulator usage (p=0.127) between the two different surgical approaches. Only 1 (2.2%) conversion to standard laparoscopy occurred in m-LPS-H group (p=0.691). One intra-operative complication was recorded 1 (1.3%) in the PSS-H group (p=0.367). The post-operative early complication was recorded in five cases of PSS-H group (p=0.158), none for m-LPS-H procedures. The results in post-operative pain detection was statistically significant after 4 h in favor of m-LPS-H group (p=0.001). After 30 days no differences in cosmetic satisfaction were detected between the two groups (p=0.206). PSS-H and m-LPS-H are two valid U-MIS alternatives for benign gynecological conditions and low/intermediate risk endometrial cancer.Copyright © 2020. Italian Society of Surgery (SIC).

Ciavattini, A., et al. (2021). "The Impact of 9-Valent HPV Vaccination on Couple Infertility Prevention: A Comprehensive Review." Frontiers in Medicine 8: 700792.
	A comprehensive literature review was performed to determine the relationship between HPV infection and infertility and the eventual role of the 9-valent vaccine for infertility prevention. The search was extended from January 1997 through July 2021. Data collected from selected articles focused on three main topics: statistical associations between HPV prevalence and assisted reproductive technology (ART) outcome, association between HPV and characteristics of semen, and associations between HPV and miscarriage. Articles that identified HPV genotypes were selected for this review to study the possible role of the 9-valent vaccine in infertility prevention. To date, there is no agreement on the implication HPV female infection has on the fertility and miscarriage rate. Although it can be stated that HPV prevalence among couples with infertility undergoing ART treatment is consistent, it does not seem to affect the performance of oocytes. Otherwise, HPV infection affects sperm parameters, in particular spermatozoa motility. When an association can be found, most cases of HR-HPV involved are those included in the 9-valent vaccine. The correlation between HPV male infection both with asthenozoospermia and increased risk of pregnancy loss could recommend the extension of anti-HPV vaccination to adolescent males along with cancer prevention. Despite the fact that the relation between 9-valent HPV genotypes involved in female infection and miscarriage/infertility is not clear, the impact of this virus on health reproduction is evident. Considering this, the importance of HPV vaccination in adolescent females is confirmed. A vaccine efficacy study could be useful to confirm the importance of primary prevention for couple reproductive health.© Copyright © 2021 Ciavattini, Marconi, Giannella, Delli Carpini, Sopracordevole and Di Giuseppe.

Cibralic, S., et al. (2022). "The impact of midwifery continuity of care on maternal mental health: A narrative systematic review." Midwifery 116: 103546.
	BACKGROUND: Systematic reviews have shown that midwifery continuity of care programs lead to improvements in birth outcomes for women and babies, but no reviews have focused specifically on the impact of midwifery continuity of care on maternal mental health outcomes. OBJECTIVE: To systematically review the available evidence on the impact of midwifery continuity of care on maternal mental health during the perinatal period. METHOD: A systematic search of published literature available through to March 2021 was conducted. A narrative approach was used to examine and synthesise the literature. RESULTS: The search yielded eight articles that were grouped based on the mental health conditions they examined: fear of birth, anxiety, and depression. Findings indicate that midwifery continuity of care leads to improvements in maternal anxiety/worry and depression during the perinatal period. CONCLUSION: There is preliminary evidence showing that midwifery continuity of care is beneficial in reducing anxiety/worry and depression in pregnant women during the antenatal period. As the evidence stands, midwifery continuity of care may be a preventative intervention to reduce maternal anxiety/worry and depression during the perinatal period.

Cibula, D., et al. (2019). "A prospective multicenter trial on sentinel lymph node biopsy in patients with early-stage cervical cancer (SENTIX)." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 29(1): 212-215.
	Objective: Sentinel lymph node (SLN) biopsy has been increasingly used in the management of early-stage cervical cancer. It appears in guidelines as an alternative option to systematic pelvic lymphadenectomy. The evidence about safety is, however, based mostly on retrospective studies, in which SLN was combined with systematic lymphadenectomy.; Materials and Methods: SENTIX is a prospective multicenter trial aiming to prove that less-radical surgery with SLN is non-inferior to treatment with systematic pelvic lymphadenectomy. The primary end point is recurrence rate; the secondary end point is the prevalence of lower-leg lymphedema and symptomatic pelvic lymphocele. The reference recurrence rate was set up conservatively at 7% at 24 months after treatment. With a sample size of 300 patients treated per protocol, the trial is powered to detect a non-inferiority margin of 5% (90% power, p = 0.05) for recurrence rate, 30% reduction in the prevalence of symptomatic lymphocele or lower-leg lymphedema, with reference rates of 30% and 6% at 12 months (p = 0.025, Bonferroni correction). The patients eligible for SENTIX have stage IA1/LVSI+, IA2, IB1 (<2 cm for fertility sparing), with negative LN on pre-operative imaging. Intra-operatively, patients are excluded when there is a failure to detect SLN on both sides of the pelvis in cases of more advanced cancer (stage >IB1), or a positive intra-operative SLN assessment. The quality of SLN pathology evaluation will be assessed by central review. Three interim safety analyses are pre-planned when 30, 60, 150 patients complete 12 months' follow-up.; Conclusions: The first patient was enrolled into the study in June 2016 and, by June 2018, 340 patients had been enrolled. The first analysis of secondary outcomes should be available in 2019 and the oncological outcome of 300 patients at the end of 2021. The trial is registered as a CEEGOG trial (CEEGOG CX-01), ENGOT trial (ENGOT-Cx 2), and at the ClinicalTrials.gov database (NCT02494063).; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Cibula, D., et al. (2021). "Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial." Gynecologic Oncology 162(3): 652-660.
	OBJECTIVE: DCVAC/OvCa is an active cellular immunotherapy designed to stimulate an immune response against ovarian cancer. We explored the safety and efficacy of DCVAC/OvCa plus carboplatin and gemcitabine in platinum-sensitive ovarian cancer. METHODS: In this open-label, parallel-group, phase 2 trial (ClinicalTrials.gov number NCT02107950), patients with platinum-sensitive ovarian cancer relapsing after first-line chemotherapy were randomized to DCVAC/OvCa and chemotherapy or chemotherapy alone. DCVAC/OvCa was administered every 3-6 weeks (10 doses). Endpoints included safety, progression-free survival (PFS; primary efficacy endpoint) and overall survival (OS; secondary efficacy endpoint). RESULTS: Between November 2013 and May 2015, 71 patients were randomized to chemotherapy in combination with DCVAC/OvCa or to chemotherapy alone. Treatment-emergent adverse events related to DCVAC/OvCa, leukapheresis and chemotherapy occurred in six (16.2%), two (5.4%), and 35 (94.6%) patients in the DCVAC/OvCa group. Chemotherapy-related events occurred in all patients in the chemotherapy group. Seven patients in the DCVAC/OvCa group were excluded from primary efficacy analyses due to failure to receive ≥1 dose of DCVAC/OvCa. PFS was not improved (hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.42-1.28, P = 0.274, data maturity 78.1%). Median OS was significantly prolonged (by 13.4 months) in the DCVAC/OvCa group (HR 0.38, 95% CI 0.20-0.74, P = 0.003; data maturity 56.3%). A signal for enhanced surrogate antigen-specific T-cell activity was seen with DCVAC/OvCa. CONCLUSIONS: DCVAC/OvCa combined with chemotherapy had a favorable safety profile in patients with platinum-sensitive ovarian cancer. DCVAC/OvCa did not improve PFS, but the exploratory analyses revealed OS prolongation and enhanced surrogate antigen-specific T-cell activity.

Cibula, D., et al. (2023). "ESGO/ESTRO/ESP Guidelines for the management of patients with cervical cancer - Update 2023." Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology 184: 109682.
	In 2018, the European Society of Gynecological Oncology (ESGO) jointly with the European Society for Radiotherapy and Oncology (ESTRO) and the European Society of Pathology (ESP) published evidence-based guidelines for the management of patients with cervical cancer. Given the large body of new evidence addressing the management of cervical cancer, the three sister societies jointly decided to update these evidence-based guidelines. The update includes new topics to provide comprehensive guidelines on all relevant issues of diagnosis and treatment in cervical cancer. To serve on the expert panel (27 experts across Europe) ESGO/ESTRO/ESP nominated practicing clinicians who are involved in managing patients with cervical cancer and have demonstrated leadership through their expertise in clinical care and research, national and international engagement, profile, and dedication to the topics addressed. To ensure the statements were evidence based, new data identified from a systematic search was reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the international development group. Before publication, the guidelines were reviewed by 155 independent international practitioners in cancer care delivery and patient representatives. These updated guidelines are comprehensive and cover staging, management, follow-up, long-term survivorship, quality of life and palliative care. Management includes fertility sparing treatment, early and locally advanced cervical cancer, invasive cervical cancer diagnosed on a simple hysterectomy specimen, cervical cancer in pregnancy, rare tumors, recurrent and metastatic diseases. The management algorithms and the principles of radiotherapy and pathological evaluation are also defined.; Competing Interests: Declaration of competing interests CCh has reported advisory boards for GSK, MSD and EISAI; SFL has reported advisory boards for MSD, GSK, AstraZeneca and Novartis; DL has reported consultant honoria from AstraZeneca, Clovis Oncology, GSK, MSD, Immunogen, Genmab, Amgen, Seagen and PharmaMar, advisory boards for AstraZeneca, Merck Serono, Seagen, Immunogen, Genmab, Oncoinvest, Corcept and Sutro, research institutional funding from Clovis Oncology, GSK, MSD and PharmaMar, research sponsored by AstraZeneca, Clovis Oncology, Genmab, GSK, Immunogen, Incyte, MSD, Roche, Seagen and Novartis, and speakers’ bureau activities for AstraZeneca, Clovis Oncology, GSK, MSD and PharmaMar; UM has reported advisory boards for AstraZeneca (Steering committee member for CALLA Study); RN has reported research grants from Elekta, Varian, Accuray, Dutch Research Council, and Dutch Cancer Society; AO has reported personal fees for advisory board membersip from Agenus, AstraZeneca, Clovis Oncology, Corcept Therapeutics, Deciphera Pharmaceuticals, Eisai, EMD Serono, F. Hoffmann-La Roche, Genmab/Seagen, GSK, ImmunoGen, Itheos, Merck Sharp & Dohme de Espana, SA, Mersana Thereapeutics, Novocure, PharmaMar, piIME Oncology, Roche, Sattucklabs, Sutro Biopharma and Tesaro, and personal fees for travel/accomodation from AstraZeneca, PharmaMar and Roche; DQ has reported advisory boards for Mimark inc; MPS has reported research grants and personal fees for workshops from Elekta AB; DC, MRR, FP, CC, AF, DF, DJK, FJ, CK, PM, RN, FPec, JP, SR, AS, VS, KT, IZ and JCL have reported no conflicts of interest. (Copyright © 2023 ESGO, ESTRO, ESP. Published by Elsevier B.V. All rights reserved.)

Cicogna, S., et al. (2023). "Aggressive Angiomyxoma of the Lower Female Genital Tract in Pregnancy: A Review of the MITO Rare Tumors Group." Cancers 15(13): 3403.
	Deep (aggressive) angiomyxoma of the lower genital tract is a rare malignancy affecting women of reproductive age. Being a hormone-sensitive tumor, its growth is particularly benefitted during pregnancy. Surgical excision with complete resection is indicated, even if a wait-and-see approach can be considered until delivery, to avoid destructive surgeries. The mode of delivery is to be evaluated based on the location and size of the neoplasm; vaginal delivery is not contraindicated, as long as the tumor does not obstruct the birth canal. Positive surgical margins are the most important prognostic factor for recurrence. Adjuvant therapy with gonadotropin-releasing hormone analogues may be proposed after pregnancy, in the case of non-radical surgery. Despite the high local relapse rate, the outcomes for mother and child are favorable. Since recurrences can occur after many years, the patient should be included in long-term follow-up.Copyright © 2023 by the authors.

Cimadomo, D., et al. (2023). "ESHRE good practice recommendations on recurrent implantation failure." Human Reproduction Open 2023(3): hoad023.
	STUDY QUESTION: How should recurrent implantation failure (RIF) in patients undergoing ART be defined and managed? SUMMARY ANSWER: This is the first ESHRE good practice recommendations paper providing a definition for RIF together with recommendations on how to investigate causes and contributing factors, and how to improve the chances of a pregnancy. WHAT IS KNOWN ALREADY: RIF is a challenge in the ART clinic, with a multitude of investigations and interventions offered and applied in clinical practice, often without biological rationale or with unequivocal evidence of benefit. STUDY DESIGN, SIZE, DURATION: This document was developed according to a predefined methodology for ESHRE good practice recommendations. Recommendations are supported by data from the literature, if available, and the results of a previously published survey on clinical practice in RIF and the expertise of the working group. A literature search was performed in PubMed and Cochrane focussing on 'recurrent reproductive failure', 'recurrent implantation failure', and 'repeated implantation failure'. PARTICIPANTS/MATERIALS, SETTING, METHODS: The ESHRE Working Group on Recurrent Implantation Failure included eight members representing the ESHRE Special Interest Groups for Implantation and Early Pregnancy, Reproductive Endocrinology, and Embryology, with an independent chair and an expert in statistics. The recommendations for clinical practice were formulated based on the expert opinion of the working group, while taking into consideration the published data and results of the survey on uptake in clinical practice. The draft document was then open to ESHRE members for online peer review and was revised in light of the comments received. MAIN RESULTS AND THE ROLE OF CHANCE: The working group recommends considering RIF as a secondary phenomenon of ART, as it can only be observed in patients undergoing IVF, and that the following description of RIF be adopted: 'RIF describes the scenario in which the transfer of embryos considered to be viable has failed to result in a positive pregnancy test sufficiently often in a specific patient to warrant consideration of further investigations and/or interventions'. It was agreed that the recommended threshold for the cumulative predicted chance of implantation to identify RIF for the purposes of initiating further investigation is 60%. When a couple have not had a successful implantation by a certain number of embryo transfers and the cumulative predicted chance of implantation associated with that number is greater than 60%, then they should be counselled on further investigation and/or treatment options. This term defines clinical RIF for which further actions should be considered. Nineteen recommendations were formulated on investigations when RIF is suspected, and 13 on interventions. Recommendations were colour-coded based on whether the investigations/interventions were recommended (green), to be considered (orange), or not recommended, i.e. not to be offered routinely (red). LIMITATIONS, REASONS FOR CAUTION: While awaiting the results of further studies and trials, the ESHRE Working Group on Recurrent Implantation Failure recommends identifying RIF based on the chance of successful implantation for the individual patient or couple and to restrict investigations and treatments to those supported by a clear rationale and data indicating their likely benefit. WIDER IMPLICATIONS OF THE FINDINGS: This article provides not only good practice advice but also highlights the investigations and interventions that need further research. This research, when well-conducted, will be key to making progress in the clinical management of RIF. Copyright © 2023 The Author(s).

Cina, A., et al. (2022). "Optimizing the Angiography Protocol to Reduce Radiation Dose in Uterine Artery Embolization: The Impact of Digital Subtraction Angiographies on Radiation Exposure." Cardiovascular and interventional radiology 45(2): 249-254.
	Purpose: The aim was to compare a protocol of uterine artery embolization (UAE) consisting in three digital subtraction angiographies (DSAs)-Group A, with a protocol based on a single DSA-Group B.; Materials and Methods: This is a single-center prospective randomized study enrolling 20 women (mean age 41 years, range 22-55 years) with uterine fibroids treated with UAE, from January 2015 to February 2016. All UAEs were performed by two interventional radiologists using the same angiography machine. Protocol of Group A consisted in three DSA runs (non-selective pelvic view and selective uterine views before and after embolization). Protocol of Group B consisted in 1 DSA run: selective UA angiography before embolization. (Fluoroscopic roadmap was used for UA catheterization; fluoroscopy storage was used as control after embolization.) Each patient was randomized to receive Protocol A in one pelvic side and Protocol B on the other.; Results: All patients received bilateral UAE. Mean fluoroscopy time for UA catheterization was 11.3 ± 3.7 s. (Protocol A) and 9.93 ± 2.99 s. (Protocol B) (p = 0.19). Fluoroscopy dose for catheterization and embolization was not different between both protocols (p = 0.14). Identification of the UA origin score was similar in both protocols (median error = 0, p = 0.79). Mean dose area product (DAP) was 40859 mGy/cm 2 (Protocol A) and 28839 mGy/cm 2 (Protocol B) (p = 0.003). Mean effective dose (ED) decreased from Protocol A (14.6 mSv) to Protocol B (9.2 mSv; - 37%). Mean absorbed dose (AD) to ovaries and uterus, respectively, decreased of 53% and 55% from Protocol A to Protocol B.; Conclusion: Reducing the number of DSA runs from 3 to 1 during UAE allows at least a 30% reduction on radiation exposure, without compromising technical outcomes. (© 2021. Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).)

Cincione, I. R., et al. (2023). "Short-time effects of ketogenic diet or modestly hypocaloric Mediterranean diet on overweight and obese women with polycystic ovary syndrome." Journal of endocrinological investigation 46(4): 769-777.
	Introduction: Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women during reproductive age. It is characterized clinically by oligo-ovulation or anovulation, hyper-androgenism, and the presence of polycystic ovaries. Often comorbid with insulin resistance, dyslipidemia, and obesity, it also carries significant risk for the development of cardio-vascular and metabolic sequelae, including diabetes and metabolic syndrome. In light of these evidences, the most therapeutic option prescribed to PCOS women with obesity, regardless of the phenotype from the severity of clinical expression, is lifestyle correction by diet and physical activity.; Purpose: The aim of this study was to evaluate the association between PCOS with KD in overweight and/or obese women with PCOS, and evaluate the possible beneficial effects on metabolic and endocrine parameters, compared to a standard, balanced hypocaloric diet such as Mediterranean diet (MD).; Methods: Participants were assigned to receive, in a 1:1 ratio, one of the two following dietary sequences: KD or MD. In all subjects anthropometric parameters, body composition and metabolic and endocrine parameters were obtained at baseline and after dietetic treatment.; Results: Our results showed a significant change in the anthropometric and biochemical parameters in both groups after both diet therapies, with statistically significant differences (p < 0.001). Though, the reductions of all parameters were significantly greater in KD group than in MD group.; Conclusion: Our results suggest that a reduction of dietary intake of carbohydrates by KD may be considered as a valuable non-pharmacological treatment for PCOS. (© 2022. The Author(s), under exclusive licence to Italian Society of Endocrinology (SIE).)

Cincione, R. I., et al. (2021). "Effects of Mixed of a Ketogenic Diet in Overweight and Obese Women with Polycystic Ovary Syndrome." International Journal of Environmental Research and Public Health 18(23).
	Polycystic ovary syndrome (PCOS) is a commonly occurring endocrine disorder characterized by hirsutism, anovulation, and polycystic ovaries. Often comorbid with insulin resistance, dyslipidemia, and obesity, it also carries significant risk for the development of cardiovascular and metabolic sequelae, including diabetes and metabolic syndrome. The relationship between central obesity and the development of insulin resistance is widely verified. Adipose tissue excess and the coexistent dysregulation of adipocyte functions directly contribute to the pathogenesis of the metabolic complications observed in women with PCOS. In the light of these evidence, the most therapeutic option prescribed to obese women with PCOS, regardless of the phenotype e from the severity of clinical expression, is lifestyle correction by diet and physical activity. The aim of this study is to evaluate the beneficial effects of ketogenic diet in 17 obese women with PCOS. Our results showed that the ketogenic diet inducing therapeutic ketosis, improves the anthropometric and many biochemical parameters such as LH, FSH, SHBG, insulin sensitivity and HOMA index. In addition, it induces a reduction in androgenic production, whereas the contextual reduction of fat mass reduced the acyclic production of estrogens deriving from the aromatization in the adipose tissue of the androgenic excess, with an improvement of the LH/FSH ratio. This is the first study on the effects of the ketogenic diet on PCOS, however, further studies are needed to elucidate the mechanism underlying ketogenic diet effects.

Cirino, N. H. and J. M. Knapp (2019). "Perinatal Posttraumatic Stress Disorder: A Review of Risk Factors, Diagnosis, and Treatment." Obstetrical and Gynecological Survey 74(6): 369-376.
	Importance Perinatal posttraumatic stress disorder (P-PTSD) occurs in approximately 3% to 15% of women in the postpartum period. It is often underrecognized, poorly characterized, and undertreated. If untreated, it can lead to maternal and infant morbidity. Objective The aim of this review article is to discuss P-PTSD as it relates to the obstetrician gynecologist, focusing specifically on identifying perinatal risk factors, P-PTSD diagnostic tools, and treatment options. Evidence Acquisition PubMed, PsycINFO, Cochrane Library, and Scopus were searched on MeSH terms and free text for terms related specifically to P-PTSD. Because of the lack of data on treatment specifically for the perinatal population, a second search for general PTSD treatment guidelines was conducted and incorporated into this review. Results Risk factors have been identified in the literature in 4 major categories: obstetric, psychiatric, social, and subjective distress during delivery. Two diagnostic tests, the general PTSD diagnostic tool, the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and the specific diagnostic tool, the Perinatal Post-Traumatic Stress Disorder Questionnaire, can both be helpful for the clinician to diagnose patients who may have P-PTSD. Individual trauma-focused psychotherapy is first line for treatment of P-PTSD. Immediate debriefing interventions and non-trauma-focused psychotherapy has not been shown to be helpful. If trauma-focused psychotherapy is not available or not preferred, selective serotonin reuptake inhibitors and non-trauma-focused psychotherapy can be used. Conclusions and Relevance Identifying and treating P-PTSD have important implications for maternal and neonatal health. Few treatment studies exist for P-PTSD specifically, so combining P-PTSD research with current guidelines for PTSD is necessary to inform clinical practice. Target Audience Obstetricians and gynecologists, family physicians. Learning Objectives After participating in this CME activity, the participant should be better able to identify several risk factors for the development of PTSD in the perinatal period; describe 2 diagnostic tools to help diagnose and monitor P-PTSD; and compare effective and ineffective treatment options for perinatal PTSD, recognizing the importance of timing of interventions.Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

Clamp Andrew, R., et al. (2022). "Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal cancer treatment (ICON8): overall survival results from an open-label, randomised, controlled, phase 3 trial." The Lancet. Oncology 23(7): 919-930.
	Background: Standard-of-care first-line chemotherapy for epithelial ovarian cancer is carboplatin and paclitaxel administered once every 3 weeks. The JGOG 3016 trial reported significant improvement in progression-free and overall survival with dose-dense weekly paclitaxel and 3-weekly (ie, once every 3 weeks) carboplatin. However, this benefit was not observed in the previously reported progression-free survival results of ICON8. Here, we present the final coprimary outcomes of overall survival and updated progression-free survival analyses of ICON8.; Methods: In this open-label, randomised, controlled, phase 3 trial (ICON8), women aged 18 years or older with newly diagnosed stage IC-IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (here collectively termed ovarian cancer, as defined by International Federation of Gynecology and Obstetrics [FIGO] 1988 criteria) and an Eastern Cooperative Oncology Group performance status of 0-2 were recruited from 117 hospitals with oncology departments in the UK, Australia and New Zealand, Mexico, South Korea, and Ireland. Patients could enter the trial after immediate primary surgery (IPS) or with planned delayed primary surgery (DPS) during chemotherapy, or could have no planned surgery. Participants were randomly assigned (1:1:1), using the Medical Research Council Clinical Trials Unit at University College London randomisation line with stratification by Gynecologic Cancer Intergroup group, FIGO disease stage, and outcome and timing of surgery, to either 3-weekly carboplatin area under the curve (AUC)5 or AUC6 and 3-weekly paclitaxel 175 mg/m 2 (control; group 1), 3-weekly carboplatin AUC5 or AUC6 and weekly paclitaxel 80 mg/m 2 (group 2), or weekly carboplatin AUC2 and weekly paclitaxel 80 mg/m 2 (group 3), all administered via intravenous infusion for a total of six 21-day cycles. Coprimary outcomes were progression-free survival and overall survival, with comparisons done between group 2 and group 1, and group 3 and group 1, in the intention-to-treat population. Safety was assessed in all patients who started at least one chemotherapy cycle. The trial is registered on ClinicalTrials.gov, NCT01654146, and ISRCTN registry, ISRCTN10356387, and is closed to accrual.; Findings: Between June 6, 2011, and Nov 28, 2014, 1566 patients were randomly assigned to group 1 (n=522), group 2 (n=523), or group 3 (n=521). The median age was 62 years (IQR 54-68), 1073 (69%) of 1566 patients had high-grade serous carcinoma, 1119 (71%) had stage IIIC-IV disease, and 745 (48%) had IPS. As of data cutoff (March 31, 2020), with a median follow-up of 69 months (IQR 61-75), no significant difference in overall survival was observed in either comparison: median overall survival of 47·4 months (95% CI 43·1-54·8) in group 1, 54·8 months (46·6-61·6) in group 2, and 53·4 months (49·2-59·6) in group 3 (group 2 vs group 1: hazard ratio 0·87 [97·5% CI 0·73-1·05]; group 3 vs group 1: 0·91 [0·76-1·09]). No significant difference was observed for progression-free survival in either comparison and evidence of non-proportional hazards was seen (p=0·037), with restricted mean survival time of 23·9 months (97·5% CI 22·1-25·6) in group 1, 25·3 months (23·6-27·1) in group 2, and 24·8 months (23·0-26·5) in group 3. The most common grade 3-4 adverse events were reduced neutrophil count (78 [15%] of 511 patients in group 1, 183 [36%] of 514 in group 2, and 154 [30%] of 513 in group 3), reduced white blood cell count (22 [4%] in group 1, 80 [16%] in group 2, and 71 [14%] in group 3), and anaemia (26 [5%] in group 1, 66 [13%] in group 2, and 24 [5%] in group 3). No new serious adverse events were reported. Seven treatment-related deaths were reported (two in group 1, four in group 2, and one in group 3).; Interpretation: In our cohort of predominantly European women with epithelial ovarian cancer, we found that first-line weekly dose-dense chemotherapy did not improve overall or progression-free survival compared with standard 3-weekly chemotherapy and should not be used part of standard multimodality front-line therapy in this patient group.; Funding: Cancer Research UK, Medical Research Council, Health Research Board in Ireland, Irish Cancer Society, and Cancer Australia.; Competing Interests: Declarations of interests ARC reports institutional funding from Cancer Research UK for the present Article, consulting fees from AstraZeneca, payment or honoraria for lectures and presentations from Clovis Oncology and AstraZeneca, and support for attending meetings from GSK/Tesaro. IAM reports consulting fees from Clovis Oncology, AstraZeneca, GSK/Tesaro, and Roche; honoraria for lectures of presentations from AstraZeneca and GSK; travel support for attending meetings from AstraZeneca and GSK; and participation on an Independent Data Monitoring Committee for Transgene. SBl reports consulting fees from Ellipses Pharma, Theolytics, Amphista, and RApport Global Strategic Services; honoraria for lectures or presentations from Nucana and the Norwegian Cancer Society; has a planned patent (WO1999062548A90); being a member of advisory boards for the UCB6114, TORCH, AVAT-M, MROC, and OCTOVA studies; being founder and treasurer of La-Related Protein Society; and has received institutional support to conduct clinical trials from Nucana, UCB, Nurix, Astex, BergenBio, MSD, Redx, and MiNA Therapeutics. JBr reports royalties from Inivata; consulting fees from AstraZeneca; payment or honoraria for lectures or presentations from GSK and AstraZeneca; holding two patents that have been issued (1818159.5 and 1818159.4); being a cofounder and shareholder of Tailor Bio; and being a previous cofounder and shareholder of Inivata. TJP reports consulting fees from AstraZeneca, Exact Health, and MSD, and support for attending meetings from Gilead. SS reports honoraria for lectures or presentations from AstraZeneca and MSD, participation in advisory board meetings for AstraZeneca, and is current President of the British Gynaecological Cancer Society. RL reports advisory works for and honoraria for educational events and support for travel and enrolment at conferences from AstraZeneca and GSK. MH reports consulting fees and payment or honoraria for lectures or presentations from GSK and Clovis Oncology. SBa reports grants from AstraZeneca, Tesaro, and GSK; consulting fees from Amgen, AstraZeneca, Genmabs, GSK, Immunogen, MSD, Merck Sereno, Mersana, Oncxerna, Seagen, and Shattuck Labs; payment or honoraria for lectures from Amgen, AstraZeneca, Clovis Oncology, GSK, Immunogen, MSD, Mersana, Pfizer, Roche, and Takeda; and is European Society for Medical Oncology (ESMO) Director of Membership. RMG reports grants from Clovis Oncology, Boehringer Ingelheim, and Lily/Ignyta; consulting fees from Clovis Oncology, AstraZeneca, MSD, GSK, Sotio, Immunogen, and Novartis; payment or honoraria for lectures or presentations from Clovis Oncology, AstraZeneca, and GSK; support for attending conferences from GSK; being a member of the Independent Data Monitoring Committee for the Glasgow Cancer Research Trials Unit and Swiss GO Trials Group; and receipt of equipment (drugs) to institution from GSK. CLH reports royalties from Cambridge University Press, support for attending conferences from Tesaro, being chair of the Wales Cancer Network Gynaecological Cancer Site Group, and a member of British Gynaecological Society Guidelines Group. JAL reports institutional research grants from AstraZeneca and MSD/Merck; payment or honoraria for lectures or presentations from Pfizer, AstraZeneca, GSK, MSD, Clovis Oncology, Eisai, Bristol Myers Squibb, Artios Pharma, VBL Therapeutics, and Neopharm; being chair of an Independent Data Monitoring Committee for Regeneron; being editor of the Gynaecological Clinical Practice Guidelines (for ESMO); and former Vice President of European Society of Gynaecological Oncology. All other authors declare no competing interests. (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Clamp, A. R., et al. (2021). "Rucaparib maintenance treatment for recurrent ovarian carcinoma: the effects of progression-free interval and prior therapies on efficacy and safety in the randomized phase III trial ARIEL3." International Journal of Gynecological Cancer 31(7): 949‐958.
	INTRODUCTION: In ARIEL3 (NCT01968213), the poly(adenosine diphosphate‐ribose) polymerase inhibitor rucaparib significantly improved progression‐free survival versus placebo regardless of biomarker status when used as maintenance treatment for recurrent ovarian cancer. The aim of the current analyses was to evaluate the efficacy and safety of rucaparib in subgroups based on progression‐free interval following penultimate platinum, number of prior chemotherapies, and prior use of bevacizumab. METHODS: Patients were randomized 2:1 to rucaparib 600 mg twice daily or placebo. Within subgroups, progression‐free survival was assessed in prespecified, nested cohorts: BRCA‐mutant, homologous recombination deficient (BRCA‐mutant or wild‐type BRCA/high genomic loss of heterozygosity), and the intent‐to‐treat population. RESULTS: In the intent‐to‐treat population, median investigator‐assessed progression‐free survival was 8.2 months with rucaparib versus 4.1 months with placebo (n=151 vs n=76; HR 0.33, 95% CI 0.24 to 0.46, p<0.0001) for patients with progression‐free interval 6 to ≤12 months, and 13.6 versus 5.6 months (n=224 vs n=113; HR 0.39, 95% CI 0.30 to 0.52, p<0.0001) for those with progression‐free interval >12 months. Median progression‐free survival was 10.4 versus 5.4 months (n=231 vs n=124; HR 0.42, 95% CI 0.32 to 0.54, p<0.0001) for patients who had received two prior chemotherapies, and 11.1 versus 5.3 months (n=144 vs n=65; HR 0.28, 95% CI 0.19 to 0.41, p<0.0001) for those who had received ≥3 prior chemotherapies. Median progression‐free survival was 10.3 versus 5.4 months (n=83 vs n=43; HR 0.42, 95% CI 0.26 to 0.68, p=0.0004) for patients who had received prior bevacizumab, and 10.9 versus 5.4 months (n=292 vs n=146; HR 0.35, 95% CI 0.28 to 0.45, p<0.0001) for those who had not. Across subgroups, median progression‐free survival was also significantly longer with rucaparib versus placebo in the BRCA‐mutant and homologous recombination deficient cohorts. Safety was consistent across subgroups. CONCLUSIONS: Rucaparib maintenance treatment significantly improved progression‐free survival versus placebo irrespective of progression‐free interval following penultimate platinum, number of lines of prior chemotherapy, and previous use of bevacizumab.

Clapp, M. A., et al. (2024). "The Impact of a Behavioral-Economics Informed Intervention on Primary Care Utilization for Postpartum Individuals with Chronic Conditions: A Randomized Controlled Trial." MedRxiv.
	Importance: Despite careful monitoring of chronic and gestational conditions during pregnancy, most postpartum individuals with (or at high risk for) chronic conditions are not engaged in primary care following delivery. This lack of postpartum obstetric-to-primary care transition reflects a missed opportunity to improve short- and long-term health and well-being. Objective(s): To evaluate the efficacy of a behavioral economics-informed intervention designed to reduce patient administrative burden and information gaps on postpartum primary care visit completion. Design(s): Individual-level randomized controlled trial. Setting(s): Academic obstetric practice that included hospital- and community-based outpatient clinics. Participant(s): English- and Spanish-speaking pregnant or recently postpartum adults who had obesity (pre-pregnancy body mass index (>=30 kg/m2)), anxiety or depressive mood disorder, type 1 or 2 diabetes mellitus, chronic hypertension, gestational diabetes, and pregnancy-related hypertension listed in their medical record were eligible to participate. Participants also were required to have a primary care clinician (PCP) listed in their electronic health record. Intervention(s): A behavioral economics-informed intervention bundle, which included automatic scheduling of PCP appointments after delivery, patient-tailored health information, and appointment reminder nudges. Main Outcome: Attending a "health care maintenance" (i.e., "annual exam") appointment or receiving disease-specific management relating to the eligibility criteria (obesity, anxiety/depression, diabetes, or hypertension) by a PCP within 4 months of delivery. Result(s): 360 patients were randomized: 176 to the control group and 184 to the intervention group. primary outcome occurred in 22.0% in the control group and 40.0% in the intervention group (p<0.001). In the regression model that accounted for the randomization strata, the intervention increased PCP visit completion within 4 months of a patient's EDD by 19.9 percentage points (95% confidence interval (CI) 10.7-29.1). Conclusions and Relevance: Standard postpartum care practice encourages but does not facilitate transitions from obstetric to primary care. This study found that a behavioral science-informed intervention designed to facilitate this transition through default PCP visit scheduling, tailored messages, and nudge reminders substantially increased postpartum primary care visit completion for patients with or at risk for common comorbidities. This intervention represents a potentially low-cost and scalable solution to increase primary care engagement and ongoing health condition management after pregnancy, a time of high engagement and health activation. Trial Registration: NCT05543265.Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license.

Clara, B., et al. (2020). "Efficacy of phloroglucinol for the treatment of pain of gynaecologic or obstetrical origin: a systematic review of literature of randomised controlled trials." European Journal of Clinical Pharmacology 76(1): 1-6.
	Purpose: Antispasmodics like phloroglucinol are commonly used to alleviate pain. Various authorities recommend the use of this drug for conditions such as dysmenorrhoea, threatened abortion or labour pains. The goal was to carry out a systematic review analysing the existing data concerning the efficacy of phloroglucinol to treat pain in obstetrical or gynaecologic cases. The protocol was registered in Prospero (CRD 42018094065).; Methods: The keywords "phloroglucinol" and "randomised controlled trials" were used to search Medline, Embase and the Cochrane Library. We selected randomised, controlled against placebo trials testing the effect of phloroglucinol on gynaecologic or obstetrical pain either as a primary or secondary endpoint. We excluded trials exploring pain caused by intestinal, renal, metabolic or other causes and trials that were not available for critical review in either English or French. A quantitative synthesis (meta-analysis) was planned if the included trials were sufficiently homogenous. If this were not the case, a descriptive synthesis would be presented.; Results: Twelve trials identified studied the effect of phloroglucinol in gynaecologic or obstetrical conditions. Only two trials corresponded to the inclusion criteria of this review, one of which was not available for critical review.; Conclusions: Phloroglucinol is not well evaluated in this field. Whether for labour pains, abortion pains or benign gynaecologic pains, the results found are insufficient to promote the use of this drug in these indications.

Clark, K. and M. Westberg Sarah (2019). "Benefits of Levonorgestrel Intrauterine Device Use vs. Oral or Transdermal Progesterone for Postmenopausal Women Using Estrogen Containing Hormone Therapy." Innovations in pharmacy 10(3).
	Background: Endometrial hyperplasia is a major concern for women that start estrogen replacement therapy (ERT) to control symptoms experienced during perimenopause and postmenopause. Progesterone provides protection against endometrial hyperplasia, and there are multiple dosage forms of progesterone available. Intrauterine progesterone may offer an appealing option with additional benefits beyond endometrial protection for patients.; Objective: The overarching objective of this systematic review is to characterize the relationship between levonorgestrel containing intrauterine devices (LNG-IUD) and the prevention of endometrial hyperplasia in peri- and postmenopausal women. Specifically, this systematic review addresses whether LNG-IUD has equivalent efficacy of protecting against endometrial hyperplasia, but an improved safety profile when compared to oral progesterone in women using ERT.; Methods: OVID Medline, Scopus, and Cochrane were used to find available studies that have investigated the relationship between endometrial hyperplasia prevention and varying dosage forms of progesterone. Randomized control studies comparing LNG-IUD with no treatment, placebo, or other hormonal therapy in adult females were included. In addition, due to a lack of randomized control studies, four non-comparative studies were included.; Results: There were eleven total studies included that investigated LNG-IUD use in women on ERT. According to the studies, the LNG-IUD was equally effective as other routes (oral, vaginal) of progesterone administration in protecting against endometrial hyperplasia.; Conclusions: The LNG-IUD prevents endometrial proliferation at least as effective as oral or vaginal forms of progesterone. LNG-IUD is a safe option for women starting estrogen replacement therapy and has added benefits due to decreased adverse effects.; Competing Interests: Conflicts of interest: None (© Individual authors.)

Clark, L., et al. (2022). "Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment." Trials 23(1): 628.
	Background: Women with stress urinary incontinence (SUI) experience urine leakage with physical activity. Currently, the interventional treatments for SUI are surgical, or endoscopic bulking injection(s). However, these procedures are not always successful, and symptoms can persist or come back after treatment, categorised as recurrent SUI. There are longstanding symptoms and distress associated with a failed primary treatment, and currently, there is no consensus on how best to treat women with recurrent, or persistent, SUI. Method(s): A two-arm trial, set in at least 20 National Health Service (NHS) urology and urogynaecology referral units in the UK, randomising 250 adult women with recurrent or persistent SUI 1:1 to receive either an endoscopic intervention (endoscopic bulking injections) or a standard NHS surgical intervention, currently colposuspension, autologous fascial sling or artificial urinary sphincter. The aim of the trial is to determine whether surgical treatment is superior to endoscopic bulking injections in terms of symptom severity at 1 year after randomisation. This primary outcome will be measured using the patient-reported International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF). Secondary outcomes include assessment of longer-term clinical impact, improvement of symptoms, safety, operative assessments, sexual function, cost-effectiveness and an evaluation of patients' and clinicians' views and experiences of the interventions. Discussion(s): There is a lack of high-quality, randomised, scientific evidence for which treatment is best for women presenting with recurrent SUI. The PURSUIT study will benefit healthcare professionals and patients and provide robust evidence to guide further treatment and improve symptoms and quality of life for women with this condition. Trial registration: International Standard Randomised Controlled Trials Number (ISRCTN) registry ISRCTN12201059. Registered on 09 January 2020.Copyright © 2022, The Author(s).

Clark, L., et al. (2021). "The role of fitness trackers and tailored feedback messages in motivating endometrial cancer survivors to increase physical activity: results of the MOVES trial." Gynecologic Oncology 162: S304.
	Objectives: Endometrial cancer (EC) survivors are often overweight or obese and may benefit from increased physical activity. Increases in daily step count of 2,000 steps per day has been shown to improve cardiovascular health. We sought to assess a fitness intervention (fitness tracker + tailored feedback messages) for EC survivors. Methods: A prospective trial of EC survivors was undertaken from September 2018 to December 2019. Thirty‐nine survivors were approached for enrollment with 36 randomized (18 intervention, 18 control). All participants received a fitness tracker. Survivors were randomized 1:1 to receipt or non‐receipt of weekly tailored feedback messages. The primary outcome was change in average daily step count from baseline (week 1) to study completion (week 12). Secondary outcomes included acceptability, and changes in metabolic lab parameters (serum glucose, LDL, and insulin levels), body mass index (BMI) and waist to hip ratio (W/H). The trial was powered to detect a clinically significant change in daily step count of 2,000 steps. Comparisons of baseline to study completion labs were made using the Wilcoxon Two‐sample test. Student's T‐test was used for comparisons of control and intervention groups. Results: At baseline, there was no difference in BMI (35.9 vs 36.7, p=0.81) or W/H ratio (0.9 vs 0.89, p=0.40) between control and intervention arms. Baseline daily step count was 5291 steps in the control arm and 4295 in the intervention arm (p=0.16). There was no difference in baseline metabolic labs including glucose (100 vs 103, p=0.85), serum insulin (13.1 vs 16.8, p=0.78), and LDL (150 vs 113, p=0.07). The intervention group saw a statistical change in average daily step count (4295 to 5332, p=0.02). The control group did not have a statistically significant change (5291 to 5600, p=0.40). For the primary outcome of average daily step count change, there was no statistically significant difference between the two groups (+309 control vs +1037 intervention, p=0.21). There was no difference in change in BMI (‐0.27 vs ‐0.02, p=0.7), glucose (+1 vs ‐3, p=0.29), LDL (‐9.1 vs ‐3.5, p=0.95) or insulin (‐2.15 vs ‐1.95, p=0.32) between the control and intervention arms. Regarding acceptability, survivors found the feedback to be helpful (87%) and easy to understand (87%). Two‐thirds of survivors found the messages to be motivating, 47% desired increased frequency of messaging, and 53% thought the weekly message was adequate. Overall, 33% of intervention survivors versus 22% of control survivors had decline in fitness tracker use during the intervention, resulting in missing step data (p=0.46). Conclusions: A fitness intervention using fitness trackers and tailored feedback messaging may improve physical activity as measured by daily step count in EC survivors, however, significant noncompliance with fitness tracker use was seen in both groups by study end. Tailoring the frequency of feedback messages to survivor preference may be important to optimizing this intervention.

Clark, N. (2021). "Laparoscopic abdominal cerclage: an effective option for refractory cervical insufficiency." Contemporary ob/gyn 66(1): 18‐21.
	
Clarke, M., et al. (2021). "A silent burden-prolapse, incontinence, and infertility in Australian Aboriginal and Torres Strait Islander women: A systematic search and narrative review." International Journal of Gynecology and Obstetrics 155(2): 268-274.
	Background: Pelvic organ prolapse (POP), urinary incontinence, and infertility are all prevalent conditions associated with considerable reduction in quality of life. As a group, Aboriginal and Torres Strait Islander women may be at higher risk of these conditions, but studies are scarce. Objective(s): To review the literature pertaining to the epidemiology, diagnosis, and management of these conditions in Indigenous Australian women. Search strategy: Medline, Embase, and Scopus were searched for articles published between 1980 and 2021 pertaining to these conditions in Indigenous Australian women. Selection Criteria: Studies that did not directly address the epidemiology, diagnosis, and management of these conditions were excluded. Main Result(s): It was possible to identify only 11 papers dealing with these conditions in Indigenous Australian women. Only one dealt with POP and was a retrospective audit of a health outreach program in the Northern Territory concluding that there was significant underreporting of the condition. Five papers dealt with urinary incontinence and, again, described significant underreporting and poor referral pathways. Five papers reported small studies about infertility, one reporting poor engagement from clinical directors. Conclusion(s): It was concluded that despite the importance of these conditions, there is almost no body of research and this is an urgent national problem.Copyright © 2021 International Federation of Gynecology and Obstetrics

Classe, J.-M., et al. (2022). "CHRONO: randomized trial of the CHROnology of surgery after Neoadjuvant chemotherapy for Ovarian cancer." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 32(8): 1071-1075.
	Background: In patients treated for advanced ovarian cancer not suitable for complete primary surgery, interval surgery after three courses of neoadjuvant chemotherapy has been considered standard management since the EORTC randomized trial published in 2010. An alternative approach with delayed surgery after six courses of neoadjuvant chemotherapy was reported in retrospective series.; Primary Objectives: To assess the efficacy on progression free survival of interval cytoreduction surgery after three cycles of neoadjuvant chemotherapy compared with delayed surgery after six cycles of neoadjuvant chemotherapy.; Study Hypothesis: In women with ovarian cancer not suitable for primary surgical cytoreduction, surgery after six cycles of neoadjuvant chemotherapy will prove better disease-free survival than cytoreductive surgery after only three cycles.; Trial Design: CHRONO is a multicenter, randomized phase III trial. After three courses of neoadjuvant chemotherapy, eligible patients will be randomized (1:1) to either completion surgery followed by an additional five cycles of chemotherapy (control arm) or an additional three cycles of neoadjuvant chemotherapy followed by completion surgery and then two additional cycles of chemotherapy (experimental arm). Patients in both groups will receive eight total cycles of chemotherapy.; Major Inclusion/exclusion Criteria: The main inclusion criteria are histologically confirmed epithelial high-grade serous or endometrioid ovarian cancer, documented FIGO stage IIIB-IVA unsuitable for complete primary surgery but considered resectable after three courses of neoadjuvant chemotherapy. The main exclusion criteria are mucinous, clear cell, carcinosarcoma, or low-grade serous histologies.; Primary Endpoint: The primary endpoint is progression-free survival.; Sample Size: 210 eligible patients ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: The estimated date for completing accrual will be Q2 2023. The estimated date for presentation of the first results is Q3 2028.; Trial Registration Number: NCT03579394.; Competing Interests: Competing interests: J-MC: lectures/other education events from Astra Zeneca, GSK, and Clovis. (© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Clayton, A. H., et al. (2024). "The magnitude and sustainability of treatment benefit of zuranolone on function and well-being as assessed by the SF-36 in adult patients with MDD and PPD: An integrated analysis of 4 randomized clinical trials." Journal of Affective Disorders 351: 904-914.
	Background: Major depressive disorder (MDD) and postpartum depression (PPD) are disabling conditions. This integrated analysis of MDD and PPD clinical trials investigated the impact of zuranolone-a positive allosteric modulator of synaptic and extrasynaptic GABAA receptors and neuroactive steroid under investigation for adults with MDD and approved as an oral, once-daily, 14-day treatment course for adults with PPD in the US-on health-related quality of life, including functioning and well-being, as assessed using the 36-item Short Form Health Survey V2 (SF-36). Method(s): Integrated data from 3 MDD (201B, MOUNTAIN, WATERFALL) and 1 PPD trial (ROBIN) for individual SF-36 domains were compared for zuranolone (30- and 50-mg) vs placebo at Day (D)15 and D42. Comparisons between zuranolone responders (>=50 % reduction from baseline in 17-item Hamilton Depression Rating Scale total score) and nonresponders were assessed. Result(s): Overall, 1003 patients were included (zuranolone, n = 504; placebo, n = 499). Significant differences in change from baseline (CFB) to D15 for patients in zuranolone vs placebo groups were observed in 6/8 domains; changes were sustained or improved at D42, with significant CFB differences for all 8 domains. Zuranolone responders had significantly higher CFB scores vs nonresponders for all domains at D15 and D42 (p < 0.001). Limitation(s): Two zuranolone doses were integrated across populations of 2 disease states with potential differences in functioning, comorbidities, and patient demographics. All p-values presented are nominal. Conclusion(s): Integrated data across 4 zuranolone clinical trials showed improvements in functioning and well-being across all SF-36 domains. Benefits persisted after completion of treatment course at D42.Copyright © 2024

Clifford, R. E., et al. (2021). "Metformin as a radiosensitiser for pelvic malignancy: A systematic review of the literature." European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology 47(6): 1252-1257.
	Background: The treatment of pelvic malignancies has continued to improve over recent years, with neoadjuvant radiotherapy often considered the gold standard to downstage disease. Radiosensitisers are routinely employed in an attempt to improve response of cancers to radiotherapy. Previous preclinical evidence has suggested a role for metformin, a commonly used drug for type 2 diabetes.; Method: A literature search was performed for published full text articles using the PubMed, Cochrane and Scopus databases using the search criteria string 'Metformin' AND ('Radiosensitivity' OR 'radiosensitising' OR 'radiosensitising'). Additional papers were detected by scanning the references of relevant papers. Data were extracted from each study by two authors onto a dedicated proforma. The review was registered on the PROSPERO database (ID: CRD42020199066).; Results: A total of 242 papers were identified, 11 of which were included in this review; an additional 5 papers were obtained from reference searches. Metformin has been demonstrated to reduce cell-viability post-radiotherapy in both rectal and prostate cancer cell lines, with an enhanced effect in tumours with a p53 mutation and increased apoptosis post-radiotherapy for cervical cancer. Clinical trials demonstrate improved tumour and nodal downstaging and pCR rates for rectal cancer using metformin as a radiosensitiser.; Conclusion: With an increasing understanding of the underlying mechanism of the effects on metformin prospective studies are required to assess the effect of routine use on cancer related outcomes. Progressive future studies may be better served by the use of predictive biomarker guided treatment to enable identification of the appropriate cohort to target.; Competing Interests: Declaration of competing interest None. (Copyright © 2020 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Climent Maria, T., et al. (2023). "Should We Abandon Intraperitoneal Chemotherapy in the Treatment of Advanced Ovarian Cancer? A Meta-Analysis." Journal of Personalized Medicine 13(12).
	Background: Ovarian cancer is the gynaecological malignancy with the highest mortality and diagnosis often occurs in its advanced stages. Standard treatment in these cases is based on complete cytoreductive surgery with adjuvant intravenous chemotherapy. Other types of treatment are being evaluated to improve the prognosis of these patients, including intraperitoneal chemotherapy and antiangiogenic therapy. These may improve survival or time to relapse in addition to intravenous chemotherapy.; Objective: The aim of this meta-analysis is to determine whether treatment with intravenous chemotherapy remains the gold standard, or whether the addition of intraperitoneal chemotherapy has a benefit in overall survival (OS) and disease-free interval (DFS).; Materials and Methods: A literature search was carried out in Pubmed and Cochrane, selecting clinical studies and systematic reviews published in the last 10 years. Statistical analysis was performed using the hazard ratio measure in the RevMan tool.; Results: Intraperitoneal chemotherapy shows a benefit in OS and DFS compared with standard intravenous chemotherapy. The significant differences in OS (HR: 0.81 CI 95% 0.74-0.88) and in DFS (HR: 0.81 CI 95% 0.75-0.87) are statistically significant ( p < 0.00001). There were no clinical differences in toxicity and side-effects.; Conclusion: Intraperitoneal chemotherapy is an option that improves OS and DFS without significant toxicity regarding the use of intravenous chemotherapy alone. However, prospective studies are needed to determine the optimal dose and treatment regimen that will maintain the benefits while minimising side effects and toxicity and the profile of patients who will benefit most from this treatment.

Climent Maria, T., et al. (2023). "Surgery in Recurrent Ovarian Cancer: A Meta-Analysis." Cancers 15(13).
	Background : The second cytoreductive surgery performed for a patient who has recurrent ovarian cancer remains controversial. Our study analyzes overall survival (OS) and disease-free survival (DFS) for cytoreductive surgery in addition to chemotherapy in recurrent ovarian cancer instead of chemotherapy alone. Methods : A meta-analysis was conducted using PubMed and the Cochrane database of systematic reviews to select randomized controlled studies. In total, three randomized studies were used, employing a total of 1249 patients. Results : The results of our meta-analysis of these randomized controlled trials identified significant differences in OS (HR = 0.83, IC 95% 0.70-0.99, p < 0.04) and DFS (HR = 0.63, IC 95% 0.55-0.72, p < 0.000001). A subgroup analysis comparing complete cytoreductive surgery and surgery with residual tumor achieved better results for both OS (HR = 0.65, IC 95% 0.49-0.86, p = 0.002) and DFS (HR = 0.67, IC 95% 0.53-0.82, p = 0.0008), with statistical significance. Conclusions : A complete secondary cytoreductive surgery (SCS) in recurrent ovarian cancer (ROC) demonstrates an improvement in the OS and DFS, and this benefit is most evident in cases where complete cytoreductive surgery is achieved. The challenge is the correct patient selection for secondary cytoreductive surgery to improve the results of this approach.

Clinkscales, N., et al. (2022). "The effectiveness of psychological interventions for anxiety in the perinatal period: A systematic review and meta-analysis." Psychology and psychotherapy 96(2).
	PURPOSE: Anxiety disorders are relatively common during pregnancy and the postnatal period. Despite their potential acceptability to users, psychological interventions research for this population is still in its infancy. The meta-analysis aimed to comprehensively evaluate the evidence of the effectiveness of psychological interventions for reducing perinatal anxiety. METHOD: The review followed PRISMA guidelines. A total of 26 studies published between 2004 and 2022 fulfilled inclusion criteria of which 22 were included in the meta-analysis. RESULTS: Results indicated that psychological interventions were more effective than control conditions in reducing symptoms of perinatal anxiety (equivalent to a medium post treatment effect size). Effect sizes were robust for cognitive, behavioural and mindfulness-based interventions. Targeting anxiety also appeared to impact on depression symptoms. There was substantial evidence of methodological heterogeneity. CONCLUSIONS: This review demonstrates that psychological interventions are effective in reducing symptoms of both anxiety and comorbid anxiety and depression in both the antenatal and postnatal periods. Further research on longer-term effects, infant outcomes, treatment approach and modality are required.

Close, A., et al. (2023). "Exclusive manual perineal rehabilitation with lidocaine 2% gel in the treatment of provoked vestibulodynia: results from a single-arm interventional study." International journal of impotence research 35(2): 157-163.
	As of now, there is no adequate therapeutic strategy for provoked vestibulodynia (PVD). Pelvic Floor Muscle Therapy (PFMT) is a widely used technique in general pelvic floor rehabilitation. The objective of this study is to examine the effects of exclusive manual perineal rehabilitation with lidocaine 2% gel on PVD. During the first session, recruited patients (n = 68; mean age 31 ± 8.6; range: 18-52) received a questionnaire (Q1) on general well-being and health, pain of the genital area, sexual function, and symptoms during vaginal penetration. This questionnaire was based on a generalised questionnaire on the quality of life, the Medical Outcomes Study 36-item (SF-36), the Female Sexual Function Index (FSFI), and the Visual Analogue Scale (VAS). A second identical questionnaire with an additional set of open-ended questions concerning the assessment of the treatment was collected after treatment (Q2). A total of 45 questionnaires were completed. Statistical results showed a significant improvement of all items before and after treatment (p < 0.001): perceived general well-being and health, perceived vulvar pain, perceived sexual function, and perceived vaginal penetration. In conclusion, exclusive manual perineal rehabilitation using lidocaine 2% gel seems to be a safe and effective treatment option for vulvodynia in women. (© 2022. The Author(s), under exclusive licence to Springer Nature Limited.)

Co, D. M., et al. (2022). Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer.
	No Results Available Drug: Envafolimab+Lenvatinib|Drug: Envafolimab ORR of Envafolimab alone or with Lenvatinib|The duration of response (DoR）|Disease control rate (DCR)|Time to response (TTR)|Progression-free survival (PFS)|To evaluate the overall survival (OS) in in subjects with advance endometrial cancer Female Phase 2 108 Industry Allocation: Non-Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment KN035-CN-011 October 2024

Coada Camelia, A., et al. (2023). "Optimal number of neoadjuvant chemotherapy cycles prior to interval debulking surgery in advanced epithelial ovarian cancer: a systematic review and meta-analysis of progression-free survival and overall survival." Journal of Gynecologic Oncology 34(6): e82.
	Objective: Neoadjuvant chemotherapy (NACT) represents a treatment option in patients with advanced epithelial ovarian cancer (AEOC) who are not good candidates for primary debulking surgery. Usually, 3 cycles of chemotherapy before surgery have been considered the best option for patient survival, although quite often some patients receive more than 3 cycles. The aim of this systematic review and meta-analysis was to identify the optimal number of NACT cycles reporting better survival in AEOC patients.; Methods: PubMed, Cochrane Library, and Scopus were searched for original articles that analyzed the relationship between the number of chemotherapy cycles and clinical outcomes in AEOC patients before interval debulking surgery (IDS). The main outcomes were progression-free survival (PFS) and overall survival (OS).; Results: A total of 22 studies comprising 7,005 patients diagnosed with AEOC were included in our analysis. In terms of survival, the reviewed studies dividing the patients in ≤3 NACT cycles vs. >3, showed a trend for a decrease in PFS and a significant reduction in OS with an increasing number of cycles, while a difference in both PFS and OS was revealed if early IDS included patients with 4 NACT cycles. These results should be interpreted with caution due to the complex characteristics of AEOC patients.; Conclusion: In conclusion, our review and meta-analysis revealed that there is not enough evidence to determine the optimal number of NACT treatments before surgery. Further research in the form of well-designed randomized controlled trials is necessary to address this issue.; Trial Registration: PROSPERO Identifier: CRD42022334959.; Competing Interests: No potential conflict of interest relevant to this article was reported. (© 2023. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.)

Coccolini, F., et al. (2021). "Intraperitoneal chemotherapy for ovarian cancer with peritoneal metastases, systematic review of the literature and focused personal experience." Journal of gastrointestinal oncology 12(Suppl 1): S144-S181.
	Epithelial ovarian cancer (EOC) causes 60% of ovarian cancer cases and is the fourth most common cause of death from cancer in women. The standard of care for EOC includes a combination of surgery followed by intravenous chemotherapy. Intraperitoneal (IP) chemotherapy (CT) has been introduced into the therapeutic algorithm of EOC with positive results. To explore existing results regarding intraperitoneal chemotherapy a systematic review of the literature and an analysis of our own institutional prospective database of patients treated with cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) for EOC at different stages were conducted. The focused report concerning our personal experience with advanced EOC treated with cytoreductive surgery and HIPEC produced the following results: In 57 patients cisplatin + paclitaxel as HIPEC was the only significant factor improving overall survival (OS) at multivariate analysis (OR 6.54, 95% CI: 1.24-34.47, P=0.027). Patients treated with HIPEC cisplatin + paclitaxel showed a median OS of 46 months (SD 6.4, 95% CI: 33.4-58.6), while patients treated with other HIPEC regimens showed a median OS of 12 months (SD 3.1, 95% CI: 6.0-18.0). The 2y-OS was 72% and 3y-OS was 68% for cisplatin + paclitaxel as HIPEC, while the 2y- and 3y-OS was 0% for other HIPEC regimens. Patients treated with HIPEC cisplatin + paclitaxel showed a median disease-free survival (DFS) of 13 months (SD 1.6, 95% CI: 9.9-16.1), while patients treated with other HIPEC regimens showed a median DFS of 8 months (SD 3.1, 95% CI: 1.9-14.1). In conclusion, HIPEC cisplatin + paclitaxel in ovarian cancer showed positive results that may be considered semi-definitive according to the level of evidence and should be considered a starting point for further investigations. At present HIPEC cisplatin + paclitaxel should be proposed to patients with advanced ovarian cancer as standard treatment at almost all stages of disease. Platinum + taxane-based intraperitoneal regimens demonstrated superior results compared to other regimens.; Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/jgo-2020-06). The focused issue was sponsored by the Peritoneal Surface Oncology Group International (PSOGI). The authors have no other conflicts of interest to declare. (2021 Journal of Gastrointestinal Oncology. All rights reserved.)

Cochrane Kelsey, M., et al. (2023). "Optimizing vitamin D status in polycystic ovary syndrome: a systematic review and dose-response meta-analysis." Nutrition reviews.
	Context: Polycystic ovary syndrome (PCOS) is a common and complex endocrine disorder in women of reproductive age. Vitamin D supplementation is a promising complementary therapy for PCOS, yet there is no consensus on an optimal dose, leading to a lack of evidence-based supplementation guidelines.; Objective: The objective of this study was to conduct a vitamin D dose-response meta-analysis among women with PCOS.; Data Sources: MEDLINE, CINAHL, and EMBASE databases from inception to November 2022 were searched for relevant articles.; Data Extraction: Study screening and bias assessment were conducted by 2 independent reviewers. Eight relevant studies were identified; data for serum 25(OH)D (nmol/L) at baseline and at 12 weeks in each intervention group (mean ± SD) and vitamin D dose were extracted.; Data Analysis: Estimates across studies were used to create a pooled curve, using restricted cubic splines with knots at the 10th, 50th, and 90th percentiles of the distribution of doses, to estimate the mean difference in effect for serum 25(OH)D at each dose compared with 0 IU/day. Sensitivity analyses were conducted fixing knots at 4000 IU/day and 7000 IU/day, which were a priori identified as potentially important thresholds, and to assess model fit and estimate heterogeneity. The pooled analysis demonstrated strong evidence of a dose-response relationship (P < .001), suggesting an increasing effect with increasing dose. An initial increase in serum 25(OH)D was evident until doses of approximately 3000 IU/day; this was followed by a plateau in effect between approximately 3000 IU/day and 5000 IU/day. The effect of supplementation with >5000 IU/day was unclear, given the minimal data at higher doses. The curve produced robust results for moderate doses (3000 IU/day to 4000 IU/day), which were not sensitive to model specification.; Conclusion: Women with PCOS are responsive to vitamin D supplementation, but the benefit of providing doses of >3000 IU/day appears minimal. Further data is required to determine dose-response at doses of >5000 IU/day, and whether higher intakes provide a clinically meaningful advantage in this population.; Systematic Review Registration: PROSPERO registration no. CRD42021259396. (© The Author(s) 2023. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Coelho, N., et al. (2020). "Definitions, prevalence, clinical implications and treatment of T-shaped uterus: systematic review." Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology.
	OBJECTIVE: This study aims to summarize the current evidence regarding definitions, diagnosis, prevalence, clinical implications and impact of surgical treatment for T-shaped uterus not related to Diethystilbestrol (DES) exposure in a systematic review and to highlight what needs to be better clarified regarding T-shaped uterus. METHODS: A search on PubMed, Scopus and EMBASE was performed on Mar-2020. The following search terms were used: t-shaped OR t-shape OR infantile OR (lateral indentation) OR (Diethylstilbestrol OR DES) AND (uterus OR uterine OR uteri), AND (anomaly OR anomalies OR malformation OR malformations). Additionally, we hand-searched reference list from included studies for other relevant publications. All studies presenting any data regarding T-shaped uterus not related to DES exposure including at least 10 women were considered eligible. All the studies regarding DES-related T-shaped uterus were excluded because DES is not used since 1971. RESULTS: The search has found 2,504 records and 20 studies were included in the systematic review. There are only poor-quality studies (observational and quasi-experimental with uncontrolled before-after design). In most of the studies, the diagnosis of T-shaped uterus was based in three-dimensional US (3D-US) (11/16 studies). There is no consensus on definition of T-shaped uterus, but the most cited criteria (4/16 studies) is the criteria from European Society of Human Reproduction and Embryology and the European Society for Gynecological Endoscopy (ESHRE/ESGE) 2013 (narrow uterine cavity due to thickened lateral walls with a correlation 2/3 uterine corpus and 1/3 cervix), which is subjective. The prevalence of T-shaped uterus varied from 0.2-10% in the included studies. Regarding etiology of T-shaped uterus except for DES, there was mention to adenomyosis (1 study); adhesions (5 studies) and it was cited as primary condition (3 studies). Worse reproductive outcomes were related to T-shaped uterus due to infertility (9 studies), miscarriage (7 studies), preterm delivery (2 studies), ectopic pregnancy (1 study) and repeated implantation failure (7 studies). From the studies that analyzed benefits of surgical treatment by hysteroscopic metroplasty (12 studies), some of them had mentioned some improvement on pregnancy rate (49.6%- 88%; 8 studies), live birth rate (66.7-86.6%; 7 studies), term delivery rate (4 studies), reduction in miscarriage (12-24.2%; 5 studies) and ectopic pregnancy (1 study). This evidence is of very low quality with serious/critical risk of bias toward to overestimate the effect of the intervention, because it remains unknown whether before/after changes are the effect of metroplasty or other factors. Some authors reported no complications related to the procedure while others mentioned persistence of the dysmorphism (1.4-11%); bleeding (1.3%); infection (2.6%) and adhesions (11.1-16.8%). CONCLUSIONS: Until now, diagnosis, prevalence, and clinical relevance on reproductive outcomes in women with T-shaped uterus is unknown. Expectant management must be considered the most appropriate choice for daily practice until randomized controlled trials shows otherwise. This article is protected by copyright. All rights reserved.

Coelingh, B., et al. (2024). "Health benefits of combined oral contraceptives - a narrative review." The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception: 1-13.
	PURPOSE: This review presents an update of the non-contraceptive health benefits of the combined oral contraceptive pill. METHOD(S): We conducted a literature search for (review) articles that discussed the health benefits of combined oral contraceptives (COCs), in the period from 1980 to 2023. RESULT(S): We identified 21 subjective and/or objective health benefits of COCs related to (i) the reproductive tract, (ii) non-gynaecological benign disorders and (iii) malignancies. Reproductive tract benefits are related to menstrual bleeding(including anaemia and toxic shock syndrome), dysmenorrhoea, migraine, premenstrual syndrome (PMS), ovarian cysts, Polycystic Ovary Syndrome (PCOS), androgen related symptoms, ectopic pregnancy, hypoestrogenism, endometriosis and adenomyosis, uterine fibroids and pelvic inflammatory disease (PID). Non-gynaecological benefits are related to benign breast disease, osteoporosis, rheumatoid arthritis, multiple sclerosis, asthma and porphyria. Health benefits of COCs related to cancer are lower risks of endometrial cancer, ovarian cancer and colorectal cancer. CONCLUSION(S): The use of combined oral contraceptives is accompanied with a range of health benefits, to be balanced against its side-effects and risks. Several health benefits of COCs are a reason for non-contraceptive COC prescription.

Coffman Lan, G., et al. (2022). "Phase I trial of ribociclib with platinum chemotherapy in ovarian cancer." JCI insight 7(18).
	BACKGROUNDNew therapeutic combinations to improve outcomes of patients with ovarian cancer are clearly needed. Preclinical studies with ribociclib (LEE-011), a CDK4/6 cell cycle checkpoint inhibitor, demonstrate a synergistic effect with platinum chemotherapy and efficacy as a maintenance therapy after chemotherapy. We tested the safety and initial efficacy of ribociclib in combination with platinum-based chemotherapy in recurrent ovarian cancer.METHODSThis phase I trial combined weekly carboplatin and paclitaxel chemotherapy with ribociclib, followed by ribociclib maintenance in patients with recurrent platinum-sensitive ovarian cancer. Primary objectives were safety and maximum tolerated dose (MTD) of ribociclib when given with platinum and taxane chemotherapy. Secondary endpoints were response rate (RR) and progression-free survival (PFS).RESULTSThirty-five patients were enrolled. Patients had a mean of 2.5 prior lines of chemotherapy, and 51% received prior maintenance therapy with poly(ADP-ribose) polymerase inhibitors and/or bevacizumab. The MTD was 400 mg. The most common adverse events included anemia (82.9%), neutropenia (82.9%), fatigue (82.9%), and nausea (77.1%). The overall RR was 79.3%, with a stable disease rate of 18%, resulting in a clinical benefit rate of 96.6%. Median PFS was 11.4 months. RR and PFS did not differ based on the number of lines of prior chemotherapy or prior maintenance therapy.CONCLUSIONThis work demonstrates that the combination of ribociclib with chemotherapy in ovarian cancer is feasible and safe. With a clinical benefit rate of 97%, this work provides encouraging evidence of clinical efficacy in patients with recurrent platinum-sensitive disease.TRIAL REGISTRATIONClinicalTrials.gov NCT03056833.FUNDINGThis investigator-initiated trial was supported by Novartis, which provided drugs and funds for trial execution.

Cohen, C. R. (2021). "The promise of Lactobacillus crispatus CTV-05 (LACTIN-V) to prevent recurrence of bacterial vaginosis, HIV acquisition, and pretermlabor." American Journal of Reproductive Immunology 85(SUPPL 1): 34‐35.
	Problem: Bacterial vaginosis (BV) affects 15‐50% of women worldwide. After treatment with antibiotics, 20‐75% of women have recurrent BV within 3 months. BV has been associated with an increased risk of HIV and premature birth. Method of Study: We conducted a randomized, placebo‐controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV‐05 (LACTIN‐V) to prevent the recurrence of BV following antibiotic treatment. Women 18‐45 years of age who diagnosed with BV and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered LACTIN‐V or placebo for 11 weeks; follow‐up occurred through week 24. To address the effect of metronidazole treatment failure on the efficacy of LACTIN‐V on BV recurrence, we performed post hoc analyses to determine: 1) the effect of LACTIN‐V on therapeutic test of cure (TOC) at the 4‐week visit, and BV recurrence rates for LACTIN‐V vs. placebo in the TOC cohort analysis at the 12‐and 24‐week visits. Genital cytokine levels were assayed for 48 participants who reported near‐perfect adherence to assigned treatment during the trial. Vaginal swabs were collected before and after metronidazole therapy, and then at 4‐, 8‐, 12‐, and 24‐weeks. The primary comparison was the impact of LACTIN‐V use on vaginal levels of IL‐1α, the prototypic inflammatory cytokine elevated during BV. Results: A total of 228 women underwent randomization: 152 to the LACTIN‐V group and 76 to the placebo group; of these participants, In the intention‐to‐treat population, recurrence of BV by week 12 occurred in 46 participants (30%) in the LACTIN‐V group and in 34 participants (45%) in the placebo group (RR = 0.66; 95%CI, 0.44‐0.87; p = .01). The risk ratio for recurrence by week 24 was 0.73 (95%CI, 0.54‐0.92). At the 12‐week visit, L crispatus CTV‐05 was detected in 79% of participants in the LACTIN‐V group. Following treatment with metronidazole, 72 (47.7%) participants in the LACTIN‐V group met the therapeutic TOC criteria 4‐weeks after treatment compared to 25 (32.9%) participants in the placebo group (RR = 0.77; 95% CI 0.59‐1.00; p = .05). Furthermore, by restricting the analysis to the TOC cohort, recurrence of BV by week 24 occurred in 14 of 72 (19.4%) in the LACTIN‐V arm compared to 9 of 25 (36%) in the placebo arm (RR = 0.49, 95%CI 0.25‐0.95). Among the 48 participant in the immune study, vaginal IL‐1α levels fell promptly in all participants immediately following metronidazole treatment (3.319 vs. 2.832; p = .0055). While this reduction was sustained for at least 24 weeks among participants subsequently receiving LACTIN‐V, vaginal IL‐1α levels rebounded to baseline levels by 24 weeks in the placebo arm (p = .012). Conclusions: Treatment with LACTIN‐V following standard antibiotic treatment of BV not only reduced BV recurrence and increased L crispatus CTV‐05 colonization, but also resulted in more sustained reductions in vaginal IL‐1α levels. Given the link between genital pro‐inflammatory cytokines with female HIV acquisition and preterm delivery, LACTIN‐V may represent a novel strategy to reduce the risk of both conditions.

Cohen, D., et al. (2023). "A lesson in humility: the added values of PET-MRI over PET-CT in detecting malignant hepatic lesions." European Journal of Nuclear Medicine and Molecular Imaging 50(5): 1423-1433.
	Purpose: The recent introduction of integrated PET-MRI systems into practice seems promising in oncologic imaging, and efforts are made to specify their added values. The current study evaluates the added values of PET-MRI over PET-CT in detecting active malignant hepatic lesions. Method(s): As part of an ongoing prospective study in our institution that assesses the added values of PET-MRI, subjects undergo PET-CT and subsequent PET-MRI after single radiotracer injection. The current study included 97 pairs of whole-body PET-CT and liver PET-MRI scans, of 61 patients (19/61 had >= 2 paired scans), all performed with [18F]FDG and interpreted as showing active malignant hepatic involvement. Primary malignancies were of colorectal/biliary/pancreatic/breast/other origins in 19/9/9/7/17 patients. Monitoring response to therapy was the indication in 86/97 cases. When PET-MRI detected additional malignant lesions over PET-CT, lesions size, their characteristics on PET-MRI, and the influence on the final report were recorded. Result(s): In 37/97 (38.1%) cases, a total of 78 malignant lesions were identified on PET-MRI but not on PET-CT: 19 lesions (11 cases) were identified on PET of PET-MRI but not on PET of PET-CT; 37 lesions (14 cases) were small (<= 0.8 cm) and identified on MRI only; 22 lesions (12 cases) were > 0.8 cm, had low/no [18F]FDG uptake, but were categorized as viable based on MRI. These 78 lesions caused major effect on final reports in 11/97 (11.3%) cases, changing reported response assessment category (10/86 cases) or defining malignant hepatic disease on staging/restaging scans (1/11 cases). Conclusion(s): PET-MRI offers several advantages over PET-CT in assessing the extent and response to therapy of malignant hepatic involvement. Additional malignant lesions detected on PET-MRI are attributed to superior PET performance (compared with PET of PET-CT), greater spatial resolution provided by MRI, and improved multi-parametric viability assessment. In around one-tenth of cases, findings identified on PET-MRI but not on PET-CT significantly change the final report's conclusion.Copyright © 2023, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Cohen Paul, A., et al. (2019). "Pathological chemotherapy response score is prognostic in tubo-ovarian high-grade serous carcinoma: A systematic review and meta-analysis of individual patient data." Gynecologic Oncology 154(2): 441-448.
	Objective: There is a need to develop and validate biomarkers for treatment response and survival in tubo-ovarian high-grade serous carcinoma (HGSC). The chemotherapy response score (CRS) stratifies patients into complete/near-complete (CRS3), partial (CRS2), and no/minimal (CRS1) response after neoadjuvant chemotherapy (NACT). Our aim was to review current evidence to determine whether the CRS is prognostic in women with tubo-ovarian HGSC treated with NACT.; Methods: We established an international collaboration to conduct a systematic review and meta-analysis, pooling individual patient data from 16 sites in 11 countries. Patients had stage IIIC/IV HGSC, 3-4 NACT cycles and >6-months follow-up. Random effects models were used to derive combined odds ratios in the pooled population to investigate associations between CRS and progression free and overall survival (PFS and OS).; Results: 877 patients were included from published and unpublished studies. Median PFS and OS were 15 months (IQR 5-65) and 28 months (IQR 7-92) respectively. CRS3 was seen in 249 patients (28%). The pooled hazard ratios (HR) for PFS and OS for CRS3 versus CRS1/CRS2 were 0·55 (95% CI, 0·45-0·66; P < 0·001) and 0·65 (95% CI 0·50-0·85, P = 0·002) respectively; no heterogeneity was identified (PFS: Q = 6·42, P = 0·698, I2 = 0·0%; OS: Q = 6·89, P = 0·648, I2 = 0·0%). CRS was significantly associated with PFS and OS in multivariate models adjusting for age and stage. Of 306 patients with known germline BRCA1/2 status, those with BRCA1/2 mutations (n = 80) were more likely to achieve CRS3 (P = 0·027).; Conclusions: CRS3 was significantly associated with improved PFS and OS compared to CRS1/2. This validation of CRS in a real-world setting demonstrates it to be a robust and reproducible biomarker with potential to be incorporated into therapeutic decision-making and clinical trial design. (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Coitinho, B., et al. (2023). "Hypnotherapy for chronic pelvic pain: A scoping systematic review and meta-analysis." Complementary Therapies in Clinical Practice 52: 101771.
	Background: Chronic pelvic pain (CPP) is typically managed with anti-inflammatory analgesics and opioids; however, these do not adequately manage the pain or address the associated negative impact on quality of life. Hypnotherapy has been found to reduce pain associated with a range of disorders, including some with symptoms of chronic pain.; Aim: The aim of this review is to systematically scope research investigating the use of hypnosis on chronic pelvic pain, quality of life, anxiety, depression and fatigue.; Method: The scoping review was guided by the method described by Arksey and O'Mallee [1]. A systematic search was conducted in six databases. The Covidence Risk of Bias tool and the National Institutes of Health (NIH) quality assessment tool were used.; Results: Nine studies (four RCT's and five case series) were suitable for inclusion. Meta-analysis of the RCT's found no significant difference in pain or quality of life for the intervention group compared to controls. Only one study reported a reduction in pain after hypnotherapy and did not outperform controls. These results are limited due to lack of a standardised intervention and heterogeneity of the included studies.; Conclusion: There is a need for further research using well designed randomized controlled trials with validated measures of pain, quality of life, anxiety, depression and fatigue. Hypnotherapy interventions utilised in further research should be grounded in evidence-based best practice for dealing with pain.; Competing Interests: Declaration of competing interest None. (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Cokan, A., et al. (2021). "Comparison of conservative treatment of cervical intraepithelial lesions with imiquimod with standard excisional technique using lletz: a randomized controlled trial." Journal of Clinical Medicine 10(24).
	(1) Background: There are limited data on the success of conservative treatment of high‐grade cervical squamous intraepithelial lesions (HSIL) with imiquimod directly compared to standard of treatment with LLETZ. (2) Methods: Patients aged 18–40 with histological HSIL (with high‐grade cervical intraepithelial neoplasia, CIN2p16+ and CIN3), were randomly assigned to treatment with imiquimod or LLETZ. The primary outcome was defined as the absence of HSIL after either treatment modality. The secondary outcomes were the occurrence of side effects. (3) Results: 52 patients were allocated in each group and were similar regarding baseline characteristics. In the imiquimod group, 82.7% of patients completed treatment, which was successful in 51.9%. All patients in the LLETZ group completed treatment, which was successful in 92.3% (p < 0.001). In the subgroup of CIN2p16+ patients, treatment with imiquimod was not inferior to LLETZ (73.9% vs. 84.2%, p = 0.477). During and after treatment, no cases of progression to cancer were observed. Side effects and severe side effects (local and systemic) were more prevalent in the imiquimod than in the LLETZ group (88.5% vs. 44.2% (p‐value < 0.001) and 51.9% vs. 13.5% (p‐value < 0.001), respectively). (4) Conclusion: Generally, in patients with HSIL, LLETZ remains the gold standard of treatment. However, in a subgroup analysis of patients with CIN2p16+, the success rate was comparable between the two treatment modalities. Due to the prevalence of side effects, the treatment compliance with imiquimod use may, however, present a clinically important issue.

Cole, J., et al. (2019). "A systematic review of the safety and effectiveness of repetitive transcranial magnetic stimulation in the treatment of peripartum depression." Journal of Psychiatric Research 115: 142-150.
	Background: Repetitive Transcranial Magnetic Stimulation (rTMS) is an efficacious treatment for major depressive disorder (MDD), however there is limited safety and efficacy data in the peripartum period. The purpose of this review is to systematically examine the safety, acceptability and effectiveness of rTMS administered during the peripartum period as an intervention for MDD. Method(s): We searched MEDLINE, EMBASE and PsychINFO from 2008 to January 2019 to identify peer reviewed publications evaluating rTMS during the peripartum period as an intervention for peripartum MDD. We systematically extracted reported adverse events, side effects, rates of discontinuation, as well as clinical response and remission. Result(s): Data was synthesized from 1 randomized control trial, 3 uncontrolled trials, 3 case series and 5 case studies, representing a total of 87 patients. No serious adverse events were reported. Side effects occurred at rates comparable to those observed in the non-peripartum population, and obstetric and neonatal complications are infrequent and do not separate from sham-rTMS. Randomized controlled data suggests antidepressant efficacy with an effect size of 0.87. Uncontrolled studies report rates of clinical response between 41.4% and 71.4%, and rates of clinical remission between 20.7 and 30.0%. The treatment appears acceptable, with few patients opting to discontinue treatment. Limitation(s): Due to the paucity of research in this population, majority of data comes from sources with inherently higher risk of bias. Conclusion(s): rTMS in the peripartum period appears to be efficacious, acceptable and well tolerated. Additional research is required, however rTMS's risk benefit profile may be attractive to women in the peripartum period.Copyright © 2019 Elsevier Ltd

Coleman, N., et al. (2024). "Phase I study of sapanisertib (CB-228/TAK-228/MLN0128) in combination with ziv-aflibercept in patients with advanced solid tumors." Cancer Medicine 13(3): e6877.
	Background: Sapanisertib is a potent ATP-competitive, dual inhibitor of mTORC1/2. Ziv-aflibercept is a recombinant fusion protein comprising human VEGF receptor extracellular domains fused to human immunoglobulin G1. HIF-1α inhibition in combination with anti-angiogenic therapy is a promising anti-tumor strategy. This Phase 1 dose-escalation/expansion study assessed safety/ tolerability of sapanisertib in combination with ziv-aflibercept in advanced solid tumors.; Methods: Fifty-five patients with heavily pre-treated advanced metastatic solid tumors resistant or refractory to standard treatment received treatment on a range of dose levels.; Results: Fifty-five patients were enrolled and treated across a range of dose levels. Forty were female (73%), median age was 62 (range: 21-79), and ECOG PS was 0 (9, 16%) or 1 (46, 84%). Most common tumor types included ovarian (8), colorectal (8), sarcoma (8), breast (3), cervical (4), and endometrial (4). Median number of prior lines of therapy was 4 (range 2-11). Sapanisertib 4 mg orally 3 days on and 4 days off plus 3 mg/kg ziv-aflibercept IV every 2 weeks on a 28-day cycle was defined as the maximum tolerated dose. Most frequent treatment-related grade ≥2 adverse events included hypertension, fatigue, anorexia, hypertriglyceridemia, diarrhea, nausea, mucositis, and serum lipase increase. There were no grade 5 events. In patients with evaluable disease (n = 50), 37 patients (74%) achieved stable disease (SD) as best response, two patients (4%) achieved a confirmed partial response (PR); disease control rate (DCR) (CR + SD + PR) was 78%.; Conclusion: The combination of sapanisertib and ziv-aflibercept was generally tolerable and demonstrated anti-tumor activity in heavily pre-treated patients with advanced malignancies. (© 2024 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Coleman, R. L., et al. (2021). "Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study." The Lancet. Oncology 22(5): 609‐619.
	BACKGROUND: Few effective second‐line treatments exist for women with recurrent or metastatic cervical cancer. Accordingly, we aimed to evaluate the efficacy and safety of tisotumab vedotin, a tissue factor‐directed antibody‐drug conjugate, in this patient population. METHODS: This multicentre, open‐label, single‐arm, phase 2 study was done across 35 academic centres, hospitals, and community practices in Europe and the USA. The study included patients aged 18 years or older who had recurrent or metastatic squamous cell, adenocarcinoma, or adenosquamous cervical cancer; disease progression on or after doublet chemotherapy with bevacizumab (if eligible by local standards); who had received two or fewer previous systemic regimens for recurrent or metastatic disease; had measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1); and had an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received 2·0 mg/kg (up to a maximum of 200 mg) tisotumab vedotin intravenously once every 3 weeks until disease progression (determined by the independent review committee) or unacceptable toxicity. The primary endpoint was confirmed objective response rate based on RECIST (version 1.1), as assessed by the independent review committee. Activity and safety analyses were done in patients who received at least one dose of the drug. This study is ongoing with recruitment completed and is registered with ClinicalTrials.gov, NCT03438396. FINDINGS: 102 patients were enrolled between June 12, 2018, and April 11, 2019; 101 patients received at least one dose of tisotumab vedotin. Median follow‐up at the time of analysis was 10·0 months (IQR 6·1‐13·0). The confirmed objective response rate was 24% (95% CI 16‐33), with seven (7%) complete responses and 17 (17%) partial responses. The most common treatment‐related adverse events included alopecia (38 [38%] of 101 patients), epistaxis (30 [30%]), nausea (27 [27%]), conjunctivitis (26 [26%]), fatigue (26 [26%]), and dry eye (23 [23%]). Grade 3 or worse treatment‐related adverse events were reported in 28 (28%) patients and included neutropenia (three [3%] patients), fatigue (two [2%]), ulcerative keratitis (two [2%]), and peripheral neuropathies (two [2%] each with sensory, motor, sensorimotor, and neuropathy peripheral). Serious treatment‐related adverse events occurred in 13 (13%) patients, the most common of which included peripheral sensorimotor neuropathy (two [2%] patients) and pyrexia (two [2%]). One death due to septic shock was considered by the investigator to be related to therapy. Three deaths unrelated to treatment were reported, including one case of ileus and two unknown causes. INTERPRETATION: Tisotumab vedotin showed clinically meaningful and durable antitumour activity with a manageable and tolerable safety profile in women with previously treated recurrent or metastatic cervical cancer. Given the poor prognosis for this patient population and the low activity of current therapies in this setting, tisotumab vedotin, if approved, would represent a new treatment for women with recurrent or metastatic cervical cancer. FUNDING: Genmab, Seagen, Gynaecologic Oncology Group, and European Network of Gynaecological Oncological Trial Groups.

Coleman, R. L., et al. (2021). "Clinical and molecular characteristics of ariel3 patients who derived exceptional benefit from rucaparib maintenance treatment for high-grade ovarian cancer (HGOC)." International Journal of Gynecological Cancer 31(SUPPL 4): A10.
	Objectives ARIEL3 is a placebo‐controlled randomized trial of the PARP inhibitor (PARPi) rucaparib as maintenance treatment in HGOC patients who responded to the latest line of platinum therapy (NCT01968213). Rucaparib improved progression‐ free survival (PFS) across all predefined subgroups. Here, we present an exploratory analysis of characteristics associated with exceptional benefit from rucaparib. Methods Patients were randomized 2:1 to rucaparib 600 mg BID or placebo. As of 31 Dec 2019 (data cutoff), 33/375 (9%) and 1/189 (0.5%) patients were still ongoing and receiving rucaparib or placebo. Molecular features (genomic alterations, BRCA1 promoter methylation) and baseline clinical characteristics were compared between patients who derived exceptional benefit (PFS ≥2 yrs), and those with disease progression on first scan (?12 wks; the short‐term subgroup) within each treatment arm. Results of 564 patients, 79/375 (21%) in the rucaparib arm and 4/189 (2%) in the placebo arm showed exceptional benefit. Within the rucaparib arm, exceptional benefit patients had more favorable clinical prognostic factors at baseline versus the short‐term subgroup (Table). Although BRCA mutations were enriched in the rucaparib exceptional benefit subgroup, 33/79 (42%) of these patients were BRCA wild type. Patterns of enrichment varied among other biomarkers. Overall trends were similar in the placebo arm. Conclusions Exceptional benefit in ARIEL3 was more common in, but not exclusive to, patients with favorable clinical characteristics and known mechanisms of PARPi sensitivity. Our results suggest rucaparib can deliver exceptional benefit to a diverse set of patients with HGOC.

Collée, G. E., et al. (2020). "Interventions that Facilitate Shared Decision-Making in Cancers with Active Surveillance as Treatment Option: a Systematic Review of Literature." Current oncology reports 22(10): 101.
	Purpose of Review: Medical decisions concerning active surveillance are complex, especially when evidence on superiority of one of the treatments is lacking. Decision aids have been developed to facilitate shared decision-making on whether to pursue an active surveillance strategy. However, it is unclear how these decision aids are designed and which outcomes are considered relevant. The purpose of this study is to systematically review all decision aids in the field of oncological active surveillance strategies and outcomes used by authors to assess their efficacy.; Recent Findings: A search was performed in Embase, Medline, Web of Science, Cochrane, PsycINFO Ovid and Google Scholar until June 2019. Eligible studies concerned interventions aiming to facilitate shared decision-making for patients confronted with several treatment alternatives, with active surveillance being one of the treatment alternatives. Twenty-three eligible articles were included. Twenty-one articles included patients with prostate cancer, one with thyroid cancer and one with ovarian cancer. Interventions mostly consisted of an interactive web-based decision aid format. After categorization of outcomes, seven main groups were identified: knowledge, involvement in decision-making, decisional conflict, treatment preference, decision regret, anxiety and health-related outcomes. Although active surveillance has been implemented for several malignancies, interventions that facilitate shared decision-making between active surveillance and other equally effective treatment alternatives are scarce. Future research should focus on developing interventions for malignancies like rectal cancer and oesophageal cancer as well. The efficacy of interventions is mostly assessed using short-term outcomes.

Collineau, B., et al. (2023). "[Uterine leiomyosarcoma - French guidelines from the GSF/NETSARC and TMRG groups]." Bulletin du cancer 110(4): 440-449.
	Uterine leiomyosarcomas represent the most common uterine sarcomas. The prognosis is poor with metastatic recurrence in more than half of the cases. The purpose of this review is to make French recommendations for the management of uterine leiomyosarcomas within the framework of the French Sarcoma Group - Bone Tumor Study Group (GSF-GETO)/NETSARC+ and Malignant Rare Gynecological Tumors (TMRG) networks in order to optimize their therapeutic management. The initial assessment includes a MRI with diffusion perfusion sequence. The diagnosis is histological with a review in an expert center (Reference Network in Sarcoma Pathology (RRePS)). Total hysterectomy with bilateral salpingectomy, en bloc without morcellation, is performed when complete resection is possible, whatever the stage. There is no indication of systematic lymph node dissection. Bilateral oophorectomy is indicated in peri-menopausal or menopausal women. Adjuvant external radiotherapy is not a standard. Adjuvant chemotherapy is not a standard. It can be an option and consists in doxorobucin based protocols. In the event of local recurrence, the therapeutic options are based on revision surgery and/or radiotherapy. Systemic treatment with chemotherapy is most often indicated. In case of metastatic disease, surgical treatment remains indicated when resecable. In cases of oligo-metastatic disease, focal treatment of metastases should be considered. In the case of stage IV, chemotherapy is indicated, and is based on first-line doxorubicin-based protocols. In the event of excessive deterioration in general condition, management by exclusive supportive care is recommended. External palliative radiotherapy can be proposed for symptomatic purposes. (Copyright © 2023 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

Collins, L. C., et al. (2024). "Luteal Phase Defects and Progesterone Supplementation." Obstetrical and Gynecological Survey 79(2): 122-128.
	Importance Luteal phase defects (LPDs), or an insufficiency of progesterone production during the luteal phase of the menstrual cycle, have been identified as a potential cause of recurrent pregnancy loss (RPL), but its exact contribution to RPL is not well-defined. In addition, the role of exogenous progesterone supplementation during pregnancy remains controversial. Objective The goal of this review is to provide an updated, evidence-based summary of LPD, including prevalence and potential pathophysiologic mechanisms, and to explore the current controversies regarding progesterone supplementation for management and treatment of RPL. Evidence Acquisition A literature review identified relevant research using a PubMed search, Cochrane summaries, review articles, textbook chapters, databases, and society guidelines. Results Endogenous progesterone plays a crucial role in the first trimester of pregnancy, and therefore, insufficiency may contribute to RPL. However, the precise relationship between LPD and RPL remains unclear. Luteal phase defect is primarily a clinical diagnosis based on a luteal phase less than 10 days. Although there may be a possibility of incorporating a combined clinical and biochemical approach in defining LPD, the current lack of validated diagnostic criteria creates a challenge for its routine incorporation in the workup of infertility. Moreover, no treatment modality has demonstrated efficacy in improving fertility outcomes for LPD patients, including progesterone supplementation, whose inconsistent data do not sufficiently support its routine use, despite its minimal risk. It is imperative that women diagnosed with LPD should be worked up for other potential conditions that may contribute to a shortened luteal phase. Future work needs to focus on identifying a reproducible diagnostic test for LPD to guide treatment. Conclusions and Relevance Currently, the perceived relationship between LPD and RPL is challenged by conflicting data. Therefore, patients with an abnormal luteal phase should undergo a thorough workup to address any other potential etiologies. Although supplemental progesterone is commonly utilized for treatment of LPD and RPL, inconsistent supporting data call for exogenous hormone therapy to be only used in a research setting or after a thorough discussion of its shortcomings. Target Audience Obstetricians and gynecologists, family physicians Learning Objectives After completing this activity, the learner will be better able to explain the various definitions, diagnostic criteria, and potential pathophysiologic mechanisms of LPD; discuss the current controversies surrounding the role of LPD within RPL; and delineate the current studies and recommendations for treatment, specifically the use of progesterone supplementation.Copyright © Wolters Kluwer Health, Inc. All rights reserved.

Collins, M. H., et al. (2022). "Brief Mindfulness Video to Reduce Pelvic Exam- Related Anxiety and Pain." Obstetrics and Gynecology 139(SUPPL 1): 26S‐27S.
	INTRODUCTION: Purpose: Pelvic examinations frequently cause anxiety and discomfort for women, which may lead to avoidance of medical appointments. This study evaluated the efficacy of a brief mindful movement video in reducing pelvic exam anxiety and pain. METHODS: Women (n=90) scheduled for pelvic examination were recruited at an outpatient gynecology clinic and randomized to mindfulness intervention (5‐minute mindful movement video [n=44]) or control (educative materials [n=46]) groups. Upon arrival, women completed baseline measurements of anxiety and pain (visual analogue scale [VAS]). They then completed group specific activities and rated anxiety prior to pelvic exam. After exam, participants rated exam pain, post‐exam anxiety, and completed questionnaires assessing intervention acceptability. RESULTS: Fifty‐two percent of women who presented for pelvic examination reported clinically significant anxiety (i.e., VAS .34). Analysis of covariance controlling for baseline anxiety found clinically anxious individuals who received the intervention reported significantly lower anxiety before pelvic examination (P=<.001, partial η2=.232) and after (P=.006, partial η2=.165) compared to control. Analysis of covariance controlling for baseline pain found individuals who received the intervention rated pelvic examination as significantly less painful (P=< .01, partial η2=.075) compared to control. Intervention participants reported high interest, acceptability, and helpfulness of the mindful movement video. CONCLUSION: A 5‐minute mindful movement video viewed prior to pelvic examination significantly lowered anxiety for individuals with clinically significant anxiety and reduced perceived painfulness of pelvic examination. This study demonstrates the ability to integrate a brief mindfulness intervention into the flow of a medical clinic and reduce pelvic exam anxiety and pain.

Colomban, O., et al. (2023). "Benefit From Fractionated Dose-Dense Chemotherapy in Patients With Poor Prognostic Ovarian Cancer: ICON-8 Trial." JCO clinical cancer informatics 7: e2200188.
	Purpose: An international meta-analysis identified a group of patients with advanced epithelial ovarian cancer (EOC) with a very poor survival because of two unfavorable features: (1) a poor chemosensitivity defined by an unfavorable modeled CA-125 ELIMination rate constant K (KELIM) score <1.0 with the online calculator CA-125-Biomarker Kinetics, and (2) an incomplete debulking surgery. We assumed that patients belonging to this poor prognostic group would benefit from a fractionated densified chemotherapy regimen.; Methods: The data set of ICON-8 phase III trial (ClinicalTrials.gov identifier: NCT01654146), where patients with EOC were treated with the standard three-weekly, or the weekly dose-dense, carboplatin-paclitaxel regimens and debulking primary surgery (immediate primary surgery [IPS] or delayed primary [or interval] surgery [DPS]), was investigated. The association between treatment arm efficacy, standardized KELIM (scored as favorable ≥1.0, or unfavorable <1.0), and surgery completeness was assessed by univariate/multivariate analyses in IPS and DPS cohorts.; Results: Of 1,566 enrolled patients, KELIM was calculated with the online model in 1,334 with ≥3 CA-125 available values (85%). As previously reported, both KELIM and surgery completeness were complementary prognostic covariates, and could be combined into three prognostic groups with large OS differences: (1) good if favorable KELIM and complete surgery; (2) intermediate if either unfavorable KELIM or incomplete surgery; and (3) poor if unfavorable KELIM and incomplete surgery. Weekly dose-dense chemotherapy was associated with PFS/OS improvement in the poor prognostic group in both the IPS cohort (PFS: hazard ratio [HR], 0.50; 95% CI, 0.31 to 0.79; OS: HR, 0.58; 95% CI, 0.35 to 0.95) and the DPS cohort (PFS: HR, 0.53; 95% CI, 0.37 to 0.76; OS: HR, 0.57; 95% CI, 0.39 to 0.82).; Conclusion: Fractionated dose-dense chemotherapy might be beneficial for patients belonging to the poor prognostic group characterized by lower tumor chemosensitivity assessed with the online calculator CA-125-Biomarker Kinetics and incomplete debulking surgery. Further investigation in the future SALVOVAR trial is warranted.

Colomban, O., et al. (2019). "Early Modeled Longitudinal CA-125 Kinetics and Survival of Ovarian Cancer Patients: A GINECO AGO MRC CTU Study." Clinical cancer research : an official journal of the American Association for Cancer Research 25(17): 5342-5350.
	Purpose: Regarding cancer antigen 125 (CA-125) longitudinal kinetics during chemotherapy, the actual predictive value of the Gynecologic Cancer Intergroup (GCIG) CA-125 response criterion is questioned. The modeled CA-125 elimination rate constant KELIM exhibited higher prognostic value in patients with recurrent ovarian cancer enrolled in the CALYPSO trial. The objective was to validate the higher predictive and prognostic values of KELIM during first-line treatments.; Experimental Design: Data from three large phase III trials were analyzed: AGO OVAR 9 [learning set: carboplatin-paclitaxel (CP) ± gemcitabine; n = 1,288]; AGO OVAR 7 (validation set: CP ± topotecan; n = 192); and ICON7 (validation set: CP ± bevacizumab; n = 1,388). The CA-125 profiles were fit with a nonlinear mixed-effect model during the first 100 days, and the individual KELIM were calculated. KELIM prognostic and predictive values for survival were assessed against GCIG criterion and other prognostic factors in univariate/multivariate analyses.; Results: The GCIG CA-125 endpoint provided no meaningful predictive/prognostic information. C-index analyses confirmed the higher predictive value of KELIM compared with GCIG criterion for progression-free survival and overall survival (OS). KELIM provided reproducible prognostic information. Patients with favorable KELIM ≥ upper tercile (0.0711 per days) consistently experienced better OS, with HRs between 0.44 and 0.58 (e.g., median OS >65 months vs. <35 months).; Conclusions: Modeled KELIM provides higher predictive and prognostic information based on CA-125 longitudinal kinetics compared with GCIG response criteria during first-line chemotherapy. Integration of this endpoint in guidelines may be considered. Individual KELIM and survival simulations can be calculated at http://www.biomarker-kinetics.org/. Further assessment of the surrogate value of KELIM treatment-related variations in a GCIG meta-analysis is warranted. See related commentary by Maitland et al., p. 5182 . (©2019 American Association for Cancer Research.)

Colombo, C., et al. (2023). "Does luteal phase progesterone supplementation affect physical and psychosocial well-being among women undergoing modified natural cycle-FET? A sub-study of a randomized controlled trial." Human reproduction (Oxford, England) 38(10): 1970-1980.
	Study Question: Are there any differences in physical and psychosocial well-being among women undergoing modified natural cycle frozen embryo transfer (mNC-FET) with or without vaginal progesterone as luteal phase support (LPS)?; Summary Answer: Women undergoing mNC-FET with vaginal progesterone supplementation were more likely to experience physical discomfort but there was no difference in psychosocial well-being between the two groups.; What Is Known Already: mNC-FET can be carried out with or without vaginal progesterone as LPS, which has several side-effects. It is commonly known that fertility treatment can cause stress and psychosocial strain, however, most studies on this subject are conducted in fresh cycle regimes, which differ from NC-FET and results may not be comparable.; Study Design, Size, Duration: This is a sub-study of an ongoing RCT investigating whether progesterone supplementation has a positive effect on live birth rate in mNC-FET. The RCT is conducted at eight fertility clinics in Denmark from 2019 and is planned to end primo 2024. The sub-study is based on two questionnaires on physical and psychosocial well-being added to the RCT in August 2019. On the time of data extraction 286 women had answered both questionnaires.; Participants/materials, Setting, Methods: Women who had answered both questionnaires were included in the sub-study. Participants were equally distributed, with 143 in each of the two groups. Participants in both groups received the same questionnaires at two time-points: on cycle day 2-5 (baseline) and after blastocyst transfer. Participants in the progesterone group had administered progesterone for 7 days upon answering the second questionnaire. All items in the questionnaires were validated. Items on psychosocial well-being originate from the Copenhagen Multi-Centre Psychosocial Infertility-Fertility Problem Stress Scale (COMPI-FPSS) and from the Mental Health Inventory-5.; Main Results and the Role of Chance: Women receiving progesterone experienced more vaginal itching and/or burning than women in the non-progesterone group (P < 0.001). Women in the progesterone group also experienced more self-reported vaginal yeast infection, this was, however, not significant after adjustment for multiple testing (P/adjusted P = 0.049/0.881). No differences regarding psychosocial well-being were found between the two groups. Within the progesterone group, a shift toward feeling less 'downhearted and blue' was found when comparing response distribution at baseline and after blastocyst transfer (P < 0.001).; Limitations, Reasons for Caution: All items on physical symptoms were self-reported. The item on vaginal yeast infection was therefore not diagnosed by a doctor. Inclusion in the study required a few extra visits to the clinic, participants who felt more burdened by fertility treatment might have been more likely to decline participation. Women who experienced a lot of side-effects to progesterone prior to this FET cycle, might be less likely to participate.; Wider Implications of the Findings: Our results are in line with previous known side-effects to progesterone. Physical side-effects of progesterone should be considered before administration.; Study Funding/competing Interest(s): The RCT is fully supported by Rigshospitalet's Research Foundation and a grant from Gedeon Richter. Gedeon Richter were not involved in the design of protocol nor in the conduction of the study or analysis of results. A.P., L.P., and N.I.-C.F. report grants from Gedeon Richter, Ferring and Merck with no relations to this study. N.I.-C.F. has received travel support from Ferring, Merck A/S, & Gideon Richter, and is the head of the steering committee for the Danish Fertility Guidelines made by the members of from the Danish Fertility Society. A.P. reports consulting fees from Preglem, Novo Nordisk, Ferring, Gedeon Richter, Cryos, & Merck A/S, honoraria from Gedeon Richter, Ferring, Merck A/S, Theramex, and Organon, has received travel support from Gedeon Richter (payment to institution), pa ticipated on an advisory board for Preglem and was loaned an embryoscope from Gedeon Richter to their institution. A.L.S. has stock options for Novo Nordisk B A/S. B.A. have received unrestricted grant from Gedeon Richter Nordic and Merck and honoraria for lectures from Gedeon Richter, Merck, IBSA, and Marckyrl Pharma.; Trial Registration Number: The RCT is registered on ClinicalTrials. gov (NCT03795220) and in EudraCT (2018-002207-34). (© The Author(s) 2023. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Colombo, N., et al. (2024). "Characterization and Management of Adverse Reactions in Patients With Advanced Endometrial Cancer Receiving Lenvatinib Plus Pembrolizumab." Oncologist 29(1): 25-35.
	Background: Lenvatinib plus pembrolizumab significantly improved efficacy compared with chemotherapy in patients with advanced endometrial cancer (aEC) regardless of microsatellite instability status or histologic subtype, who had disease progression following prior platinum-based therapy, in Study-309/KEYNOTE-775. The safety profile of the combination was generally consistent with that of each monotherapy drug and of the combination in patients with endometrial cancer and other solid tumors. Given the medical complexity of patients with aEC, this paper aims to characterize key adverse reactions (ARs) of the combination treatment and review management strategies, providing a guide for AR management to maximize anticancer benefits and minimize treatment discontinuation. Material(s) and Method(s): In Study-309/KEYNOTE-775, patients received lenvatinib (20 mg orally once daily) plus pembrolizumab (200 mg intravenously every 3 weeks) or chemotherapy (doxorubicin or paclitaxel). The incidence and median time to the first onset of ARs, dose modifications, and concomitant medications are described. Key ARs characterized include hypothyroidism, hypertension, fatigue, diarrhea, musculoskeletal disorders, nausea, decreased appetite, vomiting, stomatitis, weight decreased, proteinuria, and palmar-plantar erythrodysesthesia syndrome. Result(s): As expected, the most common any-grade key ARs included: hypothyroidism, hypertension, fatigue, diarrhea, and musculoskeletal disorders. Grades 3-4 key ARs with incidence >=10% included: hypertension, fatigue, and weight decreased. Key ARs first occurred within approximately 3 months of treatment initiation. AR management strategies consistent with the prescribing information and the study protocol are discussed. Conclusion(s): Successful AR management strategies for lenvatinib plus pembrolizumab include education of the patient and entire treatment team, preventative measures and close monitoring, and judicious use of dose modifications and concomitant medications. Clinicaltrials.gov ID: NCT03517449Copyright © 2024 Wiley-Blackwell. All rights reserved.

Colombo, N., et al. (2021). "Tolerability of maintenance olaparib in newly diagnosed patients with advanced ovarian cancer and a BRCA mutation in the randomized phase III SOLO1 trial." Gynecologic Oncology 163(1): 41-49.
	OBJECTIVES: In the phase III SOLO1 trial (NCT01844986), maintenance olaparib provided a substantial progression-free survival benefit in patients with newly diagnosed, advanced ovarian cancer and a BRCA mutation who were in response after platinum-based chemotherapy. We analyzed the timing, duration and grade of the most common hematologic and non-hematologic adverse events in SOLO1. METHODS: Eligible patients were randomized to olaparib tablets 300 mg twice daily (N = 260) or placebo (N = 131), with a 2-year treatment cap in most patients. Safety outcomes were analyzed in detail in randomized patients who received at least one dose of study drug (olaparib, n = 260; placebo, n = 130). RESULTS: Median time to first onset of the most common hematologic (anemia, neutropenia, thrombocytopenia) and non-hematologic (nausea, fatigue/asthenia, vomiting) adverse events was <3 months in olaparib-treated patients. The first event of anemia, neutropenia, thrombocytopenia, nausea and vomiting lasted a median of <2 months and the first event of fatigue/asthenia lasted a median of 3.48 months in the olaparib group. These adverse events were manageable with supportive treatment and/or olaparib dose modification in most patients, with few patients requiring discontinuation of olaparib. Of 162 patients still receiving olaparib at month 24, 64.2% were receiving the recommended starting dose of olaparib 300 mg twice daily. CONCLUSIONS: Maintenance olaparib had a predictable and manageable adverse event profile in the newly diagnosed setting with no new safety signals identified. Adverse events usually occurred early, were largely manageable and led to discontinuation in a minority of patients.

Colombo, N., et al. (2021). "Relacorilant, a selective glucocorticoid receptor modulator, in combination with nab-paclitaxel improves progression-free survival in patients with recurrent platinum-resistant ovarian cancer: a 3-arm, randomized, open-label, phase II study."  32: S725‐.
	Background: Pre‐clinical and clinical data indicate that glucocorticoid receptor (GR) antagonism may enhance/restore chemotherapy sensitivity. This is the first randomized, controlled study to explore the efficacy and safety of relacorilant (RELA), a selective GR modulator, in combination w/ nab‐paclitaxel (nab‐pac) compared to nab‐pac alone. Methods: Women w/ recurrent platinum‐resistant/refractory high grade serous or endometroid epithelial ovarian, primary peritoneal, or fallopian tube cancer or ovarian carcinosarcoma w/ measurable or non‐measurable disease and up to 4 chemotherapeutic regimens were 1:1:1 randomized to: ‐CONTINUOUS 100mg RELA daily (w/discretionary escalation to 150mg) + 80mg/m2 nab‐pac on days 1, 8, and 15 of a q28‐day schedule; or ‐INTERMITTENT 150mg RELA the day before, of, and after 80mg/m2 nab‐pac on days 1, 8, and 15, of a q28‐day schedule; or ‐COMPARATOR,100mg/m2 nab‐pac on days 1, 8, and 15, of a q28‐day schedule. A lower nab‐pac dose was used with RELA because RELA inhibits the metabolism of nab‐pac. The primary endpoint was progression‐free survival (PFS) determined by the investigator per RECIST 1.1. Results: 178 women were randomized. At median follow‐up of 11.07 mos, the INTERMITTENT regimen significantly improved median PFS compared to nab‐pac alone (HR, 0.66, 95%CI 0.44‐0.98, log‐rank test p=0.038). While ORR was similar, Duration of Response (DoR) was significantly improved (HR 0.36, 95% 0.16‐0.77, p=0.006) in the INTERMITTENT regimen vs. nab‐pac alone. Overall survival will be assessed at maturity. Most common grade ?3 adverse events were neutropenia, anemia, and peripheral sensory neuropathy. [Formula presented] Conclusions: INTERMITTENT RELA + nab‐pac improved PFS and had a favorable safety profile in recurrent platinum‐resistant and/or platinum‐refractory ovarian cancer patients. Clinical trial identification: NCT03776812. Legal entity responsible for the study: Corcept Therapeutics. Funding: Corcept Therapeutics. Disclosure: N. Colombo: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Speaker?s Bureau: AstraZeneca; Financial Interests, Personal, Principal Investigator: AstraZeneca; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Speaker?s Bureau: Clovis; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Speaker?s Bureau: MSD; Financial Interests, Personal, Speaker?s Bureau: GSK; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Immunogen; Financial Interests, Personal, Advisory Board: Mersana; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Oncxe; Financial Interests, Personal, Speaker?s Bureau, Corcept Therapeutics: Novartis; Financial Interests, Personal, Principal Investigator: Corcept Therapeutics. D.D. Nguyen: Financial Interests, Personal, Full or part‐time Employment: Corcept Therapeutics. G.F. Fleming: Financial Interests, Personal, Principal Investigator: Corcept Therapeutics; Financial Interests, Personal, Principal Investigator: Roche; Financial Interests, Personal, Principal Investigator: Syros; Financial Interests, Personal, Principal Investigator: GSK; Financial Interests, Personal, Principal Investigator: Iovance; Financial Interests, Personal, Principal Investigator: Sermonix; Financial Interests, Personal, Principal Investigator: Compugen; Financial Interests, Personal, Principal Investigator: Celldex; Financial Interests, Personal, Principal Investigator: Plexxicon; Financial Interests, Personal, Principal Investigator: AstraZeneca. R.N. Grisham: Financial Interests, Personal, Advisory Board: Signatera; Financial Interests, Personal, Advisory Board: Verastem; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: PER; Financial Interests, Pe sonal, Advisory Board: Aptitude; Financial Interests, Personal, Principal Investigator: Corcept Therapeutics; Financial Interests, Personal, Principal Investigator: Context; Financial Interests, Personal, Principal Investigator: Verastem; Financial Interests, Personal, Principal Investigator: Bayer; Financial Interests, Personal, Principal Investigator: Pfizer; Financial Interests, Personal, Principal Investigator: Novartis. D. Lorusso: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Speaker?s Bureau: AstraZeneca; Financial Interests, Personal, Principal Investigator: AstraZeneca; Financial Interests, Personal, Other, Travel Grant: AstraZeneca; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Speaker?s Bureau: Clovis; Financial Interests, Personal, Principal Investigator: Clovis; Financial Interests, Personal, Principal Investigator: Corcept Therapeutics; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Speaker?s Bureau: GSK; Financial Interests, Personal, Principal Investigator: GSK; Financial Interests, Personal, Other, Travel Grant: GSK; Financial Interests, Personal, Advisory Board: Merck Serono; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Principal Investigator: MSD; Financial Interests, Personal, Advisory Board: Pharmamar; Financial Interests, Personal, Principal Investigator: Immonogen; Financial Interests, Personal, Principal Investigator: Genmab; Financial Interests, Personal, Other, Travel Grant: Roche. T. Van Gorp: Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Advisory Board: OncXerna; Financial Interests, Institutional, Advisory Board: Eisai; Financial Interests, Institutional, Principal Investigator: Amgen; Financial Interests, Institutional, Principal Investigator: Roche; Financial Interests, Institutional, Principal Investigator: Corcept Therapeutics. A. Oaknin: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: PharmaMar; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Advisory Board: Tesaro; Financial Interests, Personal, Advisory Board: Immunogen; Financial Interests, Personal, Advisory Board: Genmab; Financial Interests, Personal, Advisory Board: Mersana; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: Deciphera; Financial Interests, Institutional, Principal Investigator: Abbvie Deutschland; Financial Interests, Institutional, Principal Investigator: Ability; Financial Interests, Institutional, Principal Investigator: Advaxis; Financial Interests, Institutional, Principal Investigator: Aeterna Zentaris. H.I. Pashova: Financial Interests, Personal, Full or part‐time Employment: Corcept Therapeutics. A. Grauer: Financial Interests, Personal, Full or part‐time Employment: Corcept Therapeutics.

Colombo, N., et al. (2023). "Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study." Journal of clinical oncology : official journal of the American Society of Clinical Oncology 41(30): 4779-4789.
	Purpose: Despite therapeutic advances, outcomes for patients with platinum-resistant/refractory ovarian cancer remain poor. Selective glucocorticoid receptor modulation with relacorilant may restore chemosensitivity and enhance chemotherapy efficacy.; Methods: This three-arm, randomized, controlled, open-label phase II study (ClinicalTrials.gov identifier: NCT03776812) enrolled women with recurrent, platinum-resistant/refractory, high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer, or ovarian carcinosarcoma treated with ≤4 prior chemotherapeutic regimens. Patients were randomly assigned 1:1:1 to (1) nab-paclitaxel (80 mg/m 2 ) + intermittent relacorilant (150 mg the day before, of, and after nab-paclitaxel); (2) nab-paclitaxel (80 mg/m 2 ) + continuous relacorilant (100 mg once daily); or (3) nab-paclitaxel monotherapy (100 mg/m 2 ). Nab-paclitaxel was administered on days 1, 8, and 15 of each 28-day cycle. The primary end point was progression-free survival (PFS) by investigator assessment; objective response rate (ORR), duration of response (DOR), overall survival (OS), and safety were secondary end points.; Results: A total of 178 women were randomly assigned. Intermittent relacorilant + nab-paclitaxel improved PFS (hazard ratio [HR], 0.66; log-rank test P = .038; median follow-up, 11.1 months) and DOR (HR, 0.36; P = .006) versus nab-paclitaxel monotherapy, while ORR was similar across arms. At the preplanned OS analysis (median follow-up, 22.5 months), the OS HR was 0.67 ( P = .066) for the intermittent arm versus nab-paclitaxel monotherapy. Continuous relacorilant + nab-paclitaxel showed numerically improved median PFS but did not result in significant improvement over nab-paclitaxel monotherapy. Adverse events were comparable across study arms, with neutropenia, anemia, peripheral neuropathy, and fatigue/asthenia being the most common grade ≥3 adverse events.; Conclusion: Intermittent relacorilant + nab-paclitaxel improved PFS, DOR, and OS compared with nab-paclitaxel monotherapy. On the basis of protocol-prespecified Hochberg step-up multiplicity adjustment, the primary end point did not reach statistical significance ( P < .025). A phase III evaluation of this regimen is underway (ClinicalTrials.gov identifier: NCT05257408).

Colonetti, L., et al. (2022). "Green tea promotes weight loss in women with polycystic ovary syndrome: Systematic review and meta-analysis." Nutrition research (New York, N.Y.) 104: 1-9.
	Among the main consequences of polycystic ovary syndrome (PCOS) are menstrual dysfunction, infertility, hyperandrogenism, insulin resistance, and weight gain; in aggravated cases, it can become a risk factor for the development of metabolic syndrome and cardiovascular disease. We hypothesized that green tea can be an option to complement the treatment of PCOS. Thus, this systematic review aims to evaluate the effects of green tea supplementation in women with PCOS. We searched for randomized controlled trials (RCTs) that evaluated women with PCOS who received green tea compared with placebo in electronic databases: MEDLINE via PubMed, EMBASE via Elsevier, Cochrane Library, LILACS via BVS, and Web of Science using the terms: "polycystic ovary syndrome," "green tea," "Camellia sinensis," "epigallocatechin gallate." The outcomes listed in the study protocol were body weight, fasting insulin, body mass index, body fat percentage, daily caloric intake, waist circumference, hip circumference, and waist/hip ratio. Four double-blind RCTs were included, with a total of 169 women: 85 in the green tea group and 84 in the placebo group. We found a significantly lower body weight (kg) for green tea group (mean difference, -2.80; 95% confidence interval, -5.25 to -0.35; P = .03; I² = 0%; 4 studies, 169 participants, very low-quality evidence). Green tea has potential positive effects for the reduction of weight, and future studies will be needed to confirm the estimated effect size; we reasonably expect this to be an option of adjuvant treatment in PCOS clinical management. Registration number: CRD42021226296. (Copyright © 2022. Published by Elsevier Inc.)

Columbia University of, B., et al. (2022). The SUPPORT Study: Effectiveness and Usability of a Web-Enabled Resource for Postpartum Mental Health.
	No Results Available Other: Postpartumcare.ca (Web-Enabled Intervention) Change from Baseline Postpartum Depression at 4 weeks and 6 weeks, evaluated using the Edinburgh Postnatal Depression Scale (EPDS).|Change from Baseline Postpartum Anxiety at 4 weeks and 6 weeks, evaluated using the Perinatal Anxiety Screening Scale (PASS).|Website usability, as evaluated using the System Usability Scale (SUS)|Website satisfaction, evaluated using the Patient Global Impression of Change (PGIC) questionnaire|Website satisfaction, evaluated using the user-perceived web quality instrument|Website satisfaction, evaluated using the Patient Education Materials Assessment Tool (PEMAT)|Website metrics including average time on page, average session duration, returning visitors, and number of pages visited per session. All Phase 2 103 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment H21-03407 May 1, 2023

Comba, C., et al. (2022). "The effect of omentectomy on the blood levels of adipokines in obese patients with endometrial cancer." Obesity Research & Clinical Practice 16(3): 242-248.
	Objective: To investigate the blood levels of adipokines in obese patients with endometrial cancer who have and have not undergone omentectomy.; Methods: Between September 2017 and September 2019, the study recruited 54 patients with endometrial cancer. Measurements were taken of blood levels of human leptin, perilipin-1, adiponectin, adipolin, resistin, visfatin, and estrone preoperatively and postoperatively before adjuvant therapy or at the end of one month. The serum samples were separated by centrifugation for 10 mins at 3,000 revolutions/min, then stored at -80 °C until assay.; Results: In this prospective study, a total of 54 endometrial cancer patients were analyzed in two separate groups according to the omentectomy status. Comprehensive staging surgery with omentectomy and without omentectomy was performed in 26 patients and 28 patients, respectively. The age, body mass index, body fat index, waist circumference, and skin thickness values of the patients with and without omentectomy were found to be similar. No statistically significant difference was determined between the patients with and without omentectomy in respect of the blood level of the adipokines measured preoperatively. A strong statistically significant correlation was determined between the pre and postoperative levels of Human Leptin (p = 0.002), perilipin-1(p = 0.001), adipolin (p < 0.001), adiponectin (p < 0.001), resistin (p = 0.001), visfatin (p < 0.001), and estrone (p = 0.004) (r = -0.43, -0.47, 0.75, 0.84, -0.47, - 0.58, -0.41, respectively) CONCLUSIONS: Omentectomy affected the postoperative blood levels of adipokines in obese patients with endometrial cancer. As omentectomy may have some positive effects on metabolism in these patients, it may be considered during endometrial cancer surgery due to the possible positive metabolic effects. (Copyright © 2022. Published by Elsevier Ltd.)

Combs, A., et al. (2023). "A Systematic Review of Vitamin D and Fibroids: Pathophysiology, Prevention, and Treatment." Reproductive sciences (Thousand Oaks, Calif.) 30(4): 1049-1064.
	Uterine fibroids are the most common tumor of reproductive-age women worldwide and cause significant morbidity in affected women. Vitamin D has emerged as a potential therapy for uterine fibroids based on experimental and epidemiologic evidence. The objective of this systematic review was to evaluate the role of vitamin D in the pathophysiology of uterine fibroids and its efficacy for prevention and treatment of fibroids. A comprehensive search was conducted of Cochrane Library, Embase, PubMed, Scopus, and Web of Science from inception to March 2022. English-language publications that evaluated vitamin D and uterine fibroids in humans, whether experimental or clinical, were considered. The search yielded 960 publications, and 89 publications met inclusion criteria: 23 preclinical studies, 25 clinical studies, and 41 review articles. Preclinical studies indicated that the vitamin D receptor was decreased in fibroid cells. Vitamin D treatment of fibroid cells decreased proliferation, extracellular matrix protein expression, and Wnt/β-catenin signaling. Fourteen clinical studies (n = 3535 participants) assessed serum vitamin D level in women with ultrasound-proven fibroids, and all found an inverse correlation between serum vitamin D level and presence of fibroids. Five clinical studies (n = 472 patients) evaluated treatment of fibroids with vitamin D. Four of five studies showed vitamin D significantly inhibited fibroid growth. One pilot study (n = 109 patients) of vitamin D for secondary prevention of fibroids demonstrated smaller recurrent fibroids in the treated group. These studies provide evidence for vitamin D as a therapy for uterine fibroids and underscore the need for well-designed, randomized, placebo-controlled clinical trials. (© 2022. Society for Reproductive Investigation.)

Combs, J. C., et al. (2022). "DO THE NUMBERS ADD UP FOR PERSONALIZED EMBRYO TRANSFER? – A COST EFFECTIVENESS ANALYSIS STUDY." Fertility and Sterility 118(5): e26.
	Background: As efforts to maximize assisted reproductive outcomes continue, focus has turned to endometrial receptivity analysis (ERA) as a possible next frontier. Current testing offers assessment of 238 genes via endometrial tissue biopsy during a mock transfer cycle and produces a computationally predicted window of implantation to guide the timing of future embryo transfers[1]. Conflicting data exists as to the clinical efficacy of ERA and minimal analysis has been done regarding the cost effectiveness of this additional testing. Objective: To evaluate the cost effectiveness of ERA derived personalized embryo transfer (PET) versus fresh (FT) and frozen embryo transfer (FET). Materials and Methods: A decision‐tree mathematical model comparing PET versus FT versus FET was created. Live birth rates were obtained from previously published randomized controlled trial data and costs from published literature [1‐3]. Average cost per live birth in each transfer modality was calculated for the initial transfer and one additional frozen embryo transfer. Sensitivity analyses were performed over a range of procedural costs and live birth rates. Results: Fresh embryo transfer had the lowest average cost per live birth following initial transfer at $43,368 versus $65,125 for PET and $68,726 for FET. PET would need a live birth rate of ≥61% compared to fresh transfer (44.1%) to be cost effective. Even if PET added >source in cost, it was never cost effective versus fresh embryo transfer. PET was cost effective versus planned FET when adding <$4100 in cost. Following a second transfer, the fresh‐then‐frozen modality again had the lowest average cost per live birth at $37,076 versus $46,601 for PET and $48,288 for FET. Through two embryo transfers, PET would need a cumulative live birth rate of 79% compared to fresh transfer (58.6%) to be cost effective. Even if PET added >source in cost, it was never cost effective versus fresh‐then‐frozen embryo transfer. PET was cost effective versus planned FET when adding <$3700 in cost. Conclusions: Our model suggests that ERA derived PET is less cost‐effective than traditional fresh‐then supernumerary‐frozen embryo transfer. Future evaluation of these findings is needed as ERA processing migrates to the Next Generation Sequencing platform and additional clinical efficacy data is published. Support: No disclosures REFERENCES: 1. Simon, C., et al., A 5‐year multicentre randomized controlled trial comparing personalized, frozen and fresh blastocyst transfer in IVF. Reprod Biomed Online, 2020. 41(3): p. 402‐415. 2. Evans, M.B., et al., Evaluation of the cost‐effectiveness of ovulation suppression with progestins compared with GnRH analogs in assisted reproduction cycles. Reprod Biomed Online, 2019. 38(5): p. 691‐698. 3. Neal, S.A., et al., Preimplantation genetic testing for aneuploidy is cost‐effective, shortens treatment time, and reduces the risk of failed embryo transfer and clinical miscarriage. Fertil Steril, 2018. 110(5): p. 896‐904.

Comini, A. C. M., et al. (2023). "Safety and Serum Estradiol Levels in Hormonal Treatments for Vulvovaginal Atrophy in Breast Cancer Survivors: A Systematic Review and Meta-Analysis." Clinical Breast Cancer 23(8): 835-846.
	Vulvo-vaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) is a common condition among breast cancer (BC) patients, especially those undergoing antiestrogen therapy. Despite being an option in refractory cases, the safety of hormonal treatment remains uncertain in this population. The aim of this study was to review the safety and serum estrogen levels of hormonal therapy in patients with BC history presenting with VVA symptoms. Pubmed, Embase, and Cochrane were searched for studies comparing different hormonal treatment options for VVA in breast cancer survivors. Statistical analysis was performed using a random effects model and heterogeneity using Cochran's Q-statistic and the I2 index. We included 17 studies, of which 5 were randomized controlled trials (RCTs). Treatment modalities included in this study were topical vaginal estradiol and estriol preparations, vaginally applied testosterone, DHEA, and ospemifene. We found that, among patients treated with the estriol and estradiol preparations, there was an average increase of 7.67 pg/mL (SMD 7.67 pg/mL; 95% CI -1.00, 16.35; p < .001). Analysis of the testosterone group found temporary peaks of serum estradiol levels, but 1 study showed persistent elevation above normal postmenopausal levels. One study with prasterone revealed no elevation of serum estradiol concentration. One study with ospemifene demonstrated no increase in the risk of BC recurrence. In conclusion, among treatments available for BC survivors, low-dose vaginal estrogen showed the smallest changes in serum estradiol levels and had the most evidence, but safety remains unclear, especially for patients on aromatase inhibitors. Alternative treatments such as ospemifene need more data supporting safety and efficacy. These results suggest that concerns related to cancer recurrence should keep aiming for the lowest possible concentration.Copyright © 2023 Elsevier Inc.

Conceptra, B. and Llc (2023). CCT-102 vs. Expectant Management in Delayed Pregnancy Loss.
	No Results Available Combination Product: CCT-102 A and CCT-102 B Resolution of pregnancy loss Female Phase 3 160 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment PRT-CO-CCT-102.001 July 2024

Conforti, A., et al. (2021). "Luteal Phase Support Using Subcutaneous Progesterone: A Systematic Review." Frontiers in Reproductive Health 3: 634813.
	Luteal phase support (LPS) is crucial in assisted reproductive technology (ART) cycles when the luteal phase has been found to be defective. Such deficiency is most likely related to the supraphysiological steroid levels that usually occurr in stimulated cycles which, in turn, could severely affect luteinizing hormone (LH) secretion and function, thereby negatively influencing the luteal phase. A number of different medications and routes have been successfully used for LPS in ART. Although an optimal protocol has not yet been identified, the existing plethora of medications offer the opportunity to personalize LPS according to individual needs. Subcutaneous administration progesterone has been proposed for LPS and could represent an alternative to a vaginal and intramuscular route. The aim of the present systematic review is to summarize the evidence found in the literature concerning the application of subcutaneous progesterone in ARTs, highlighting the benefits and limits of this novel strategy. With this aim in mind, we carried out systematic research in the Medline, ISI Web of Knowledge, and Embase databases from their inception through to November 2020. Randomized controlled trials (RCTs) were preferred by the authors in the elaboration of this article, although case-control and cohort studies have also been considered. According to our findings, evidence exists which supports that, in women with a good prognosis undergoing a fresh in vitro fertilization (IVF) cycle, subcutaneous Pg is not inferior to vaginal products. In the Frozen-thawed embryo transfer (FET) cycle, data concerning efficacy is mixed with an increased miscarriage rate in women undergoing a subcutaneous route in oocyte donor recipients. Data concerning the acceptance of the subcutaneous route versus the vaginal route are encouraging despite the different scales and questionnaires which were used. In addition, a cost-effective analysis has not yet been conducted.; Competing Interests: AC and CA decleare fees from Merck Serono Italia outside the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2021 Conforti, Carbone, Iorio, Cariati, Bagnulo, Marrone, Strina and Alviggi.)

Conforti, A., et al. (2019). "The role of recombinant LH in women with hypo-response to controlled ovarian stimulation: a systematic review and meta-analysis." Reproductive biology and endocrinology : RB&E 17(1): 18.
	Objective: To study the role of recombinant human LH supplementation in women with hypo-response to ovarian stimulation.; Methods: We performed a systematic review and meta-analysis of prospective clinical trials in which recombinant FSH monotherapy protocols were compared with LH-supplemented protocols in hypo-responders. A search was conducted of the Scopus, MEDLINE databases without time or language restrictions. Primary outcome was clinical pregnancy rate.; Results: Significantly higher clinical pregnancy rates (odds ratio: 2.03, P = 0.003), implantation rates (odds ratio: 2.62, P = 0.004) and number of oocytes retrieved (weight mean differences: 1.98, P = 0.03) were observed in hypo-responders supplemented with recombinant LH versus hypo-responders who underwent FSH monotherapy. No differences in terms of mature oocytes or miscarriage rates were found between the two groups.; Conclusion: In conclusion, our analysis confirms that women with a hypo-response to exogenous gonadotropins might benefit from LH supplementation. However, more trials are required before a definitive conclusion can be drawn.

Conic Rosalynn, R. Z., et al. (2024). "Hypertension and urologic chronic pelvic pain syndrome: An analysis of MAPP-I data." BMC Urology 24(1): 21.
	Background: Urologic chronic pelvic pain syndrome (UCPPS), which includes interstitial cystitis/bladder pain syndrome (IC/BPS) and chronic prostatitis (CP/CPPS), is associated with increased voiding frequency, nocturia, and chronic pelvic pain. The cause of these diseases is unknown and likely involves many different mechanisms. Dysregulated renin-angiotensin-aldosterone-system (RAAS) signaling is a potential pathologic mechanism for IC/BPS and CP/CPPS. Many angiotensin receptor downstream signaling factors, including oxidative stress, fibrosis, mast cell recruitment, and increased inflammatory mediators, are present in the bladders of IC/BPS patients and prostates of CP/CPPS patients. Therefore, we aimed to test the hypothesis that UCPPS patients have dysregulated angiotensin signaling, resulting in increased hypertension compared to controls. Secondly, we evaluated symptom severity in patients with and without hypertension and antihypertensive medication use.; Methods: Data from UCPPS patients (n = 424), fibromyalgia or irritable bowel syndrome (positive controls, n = 200), and healthy controls (n = 415) were obtained from the NIDDK Multidisciplinary Approach to the Study of Chronic Pelvic Pain I (MAPP-I). Diagnosis of hypertension, current antihypertensive medications, pain severity, and urinary symptom severity were analyzed using chi-square test and t-test.; Results: The combination of diagnosis and antihypertensive medications use was highest in the UCPPS group (n = 74, 18%), followed by positive (n = 34, 17%) and healthy controls (n = 48, 12%, p = 0.04). There were no differences in symptom severity based on hypertension in UCPPS and CP/CPPS; however, IC/BPS had worse ICSI (p = 0.031), AUA-SI (p = 0.04), and BPI pain severity (0.02). Patients (n = 7) with a hypertension diagnosis not on antihypertensive medications reported the greatest severity of pain and urinary symptoms.; Conclusion: This pattern of findings suggests that there may be a relationship between hypertension and UCPPS. Treating hypertension among these patients may result in reduced pain and symptom severity. Further investigation on the relationship between hypertension, antihypertensive medication use, and UCPPS and the role of angiotensin signaling in UCPPS conditions is needed. (© 2024. The Author(s).)

Conklin, D. Y. and G. Karakurt (2023). "Women with mood disorders and couples conflict: menopause symptom improvement, after group therapy." Climacteric : the journal of the International Menopause Society 26(6): 565-570.
	Objective: Although a public health crisis, intimate partner violence (IPV) has been understudied for middle-aged women with mood disorders during their perimenopausal and postmenopausal years. The aims of this study were to examine the relationship between IPV and hot flashes/night sweats (HF/NS) frequency and severity among women with mood disorders and to test whether the effect of cognitive behavioral group therapy on menopausal symptoms differs between those with and without IPV at baseline and post-test.; Methods: Of 59 participants from a mood disorders outpatient clinic enrolled in the parent study, 24 experienced IPV. This study analyzed pretreatment and post-treatment data from the Revised Conflict Tactic Scale - Short Form-2, and HF/NS frequency and severity ratings on the Hot Flash Daily Diary using the McNemar chi-square test.; Results: The presence of any type of violence at pretreatment was significantly ( p < 0.01) linked to improvements in HF/NS frequency and severity. Women who showed improvements in negotiation skills had better outcomes in menopausal symptoms. Sexual coercion increased from one to three women.; Conclusions: Negotiation skills may help women with mood disorders to reduce HF/NS frequency and severity. More studies need to be conducted with a special focus on helping women in this population.

Conley Alexander, C., et al. (2022). "Estradiol treatment in young postmenopausal women with self-reported cognitive complaints: Effects on cholinergic-mediated cognitive performance." Human psychopharmacology 37(5): e2838.
	Objective: Older women are at increased risk of developing Alzheimer's disease compared to men. One proposed reason is that following menopause there is a decline in estrogens. Estrogens are important for cholinergic functioning and attenuate the impact of cholinergic antagonists on cognitive performance in postmenopausal women. Self-reported or subjective cognitive complaints in middle or older age may represent a harbinger of cognitive decline and those who endorse cognitive complaints appear more likely to develop future cognitive impairment. However, the response of individuals with cognitive complaints after menopause to estrogen and the relationship to cholinergic functioning has not been investigated. This study investigated the effect of estrogen treatment using 17β-estradiol on cognitive performance following anticholinergic blockade in postmenopausal women and the relationship of this interaction with the level of self-reported (subjective) postmenopausal cognitive complaints.; Methods: Forty postmenopausal women (aged 50-60 years) completed a 3-month treatment regimen of either 1 mg oral estradiol or placebo. Participants then completed four challenge days in which they completed cognitive and behavioral tasks after one of four cholinergic antagonist drug conditions (oral mecamylamine (MECA), intravenous scopolamine, combined MECA and scopolamine, or PLC).; Results: Compared to PLC, the estradiol treated group performed worse on attention tasks under cholinergic challenge including the choice reaction time task and the critical flicker fusion task. In addition, participants who endorsed greater cognitive complaints showed reduced performance on the N-back working memory task, regardless of whether they received estradiol treatment.; Conclusions: The findings of this study indicate that estradiol treatment was unable to mitigate anticholinergic blockade in postmenopausal women with subjective cognitive complaints, and worsened performance on attention tasks. Moreover, the present study suggests that greater levels of cognitive complaints following menopause may be associated with an underlying decline in cholinergic function that may manifest as an inability to compensate during working memory tasks. (© 2022 John Wiley & Sons Ltd.)

Constantine Ginger, D., et al. (2019). "Endometrial safety of low-dose vaginal estrogens in menopausal women: a systematic evidence review." Menopause (New York, N.Y.) 26(7): 800-807.
	Objective: The aim of the study was to systematically review studies that evaluated endometrial hyperplasia or cancer incidence with unopposed vaginal estrogens.; Methods: PubMed and EMBASE were searched from inception to August 2017 for relevant articles and abstracts. Bibliographies of review articles and abstracts of major women's health medical meetings were examined. Eligible studies (independently reviewed by 4 authors) had to report menopausal vaginal estrogen use and endometrial histology, or incidence of endometrial hyperplasia or cancer.; Results: Of 5,593 abstracts from the literature search and 47 articles from other sources, 36 articles and 2 abstracts were eligible, describing 20 randomized controlled studies, 8 interventional studies, and 10 observational studies. Collectively, the studies did not support an increased risk of endometrial hyperplasia or cancer with low-dose vaginal estrogens. Rates of endometrial cancer and hyperplasia were 0.03% and 0.4%, respectively, from 20 randomized controlled trials (2,983 women) of vaginal estrogens. Overall, reports of endometrial hyperplasia were observed with various doses and durations and appeared sporadic (except 1.25 mg conjugated equine estrogens), consistent with endometrial hyperplasia rates in the general population. A Denmark registry study was an exception and may be of limited applicability to the United States. The Women's Health Initiative Observational Study showed no association (1.3 cases/1,000 women-years with vaginal estrogens versus 1.0/1,000 women-years for nonuse).; Conclusion: This systematic review supports the use of low-dose vaginal estrogens for treating vulvar and vaginal atrophy in menopausal women without a concomitant progestogen. This review does not support increased endometrial hyperplasia or cancer risk with low-dose, unopposed vaginal estrogens; however, longer-term, real-world data are needed.

Conte, E., et al. (2023). "An evaluation of longitudinal quality of life in patients with advanced-stage cancer seeking care at Canadian naturopathic oncology clinics: Outcomes from the Canadian/US Integrative oncology study." Journal of Complementary and Integrative Medicine 20(1): eA5.
	Background: Quality of life (QOL) is an important outcome for patients with advanced cancer as treatments are usually not curative. Naturopathic medicine is a form of complementary care often used by patients to support QOL; however, data on efficacy is limited. In this study, we evaluated longitudinal QOL and symptom burden in a subset of participants from the Canadian/US Integrative Oncology Study. Method(s): Participants from CUSIOS (stage IV breast/colorectal or stage III/IV ovarian/pancreatic cancer) seen at a Canadian naturopathic clinic were included in this sub-study. QOL and symptom burden were characterized using the European Organization for Research and Treatment of Cancer's (EORTC) Quality of Life Questionnaire C30, Edmonton Symptom Assessment Scale (ESAS), and Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire. Assessments were completed six times over 36months. Within person changeswere analyzedwith unadjusted paired t-tests using the Bonferroni correction for multiple assessments. Result(s): 104 participants were enrolled with 97 included in the analyses. Questionnaire completion rates were 91% at baseline, 63-73% between months 3 and 24, and 52% atmonth 36 (excluding those deceased). Compared to baseline, EORTC global health improved at all timepoints with 3/6 reaching statistical significance; ESAS total symptom score improved at all timepoints with 5/6 reaching statistical significance;MYCAWconcerns improved at all timepointswith 5/6 reaching statistical significance. Improvements were above the minimum important difference. Conclusion(s): Longitudinal QOL and symptom data in advanced cancer patients receiving naturopathic care was collected, but response rates were suboptimal. QOL and symptom burden generally improved; however, due to the lack of a control group, it is not clear if this was a result of naturopathic medicine. More rigorous and well-controlled research is needed..

Contegiacomo, A., et al. (2021). "Uterine Myomas: Endovascular Treatment." Seminars in ultrasound, CT, and MR 42(1): 13-24.
	Uterine fibroids embolization is a safe and effective organ sparing treatment for fibroid-related symptoms based on a broad range of published evidence including randomized-controlled trials. Indication to treatment is usually the presence of symptomatic uterine fibroids. In this review, a systematic search of journal articles relevant to the treatment of symptomatic uterine fibroids was conducted, with a special focus on the indication to treatment, technique, procedural outcomes and pain control. All clinical trials published in English language, representing original research, and reporting clinical outcomes associated with interventions for the management of symptomatic uterine fibroids were considered. (Copyright © 2020 Elsevier Inc. All rights reserved.)

Contreras, N.-A., et al. (2022). "Fertility-Sparing Approaches in Atypical Endometrial Hyperplasia and Endometrial Cancer Patients: Current Evidence and Future Directions." International Journal of Molecular Sciences 23(5).
	Endometrial cancer (EC) is the fourth most common cancer in women in developed countries. Although it is usually diagnosed in postmenopausal women, its incidence has increased in young women, as well in recent decades, with an estimated rate of 4% in those under 40 years of age. Factors involved in this increase, particularly in resource-rich countries, include delayed childbearing and the rise in obesity. The new molecular classification of EC should help to personalize treatment, through appropriate candidate selection. With the currently available evidence, the use of oral progestin either alone or in combination with other drugs such as metformin, levonorgestrel-releasing intrauterine devices and hysteroscopic resection, seems to be feasible and safe in women with early-stage EC limited to the endometrium. However, there is a lack of high-quality evidence of the efficacy and safety of conservative management in EC. Randomized clinical trials in younger women and obese patients are currently underway.

Cooijmans, K. H. M., et al. (2022). "Daily mother-infant skin-to-skin contact and maternal mental health and postpartum healing: a randomized controlled trial." Scientific Reports 12(1): 10225.
	This randomized controlled trial examined the effects of a daily hour of mother-infant skin-to-skin contact (SSC) during the first five postnatal weeks, compared to care-as-usual, on maternal depressive (primary outcome), anxiety, stress, fatigue, pain, and delivery-related post-traumatic stress symptoms (PTSS). Prenatal symptom severity and touch discomfort were examined as moderators. Mothers and full-term infants were randomly allocated to SSC or care-as-usual conditions and followed during the first postnatal year. For the total group (intention-to-treat analyses), care-as-usual mothers showed an increase of anxiety symptoms from week 2 to 12, while SSC mothers displayed a stability of anxiety symptoms. Also, care-as-usual mothers showed an initial decrease in fatigue followed by an increase, while SSC mothers showed a decrease from week 2 to 12. In per-protocol analyses, including only the SSC dyads who adhered to SSC guidelines, findings on anxiety, but not fatigue, were replicated. No SSC effects were found for depressive, stress, and pain symptoms. No moderator, dose-response, or 52-week follow-up effects were found. PTSS were low with little variation; consequently, analyses were discontinued. Daily SSC in healthy mother-infant dyads may reduce anxiety and fatigue symptoms, but not depressive, stress, and pain symptoms, during the early postpartum period. Replication studies are recommended.

Coomarasamy, A., et al. (2020). "Micronized vaginal progesterone to prevent miscarriage: a critical evaluation of randomized evidence." American Journal of Obstetrics and Gynecology 223(2): 167-176.
	Progesterone is essential for the maintenance of pregnancy. Several small trials have suggested that progesterone supplementation may reduce the risk of miscarriage in women with recurrent or threatened miscarriage. Cochrane Reviews summarized the evidence and found that the trials were small with substantial methodologic weaknesses. Since then, the effects of first-trimester use of vaginal micronized progesterone have been evaluated in 2 large, high-quality, multicenter placebo-controlled trials, one targeting women with unexplained recurrent miscarriages (the PROMISE [PROgesterone in recurrent MIScarriagE] trial) and the other targeting women with early pregnancy bleeding (the PRISM [PRogesterone In Spontaneous Miscarriage] trial). The PROMISE trial studied 836 women from 45 hospitals in the United Kingdom and the Netherlands and found a 3% greater live birth rate with progesterone but with substantial statistical uncertainty. The PRISM trial studied 4153 women from 48 hospitals in the United Kingdom and found a 3% greater live birth rate with progesterone, but with a P value of .08. A key finding, first observed in the PROMISE trial, and then replicated in the PRISM trial, was that treatment with vaginal micronized progesterone 400 mg twice daily was associated with increasing live birth rates according to the number of previous miscarriages. Prespecified PRISM trial subgroup analysis in women with the dual risk factors of previous miscarriage(s) and current pregnancy bleeding fulfilled all 11 conditions for credible subgroup analysis. For the subgroup of women with a history of 1 or more miscarriage(s) and current pregnancy bleeding, the live birth rate was 75% (689/914) with progesterone vs 70% (619/886) with placebo (rate difference 5%; risk ratio, 1.09, 95% confidence interval, 1.03-1.15; P=.003). The benefit was greater for the subgroup of women with 3 or more previous miscarriages and current pregnancy bleeding; live birth rate was 72% (98/137) with progesterone vs 57% (85/148) with placebo (rate difference 15%; risk ratio, 1.28, 95% confidence interval, 1.08-1.51; P=.004). No short-term safety concerns were identified from the PROMISE and PRISM trials. Therefore, women with a history of miscarriage who present with bleeding in early pregnancy may benefit from the use of vaginal micronized progesterone 400 mg twice daily. Women and their care providers should use the findings for shared decision-making. (Copyright © 2019 The Author(s). Published by Elsevier Inc. All rights reserved.)

Coomarasamy, A., et al. (2020). "Progesterone to prevent miscarriage in women with early pregnancy bleeding: the PRISM RCT." Health technology assessment (Winchester, England) 24(33): 1-70.
	Background: Progesterone is essential for a healthy pregnancy. Several small trials have suggested that progesterone therapy may rescue a pregnancy in women with early pregnancy bleeding, which is a symptom that is strongly associated with miscarriage.; Objectives: (1) To assess the effects of vaginal micronised progesterone in women with vaginal bleeding in the first 12 weeks of pregnancy. (2) To evaluate the cost-effectiveness of progesterone in women with early pregnancy bleeding.; Design: A multicentre, double-blind, placebo-controlled, randomised trial of progesterone in women with early pregnancy vaginal bleeding.; Setting: A total of 48 hospitals in the UK.; Participants: Women aged 16-39 years with early pregnancy bleeding.; Interventions: Women aged 16-39 years were randomly assigned to receive twice-daily vaginal suppositories containing either 400 mg of progesterone or a matched placebo from presentation to 16 weeks of gestation.; Main Outcome Measures: The primary outcome was live birth at ≥ 34 weeks. In addition, a within-trial cost-effectiveness analysis was conducted from an NHS and NHS/Personal Social Services perspective.; Results: A total of 4153 women from 48 hospitals in the UK received either progesterone ( n = 2079) or placebo ( n = 2074). The follow-up rate for the primary outcome was 97.2% (4038 out of 4153 participants). The live birth rate was 75% (1513 out of 2025 participants) in the progesterone group and 72% (1459 out of 2013 participants) in the placebo group (relative rate 1.03, 95% confidence interval 1.00 to 1.07; p = 0.08). A significant subgroup effect (interaction test p = 0.007) was identified for prespecified subgroups by the number of previous miscarriages: none (74% in the progesterone group vs. 75% in the placebo group; relative rate 0.99, 95% confidence interval 0.95 to 1.04; p = 0.72); one or two (76% in the progesterone group vs. 72% in the placebo group; relative rate 1.05, 95% confidence interval 1.00 to 1.12; p = 0.07); and three or more (72% in the progesterone group vs. 57% in the placebo group; relative rate 1.28, 95% confidence interval 1.08 to 1.51; p = 0.004). A significant post hoc subgroup effect (interaction test p = 0.01) was identified in the subgroup of participants with early pregnancy bleeding and any number of previous miscarriage(s) (75% in the progesterone group vs. 70% in the placebo group; relative rate 1.09, 95% confidence interval 1.03 to 1.15; p = 0.003). There were no significant differences in the rate of adverse events between the groups. The results of the health economics analysis show that progesterone was more costly than placebo (£7655 vs. £7572), with a mean cost difference of £83 (adjusted mean difference £76, 95% confidence interval -£559 to £711) between the two arms. Thus, the incremental cost-effectiveness ratio of progesterone compared with placebo was estimated as £3305 per additional live birth at ≥ 34 weeks of gestation.; Conclusions: Progesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with threatened miscarriage overall, but an important subgroup effect was identified. A conclusion on the cost-effectiveness of the PRISM trial would depend on the amount that society is willing to pay to increase the chances of an additional live birth at ≥ 34 weeks. For future work, we plan to conduct an individual participant data meta-analysis using all existing data sets.; Trial Registration: Current Controlled Trials ISRCTN14163439, EudraCT 2014-002348-42 and Integrated Research Application System (IRAS) 158326.; Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 33. See the NIHR Journals Library website for further project information.; Competing Interests: Jane P Daniels declares membership of the Clinical Trials Unit Standing Advisory Committee. Mee akshi Choudhary declares m mbership of Health Technology Assessment (HTA) Maternal, Newborn and Child Health (MNCH) Panel and the HTA Prioritisation Committee. Jane E Norman declares membership of the HTA MNCH Panel, that she currently receives funding from the National Institute for Health Research Efficacy and Mechanism Evaluation (EME) programme, that she participates in a Data Monitoring and Ethics Committee for GlaxoSmithKline plc (Brentford, UK) and that she is a paid consultant for Dilafor AB (Solna, Sweden). She was a member of the HTA and EME Editorial Board from 2012 to 2014. Caroline Overton declares that she was a Mylan clinical educator for general practitioner education about hormone replacement therapy and incorporated private practice in April 2017 (now called Bristol Women’s Clinic Ltd).

Cooper Miranda, C., et al. (2019). "Using Matching-Adjusted Indirect Comparisons and Network Meta-analyses to Compare Efficacy of Brexanolone Injection with Selective Serotonin Reuptake Inhibitors for Treating Postpartum Depression." CNS drugs 33(10): 1039-1052.
	Background: Brexanolone injection, the first therapy approved by the US FDA for the treatment of postpartum depression (PPD) in adults, has been shown to produce a significantly greater decrease in the Hamilton Rating Scale for Depression (HAM-D) total score than placebo in randomised controlled trials (RCTs) of women with PPD.; Objectives: Given the rapid effect of brexanolone injection (within 60 h) sustained throughout the length of the trials (30 days), we sought to compare its efficacy data against selective serotonin reuptake inhibitors (SSRIs), the class of antidepressants most commonly prescribed for PPD, using HAM-D and Edinburgh Postnatal Depression Scale (EPDS) outcomes from currently available RCTs.; Methods: We extracted data from 26 studies identified in a systematic literature review of pharmacological and pharmacological/nonpharmacological combination therapies in PPD. Six studies were suitable to form evidence networks through which to perform indirect treatment comparisons (ITCs) of HAM-D and EPDS outcomes between brexanolone and SSRIs. Having assessed the comparability and suitability of the available evidence for analysis, we discovered significant heterogeneity in the study designs, most notably in the placebo arms of the trials. We therefore conducted matching-adjusted indirect comparisons (MAICs) between brexanolone and the placebo arms of comparator studies, subsequently using the MAIC results of brexanolone versus placebo, and results for SSRIs versus placebo, to form ITCs of brexanolone versus SSRIs at three separate time points-day 3, week 4 and last observation. ITCs were calculated as the differences in change from baseline (CFB) in HAM-D and, separately, CFB in EPDS, between treatments, and reported with 95% confidence intervals (CIs).; Results: For all time points, MAICs showed larger differences in CFB for brexanolone compared with SSRIs. Differences (95% CIs) between brexanolone and SSRIs were 12.79 (8.04-17.53) [day 3], 5.87 (- 1.62 to 13.37) [week 4] and 0.97 (- 6.35 to 8.30) [last observation] for the HAM-D. For the EPDS, the differences in CFB were 7.98 (5.32-10.64) [day 3], 6.35 (3.13-9.57) [week 4] and 4.05 (0.79-7.31) [last observation]. Other analytical approaches are also presented to demonstrate the similarity of results, using a network meta-analysis approach, and the importance of using the MAIC method to control for the important heterogeneity between placebo arms.; Conclusions: Acknowledging the limitations of ITCs and this evidence base, when compared with SSRIs, these analyses suggest that brexanolone demonstrated larger differences in CFB for both patient- and clinician-reported PPD outcomes and at all investigated time points after adjusting for differences between placebos in the included studies.

Coopmans, L., et al. (2023). "Surgical Management of Gestational Trophoblastic Disease." Gynecologic and Obstetric Investigation.
	Background: Gestational trophoblastic disease (GTD) is a rare pregnancy-related condition consisting of premalignant and malignant forms arising from proliferation of trophoblastic cells. The malignant forms are collectively referred to as gestational trophoblastic neoplasia (GTN) and are highly sensitive to chemotherapy. However, surgical procedures remain indispensable in the diagnosis and treatment of GTD. Objective(s): The aim of this review was to summarize surgical interventions in the treatment of GTD and GTN. We reviewed indications, efficacy, possible complications, and oncological outcomes of surgery. Method(s): Three searches were performed in the databases of PubMed, Embase, and the Cochrane Library to create an up-to-date overview of existing literature on the following subjects: (1) the role of primary hysterectomy in GTD and GTN; (2) the role of second curettage in GTD and GTN; (3) fertility sparing surgery in GTN; (4) surgical management of metastases. Included articles originated from the time period 1952-2022. Articles written in English, Spanish, and French were included. Outcome(s): Thirty-eight articles were found and selected. Surgical evacuation through suction curettage is most used and advised in the treatment of GTD. A second curettage could be beneficial in patients with low hCG levels and low FIGO scores. In women who have completed their families, primary hysterectomy might be considered as the risk of subsequent GTN is lower than after suction curettage. In case of the rare forms of GTN (epithelioid trophoblastic tumor or placental site trophoblastic tumor) surgical tumor resection remains the most important step in treatment. Data on fertility sparing surgery in GTN are scarce and this treatment should be considered experimental. Conclusion and Outlook: Surgery remains an important part of treatment of GTD and is sometimes indispensable to achieve curation. Further collection of evidence is needed to determine treatment steps. © 2023 S. Karger AG, Basel. Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.

Cope, A. G., et al. (2020). "Nonsurgical radiologic intervention for management of abdominal wall endometriosis: A systematic review and meta-analysis." Journal of Endometriosis and Pelvic Pain Disorders 12(1): 41-50.
	Objective: To describe reported outcomes of nonsurgical radiologic interventions for abdominal wall endometriosis in comparison with surgery where available. Data sources: A systematic search of Ovid Medline, Embase, PubMed, and Cochrane Controlled Register of Trials was performed from inception to January 2019 with no language restrictions. Study eligibility criteria: Studies were included if they evaluated a nonsurgical intervention in women with symptomatic abdominal wall endometriosis with both comparative and noncomparative study designs. Study appraisal and synthesis methods: Titles and abstracts were reviewed for relevance, and full-text articles were obtained and evaluated for inclusion, all in duplicate. Meta-analysis was performed when possible using a fixed effects model. Result(s): Of the 114 records reviewed, 16 full-text articles were assessed and 7 were included in analysis. The standard mean difference between pre- and post-intervention pain scores was similar between ultrasound-guided high-intensity focused ultrasound (USgHIFU) (-3.00; 95% confidence interval -3.34, -2.66) and cryoablation (-3.93; 95% confidence interval -5.73, -2.12). The mean percent decrease in lesion size following intervention was similar between USgHIFU (-61.38%; 95% confidence interval -78.64%, -44.11%), and cryoablation (-88.16%; 95% confidence interval -83.90%, -55.06%). When compared with surgical excision, mean length of stay was 2.78 days less in the nonsurgical intervention group (95% confidence interval -3.78, -1.79). Conclusion(s): Both USgHIFU and cryoablation are effective at reducing pain scores and lesion size in abdominal wall endometriosis. Mean length of stay was significantly less following a nonsurgical radiologic intervention for abdominal wall endometriosis compared with surgery. More studies are needed comparing complication and recurrence rates between nonsurgical radiologic interventions for abdominal wall endometriosis and surgery.Copyright © The Author(s) 2020.

Coquan, E., et al. (2021). "CABOCOL-01 trial: a single-arm phase II study assessing safety and efficacy of Cabozantinib for advanced or metastatic cervical carcinoma after platinum treatment failure." BMC Cancer 21(1): 1054.
	BACKGROUND: Cervical cancer is the tenth diagnosed cancer in the world. Early-stage and locally recurrent disease may be cured with radical surgery or chemo-radiotherapy. However, if disease persists or recurs, options are limited and the prognosis is poor. In addition to chemotherapy, bevacizumab, an antiangiogenic agent, has recently demonstrated its efficacy in this setting. Cabozantinib is an oral small molecule tyrosine kinase inhibitor that exhibits potent inhibitory activity against several receptor tyrosine kinases that are known to influence tumor growth, metastasis, and angiogenesis. The main targets of Cabozantinib are VEGFR2, MET and AXL. It is currently approved for the treatment of metastatic renal cell carcinoma, hepatocellular carcinoma and medullary thyroid carcinoma. Given its angiogenic properties associated with growth factor receptors inhibition, Cabozantinib represents a potential active treatment in cervical carcinoma. In this context, we propose to assess the efficacy and safety of cabozantinib monotherapy in advanced/metastatic cervical carcinoma (CC) after failure to platinum-based regimen treatment. METHODS: This study is a single-arm two-stage multicenter phase II aiming to simultaneously assess efficacy and safety of Cabozantinib among advanced/metastatic cervical carcinoma (CC) after failure to platinum-based regimen treatment. The main criterion will be based on both safety and clinical efficacy by conducting a Bryant-and-Day design. Safety endpoint is the proportion of patients with clinical gastro-intestinal (GI) perforation/fistula, GI-vaginal fistula and genito-urinary (GU) fistula events grade ≥ 2 (NCI CTCAE V.5.0) occurring up to one month after the end of treatment. Efficacy endpoint is the proportion of patients with disease control rate 3 months after Cabozantinib initiation. A patients' self-reported quality of life evaluation is also planned, as well as the investigation of nutritional outcomes. Cabozantinib will be administered at the daily dose of 60 mg given orally, without interruption until disease progression or discontinuation for any cause. DISCUSSION: Cabozantinib is a promising drug for patients with advanced/metastatic cervical cancer where few therapeutics options are available after failure to platinum-based regimen metastatic CC. It appears challenging to assess the interest of Cabozantinib in this indication, taking into account the potential toxicity of the drug. TRIAL REGISTRATION: NCT04205799 , registered "2019 12 19". PROTOCOL VERSION: Version 3.1 dated from 2020 08 31.

Coquoz, A., et al. (2019). "Impact of micronized progesterone on body weight, body mass index, and glucose metabolism: a systematic review." Climacteric : the journal of the International Menopause Society 22(2): 148-161.
	In women, body weight increases with age. Often menopausal hormone therapy (MHT) is blamed for enhancing this effect. In recent years, the debate on bioidentical MHT including micronized progesterone (MP) has increased. Among others, the question has been raised of whether MHT containing MP has an impact on body weight and glucose metabolism. Based on a systematic literature review on the impact of MHT containing MP on body weight, body mass index (BMI), and glucose metabolism, the following conclusions can be drawn: estrogens combined with MP (1) either do not change or reduce body weight in normal weight postmenopausal women, (2) do not change BMI in normal and overweight postmenopausal women, (3) do not change or improve fasting serum glucose levels in (non-)diabetic postmenopausal women, (4) do not change or improve fasting serum insulin levels in (non-)diabetic postmenopausal women, and (5) do not have an impact on serum glycated hemoglobin in postmenopausal diabetic women. This beneficial effect is probably mostly due to the estrogen MHT component.

Coracao Hospital, d. and S. Paulo University of (2023). Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer.
	This study hypothesizes that patients who persist with cell-free human papillomavirus deoxyribonucleic acid (cfHPV-DNA) plasma expression at the end of standard treatment, can derive the benefit of using adjuvant chemotherapy in locally advanced cervical cancer (CC). After standard treatment based on concomitant chemoradiotherapy regime, a qualitative and quantitative research of cfHPV-DNA in plasma of patients will be conducted. Patients who have positive research for plasma cfHPV-DNA at the end of chemoradiotherapy treatment will be randomized to receive two additional cycles of adjuvant chemotherapy or observation. Patients will be followed with conduction of computed tomography (CT) scan of the thorax and magnetic resonance (MRI) of abdomen and pelvis and clinical and gynecological examination at every four months.

Corbally, L. and M. Wilkinson (2021). "The effect of mindfulness-based interventions on stress, depression and anxiety during the perinatal period in women without pre-existing stress, depressive or anxiety disorders: A systematic review and meta-analysis of controlled trials." Mindfulness 12(10).
	OBJECTIVES: The objective of this systematic review and meta-analysis was to examine controlled trial evidence for the effectiveness of mindfulness-based interventions on stress, anxiety and depression in the perinatal period in women without pre-existing mental health issues. METHODS: Six databases were searched for studies exploring the effects of mindfulness-based interventions on mental health outcomes of women during the perinatal period. Quality of both controlled trial meeting inclusion criteria were assessed using a tool specifically designed for meta-analyses of mindfulness-based interventions. Effect sizes were extracted for measures of mindfulness, depression, stress and anxiety outcomes. Effects were pooled in separate meta-analyses for all outcomes except anxiety which lacked sufficient studies. RESULTS: Twelve studies were analysed. Pooled effects suggest that mindfulness-based interventions cause small but clear increases in mindfulness and reductions in depression in women without pre-existing disorders. Effects of mindfulness-based interventions on other outcomes were unclear and confounded by heterogeneity. CONCLUSIONS: Available controlled trial evidence suggests that mindfulness-based interventions improve mindfulness and decrease symptoms of depression during pregnancy in women without pre-existing mental health issues and might be a useful approach to prevent or attenuate the development of depression in the perinatal period. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

Corbaux, P., et al. (2023). "Survival and modelled cancer antigen-125 ELIMination rate constant K score in ovarian cancer patients in first-line before poly(ADP-ribose) polymerase inhibitor era: A Gynaecologic Cancer Intergroup meta-analysis." European journal of cancer (Oxford, England : 1990) 191: 112966.
	Background: In patients with advanced ovarian cancer, the modelled CA-125 ELIMination rate constant K (KELIM) is an early indicator of the tumour intrinsic chemosensitivity. We assessed the prognostic and surrogate values of KELIM with respect to those of surgery outcome (based on post-operative residual lesions) in the Gynaecologic Cancer Intergroup (GCIG) individual patient data meta-analysis MAOV (Meta-Analysis in OVarian cancer) built before the emergence of poly(ADP-ribose) polymerase (PARP) inhibitors.; Methods: The dataset was split into learning and validation cohorts (ratio 1:2). The individual modelled KELIM values were estimated, standardised by the median value, then scored as unfavourable (<1.0) or favourable (≥1.0). Overall survival (OS) and progression-free survival (PFS) analyses were performed with a two-step meta-analytic approach and surrogacy through a two-level meta-analytic model.; Results: KELIM was assessed in 5884 patients from eight first-line trials (learning, 1962; validation, 3922). A favourable KELIM score was significantly associated with longer OS (validation set, median, 78.8 versus 28.4 months, hazard-ratios [HR] 0.46, 95% confidence interval [CI], 0.41-0.50, C-index 0.68), and longer PFS (validation set, median 30.5 versus 9.8 months, HR 0.49, 95% CI, 0.45-0.54, C-index 0.68), as were International Federation of Gynaecology and Obstetrics (FIGO) stage and debulking surgery outcome. Three prognostic groups were identified based on the surgery outcome and KELIM score, with large differences in OS (105.1, ∼45.0, and 22.1 months) and PFS (58.1, ∼15.0, and 8.0 months). Surrogacy for OS and for PFS was not established.; Conclusion: KELIM is an independent prognostic biomarker for survival, complementary to surgery outcome, representing a new determinant of first-line treatment success.; Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Benoit You has received compensation for his advisory role for MSD, AstraZeneca, GSK-TESARO, BAYER, Roche-Genentech, ECS Progastrine, Novartis, LEK, Amgen, Clovis Oncology and Merck Serono. Rosalind Glasspool declares personal financial interests for her advisory role for AstraZeneca, MSD, Clovis Oncology, GSK/Tesaro and Immunogen. She also has received compensation for speaker fees and funding to attend medical conferences from TSK/Tesaro, and consultancy fees from Sotio. Anna Tinker has received honoraria from AstraZeneca and Eisai, a research grant from AstraZeneca and declares her role within the advisory committee and speaker’s bureau of GSK. Kristina Lindemann has received compensation for her advisory role for GSK, AstraZeneca and Eisai, and a research grant from GSK. Isabelle Ray-Coquard declares personal fees from AstraZeneca, GSK, Clovis Oncology, Mersana, Deciphera, Eisai, Amgen, BMS, Onxena, Aravive and Roche. Mansoor Raza Mirza has received compensation for his advisory role for AstraZeneca, Biocad, GSK, Karyopharm, Merck, Roche and Zailab. He also received financial interest from Karyopharm as a member of the board of directors and related to stocks and shares. Julien Péron declares compensation from Fab’entech for advisory role; from Eisai as invited speaker, consultant and member of board of directors and from Lilly as invited speaker. He also has received research funding from Roche. Iain McNeish has received compensation for his advisory role for AstraZeneca, Clovis Oncology, GSK, Roche and ScannCell. All remaining authors have declared no conflicts of interest. (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Corbaz, F., et al. (2023). "'connEcted caesarean section': creating a virtual link between MOthers and their infanTs to ImprOve maternal childbirth experieNce - study protocol for a PILOT trial (e-motion-pilot)." BMJ Open 13(6): e065830.
	Introduction: One-third of mothers rate their childbirth as traumatic. The prevalence of childbirth-related post-traumatic stress disorder (CB-PTSD) is 4.7%. Skin-to-skin contact is a protective factor against CB-PTSD. However, during a caesarean section (CS), skin-to-skin contact is not always feasible and mothers and infants are often separated. In those cases, there is no validated and available solution to substitute this unique protective factor. Based on the results of studies using virtual reality and head-mounted displays (HMDs) and studies on childbirth experience, we hypothesise that enabling the mother to have a visual and auditory contact with her baby could improve her childbirth experience while she and her baby are separated. To facilitate this connection, we will use a two-dimensional 360° camera filming the baby linked securely to an HMD that the mother can wear during the end of the surgery.; Methods and Analysis: This study protocol describes a monocentric open-label controlled pilot trial with minimal risk testing the effects of a visual and auditory contact via an HMD worn by the mother airing a live video of her newborn compared with treatment-as-usual in 70 women after CS. The first 35 consecutive participants will be the control group and will receive the standard care. The next 35 consecutive participants will have the intervention. The primary outcome will be differences in maternal childbirth experience (Childbirth Experience Questionnaire 2) at 1-week postpartum between the intervention and control groups. Secondary outcomes will be CB-PTSD symptoms, birth satisfaction, mother-infant bonding, perceived pain and stress during childbirth, maternal anxiety and depression symptoms, anaesthesiological data and acceptability of the procedure.; Ethics and Dissemination: Ethics approval was granted by the Human Research Ethics Committee of the Canton de Vaud (study number 2022-00215). Dissemination of results will occur via national and international conferences, peer-reviewed journals, public conferences and social media.; Trial Registration Number: NCT05319665.; Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Corbeau, A., et al. (2021). "Correlations between bone marrow radiation dose and hematologic toxicity in locally advanced cervical cancer patients receiving chemoradiation with cisplatin: a systematic review." Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology 164: 128-137.
	Patients with locally advanced cervical cancer (LACC) treated with chemoradiation often experience hematologic toxicity (HT), as chemoradiation can induce bone marrow (BM) suppression. Studies on the relationship between BM dosimetric parameters and clinically significant HT might provide relevant indices for developing BM sparing (BMS) radiotherapy techniques. This systematic review studied the relationship between BM dose and HT in patients with LACC treated with primary cisplatin-based chemoradiation. A systematic search was conducted in Embase, Medline, and Web of Science. Eligibility criteria were treatment of LACC-patients with cisplatin-based chemoradiation and report of HT or complete blood cell count (CBC). The search identified 1346 papers, which were screened on title and abstract before two reviewers independently evaluated the full-text. 17 articles were included and scored according to a selection of the TRIPOD criteria. The mean TRIPOD score was 12.1 out of 29. Fourteen studies defining BM as the whole pelvic bone contour (PB) detected significant associations with V10 (3/14), V20 (6/14), and V40 (4/11). Recommended cut-off values were V10 > 95-75%, V20 > 80-65%, and V40 > 37-28%. The studies using lower density marrow spaces (PBM) or active bone marrow (ABM) as a proxy for BM only found limited associations with HT. Our study was the first literature review providing an overview of articles evaluating the correlation between BM and HT for patients with LACC undergoing cisplatin-based chemoradiation. There is a scarcity of studies independently validating developed prediction models between BM dose and HT. Future studies may use PB contouring to develop normal tissue complication probability models.; Competing Interests: Conflicts of interest Erasmus MC Radiotherapy has research agreements with Accuray and Elekta. NH reports to have received research grants from the Dutch Cancer Society and Varian. MH reports to have received research grants from Varian Medical Systems and clinical advisory membership of Accuracy. RN reports to have received research grants outside the submitted work from Dutch Cancer Society, Dutch Research Council, Elekta, Varian Medical Systems, and Accuracy. The other authors have declared no conflicts of interest. (Copyright © 2021 The Author(s). Published by Elsevier B.V. All rights reserved.)

Corbeau, A., et al. (2021). "Protect: Prospective phase-ii-trial evaluating adaptive proton therapy for cervical cancer to reduce the impact on morbidity and the immune system." Cancers 13(20): 5179.
	External beam radiation therapy (EBRT) with concurrent chemotherapy followed by brachytherapy is a very effective treatment for locally advanced cervical cancer (LACC). However, treatment-related toxicity is common and reduces the patient's quality of life (QoL) and ability to complete treatment or undergo adjuvant therapies. Intensity modulated proton therapy (IMPT) enables a significant dose reduction in organs at risk (OAR), when compared to that of standard intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT). How-ever, clinical studies evaluating whether IMPT consequently reduces side effects for LACC are lacking. The PROTECT trial is a nonrandomized prospective multicenter phase-II-trial comparing clinical outcomes after IMPT or IMRT/VMAT in LACC. Thirty women aged >18 years with a histological diagnosis of LACC will be included in either the IMPT or IMRT/VMAT group. Treatment includes EBRT (45 Gy in 25 fractions of 1.8 Gy), concurrent five weekly cisplatin (40 mg/m2 ), and 3D image (MRI)-guided adaptive brachytherapy. The primary endpoint is pelvic bones Dmean and mean bowel V15Gy . Secondary endpoints include dosimetric parameters, oncological outcomes, health-related QoL, immune response, safety, and tolerability. This study provides the first data on the potential of IMPT to reduce OAR dose in clinical practice and improve toxicity and QoL for patients with LACC.Copyright © 2021 by the authors. Licensee MDPI, Basel, Switzerland.

Corchero-Falcón, M. D. R., et al. (2023). "Risk Factors for Working Pregnant Women and Potential Adverse Consequences of Exposure: A Systematic Review." International journal of public health 68: 1605655.
	Objective: To assess the risk factors perceived as stressors by pregnant women in the work environment and the possible adverse consequences of such exposure for the normal development of pregnancy. Methods: Systematic review, guided by the PRISMA guidelines, and using Pubmed, Web of Science, Dialnet, SciELO, and REDIB databases. Methodological quality was assessed using the critical appraisal tools for non-randomised studies of the Joanna Briggs Institute. Results: A total of 38 studies were included. The main risk factors found in the work environment of pregnant women were chemical, psychosocial, physical-ergonomic-mechanical factors, and other work-related factors. The main adverse consequences of exposure to these factors include low birth weight, preterm birth, miscarriage, hypertension and pre-eclampsia, as well as various obstetric complications. Conclusion: During pregnancy, working conditions that are considered acceptable in normal situations may not be so during this stage due to the major changes that occur during pregnancy. Many obstetric effects may have an important impact in the mother's psychological status; therefore, it is important to optimise working conditions during this stage and to reduce or eliminate possible risks.

Cordova, O., et al. (2022). "A prospective, randomized, placebo-controlled pilot trial investigating telomere length dynamics and ovarian function in patients with diminished ovarian reserve (DOR) after danazol treatment." Human Reproduction 37(Supplement 1): i483-i484.
	Study question: Could the administration of a synthetic steroid -danazolfor 3 months reactivate telomerase activity and lengthen telomeres in patients with DOR? Summary answer: Danazol treatment resulted in an increase of the mean leukocyte telomeric length (TL) but did not improve fertility results after the nearest ovarian stimulation (OS). What is known already: A primary molecular cause of aging is telomere attrition, given that the accumulation of critically short telomeres leads organ dysfunction. Telomere shortening can be counteracted by the telomerase enzyme, which is responsible for adding deoxyribonucleotides to the linear ends of chromosomes. In patients with DOR, TL in granulosa cells (GCs) is short and telomerase activity is absent, compromising their proliferative capacity. Previuos studies have shown that estrogens can activate telomerase gene transcription through estrogen-responsive elements located in the promoter of the telomerase gene. Therefore, telomere attrition could be reduced in patients with DOR upon telomerase reactivation. Study design, size, duration: This blinded, placebo-controlled pilot trial was carried out at IVIRMA Madrid clinic between February 2020 and February 2022. The study included 12 patients with DOR (AMH<2ng/ml) which were randomized to danazol or placebo. Patients had 12 visits for health supervision and in vitro fertilization (IVF) treatment. Both groups received danazol (400mg per day) or placebo for 3 months. As control group, 7 patients with normal ovarian reserve (AMH-2ng/ml) were included. Participants/materials, setting, methods: In both groups, blood samples were collected prior (PT) and after the treatment (AT). Luteinized GCs and blood samples were obtained during oocyte retrieval, after OS. Leukocytes were purified in Ficoll gradients and then, evaluated for TL and TRF1 levels by Quantitative Fluorescent in Situ Hybridization followed by image acquisition using high resolution confocal microscope. IVF parameters were assessed according to IVIRMA standard protocols. Main results and the role of chance: A total of 19 women were recruited: 5 in the placebo group (39.8+/-2.7 years), 7 in Danazol group (41.0+/-3.0 years) and 7 in control group (39.5+/-3.0 years). The Danazol group showed a trend to higher mean TL in leukocytes after the treatment (108.2+/-37.4 versus 99+/-13.2 a.u., AT vs PT). Interestingly, the percentage of long telomeres also increased with treatment (15.5+/-0.0 versus 10.8+/-8.1 a.u., AT vs PT). In addition, there was a decrease of the percentage of critically short telomeres (15.7+/-0.0 versus 20.8+/-9.9 a.u. AT vs PT). In the placebo group, mean leukocyte TL and the percentage of long and short telomeres remained constant. These findings suggest that telomeres lengthen after Danazol treatment. The protein levels of TRF1, a shelterin involved in telomere protection, were similar in both Danazol and placebo groups. Regarding fertility, there were no differences in the number of antral follicles, total and MII oocytes, fertilization rate and blastocyst formation. The control group had, as expected, signficantly higher mean follicle number after OS when compared with Danazol (16.0+/-1.4 and 0.7+/-0.9, P<0.0001) and placebo (16.0+/-1.4 and 5.0+/-3.8, p=0.0127) groups, and higher numbers of total oocytes retrieved (p=0.006; control and Danazol, and p=0.007; control and placebo). Limitations, reasons for caution: Firstly, the number of patients included in the study is limited due to strict inclusion/exclusion criteria. Secondly, because follicle growth can take up to 150 days, danazol effects could be noticeable at later OS and not only in the first OS, which was the only one studied here. Wider implications of the findings: Since telomeres seem to elongate in blood samples after Danazol treatment in DOR patients, we could hypothesize that this may have a positive impact for general health, including the ovaries. Thus, danazol therapy might help improving IVF outcomes, perhaps at later OS.

Corinna, C., et al. (2021). "The effect of mother/infant group music classes on postnatal depression – a systematic review protocol."
	
Cork University, C., et al. (2021). The LYSA (Linking You to Support and Advice) Trial.
	No Results Available Other: Survivorship Clinic Assessments|Other: Survivorship Clinic Nurse Resource|Other: Survivorship Clinic Dietitian Resource Number of patients enrolled in the clinic.|Reasons for not enrolling to the study.|Reasons for not completing the intervention (drop out).|Percentage of adherence to the intervention completing ePROs surveys|Number of patients who partake in healthcare professional consultations after ePRO data triggers.|Average consultation time in the Womens Survivorship Clinic.|Change from Baseline in cancer-related symptoms scores assessed by Patient-Reported Outcomes.|Change from Baseline in Health related-Quality of Life Questionnaire (QLQ) scores assessed by European Organization for the Research and Treatment of Cancer (EORTC).|Change from Baseline in Health related-Quality of Life Questionnaire (QLQ) Breast Cancer Module scores assessed by European Organization for the Research and Treatment of Cancer (EORTC).|Change from Baseline in Health related-Quality of Life Questionnaire (QLQ) Cervical Cancer Module scores assessed by European Organization for the Research and Treatment of Cancer (EORTC).|Change from Baseline in Health related-Quality of Life Questionnaire (QLQ) Endometrial Cancer Module scores assessed by European Organization for the Research and Treatment of Cancer (EORTC).|Change from Baseline in EuroQol 5-Level 5-Dimensions quality-adjusted life-year version (EQ-5D-5L-QALY) scores.|Change from Baseline in Appraisal Self-Care Agency-R scores (15 items).|Change from Baseline in adjuvant endocrine therapy medication adherence.|Assessment of Usability and Satisfaction of the survivorship clinic will be assessed by the Usability and Satisfaction Scale (Lewis, 1995).|Experience and opinions from patients, HCP and wider stakeholders about the Women Survivorship Study including the clinic.|Number of resources used by each patient with a cancer related symptom to evaluate the economic impact.|Change from Baseline in Diet intake scores from multiple 24-hour recalls, complemented by a Food Frequency Questionnaire (FFQ).|Change from Baseline in Diet quality scores from The World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) standardised scoring system (Shams-White et al 2019).|Change from Baseline in BMI scores.|Change from Baseline in Lean Body Mass (LBM) scores.|Change from Baseline in waist circumference scores.|Change from Baseline in Segmental Body Composition scores assessed measured by Body Composition Monitor bioimpedance spectroscopy (BIS).|Change from Baseline in muscle strength scores on handgrip measurements.|Change from Baseline in Nutritional risk scores assessed by the Malnutrition Screening Tool (MST). The higher the score, the higher risk of malnutrition. Female Not Applicable 200 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Supportive Care R19258|WHI19CON|BCR-2019-09-ICS-UCC April 2024

Cornelisse, S., et al. (2021). "Comparing the cumulative live birth rate of cleavage-stage versus blastocyst-stage embryo transfers between IVF cycles: a study protocol for a multicentre randomised controlled superiority trial (the ToF trial)." BMJ Open 11(1): e042395.
	INTRODUCTION: In vitro fertilisation (IVF) has evolved as an intervention of choice to help couples with infertility to conceive. In the last decade, a strategy change in the day of embryo transfer has been developed. Many IVF centres choose nowadays to transfer at later stages of embryo development, for example, transferring embryos at blastocyst stage instead of cleavage stage. However, it still is not known which embryo transfer policy in IVF is more efficient in terms of cumulative live birth rate (cLBR), following a fresh and the subsequent frozen-thawed transfers after one oocyte retrieval. Furthermore, studies reporting on obstetric and neonatal outcomes from both transfer policies are limited. METHODS AND ANALYSIS: We have set up a multicentre randomised superiority trial in the Netherlands, named the Three or Fivetrial. We plan to include 1200 women with an indication for IVF with at least four embryos available on day 2 after the oocyte retrieval. Women are randomly allocated to either (1) control group: embryo transfer on day 3 and cryopreservation of supernumerary good-quality embryos on day 3 or 4, or (2) intervention group: embryo transfer on day 5 and cryopreservation of supernumerary good-quality embryos on day 5 or 6. The primary outcome is the cLBR per oocyte retrieval. Secondary outcomes include LBR following fresh transfer, multiple pregnancy rate and time until pregnancy leading a live birth. We will also assess the obstetric and neonatal outcomes, costs and patients' treatment burden. ETHICS AND DISSEMINATION: The study protocol has been approved by the Central Committee on Research involving Human Subjects in the Netherlands in June 2018 (CCMO NL 64060.000.18). The results of this trial will be submitted for publication in international peer-reviewed and in open access journals. TRIAL REGISTRATION NUMBER: Netherlands Trial Register (NL 6857).

Coronado, P. J., et al. (2024). "Eligibility criteria for using menopausal hormone therapy in breast cancer survivors: a safety report based on a systematic review and meta-analysis." Menopause 31(3): 234-242.
	Importance Menopause hormone therapy (MHT) effectively alleviates menopausal symptoms. However, it is generally not recommended for breast cancer survivors, although the scientific evidence is scarce. Objective This study aimed to establish eligibility criteria for use of the MHT in breast cancer survivors based on a systematic review and meta-analysis of the literature. Evidence Review We conducted exhaustive literature searches until June 2022 in MEDLINE, The Cochrane Library, and EMBASE, using a tailored strategy with a combination of controlled vocabulary and search terms related to breast cancer survivors and MHT. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and assessed the risk of bias using the Cochrane and Risk of Bias in Non-randomized Studies - of Interventions tools. The quality of the evidence was graded according to grading quality of evidence and strength of recommendations criteria (A, high; B, moderate; C, low; and D, very low). We categorized MHT use into four levels: category 1 (no restrictions on use), category 2 (the benefits outweigh the risks), category 3 (the risks generally outweigh the benefits), and category 4 (MHT should not be used). Findings A total of 12 studies met the eligibility criteria. Analysis of the three randomized clinical trials using combined MHT or tibolone revealed no significant differences concerning tumor recurrence (relative risk [RR], 1.46; 95% CI, 0.99-2.24). A combined analysis of randomized clinical trials, prospective, and retrospective trials found no elevated risk of recurrence (RR, 0.85; 95% CI, 0.54-1.33) or death (RR, 0.91; 95% CI, 0.38-2.19). The eligibility criteria for patients with hormone receptor (HR)-positive tumors fell into categories 3B and 3C for combined MHT or estrogen alone and 4A for tibolone. For HR-negative tumors, the category was 2B and 2C. Conclusions and Relevance Our findings suggest that MHT could be a viable treatment alternative for breast cancer survivors experiencing menopausal symptoms, especially those with HR-negative tumors. Personalized management is recommended for each peri/postmenopausal woman facing a diminished quality of life because of menopause symptoms. Further randomized trials are needed before considering changes to current standards of care. Copyright © Wolters Kluwer Health, Inc. All rights reserved.

Coronado, P. J., et al. (2023). "Pharmacological interactions and menopausal hormone therapy: a review." Menopause 30(8): 873-880.
	Importance and Objective Menopausal hormone therapy (HT) is widely used, and there are several statements of international scientific societies to guide prescribers; however, a summary of existing literature about possible drug interactions with HT does not exist, although many midlife women take medications for other conditions. Therefore, our objective was to create a document that presents and synthesizes the most relevant interactions. The impact of the interaction itself and the number of candidates for HT who are likely to use other treatments are considered based on the best available evidence. Methods A systematic review was performed to determine the best evidence of interaction effects on relevant outcomes of interest for decision making. A working framework was developed to formulate explicit and reasoned recommendations according to four predefined categories for coadministration: (1) can be used without expected risks, (2) acceptable use (no evidence of negative interaction), (3) alternative treatment should be considered, and (4) nonuse without express justification. The project protocol was registered in the Open Science Framework platform (doi: 10.17605/OSF.IO/J6WBC) and in PROSPERO (registration number CRD42020166658). Results Studies targeting our objective are scarce, but 23 pharmacological groups were assigned to one of the predefined categories of recommendation for concomitant use of HT. Vaginal HT was assigned to category 1 for 21 of the analyzed pharmacological groups. For oral and transdermal HT (estrogen-only or combined) and tibolone, there were 12 pharmacological groups assigned to category 1, 12 to category 2, 5 to category 3, and 4 to category 4. Results are shown in crossed-tables that are useful for counseling and prescription. Discussion and conclusions Available evidence of HT interactions with other drugs is scarce and mainly indirect. It comes from biological plausibility, knowledge of extensive concomitant use without reported incidents, and/or extrapolation from hormonal contraception, but there are pharmacological groups in all categories showing that information is useful. These eligibility criteria summarize it and can help in the decision process of HT coadministration with other drugs. Decisions should be taken based on these recommendations but also individualized risk/benefit evaluation, according to underlying pathology, patient's clinical requirements, and the existence or nonexistence of alternatives.Copyright © Wolters Kluwer Health, Inc. All rights reserved.

Corporation, G. and G. O. G. Foundation (2022). Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Platinum-doublet + Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (OnPrime, GOG-3076).
	No Results Available Biological: olvimulogene nanivacirepvec|Drug: Platinum chemotherapy: carboplatin (preferred) or cisplatin|Drug: Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin|Drug: Bevacizumab (or biosimilar) Progression-free survival (PFS) by RECIST 1.1 in the Intention-to-Treat (ITT) population (all randomized participants regardless of whether they received any dose of treatment)|Incidence of Treatment-emergent Adverse Events in the ITT population|Duration of Response (DOR) by RECIST 1.1 in the ITT population|PFS by RECIST 1.1 in the modified ITT (mITT) population (participants who received at least 1 dose of treatment in either Arm)|PFS by iRECIST in the ITT population|Overall Response Rate (ORR) by RECIST 1.1 in the ITT population|Overall Survival in the ITT population Female Phase 3 186 Industry|Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Olvi-Vec-022|GOG-3076 October 2026

Corr, B., et al. (2023). "Treatment-related adverse events in a randomized trial in stage three and four ovarian cancer testing patient-specific dendritic cell vaccines loaded with tumor antigens from self-renewing autologous tumor cells (1258)." Gynecologic Oncology 176(Supplement 1): S164.
	Objectives: The purpose of this study was to determine the clinical effects of a patient-specific therapeutic ovary cancer vaccine consisting of autologous dendritic cells (DC) loaded with autologous tumor antigens (ATA) from self-renewing autologous cancer cells. The objectives of the double-blind 2:1 randomized trial were to determine: (1) the feasibility and efficiency of manufacturing DC-ATA, (2) adverse events associated with DC-ATA injections compared to injections of autologous monocytes (MC) as a control arm, and (3) survival in the two arms. This report focused on the safety comparison. Method(s): A multi-institutional, double-blind, randomized phase II clinical trial was designed to determine treatment-related adverse events (TEAE) associated with the granulocyte-macrophage colony-stimulating factor (GM-CSF) and DC-ATA compared to GM-CSF plus MC. Key eligibility criteria were: (1) primary diagnosis of stage III or IV ovary epithelial cancer, (2) successful cell culture of ovarian cancer cells, (3) successful monocyte collection by leukapheresis, (4) completion of primary multimodality therapy and (5) ECOG of 0 or 1 at the time of randomization. After completing primary systemic therapy, patients were stratified by whether they had residual disease and then randomized 2:1 to vaccine or control arms. Randomization occurred about 7 months after the initial surgery. IL-4 and GM-CSF were used to differentiate monocytes into DC, which were incubated with the lysate of cultured ovarian cancer cells as the ATA source. Patients in the control arm received cryopreserved autologous MC from their leukapheresis product. Each dose was admixed with 500 mug GM-CSF at the time of subcutaneous injections at weeks 1, 2, 3, 8, 12, 16, 20, and 24. Fisher's exact test was used to compare proportions, and t-test to compare means. Result(s): The trial was halted by the sponsor after 45 patients were randomized. All patients had an opportunity to receive all 8 possible injections and an additional month of follow-up for safety assessment. The median age was 61 years (range: 38 to 84). ECOG status was 0 for 30, 1 for 13, and 2 for two subjects. Thirty-two were stage III, and 13 were stage IV at the time of surgery. Thirty patients received neoadjuvant therapy. Forty-five patients received 333 injections; 29 patients received DC-ATA, and 16 received MC. No patient discontinued treatment because of toxicity, but 1 patient in the MC arm was hospitalized after the eighth dose for refractory urticaria that necessitated high-dose corticosteroids. Most TEAE possibly associated with investigational treatment were mild to moderate in severity. Most common were local injection site reactions (58%), malaise-fatigue (44%), rash and/or pruritus (36%), headache (27%), myalgias (27%), arthralgias (27%), and bone discomfort (27%). There were no differences in the proportions of these events between study arms. The number of TEAE ranged from 0 to 24 (mean 7.9) in the DC-ATA arm and 1 to 12 (mean 6.5) in the MC arm (P = 0.309). There were 4 grade 3 TEAE possibly due to study treatment: 2 episodes of hypertension, 1 headache, and 1 rash and pruritus, including urticaria. There were 5 grade 3 and 1 grade 4 TEAE due to cytopenias in patients receiving concurrent chemotherapy, and 2 grade 3 due to abdominal/pelvic pain that was attributed to ovarian cancer or prior surgery. There was no difference in the proportion of grade 3 or 4 by study arm (P = 1.00). Conclusion(s): DC-ATA was well-tolerated, with no differences between study arms. Most TEAE attributed to study products are probably due to GM-CSF rather than differences between DC-ATA and MC.Copyright © 2023

Corrado, G., et al. (2023). "Patterns of recurrence in FIGO stage IB1-IB2 cervical cancer: Comparison between minimally invasive and abdominal radical hysterectomy." European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology 49(11): 107047.
	Objective: Aim of our study was to evaluate whether the different laparotomic (ARH) or minimally invasive (laparoscopic and robotic) approaches (MIS) in FIGO stage IB1-IB2 cervical cancer, present different patterns of recurrence of the disease. The secondary endpoint of the study was the evaluation of the variables most involved with the risk of relapse and therefore lower DFS and OS.; Material and Methods: The study enrolled patients with definitive histological diagnosis of squamous or adenocarcinoma stage IB1-IB2 cervical cancer who underwent minimally invasive or abdominal radical hysterectomy from 2001 to 2018.; Results: The study enrolled 360 patients and 59 patients (16.4 %) reported a disease relapse. The data showed that ARH group was not associated with different recurrence patterns than MIS group (p = 0.14). Moreover, there was no statistically significant difference regarding DFS (p = 0.52) and OS (p = 0.29) between the ARH group and the MIS group.; Conclusions: MIS, in FIGO stage IB1-IB2 cervical cancer, is not associated with different relapse patterns compared to ARH, nor with a higher risk of distance metastasis and finally, without significant difference in term of DFS and OS. More studies are needed to determine the factors that modify the site of relapse.; Competing Interests: Declaration of competing interest No conflict of interest is disclosed. (© 2023 Elsevier Ltd, BASO ∼ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Cory, R., et al. (2021). "HIIT’ing or MISS’ing the optimal management of polycystic ovary syndrome: a systematic review and meta-analysis of high- versus moderate-intensity exercise prescription."
	
Costa Kamilla, R. and B. Metzger Patrick (2020). "Endovascular treatment of uterine myomatosis: a systematic review." Jornal vascular brasileiro 19: e20190149.
	Uterine Artery Embolization (UAE) is a noninvasive alternative to open surgery for treatment of uterine myomatosis. This study aims to analyze the efficacy and safety of UAE in these cases. A systematic review was carried out of studies available on the Medline (via PubMed) and the LILACS and PEDro (via the Biblioteca Virtual em Saúde) databases. The searches found 817 studies, 7 of which were selected according to the eligibility criteria (analytical, longitudinal, retrospective, or prospective studies), with a total of 367 patients studied. The variables analyzed and the characteristics of the studies included were collated and input to a database. Rates of volume reduction of the uterus and the dominant myoma were 44.1% and 56.3%, respectively. Mean rate of complete infarction of the dominant myoma was 88.6% (82-100%). The mean number of complications observed was 15±8.6 cases, most of which were classified as minor, and no deaths were recorded. The mean number of re-interventions in absolute values was 12.2±15.5 cases. Therefore, in the literature analyzed, uterine artery embolization is an effective procedure with a low rate of complications for treatment of uterine leiomyomatosis.; Competing Interests: Conflicts of interest: No conflicts of interest declared concerning the publication of this article.

Costello Michael, F., et al. (2019). "A brief update on the evidence supporting the treatment of infertility in polycystic ovary syndrome." The Australian & New Zealand Journal of Obstetrics & Gynaecology 59(6): 867-873.
	Background: Polycystic ovary syndrome (PCOS) is complex with reproductive, metabolic and psychological features. Infertility is a prevalent presenting feature of PCOS with approximately 75% of these women suffering infertility due to anovulation, making PCOS by far the most common cause of anovulatory infertility. Previous guidelines either lacked rigorous evidence-based processes, did not engage consumer and international multidisciplinary perspectives, or were outdated.; Aims: This review paper aims to provide a brief update on the best available and most current research evidence supporting the treatment of PCOS which informed the recommendations in the assessment and treatment of infertility section of the international evidence-based guideline on PCOS 2018.; Materials and Methods: International evidence-based guideline development engaged professional societies and consumer organisations with multidisciplinary experts and women with PCOS directly involved at all stages.; Results: Lifestyle change alone is considered the first-line treatment for the management of infertile anovulatory PCOS women who are overweight or obese. Letrozole should now be considered first-line pharmacological treatment for ovulation induction to improve fertility outcomes. Clomiphene citrate alone and metformin alone could also be used as first-line pharmacological therapy, although both are less effective than letrozole and metformin is less effective than clomiphene citrate in obese women. Gonadotrophins or laparoscopic ovarian surgery are usually second-line ovulation induction therapies. In the absence of an absolute indication for in vitro fertilisation (IVF) / intracytoplasmic sperm injection, women with PCOS and anovulatory infertility could be offered IVF as third-line therapy where first- or second-line ovulation induction therapies have failed.; Conclusion: This review provides the best available evidence informing recommendations (along with clinical expertise and consumer preference) which provide clinicians with clear advice on best practice for the management of infertile women with PCOS. (© 2019 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Cote, G. M., et al. (2022). "A phase 1b lead-in to a randomized phase 2 trial of lurbinectedin plus doxorubicin in leiomyosarcoma (LMS)." Journal of Clinical Oncology 40(16 Supplement 1).
	Background: Single agent or combination chemotherapy regimens, typically including doxorubicin or gemcitabine, represent standard of care options for first- and second-line therapy in patients (pts) with metastatic LMS. However, response rates (ORR) and progression-free (PFS)/overall survival (OS) remain poor. Lurbinectedin (PharmaMar S.A. and Jazz Pharmaceuticals) uniquely binds DNA, inducing DNA double strand breaks leading to apoptosis and delaying progression through phase S/G2 of the cell cycle. Lurbinectedin is a novel structural analog of trabectedin with improved toxicity profile, potency, and pharmacokinetics. In a prior pilot study, we showed that the combination of lurbinectedin and doxorubicin (L+D) was safe, with early signs of clinical activity, particularly in LMS. Thus, we designed this investigator-initiated/investigator-sponsored phase 1b lead-in to optimize doses of L+D, to be followed by a randomized (1:1) phase 2 study of L+D versus doxorubicin monotherapy in anthracycline- naive LMS. Method(s): Pts age > 18 years with locally advanced or metastatic, unresectable LMS (non-GIST soft-tissue sarcoma histologies allowed in Phase 1b), without prior anthracycline or lurbinectedin/ trabectedin, ECOG PS < 3, measurable disease by RECIST 1.1, and normal organ function, are eligible. Phase 1b dosing will include a fixed dose of lurbinectedin and two dose levels of doxorubicin. The Phase 1b lead-in follows a standard 3+3 design where dose escalation will occur if 0/3 or 1/6 patients experience a dose-limiting toxicity (DLT). Tumor assessments are conducted every two cycles. Once the recommended phase 2 dose (RP2D) is confirmed, Phase 2 will be initiated. Fifty pts will be randomized 1:1 including doxorubicin +/- lurbinectedin. Randomization will be stratified by uterine v. non-uterine origin of LMS. Pts progressing on single agent doxorubicin will be allowed to cross over to lurbinectedin monotherapy. The Phase 2 primary endpoint is PFS. Secondary endpoints include disease control rate, ORR, OS, PFS2 (for doxorubicin monotherapy patients who cross to lurbinectedin monotherapy). Archival tumor, germline DNA, and ctDNA will be collected for correlative studies exploring genomic markers of sensitivity/resistance. We will provide respective point estimate along with 90% confidence interval for each of the arms. Log-rank test will be performed to test the difference in survival (both PFS and OS) between groups. Regression analyses of survival data will be based on the Cox proportional hazards model. The first pt in dose-level 1 of the Phase 1b lead-in was enrolled in February 2022.

Coutzac, C., et al. (2022). "Immunotherapy in MSI/dMMR tumors in the perioperative setting: The IMHOTEP trial." Digestive and Liver Disease 54(10): 1335-1341.
	Background: Immune checkpoint inhibitors (ICI) targeting Programmed death-1 (PD-1) have shown their efficacy in advanced MSI/dMMR (microsatellite instability/deficient mismatch repair) tumors. The MSI/dMMR status predicts clinical response to ICI. The promising results evaluating ICI in localized MSI/dMMR tumors in neoadjuvant setting need to be confirmed in MSI/dMMR solid tumors. The aim of the IMHOTEP trial is to assess the efficacy of neoadjuvant anti-PD-1 treatment in MSI/dMMR tumors regarding the pathological complete response rate. Method(s): This study is a prospective, multicenter, phase II study including 120 patients with localized MSI/dMMR carcinomas suitable for curative surgery. A single dose of pembrolizumab will be administered before the surgery planned 6 weeks later. Primary objective is to evaluate the efficacy of neoadjuvant pembrolizumab according to pathological complete tumor response. Secondary objectives are to assess safety, recurrence-free survival and overall survival. Ancillary studies will assess molecular and immunological biomarkers predicting response/resistance to ICI. First patient was enrolled in December 2021. Discussion(s): The IMHOTEP trial will be one of the first clinical trial investigating perioperative ICI in localized MSI/dMMR in a tumor agnostic setting. Assessing neoadjuvant anti-PD-1 is mandatory to improve MSI/dMMR patient's outcomes. The translational program will explore potential biomarker to improve our understanding of immune escape and response in this ICI neoadjuvant setting.Copyright © 2022 The Authors

Cowan, M., et al. (2021). "Efficacy and safety of tivozanib in recurrent, platinum-resistant ovarian, fallopian tube or primary peritoneal cancer, an NCCN phase II trial." Gynecologic Oncology 163(1): 57‐63.
	OBJECTIVE: Tivozanib is a potent selective pan‐vascular endothelial growth factor receptor tyrosine kinase inhibitor with a long half‐life. This study assessed its activity in patients with recurrent, platinum‐resistant ovarian, fallopian tube or primary peritoneal cancer (OC). METHODS: This open‐label phase II study used a Simon's two‐stage design. Eligible patients had recurrent, platinum‐resistant OC and measurable or detectable disease. There was no limit on the number of prior regimens. Treatment consisted of tivozanib 1.5 mg orally once daily for 21 days in a 28‐day cycle. The primary endpoint was objective response rate (ORR). Secondary endpoints were progression‐free survival (PFS), overall survival (OS), and toxicity assessment. RESULTS: Thirty‐one patients were enrolled, and 30 were treated. The median age was 59.5 years, and median number of prior regimens was 4 (range 1‐9). Twenty‐four patients were evaluable for response, and four (16.7%) achieved a partial response (PR; ORR = 16.7%). An additional fourteen (58.3%) patients had stable disease (SD). The clinical benefit rate (PR + SD) was 75.0%, and the median duration of objective response was 5.7 months. For all patients on trial, the median PFS was 4.1 months (95% confidence interval (CI): 1.7‐5.8) and OS 8.6 months (95% CI: 5.4‐12.5). There were no treatment‐related deaths. Serious adverse events occurred in 13.3% of patients and included small intestinal perforation or obstruction and stroke. Grade 3‐4 adverse events occurred in 60% of patients, including hypertension (26.7%) and fatigue (10%). CONCLUSIONS: Tivozanib is effective in patients with recurrent OC, with moderate toxicity and no treatment‐related deaths, supporting its further development.

Coward, J. I., et al. (2021). "Maximum Tolerated Dose and Anti-Tumor Activity of Intraperitoneal Cantrixil (TRX-E-002-1) in Patients with Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer: Phase I Study Results." Cancers 13(13).
	Survival outcomes in ovarian cancer are poor. The aims of this Phase I progressive design study (NCT02903771) were to evaluate the maximum tolerated dose (MTD), tolerability, and antitumor activity of Cantrixil-a novel third-generation benzopyran molecule-in patients (n = 25) with advanced, recurrent/persistent epithelial ovarian, primary peritoneal, or fallopian tube cancer. All had completed ≥ 2 prior regimens; 3 (12%) had platinum-refractory disease, and 17 (68%) had platinum-resistant disease. Following intraperitoneal (IP) port placement, patients received weekly IP Cantrixil in 3-week cycles as monotherapy (Cycles 1-2), and then in combination with intravenous (IV) chemotherapy (Cycles 3-8). Part A (dose escalation) enrolled 11 patients in 6 dose-level cohorts. An MTD of 5 mg/kg was established with dose-limiting toxicity of ileus. Most treatment-related adverse events were gastrointestinal. Across Parts A and B (dose expansion), 16 (64%) patients received ≥ 1 3-week Cantrixil cycle, and had ≥ 1 post-baseline efficacy measurement available. The results show promising anti-tumor activity in monotherapy (stable disease rate of 56%) and in combination with IV chemotherapy (objective response rate of 19%, disease control rate of 56%, and median progression-free survival of 13.1 weeks). The molecular target and mechanism of action of Cantrixil are yet to be confirmed. Preliminary analysis of stem cell markers suggests that IP Cantrixil might induce ovarian cancer stem cell death and sensitize cells to standard chemotherapy, warranting further evaluation.

Coyle Meaghan, E., et al. (2021). "Licorice (Glycyrrhiza spp.) and jujube (Ziziphus jujuba Mill.) formula for menopausal symptoms: Classical records, clinical evidence and experimental data." Complementary Therapies in Clinical Practice 44: 101432.
	Objectives: This study sought to determine the most common oral herbal formula for menopausal symptoms in classical Chinese medicine textbooks and investigate its clinical effectiveness and potential mechanisms of action.; Methods: The most common formula used for menopause-like symptoms in past eras was identified from the Encyclopedia of Traditional Chinese Medicine. A systematic review of randomized controlled trials (RCTs) was undertaken and findings from relevant experimental studies were summarized.; Results: Licorice (Glycyrrhiza spp.) and jujube (Ziziphus jujuba Mill.) formula (LJF) was used in 63 of the 175 citations (36%) in the classical literature. Evidence from four RCTs showed that while LJF may improve sleep symptoms, there is insufficient evidence to provide recommendations for clinical practice. Experimental studies showed sedative, antidepressant-like, estrogenic and antiprogestogenic actions.; Conclusions: LJF has a long history of use for menopause-like symptoms, but further research is needed to confirm its clinical effects and guide clinical decision-making. (Copyright © 2021. Published by Elsevier Ltd.)

Coyne, E., et al. (2020). "Acknowledging cancer as a family disease: A systematic review of family care in the cancer setting." European Journal of Oncology Nursing 49.
	Purpose: Family members are a part of the team to improve the outcomes of the person with cancer. Families require support and information to optimise their care, however, their needs are often unacknowledged and within clinical areas there is a lack of family focused interventions. Studies highlight families' needs but lack a family representation. The aim was to explore research with family as the unit-of-care during cancer treatment. Method: The Pickering systematic quantitative literature review method; a 15-step process from searching, database development and analysis was followed. Research published 2008-2019 within databases: MEDLINE, SCOPUS, PsycINFO, Cochrane, CINAHL; key words, 'family* or caregiver*, and cancer*, neoplasm* and coping*, distress* in November 2019. Quality assessment completed using Mixed Methods Appraisal Tool, descriptive quantitative analysis and thematic analysis. Results: Studies involving patients and family members were included in the review (N = 73). The analysis identified participants had a mean age of 58 years and primarily lung, breast or prostate cancer. Over 80% were from America and European countries; 93% had a dyad sample, quantitative studies (76%). There was eight intervention studies between four to sixteen weeks long, focused on family wellbeing. Themes described the impact of cancer on the whole family, the importance of communication between family members, and resources for family members. Conclusion: The review identified four main scales and optimum intervention styles. Family research in the adult cancer needs to focus on intervention studies, increase international focus and inclusion of other family members such as children, friends and older adults. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

Cozzolino, M., et al. (2020). "How vitamin D level influences in vitro fertilization outcomes: results of a systematic review and meta-analysis." Fertility and Sterility 114(5): 1014-1025.
	Objective: To investigate the impact of serum vitamin D level on in vitro fertilization (IVF) outcomes.; Design: Systematic review and meta-analysis.; Setting: Not applicable.; Patients: Infertile women undergoing conventional IVF or intracytoplasmic sperm injection (ICSI).; Interventions: Systematic search of PubMed, MEDLINE, EMBASE, Global Health, The Cochrane Library, Health Technology Assessment Database, and Web of Science from inception until July 2019 with cross-checking of references from relevant articles in English. Vitamin D levels were categorized into three groups: deficient (<20 ng/mL), insufficient (20-30 ng/mL), and replete (>30 ng/mL). Before starting the data extraction, we registered the review protocol in PROSPERO (CRD42019134258).; Main Outcome Measures: We consider clinical pregnancy rate (CPR), live birth rate (LBR), and/or ongoing pregnancy rate (OPR) as primary outcomes. Likewise, the miscarriage rate was considered as a secondary outcome.; Results: Primary analysis showed that women with a replete level of vitamin D had higher CPR and LBR/OPR compared to those with a deficient of insufficient level of vitamin D. However, sensitivity analysis led to non-significant differences between the comparators for CPR (odds ratio 0.71, 95% confidence interval 0.47-1.08, I2 = 61%) and OPR/LBR (odds ratio 0.78, 95% confidence interval 0.56-1.08], I2 = 61%). Also, for miscarriage a statistically different rate was not reached.; Conclusion: Serum vitamin D levels do not influence IVF outcomes in terms of CPR, LBR/OPR, and miscarriage rate. Future large cohort studies are warranted to determine whether the threshold of vitamin D affects reproductive outcomes. Currently, there is a lack of consensus between the appropriate vitamin D threshold to predict reproductive outcomes compared to the one established for bone health.; Prospero Number: CRD42019134258. (Copyright © 2020 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Cozzolino, M., et al. (2020). ""Delayed start" gonadotropin-releasing hormone antagonist protocol in Bologna poor-responders: A systematic review and meta-analysis of randomized controlled trials." European Journal of Obstetrics, Gynecology, and Reproductive Biology 244: 154-162.
	To evaluate the effectiveness of delay start protocol in improving the success of in vitro fertilization (IVF) in poor responders according to Bologna's criteria. Only randomized controlled trial (RCT) of infertile women undergoing a single IVF/ICSI cycle with ovarian stimulation protocol based on daily injections with delay start protocol or a conventional antagonist protocol were included in this systematic review and meta-analysis. The review protocol was registered in PROSPERO before starting the data extraction (CRD42019128284). Primary outcome was clinical pregnancy rate. Ongoing pregnancy rate, miscarriage rate, number of oocytes, number of MII oocytes, stimulation length, gonadotropin amount and cancellation rate were considered as secondary outcomes. Four randomized controlled trials were included with a total number of 380 participants. 189 patients were included in the delayed start protocol and 191 were allocated to the comparison group. The results showed a significant higher clinical pregnancy rate (CPR) in patients allocated to the intervention. Data from all studies failed to detect a statistical difference between groups in terms of ongoing pregnancy rate (OPR), miscarriage rate (MR), Total-Oocyte, MII-Oocyte and Total-Embryos. Gonadotropin amount (GA) was significantly lower in the intervention group in comparison to controls, with no difference in stimulation length (SL) and cancelled cycle (CC). Delayed start GnRH-antagonist protocol may reduce GA and improve CPR in poor ovarian responder according to Bologna criteria. (Copyright © 2019 Elsevier B.V. All rights reserved.)

Cozzolino, M., et al. (2022). "The Effect of Uterine Adenomyosis on IVF Outcomes: a Systematic Review and Meta-analysis." Reproductive sciences (Thousand Oaks, Calif.) 29(11): 3177-3193.
	To investigate the impact of uterine adenomyosis on in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) clinical outcomes and also to evaluate the impact of gonadotropin-releasing hormone agonist (GnRHa) and surgical treatments. Infertile women with adenomyosis undergoing conventional IVF or ICSI were compared with women without adenomyosis. Fertility outcomes were evaluated in two patients with adenomyosis untreated and treated surgically or medically therapy. The review protocol was registered in PROSPERO (CRD42020214586). We consider the live birth rate (LBR) as the primary outcome. The analysis showed that women with adenomyosis had lower LBR (OR 0.59, 95% CI 0.37-0.92, p = 0.02), clinical pregnancy rate (OR 0.66, 95% CI 0.48-0.90), and ongoing pregnancy rate (OR 0.43, 95% CI 0.21-0.88) compared to those without adenomyosis, and miscarriage rate was higher in women with adenomyosis (OR 2.11, 95% CI 1.33-3.33). Surgical treatment increases natural conception in women with adenomyosis although the paucity of data (only two studies), and conversely, treatment with GnRHa does not increase the IVF outcomes. Women with adenomyosis have decreased IVF clinical outcomes. Pretreatment with the use of long-term GnRHa could not be beneficial, even though only three studies were included in the meta-analysis. The major part of the studies has not divided focal and diffuse adenomyosis, and this represents a relevant source of bias: studies conducted with standardized diagnostic criteria for adenomyosis are still needed to determine if the different clinical presentations of such condition could compromise IVF outcomes. (© 2021. Society for Reproductive Investigation.)

Cozzolino, M., et al. (2020). "Therapy with probiotics and synbiotics for polycystic ovarian syndrome: a systematic review and meta-analysis." European journal of nutrition 59(7): 2841-2856.
	Objective: Several randomized controlled trials (RCTs) have investigated the use of probiotic/synbiotic in PCOS patients, without clarifying the real use in clinical practice. The aim of this meta-analysis was to evaluate the effectiveness of probiotics and synbiotics on metabolic, hormonal and inflammatory parameters of PCOS.; Methods: Electronic databases (MEDLINE, Scopus, EMBASE, ScienceDirect, The Cochrane Database of Systematic Reviews and ClinicalTrials.gov) were searched from their inception until May 2019. The study protocol was registered in PROSPERO with number CRD42018111534. Randomized controlled trials (RCTs) of PCOS's women undergoing therapy at least 8 weeks with probiotics or synbiotics or without therapy were included. The primary outcomes were changes in anthropometric parameters, glucose/insulin metabolism, lipid profile, sex hormones profile, inflammation markers.; Results: 587 patients were included in nine RCT. The administration of probiotic/synbiotic were associated with a significant improvement in FPG, FBI, HOMA I-R, BMI. It also modified Ferriman-Gallway, serum triglycerides, serum testosterone, hs-CRP, NO, TAC, GSH, and MDA. Subgroup analysis of the type of intervention showed that probiotics were associated with greater testosterone and FPG reduction; synbiotics administration resulted in a more pronounced decrease of the FBI. Subgroup analyses on the duration of therapy showed that, probiotic/synbiotic administration had a significantly greater effect on QUICK-I in the case of women with 12-weeks of therapy than in the 8-weeks therapy group. Nevertheless, we did not observe any significant difference was observed in terms of FBI, HOMA-IR, and FPG.; Conclusions: Probiotics and synbiotics seem to either an effect on/influence metabolic, hormonal and inflammatory parameters, or can influence them. Consequently, it could lead to an improvement of fertility in PCOS.

Cozzolino, M., et al. (2022). "Correction to: Therapy with probiotics and synbiotics for polycystic ovarian syndrome: a systematic review and meta‑analysis." European journal of nutrition 61(4): 2233-2235.
	
Craciunas, L., et al. (2022). "Hormone therapy for uterine and endometrial development in women with premature ovarian insufficiency." The Cochrane Database of Systematic Reviews 10: CD008209.
	Background: Premature ovarian insufficiency (POI) is a clinical syndrome resulting from loss of ovarian function before the age of 40. It is a state of hypergonadotropic hypogonadism, characterised by amenorrhoea or oligomenorrhoea, with low ovarian sex hormones (oestrogen deficiency) and elevated pituitary gonadotrophins. POI with primary amenorrhoea may occur as a result of chromosomal and genetic abnormalities, such as Turner syndrome, Fragile X, or autosomal gene defects; secondary amenorrhoea may be iatrogenic after the surgical removal of the ovaries, radiotherapy, or chemotherapy. Other causes include autoimmune diseases, viral infections, and environmental factors; in most cases, POI is idiopathic. Appropriate replacement of sex hormones in women with POI may facilitate the achievement of near normal uterine development. However, the optimal effective hormone therapy (HT) regimen to maximise the reproductive potential for women with POI remains unclear.; Objectives: To investigate the effectiveness and safety of different hormonal regimens on uterine and endometrial development in women with POI.; Search Methods: We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and two trials registers in September 2021. We also checked references of included studies, and contacted study authors to identify additional studies.; Selection Criteria: We included randomised controlled trials (RCTs) investigating the effect of various hormonal preparations on the uterine development of women diagnosed with POI.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. The primary review outcome was uterine volume; secondary outcomes were endometrial thickness, endometrial histology, uterine perfusion, reproductive outcomes, and any reported adverse events.; Main Results: We included three studies (52 participants analysed in total) investigating the role of various hormonal preparations in three different contexts, which deemed meta-analysis unfeasible. We found very low-certainty evidence; the main limitation was very serious imprecision due to small sample size. Conjugated oral oestrogens versus transdermal 17ß-oestradiol We are uncertain of the effect of conjugated oral oestrogens compared to transdermal 17ß-oestradiol (mean difference (MD) -18.2 (mL), 95% confidence interval (CI) -23.18 to -13.22; 1 RCT, N = 12; very low-certainty evidence) on uterine volume, measured after 12 months of treatment. The study reported no other relevant outcomes (including adverse events). Low versus high 17ß-oestradiol dose We are uncertain of the effect of a lower dose of 17ß-oestradiol compared to a higher dose of 17ß-oestradiol on uterine volume after three or five years of treatment, or adverse events (1 RCT, N = 20; very low-certainty evidence). The study reported no other relevant outcomes. Oral versus vaginal administration of oestradiol and dydrogesterone We are uncertain of the effect of an oral or vaginal administration route on uterine volume and endometrial thickness after 14 or 21 days of administration (1 RCT, N = 20; very low-certainty evidence). The study reported no other relevant outcomes (including adverse events).; Authors' Conclusions: No clear conclusions can be drawn in this systematic review, due to the very low-certainty of the evidence. There is a need for pragmatic, well designed, randomised controlled trials, with adequate power to detect differences between various HT regimens on uterine growth, endometrial development, and pregnancy outcomes following the transfer of donated gametes or embryos in women diagnosed with POI. (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Creinin, M. D., et al. (2022). "Heavy Menstrual Bleeding Treatment With a Levonorgestrel 52-mg IUS." Obstetrics and Gynecology 139(SUPPL 1): 34S.
	INTRODUCTION: Prior levonorgestrel 52-mg intrauterine system (IUS) studies for heavy menstrual bleeding (HMB) limited body mass index (BMI) and included only parous women. We evaluated outcomes in a population without BMI or parity restrictions. METHOD(S): We performed an institutional review board- approved, Phase 3 study of Liletta for HMB. Participants had up to three screening cycles with collection of study-specific sanitary products for alkaline hematin blood loss measurement. We enrolled those with two menses >=80 mL (values averaged for baseline blood loss) and placed the IUS. Participants collected sanitary products used during months 3 and 6 post-placement for blood loss measurement if any bleeding occurred. We evaluated median absolute change in blood loss in participants with at least one follow-up assessment and compared BMI and parity outcomes using Wilcoxon rank sum tests. RESULT(S): Of the 105 enrolled participants, 68 (65%) were White, 25 (24%) were Black, 47 (45%) were obese (BMI >=30), and 29 (28%) were nulliparous. Baseline mean blood loss ranged from 73 mL to 520 mL (median, 143 mL; interquartile range [IQR], 112-196 mL), with median 3-month (n586) and 6-month (n581) values of 9.5 mL (IQR, 2.5-22.9 mL) and 3.8 mL (IQR, 0-10.1 mL), respectively. The median percentage decreases per participant were 93% (IQR, 82-98%) and 97% (IQR, 90-100%), respectively. At six months, median decreases in non-obese (n546) and obese (n535) participants did not differ (97% [IQR, 90-100%] and 97% [IQR, 89-100%], respectively; P5.73) with similar findings for nulliparous (n525) and parous (n556) participants (97% [IQR, 92-99%] and 97.5% [IQR, 89-100%], respectively; P5.74). Discontinuations included 4 (4%) expulsions, +/- (6%) removals for bleeding/cramping, and 12 (11%) participant choice/lost to follow-up/consent withdrawal. CONCLUSION(S): Levonorgestrel 52-mg IUS reduces blood loss more than 90% for most users with HMB regardless of BMI and parity.

Creinin Mitchell, D., et al. (2023). "Heavy Menstrual Bleeding Treatment With a Levonorgestrel 52-mg Intrauterine Device." Obstetrics and Gynecology 141(5): 971-978.
	Objective: To evaluate heavy menstrual bleeding treatment outcomes with levonorgestrel 52-mg intrauterine device (IUD) use in participants without body mass index (BMI) or parity restrictions.; Methods: Investigators included participants aged 18-50 years with no pelvic or systemic pathology causing heavy menstrual bleeding at 29 U.S. centers in a prospective trial. Participants had up to three screening cycles with menstrual product collection for alkaline hematin blood-loss measurements. Investigators enrolled those with two menses with blood loss of 80 mL or more (values averaged for baseline blood loss), placed the IUD, and followed participants for up to six 28-day cycles. Participants collected any menstrual products used during cycles 3 and 6 for blood-loss measurement. We evaluated outcomes in participants with at least one follow-up assessment for the primary outcome of median absolute blood-loss change and, secondarily, treatment success , defined as the proportion with a final measured blood loss less than 80 mL and at least 50% reduction from baseline. We evaluated exploratory outcomes of differences in blood-loss changes by BMI and parity using Wilcoxon rank sum test.; Results: Of 105 enrolled participants, 47 (44.8%) had obesity (BMI 30.0 or higher) and 29 (27.6%) were nulliparous. Baseline mean blood loss ranged from 73 to 520 mL (median 143 mL, interquartile range 112-196 mL). Eighty-nine (84.8%) had at least one evaluable follow-up evaluation. Participants had median (interquartile range) absolute blood-loss decreases at cycles 3 (n=86) and 6 (n=81) of 93.3% (86.1-97.7%) and 97.6% (90.4-100%), respectively. At cycle 6, participants without obesity (n=43) and with obesity (n=38) had similar median [interquartile range] decreases (97.6% [91.8-100%] and 97.5% [90.3-100%], respectively; P =.89), with comparable findings for nulliparous (n=25) and parous (n=56) participants (97.0% [91.7-99.1%] and 98.1% [89.9-100%], respectively; P =.43). Treatment success occurred in 81.8% (95% CI 74.2-89.4%) of 99 participants, excluding those with no outcomes due to lost to follow-up or consent withdrawal, and did not vary by BMI or parity. The most common adverse events leading to discontinuation were bleeding or cramping (n=6 [5.7%]) and expulsion (n=5 [4.8%]).; Conclusion: This levonorgestrel 52-mg IUD reduces blood loss by more than 90% over 6 months compared with baseline for most users with heavy menstrual bleeding.; Funding Source: Medicines360.; Clinical Trial Registration: ClinicalTrials.gov , NCT03642210.; Competing Interests: Financial Disclosure Mitchell D. Creinin has received speaking honoraria from Gedeon Richter, Mayne and Organon. He has served on the Advisory Boards for Evofem, Fuji Pharma, Gedeon Richter, GlaxoSmithKline, Mayne, Merck & Co., OLIC, Organon, and Searchlight. He has been a Consultant for Estetra SRL, Libbs, Mayne, and Medicines360, and his university department receives contraceptive research funding for Dr. Creinin from Chemo Research SL, Evofem, HRA Pharma, Medicines360 (includes support for medical and safety oversight of this study), Merck & Co., and Sebela. Kurt T. Barnhart has served on the Advisory Board for Merck & Co. His university department receives contraceptive research funding from Bayer HealthCare, Medicines360, Merck & Co., and Sebela. Lori M. Gawron's university department receives contraceptive research funding from Bayer HealthCare, Cooper Surgical, Medicines360, Merck & Co., Sebela, Femasys, and Teva. David Eisenberg has served on the Advisory Board for Merck & Co. He has been a consultant for Evofem Biosciences and FemaSys. He has received honoraria from Omnia Education. His university department receives contraceptive research funding from Evofem Biosciences, Medicines360, Merck & Co., Myovant and Sebela. R. Garn Mabey has received research funding from Allergan, Medicines360, Mithra, and Sebela. Jeffrey T. Jensen has received payments for consulting from Bayer Healthcare, Evofem, Hope Medicine, Foundation Consumer Healthcare, Mayne Pharma, ViiV Healthcare, and erapeuticsMD. OHSU has received research support from AbbVie, Bayer Healthcare, Daré, Estetra SPRL, Hope Medicine, Medicines360, Merck, Myovent, and Sebela. These companies and organizations may have a commercial or financial interest in the results of this research and technology. These potential conflicts of interest have been reviewed and managed by OHSU. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Creutzberg Carien, L. (2022). "Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features." ClinicalTrials.gov.
	The p53abn‐RED trial (NCT05255653‐1) is an international, multicenter, phase III randomised trial wherein adjuvant chemoradiation followed by olaparib for two years is compared to adjuvant chemoradiation. The MMRd‐GREEN trial (NCT05255653‐2) is an international, multicenter, phase III randomised trial wherein adjuvant pelvic external beam radiotherapy combined with and followed by durvalumab for one year is compared to adjuvant pelvic external beam radiotherapy. The NSMP‐ORANGE trial (NCT05255653‐3) is an international, multicenter, phase III randomised trial wherein adjuvant pelvic external beam radiotherapy followed by progestogens for two years is compared to adjuvant chemoradiation. The POLEmut‐BLUE trial (NCT05255653‐4) is an international, multicenter, single arm, phase II trial wherein safety of de‐escalation of adjuvant therapy is investigated: no adjuvant therapy for stage I‐II disease and no adjuvant therapy or pelvic external beam radiotherapy only for stage III disease. The overarching RAINBO research project will combine the data and tumor material of the four RAINBO clinical trials to perform translational research and compare molecular profile‐based adjuvant therapy to standard adjuvant therapy in terms of effectiveness, toxicity, quality of life and cost utility.

Crisp Carol, D., et al. (2023). "Complementary Approaches for Military Women with Chronic Pelvic Pain: A Randomized Trial." Journal of Integrative and Complementary Medicine 29(1): 22-30.
	Introduction: Active duty (AD) women suffer with chronic pelvic pain (CPP) while providers tackle diagnoses and treatments to keep them functional without contributing to the opioid epidemic. The purpose of this randomized trial was to determine the effectiveness of noninvasive, self-explanatory mindfulness-based stress reduction (MBSR) or self-paced healthy lifestyle (HL) interventions on CPP in AD women. Methods: A 6-week, interventional prospective study with AD women aged 21-55 years at Mountain Home (MTHM), Idaho, was conducted. Women were randomly assigned to MBSR ( N = 21) or HL ( N = 20) interventions. The primary outcome was pain perception. The secondary outcomes were depression and circulating cytokine levels. Results: Women in the MBSR group exhibited reduced pain interference ( p < 0.01) and depression ( p < 0.05) alongside decreased interleukin (IL)-4 ( p < 0.05), IL-6 ( p < 0.05), eotaxin ( p < 0.05), monocyte chemoattractant protein-1 ( p = 0.06), and interleukin-1 receptor antagonist (IL-1ra) ( p < 0.01) and increased vascular endothelial growth factor ( p < 0.05). Women in the HL group did not have changes in pain; however, they did exhibit reduced depression ( p < 0.05) alongside decreased granulocyte-macrophage colony-stimulating factor ( p < 0.05) and increased tumor necrosis factor alpha ( p < 0.05), stromal cell-derived factor-1 ( p < 0.01), and IL-1ra ( p < 0.01). Conclusions: AD women receiving MBSR or HL had reduced depression scores and altered circulating cytokine levels; however, only those receiving MBSR had reduced pain perception. Findings support MBSR as an effective and viable behavioral treatment for AD women suffering from CPP and provide premise for larger randomized controlled studies. Clinical Trial Registration: MOCHI-An RCT of mindfulness as a treatment for CPP in AD Women NCT04104542 (September 26, 2019).

Cristian de Guirior, M. n., et al. (2022). "Comparation of pregnancy and newborn rate after different endometrioma treatment modalities (ablative, excisional, sclerotherapy)."
	
Critchlow Annabel, J., et al. (2023). "The role of estrogen in female skeletal muscle aging: A systematic review." Maturitas 178: 107844.
	Aging is associated with a loss of skeletal muscle mass and function that negatively impacts the independence and quality of life of older individuals. Females demonstrate a distinct pattern of muscle aging compared to males, potentially due to menopause, when the production of endogenous sex hormones declines. This systematic review aims to investigate the current knowledge about the role of estrogen in female skeletal muscle aging. A systematic search of MEDLINE Complete, Global Health, Embase, PubMed, SPORTDiscus, and CINHAL was conducted. Studies were considered eligible if they compared a state of estrogen deficiency (e.g. postmenopausal females) or supplementation (e.g. estrogen therapy) to normal estrogen conditions (e.g. premenopausal females or no supplementation). Outcome variables of interest included measures of skeletal muscle mass, function, damage/repair, and energy metabolism. Quality assessment was completed with the relevant Johanna Briggs critical appraisal tool, and data were synthesized in a narrative manner. Thirty-two studies were included in the review. Compared to premenopausal women, postmenopausal women had reduced muscle mass and strength, but the effect of menopause on markers of muscle damage and expression of the genes involved in metabolic signaling pathways remains unclear. Some studies suggest a beneficial effect of estrogen therapy on muscle size and strength, but evidence is largely conflicting and inconclusive, potentially due to large variations in the reporting and status of exposure and outcomes. The findings from this review point toward a potential negative effect of estrogen deficiency on aging skeletal muscle, but further mechanistic evidence is needed to clarify its role.; Competing Interests: Declaration of competing interest The authors declare that they have no competing interest. (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Critelli, P., et al. (2023). "Outcomes and toxicity in re-irradiation of gynecologic cancer: Systematic review of the Italian association of radiation and clinical oncology (AIRO)." Gynecologic Oncology 179: 33-41.
	Aims: The aim of this study was to provide a literature review on the efficacy and safety of reirradiation(re-I) of locoregional recurrences in gynecological malignancies.; Methods: A computerized literature search was performed in 4 electronic databases (1993-2020). Random-effects models and a tendency towards high heterogeneity (Cochran Q chi-square test and the I 2 statistic) were used. A meta-analysis technique over single and multi-arm studies was performed to determine the pooled acute and late toxicity rate ≥ G3, locoregional control (LC), and overall survival (OS).; Results: Out of 178 articles, only 18 articles accounting for 820 patients (pts) met the inclusion criteria. Outcomes were evaluable for 522 patients. Subgroup analyses highlighted moderate to high heterogeneity among studies. BT (Brachytherapy) showed a 2y OS of 63% (95% CI, 55 to 71 p = 0,36) and 5y OS of 42% (95% CI, 35 to 50, p = 0,43) with 1y-2y-3y LC of 74 (95% CI, 62 to 75, p = 0.04)49% (95% CI, 40 to 58, p = 0.38) and 48% (95% CI, 39 to 58, p = 0,45) respectively. Chemotherapy does not improve SBRT outcomes: BT showed a G3- G4 toxicities rate was of26% (95% CI: 8-49%); studies on SBRT re-I showed a G3-G4 toxicity around of 20% if combined with CHT, and <10 when alone.; Conclusion: A large heterogeneity among studies was revealed, but showing promising results in terms of safety and feasibility. BT resulted the best kind of radiation therapy delivery in terms of clinical outcome and comparable to the SBRT technique in terms of toxicities.; Competing Interests: Declaration of Competing Interest The authors declares no conflict of interest. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Crockett, K. L., et al. (2019). "A Review of the Effects of Physical Therapy on Self-Esteem in Postpartum Women With Lumbopelvic Dysfunction." Journal of Obstetrics and Gynaecology Canada 41(10): 1485-1496.
	This study sought to determine the impact of physical therapy for lumbopelvic dysfunction on self-esteem in postpartum women. Systematic searches were carried out in CINAHL, Embase, PsycINFO, Medline (OVID), Cochrane, and Web of Science by a health sciences librarian using various combinations of subject headings and key words. A dual review process was used first to assess titles and abstracts and then to examine the full text. Conflicts were resolved through discussion or a third reviewer as needed. Dual data extraction was completed using a standardized collection form. Pairs of reviewers met to discuss conflicts. Data quality was assessed using the Cochrane Collaboration's Risk of Bias Tool, the Joanna Briggs Critical Appraisal Tool, and the Critical Appraisal Skills Programme Checklist. Thirteen articles were included in the review. None of the articles assessed self-esteem specifically; however, each article assessed aspects of self-esteem (self-concept, self-efficacy, self-worth, depression, quality of life, general well-being, or physical function). All articles reported improvements in the selected outcome measures compared with baseline; two studies that compared two different physical therapy interventions found no significant differences between the interventions. To our knowledge, there is no literature explicitly evaluating self-esteem in postpartum women following physical therapy intervention for lumbopelvic dysfunction. Low self-esteem is shown to predict depression and anxiety; therefore, interventions that increase self-esteem may be useful in reducing the risk of depression.Copyright © 2019 The Society of Obstetricians and Gynaecologists of Canada/La Societe des obstetriciens et gynecologues du Canada.

Croisier, E., et al. (2021). "The Efficacy of Dietary Fiber in Managing Gastrointestinal Toxicity Symptoms in Patients with Gynecologic Cancers undergoing Pelvic Radiotherapy: A Systematic Review." Journal of the Academy of Nutrition and Dietetics 121(2): 261.
	Background: Pelvic radiotherapy is a common part of treatment used in gynecologic malignancies. The side effects associated with treatment, such as gastrointestinal toxicity, can be acute and chronic. Previous studies have provided little clarity in regard to the best dietary intervention for management of symptoms.; Objective: The aim of this systematic review was to summarize the evidence on the efficacy of nutrition interventions involving fiber modification in patients with gynecologic cancers undergoing pelvic radiotherapy to prevent or alleviate gastrointestinal side effects, in comparison to standard care, placebo, or no intervention.; Methods: Studies, inclusive of any language and date, up to December 1, 2019, were selected from eight electronic databases: PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature, Scopus, Science direct, Clinical Key, Web of Science, and Cochrane. Key study outcomes included gastrointestinal toxicity such as diarrhea/bowel changes, abdominal pain or bloating, and nausea; nutritional status; and quality of life. All studies underwent a quality appraisal using the Academy of Nutrition and Dietetics Quality Criteria Checklist and certainty of evidence was assessed via the Grading of Recommendations Assessment, Development, and Evaluation criteria.; Results: Four studies were included (total number of participants = 89), with quality ratings of neutral or negative. Due to the risk of bias, inconsistency, indirectness, and imprecision, there was very low certainty of evidence that dietary fiber modifications improved these outcomes. Some positive trends regarding improvements in incidence and severity of diarrhea and bowel symptoms were reported; however, the body of evidence was insufficient to form specific recommendations for clinical practice. This is reflected in the Grading of Recommendations Assessment, Development, and Evaluation criteria rating (very low level of certainty) for quality of life and gastrointestinal toxicity outcomes.; Conclusions: This systematic review suggests that supplementary fiber modification during radiation therapy may have some potential benefits with improving gastrointestinal symptoms; however, more definitive evidence and further exploration of fiber in a therapeutic role is required to inform dietary practice. (Copyright © 2021 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)

Crosby David, A., et al. (2022). "Mid-luteal uterine artery Doppler indices in the prediction of pregnancy outcome in nulliparous women undergoing assisted reproduction." Human fertility (Cambridge, England) 25(4): 670-676.
	Traditionally, the assessment of endometrial receptivity at transvaginal ultrasound scan has been based on the thickness and the morphological appearance of the endometrium. The objective of this study was to prospectively evaluate endometrial thickness (ET), endometrial morphology and uterine artery Doppler parameters prior to assisted reproduction treatment (ART) in the prediction of pregnancy outcome. This was a prospective cohort study. ET, morphology and uterine artery Doppler (UtAD) pulsatility index (PI) and resistance index (RI) were measured in the mid-luteal stage of the menstrual cycle ultrasonographically, timed with urinary luteinizing hormone testing. A total of 50 women were included in the analysis. The clinical pregnancy rate (CPR) per embryo transfer was 42.0% ( n = 21/50). Twenty nine women (58.0%) had an unsuccessful outcome. There were no differences in mean ± SD endometrial thickness (ET) (10.0 ± 1.8 mm vs. 10.5 ± 2.4; p = 0.43), or endometrial morphology (100% ( n = 21) vs 100% ( n = 29); p = 1.00) between the pregnant and not pregnant groups. Similarly, there were no differences in mean ± SD UtAD PI (2.17 ± 0.83 vs. 2.07 ± 0.81; p = 0.67 or mean ± SD UtAD RI (0.84 ± 0.10 vs. 0.81 ± 0.10; p = 0.30). Ultrasonographic endometrial assessment did not differentiate between those who would have a subsequent clinical pregnancy.

Cross, D., et al. (2023). "Does a Kegel Exercise Program Prior to Resistance Training Reduce the Risk of Stress Urinary Incontinence?" International Journal of Environmental Research and Public Health 20(2): 1481.
	This comparative pre-post intervention study investigated the feasibility and benefits of Kegel exercises amongst incontinent women, prior to commencing resistance training (RT), to reduce the risk of stress urinary incontinence (SUI) compared to a group of women without prior Kegel exercises (KE). Incontinence severity index (ISI) score, pelvic floor muscle strength (PFMS), and body composition (such as body mass index (BMI), fat, and muscle mass), were obtained pre and post intervention. Results demonstrated that RT reduced SUI to a significantly greater extent only if preceded by KE as was observed in the Kegel exercise plus RT group (KE + RT) over time. The improvements in total ISI in both the KE + RT and RT groups were large (d = 1.50 and d = 1.17 respectively). A two-way ANOVA indicated a statistically significant improvement in average PFMS within the KE + RT group over time and between the two groups. A positive correlation was found between the average strength of pelvic floor muscles and SUI. Participants in KE + RT group demonstrated a significant increase in muscle mass (p <= 0.001) and concomitant reduction in fat mass (p = 0.018). This study determined a dedicated program of KE preceding a RT program improved average pelvic floor muscle strength and was effective in reducing SUI among incontinent women.Copyright © 2023 by the authors.

Crouthamel, B., et al. (2022). "Effect of Paracervical Block Volume on Pain Control for Dilation and Aspiration: A Randomized Controlled Trial." Obstetrics and Gynecology 140(2): 234-242.
	Objective: To compare pain scores during office dilation and aspiration between low-volume and high-volume paracervical block of the same dose.; Methods: We conducted a multi-site, randomized, single-blind, placebo-controlled trial from October 2018 to December 2020. We randomized participants presenting for office dilation and aspiration under minimal sedation stratified by procedural indication (induced abortion vs early pregnancy loss) to a 20-mL buffered 1% lidocaine paracervical block or a 40-mL buffered 0.5% lidocaine paracervical block, both with two units of vasopressin in a standardized technique. To detect a 15-mm or greater difference in pain at the time of cervical dilation with 80% power and a two-sided alpha of 0.05, a total of 104 participants was required. The study was also powered to detect a 20-mm or greater difference in pain at the time of cervical dilation within each stratum (induced abortion and early pregnancy loss). The primary outcome was pain with cervical dilation on a 100-mm visual analog scale in the overall cohort. Secondary outcomes included pain with cervical dilation within each stratum. We used a Wilcoxon rank-sum test to compare median pain scores between groups.; Results: We enrolled 114 participants. There was no difference in median pain scores between low-volume and high-volume groups during dilation (62 mm vs 59 mm, P=.94), aspiration (69.5 mm vs 70 mm, P=.47), postprocedure (25 mm vs 25 mm, P=.76), or overall (60 mm vs 60 mm, P=.23). Stratified by indication, there were no significant differences in scores at any time point between the low-volume and high-volume paracervical block groups. There was decreased overall pain in patients with induced abortion who received the higher volume paracervical block, though this did not reach statistical significance (67.5 mm vs 60.5 mm, P=.08). Pain during paracervical block administration was similar between groups (55 mm vs 45 mm, P=.24) and there was no difference in occurrence of side effects (P=.63).; Conclusion: We found no difference in pain with cervical dilation among participants who received the low-volume compared with high-volume paracervical block when studied alone.; Clinical Trial Registration: ClinicalTrials.gov, NCT03636451.; Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest. (Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Crowe, L., et al. (2023). "Assessing the unmet needs of patients with advanced cancer treated by biological and precision therapies: protocol for TARGET, a mixed methods study." BMJ Open 13(5): e066229.
	Introduction: Biological and precision therapies are increasingly used in cancer treatment. Although they may improve survival, they are also associated with various-and unique-adverse effects, which can be long lasting. Little is known about the experiences of people treated with these therapies. Moreover, their supportive care needs have not been fully explored. Consequently, it is unclear whether existing instruments adequately capture the unmet needs of these patients. The TARGET study seeks to address these evidence gaps by exploring the needs of people treated with these therapies with the aim of developing an unmet needs assessment instrument for patients on biological and precision therapies.; Methods and Analysis: The TARGET study will adopt a multi-methods design involving four Workstreams (1) a systematic review to identify, describe and assess existing unmet needs instruments in advanced cancer; (2) qualitative interviews with patients on biological and precision therapies, and their healthcare professionals, to explore experiences and care needs; (3) development and piloting of a new (or adapted) unmet needs questionnaire (based on the findings of Workstream 1 and Workstream 2) designed to capture the supportive care needs of these patients; and finally, (4) a large-scale patient survey using the new (or modified) questionnaire to determine (a) the psychometric properties of the questionnaire, and (b) the prevalence of unmet needs in these patients. Based on the broad activity of biological and precision therapies, the following cancers will be included: breast, lung, ovarian, colorectal, renal and malignant melanoma.; Ethics and Dissemination: This study was approved by National Health Service (NHS) Heath Research Authority Northeast Tyne and Wear South Research Ethics Committee (REC ref: 21/NE/0028). Dissemination of the research findings will take several formats to reach different audiences, including patients, healthcare professionals and researchers. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Csupor, D., et al. (2019). "Vitex agnus-castus in premenstrual syndrome: A meta-analysis of double-blind randomised controlled trials." Complementary Therapies in Medicine 47: 102190.
	Although chasteberry (Vitex agnus-castus, VAC) has been studied in several clinical trials and available as medicine for the alleviation of premenstrual syndrome (PMS) symptoms, the efficacy of properly characterised preparations has not been assessed in meta-analyses. The aim of our work was to evaluate the efficacy of VAC in PMS. The meta-analysis was performed following the PRISMA guidelines using the PICOS format, taking into account the CONSORT recommendations. PubMed, Embase, the Cochrane Central Register of Controlled Trials and Web of Science were searched for studies on VAC. The analysis assessed the efficacy of properly characterised products VAC compared to a placebo for the alleviation of PMS symptoms in terms of responder rate, considering the decrease of Total Symptom Score or PMS Diary score. The random effects model was used to calculate summary relative risk (RR) and 95% confidence interval (CI). Only those randomised, double-blind, placebo-controlled trials were included that fulfilled the criteria of the CONSORT recommendations aiming at the proper characterization of herbal products. Out of the 21 clinical trials, three studies (520 females) fulfilled the inclusion criteria, comparing the efficacy of special extracts Ze 440 and BNO 1095 to a placebo for the treatment of PMS. VAC preparations were confirmed to be effective in the reduction of PMS symptoms: women taking VAC were 2.57 (95% CI 1.52-4.35) times more likely to experience a remission in their symptoms compared to those taking the placebo. Although several clinical trials have been carried out with VAC, the majority of the studies cannot be used as evidence for efficacy due to incomplete reporting, especially concerning the description of the used medication. More trials following the CONSORT recommendations are needed to assess the efficacy of VAC extracts. (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Ctis (2023). "Effect of preventive analgesia by injection of a local anesthetic before vaginal incision for hysterectomy by the vNOTES approach: a randomized double-blind study ANOTES study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Code: SCP1698700,Pharmaceutical Form: ,Other descriptive name: ,Product Code: SCP2092119,Pharmaceutical Form: ,Other descriptive name: CONDITION: hysterectomy,Hysterectomy Therapeutic area: Diseases [C] ‐ Female Urogenital Diseases and Pregnancy Complications [C13] PRIMARY OUTCOME: Main Objective:Determine if the injection of Ropivacaine vs. placebo provides a reduction in postoperative pain at H4 after hysterectomy via vNOTES approach. Primary end point(s):The primary endpoint is pain at H4 using the numerical rating scale (NRS for pain). Pain will be assessed by the post‐operative hospital nurse. Secondary Objective:1.Comparison between the 2 groups of Morphine doses administered in the ICU.,2.Comparison between the 2 groups of the time spent in the ICU before returning to the ward.,3.Comparison between the 2 groups of the maximum pain felt in the hospital room between ICU discharge and H4 (before administration of an analgesic on demand). If the patient is still in the ICU at H4 postop, this measurement will be carried out by the ICU nurse).,4.Comparison between the 2 groups of pain at H6 and H8 (at rest, when coughing and when standing), then in the morning, every day, during the first post‐operative week and at the 6‐week post‐operative visit.,5.Comparison between the 2 groups of analgesic consumption (standardized protocol on request. Appendix 1) during inpatient monitoring, then during the first postoperative week.,6.Comparison between the 2 groups of the conversion rate from day hospitalization to conventional hospitalization.,7.Comparison between the 2 groups of preoperative global quality of life at 6 weeks, 6 months and 1 year.,8.Comparison between the 2 groups of sexual quality of life preoperatively, at 6 months and at 1 year.,9.Comparison between the 2 groups of intraoperative and postoperative morbidity (Clavien‐Dindo classification), at 6 weeks. .,10.Comparison between the 2 groups of the occurrence of neuropathic pain, at 24h J7 and 6 months.,11.Comparison between the 2 groups of the occurrence of bleeding during surgery SECONDARY OUTCOME: Secondary end point(s):1. Morphine doses administered in SSPI (in mg) Secondary end point(s):2. Time spent in the ICU before returning to the ward (in minutes) Secondary end point(s):3. Maximum pain experienced in hospital room between ICU discharge and H4. If this pain gives rise to the administration of an analgesic on demand, the pain assessment will be carried out just INCLUSION CRITERIA: • Adult patients aged 18 to 70 inclusive,• Patient scheduled for vNOTES surgery for total hysterectomy for benign pathology, whether or not associated with an adnexal procedure (unilateral or bilateral salpingectomy or adnexectomy (for cysts smaller than 6 cm)).,• Person having read and understood the information letter and signed the consent form,• Person affiliated to a social security scheme

Ctis (2023). "The iCaD Study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: INFLIXIMAB,Product Code: SUB02681MIG,Pharmaceutical Form: POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION,Other descriptive name: ,Strength: 100mg,Product Name: PREDNISOLONE,Product Code: SUB10018MIG,Pharmaceutical Form: TABLET,Other descriptive name: ,Strength: 25mg,Product Name: METHYLPREDNISOLONE,Product Code: SUB08872MIG,Pharmaceutical Form: SUSPENSION FOR INJECTION,Other descriptive name: ,Strength: 40mg,Product Name: PREDNISOLONE,Product Code: SUB10018MIG,Pharmaceutical Form: TABLET,Other descriptive name: ,Strength: 5mg CONDITION: Immune checkpoint inhibitor related colitis Therapeutic area: Diseases [C] ‐ Neoplasms [C04]‐Diseases [C] ‐ Digestive System Diseases [C06] PRIMARY OUTCOME: Main Objective:The objectives of the study are to compare the efficacy and safety of an anti‐inflammatory regimen consisting of initial infliximab concomitant to corticosteroid to corticosteroid alone for the treatment of severe ICI induced colitis/diarrhoea. Primary end point(s):Time (days) to persistent modified CTCAE (mCTCAE; definition according to Table 3) grade = 1 ir‐colitis/diarrhoea. Persistent is defined as grade = 1 ir‐colitis/diarrhoea for five consecutive days or more with no increase in corticosteroid intake, and the event will be calculated from the first day of grade = 1 ir‐colitis/diarrhoea of that period (time frame: seven weeks) Secondary Objective: INCLUSION CRITERIA: Untreated mCTCAE grade 2‐4 diarrhoea or colitis, or persistent mCTCAE grade 2 diarrhoea after administration of loperamide or equivalent for mCTCAE grade = 2 diarrhoea,Usage of prednisolone = 10 mg daily for non irAE is allowed,Diagnostic work up including screening for viral hepatic infection and QuantiFERON‐TB for mycobacterium tuberculosis must be requisitioned but will not need to be reported prior to study enrolment,Women of child bearing potential must have a negative serum (preferred) or urine pregnancy test within 72 hours prior to registration. Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females who have had evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, lo SECONDARY OUTCOME: Secondary end point(s):Cumulative corticosteroid exposure (time frame: seven weeks) Secondary end point(s):Overall Survival stratified by cancer type (time frame: the duration of time from start of randomisation to time of death or up to 24 months) Secondary end point(s):Progression Free Survival stratified by cancer type (time frame: duration of time from start of randomisation to time of progression or death, whichever occurs first or up to 24 months) Secondary end point(s):Proportion of study subjects requiring rescue immunosuppressive medication; Arm A (initial corticosteroid only): infliximab if no improvement to grade = 2 ir‐colitis/diarrhoea after 3 days (time frame: seven weeks); Arm B (initial infliximab): second dose infliximab according to physicians decision if no improvement to grade = 2 ir‐colitis/diarrhoea after seven days Secondary end point(s):Proportion of study subjects with a corticosteroid‐free clinical remission (grade = 1 ir‐colitis/diarrhoea) after seven weeks (time frame: seven weeks) Secondary end point(s):Proportion of study subjects with colectomy or colitis‐specific mortality (time frame: seven weeks) Secondary end point(s):Proportion of study subjects with grade = 1 ir‐colitis/diarrhoea at 72 hours (time frame: 72 hours) Secondary end point(s):Proportion of study subjects with persistent grade = 1 ir‐colitis/diarrhoea at three weeks. Persistent is defined as grade = 1 ir‐colitis/diarrhoea for five consecutive days or more, and the event will be calculated from the first day of grade = 1 ir‐colitis/diarrhoea of that period (time frame: three weeks) Secondary end point(s) roportion of study subjects with recurrence of ir‐colitis/diarrhoea on subsequent reintroduction of ICI Secondary end point(s):Proportion of study subjects with treatment related adverse events as assessed by CTCAE v5.0 (time frame: 12 weeks) Secondary end point(s):QoL by means of EORTC‐QLQ‐C30 questionnaire and selected PRO‐CTCAE items at baseline, 3, 12, 24, and 52 weeks after randomisation (time frame: 52 weeks) Secondary end point(s):Subgroup analyses stratified for ipilimumab containing ICI for time (days) to persistent grade = 1 ir‐colitis/diarrhoea. Persistent is defined as grade = 1 ir‐colitis/diarrhoea for five consecutive days or more, and the event will be calculated from the first day of grade = 1 ir‐colitis/diarrhoea of that period (time frame: seven weeks) Secondary end point(s):Translational research projects to explore the diversity and evolution of the immunologic cells and faecal microbiome from initiation of immune checkpoint inhibition, to the event of ir‐colitis/diarrhoea, and to resolution after immunosuppressive therapy

Ctri (2021). "Comparison of epidural catheter fixation methods." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention1: Lockit fixator device: The epidural catheter will be threaded through the central eyelet of Lockit fixator device, after its exit from skin. The adhesive on the Lockit device sticks on the skin and the clamp is closed over the catheter. Intervention2: Subcutaneous tunneling: The epidural catheter will be subcutaneously tunneled vertically using a Tuohy 18G epidural needle 1.5 cm lateral to the midline. The epidural needle will be used to create the tunnel 3‐4 cm long in subcutaneous plane, moving from above downward after local infiltration, with its lower end at the same horizontal level as the epidural puncture site. A small loop of catheter will be left between the epidural puncture site and the tunnel entry. A piece of sterile gauze will be placed under this loop. The catheter is gently pulled up to the right shoulder, and the entire length will be covered by Tegaderm. Control Intervention1: Standard dressing: coiled catheter at skin exit under a transparent adhesive dressing CONDITION: Health Condition 1: K319‐ Disease of stomach and duodenum, unspecified Health Condition 2: C189‐ Malignant neoplasm of colon, unspecified Health Condition 3: C649‐ Malignant neoplasm of unspecifiedkidney, except renal pelvis Health Condition 4: C55‐ Malignant neoplasm of uterus, partunspecified Health Condition 5: V099‐ Pedestrian injured in unspecifiedtransport accident Health Condition 6: S729‐ Unspecified fracture of femur Health Condition 7: S829‐ Unspecified fracture of lower leg PRIMARY OUTCOME: To identify a simple, safe and effective method of fixing the epidural catheter.Timepoint: During fixation ; At end of surgery during shifting ; During removal ‐ at 24hrs SECONDARY OUTCOME: Patient comfortTimepoint: During catheter placement INCLUSION CRITERIA: Patients requiring post operative epidural analgesia

Ctri (2021). "Effect of Lidocaine Infusion on Post Operative Pain Relief and Recovery After Major Abdominal Cancer Surgery." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention1: LIDOCAINE INFUSION: AFTER GA, IV LIDOCAINE INFUSION WILL BE STARTED AT THE RATE OF 1.5MG/KG BOLUS OVER 10 MIN, FOLLOWED BY 1 MG/KG/HR TILL END OF SURGERY Control Intervention1: PLACEBO CONTROLL WITH NORMAL SALINE: EQUAL VOLUME OF NORMAL SALINE WILL BE INFUSED OVER 10 MINS AND TILL THE END OF SURGERY CONDITION: Health Condition 1: C19‐ Malignant neoplasm of rectosigmoidjunction Health Condition 2: C689‐ Malignant neoplasm of urinary organ, unspecified Health Condition 3: C55‐ Malignant neoplasm of uterus, partunspecified PRIMARY OUTCOME: TOTAL OPIOID CONSUMPTION, NUMERICAL RATING SCALE FOR PAIN,TIME TO RESCUE ANALGESIA, RECOVERY PROFILETimepoint: T1‐END OF SURGERY, T2‐T7‐2,4,6,8,12,24 HR POST SURGERY SECONDARY OUTCOME: TIME TO RETURN OF GI FUNATION, TIME OF ICU DISCHARGE, LA TOXICITY, INCIDENCE OF CHRONIC PAIN AT 3 MONTHSTimepoint: T1‐END OF SURGERY, T2‐T7‐2,4,6,8,12,24 HR POST SURGERY,T8‐3 MONTHS POST SURGERY INCLUSION CRITERIA: all adult female patients undergoing major abdominal oncosurgeries

Ctri (2021). "INTERNATIONAL VALIDATION STUDY OF SENTINEL NODE BIOPSY IN EARLY CERVICAL CANCER." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention1: SLN dissection only: A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done Control Intervention1: SLN and PLN dissection: A full lymphadenectomy will be performed. The radical hysterectomy or trachelectomy will be done CONDITION: Health Condition 1: C539‐ Malignant neoplasm of cervix uteri, unspecified Health Condition 2: C00‐D49‐ Neoplasms PRIMARY OUTCOME: DFS defined as the time interval between randomization and recurrence ; (local/distant) or second cancer or death (all causes) ; HR‐QoL of patients assessed with EORTC QLQC 30 and QLQ‐CX24 with 3 ; targeted dimensions: pain, global health score and physical functioning ; scores at 3 years.Timepoint: 3 years SECONDARY OUTCOME: Outcome of pN1 patients according to the size of metastasis and treatment; ; Evaluation of mapping with ; indocyanine green (ICG); ; Surgical morbidity and mortality; ; Other dimensions of HR‐QoL; ; Positive and negative predictive ; values of SLN biopsy; ; Overall survival (OS); ; Recurrence free survival (RFS); ; A cost analysis will be performed; ; Lymphatic and lower limb ; complications ; ; Timepoint: At 3 years INCLUSION CRITERIA: 1. Patient must be â?¥ 18 years old. 2. With squamous or adenocarcinoma of the cervix (proven by biopsy or cone biopsy) 3. Stage Ia1 with lymphovascular emboli, Ia2, Ib1, Ib2 and IIa1, (clinical stage) of the 2018 FIGO classification. 4. Maximum diameter â?¤ 40 mm by clinical examination and/or magnetic resonance imaging (MRI) 5. No suspicious on pelvic MRI with an exploration up to the left renal vein 6. ECOG performance status 0‐2 7. Signed informed consent and ability to comply with follow‐up

Cuccia, F., et al. (2023). "The Role of Radiotherapy in the Management of Vaginal Melanoma: A Literature Review with a Focus on the Potential Synergistic Role of Immunotherapy." Journal of Personalized Medicine 13(7).
	Among the mucosal melanomas, vaginal melanomas are very rare tumors, accounting for less than 20% of melanomas arising from the female genital tract. They occur most frequently in women in post-menopausal age, but younger patients may also experience this neoplasm, mainly located in the lower third of the vagina or the anterior wall. The optimal management of this tumor remains controversial, with surgery reported as the most frequently adopted approach. However, a clear benefit of surgical treatment in terms of survival has not yet been demonstrated. Conversely, radiotherapy may represent an attractive non-invasive alternative, and there are several favorable reports of the role of radiation therapy, either delivered with photons, brachytherapy, or hadrontherapy. A wide range of techniques and fractionation regimens are reported with substantially good tolerance to the treatment, and acute G3 or higher toxicities are reported only in the case of concurrent immunotherapy. Of note, due to the rarity of the disease, there is a lack of high-level evidence for the optimal therapeutic option. In this scenario, recent studies theorize the possibility of developing combinatorial approaches of radiotherapy with immunotherapy based on cutaneous melanomas reports. In this review, we aim to summarize the evidence available in the literature supporting the role of definitive radiotherapy for vaginal melanomas, with a focus on the combination of RT with immunotherapy, in terms of optimal timing and biological rationale.

Cui, Q., et al. (2024). "Systematic analysis of perivascular epithelioid cell neoplasms in the female reproductive tract: a comprehensive review." Future oncology (London, England) 20(5): 283-295.
	Perivascular epithelioid cell neoplasms (PEComas) are rare mesenchymal lesions, with gynecological PEComas accounting for just over a quarter of cases. Limited reports exist on gynecological PEComa, primarily treated with surgery; adjuvant therapy is considered in high-risk cases. This systematic review aims to summarize the origin and clinical, pathological and molecular characteristics of uterine PEComa, focusing on treatment options for gynecological PEComa. A comprehensive PubMed review of gynecological PEComa reports was conducted. A detailed examination of the literature ensured a thorough understanding. Gynecological PEComa diagnosis relies on histology and immunology. Despite therapy controversies, surgery remains the mainstay. Adjuvant therapy efficacy in high-risk cases is uncertain. mTOR inhibitors are the first line; alternative treatments, including angiogenesis and aromatase inhibitors, should be considered.

Cui, Y., et al. (2022). "Does electroacupuncture benefit mixed urinary incontinence? A systematic review and meta-analysis with trial sequential analysis." International Urogynecology Journal 33(4): 751-766.
	Introductin and hypothesis: Mixed urinary incontinence (MUI) comprises a combination of urgency and stress. The efficacy and safety of electroacupuncture (EA) for the treatment of MUI remain unclear. Objective(s): To assess the efficacy and safety of EA in treating MUI. Method(s): We searched PubMed, CENTRAL, Embase, Web of Science, four Chinese databases, clinical research registration platforms, grey literature, and the reference lists of the selected studies. Risk of bias and quality were evaluated using the Revman 5.4 and Jadad scores. Meta-analysis was performed using Stata 15.1 software. Trial sequential analysis (TSA) was used to assess the stability of the results. Result(s): Eight randomized controlled trials comprising 847 patients were included. The meta-analysis results showed that compared with antimuscarinic drugs plus pelvic floor muscle training, EA resulted in significantly less pad weight on the 1-h pad test and statistically significantly lower severity scores on the International Consultation on Incontinence Questionnaire Short Form. The change in the 72-h incontinence episode frequency difference was not statistically significant, and there was no outcome of overall response rate and quality of life in this meta-analysis. Few adverse events occurred in the EA group. The TSA results suggested that the result of change from baseline in the 1-h pad test was stable and the evidence was conclusive. Conclusion(s): EA could be a potential treatment option for MUI and is relatively safe. Nevertheless, because of the limitations of this study, our conclusions should be interpreted with caution, and further studies are needed to confirm the comprehensive clinical efficacy and placebo effect of EA.Copyright © 2021, The Author(s).

Cuijpers, P. and E. Karyotaki (2021). "The effects of psychological treatment of perinatal depression: an overview." Archives of Women's Mental Health 24(5): 801-806.
	Perinatal depression is an important public health problem. Psychological interventions play an essential role in the treatment of depression. In the current paper, we will present the results of a series of meta-analyses on psychological treatments of perinatal depression. We report the results of a series of meta-analyses on psychological treatments of depression, including perinatal depression. The meta-analyses are based on a database of randomized trials on psychotherapies for depression that has been systematically developed and updated every year. Psychological interventions are effective in the treatment of perinatal depression with a moderate effect size of g = 0.67, corresponding with a NNT of about 4. These effects were still significant at 12 months after the start of the treatment. These interventions also have significant effects on social support, anxiety, functional impairment, parental stress, and marital stress. Possibly the effects are overestimated because of the use of waiting list control groups, the low quality of the majority of trials and publication bias. Research on psychotherapies for depression in general has shown that there are no significant differences between the major types of therapy, except for non-directive counseling that may have somewhat smaller effects. CBT can also be delivered in individual, group, telephone, and guided self-help format. Interventions in subthreshold depression are also effective and may prevent the onset of a full-blown depressive disorder, while therapies may be less effective in chronic depression. Psychological interventions are effective and deserve their place as first-line treatment of perinatal depression.Copyright © 2021, The Author(s).

Culpin, I., et al. (2023). "Maternal postnatal depressive symptoms and offspring emotional and behavioral development at age 7 years in a U.K. birth cohort: The role of paternal involvement." Developmental psychology 59(4): 770-785.
	There is considerable variability in developmental outcomes of children whose mothers experience depression. Few longitudinal studies have examined contributions of paternal involvement in the association between maternal postnatal depression (PND) and offspring development. We examined pathways from maternal PND at 8 weeks (Edinburgh Postnatal Depression Scale; total score) to offspring emotional and behavioral development at 7 years (Strengths and Difficulties Questionnaire; total score) through behavioral, affective, and cognitive dimensions of paternal involvement in a U.K.-based birth cohort (Avon Longitudinal Study of Parents and Children; n = 3,434). Analyses were adjusted for baseline confounders and paternal PND (Edinburgh Postnatal Depression Scale; total score) as an intermediate confounder. Maternal PND was strongly associated with offspring development, but this association was not mediated by the combination of all indirect pathways through various dimensions of paternal involvement. Only father-child conflict emerged as a risk factor for adverse offspring development and as a mediator in the association between maternal PND and offspring development (albeit the effect size was small). If found causal, interventions that reduce father-child conflict may reduce the risk of adverse development in offspring of mothers with PND. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Cunningham Jasmyn, E. A., et al. (2021). "Sleep, biological rhythms and anxiety in the perinatal period: a systematic review protocol." BMJ Open 11(8): e046767.
	Introduction: Pregnancy and new parenthood is an exciting time, but also a stressful life event that can predispose to mental health challenges. Perinatal anxiety is one such challenge, and is an important contributor to parental distress and other negative outcomes. Sleep and biological rhythms are often disrupted in the perinatal period. These disruptions have been associated with postpartum depression, and in some cases with perinatal anxiety. However, the literature concerning the association with perinatal anxiety is inconsistent and may be methodologically limited. To our knowledge, there has been no comprehensive review published characterising the relationships between sleep, biological rhythms, and perinatal anxiety and related disorders to date. In this systematic review, we will summarise the current state of the literature concerning these relationships, allowing us to highlight gaps and potentially inform clinical understanding of perinatal anxiety, sleep and biological rhythms.; Methods and Analysis: Primary research articles will be eligible for inclusion if they assess perinatal anxiety or related disorders using validated criteria (self-report or diagnostic), assess sleep and biological rhythms in the perinatal period, include >4 participants and meet other inclusion/exclusion criteria. We will conduct comprehensive searches of MEDLINE, PsycINFO, Embase and CINAHL, with coverage spanning from database conception to search date (August 1, 2021). Key search concepts include (1) the perinatal period, (2) sleep/biological rhythms and (3) anxiety. Risk of bias will be evaluated using the Cochrane Risk of Bias Tool. Data will be narratively synthesised, with quantitative synthesis included if possible. When relevant, strength of evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation criteria, and potential publication bias will be assessed.; Ethics and Dissemination: Research ethics approval is not required. Study results will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results will be disseminated to relevant stakeholders as conference presentation(s) and submitted for publication in a peer-reviewed journal.; Prospero Registration Number: 200166.; Competing Interests: Competing interests: AS has received research funding from Pfizer. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Curillo-Aguirre, C. A. and E. Gea-Izquierdo (2023). "Effectiveness of Pelvic Floor Muscle Training on Quality of Life in Women with Urinary Incontinence: A Systematic Review and Meta-Analysis." Medicina (Kaunas, Lithuania) 59(6).
	Background and Objectives: Urinary incontinence (UI) is a condition that is more common in women than men and has an increasing prevalence with age. It provides a range of psychological and physical burdens that negatively affect the patient's quality of life (QoL). However, the economic burden for the healthcare system is being augmented due to the increasing life expectancy of the population. This article aims to identify the effectiveness of pelvic floor muscle training (PFMT) on the QoL in women with UI. Material(s) and Method(s): A systematic review and meta-analysis were conducted in the PubMed, EMBASE, ProQuest medicine, Cochrane Library, and Google Scholar databases. The terms selected according to components of PICOS were women with urinary incontinence, pelvic floor muscle training, watchful or other types of therapies, quality of life, randomized controlled trials, and interventional or observational studies. The articles included were those published between November 2018 and November 2022. Ten articles were found for the systematic review and eight for the meta-analysis. Result(s): The QoL moderately increased when PFMT was used on women with UI, the results indicating an overall small effect on the QoL across the controlled studies and a moderate effect on the QoL across the one-group pre-post-studies. Conclusion(s): Specific QoL domains, such as social activities and general health, also demonstrated benefits from PFMT interventions. This study confirmed the effectiveness of PFMT on the QoL in women with UI, mainly for patients with stress urinary incontinence.

Curlin, H. L. and T. L. Anderson (2022). "Endometrial Cryoablation for the Treatment of Heavy Menstrual Bleeding: 36-Month Outcomes from the CLARITY Study." International Journal of Women's Health 14: 1083-1092.
	Study Objective: To examine long-term outcomes from the pivotal study that evaluated the safety and effectiveness of the Cerene Cryotherapy Device (Channel Medsystems, Berkeley, CA) in premenopausal women with heavy menstrual bleeding due to benign causes who have completed childbearing. Method(s): The prospective, multicenter, single-arm, open-label study had eight sites in the USA, one in Mexico, and two in Canada. Inclusion criteria included uterine sound <=10 cm, endometrial cavity length 2.5 to 6.5 cm, age 25 to 50 years, a pictorial blood loss assessment chart score of >=150, no submucosal myomata and/or uterine obstruction, distortion, or abnormality. A total of 242 subjects underwent a 2.5-minute cryoablation. Long-term follow-up visits were conducted at Month 24 and Month 36. Data collected included gynecological adverse events, description of last menstrual period, contraception status, self-report of pregnancy, medical or surgical interventions to treat abnormal uterine bleeding, satisfaction, recommendation, and quality of life (QoL). QoL outcomes were measured with the Menorrhagia Impact Questionnaire (MIQ) and the Premenstrual Symptoms Impact Survey (PMSISTM). Result(s): 201 subjects completed their Month 36 final study visit. Subject outcomes were comparable to those at Month 12. Eighty-nine percent of subjects reported amenorrhea, a lighter-than-normal, or normal period, 91% of subjects had no or slight limitations in MIQ measured activities, and 85% reported premenstrual symptoms at a low frequency. Eighty-five percent of the subjects were satisfied or very satisfied. The cumulative incidence of hysterectomy was 5% and reintervention was 8.7%. Forty-nine gynecologic adverse events (AE) were reported; one non-serious AE, postcoital bleeding, was reported as related to the procedure. No serious device-related or procedure-related AEs were reported. Conclusion(s): Study data demonstrate that the positive effects of Cerene Cryotherapy Device treatment are sustained through Month 36 and that the risks associated with the device and procedure are low (ClinicalTrials.gov; NCT02842736).Copyright © 2022 Curlin and Anderson. All rights reserved.

Currie Cheryl, L., et al. (2020). "The impact of eHealth group interventions on the mental, behavioral, and physical health of adults: a systematic review protocol." Systematic Reviews 9(1): 217.
	Background: COVID-19 has resulted in an increased demand for eHealth services globally. There is emerging evidence for the efficacy for group eHealth interventions that support population-based mental health and wellbeing, but a systematic review is lacking. The primary objective of this systematic review is to summarize the evidence for eHealth group counseling and coaching programs for adults. A second objective is to assess, within studies selected for our primary objective, the impact of programs that encourage PA on outcomes compared to those that do not.; Methods: Randomized controlled trials that assess the impact of eHealth group counseling or coaching programs on mental health, health behavior, or physical health activity among community-dwelling adults will be included. We will search the following electronic databases (from January 2005 onwards): MEDLINE, PsycINFO, CINHAL, and the Central Register of Controlled Trials. The primary outcomes will be changes in mental health conditions (e.g., depression, anxiety, stress, quality of life), behavioral health conditions (e.g., substance use, smoking, sexual behavior, eating behavior, medication adherence), and physical health conditions (e.g., coping with cancer, menopausal symptoms, arthritis pain). Secondary outcomes will be changes in physical activity. Two reviewers will independently screen all citations, full-text articles, and abstract data. Potential conflicts will be resolved through discussion with a third reviewer. A narrative synthesis without meta-analysis will be conducted. The strength of the body of evidence will be assessed using GRADE. The risk of bias in individual studies will be appraised using the Cochrane Risk of Bias 2.0 tool. Potential sources of gender bias in included studies will be considered at all stages of the planned review.; Discussion: This review will contribute to the literature by providing evidence on the effectiveness of eHealth counseling and coaching programs delivered to adults in a group format.; Systematic Review Registration: The protocol has been registered at the International Prospective Register of Systematic Reviews (PROSPERO: CRD42020187551 ).

Cutting, H., et al. (2023). "Baseline Characteristics of Participants in a Multicenter Randomized Clinical Trial of Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments (Vestibulodynia: UPDATe) . Show more." Journal of Sexual Medicine 20(Supplement 2).
	Introduction Vestibulodynia (VBD) is a common cause of sexual pain that affects ~14 million women in the United States. Many different therapies are used on a trial-and-error basis which can delay effective care. Two distinct VBD subtypes may benefit from different types of treatment: 1) VBD peripheral (VBD-p) - pain localized to the vulvar vestibule and 2) VBD central (VBD-c) - VBD and >1 chronic overlapping pain condition(s) affecting remote body regions. Thus, we are evaluating the efficacy of peripheral, central, and combined treatments for VBD-p vs VBD-c. We will also evaluate cytokine and microRNA biomarkers to help determine pathophysiology and predict treatment response. Objective To describe the design and present baseline participant characteristics of our ongoing RCT for VBD. Methods This is a multi-site randomized, double-blind trial that will enroll participants to one of four parallel arms: 1) peripheral treatment with 5% lidocaine/0.5 mg/ml 0.02% estradiol compound cream and placebo pills, 2) central treatment with tricyclic antidepressant nortriptyline pills and placebo cream, 3) lidocaine/estrogen cream and nortriptyline pills, or 4) placebo cream and placebo pills. The treatment phase will last 16 weeks, with clinical outcome measures and biomarkers assessed at 4 time points (0, 8, 16, and 24 weeks). We will enroll 400 women 18-50 years who report tenderness at the vulvar vestibule and report >3/10 pain with tampon insertion on a numeric rating scale (NRS). Primary outcome is pain with tampon test. Secondary outcomes include self-reported pain on the McGill Pain Questionnaire, psychosocial measures, pressure pain thresholds (PPTs) measured at the vaginal vestibule, levator ani muscles, and remote body sites, and levels of cytokines and microRNAs in local vaginal and circulating blood samples using multiplex assays and RNA sequencing to determine the ability of these biomarkers to predict treatment response. Results So far 135 subjects have enrolled and 78 of these have completed the study. Enrollment remains open, with 27 subjects active and 30 subjects discontinued. Mean (range) age is 26.9 (18-48) years and body mass index is 23.7 (16-37). Self-disclosed racial identity of subjects is: White (67.4%), Asian (14.1%), Multiracial (9.6%), Black (8.9%), with 14.8% of subjects identifying as Hispanic or Latino. Of the enrolled subjects, 94/135 (69.6%) subjects are categorized VBD-c, and 41/135 (30.4%) are categorized VBD-p. Of those categorized as VBD-c, fibromyalgia syndrome (39.3%), endometriosis (34.1%), back pain (25.20%), irritable bowel syndrome (19.3%), chronic headaches (16.3%), temporomandibular disorder (11.1%), interstitial cystitis (10.4%) and chronic fatigue syndrome (1.5%) have been reported. At baseline visit, subjects report an average tampon test score of 4.2 (2.11) and 93.3% of subjects report pain during vaginal intercourse. Conclusions We have launched a multicenter randomized trial to evaluate the efficacy of peripherally and centrally acting medications used for treating unique VBD subtypes based on distinct clinical and biological signatures. We hope to advance our knowledge of the pathophysiologic mechanisms underlying VBD-p and VBD-c, determine the efficacy of peripheral, central, and combined therapies in alleviating pain in women with VBD-p and VBD-c, and identify biomarkers that predict treatment response.

Cyr, M. P., et al. (2022). "Changes in pelvic floor morphometry and muscle function after multimodal physiotherapy for gynaecological cancer survivors suffering from dyspareunia: a prospective interventional study." Physiotherapy (United Kingdom) 114: 54-62.
	Objective: To investigate the changes in pelvic floor morphometry and muscle function after multimodal pelvic floor physiotherapy treatment in gynaecological cancer survivors suffering from painful intercourse (dyspareunia). Design(s): Prospective interventional study. Setting(s): Three university hospitals. Participant(s): Thirty-one gynaecological cancer survivors with dyspareunia. Intervention(s): The treatment consisted of 12 weekly sessions of physiotherapy combining education, pelvic floor muscle exercises with biofeedback, manual therapy and home exercises. Main Outcome Measure(s): Women were assessed at baseline and post-treatment. Pelvic floor morphometry was evaluated at rest and on maximal contraction by measuring bladder neck position, anorectal and levator plate angles as well as levator hiatal dimensions with three-dimensional/four-dimensional transperineal ultrasound imaging. Pelvic floor muscle function was evaluated by measuring passive forces (muscle tone measure), flexibility, stiffness, strength, coordination and endurance with an intra-vaginal dynamometric speculum. Result(s): Significant changes in pelvic floor morphometry and muscle function were found post-treatment. The parameters assessing the changes from rest to maximal contraction significantly improved (e.g., mean change of levator hiatal area narrowing 14%, 95% CI 11-18, Cohen's d effect size 1.48)), supporting the hypothesis of decreased muscle tone and improved muscle contractility following treatment. Women also presented with a significant decrease in tone (mean change -0.4 N, 95% CI -0.7 to -0.1, Cohen's d effect size 0.57) and stiffness (mean change -0.1 N/mm, 95% CI -0.2 to -0.1, Cohen's d effect size 0.59), as well as significant improvements in flexibility (mean change 9.0 mm, 95% CI 5.8-12.2, Cohen's d effect size 1.08), coordination (mean change 3 rapid contractions, 95% CI 2-4, Cohen's d effect size 0.85) and endurance (mean change 683%*s, 95% CI 388-978, Cohen's d effect size 0.90). Conclusion(s): Our findings suggest significant improvements in pelvic floor morphometry and muscle function after a multimodal physiotherapy treatment in gynaecological cancer survivors with dyspareunia. These effects may represent key treatment mechanisms to reduce dyspareunia, supporting the rationale for multimodal physiotherapy in this population. Clinical trial registration number (ClinicalTrials.gov): NCT03935698.Copyright © 2021 Chartered Society of Physiotherapy

Czakert, J., et al. (2022). "Plant Fragrances Are Like Music for Our Senses: A Scoping Review of Aromatherapy in Gynecologic Cancers and Breast Cancer Care." Journal of Integrative and Complementary Medicine 28(5): 377-390.
	Introduction: Essential oil (EO) applications via inhalation and/or absorption through the skin-often referred to as aromatherapy-have particular relevance as complementary to cancer treatment and follow-up care. Aromatherapy is of particular interest for controlling symptoms and enhancing the general well-being of people with cancer. This is indicated by the increasing number of empirical studies on this topic. Although numerous reviews have summarized the extensive primary research about aromatherapy and cancer, no review on aromatherapy use targeting women with gynecologic and breast cancers currently exists. Our scoping review aims at giving an overview of the state of research about aromatherapy in this specific target group. By summarizing and describing study characteristics, based on methodological decisions and content, we intend to offer implications for future research, focused on the use of EO in women with gynecologic and breast cancers. Methods: A systematic scoping review was conducted, based on the literature, and using the extension of the PRISMA statement for scoping reviews (PRISMA-ScR). The databases PubMed and CINHAHL were searched in a multi-stage, iterative process taking the most relevant terms under consideration, given our research interest and Boolean operators. The included studies were analyzed and summarized through (1) a table matrix including categories of interest and (2) qualitative content analysis. Results: One hundred seventy studies were examined, and 10 were included in this review. They show high heterogeneity in how the term aromatherapy is defined, in content, research design, EO used, application, and outcomes. However, all 10 studies exclusively targeted women with breast cancer in different states of cancer treatment. Conclusions: Challenges of research within this field point to the heterogeneous use and classification of the term aromatherapy, the differentiation of the principle of action of EO, the lack of transparency in how EO are reported and described (e.g., botanical names, company, dosage, mixing ratios), and the need to include subjective perceptions. Ten implications for future research based on these challenges are given.

da Mata Kyannie Risame, U., et al. (2021). "Telehealth in the rehabilitation of female pelvic floor dysfunction: a systematic literature review." International Urogynecology Journal 32(2): 249-259.
	Introduction and Hypothesis: The pandemic caused by coronavirus disease 2019 (COVID-19) increased the awareness and efforts to provide care from distance using information technologies. We reviewed the literature about the practice and effectiveness of the rehabilitation of the female pelvic floor dysfunction via telehealth regarding symptomatology and quality of life and function of pelvic floor muscles (PFM).; Methods: A bibliographic review was carried out in May 2020 in the databases: Embase, Medline/PubMed, LILACS and PEDro. A total of 705 articles were reviewed after the removal of duplicates. The methodological quality of the articles was evaluated by the PEDro scale. Two authors performed data extraction into a standardized spreadsheet.; Results: Four studies were included, two being randomized controlled trials. Among the RCTs, only one compared telehealth with face-to-face treatment; the second one compared telehealth with postal treatment. The other two studies are follow-up and cost analysis reports on telehealth versus postal evaluation. Data showed that women who received the intervention remotely presented significant improvement in their symptoms, such as reducing the number of incontinence episodes and voiding frequency, improving PFM strength and improving quality of life compared to women who had the face-to-face treatment.; Conclusions: Telehealth promoted a significant improvement in urinary symptoms, PFM function and quality of life. Telehealth is still emerging, and more studies are needed to draw more conclusions. The recommendations of the governmental authorities, physical therapy councils and corresponding associations of each country also need to be considered.

da Rocha Rodrigues, A., et al. (2022). "ESTIMULAÇÃO ELÉTRICA NERVOSA TRANSCUTÂNEA E SÍNDROME DA DISMENORREIA PRIMÁRIA: EXISTE RELAÇÃO DO TEMPO DE INTERVENÇÃO COM O ALÍVIO DE DOR?" Revista inspirar movimento & saude 22(4): 1‐18.
	
Dafni, U., et al. (2021). "Efficacy of cancer vaccines in selected gynaecological breast and ovarian cancers: A 20-year systematic review and meta-analysis." European journal of cancer (Oxford, England : 1990) 142: 63-82.
	Background: Therapeutic cancer vaccination is an area of interest, even though promising efficacy has not been demonstrated so far.; Design: A systematic review and meta-analysis was conducted to evaluate vaccines' efficacy on breast cancer (BC) and ovarian cancer (OC) patients. Our search was based on the PubMed electronic database, from 1st January 2000 to 4th February 2020.; Objective: response rate (ORR) was the primary end-point of interest, while progression-free survival (PFS), overall survival (OS) and toxicity were secondary end-points. Analysis was performed separately for BC and OC patients. Pooled ORRs were estimated by fixed or random effects models, depending on the detected degree of heterogeneity, for all studies with more than five patients. Subgroup analyses by vaccine type and treatment schema as well as sensitivity analyses, were implemented.; Results: Among 315 articles initially identified, 67 were eligible for our meta-analysis (BC: 46, 1698 patients; OC: 32, 426 patients; where both BC/OC in 11). Dendritic-cell and peptide vaccines were found in more studies, 6/10 BC and 10/13 OC studies, respectively. In our primary BC analysis (21 studies; 428 patients), the pooled ORR estimate was 9% (95%CI[5%,13%]). The primary OC analysis (12 studies; 182 patients), yielded pooled ORR estimate of 4% (95%CI[1%,7%]). Similar were the results derived in sensitivity analyses. No statistically significant differences were detected by vaccine type or treatment schema. Median PFS was 2.6 months (95% confidence interval (CI)[1.9,2.9]) and 13.0 months (95%CI[8.5,16.3]) for BC and OC respectively, while corresponding median OS was 24.8 months (95%CI[15.0,46.0]) and 39.0 months (95%CI[31.0,49.0]). In almost all cases, the observed toxicity was only moderate.; Conclusion: Despite their modest results in terms of ORR, therapeutic vaccines in the last 20 years display relatively long survival rates and low toxicity. Since a plethora of different approaches have been tested, a better understanding of the underlying mechanisms is needed in order to further improve vaccine efficacy.; Competing Interests: Conflict of interest statement UD has served as advisor/consultant for Roche. GC has received grants, research support and/or is coinvestigator in clinical trials by BMS, Celgene, Boehringer Ingelheim, Roche, Iovance and Kite; has received honoraria for consultations or presentations by Roche, Genentech, BMS, AstraZeneca, Sanofi-Aventis, Nextcure and GeneosTx; has patents in the domain of antibodies and vaccines targeting the tumour vasculature as well as technologies related to T-cell expansion and engineering for T-cell therapy; and receives royalties from the University of Pennsylvania related to T-cell therapy. KZ has provided consulting or participation in advisory boards of: AstraZeneca, Daiichi, Genomic Health (Exact Science), Lilly, MSD, Mylan, Novartis, Pfizer, Roche; has received travel funding by AstraZeneca, Pfizer, Roche, Pierre Fabre; has unrestricted funding for organisation of scientific events by AstraZeneca, Daiichi, Eisai, Exact Science, Lilly, MSD, Mylan, Novartis, Pfizer, Roche, Synlab; has research funding by Roche. AS has served as advisor/consultant for Roche, AstraZenca, Tesaro-GSK, Celgene-BMS; has received travel/educational/research grants by Roche, AstraZenca-MSD, GSK, Celgene, Agen, BMS, Pfizer, Clovis, Novartis. LK has received grants in clinical trials by BMS, BTG and Nestle.; has received honoraria for consultations GeneosTx. All remaining authors have declared no conflicts of interest. (Copyright © 2020. Published by Elsevier Ltd.)

Daggez, M., et al. (2023). "Prophylactic complex physiotherapy in gynecologic cancer survivors: patient-reported outcomes based on a lymphedema questionnaire." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 33(12): 1928-1933.
	Objective: Lower extremity lymphedema secondary to cancer treatment impacts quality of life for gynecological cancer survivors. Complex decongestive physiotherapy is applied when lymphedema is diagnosed, but prophylactic physiotherapy is not yet a standard of care. The aim of this study is to evaluate prophylactic complex physiotherapy in patients with gynecological cancer and its effects on patient-reported symptoms based on the Gynecologic Cancer Lymphedema Questionnaire.; Methods: The data of patients diagnosed with gynecological cancers who underwent lymphadenectomy from July 2021 to June 2022 was evaluated. All patients were referred to the physiotherapy unit before adjuvant treatment. Patients who accepted prophylactic physiotherapy were informed and massage and exercise training were implemented, whereas patients who declined were solely informed. Bilateral lower extremity circumferences were measured at 1, 3, 6, and 12 months at the levels of 10 cm, 30 cm, and 50 cm above the heels. A translated form of the Gynecologic Cancer Lymphedema Questionnaire was administered to all patients at the last visit.; Results: A total of 100 patients were included in the study. Patients were diagnosed with endometrial (50%), ovarian (32%), cervical (16%), and vulvar (2%) cancer. Overall, 70% underwent systematic pelvic±para-aortic lymphadenectomy whereas sentinel lymph node mapping was performed in 30%. Lymphedema was seen in 5% (n=3) of the prophylactic physiotherapy positive group and in 60% (n=24) of the physiotherapy negative group. The median score was 3 (range 1-5) in the physiotherapy positive group and 16 (range 9-20) in the physiotherapy negative group. In patients diagnosed with lymphedema in the physiotherapy negative group, systematic lymphadenectomy was performed in 91.7% (n=22) and a higher number of lymph nodes was extracted (median 45.5; p=0.002).; Conclusion: Prophylactic complex physiotherapy is associated with lower rates of lymphedema and better patient-reported symptom scores according to the Gynecologic Cancer Lymphedema Questionnaire.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Dagher, C., et al. (2023). "Molecular subtyping in endometrial cancer: A promising strategy to guide fertility preservation." Gynecologic Oncology 179: 180-187.
	Objectives: To investigate the association of molecular subtype with progesterone response in patients with endometrial cancer (EC) or atypical endometrial hyperplasia (AEH). Method(s): Premenopausal patients aged <=48 years with tumor-normal sequencing data who received progesterone for EC/AEH from 1/1/2010-6/30/2021 were identified. Tumors were classified as POLE-ultramutated, microsatellite instability-high (MSI-H), copy number-high (CN-H), or copy number-low (CN-L) molecular subtype. Best response to progesterone was compared by subtype. Appropriate statistical tests were performed. Result(s): Of 20 patients, 7 (35%) had AEH and 13 (65%) had EC. Sixteen tumors (80%) were CN-L, 3 (15%) were MSI-H, and 1 (5%) was POLE-ultramutated. Median time on progesterone was 22 months (range, 3-115). Ten patients (50%) had complete response (CR); median time to CR was 9 months (range, 3-32). Four patients (20%) had stable disease (SD) and 6 (30%) had progressive disease (PD). For CN-L tumors, 10 patients (62%) had CR, 3 (19%) had SD, and 3 (19%) had PD. For MSI-H tumors, 1 patient (33%) had SD and 2 (66%) had PD. For POLE-ultramutated tumors, 1 patient had PD. Median follow-up was 48 months (range, 12-123). Four of 10 patients (40%) with CR recurred; median time from CR to recurrence was 16 months (range, 5-102). Conclusion(s): Molecular subtype may be associated with progesterone response in patients with EC/AEH. CN-L tumors had the best response, and MSI-H tumors had the poorest. Recurrence after CR is common, and close surveillance is warranted. Larger studies investigating the role of molecular classification in medical management of EC/AEH are needed.Copyright © 2023 Elsevier Inc.

Dai, Q., et al. (2023). "Antitumor Activity of s-Triazine Derivatives: A Systematic Review." Molecules (Basel, Switzerland) 28(11).
	1,3,5-triazine derivatives, also called s-triazines, are a series of containing-nitrogen heterocyclic compounds that play an important role in anticancer drug design and development. To date, three s-triazine derivatives, including altretamine, gedatolisib, and enasidenib, have already been approved for refractory ovarian cancer, metastatic breast cancer, and leukemia therapy, respectively, demonstrating that the s-triazine core is a useful scaffold for the discovery of novel anticancer drugs. In this review, we mainly focus on s-triazines targeting topoisomerases, tyrosine kinases, phosphoinositide 3-kinases, NADP+-dependent isocitrate dehydrogenases, and cyclin-dependent kinases in diverse signaling pathways, which have been extensively studied. The medicinal chemistry of s-triazine derivatives as anticancer agents was summarized, including discovery, structure optimization, and biological applications. This review will provide a reference to inspire new and original discoveries.

Dai, Y., et al. (2022). "PD-1/PD-L1 Inhibitors Monotherapy for the Treatment of Endometrial Cancer: Meta-Analysis and Systematic Review." Cancer Investigation 40(3): 293-309.
	Purpose: The efficacy of programmed cell death protein 1(PD-1)/Programmed cell death 1 ligand 1 (PD-L1) inhibitors for endometrial cancer remain controversial, and guidelines are inconsistent on which are preferred therapies for advanced disease, or who develop metastases and recurrence. Therefore, we aimed to estimate the efficacy and safety of PD-1/PD-L1 inhibitors in endometrial cancer on a more complete database by adding multiple randomized trials.; Methods: A systematic and comprehensive search was carried out in PD-1/PD-L1 inhibitors monotherapy.; Results: The ORR of PD-1/PDL-1 inhibitors was 29%, and subgroup analysis showed that the pooled ORR of the proficient mismatch repair (pMMR) group was 4% and which was 45% of the deficient mismatch repair (dMMR) group. The DCR of PD-1/PD-L1 inhibitors was 48%, through subgroup analysis, we found that the DCR of the pMMR group was 21% and which was 58% of the dMMR group. The proportion of patients occurring overall adverse events was 65% and grade three or higher adverse events was 14%. The proficient mismatch repair (pMMR) group and the deficient mismatch repair (dMMR) group showed different results.; Conclusion: PD-1/PD-L1 inhibitors had shown little success in the pMMR population and better efficacy in the dMMR population.

Daix, M., et al. (2022). "Extended pelvic resection for gynecological malignancies: A review of out-of-the-box surgery." Gynecologic Oncology 165(2): 393-400.
	The term 'out-of-the-box surgery' in gynecologic oncology was recently coined to describe the resection of tumor growing out of the endopelvic cavity. In the specific case of pelvic sidewall involvement, a laterally extended pelvic resection may be required. As previously defined by Hockel, this resection requires the en bloc removal of structures including the pelvic sidewall muscles, bones, nerves, and/or major vessels. This complex radical procedure leads to tumor-free margins in more than 75% of the patients, with reliable functional results. The rate of recurrence and overall survival are directly correlated with clear resection margins. Progress in imaging, surgical techniques, and perioperative care currently offer the opportunity to attempt surgical curative resection in selected patients for whom palliative therapy was the only alternative. However, the procedure is associated with a high rate of major postoperative complications affecting up to 60% of patients. Multidisciplinary expert centers are the most likely to achieve this complex surgery with favorable oncological outcomes. The aim of this review is to summarize the key issues of out-of-the-box surgery in gynecologic cancer.Copyright © 2022 Elsevier Inc.

Daiyu, Z., et al. (2021). "Effect of metformin on pregnancy outcome and offspring development among women with polycystic ovarian syndrome: a systematic review and meta-analysis."
	
Dalkalitsis, A., et al. (2022). "Inguinal endometriosis: A systematic review." Taiwanese Journal of Obstetrics & Gynecology 61(1): 24-33.
	Inguinal endometriosis is a very rare entity with uncertain pathophysiology, that poses several diagnostic and therapeutic challenges. This study aimed to summarize published literature on the diagnosis and treatment of this condition. Thus, a systematic literature search was conducted in PubMed/MEDLINE, Scopus and the Cochrane Library. An effort was made to numerically analyze all parameters included in case reports and retrospective analyses, as well. The typical and atypical features of this condition, investigations used, type of treatment and histopathology were recorded. More specifications about the surgical treatment, such as operations previously performed, type of surgery and treatment after surgery have been acknowledged. Other sites of endometriosis, the presence of pelvic endometriosis and the follow-up and recurrence have been also documented. Overall, the search yielded 61 eligible studies including 133 cases of inguinal endometriosis. The typical clinical presentation includes a unilateral inguinal mass, with or without catamenial pain. Transabdominal or transvaginal ultrasound was typically used as the first line method of diagnosis. Groin incision and exploratory surgery was the treatment indicated by the majority of the authors, while excision of part of the round ligament was reported in about half of the cases. Chemotherapy and radiotherapy were initiated in cases of coexisting endometriosis-related neoplasia. Inguinal recurrence or malignant transformation was rarely reported. The treatment of inguinal endometriosis is surgical and a long-term follow-up is needed. More research is needed on the effectiveness of suppressive hormonal therapy, recurrence rate and its relationship with endometriosis-associated malignancies.; Competing Interests: Declaration of competing interest None. (Copyright © 2021. Published by Elsevier B.V.)

Dallagiovanna, C., et al. (2022). "Effect of letrozole on follicular fluid steroids concentrations in cancer patients undergoing oocyte cryopreservation." Journal of Assisted Reproduction and Genetics 39(5): 1169-1176.
	Purpose: To investigate the impact of letrozole administration on follicular steroid hormones during controlled ovarian hyperstimulation for fertility preservation.; Methods: One hundred and nineteen women with cancer undergoing oocytes retrieval for fertility preservation were recruited. All women underwent ovarian hyperstimulation according to a random start protocol. Those with hormone-sensitive tumors also received letrozole, an aromatase inhibitor aimed at keeping peripheral estrogen levels low. At the time of oocytes retrieval, a sample of follicular fluid was collected and frozen. All samples were assayed concomitantly after thawing, by liquid chromatography tandem mass spectrometry. The concentration of 15 steroid hormones was determined and results were compared between women who did and did not receive letrozole.; Results: Fifty-two women were treated with letrozole, while 67 were not. Statistically significant differences emerged for 12 of the 15 tested steroids. They were the following: cortisol, 11-deoxycortisol, 21-deoxycortisol, dehydroepiandrosterone sulfate (DHEAS), dehydroepiandrosterone (DHEA), estradiol, androstenedione, testosterone, dihydrotestosterone (DHT), 17-hydroxyprogesterone, progesterone and corticosterone. The most striking differences were observed for testosterone that showed a more than 200-time increase in women receiving letrozole. Estradiol was conversely reduced to a third.; Conclusions: The endocrine microenvironment surrounding oocytes is markedly perturbed by the concomitant assumption of letrozole. Robust clinical evaluation is pressingly needed to rule out any detrimental effect on the chance of live birth with the use of these oocytes. (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

D'Alterio, M. N., et al. (2021). "Medical and surgical interventions to improve the quality of life for endometriosis patients: A systematic review." Gynecological Surgery 18(1): 13.
	Endometriosis impairs the quality of life (QoL) of many women, including their social relationships, daily activity, productivity at work, and family planning. The aim of this review was to determine the instruments used to examine QoL in previous clinical studies of endometriosis and to evaluate the effect of medical and surgical interventions for endometriosis on QoL. We conducted a systematic search and review of studies published between January 2010 and December 2020 using MEDLINE. Search terms included "endometriosis" and "quality of life." We only selected studies that used a standardized questionnaire to evaluate QoL before and after medical or surgical interventions. Only articles in the English language were examined. The initial search identified 720 results. After excluding duplicates and applying inclusion criteria, 37 studies were selected for analysis. We found that the two scales most frequently used to measure QoL were the Short Form-36 health survey questionnaire (SF-36) and the Endometriosis Health Profile-30 (EHP-30). Many medical and surgical treatments demonstrated comparable benefits in pain control and QoL improvement. There is no clear answer as to what is the best treatment for improving QoL because each therapy must be personalized for the patient and depends on the woman's goals. In conclusion, women must be informed about endometriosis and given easily accessible information to improve treatment adherence and their QoL.Copyright © The Author(s).

d'Alterio, M. N., et al. (2022). "Pregnancy outcomes in women with polycystic ovarian syndrome." Minerva Obstetrics and Gynecology 74(1): 45-59.
	Polycystic ovarian syndrome (PcOs) is the most common endocrinological disease of reproductive-aged women, with an estimated incidence ranging from 5% to 15%. the clinical manifestations of PcOs are heterogeneous and vary according to the age of the patient. insulin resistance (ir), hyperandrogenism, and obesity are widely assumed to play a pivotal role in the pathophysiological mechanism of PcOs. as previously stated by many conducted meta-analyses, PcOs can cause a rising risk of pregnancy complications, including maternal, fetal, and neonatal complications. Pregnancy-induced hypertension (PiH), preeclampsia (Pe), gestational diabetes mellitus (GdM), spontaneous preterm birth (Ptb), and an increased necessity for a cesarean section (cs) are the most documented maternal implications. regarding fetal outcomes, PcOs has also been correlated with elevated neonatal morbidity, prematurity, fetal growth restriction (FGr), birth weight variations (large for gestational age [lGa] and small for gestational age [sGa]), and transfer to the Neonatal intensive care Unit (NicU). Owing to the variability of the studies performed, the association of PcOs with an elevated risk of adverse pregnancy outcomes is still controversial. this variability is found in the diagnosis and clinical presentations of PCOS, and can be influenced by prepregnancy circumstances and therapies as well as particular population and environmental features. The Amsterdam Consensus Guidelines confirm that obesity and IR can worsen maternal and fetal complications; thus, a closer follow-up should be offered to PcOs women during pregnancy.Copyright © 2021 Edizioni Minerva Medica

Dama Manish, H. and J. Van Lieshout Ryan (2024). "Perinatal Depression: A Guide to Detection and Management in Primary Care." Journal of the American Board of Family Medicine : JABFM 36(6): 1071-1086.
	Introduction: Existing guidelines for primary care clinicians (PCCs) on the detection and management of perinatal depression (PD) contain important gaps. This review aims to provide PCCs with a summary of clinically relevant evidence in the field.; Methods: A narrative literature review was conducted by searching PubMed and PsycINFO for articles published between 2010 to 2023. Guidelines, systematic reviews, clinical trials, and/or observational studies were all examined.; Results: Screening with the Edinburgh Postnatal Depression Scale or Patient Health Questionnaire-9 followed by a diagnostic evaluation for major depressive disorder in probable cases can enhance PD detection. At-risk individuals and mild to moderate PD should be referred for cognitive behavioral therapy or interpersonal psychotherapy when available. Selective serotonin reuptake inhibitors should be used for moderate to severe PD, with sertraline, escitalopram, or citalopram being preferred first. Using paroxetine or clomipramine in pregnancy, and fluoxetine or doxepin during lactation is generally not preferred. Gestational antidepressant use is associated with a small increase in risk of reduced gestational age at birth, low birth weight, and lower APGAR scores, though whether these links are causal is unclear. Sertraline and paroxetine have the lowest rate of adverse events during lactation. Consequences of untreated PD can include maternal and offspring mortality, perinatal complications, poor maternal-infant attachment, child morbidity and maltreatment, less breastfeeding, and offspring developmental problems.; Conclusions: These clinically relevant data can support the delivery of high-quality care by PCCs. Risks and benefits of PD treatments and the consequences of untreated PD should be discussed with patients to support informed decision making.; Competing Interests: Conflict of interest: The authors have no conflicts of interest to declare. (© Copyright by the American Board of Family Medicine.)

Damodaran, S., et al. (2022). "Phase II Study of Copanlisib in Patients with Tumors with PIK3CA Mutations: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1F." Journal of Clinical Oncology 40(14): 1552-1561.
	PURPOSEActivating mutations in PIK3CA are observed across multiple tumor types. The NCI-MATCH (EAY131) is a tumor-agnostic platform trial that enrolls patients to targeted therapies on the basis of matching genomic alterations. Arm Z1F evaluated copanlisib, an alpha and delta isoform-specific phosphoinositide 3-kinase (PI3K) inhibitor, in patients with PIK3CA mutations (with or without PTEN loss).PATIENTS AND METHODSPatients received copanlisib (60 mg intravenous) once weekly on days 1, 8, and 15 in 28-day cycles until progression or toxicity. Patients with KRAS mutations, human epidermal growth factor receptor 2-positive breast cancers, and lymphomas were excluded. The primary end point was centrally assessed objective response rate (ORR); secondary end points included progression-free survival, 6-month progression-free survival, and overall survival.RESULTSThirty-five patients were enrolled, and 25 patients were included in the primary efficacy analysis as prespecified in the Protocol. Multiple histologies were enrolled, with gynecologic (n = 6) and gastrointestinal (n = 6) being the most common. Sixty-eight percent of patients had >= 3 lines of prior therapy. The ORR was 16% (4 of 25, 90% CI, 6 to 33) with P =.0341 against a null rate of 5%. The most common reason for protocol discontinuation was disease progression (n = 17, 68%). Grade 3/4 toxicities observed were consistent with reported toxicities for PI3K pathway inhibition. Sixteen patients (53%) had grade 3 toxicities, and one patient (3%) had grade 4 toxicity (CTCAE v5.0). Most common toxicities include hyperglycemia (n = 19), fatigue (n = 12), diarrhea (n = 11), hypertension (n = 10), and nausea (n = 10).CONCLUSIONThe study met its primary end point with an ORR of 16% (P =.0341) with copanlisib showing clinical activity in select tumors with PIK3CA mutation in the refractory setting.Copyright © American Society of Clinical Oncology.

Danaher Brian, G., et al. (2023). "Trial of a patient-directed eHealth program to ameliorate perinatal depression: the MomMoodBooster2 practical effectiveness study." American Journal of Obstetrics and Gynecology 228(4): 453.e451-453.e410.
	Background: Depression is one of the most common complications of childbirth, and is experienced by approximately 17% of pregnant women and 13% of postpartum women. An estimated 85% of these women go untreated-an alarming statistic given the serious consequences for the mother, her child, other family members, and society. Professional societies (the American College of Obstetricians and Gynecologists and American Academy of Pediatrics) have recommended improvements in screening and treatment. Meta-analyses indicate that cognitive behavioral therapy eHealth interventions are efficacious for depression, generally, and for perinatal depression, specifically. Earlier controlled trials have established the effectiveness and acceptability of MomMoodBooster (including an Australian version, MumMoodBooster), an eHealth program for ameliorating postpartum depression.; Objective: This study aimed to evaluate the effectiveness of a perinatal version of MomMoodBooster encompassing both prenatal and postpartum content in a healthcare delivery setting already providing universal screening and referral of at-risk patients as part of routine care.; Study Design: A practical effectiveness study randomly assigned 95 pregnant and 96 postpartum women screened as depressed and satisfying eligibility criteria to experimental groups: the healthcare organization's perinatal depression care program (routine-care group) and routine care+MomMoodBooster2 program (eHealth group). Eligibility criteria included: pregnant or <1 year postpartum, ≥18 years of age, no active suicidal ideation, access to broadband internet via desktop/laptop, tablet, or smartphone, and English language proficiency.; Results: Intent-to-treat analyses of group effects used fixed-effects growth models to assess 12-week posttest change in outcomes. Results showed that both groups had significantly decreased depression severity, anxiety, stress, and automatic thoughts, and increased behavioral activation and self-efficacy. Relative to the routine-care group, the eHealth group displayed significantly greater decreases in depression severity and stress. These group comparisons were not moderated by depression severity (screening or baseline), anxiety, stress, or pregnant/postpartum status. Almost all (93%; n=89) women in the eHealth group visited their program, of whom 99% visited program sessions (M sessions visited=4.3±2.0; M total session duration=73.0±70.2 minutes; 49% viewed all 6 sessions). Among confirmed eHealth program users who provided ratings, 96% (79/82) rated their program as easy to use, 83% rated it helpful, and 93% (76/82) indicated that they would recommend it.; Conclusion: Results support the effectiveness of using MomMoodBooster2 as a treatment option for perinatal women with depression, especially when combined with universal depression screening and referral. Consequently, the eHealth program shows promise as a tool to increase the reach of treatment delivery and to potentially reduce the number of untreated perinatal women with depression. (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Daniela, F. and C. Graziele (2021). "Assessment of sexual function in patients with deep endometriosis after surgery."
	
Daniela, F. and Q. Ricardo de Almeida (2021). "Assessment of bowel function in women with deep bowel endometriosis after surgery: systematic review."
	
Daniele, G., et al. (2019). "Prognostic role of chemotherapy-induced neutropenia in first-line treatment of advanced ovarian cancer. A pooled analysis of MITO2 and MITO7 trials." Gynecologic Oncology 154(1): 83-88.
	Background: Chemotherapy-induced neutropenia (CIN) has been associated with improved prognosis in several cancer conditions. Contrasting data have been produced in ovarian cancer. (Copyright © 2019 Elsevier Inc. All rights reserved.)

Danielly, Y., et al. (2022). "The impact of practical women and physical exercise on menopause. A systematic review with meta-analysis."
	
Daniels, J., et al. (2022). "Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial." European Journal of Obstetrics and Gynecology and Reproductive Biology: X 13: 100139.
	Objective: To examine the quality of life experienced by women with symptomatic uterine fibroids who had been treated with UAE in comparison to myomectomy. We report the four-year follow-up of the FEMME randomised trial. Two-year follow-up data has been previously reported. Study Design: Premenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolization were recruited from 29 UK hospitals. Women were excluded if they had significant adenomyosis, any malignancy, pelvic inflammatory disease or had had a previous open myomectomy or uterine artery embolization. Participants were randomised to myomectomy or embolization in a 1:1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic, according to clinician preference. Embolization of the uterine arteries was performed according to local practice, under fluoroscopic guidance. The primary outcome measure was the Uterine Fibroid Symptom Quality of Life questionnaire, adjusted for baseline score and reported here at four years post-randomisation. Subsequent procedures for fibroids, pregnancy and outcome were amongst secondary outcomes. Trial registration ISRCTN70772394 https://doi.org/10.1186/ISRCTN70772394 Results: 254 women were randomized, 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolization (98 underwent embolization). At four years, 67 (53%) and 81 (64%) completed UFS-QoL quality of life scores. Mean difference in the UFS-QoL at 4 years was 5.0 points (95% CI -1.4 to 11.5; p = 0.13) in favour of myomectomy. There were 15 pregnancies in the UAE group and 7 in the myomectomy group, with a cumulative pregnancy rate to four years of 15% and 6% respectively (hazard ratio: 0.48; 95% CI 0.18-1.28). The cumulative repeat procedure rate to four years was 24% in the UAE group and 13% in the myomectomy group (hazard ratio: 0.53; 95% CI 0.27-1.05). Conclusion(s): Myomectomy resulted in greater improvement in quality of life compared with uterine artery embolization, although by four years, this difference was not statistically significant. Missing data may limit the generalisability of this result. The numbers of women becoming pregnant were too small draw a conclusion on the effect of the procedures on fertility.Copyright © 2021 The Authors

Daniilidis, A., et al. (2023). "Surgical Management of Ovarian Endometrioma: Impact on Ovarian Reserve Parameters and Reproductive Outcomes." Journal of Clinical Medicine 12(16): 5324.
	Ovarian endometriomas have a negative impact on a patient's reproductive potential and are likely to cause a reduction in ovarian reserve. The most commonly employed ovarian reserve parameters are anti-Mullerian hormone (AMH) and antral follicular count (AFC). Surgical management options of endometrioma include cystectomy, ablative methods, ethanol sclerotherapy and combined techniques. The optimal surgical approach remains a matter of debate. Our review aimed to summarize the literature on the impact of surgical management of endometrioma on AMH, AFC and fertility outcomes. Cystectomy may reduce recurrence rates and increase chances of spontaneous conception. However, a postoperative reduction in AMH is to be anticipated, despite there being evidence of recovery during follow-up. The reduction in ovarian reserve is likely multi-factorial. Cystectomy does not appear to significantly reduce, and may even increase, AFC. Ablative methods achieve an ovarian-tissue-sparing effect, and improved ovarian reserve, compared to cystectomy, has been demonstrated. A single study reported on AMH and AFC post sclerotherapy, and both were significantly reduced. AMH levels may be useful in predicting the chances of conception postoperatively. None of the aforementioned approaches has a clearly demonstrated superiority in terms of overall chances of conception. Surgical management of endometrioma may, overall, improve the probability of pregnancy. Evidence on its value before medically assisted reproduction (MAR) is conflicting; however, a combination of surgery followed by MAR may achieve the optimal fertility outcome. In view of the complexity of available evidence, individualization of care, combined with optimal surgical technique, is highly recommended.Copyright © 2023 by the authors.

Danis, R., et al. (2022). "Orally Administered Probiotics in the Prevention of Chemotherapy (+/- Radiotherapy)-Induced Gastrointestinal Toxicity: A Systematic Review With Meta-Analysis of Randomized Trials." Integrative Cancer Therapies 21.
	Background: Chemoradiotherapy-induced gastrointestinal toxicity may lead to a significant impairment of the oncological patient's quality of life, as well as to reduced adherence to the treatment, which may have a negative impact on survival and mortality rates. Objective(s): The aim of this review was to investigate whether oral probiotic administration prevents chemotherapy (+/- radiotherapy)-induced gastrointestinal toxicity, particularly diarrhea. Method(s): We searched the MEDLINE, Web of Science, and SCOPUS databases for randomized controlled trials in English published between 1990 and 2020. We conducted statistical data analyses expressing the treatment effect size as a risk ratio (RR) together with a 95% confidence interval (CI). Implications are based on trials rated as having a low risk of bias (RoB). Result(s): We included 8 trials (n = 697 participants), from which 3 studies rated as low RoB contained primary endpoint data; the risk of developing grade 3/4 diarrhea in patients receiving probiotics was reduced by 78% compared to the control group (RR = 0.22 [95% CI 0.05-1.08]; P =.06; n = 114 participants). Probiotics showed preventive effects in patients treated with chemotherapy alone (RR = 0.34 [0.12-0.94]; P =.04, n = 121 participants) and in patients with colorectal cancer (RR = 0.56 [0.34-0.92]; P =.02; n = 208 participants). The reduction in the incidence of overall diarrhea was not significant. Conclusion(s): Probiotics failed to prove a preventive effect of statistical significance against the development of severe and overall diarrhea in cancer patients treated with chemotherapy (+/- radiotherapy). However, we cannot rule out that the effects of probiotics are clinically relevant, especially in certain subgroups of patients. This needs to be clarified in further well-performed studies.Copyright © The Author(s) 2022.

Dankova, I., et al. (2023). "Efficacy and Safety of Platelet-Rich Plasma Injections for the Treatment of Female Sexual Dysfunction and Stress Urinary Incontinence: A Systematic Review." Biomedicines 11(11).
	Introduction: There is no clear evidence in the literature that platelet-rich plasma (PRP) injections improve female sexual dysfunction (FSD) and female stress urinary incontinence (SUI). Objectives: A systematic review was performed to study the efficacy and safety of PRP injections in women with the above pathologies, as well as to explore the optimal dosing, frequency and area of injections, and duration of treatment. Methods: A systematic search on PubMed, Embase and the Cochrane Library database was performed, as well as sources of grey literature from the date of database or source creation to January 2023. After title/abstract and full-text screening, clinical studies on humans evaluating the efficacy of PRP in gynecological disorders using standardized tools were included. Risk of bias was undertaken with RoB-2 for randomized-controlled trials (RCT) and the Newcastle-Ottawa Scale (NOS) for observational studies. Results: Four prospective and one retrospective study explored FSD, while six prospective and one RCT evaluated female SUI. A total of 327 women with a mean age of 51 ± 12 years were included. For FSD, PRP significantly improved the Female Sexual Function Index (FSFI), the Vaginal Health Index (VHI) and the Female Sexual Distress score (FSDS). For SUI, PRP led to a significant improvement in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and the Urogenital Distress Inventory (UDI-6). The identified RCT reported a significantly higher mean score of ICIQ-SF (p < 0.05) and UDI-6 (p < 0.01) in the midurethral sling group compared to the PRP injections group. Regarding the risk of bias, the RCT was characterized by high risk, whereas the observational studies were of moderate risk. The protocol for PRP injections for FSD is the injection of 2 mL of PRP into the distal anterior vaginal wall once a month for 3 months. For female SUI, 5-6 mL of PRP should be injected into the periurethral area once a month for 3 months. Conclusions: Despite the promising initial results of PRP injections, the level of current evidence is low due to methodological issues in the available studies. It becomes clear that there is an emerging need for high-quality research examining PRP injections for the treatment of FSD and female SUI.

Dannecker, C. (2021). "HPV vaccination after treatment of cervical intraepithelial neoplasia (CIN/HSIL)." Gynakologe 54(11): 816-819.
	Background: Human papillomavirus (HPV) vaccination can reliably protect against the development of cervical cancer and its precursors. Whether adjuvant HPV vaccination can reduce the recurrence rate after therapy is not yet fully understood. Objective(s): Can a benefit for adjuvant HPV vaccination be proven from the existing data? Methods: Evaluation and comparative summary of three current meta-analyses of adjuvant HPV vaccination after surgical therapy of cervical intraepithelial neoplasia (CIN). Result(s): Three meta-analyses consistently prove that the recurrence rate can be reduced by around 65% by means of adjuvant HPV vaccination after surgical therapy of a CIN. Approximately 2-3% of women vaccinated adjuvantly benefit from vaccination. The number needed to vaccinate is approximately 46. Conclusion(s): Adjuvant HPV vaccination may be recommended.Copyright © 2021, Springer Medizin Verlag GmbH, ein Teil von Springer Nature.

Danxue, H. and L. Su (2023). "Efficacy and safety of anti‑angiogenic agents in platinum-resistant ovarian cancer: a systematic review and meta-analysis."
	
Dao, D., et al. (2019). "The utility of apparent diffusion coefficients for predicting treatment response to uterine arterial embolization for uterine leiomyomas: a systematic review and meta-analysis." Diagnostic and interventional radiology (Ankara, Turkey) 25(2): 157-165.
	Purpose: Apparent diffusion coefficient (ADC) values, which are derived from diffusion-weighted imaging, have a potential role for predicting treatment response. A systematic review was conducted to examine the value of baseline ADC values for predicting leiomyoma size reduction after uterine arterial embolization (UAE).; Methods: Study selection, quality appraisal and data extraction were conducted independently by two authors. Statistical analyses included the calculation of weighted means and summary correlation coefficients (under the random effects model).; Results: Eleven studies consisting of a total of 258 patients (age, weighted mean±standard deviation [SD], 43.1±10.1 years) were included. The weighted mean±SD ADC value was 1.2±1.5 ×10-3 s/mm2 at baseline (ten studies) and 1.3±2.8 ×10-3 s/mm2 at approximately 6 months after embolization (six studies). The weighted mean percentage leiomyoma volume reduction (VR) at 6 months was 47.1%±35.6% (seven studies). Based on four studies, the weighted summary correlation coefficient for the correlation between baseline ADC and leiomyoma VR at approximately 6 months was not significant (r=0.40; 95% CI, -0.07 to 0.72; I2=69.7%). No associations were found in three of the four studies that examined changes in ADC values as a predictor.; Conclusion: Due to high heterogeneity, it is unclear whether ADC may be useful for predicting treatment responses to UAE.

Daolio, J., et al. (2020). "Uterine transplantation and IVF for congenital or acquired uterine factor infertility: A systematic review of safety and efficacy outcomes in the first 52 recipients." PloS One 15(4): e0232323.
	Uterine transplantation (UTx) associated with IVF restores fertility in women affected by absolute uterine factor infertility (AUFI). Pregnancies achieved both in women undergoing any solid organ transplantation and following IVF are associated with an increased risk of maternal and neonatal complications. This systematic review evaluated this risk in UTx-IVF treated women focusing on the safety and efficacy features of the treatment. Twenty-two studies and three press releases reporting on 52 UTx-IVF treatments were identified. Regarding the safety of treatment, 38/52 (73,1%) of surgical procedures led to the restoration of uterine function in recipients, 12/52 (23,1%) of recipients experienced post-operative complications requiring hysterectomy, and 2/52 (3,8%) of procedures failed before uterine recipients' surgery due to intra-operative complications. Regarding the efficacy of treatment, results focused on transplanted patients showing full recovery of organ functioning: 16/38 (42,1%) of patients achieved a pregnancy, including two women who gave births twice. UTx-IVF pregnancies led to 16 deliveries and all new-borns were healthy. Six out of 16 (37,5%) UTx pregnancies faced major complications during gestation. Preterm births occurred in 10/16 (62,5%) UTx deliveries. Our data indicates that the risk of gestational and delivery complications deserves important consideration in AUFI women receiving UTx-IVF treatments. However, these observations are preliminary and need to be revised after larger series of data are published.; Competing Interests: The authors have declared that no competing interests exist

Darand, M., et al. (2019). "The effect of Nigella sativa on infertility in men and women: A systematic review." Progress in Nutrition 21: 33-41.
	Objective: Black seed (Nigella sativa L.) is a medicinal plant belonging to botanical family of Ranunculaceae. Given the effective role of N. sativa in treating different diseases, the present systematic review aimed to evaluate the effects of N. sativa on the reproductive system. Material(s) and Method(s): The current systematic review was carried out on randomized controlled trials (RCTs) regarding human, animal and in vivo/in vitro studies published between 2014 and 2017. The related articles were collected by searching the databases of Medline, PubMed, Scopus, Science direct, and Google scholar only in English using the search keywords of Nigella sativa, Black Seed, Thymoquinone (TQ), Infertility, Reproductive System and Reproductive Parameters. Review articles, case reports, abstract in symposium and congress were excluded. Result(s): Finally, 24 articles were selected for analyses. The results showed that the treatment with N. sativa has improved the sperm parameters, semen fluid in men and leydig cell count, graph follicle count, corpus luteum and level of sex hormones such as testosterone and progesterone in women (p<0.05). Conclusion(s): According to the findings, N. sativa can improve the reproductive parameters and sex hormones in both genders.Copyright © Mattioli 1885

Darbà, J. and A. Marsà (2022). "Economic Implications of Endometriosis: A Review." PharmacoEconomics 40(12): 1143-1158.
	Endometriosis is a chronic inflammatory disease that can have serious physical and emotional consequences for patients in terms of pain, quality of life, and infertility. Despite affecting about 10% of women, the pathophysiology and economic impact of the disease are not fully understood. This study aimed to review and summarize research articles quantifying the direct and indirect costs of endometriosis in the context of current national and international treatment guidelines. A search including the terms 'endometriosis' AND 'costs' OR 'cost of illness' OR 'cost analysis' OR 'economic burden' was performed, focusing on studies published between January 2000 and May 2022. Total costs, costs of primary and secondary care, productivity losses, and indirect costs were reported. The medical costs of endometriosis were principally registered in secondary care settings, where surgery was the main cost driver. There was considerable variability of populations and study settings, with the overall direct medical cost range of endometriosis from US$1459 to US$20,239 (2022) per patient per year. An increasing trend has been reported in secondary care costs over time; however, not enough data were available at this time to evaluate inpatient and outpatient costs versus treatment strategies. Similarly, further research is required to evaluate the costs and potential savings associated with new therapies. Numerous studies have evaluated the indirect costs of endometriosis in recent years, finding costs between US$4572 and US$14,079 (2022). Currently, limited data are available on the economic burden of the disease at the patient level. (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Daré, B. and Inc (2021). Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA.
	No Results Available Drug: Tamoxifen|Other: Placebo Number of Subjects with Treatment Emergent Adverse Events|Concentration of Tamoxifen in serial plasma collections over multiple timepoints|Evaluation of vaginal cytology|Evaluation of vaginal pH Female Phase 1|Phase 2 17 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Basic Science DARE-VVA-001 March 1, 2023

Daré, B. and Inc (2022). Study of DARE-HRT1 Over 12 Weeks in Healthy PostMenopausal Women.
	No Results Available Device: IVR Dose 1|Device: IVR Dose 2 Number of Participants with Treatment Emergent Adverse Events|Determination of maximum plasma concentration (Cmax)|Determination of time that maximum plasma concentration was observed (tmax)|Determination of steady-state concentration (Css) Female Phase 1|Phase 2 21 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment DARE-HRT1-002 March 23, 2023

Daré, B. and Inc (2023). A Study of Diclofenac Gel in Women With Primary Dysmenorrhea.
	No Results Available Drug: Diclofenac 1%|Drug: Diclofenac 3%|Drug: Placebo Measure the systemic Level of Diclofenac after a single dose of DARE-PDM1|Measure the systemic Level of Diclofenac after three doses of DARE-PDM1|Measure the Vaginal Fluid levels of diclofenac after three doses of DARE-PDM1|Measure the Vaginal Fluid levels of diclofenac after a single dose DARE-PDM1|Number of participants with abnormal vaginal exam findings.|Number of participants with abnormal laboratory test results. Female Phase 1 36 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment DARE-PDM1-001 May 2024

Das, R., et al. (2022). "Randomised Controlled Trial of Particles Used in Uterine fibRoid Embolisation (PURE): Non-Spherical Polyvinyl Alcohol Versus Calibrated Microspheres." Cardiovascular and interventional radiology 45(2): 207-215.
	Purpose: The PURE study is a randomised controlled trial (RCT) comparing the clinical and MRI outcomes of patients treated with non-spherical polyvinyl alcohol, ns-PVA (Contour PVA-Boston Scientific-355-500 & 500-700 microns) versus calibrated hydrogel microspheres (Embozene-Varian Inc-700 & 900 microns) for symptomatic uterine fibroids.; Materials and Methods: Prospective, ethically approved non-sponsored RCT in 84 patients in a single UK tertiary IR unit, ISRCTN registry trial number ISRCTN18191539 in 2013 and 2014. All patients with symptomatic fibroid disease were eligible. UAE followed a standardised protocol with UFS-QOL and contrast-enhanced MRI before and 6 months post UAE. Outcome measures included: (1) Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QOL). (2) Percentage total and dominant fibroid infarction. (3) Uterine and dominant fibroid volume reduction. (4) Volume of embolics.; Results: Sixty-three patients completed the QOL follow-up (33 ns-PVA vs 30 Embozenes), the groups were equivalent at baseline. Patients were followed up for 6 months following UAE. There was no significant difference in symptom scores or HR-QOL between ns-PVA and Embozenes, p = 0.67 and 0.21, respectively. 92.7% of patients treated with ns-PVA achieved > 90% dominant fibroid infarction versus 61.8% treated with Embozenes (p = 0.0016). 66% of patients treated with ns = PVA achieved > 90% total fibroid percentage infarction compared with 35% in the Embozene group (p = 0.011). The mean vials/syringes used were 5.2 with Embozenes versus 4.1 using PVA (p = 0.08).; Conclusion: The PURE study informs IRs regarding the efficacy of embolic agents in UAE, with superior fibroid infarction on MRI using ns-PVA versus Embozenes however no significant difference in clinical outcomes at 6 months after UAE. (© 2022. Crown.)

Dashti, S., et al. (2022). "A randomised controlled trial on the effects of a structural education module among women with polycystic ovarian syndrome on nutrition and physical activity changes." BMC Women's Health 22(1): 277.
	Background: Polycystic ovarian syndrome (PCOS) is a complex metabolic, endocrine and reproductive disorder that has a huge impact on the life of women. To ascertain the effectiveness of health education module among women with PCOS.; Methods: This single-centre, randomised controlled trial was conducted on female staff of the University Putra Malaysia who were diagnosed with PCOS. Subjects were randomly assigned into intervention (n = 34) and control group (n = 35). In the intervention group, they need to take part in 8 education sessions in total over 6 months, and feedback was collected at the end of the session.; Results: Primary outcome was changes in knowledge, attitude and practise of nutrition. Secondary outcomes were eating attitude and behaviour as well as knowledge, attitude and practise towards physical activity. After 6-months of intervention, there was a significant difference observed in nutrition knowledge 1 score (p < 0.001) and nutrition knowledge 2 score (p = 0.01) between intervention and control groups. Similarly, there was a significant difference observed in international physical activity questionnaire score (p = 0.02) between intervention and control groups. However there was no significant changes for attitude and practice of nutrition, eating attitude as well as knowledge, attitude and practise of physical activity.; Conclusions: Our study showed that 6-months of education intervention can improve nutrition and physical activity knowledge. Based on this study, the education module may be considered an effective intervention for women with PCOS.; Trial Registration: Name of the registry: Australian New Zealand Clinical Trials Registry (ANZCTR).; Trial Registration Number: ACTRN12617000135314. Date of registration: 24/01/2017. URL of trial registry record: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372037. (© 2022. The Author(s).)

Dason, E. S., et al. (2023). "Guideline No. 437: Diagnosis and Management of Adenomyosis." Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC 45(6): 417.
	Objective: To describe the current evidence-based diagnosis and management of adenomyosis.; Target Population: All patients with a uterus of reproductive age.; Options: Diagnostic options include transvaginal sonography and magnetic resonance imaging. Treatment options should be tailored to symptoms (heavy menstrual bleeding, pain, and/or infertility) and include medical options (non-steroidal anti-inflammatory drugs, tranexamic acid, combined oral contraceptives, levonorgestrel intrauterine system, dienogest, other progestins, gonadotropin-releasing analogues), interventional options (uterine artery embolization), and surgical options (endometrial ablation, excision of adenomyosis, hysterectomy).; Outcomes: Outcomes of interest include reduction in heavy menstrual bleeding, reduction in pelvic pain (dysmenorrhea, dyspareunia, chronic pelvic pain), and improvement in reproductive outcomes (fertility, miscarriage, adverse pregnancy outcomes).; Benefits, Harms, and Costs: This guideline will benefit patients with gynaecological complaints that may be caused by adenomyosis, especially those patients who wish to preserve their fertility, by presenting diagnostic methods and management options. It will also benefit practitioners by improving their knowledge of various options.; Evidence: Databases searched were MEDLINE Reviews, MEDLINE ALL, Cochrane, PubMed, EMBASE. The initial search was completed in 2021 and updated with relevant articles in 2022. Search terms included adenomyosis, adenomyoses, endometritis (used/indexed as adenomyosis before 2012), (endometrium AND myometrium) uterine adenomyosis/es, symptom/s/matic adenomyosis] AND [diagnosis, symptoms, treatment, guideline, outcome, management, imaging, sonography, pathogenesis, fertility, infertility, therapy, histology, ultrasound, review, meta-analysis, evaluation]. Articles included randomized controlled trials, meta-analyses, systematic reviews, observational studies, and case reports. Articles in all languages were searched and reviewed.; Validation Methods: The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See online Appendix A (Table A1 for definitions and Table A2 for interpretations of strong and conditional [weak] recommendations).; Intended Audience: Obstetrician-gynaecologists, radiologists, family physicians, emergency physicians, midwives, registered nurses, nurse practitioners, medical students, residents, and fellows.; Tweetable Abstract: Adenomyosis is common in reproductive-aged women. There are diagnostic and management options that preserve fertility available.; Summary Statements: RECOMMENDATIONS. (Copyright © 2023. Published by Elsevier Inc.)

D'Astous-Gauthier, K., et al. (2021). "Beta-2 Agonists May be Superior to Epinephrine to Relieve Severe Anaphylactic Uterine Contractions." The journal of allergy and clinical immunology. In practice 9(3): 1232-1241.
	Background: Uterine contractions are recognized as a potential manifestation of anaphylaxis, but literature on their proper management is limited. It is widely recognized that anaphylactic reactions can cause uterine contractions, but little is known about their optimal management.; Objective: Review potential treatments for painful uterine contractions associated with anaphylaxis or mast cell activation.; Methods: This systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines. PubMed, Embase, and Cochrane were searched in English, French, and Spanish for reports of uterine anaphylaxis published up until July 2020. The search strategy used a combination of Boolean operators and included the following Medical Subject Heading terms and keywords: hypersensitivity; anaphylaxis; mastocytosis; uterus; uterine contraction; pelvic pain; labor, obstetric; labor, premature; and endometriosis.; Results: This systematic review identified 19 studies reporting on 31 cases of painful uterine contractions occurring during anaphylaxis or other events associated with mast cell activation. Nine patients were pregnant. We present 2 additional cases in nonpregnant women, one associated with an oral food challenge and the other associated with oral food desensitization. The most frequent triggers were subcutaneous immunotherapy (14 cases), food (6 cases), and drugs (4 cases). Uterine cramps were associated with systemic symptoms in 24 cases and lasted on average for 2.4 hours. Pretreatment with antihistamines and montelukast generally failed to prevent recurrence, but nonsteroidal anti-inflammatory drugs were used successfully in some reports. Response to intramuscular epinephrine was inconsistent. Data from ex vivo models indicate that epinephrine may paradoxically contribute to uterine contractions through alpha-receptor activity. A small number of cases showed good response to beta-2 agonists.; Conclusions: There is a lack of quality data on painful uterine contractions occurring in the context of anaphylactic reactions and on their optimal management. In the absence of counterindication, use of a beta-2 agonist and premedication with nonsteroidal anti-inflammatory drugs could be the preferred options. (Copyright © 2020 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Datta, A. K., et al. (2019). "Accumulation of embryos over 3 natural modified IVF (ICSI) cycles followed by transfer to improve the outcome of poor responders." Facts, views & vision in ObGyn 11(1): 77-84.
	Background: Alternatives to improve treatment outcomes in poor responders are needed. For this we studied whether multiple (x3) Natural Modified (NM)-IVF(ICSI) cycles followed by an embryo transfer (ET) from the accumulated embryos can improve the treatment outcomes in poor responders.; Method: A retrospective analysis was applied to a pool of participants qualifying as poor responders according to the Bologna criteria. This was performed over a 2-year IVF center database with a Study Group including women with a minimum of 3 cycles of NM-IVF (ICSI) and subsequent vitrified-thawed ET. As a control, 1 NM-IVF (ICSI) cycle with fresh ET was used. The primary outcome accounted was the livebirth rate (LBRs) following one ET; the secondary outcome was clinical pregnancy rates (CPRs), miscarriage and cycle cancellation rates. Comparisons were held over mean numbers by t-test, over median by Mann-Whitney, and categorical data were treated by Chi-square.; Results: The prognosis for livebirth in the study (n=125) and control (n=208) group was equally poor (mean age: 40.2 ± 3.0 vs 40.0 ± 3.3; median AMH: 2.1 vs 2.2 (pmol/L), AFC 4.0 vs 4.0). The LBR was significantly higher with the study protocol (30.6% vs 13.3%; p=0.002), particularly in women aged 35-39 years (31% vs 10.8%; p=0.05) and 40-44 years (26% vs 10.3%; p=0.02). Lower LBR in women aged ≥35 years in the control-group was mainly attributable to the higher miscarriage rate. With significantly more oocytes (mean: 6.5 ± 3.8 vs 2.0 ± 1.4; p <0.0001) and embryos available (mean: 3.6 ± 2.3 vs 0.9 ± 0.7; p<0.0001), only a minority ended up with no ET in the study-group (7.2% vs 35.6%; p<0.0001). None dropped-out while undergoing 3 cycles, whereas no patient opted for further attempts after one standalone cycle.; Conclusion: Accumulation of embryos through 3 NM-IVF cycles before transfer improves livebirth rates and reduces the risk of lacking an embryo for transfer in poor responders aged ≥35 years.; Competing Interests: No funding was required to conduct this study. (Copyright © 2019 Facts, Views & Vision.)

Datta Niloy, R. and S. Bodis (2019). "Hyperthermia with radiotherapy reduces tumour alpha/beta: Insights from trials of thermoradiotherapy vs radiotherapy alone." Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology 138: 1-8.
	Purpose: Hyperthermia inhibits the repair of irradiation-induced DNA damage and thereby could alter the α/β values of tumours. This study estimates the clinical α/β HTRT values from clinical trials of thermoradiotherapy (HTRT) vs radiotherapy (RT) in recurrent breast (RcBC), head and neck (III/IV) (LAHNC) and cervix cancers (IIB-IVA) (LACC).; Methods: Three recently published meta-analyses for HTRT vs RT in RcBC, LAHNC and LACC were evaluated for complete response (CR). Studies with specified RT dose (D), dose/fraction (d) and corresponding CRs were selected. Tumour biological effective dose (BED) for each study with RT (BED RT ) was computed assuming an α/β RT of 10 Gy. As outcomes were favourable with HTRT, thermoradiobiological BED (BED HTRT ) was calculated as a product of BED RT and %CR HTRT /%CR RT . The α/β HTRT was estimated as Dd/(BED HTRT - D).; Results: 12 trials with 864 patients were shortlisted - RcBC (3 studies, n = 259), LAHNC (5 studies, n = 338) and LACC (4 studies, n = 267). Overall risk difference of 0.28 favoured HTRT (p < 0.001). Mean BED RT and BED HTRT were 64.7 Gy (SD: ±15.5) and 109.5 Gy (SD: ±32.1) respectively and global α/β HTRT was 2.25 Gy (SD: ±0.79). Mean α/β HTRT for RcBC, LAHNC and LACC were 2.05 Gy, 1.74 Gy and 3.03 Gy respectively. On meta-regression, α/β HTRT was the sole predictor for the corresponding risk differences of the studies (coefficient = -0.096; p = 0.03).; Conclusion: Thermoradiobiological effects on the repair of RT induced DNA damage results in reduction in α/β values of tumours. This should be considered to effectively optimize HTRT dose-fractionation schedules in the clinic. (Copyright © 2019 Elsevier B.V. All rights reserved.)

D'Auge, D. G., et al. (2023). "Therapeutic Approaches to Vulvar Cancer: A Review of Literature." Clinical and Experimental Obstetrics and Gynecology 50(7): 143.
	Objective: Vulvar cancer is a rare gynecological cancer that mainly affects postmenopausal women. The aim of this review is to analyze the most recent data available in the literature on the clinical and therapeutic approach to vulvar carcinoma. Mechanism: Studies available in the literature on the therapeutic management of patients with vulvar carcinoma until November 2022 have been screened. A comprehensive search was performed in the PubMed (MEDLINE), EMBASE, SCOPUS and Web of Science databases. Findings in Brief: The approach to vulvar carcinoma has deeply evolved over the years. The management of early-stage vulvar carcinomas is well established and widely shared, while that of advanced and recurrent cancers is a subject of debate. The assessment of the nodal status has changed from the past with the passage from inguinal lymphadenectomy to the removal of only the sentinel node. Conclusion(s): The gold standard for the management of vulvar cancer is surgery, applicable in the first instance in early-stage tumors and after neoadjuvant therapy for larger tumors. Assessment of the nodal state is crucial and the method to be used depends on the degree of suspicious of positive lymph nodes. The prognosis is good if the treatment is applicable as soon as possible.Copyright © 2023 The Author(s).

David, L., et al. (2021). "Effectiveness of magnetic stimulation in the treatment of urinary incontinence: a systematic review."
	
David Paru, S. and M. Kling Juliana (2022). "Moving toward health equity: the influence of race and ethnicity on choice and quality of life of menopause treatment in midlife women." Menopause (New York, N.Y.) 29(12): 1353-1354.
	Competing Interests: Financial disclosure/conflicts of interest: J.M.K. received past funding from Procter & Gamble and Triangle Insights Group. P.D. has nothing to report.

David, V.-C. and P. Rene (2023). "Up front less radical surgery for non-fertility preserving surgery in patients with early-stage cervical cancer: A systematic review."
	
David, V.-C., et al. (2021). "Fertility-sparing surgery after neoadjuvant chemotherapy in cervical tumors larger than 4 cm: A systematic review with individual patient data."
	
Davidson, T. M., et al. (2023). "Results of TRIO-15, a multicenter, open-label, phase II study of the efficacy and safety of ganitumab in patients with recurrent platinum-sensitive ovarian cancer." Gynecologic Oncology 170: 221-228.
	Background: IGF signaling has been implicated in the pathogenesis and progression of ovarian carcinoma (OC). Single agent activity and safety of ganitumab (AMG 479), a fully human monoclonal antibody against IGF1R that blocks binding of IGF1 and IGF2, were evaluated in patients with platinum-sensitive recurrent OC.; Methods: Patients with CA125 progression (GCIG criteria) or measurable disease per RECIST following primary platinum-based therapy received 18 mg/kg of ganitumab q3w. The primary endpoint was objective response rate (ORR) assessed per RECIST 1.1 by an independent radiology review committee (IRC) and/or GCIG CA125 criteria. Secondary endpoints included clinical benefit rate (CBR), progression free survival (PFS) and overall survival (OS).; Results: 61 pts. were accrued. Objective responses were seen in 5/61 patients (ORR 8.2%, 95% CI, 3.1-18.8) with 1 partial response (PR) by RECIST and 2 complete responses (CR) as well as 2 PR by CA125 criteria. CBR was 80.3% (95% CI, 67.8-89.0%). The median PFS according to RECIST by IRC was 2.1 months (95% CI, 2.0-3.1). The median PFS per RECIST IRC and/or CA125 was 2.0 months (95% CI, 1.8-2.2). The median OS was 21 months (95% CI, 19.5-NA). The most common overall adverse events were fatigue (36.1%) and hypertension (34.4%). Grade 1/2 hyperglycemia occurred in 30.4% of patients. Hypertension (11.5%) and hypersensitivity (8.2%) were the most frequent grade 3 adverse events.; Conclusions: IGF1R inhibition with ganitumab was well-tolerated, however, our results do not support further study of ganitumab as a single agent in unselected OC patients.; Competing Interests: Declaration of Competing Interest The authors declare no potential conflicts of interest. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Davies, B., et al. (2023). "Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-Myelopathy trial-study protocol." BMJ Open 13(3): e061294.
	INTRODUCTION: Degenerative cervical myelopathy (DCM) is a common and disabling condition of symptomatic cervical spinal cord compression secondary to degenerative changes in spinal structures leading to a mechanical stress injury of the spinal cord. RECEDE‐Myelopathy aims to test the disease‐modulating activity of the phosphodiesterase 3/phosphodiesterase 4 inhibitor Ibudilast as an adjuvant to surgical decompression in DCM. METHODS AND ANALYSIS: RECEDE‐Myelopathy is a multicentre, double‐blind, randomised, placebo‐controlled trial. Participants will be randomised to receive either 60‐100 mg Ibudilast or placebo starting within 10 weeks prior to surgery and continuing for 24 weeks after surgery for a maximum of 34 weeks. Adults with DCM, who have a modified Japanese Orthopaedic Association (mJOA) score 8‐14 inclusive and are scheduled for their first decompressive surgery are eligible for inclusion. The coprimary endpoints are pain measured on a visual analogue scale and physical function measured by the mJOA score at 6 months after surgery. Clinical assessments will be undertaken preoperatively, postoperatively and 3, 6 and 12 months after surgery. We hypothesise that adjuvant therapy with Ibudilast leads to a meaningful and additional improvement in either pain or function, as compared with standard routine care. STUDY DESIGN: Clinical trial protocol V.2.2 October 2020. ETHICS AND DISSEMINATION: Ethical approval has been obtained from HRA‐Wales.The results will be presented at an international and national scientific conferences and in a peer‐reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN Number: ISRCTN16682024.

Davis Elizabeth, J., et al. (2022). "First-in-human phase I/II, open-label study of the anti-OX40 agonist INCAGN01949 in patients with advanced solid tumors." Journal for Immunotherapy of Cancer 10(10).
	Background: OX40 is a costimulatory receptor upregulated on antigen-activated T cells and constitutively expressed on regulatory T cells (Tregs). INCAGN01949, a fully human immunoglobulin G1κ anti-OX40 agonist monoclonal antibody, was designed to promote tumor-specific immunity by effector T-cell activation and Fcγ receptor-mediated Treg depletion. This first-in-human study was conducted to determine the safety, tolerability, and preliminary efficacy of INCAGN01949.; Methods: Phase I/II, open-label, non-randomized, dose-escalation and dose-expansion study conducted in patients with advanced or metastatic solid tumors. Patients received INCAGN01949 monotherapy (7-1400 mg) in 14-day cycles while deriving benefit. Safety measures, clinical activity, pharmacokinetics, and pharmacodynamic effects were assessed and summarized with descriptive statistics.; Results: Eighty-seven patients were enrolled; most common tumor types were colorectal (17.2%), ovarian (8.0%), and non-small cell lung (6.9%) cancers. Patients received a median three (range 1-9) prior therapies, including immunotherapy in 24 patients (27.6%). Maximum tolerated dose was not reached; one patient (1.1%) receiving 350 mg dose reported dose-limiting toxicity of grade 3 colitis. Treatment-related adverse events were reported in 45 patients (51.7%), with fatigue (16 (18.4%)), rash (6 (6.9%)), and diarrhea (6 (6.9%)) being most frequent. One patient (1.1%) with metastatic gallbladder cancer achieved a partial response (duration of 6.3 months), and 23 patients (26.4%) achieved stable disease (lasting &gt;6 months in one patient). OX40 receptor occupancy was maintained over 90% among all patients receiving doses of ≥200 mg, while no treatment-emergent antidrug antibodies were detected across all dose levels. Pharmacodynamic results demonstrated that treatment with INCAGN01949 did not enhance proliferation or activation of T cells in peripheral blood or reduce circulating Tregs, and analyses of tumor biopsies did not demonstrate any consistent increase in effector T-cell infiltration or function, or decrease in infiltrating Tregs.; Conclusion: No safety concerns were observed with INCAGN01949 monotherapy in patients with metastatic or advanced solid tumors. However, tumor responses and pharmacodynamic effects on T cells in peripheral blood and post-therapy tumor biopsies were limited. Studies evaluating INCAGN01949 in combination with other therapies are needed to further evaluate the potential of OX40 agonism as a therapeutic approach in patients with advanced solid tumors.; Trial Registration Number: NCT02923349.; Competing Interests: Competing interests: EJD reports research funding (institution) from Actuate, BMS, FivePrime, Genentech, Incyte, Karyopharm and TopAlliance Biosciences; honoraria from MJH Life Sciences; and advisory role for Deciphera. JM-L reports lecture fees from Astellas, Bristol-Myers Squibb, MSD, Novartis, Pierre Fabre, Pfizer, Roche and Sanofi; advisory fees from Bristol-Myers Squibb, Highlight Therapeutics, Novartis, Pierre Fabre, Roche and Sanofi; research grants from Sanofi; travel grants from Bristol-Myers Squibb, Ipsen, MSD, Novartis, Pierre Fabre, Pfizer and Roche. RK reports grants from MSD, Clovis and MSD; advisory role for Basilea, PharmaMar; advisory fees from AstraZeneca, Clovis, Eisai, GSK, Incyte, iTEOS, Pfizer and Roche. DCC reports advisory role for HUYA, Nektar Therapeutics, Pfizer and Werewolf Pharmaceuticals. SPB reports research funding and honoraria from Nucana plc; advisory fees from Amphista and Ellipses; clinical trials funding from Astex, MSD, Redx Pharma, Roche and UCB. DB reports no competing interests. DBC reports advisory role with AbbVie and Rafael Pharmaceuticals; honoraria from OncLive/MJH Life Sciences; research funding (institution) from Advaxis, Array BioPharma, Bristol-Myers Squibb, Celgene, Corcept Therapeutics, EMD Serono, Incyte, Lilly, Rafael Pharmaceuticals and Synta; and travel, accommodations and expenses from AbbVie. MV reports advisory role with Debiopharm and Roche; and travel from Roche. RE reports advisory fees from AZD, Clovis Oncology, Ellipses, GSK, Merck and Shigoni; speakers' fees from AZD, Clovis Oncology, GSK and Roche. PHD and AO report no competing interests. KS reports advisory fees from QED Therapeutics. JEJ, JC and TC report former employment and stock ownership with Incyte. JP and XC report employment and stock ownership with Incyte. JMM reports grants from Amgen, AstraZeneca, Bristol-Myers Squibb, EMD Serono, Immunocore, Incyte, Macrogenics, Merck Sharp & Dohme, Novartis, Polynoma and Sanofi; advisory role with Amgen and Merck Sharp & Dohme; honoraria from EMD Serono and Pfizer; advisory board for Array BioPharma, Bristol-Myers Squibb, Eisai/Merck, EMD Serono, Sanofi/Regeneron and Seagen. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Davis, J. A., et al. (2022). "Understanding Engagement in Digital Mental Health and Well-being Programs for Women in the Perinatal Period: Systematic Review Without Meta-analysis." Journal of Medical Internet Research 24(8): e36620.
	Background: Pregnancy and the postnatal period can be a time of increased psychological distress, which can be detrimental to both the mother and the developing child. Digital interventions are cost-effective and accessible tools to support positive mental health in women during the perinatal period. Although studies report efficacy, a key concern regarding web-based interventions is the lack of engagement leading to drop out, lack of participation, or reduced potential intervention benefits. Objective(s): This systematic review aimed to understand the reporting and levels of engagement in studies of digital psychological mental health or well-being interventions administered during the perinatal period. Specific objectives were to understand how studies report engagement across 4 domains specified in the Connect, Attend, Participate, and Enact (CAPE) model, make recommendations on best practices to report engagement in digital mental health interventions (DMHIs), and understand levels of engagement in intervention studies in this area. To maximize the utility of this systematic review, we intended to develop practical tools for public health use: to develop a logic model to reference the theory of change, evaluate the studies using the CAPE framework, and develop a guide for future data collection to enable consistent reporting in digital interventions. Method(s): This systematic review used the Cochrane Synthesis Without Meta-analysis reporting guidelines. This study aimed to identify studies reporting DMHIs delivered during the perinatal period in women with subclinical mood symptoms. A systematic database search was used to identify relevant papers using the Ovid Platform for MEDLINE, PsycINFO, EMBASE, Scopus, Web of Science, and Medical Subject Headings on Demand for all English-language articles published in the past 10 years. Result(s): Searches generated a database of 3473 potentially eligible studies, with a final selection of 16 (0.46%) studies grouped by study design. Participant engagement was evaluated using the CAPE framework and comparable variables were described. All studies reported at least one engagement metric. However, the measures used were inconsistent, which may have contributed to the wide-ranging results. There was insufficient reporting for enactment (ie, participants' real-world use of intervention skills), with only 38% (6/16) of studies clearly recording longer-term practice through postintervention interviews. The logic model proposes ways of conceptualizing and reporting engagement details in DMHIs more consistently in the future. Conclusion(s): The perinatal period is the optimal time to intervene with strength-based digital tools to build positive mental health. Despite the growing number of studies on digital interventions, few robustly explore engagement, and there is limited evidence of long-term skill use beyond the intervention period. Our results indicate variability in the reporting of both short- and long-term participant engagement behaviors, and we recommend the adoption of standardized reporting metrics in future digital interventions.Copyright © 2022 Journal of Medical Internet Research. All rights reserved.

Daviu, C., et al. (2024). "Impact of FRAilty screening and Geriatric assessment and INtervention in older patients with epithelial Ovarian Cancer: A multicenter randomized clinical trial protocol (FRAGINOC)." Journal of Geriatric Oncology: 101713.
	Introduction: Radical surgery combined with chemotherapy is the only potential curative treatment of patients with advanced epithelial ovarian cancer (EOC). However, 43% of older Danish patients with EOC are not referred to surgery due to frailty, age, or fear of complications. Comprehensive geriatric assessment (CGA) has demonstrated ability to reduce frailty in older patients, but there is a knowledge gap regarding its effect before or during treatment in older adults with EOC. This protocol presents a randomized controlled trial (RCT), which evaluates the effect of CGA-based interventions including individualized physical exercise therapy in older adults with EOC during neoadjuvant chemotherapy (NACT). Material(s) and Method(s): This RCT will include patients aged >=70 years with primary EOC referred to NACT. Patients will be randomized 1:1 to intervention or standard of care, along with neoadjuvant antineoplastic treatment. Stratification for performance status and center of inclusion will be performed. In the intervention arm, a geriatrician will perform CGA and corresponding geriatric interventions and patients will undergo an individualized home-based exercise program managed by a physiotherapist. All patients will be evaluated with Geriatric-8, modified Geriatric-8, clinical frailty scale, and physical tests at randomization. Predictive values (positive/negative) will be evaluated for CGA detected impairments. The primary endpoint is the proportion of patients referred to interval debulking surgery (IDS). Secondary endpoints include the proportion who complete oncological treatment, improvements in physical tests, quality of life measured by European Organization for Research and Treatment of Cancer-Quality of Life questionnaires at inclusion, after three cycles of chemotherapy, and at end of chemotherapy treatment. Furthermore, the association between results of geriatric screening tests, CGA, and physical tests with complication rate and progression free survival will be examined. The primary outcome will be analyzed with logistic regression in the intention-to-treat population. Power calculations reveal the need to enroll 216 patients. Discussion(s): The present study examines whether CGA-based interventions including individualized physical exercise can increase the referral rate for potential curative IDS in older patients with EOC. If successful, this will result in more patients undergoing surgery and completing chemotherapy, preventing complications, and ultimately improving quality of life and survival. The study setup may establish the basis for direct clinical implementation if proven effective.Copyright © 2024 Elsevier Ltd

Davydov, A. I., et al. (2021). "Ethanol sclerotherapy and laparoscopic cystectomy for ovarian endometriomas. Comparative analysis of efficacy and reproductive outcomes." Voprosy Ginekologii, Akusherstva i Perinatologii 20(6): 110-119.
	Objective. To study and systematize the results of ethanol sclerotherapy in patients with ovarian endometriomas and perform a comparative analysis of the efficacy of sclerotherapy and cystectomy according to international research publications. Materials and methods. Electronic searching was conducted through Medline, PubMed, Google Scholar, ClinicalTrials, and Cochrane Library databases for cohort studies and randomized controlled trials only. A systematic review was performed using preferred reporting items for systematic reviews and meta-analyses (PRISMA). A total of 626 articles were reviewed. The Cochrane Collaboration's tool was used to assess the quality of the studies. Results. It was shown that ethanol sclerotherapy for ovarian endometriomas bears the lowest risk in terms of surgical complications; it is highly economical in combination with maximum fertility preservation, which is especially relevant in assisted reproductive technology programs. The effectiveness of this method is largely determined by the conditions for its use, as well as by the time of ethanol exposure (optimally not less than 7 minutes). At the same time, ethanol puncture of endometrial cysts is not a monotherapy, and its outcome is greatly influenced by the adequacy of postoperative hormonal treatment. The use of 30 microg ethinylestradiol + 2 mg dienogest was shown to be promising. Conclusion. Ethanol sclerotherapy for ovarian endometriomas should be performed in accordance with the developed conditions and indications for its use in combination with postoperative hormonal treatment.Copyright © 2021, Dynasty Publishing House. All rights reserved.

Dawkins, B., et al. (2024). "Cost-Effectiveness of eRAPID eHealth Intervention for Symptom Management During Chemotherapy." JCO oncology practice: OP2300498.
	PURPOSE: A randomized controlled trial of online symptom monitoring during chemotherapy with electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) system found improved symptom control and patient self-efficacy, without increasing hospital admissions and visits. The aim of this study was to evaluate the cost-effectiveness of the eRAPID eHealth intervention compared with usual care for patients receiving systemic treatment for colorectal, breast, or gynecologic cancers in the United Kingdom. METHOD(S): An embedded economic evaluation was conducted alongside the trial evaluating the effectiveness of eRAPID from health care provider and societal perspectives. Costs and quality-adjusted life-years (QALYs) of patients were compared over 18 weeks of the trial. Incremental cost-effectiveness ratios (ICERs) were estimated and compared with the National Institute for Health and Care Excellence cost-effectiveness threshold. Uncertainty around the ICER was explored using nonparametric bootstrapping and sensitivity analyses. Follow-up data were collected 12-months after random assignment for a subset of the study sample to conduct exploratory analysis of potential longer-term effects. RESULT(S): Patients in the eRAPID group had the highest QALY gain and lowest costs over 18 weeks. Although differences were small and not statistically significant, eRAPID had a 55%-58% probability of being more cost-effective than usual care. Patient out-of-pocket costs were lower in the eRAPID group, indicating eRAPID may help patients access support needed within the National Health Service. Exploratory 12-months analysis showed small differences in costs and QALYs, with higher QALY gains in the eRAPID group but also higher costs. Exploratory subgroup analysis by disease status indicated that the eRAPID intervention was cost-effective for patients with early-stage cancers but not for patients with metastatic disease. CONCLUSION(S): Despite small differences in QALYs and costs, the analyses show potential cost-effectiveness of online symptom monitoring, when added to usual care, particularly during adjuvant systemic treatment for early-stage cancers.

De Angelis Maria, C., et al. (2022). "Fertility outcomes after hysteroscopic removal of intrauterine leiomyomas and polyps." Minerva Obstetrics and Gynecology 74(1): 3-11.
	Thanks to the progress of science, it is now understood that a successful implantation not only depends on the quality of the embryo, but also on having a receptive endometrium. During the years, several authors have reviewed the important role of the uterine factor, ranging from the congenital anomalies, such as uterine septa and subsepta, and acquired conditions such as endometrial polyps and submucous myomas. Currently, hysteroscopy has proved to be a powerful and accurate tool for visualizing the uterine cavity and treating intrauterine pathologies. This review of the literature aims to report the current available data on the effects of the two most common endouterine pathologies (i.e. endometrial polyps and submucous myomas) and the impact of hysteroscopic removal on fertility outcomes. To date, the low number of randomized controlled trials available does not yet make it possible to give a definitive answer on what are the reproductive outcomes following treatment of endometrial polyps and leiomyomas. Nevertheless, existing evidence points to a benefit of removal of these two pathologies in infertile women, mostly when they have a history of recurrent pregnancy loss. Further studies are needed to demonstrate that surgical treatments of endometrial polyps and myomas could improve not only the morphology but also the function of the uterine cavity before undergoing any assisted fertility treatment.

de Bree, E. and D. Michelakis (2020). "An overview and update of hyperthermic intraperitoneal chemotherapy in ovarian cancer." Expert Opinion on Pharmacotherapy 21(12): 1479-1492.
	Introduction: Despite, the strong rationale and evidence of the benefit of postoperative intraperitoneal chemotherapy in advanced ovarian cancer, it has not been widely adopted, mainly due to its high morbidity and logistical difficulties. Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) is a more tolerable and technically feasible method of intraperitoneal chemotherapy, whereas other potential advantages include homogenous drug distribution, application before tumor regrowth and combination with hyperthermia, which is directly cytotoxic and enhances the efficacy of many drugs. Areas covered: In this review, the authors explain the rationale and indications for cytoreductive surgery (CRS) and HIPEC in advanced ovarian cancer. Data of major clinical studies, meta-analyses, and recent randomized trials are discussed. Expert opinion: After many encouraging clinical studies and meta-analyses, a recent randomized study demonstrated survival benefit for HIPEC during interval CRS in primary ovarian cancer, without increased morbidity, whereas another implied its benefit in recurrent ovarian cancer. Results of recently completed and numerous ongoing randomized studies will further determine the benefit of HIPEC in ovarian cancer at different time points. Patient selection and appraisal of the best protocols are crucial. The field of gynecological oncology will most likely evolve to include HIPEC eventually as a routine treatment for ovarian cancer.Copyright © 2020 Informa UK Limited, trading as Taylor & Francis Group.

De Cagna, F., et al. (2019). "The Role of Intranasal Oxytocin in Anxiety and Depressive Disorders: A Systematic Review of Randomized Controlled Trials." Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology 17(1): 1-11.
	Several studies have demonstrated the neuromodulating function of oxytocin (OT) in response to anxiogenic stimuli as well as its potential role in the pathogenesis of depression. Consequently, intranasal OT (IN-OT) has been proposed as a potential treatment of anxiety and depressive disorders. The present systematic review aimed to summarize the randomized controlled trials (RCTs) evaluating the effect of IN-OT on anxiety and depressive symptoms. Overall, 15 studies were included, involving patients with social anxiety disorders (7 studies), arachnophobia (1), major depression (3) or post-natal depression (4), and mainly evaluating single-dose administrations of IN-OT. Results showed no significant effects on core symptomatology. Five crossover studies included functional magnetic resonance imaging investigation: one trial showed reduced amygdala hyper-reactivity after IN-OT in subjects with anxiety, while another one showed enhanced connectivity between amygdala and bilateral insula and middle cingulate gyrus after IN-OT in patients but not in healthy controls. More studies are needed to confirm these results. In conclusion, up to date, evidence regarding the potential utility of IN-OT in treating anxiety and depression is still inconclusive. Further RCTs with larger samples and long-term administration of IN-OT are needed to better elucidate its potential efficacy alone or in association with standard care.

De Felice, F., et al. (2020). "Pembrolizumab for advanced cervical cancer: safety and efficacy." Expert Review of Anticancer Therapy 21(2): 1-8.
	Introduction: Pembrolizumab is an immune checkpoint inhibitor with high specificity for binding to the programmed cell death 1 (PD-1) receptor. It has been approved by the FDA in patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express the programmed cell death ligand 1 (PD-L1). Areas covered: Clinical studies of pembrolizumab in cervical cancer were analyzed and discussed. Data were obtained by searching for English peer-reviewed articles on PubMed, clinical trials registered on clincaltrials.gov and related abstracts on the ASCO meeting library. The aim was to review the status of pembrolizumab, the published and ongoing trials, and its safety and efficacy. Expert opinion: Pembrolizumab may ultimately represent a treatment of choice for advanced cervical cancer with PD-L1 expression, both in metastatic and recurrent setting. However, it is essential to better identify and characterize patients that will benefit the most.

De Felice, F., et al. (2021). "Evolution of Clinical Trials in Ovarian Cancer Management over the Past 20 Years: Never Settle Down, Always Go Beyond." Journal of oncology 2021: 1682532.
	Purpose: A practice synthesis of available evidence-based medicine data in ovarian cancer (OC), aiming to provide directions for future research.; Materials and Methods: We performed a systematic review. PubMed was searched for relevant OC trials between January 2000 and December 2019.; Results: Out of 865 references screened, 199 trials were found eligible for inclusion. Most trials were multicenter (83.9%). There was a trend reduction in the number of patients enrolled/per study over the years. Studies testing targeted/biological therapies dominated the second decade (60 trials in 2010-2019 versus 2 trials in 2000-2009). The proportion of trials with positive survival and clinical outcomes significantly increased from 23.8% in early 2000s to 54.1% in the last 5 years. Trials with histology/molecular biomarker criteria were more likely to meet progression-free survival endpoint than those without these selection criteria (69.2% versus 32.6%).; Conclusion: This systematic review suggests a trend of increased positive studies, mainly linked to precision medicine.; Competing Interests: The authors declare that they have no conflicts of interest. (Copyright © 2021 Francesca De Felice et al.)

De Gracia, S., et al. (2023). "Serious Complications and Recurrence following Sacrospinous Ligament Fixation for the Correction of Apical Prolapse." Journal of Clinical Medicine 12(2): 468.
	Objective: To evaluate the rates of serious complications and reoperation for recurrence following sacrospinous ligament fixation (SSLF) for apical pelvic organ prolapse. Method(s): This was a national registry ancillary cohort comparative study. The VIGI-MESH registry includes data from 24 French health centers prospectively collected between May 2017 and September 2021. Time to occurrence of a serious complication or reoperation for genital prolapse recurrence was explored using the Kaplan-Meier curve and Log-rank test. The inverse probability of treatment weighting, based on propensity scores, was used to adjust for between-group differences. Result(s): A total of 1359 women were included and four surgical groups were analyzed: Anterior SSLF with mesh (n = 566), Anterior SSLF with native tissue (n = 331), Posterior SSLF with mesh (n = 57), and Posterior SSLF with native tissue (n = 405). Clavien-Dindo Grade III complications or higher were reported in 34 (2.5%) cases, with no statistically significant differences between the groups. Pelvic organ prolapse recurrence requiring re-operation was reported in 44 (3.2%) women, this was higher following posterior compared with anterior SSLF (p = 0.0034). Conclusion(s): According to this large database ancillary study, sacrospinous ligament fixation is an effective and safe surgical treatment for apical prolapse. The different surgical approaches (anterior/posterior and with/without mesh) have comparable safety profiles. However, the anterior approach and the use of mesh were associated with a lower risk of reoperation for recurrence compared with the posterior approach and the use of native tissue, respectively.Copyright © 2023 by the authors.

De Gregorio Miguel, Á., et al. (2023). "A Comparative Study of a Small Series of Patients (50 Patients) with Pelvic Varicose Veins Treated with Plugs Alone or Plugs and Polidocanol." Journal of Clinical Medicine 12(16).
	Level of Evidence: Level 2.; Purpose: To compare the safety and efficacy of vascular plug (VP) and vascular plug and polidocanol foam (VPPF) treatments for embolization in pelvic congestion syndrome (PCS).; Materials and Methods: A comparative, prospective, two-center study enrolled 50 women with PCS from January 2019 to January 2020. The patients were divided into two groups, and embolization was performed with VP (n = 25) and VPPF (n = 25) treatments. The mean age of the patients was 45.6 years ± 6.9. Three clinical parameters were assessed: abdominal pain, dyspareunia, and lower limb pain. The primary outcome (clinical success at 1 yr using a VAS), number of devices, procedure and fluoroscopy times, radiation doses, costs, and complications were compared. The participants were followed-up at 1, 3, 6, and 12 months.; Results: At the 1-year follow-up, clinical success did not significantly differ between the two groups (VP vs. VPPF) regarding the improvement of the symptoms analyzed (pelvic pain, dyspareunia, lower extremity pain, and other symptoms ( p < 0.05)). The mean number of devices per case was 4 ± 1.1 for the VP group and 2 ± 0.31 for the VPPF group ( p < 0.001). No major complications were recorded in either group. The VPPF group had a significantly longer fluoroscopy time (42.8 min ± 14.2 vs. 25.4 min ± 7) and longer radiation dose (VPPF air kerma 839.4 ± 513 vs. VP air kerma 658.4 mGy ± 355 (all p < 0.001)).; Conclusions: Embolization for PCS resulted in pain relief in 90% of patients; the use of polidocanol did not demonstrate changes in the clinical outcome. The use of a VP alone was associated with decreased fluoroscopy time and radiation dose.

De Hoyos, G., et al. (2023). "Efficacy of an environmental enrichment intervention for endometriosis: a pilot study." Frontiers in psychology 14: 1225790.
	Introduction: We have previously shown that Environmental Enrichment (EE), a multi-modal psychosocial intervention consisting of increased social interaction, novelty, and open spaces, improved disease presentation, anxiety, and immune-related disturbances in the rat model of endometriosis. However, there is a knowledge gap regarding the effects of EE interventions in patients with this painful, inflammatory chronic disease.; Aim: To adapt and test the efficacy of an EE intervention on pelvic pain, mental health, perceived stress, quality of life, and systemic inflammation in endometriosis patients through a randomized clinical trial (RCT).; Materials and Methods: A multidisciplinary team with expertise in physiology, neuroscience, psychology, and women's health adapted and implemented a two-arm RCT comparing an EE intervention with a wait-list control group. Six EE modules administered on alternate weeks were provided to patients in the intervention ( N = 29); controls received education only. Survey data and biospecimens were collected at baseline, end-of-study, and 3-months post-intervention to assess pain (Brief Pain Inventory, BPI), endometriosis-related quality of life-QoL (Endometriosis Health Profile-30, EHP30), anxiety (Generalized Anxiety Disorder 7, GAD7), depression (Patient Health Questionnaire for Depression 8, PHQ8), pain catastrophizing (Pain Catastrophizing Score, PCS), stress (Perceived Stress Scale-14, PSS14), and saliva cortisol levels (AM, PM).; Results: Compared to the wait-list controls, participants in the EE intervention showed significantly decreased GAD-7 scores at the end of the intervention and 3-month follow-up. Depression, perceived stress, and QoL improved at the 3-month follow-up compared to baseline. While pain levels did not improve, they significantly correlated with anxiety, depression, QoL and pain catastrophizing scores.; Conclusion: This pilot RCT demonstrated significant improvements in anxiety and depressive symptoms, QoL, and perceived stress, supporting enriched environments as an integrative psychosocial intervention to be used as adjuvant to the standard of care for endometriosis pain.; Competing Interests: AT-R is employed by Sur180 Therapeutics. CA and IF are co-founders of Sur180 Therapeutics but are not employees. This company was not involved in the study design, collection, analysis, or interpretion of data. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2023 De Hoyos, Ramos-Sostre, Torres-Reverón, Barros-Cartagena, López-Rodríguez, Nieves-Vázquez, Santiago-Saavedra, Appleyard, Castro and Flores.)

De Jaeghere Emiel, A., et al. (2023). "Pembrolizumab, radiotherapy, and an immunomodulatory five-drug cocktail in pretreated patients with persistent, recurrent, or metastatic cervical or endometrial carcinoma: Results of the phase II PRIMMO study." Cancer immunology, immunotherapy : CII 72(2): 475-491.
	A phase II study (PRIMMO) of patients with pretreated persistent/recurrent/metastatic cervical or endometrial cancer is presented. Patients received an immunomodulatory five-drug cocktail (IDC) consisting of low-dose cyclophosphamide, aspirin, lansoprazole, vitamin D, and curcumin starting 2 weeks before radioimmunotherapy. Pembrolizumab was administered three-weekly from day 15 onwards; one of the tumor lesions was irradiated (8Gyx3) on days 15, 17, and 19. The primary endpoint was the objective response rate per immune-related response criteria (irORR) at week 26 (a lower bound of the 90% confidence interval [CI] of > 10% was considered efficacious). The prespecified 43 patients (cervical, n = 18; endometrial, n = 25) were enrolled. The irORR was 11.1% (90% CI 2.0-31.0) in cervical cancer and 12.0% (90% CI 3.4-28.2) in endometrial cancer. Median duration of response was not reached in both cohorts. Median interval-censored progression-free survival was 4.1 weeks (95% CI 4.1-25.7) in cervical cancer and 3.6 weeks (95% CI 3.6-15.4) in endometrial cancer; median overall survival was 39.6 weeks (95% CI 15.0-67.0) and 37.4 weeks (95% CI 19.0-50.3), respectively. Grade ≥ 3 treatment-related adverse events were reported in 10 (55.6%) cervical cancer patients and 9 (36.0%) endometrial cancer patients. Health-related quality of life was generally stable over time. Responders had a significantly higher proportion of peripheral T cells when compared to nonresponders (p = 0.013). In conclusion, PRIMMO did not meet its primary objective in both cohorts; pembrolizumab, radiotherapy, and an IDC had modest but durable antitumor activity with acceptable but not negligible toxicity.Trial registration ClinicalTrials.gov (identifier NCT03192059) and EudraCT Registry (number 2016-001569-97). (© 2022. The Author(s).)

De Jesus, C. and M. Rodrigues (2022). "[New drug approval: Pembrolizumab plus lenvatinib in second line for patients with advanced or recurrent endometrial cancer]." Bulletin du cancer 109(7-8): 740-741.
	
de la Rosa Consuelo, N., et al. (2022). "Statistical analysis plan for the Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian, fallopian tube or primary peritoneal cancer (of clear cell, endometrioid and high-grade serous type, and carcinosarcoma) trial (DICE)." Trials 23(1): 13.
	Background: Treatment for ovarian cancer includes platinum-based chemotherapy, but many women become resistant to chemotherapy, becoming platinum-resistant. Standard of care for these women is weekly paclitaxel chemotherapy, but cancers can often become paclitaxel resistant. TAK228, an investigational dual TORC1/2 inhibitor, is an oral therapy that can be added to standard treatment. The DICE trial is a phase II international multicentre, parallel-group, superiority clinical trial with 1:1, open label randomisation which has the aim of investigating the effectiveness of TAK228 plus weekly paclitaxel. The planned sample size is 124 women (62 per treatment arm) with platinum-resistant ovarian cancer.; Objective: To outline the planned analyses for DICE in a statistical analysis plan (SAP) before database hard lock and the start of analysis. This ensures that bias is minimised during the analysis phase.; Results: This SAP provides detailed descriptions of the analysis principles and statistical procedures for analysing primary and secondary outcomes of the trial. The primary outcome is overall progression-free survival (PFS). Secondary outcomes include progression-free survival (PFS) at 24 weeks, overall response rate (ORR), duration of response (DoR), time to progression (TTP), clinical benefit rate (CBR) at 4 months, Cancer Antigen 125 (CA125) response according to Gynaecological Cancer Intergroup (GCIG) criteria, overall survival (OS), safety and tolerability as assessed by adverse events and the quality-of-life questionnaires (EORTC QLQ-C30 and EORTC QLQ-OV28). This detailed description includes significance levels, sensitivity analyses and compliance analysis.; Discussion: The DICE trial will determine whether the addition of TAK228 to weekly paclitaxel chemotherapy shows a statistically significant improvement to participant's progression free and overall survival and that the adverse events (AEs) and quality of life (QoL) are not significantly worse than the standard treatment. The study commenced recruitment in September 2018. An interim analysis was performed in early 2021, the results of which advised continuation of the trial. The study recruitment is ongoing and is due to complete by the end of 2021.; Trial Registration: ClinicalTrials.gov NCT03648489 . Registered on 27 August 2018. (© 2021. The Author(s).)

De la Torre Perez, E., et al. (2023). "Impact of endometrial compaction on reproductive outcomes after cryotransfer of euploid embryos in a modified natural cycle: protocol for a prospective cohort study." Frontiers in Endocrinology 14: 1285040.
	Introduction: Embryo implantation is a complex and poorly understood process. Most studies to date have focused on the analysis of the endometrium at the end of the estrogenic phase, while the available data on its importance after secretory transformation are limited and inconsistent. Current evidence does not allow for a conclusive interpretation of the changes observed in the pre-implantation endometrium, whether in the natural or replacement cycle, and their relevance in the development of a pregnancy or the implications for clinical practice.; Methods: Multicenter prospective observational cohort study. Based on our sample size calculation, the study group will consist of 206 women (exposed or "compaction" group: 103 women with a decrease of ≥ 5% in endometrial thickness between the estrogenic phase and the day of embryo transfer; non-exposed "non-compaction" group: 103 women with similar or greater endometrial thickness between these time points). The main objective of this study is to compare the ongoing pregnancy rates in natural cycles for euploid embryo transfer in patients who present endometrial compaction at the time of transfer versus those who with a stable or greater endometrial thickness with respect to the estrogenic phase. The estimated duration of the study is 30 months. Inclusion criteria are: 18 to 50 years of age, with primary or secondary infertility, subjected to endometrial preparation in a modified natural cycle for transfer of a genetically euploid blastocyst, from their own oocyte or oocyte donation, with a normal uterine cavity. Exclusion criteria are: uterine or endometrial disease (e.g., multiple myomatosis, severe adenomyosis, Asherman syndrome, refractory endometrium), conditions that prevent correct ultrasound assessment (tilted uterus), or a history of recurrent implantation failure or repeated miscarriages.; Discussion: The findings from this study will provide valuable insights into the potential influence of the "endometrial compaction" phenomenon on reproductive outcomes during natural cycle endometrial preparation. By examining this aspect, we aim to contribute to a better understanding of the factors that may impact successful outcomes in fertility treatments.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2023 De la Torre Perez, Carratalá-Munuera, Castillo-Farfán, Lledó-Bosch, Moliner-Renau, Bernabeu-García and Bernabeu-Pérez.)

de Lima Nunes, R., et al. (2019). "Lifestyle interventions and quality of life for women with polycystic ovary syndrome: A systematic review and meta-analysis protocol." Medicine 98(50): e18323.
	Background: Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of reproductive age. PCOS has a significant negative impact on the health-related quality of life (HRQoL) and psychological function of women, of which there are reports of high levels of depression in women with PCOS compared to those without PCOS. However, the evidence surrounding the effects of exercise and/or dietary intervention participation on the HRQoL of women with PCOS is limited. Therefore, our objective is to examine the effects of lifestyle interventions (definition include exercise-only, diet-only, exercise + diet and behavioral or combined) on health-related quality of life or general quality of life in women with PCOS.; Methods: We will conduct an update of systematic review and we will follow the recommendations and guidelines of the Cochrane handbook for systematic reviews and Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol (PRISMA-P). We will search the studies in the following databases: MEDLINE. PubMed, PsychINFO, Embase, SportDiscus, Web of Science, Cochrane Database (via Cochrane library), Cochrane Controlled Register of Trials (CENTRAL), and Google Scholar (advance). Manual search of the reference list of identified works, without language and year restrictions. The process of study selection and data extraction will be performed independently by 2 reviewers, with a third reviewer being responsible for the final decision in case of disagreement between the first two. We will use Egger funnel chart to evaluate possible publication biases, in addition, when possible we will perform a subgroup/meta-regression analysis. The strength of the evidence will be assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE).; Protocol Registry: PROSPERO number: CRD42019124176.

de Loos, A. D., et al. (2022). "Metabolic health during a randomized controlled lifestyle intervention in women with PCOS." European Journal of Endocrinology 186(1): 53-64.
	Context: Women with polycystic ovary syndrome (PCOS) have an increased risk of metabolic syndrome (MetS). Both PCOS and MetS are associated with excess weight. Objective(s): To examine the effect of a three-component lifestyle intervention (LSI) with or without short message service (SMS+ or SMS-, respectively) on the prevalence and severity of MetS and metabolic parameters, compared to care as usual (CAU). Design(s): Randomized controlled trial. Method(s): Women diagnosed with PCOS and a BMI >25 kg/m2 (n = 183) were either assigned to a 1-year three-component (cognitive behavioural therapy, diet, and exercise) LSI, with or without SMS support, or to CAU which provided weight-loss advice only. Main outcome measures included changes in the prevalence of MetS, the continuous MetS severity z-score (cMetS z-score), metabolic parameters, and the impact of weight loss. Result(s): After 1 year, the decrease in the cMetS z-score was greater in the SMS+ group than the CAU group (-0.39, P = 0.015). The prevalence of MetS changed with -21.6% (P = 0.037), -16.5% (P = 0.190), and +7.0% (P = 0.509) in both LSI groups and CAU group, respectively. A post hoc analysis for both LSI groups combined vs CAU resulted in a MetS difference of -25.9% (P = 0.046). Moreover, weight loss per se resulted in significantly favourable effects on all metabolic parameters. Conclusion(s): This three-component LSI was more successful in improving metabolic health compared to CAU. Therefore, we recommend this intervention to women with PCOS and excess weight, provided that a clinically relevant weight loss is being pursued.Copyright © 2022 The authors

de Luis, D., et al. (2023). "RS2289487 variation in PERILIPIN gene is a predictor of weight loss and protection against impaired glucose metabolism after a meal-replacement diet in postmenopausal obese females." European Review for Medical and Pharmacological Sciences 27(19): 9355-9362.
	Objective: The PERILIPIN1 (PLIN1) gene encodes an adipocyte-associated protein that modulates weight. The objective was to evaluate the role of the rs2289487 genetic variant of the PLIN1 gene on weight loss and glucose metabolism secondary to a partial meal replacement (pMR) hypocaloric diet.; Patients and Methods: We conducted an interventional study in 111 postmenopausal obese females with body mass index (BMI) > 35 kg/m2. The subjects received two intakes per day of a normocaloric hyperproteic formula for 12 weeks.; Results: After the pMR diet, body weight, (BMI), fat mass, waist circumference, fasting insulin levels and HOMA-IR decreased in both genotype groups. The improvements in these parameters were higher in C allele carriers than in subjects with TT genotype. The percentage of patients who achieved 7.5% weight loss was higher in the C carriers (57.4% vs. 27.6%), (adjusted Odds Ratio 2.14, 95% CI = 1.33-9.40; p = 0.02). The decrease in the percentage of diabetes mellitus or impaired fasting glucose decrease was statistically significant in C allele carriers (30.2% vs. 18.9%; p = 0.01) (OR 0.54, 95% CI = 0.22-0.78; p = 0.02).; Conclusions: The C allele of rs2289487 predicts the magnitude of weight loss resulting from a pMR diet. These adiposity improvements produce a better improvement in insulin resistance and the percentage of impaired glucose metabolism.

de Mattos Lourenço Thais, R., et al. (2019). "A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery." International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 145(1): 4-11.
	Background: Evidence on efficacy and safety of pelvic organ prolapse interventions is variable, and methodological flaws preclude meaningful synthesis of primary research data.; Objective: To evaluate variations in reported outcomes and outcome measures in randomized controlled trials (RCTs) on apical prolapse surgical interventions.; Search Strategy: We searched Cochrane, EMBASE, MEDLINE, and Scopus for English-language articles published from inception to September 30, 2017, using the terms "management", "repair", "operation", and "pelvic organ prolapse".; Selection Criteria: RCTs on apical prolapse surgical treatment.; Data Collection and Analysis: Outcomes and outcome measures were identified and categorized into domains. Studies were evaluated for quality of outcomes. Descriptive statistics were used to calculate frequencies.; Main Results: Forty-three RCTs were included. Seventy-six outcomes and 66 outcome measures were identified. Bladder and ureteric injury were the most commonly reported intraoperative complications (19/31 studies; 61%). Quality of life was assessed by 19 different instruments and questionnaires. Fourteen (45%) of 31 studies used recurrence of prolapse as a postoperative anatomical outcome.; Conclusions: Substantial variation in reported outcomes and outcome measures was confirmed, precluding comparisons across trials and synthesis of the results. Development of a core outcome set will enable high-quality meta-analyses to be performed in the future. PROSPERO registration: CRD42017062456. (© 2019 International Federation of Gynecology and Obstetrics.)

de Oca, M. K. M., et al. (2023). "Use of cryocompression to reduce peripheral neuropathy in gynecologic cancer: A randomized controlled trial (020)." Gynecologic Oncology 176(Supplement 1): S15-S16.
	Objectives: To investigate the efficacy of cryocompression in preventing chemotherapy-induced peripheral neuropathy and to evaluate patient-reported acceptability and tolerability of cryocompression therapy during chemotherapy. Method(s): This was a single institution randomized, self-controlled trial of cryocompression in women with gynecologic cancer being treated with a planned 6 cycles of neurotoxic chemotherapy. Exclusion criteria were prior neurotoxic chemotherapy or baseline peripheral neuropathy. Subjects were randomized to cryocompression applied to the dominant versus non-dominant hand and foot, with no intervention on the opposite side. Compression socks and ice bags were applied to the hand and foot 15 min prior to chemotherapy, throughout the chemotherapy infusion, and 15 min after completion. Outcome measures included patient-reported assessments (Patient Neurotoxicity Questionnaire, Functional Assessment of Cancer Therapy -Taxane [FACT-NTX]), tactile disturbance using the Semmes-Weinstein monofilament test, and tolerability and acceptability using a Likert scale survey. Result(s): Ninety-one subjects were enrolled from January 2021 to August 2022: 5 withdrew prior to intervention, 14 discontinued after 1-2 cycles, 54 completed all study procedures, and 18 remained on-study. The majority had ovarian cancer (49/91, 53.8%), followed by uterine (39/91, 42.9%) and cervical (3/91, 3.3%). Most subjects were White (59/91, 64.8%) and non-Hispanic/Latino (86/91, 94.5%). With each cycle, more subjects had sensory PNQ grade >= C (moderate to severe symptoms) on the control compared to the cryocompression side: 2.2% versus 3.3% at baseline, 8.8% versus 6.6% at cycle 3; 13.2% versus 7.7% at the final assessment. FACT-NTX scores on the control side were consistently higher than on the cryocompression side: 1.3 (SD: 2.0) versus 1.2 (SD: 1.9) at the initial visit, 2.3 (SD: 3.3) versus 1.7 (SD: 2.8) at cycle 3, and 4.2 (SD: 5.2) versus 3.4 (SD: 4.4) at the final visit one month after cycle 6. At each subsequent visit, there were significant differences in FACT-NTX scores by 0.08 points, on average, favoring cryocompression (P = 0.0216). Monofilament scores remained near zero in each group throughout the study. Over 70% of subjects reported that sensations experienced during cryocompression were very tolerable with each cycle, and over 80% "agreed" or "strongly agreed" that cryocompression was acceptable and planned to continue using it during future chemotherapy. From cycle 6 through the final visit, subjects were 39% less likely to have a PNQ >= C on the cryocompression compared to the control side (P = 0.039); the odds of PNQ >= C on the cryocompression compared to the control side was 0.52 at the final visit (P = 0.021). Conclusion(s): Cryocompression reduces subjective measures of chemotherapy-induced peripheral neuropathy, is acceptable and tolerable to patients, and may improve neuropathy-related quality of life for patients with gynecologic cancer. A final statistical analysis is forthcoming.Copyright © 2023

de Oliveira Natália, M., et al. (2023). "A Review on Acupuncture Efficiency in Human Polycystic Ovary/Ovarian Syndrome." Journal of Pharmacopuncture 26(2): 105-123.
	Objectives: Human Polycystic Ovary/Ovarian Syndrome (PCOS), a frequent endocrine pathophysiology among women of fertile age, is associated with woman's lifespan endocrine, metabolic and psychological implications. Long-term usage side effects of allopathic strategies and their low efficacy made complementary medicine treatments a relevant subject for these patients. The main aim of this work is to review the efficiency of the acupuncture treatment reported in the latest studies on literature regarding PCOS patients.; Methods: A comprehensive literature search, in English language, about the use of acupuncture on the management of PCOS, was conducted in October 2020 using EBSCO, Cochrane, PubMed, Medline, Embase, databases for randomised and non-randomised controlled trials between 2015 and 2020 (09/2015-10/2020), following the PRISMA protocol.; Results: This research led us to an analysis, according to PICOS, of six final papers selected among 178 in total. The articles addressed distinct aspects of the PCOS condition, diverse acupuncture techniques and different main and secondary outcomes in agreement to the respective main objective. According to this review, acupuncture seems to be useful for the treatment of this debilitating and chronic health condition which affects millions of women worldwide, many of them part of the workforce in their community.; Conclusion: Despite of the display of these positive results addressing acupuncture treatments to manage PCOS major symptoms - whether they are reproductive, metabolic, or mental health features - more research is urgent. Randomized, double blinded controlled trials with improved quality design and following STRICTA and/or CONSORT recommendations are necessary to engage acupuncture as a standardized and scientific validated technique in PCOS condition.; Competing Interests: CONFLICTS OF INTEREST The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2023 Korean Pharmacopuncture Institute.)

De Rienzo, G., et al. (2022). "Evaluation of the effect of 100U of Onabotulinum toxin A on detrusor contractility in women with idiopathic OAB: A multicentre prospective study." Neurourology and Urodynamics 41(1): 306-312.
	Aims: Intradetrusor injection of Onabotulinum Toxin A (BTX-A) is a third-line treatment for overactive bladder (OAB). Voiding dysfunction and the need for intermittent catheterization are potential complications, consequent to bladder contractility (BC) decrement. Primary aim: to evaluate BC variation after BTX-A detrusor injection in women with idiopathic OAB. Method(s): A prospective multi-institutional observational study was conducted. Medical history, bladder diary, 24-h pad test, and invasive urodynamic parameters were recorded before and 4-6 weeks after BTX-A 100U administration. BC was measured as Modified Projected Isovolumetric Pressure (PIP1), that is, maximum flow rate (Qmax) + detrusor pressure at Qmax (PdetQmax). Continuous variables were expressed as median and interquartile range. We compared continuous variables using Wilcoxon test and proportions between two times with Fisher exact test. Result(s): No changes in PIP1 were observed (p > 0.05) in 45 women enrolled between January 2018 and September 2019. Median age was 54.6 years. At baseline, 91.1% had urge urinary incontinence, with 4.9 +/- 2.6 daily pads used and a 24-h pad test of 205.4 +/- 70.8 g. Baseline detrusor contractility was normal in all the patients. Postoperatively, an improvement in the 24-h pad test (p < 0.01), daily voids (p < 0.01), and nocturia (p < 0.01) occurred. Urodynamics pointed out a significant reduction of detrusor overactivity rate (p < 0.01) and an increase of median maximum cystometric capacity (p < 0.01). No difference was observed in median Qmax (p > 0.05), PdetQmax (p > 0.05), and PVR (p > 0.05). No patient needed postoperative catheterization. Conclusion(s): The current series provides evidence that detrusor injection of botulinum toxin is an effective option for treating OAB, without causing voiding dysfunction and BC impairment.Copyright © 2021 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC

De Seta, F., et al. (2022). "Provoked Vestibulodynia and Topical Treatment: A New Option." Healthcare (Basel, Switzerland) 10(5).
	Background: Provoked vestibulodynia is commonly associated with dyspareunia and affects 7% to 15% of women. This pathology has major implications on sexual function and quality of life, and several types of treatments are available for its management. However, a consensus has not been reached concerning the best treatment of vulvar pain. The aim of this study was to assess the efficacy and safety of a brand-new product, the vulvar emulgel Meclon ® Lenex, for the management of provoked vestibulodynia and non-infective vulvitis.; Methods: This was a monocentric, prospective, randomized, double-blind and placebo-controlled study. We enrolled 40 women with provoked vestibulodynia; 20 patients received Meclon ® Lenex, whereas the remaining received a placebo. Each woman was assessed subjectively (through questionnaires) and objectively by evaluating vaginal and vulvar symptoms (Friedrichs criteria and Marinoff dyspareunia grade). We evaluated efficacy, safety, compliance and tolerability of the brand-new product vulvar gel Meclon ® Lenex in provoked vestibulodynia.; Results: After administration of Meclon ® Lenex, we evaluated all parameters of the Friedrichs criteria (burning, dyspareunia, erythema, vulvar pain at the 5 o'clock position and 7 o'clock position), as well as the levels of Marinoff dyspareunia. The active treatment showed to be statistically significantly effective ( p value ≤ 0.05) in reducing all symptoms of Friedrichs criteria, vulvar pain and Marinoff dyspareunia.; Conclusion: This prospective study showed that Meclon ® Lenex vulvar emulgel revealed an excellent tolerability and compliance, demonstrating to be a safe and effective option in the treatment of provoked vestibulodynia and non-infective vulvitis.

De Silva, P. M., et al. (2021). "Pain and operative technologies used in office hysteroscopy: A systematic review of randomized controlled trials." Journal of Minimally Invasive Gynecology 28(10): 1699-1711.
	OBJECTIVE: To identify technologies associated with the least operative pain in women undergoing operative office hysteroscopic procedures. DATA SOURCES: MEDLINE, EMBASE, CINAHL and CENTRAL were searched until January 2021 using a combination of keywords "hysteroscop*", "endometrial ablation", "outpatient", "ambulatory", "office" and associated MeSH headings. METHODS OF STUDY SELECTION: Randomized controlled trials (RCTs) evaluating the effect of hysteroscopic devices on pain experienced by women undergoing operative office hysteroscopy were included. Data were also collected regarding efficacy, procedural time, adverse events and patient/clinician acceptability and/or satisfaction. TABULATION, INTEGRATION AND RESULTS: The search returned 5347 records. Ten studies provided data for review. Two trials compared endometrial ablation using bipolar radiofrequency with thermal balloon energy, with no significant difference in pain observed (p<0.05). Seven trials evaluated technologies for endometrial polypectomy of which four compared energy modalities; miniature bipolar electrode resection against resectoscopy (n=1), morcellation (n=2) and diode laser resection (n=1). Two studies compared hysteroscope diameter and one study compared methods of polyp retrieval. A significant reduction in pain was found using morcellators rather than miniature bipolar electrosurgical devices (p<0.001), 22Fr rather than 26Fr resectoscopes (p<0.001) and 3.5mm fiber-optic hysteroscopes with 7Fr forceps rather than 5mm lens-based hysteroscopes with 5Fr forceps (p<0.05). One study investigating septoplasty showed significant reduction in pain when cold mini-scissors, rather than a miniature bipolar electrode were used (p=0.013). Average procedural times ranged from 5 minutes 28 seconds to 22 minutes. The incidence of adverse events was low and data regarding efficacy and acceptability/satisfaction were limited. CONCLUSION: Pain is reduced when mechanical technologies such as morcellators and scissors are used compared to electrical devices for removing structural lesions in the office. For hysteroscopic and ablative procedures, smaller and quicker devices are less painful. Large-scale RCTs investigating patient pain and experience with modern operative devices in the office setting are urgently needed.

De Souza Mary, J., et al. (2022). "Bone mineral density in response to increased energy intake in exercising women with oligomenorrhea/amenorrhea: the REFUEL randomized controlled trial." The American Journal of Clinical Nutrition 115(6): 1457-1472.
	Background: Energy deficiency can result in menstrual disturbances and compromised bone health in women, a condition known as the Female Athlete Triad.; Objectives: The REFUEL randomized controlled trial assessed the impact of increased energy intake on bone health and menstrual function in exercising women with menstrual disturbances.; Methods: Exercising women with oligomenorrhea/amenorrhea (Oligo/Amen) were randomly assigned to an intervention group (Oligo/Amen + Cal, n = 40, mean ± SEM age: 21.3 ± 0.5 y; weight: 55.0 ± 1.0 kg; BMI: 20.4 ± 0.3 kg/m2) who increased energy intake 20%-40% above baseline energy needs for 12 mo or a control group (Oligo/Amen Control, n = 36; mean ± SEM age: 20.7 ± 0.5 y; weight: 59.1 ± 1.3 kg; BMI: 21.3 ± 0.4 kg/m2). Energy intake and expenditure, metabolic and reproductive hormones, body composition, and areal bone mineral density (aBMD) were assessed.; Results: Oligo/Amen + Cal improved energy status [increased body mass (2.6 ± 0.4 kg), BMI (0.9 ± 0.2 kg/m2), fat mass (2.0 ± 0.3 kg), body fat percentage (2.7% ± 0.4%), and insulin-like growth factor 1 (37.4 ± 14.6 ng/mL)] compared with Oligo/Amen Control and experienced a greater likelihood of menses (P < 0.05). Total body and spine aBMD remained unchanged (P > 0.05). Both groups demonstrated decreased femoral neck aBMD at month 6 (-0.006 g/cm2; 95% CI: -0.011, -0.0002 g/cm2 ; time main effect P = 0.043) and month 12 (-0.011 g/cm2; 95% CI: -0.021, -0.001 g/cm2; time main effect P = 0.023). Both groups demonstrated a decrease in total hip aBMD at month 6 (-0.006 g/cm2; 95% CI: -0.011, -0.002 g/cm2; time main effect P = 0.004).; Conclusions: Although higher dietary energy intake increased weight, body fat, and menstrual frequency, bone mineral density was not improved, compared with the control group. The 12-mo intervention may have been too short and the increase in energy intake (∼352 kcal/d), although sufficient to increase menstrual frequency, was insufficient to increase estrogen or improve aBMD. Future research should refine the optimal nutritional and/or pharmacological interventions for the recovery of bone health in athletes and exercising women with Oligo/Amen.This trial was registered at clinicaltrials.gov as NCT00392873. (© The Author(s) 2022. Published by Oxford University Press on behalf of the American Society for Nutrition.)

de Vrese, M., et al. (2019). "Impact of oral administration of four Lactobacillus strains on Nugent score - systematic review and meta-analysis." Beneficial microbes 10(5): 483-496.
	We aimed at assessing the evidence for an effect on vaginal dysbiosis by oral administration of a mixture of Lactobacillus strains isolated from vaginal microbiota. For this purpose, we systematically reviewed the literature for randomised clinical trials (RCTs) in which the effect of oral administration of a mixture of four Lactobacillus strains ( Lactobacillus crispatus LbV 88 (DSM 22566), Lactobacillus gasseri LbV 150N (DSM 22583), Lactobacillus jensenii LbV 116 (DSM 22567) and Lactobacillus rhamnosus LbV96 (DSM 22560)) on vaginal dysbiosis was examined based on Nugent score. Four RCTs were identified: a double-blind (DB)-RCT in 60 male-to-female transsexual women with neovagina; an open label RCT in 60 pregnant women with herpes virus infection; a DB-RCT in 36 women with bacterial vaginosis; a DB-RCT in 22 postmenopausal breast cancer patients receiving chemotherapy. Only in the three DB-RCTs Nugent score was assessed. The meta-analysis of these trials showed a significant reduction of Nugent score by probiotics compared to placebo in the fixed (standardised mean differences (SMD) -0.561; confidence interval (CI) -0.935 to -0.186; P =0.004 and random effect models (SMD -0.561; CI -0.935 to -0.186; P =0.004). The odds ratio (OR) of the cases presenting with improved Nugent score after probiotics compared to placebo treatment showed a significant effect in the fixed (OR=3.936; CI 1.702 to 9.100; P =0.001) and random effect model (OR=3.902; CI 1.681 to 9.059; P =0.001) Cochran's Q and I 2 statistics showed no heterogeneity. This meta-analysis indicates that the oral intake of the pertinent Lactobacillus strains improves the microbial pattern in vaginal dysbiosis.

de Wall, L. L., et al. (2022). "Study protocol for a parallel-group randomized controlled multi-center trial evaluating the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence (SENS-U trial)." Trials 23(1): 648.
	Background: Lower urinary tract dysfunction or functional urinary incontinence is a common condition with a prevalence up to 21% between 6 and 8 year‐old children. It is associated with an impaired quality of life, lower self‐esteem, and social stigmatization. Urotherapy is the first treatment of choice for functional daytime urinary incontinence (DUI) in children. Alarm therapy can be a part of urotherapy as it provides the child adequate feedback on wetting accidents. Current alarm systems notify either at a set interval or give a notification when wetting has already occurred to prompt the child to go to the toilet. These alarms do not teach the child the interpretation of the bladder sensation preceding wetting accidents. A new wearable bladder sensor, the SENS‐U, recently became available. This is a relative small, wireless ultrasonic sensor, which continuously monitors bladder filling. The SENS‐U is able to provide an alarm at the exact moment voiding is warranted. It facilitates the child to learn the sensation of bladder filling preceding voiding in an easier way, increasing the learning curve throughout treatment. Its additional effect in urotherapy on continence and cost‐effectiveness is to be determined. Methods/design: This is a multi‐center clinical superiority parallel‐group randomized controlled trial including a total of 480 children. Participants between 6 and 16 years of age with functional DUI in which urotherapy is offered as the next treatment of choice are eligible. Four centers, two academic hospitals, and two general care (peripheral) centers are participating. Participants will be randomized at a 1:1:1 ratio into three groups: urotherapy (care as usual), urotherapy with the SENS‐U added for 3 consecutive weeks throughout the training, or urotherapy with a SHAM device for 3 weeks. The primary outcome is number of wetting accidents per week after 3 months of training, compared between the SENS‐U and the SHAM device. The magnitude of the placebo effect will be assessed by comparing the results of the SHAM group versus the control (care as usual) group. Discussion: To our knowledge, this is the first trial studying not only the effect but also the cost‐effectiveness of alarm interventions as commonly added in urotherapy. Trial registration: ISRCTN44345202. Registered on March 2022

de Wolff, M. G., et al. (2021). "Effects of a Midwife-Coordinated Maternity Care Intervention (ChroPreg) vs. Standard Care in Pregnant Women with Chronic Medical Conditions: Results from a Randomized Controlled Trial." International Journal of Environmental Research and Public Health 18(15).
	The proportion of childbearing women with pre-existing chronic medical conditions (CMC) is rising. In a randomized controlled trial, we aimed to evaluate the effects of a midwife-coordinated maternity care intervention (ChroPreg) in pregnant women with CMC. The intervention consisted of three main components: (1) Midwife-coordinated and individualized care, (2) Additional ante-and postpartum consultations, and (3) Specialized known midwives. The primary outcome was the total length of hospital stay (LOS). Secondary outcomes were patient-reported outcomes measuring psychological well-being and satisfaction with maternity care, health utilization, and maternal and infant outcomes. A total of 362 women were randomized to the ChroPreg intervention (n = 131) or Standard Care (n = 131). No differences in LOS were found between groups (median 3.0 days, ChroPreg group 0.1% lower LOS, 95% CI -7.8 to 7%, p = 0.97). Women in the ChroPreg group reported being more satisfied with maternity care measured by the Pregnancy and Childbirth Questionnaire (PCQ) compared with the Standard Care group (mean PCQ 104.5 vs. 98.2, mean difference 6.3, 95% CI 3.0-10.0, p < 0.0001). In conclusion, the ChroPreg intervention did not reduce LOS. However, women in the ChroPreg group were more satisfied with maternity care.

de Zegher, F., et al. (2021). "The relative deficit of GDF15 in adolescent girls with PCOS can be changed into an abundance that reduces liver fat." Scientific Reports 11(1): 7018.
	A prime concern of young patients with Polycystic Ovary Syndrome (PCOS) is the control of body adiposity, given their tendency to gain weight and/or their difficulty to lose weight. Circulating growth-and-differentiation factor-15 (GDF15) facilitates the control of body weight via receptors in the brainstem. C-reactive protein (CRP) and insulin are endogenous GDF15 secretagogues. We hypothesised that PCOS in non-obese adolescents is characterised by low concentrations of circulating GDF15, when judged by the degree of CRP and insulin drive. GDF15 was added as a post-hoc endpoint of two previously reported, randomised studies in non-obese adolescent girls with PCOS (N = 58; 60% normal weight; 40% overweight) who received either an oral oestroprogestogen contraceptive (OC), or a low-dose combination of spironolactone-pioglitazone-metformin (SPIOMET) for 1 year; subsequently, all girls remained untreated for 1 year. Adolescent girls with regular menses (N = 20) served as healthy controls. Circulating GDF15, CRP and fasting insulin were assessed prior to treatment, and halfway the on- and post-treatment years. Pre-treatment, the absolute GDF15 concentrations were normal in PCOS girls, but their relative levels were markedly low, in view of the augmented CRP and insulin drives. OC treatment was accompanied by a near-doubling of circulating GDF15 (on average, from 296 to 507 pg/mL) and CRP, so that the relative GDF15 levels remained low. SPIOMET treatment was accompanied by a 3.4-fold rise of circulating GDF15 (on average, from 308 to 1045 pg/mL) and by a concomitant lowering of CRP and insulin concentrations towards normal, so that the relative GDF15 levels became markedly abundant. Post-OC, the relatively low GDF15 levels persisted; post-SPIOMET, the circulating concentrations of GDF15, CRP and insulin were all normal. BMI remained stable in both treatment groups. Only SPIOMET was accompanied by a reduction of hepato-visceral fat (by MRI) towards normal. In conclusion, early PCOS was found to be characterised by a relative GDF15 deficit that may partly explain the difficulties that young patients experience to control their body adiposity. This relative GDF15 deficit persisted during and after OC treatment. In contrast, SPIOMET treatment was accompanied by an absolute and a relative abundance of GDF15, and followed by normal GDF15, CRP and insulin concentrations. The present findings strengthen the rationale to raise the concentrations of circulating GDF15 in early PCOS, for example with a SPIOMET-like intervention that attenuates low-grade inflammation, insulin resistance and ectopic adiposity, without necessarily lowering body weight.Clinical trial registries: ISRCTN29234515 and ISRCTN11062950.

de Zegher, F. and L. Ibáñez (2024). "Insulin sensitisation for polycystic ovary syndrome: High-dose monotherapy versus low-dose combination." Clinical Endocrinology 100(3): 277.
	
Dealberti, D., et al. (2023). "The Use of Methotrexate and Mifepristone for Treatment of Interstitial Pregnancies: An Overview of Effectiveness and Complications." Journal of Clinical Medicine 12(23): 7396.
	Interstitial pregnancy is an unusual and potentially life-threatening form of ectopic pregnancy, accounting for approximately 1-6% of all ectopic pregnancies, with a maternal mortality rate of 2-2.5%. Implantation happens in the proximal portion of the fallopian tube as it passes through the myometrium. The resolution of interstitial pregnancy after medical treatment should be assessed by a decline in serum beta-hCG, which occurs in about 85-90% of cases. Nonetheless, its effectiveness and consequences have been presented through case reports and case series. However, few cases of interstitial pregnancies treated totally medically with the use of methotrexate and mifepristone have been presented in the literature. Complications of this medical treatments have also never been reviewed before. In the present manuscript, we present a case of interstitial pregnancy treated with methotrexate and mifepristone. The patient after treatment developed a uterine arteriovenous malformation, treated with uterine artery embolization. Furthermore, we performed a systematic review of the literature using Scopus, PubMed and Google Scholar. A total of 186 papers were found, and 7 papers which included 10 cases were assessed for eligibility. The systemic medical treatment with the use of methotrexate and mifepristone was effective in 7 of the 10 cases. Two cases of hemoperitoneum following combined methotrexate and mifepristone treatment were reported. The applicability of this medical conservative treatment should be tailored to the patient, taking into account their obstetric history, gestational age at diagnosis and desire for future pregnancies. Complete resolution after this treatment was achieved in most of the cases reported without major complications. The appearance of uterine arteriovenous malformation can be managed conservatively, and we propose uterine artery embolization as an effective treatment of this rare complication.Copyright © 2023 by the authors.

Deb Pratik, Q., et al. (2022). "Angiosarcoma of the Uterus: A Systematic Review." International journal of gynecological pathology : official journal of the International Society of Gynecological Pathologists 41(5): 496-502.
	Primary uterine angiosarcoma is an extremely rare neoplasm. Due to its rarity, knowledge regarding this malignancy is limited to a few scattered case reports. To better understand the prognostic factors and optimal management of these neoplasms, we have performed a systematic analysis of the disease. A systematic literature search of this entity yielded 25 reported cases of this entity. In addition, we searched the National Cancer Institute Surveillance, Epidemiology, and End Results database to find 4 additional cases and added a case diagnosed in our institution. We analyzed the patients' demographic characteristics and the different treatment protocols utilized to treat this malignancy. Patients were primarily treated by surgery with or without adjuvant chemotherapy and radiotherapy. Survival analysis was performed to examine the role of various factors in the outcome for the patients. There was no correlation with age of diagnosis, or treatment modality used, however, better outcomes were seen in patients presenting with smaller sized tumors. Our study is the first attempt to systematically study this rare malignancy in hopes of leading to a more standardized, evidence-based, and improved treatment protocol.; Competing Interests: The authors declare no conflict of interest. (Copyright © 2021 by the International Society of Gynecological Pathologists.)

Debaudringhien, M., et al. (2022). "Association between recent pregnancy or hormonal contraceptive exposure and outcome of desmoid-type fibromatosis." ESMO Open 7(5): 100578.
	BACKGROUND: The role of both hormonal contraception and pregnancy on the outcomes of desmoid-type fibromatosis (DF) is debatable. MATERIALS AND METHODS: In the present study, we selected female patients of childbearing age from the prospective ALTITUDES cohort. The primary study endpoint was event-free survival (EFS), with an event defined as relapse or progression. We estimated the risk of events according to the use of hormonal contraception [estrogen-progestin (EP) and progestin] and pregnancy status using multivariate time-dependent models, controlling for major confounders. RESULTS: A total of 242 patients (median age, 34.7 years) were included in the present study. The abdominal wall was the most common tumor site (51%). Patients were managed by active surveillance (80%) or surgery (20%). Pregnancy occurred within 24 months before, at the time of, and after DF diagnosis in 33%, 5%, and 10% of the cases, respectively. Exposure to hormonal contraception was documented within 24 months before, at the time of, and after diagnosis in 44%, 34%, and 39% of the cases, respectively. The 2-year EFS was 75%. After adjusting for DF location, tumor size, front-line treatment strategy, and hormonal contraception, we observed an increased risk of events occurring at 24 months after pregnancy [hazard ratio (HR) = 2.09, P = 0.018]. We observed no statistically significant association between the risk of events and current EP exposure (HR = 1.28, P = 0.65), recent EP exposure (within 1-24 months, HR = 1.38, P = 0.39), current progestin exposure (HR = 0.81, P = 0.66), or recent progestin exposure (HR = 1.05, P = 0.91). CONCLUSIONS: In our study, a recent history of pregnancy was associated with an increased risk of progression/relapse in patients with newly diagnosed DF, whereas hormonal contraception did not demonstrate an association with progression/relapse.

Debrabandere, M. L., et al. (2021). "A Review on Mode of Delivery during COVID-19 between December 2019 and April 2020." American journal of perinatology 38(4): 332-341.
	OBJECTIVE: This study aims to review the published literature to determine mode of delivery in pregnant women with coronavirus disease 2019 (COVID-19) and the indications reported for cesarean section early in the pandemic to add information to the current narrative and raise awareness of trends discovered. STUDY DESIGN: A systematic review was conducted by searching PubMed, Scopus, and ScienceDirect databases for articles published between December 2019 and April 29, 2020 using a combination of the keywords such as COVID-19, coronavirus 2019, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), pregnancy, vaginal delivery, cesarean section, vertical transmission, management, and guidelines. Peer-reviewed case studies with confirmed SARS-CoV-2 women who delivered were included to determine mode of delivery, indications for cesarean section, and maternal and neonatal characteristics. RESULTS: A review of 36 total articles revealed deliveries in 203 SARS-CoV-2 positive pregnant women. A comparable severity of disease in pregnant versus nonpregnant women was noted, as previously determined. Overall, 68.9% of women delivered via cesarean section, with COVID-19 status alone being a common indication. Maternal COVID-19 may also be associated with increased risk of preterm labor, although neonatal outcomes were generally favorable. Despite eight of 206 newborns testing positive for SARS-CoV-2, there remains no definitive evidence of vertical transmission. CONCLUSION: COVID-19 status alone became a common indication for cesarean delivery early in the pandemic, despite lack of evidence for vertical transmission. The increase in cesarean rate in this data may reflect obstetricians attempting to serve their patients in the best way possible given the current climate of constantly evolving guidelines on safest mode of delivery for the mother, infant, and provider. Upholding current recommendations from trusted organizations as new data are published, while also providing individualized support to expecting mothers on most appropriate mode of delivery, will reduce the amount of unnecessary, unplanned cesarean sections and could lessen the psychological impact of delivering during the COVID-19 pandemic. KEY POINTS: · COVID-19 may result in an increased rate of cesarean delivery for SARS-CoV-2 positive pregnant women.. · COVID-19 is a commonly reported indication for cesarean section, despite management guidelines urging against this.. · Although eight neonates tested positive for SARS-CoV-2, all additional fluid and tissue samples tested negative..

Debray, A., et al. (2023). "Effect of Exercise Training on Blood Pressure in Healthy Postmenopausal Females: A Systematic Review with Meta-analysis." Medicine and Science in Sports and Exercise 55(7): 1317-1325.
	Introduction: The prevalence of hypertension is greater in postmenopausal females compared with males of similar age. Previous meta-analyses of normotensive and hypertensive adults have shown that aerobic exercise training reduces systolic blood pressure (SBP) and/or diastolic blood pressure (DBP). However, the effect of aerobic exercise training on blood pressure specifically within healthy postmenopausal females remains unclear. This systematic review with meta-analysis quantified the effect of aerobic exercise training on resting SBP and DBP in healthy postmenopausal females.; Methods: The systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Review and Meta-analyses guidelines and was registered in PROSPERO (CRD42020198171). The literature search was done in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, CINAHL Plus, and SPORTDiscus. Randomized controlled trials involving healthy postmenopausal females with normal or high normal blood pressure and undergoing ≥4 wk of aerobic exercise training were included. The total weighted mean change in SBP and DBP was compared between the exercise and the control interventions. A random-effects model was used to calculate the overall effect sizes of the weighted mean differences and the 95% confidence interval (CI).; Results: Twelve studies were included in the meta-analysis (exercise interventions: n = 357, age = 60 ± 4 yr, baseline SBP/DBP = 128 ± 13/79 ± 8 mm Hg; control interventions: n = 330, age = 60 ± 4 yr, baseline SBP/DBP = 126 ± 11/77 ± 6 mm Hg). Compared with the change observed in response to the control interventions, exercise training significantly reduced SBP (-0.43 mm Hg, 95% CI = -0.78 to -0.09, P = 0.02) and DBP (-0.39 mm Hg, 95% CI = -0.73 to -0.05, P = 0.05).; Conclusions: Aerobic exercise training significantly reduces resting SBP and DBP in healthy postmenopausal females with normal or high normal blood pressure. However, this reduction is small and of uncertain clinical significance. (Copyright © 2023 by the American College of Sports Medicine.)

Decandia, D., et al. (2022). "n-3 PUFA Improve Emotion and Cognition during Menopause: A Systematic Review." Nutrients 14(9).
	Women show an increased risk of cognitive impairment and emotional disorders, such as anxiety and depression, when approaching menopause. Data on risk and protection factors have yielded robust evidence on the effects of lifestyle factors, such as diet, in preserving emotional and cognitive functioning. This review focused on the effects of omega-3 polyunsaturated fatty acids (n-3 PUFA) on anxiety, depression, and cognition during the menopausal transition. This systematic review considered all articles published until 31 December 2021, and the search was performed on two databases, PubMed and Scopus. The fields of interest were "menopause", "n-3 PUFA" and "emotional and cognitive aspects". Out of the 361 articles found on PubMed and 283 on Scopus, 17 met inclusion criteria. They encompassed 11 human and 6 animal studies. Most studies reported relieved depressive symptoms in relation to n-3 PUFA intake. While controversial results were found on anxiety and cognition in humans, n-3 PUFA consistently reduced anxiety symptoms and improved cognition in animal studies. Taken together, n-3 PUFA intake shows beneficial effects on emotional and cognitive behaviours during menopause transition. However, further investigations could increase knowledge about the effectiveness of n-3 PUFA on psychological well-being in this delicate period of feminine life.

DeCesaris, C., et al. (2023). "Financial Improvements from Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care, "SAVE" Trial." International journal of radiation oncology biology physics 117(2 Supplement): S92.
	Purpose/Objective(s): Early-stage endometrial cancer is often managed with hysterectomy followed by adjuvant VCB. Financial toxicity from cancer treatment is a strong driver of adherence. The SAVE trial is a multicenter, prospective randomized trial of standard of care (SoC) VCB doses delivered in 3-5 fractions per physician discretion compared to a 2-fraction course. We report on secondary cost endpoints, quantifying the financial impacts of shorter treatment courses on institutions and participating patients. Materials/Methods: Technical (TechCs), professional (PCs), and total charges (TotCs) were collected prospectively and are reported as raw and Medicare-adjusted charges per patient. Geographic variations were standardized with CMS Geographic Practice Cost Indices (GPCI), and inflation was adjusted using the Consumer Price Index (CPI): Medical Care. Distance to treatment center was calculated from the patient's zip code to the corresponding treatment center. Cost of commutes was estimated through round-trip travel distance multiplied by average gas MPG for new vehicles by treatment year and state. Median income for each patient's zip code was estimated using 5-year Household income in 2021 inflation-adjusted dollars from the US Census. Mann-Whitney U, T- and Chi-square tests were used to compare characteristics between the two groups. Result(s): One hundred eight patients were analyzed. SoC VCB was delivered in 3, 4 and 5 fractions for 27/54 (50%), 11/54 (20%), and 16/54 (30%), respectively. Median total distance traveled per patient for SoC vs. experimental arms was 213 vs 137 miles (p =.12), and median cost of commute for patients was 36.3 vs 18.0 USD (p =.11). Compared to 2-fraction treatment, 5-fraction treatment resulted in longer travel distances (median 462 vs. 137 miles, p < 0.01) and increased travel costs (median 59.3 v. 18.0 USD, p = < 0.01). Median income by zip code for SoC v. experimental arms was 79,704 vs. 79,671 USD (p = 1.0). For SoC v. experimental arms, 11 (20%) vs 7 (13%) of patients had zip codes with median income in the lowest or second lowest quintiles (p = 0.5). Adjusted raw PCs per patient did not differ between SoC vs. experimental arms (9,159$ vs. 7,532$, p = 0.19). TechCs were significantly higher on the SoC arm (35,734$ vs. 24,696$ p = < 0.01), as were TotCs (44,892$ vs. 32,228$, p < 0.01;). Medicare-adjusted PCs, TechCs, and TotCs were higher for the SoC arm (Table 1). Conclusion(s): Two-fraction VCB resulted in fewer treatments per patient, reduced cost of travel compared to longer courses, and an adjusted reduction in healthcare expenditures compared to standard of care. Ongoing work will include assessment of patient-reported financial toxicities.Copyright © 2023

Declercq, A., et al. (2020). "Proposition of standardized protocol for photodynamic therapy for vulvar lichen sclerosus." The Journal of dermatological treatment: 1-26.
	BACKGROUND: Photodynamic therapy (PDT) is an alternative treatment modality for vulvar lichen sclerosus (VLS) which is a chronic inflammatory mucosal condition. In literature, no consensus of optimal parameters of PDT for VLS are reached so far. OBJECTIVES: The aim of this narrative review is to develop a standardized treatment protocol for PDT in VLSMethods: A systematic literature search was conducted to identify studies reporting on PDT in VLS and used treatment parameters, side-effects and clinical outcome were summarized. RESULTS: Thirteen studies used 5-aminolevulinic acid (5-ALA) with concentrations of 20%, 10%, 5% and three studies used methyl aminolevulinate. Generally the light source was red light (median 630 nm). Light dose varied between 9 and 180 J/cm2 and light intensity between 40 and 700 mW/cm2. Incubation period with the photosensitizer ranged from two to six hours. All studies showed a substantial improvement of VLS-related pruritus, burning and pain. CONCLUSION: Based on a literature review we suggest the following protocol for PDT in VLS: 5% 5-ALA as a photosensitizer applied for three hours under occlusion before irradiation at the dose of 120 J/cm2 with red light (590-760 nm) and intensity of 204 mW/cm2.

Dedes, I., et al. (2023). "Radiofrequency Ablation for Adenomyosis." Journal of Clinical Medicine 12(9): 3069.
	Adenomyosis is a common benign gynecologic condition characterized by ectopic endometrial glands and stroma in the myometrium causing pain (dysmenorrhea) and abnormal uterine bleeding. New interventional techniques have been introduced over recent years. This study evaluates the treatment success and side effects of radiofrequency ablation. An electronic literature search in the PubMed, Scopus, and ScienceDirect databases was carried out on the outcomes of pain reduction and, secondarily, on abnormal uterine bleeding, reintervention, reproductive outcome, imaging outcome, and complications. There was a mean decrease in dysmenorrhea pain scores by -63.4 +/- 9.0% at 12 months. Data on other outcome parameters were sparse. No major complications were reported. Radiofrequency ablation represents a promising minimally invasive and organ-preserving treatment in patients with symptomatic adenomyosis. It is associated with clinically meaningful improvement of adenomyosis-related pain in the short term.Copyright © 2023 by the authors.

Deepika, K., et al. (2021). "HCG trigger versus GnRH agonist trigger in PCOS patients undergoing IVF cycles: frozen embryo transfer outcomes." JBRA Assisted Reproduction 25(1): 48-58.
	OBJECTIVE: The use of Gonadotrophin releasing hormone agonist (GnRHa), with freeze-all strategy followed by frozen embryo transfer (FET) has been found to eliminate the risk of ovarian hyperstimulation syndrome (OHSS) in women with polycystic ovarian syndrome (PCOS) undergoing IVF cycles. However, physicians still hesitate to routinely use GnRHa as a trigger, replacing human chorionic gonadotrophin (hCG), for concerns of compromised cycle outcome. We aimed to evaluate outcomes following the transfer of embryos in FET cycles obtained from GnRHa trigger in comparison with hCG trigger in PCOS patients of Asian origin. METHODS: Prospective observational cohort study. 210 PCOS patients undergoing IVF in an antagonist protocol who were randomized in the previous study (to evaluate if GnRHa trigger is a better alternative than hCG in PCOS patients to prevent OHSS; Group A: GnRHa trigger (n=92)] and Group B: hCG trigger (n=101)], were followed up in FET cycles to assess the outcomes. RESULTS: The odds of cumulative live birth rate per stimulation cycle favors GnRHa trigger against the hCG trigger [OR=2.15; (CI 1.2-3.83); p=0.008]. A significantly higher number of mature oocytes (19.1±11.7 versus 14.1±4.3; p<0.001) and blastocysts (4.2±1.63 versus 3.26±1.22; p<0.001) were available in the GnRHa group as compared to the hCG group. CONCLUSION: The cumulative live birth rate was better following transfer of frozen-thawed embryos generated from GnRHa-triggered cycles compared to hCG trigger. Hence, in PCOS undergoing IVF, as a good practice point, hCG trigger should be replaced by a GnRHa trigger with vitrification of all embryos followed by FET.

Deepthika, S. H. K., et al. (2022). "MEDICINAL EFFECTS OF NIGELLA SATIVA IN GYNECOLOGICAL DISORDERS: A SYSTEMATIC REVIEW." International Journal of Pharmaceutical Sciences and Research 13(8): 2977-2987.
	Comprehensive search of previously published research was conducted in PubMed, Science Direct, Scopus, and google scholar databases for studies published between 2012 and August 2021. The keywords used in combination to search for articles included Nigella sativa and "Gynecology". In the first stage, the total articles obtained from searching the above databases using the above keywords were pooled together, and duplicate articles were removed. The remaining articles were primarily screened by reading the title and abstracts and selecting the most relevant articles. In the last stage, articles were reviewed again by reading the entire article, and those that did not meet the inclusion requirements were eliminated. A manual search was conducted using the reference list of the included research publications to collect additional data. In the various databases, the literature search found the following number of research articles: PubMed (n=11), Science Direct (n=35), Scopus (n=07), and Google Scholar (n=1070). After removing duplicates, there were 1062 articles. Those articles were further screened first by reading topics and abstracts and secondly, reading full text that did not match the inclusions was removed. After removing those articles, there were 40 articles, and after adding 05 manual search articles, finally, 45 articles were included in the systematic review. Nigella sativa has medicinal benefits for gynecological disorders such as PCOS, menopause-related issues, Hyperprolactinemia, Candidiasis, Trichomoniasis, Cervical cancer, Breast cancer, ovarian cancer, Premenstrual syndrome and Pre-eclampsia. Nigella sativa also improves endometrium, oocyte maturity and quality and reduces ovarian tissue damage without any adverse effects.Copyright © 2022 Society of Pharmaceutical Sciences and Research. All rights reserved.

Deffieux, X., et al. (2024). "Diagnosis and management of complications following pelvic organ prolapse surgery using a synthetic mesh: French national guidelines for clinical practice." European Journal of Obstetrics and Gynecology and Reproductive Biology 294: 170-179.
	Complications associated with pelvic organ prolapse (POP) surgery using a synthetic non-absorbable mesh are uncommon (<5%) but may be severe and may hugely diminish the quality of life of some women. In drawing up these multidisciplinary clinical practice recommendations, the French National Authority for Health (Haute Autorite de sante, HAS) conducted an exhaustive review of the literature concerning the diagnosis, prevention, and management of complications associated with POP surgery using a synthetic mesh. Each recommendation for practice was allocated a grade (A,B or C; or expert opinion (EO)), which depends on the level of evidence (clinical practice guidelines). Preoperative patients' information: Each patient must be informed concerning the risks associated with POP surgery (EO). Hemorrhage, hematoma: Vaginal infiltration using a vasoconstrictive solution is not recommended during POP surgery by the vaginal route (grade C). The placement of vaginal packing is not recommended following POP surgery by the vaginal route (grade C). During laparoscopic sacral colpopexy, when the promontory seems highly dangerous or when severe adhesions prevent access to the anterior vertebral ligament, alternative surgical techniques should be discussed per operatively, including colpopexy by lateral mesh laparoscopic suspension, uterosacral ligament suspension, open abdominal mesh surgery, or surgery by the vaginal route (EO). Bladder injury: When a bladder injury is diagnosed, bladder repair by suturing is recommended, using a slow resorption suture thread, plus monitoring of the permeability of the ureters (before and after bladder repair) when the injury is located at the level of the trigone (EO). When a bladder injury is diagnosed, after bladder repair, a prosthetic mesh (polypropylene or polyester material) can be placed between the repaired bladder and the vagina, if the quality of the suturing is good. The recommended duration of bladder catheterization following bladder repair in this context of POP mesh surgery is from 5 to 10 days (EO). Ureter injury: After ureteral repair, it is possible to continue sacral colpopexy and place the mesh if it is located away from the ureteral repair (EO). Rectal injury: Regardless of the approach, when a rectal injury occurs, a posterior mesh should not be placed between the rectum and the vagina wall (EO). Concerning the anterior mesh, it is recommended to use a macroporous monofilament polypropylene mesh (EO). A polyester mesh is not recommended in this situation (EO). Vaginal wall injury: After vaginal wall repair, an anterior or a posterior microporous polypropylene mesh can be placed, if the quality of the repair is found to be satisfactory (EO). A polyester mesh should not be used after vaginal wall repair (EO). Mesh infection (abscess, cellulitis, spondylodiscitis): Regardless of the surgical approach, intravenous antibiotic prophylaxis is recommended (aminopenicillin + beta-lactamase inhibitor: 30 min before skin incision +/- repeated after 2 h if surgery lasts longer) (EO). When spondylodiscitis is diagnosed following sacral colpopexy, treatment should be discussed by a multidisciplinary group, including especially spine specialists (rheumatologists, orthopedists, neurosurgeons) and infectious disease specialists (EO). When a pelvic abscess occurs following synthetic mesh sacral colpopexy, it is recommended to carry out complete mesh removal as soon as possible, combined with collection of intraoperative bacteriological samples, drainage of the collection and targeted antibiotic therapy (EO). Non-surgical conservative management with antibiotic therapy may be an option (EO) in certain conditions (absence of signs of sepsis, macroporous monofilament polypropylene type 1 mesh, prior microbiological documentation and multidisciplinary consultation for the choice of type and duration of antibiotic therapy), associated with close monitoring of the patient. Bowel occlusion related to non-closure of the peritoneum: Peritoneal closure is recommended after placement of a synthetic me h by the abdominal approach (EO). Urinary retention: Preoperative urodynamics is recommended in women presenting with urinary symptoms (bladder outlet obstruction symptoms, overactive bladder syndrome or incontinence) (EO). It is recommended to remove the bladder catheter at the end of the procedure or within 48 h after POP surgery (grade B). Bladder emptying and post-void residual should be checked following POP surgery, before discharge (EO). When postoperative urine retention occurs after POP surgery, it is recommended to carry out indwelling catheterization and to prefer intermittent self-catheterization (EO). Postoperative pain: Before POP surgery, the patient should be asked about risk factors for prolonged and chronic postoperative pain (pain sensitization, allodynia, chronic pelvic or non-pelvic pain) (EO). Concerning the prevention of postoperative pain, it is recommended to carry out a pre-, per- and postoperative multimodal pain treatment (grade B). The use of ketamine intraoperatively is recommended for the prevention of chronic postoperative pelvic pain, especially for patients with risk factors (preoperative painful sensitization, allodynia, chronic pelvic or non-pelvic pain) (EO). Postoperative prescription of opioids should be limited in quantity and duration (grade C). When acute neuropathic pain (sciatalgia or pudendal neuralgia) resistant to level I and II analgesics occurs following sacrospinous fixation, a reintervention is recommended for suspension suture removal (EO). When chronic postoperative pain occurs after POP surgery, it is recommended to systematically seek arguments in favor of neuropathic pain with the DN4 questionnaire (EO). When chronic postoperative pelvic pain occurs after POP surgery, central sensitization should be identified since it requires a consultation in a chronic pain department (EO). Concerning myofascial pain syndrome (clinical pain condition associated with increased muscle tension caused by myofascial trigger points), when chronic postoperative pain occurs after POP surgery, it is recommended to examine the levator ani, piriformis and obturator internus muscles, so as to identify trigger points on the pathway of the synthetic mesh (EO). Pelvic floor muscle training with muscle relaxation is recommended when myofascial pain syndrome is associated with chronic postoperative pain following POP surgery (EO). After failure of pelvic floor muscle training (3 months), it is recommended to discuss surgical removal of the synthetic mesh, during a multidisciplinary discussion group meeting (EO). Partial removal of synthetic mesh is indicated when a trigger point is located on the pathway of the mesh (EO). Total removal of synthetic mesh should be discussed during a multidisciplinary discussion group meeting when diffuse (no trigger point) chronic postoperative pain occurs following POP surgery, with or without central sensitization or neuropathic pain syndromes (EO). Postoperative dyspareunia: When de novo postoperative dyspareunia occurs after POP surgery, surgical removal of the mesh should be discussed (EO). Vaginal mesh exposure: To reduce the risk of vaginal mesh exposure, when hysterectomy is required during sacral colpopexy, subtotal hysterectomy is recommended (grade C). When asymptomatic vaginal macroporous monofilament polypropylene mesh exposure occurs, systematic imaging is not recommended. When vaginal polyester mesh exposure occurs, pelvic +/- lumbar MRI (EO) should be used to look for an abscess or spondylodiscitis, given the greater risk of infection associated with this type of material. When asymptomatic vaginal mesh exposure of less than 1 cm2 occurs in a woman with no sexual intercourse, the patient should be offered observation (no treatment) or local estrogen therapy (EO). However, if the patient wishes, partial excision of the mesh can be offered. When asymptomatic vaginal mesh exposure of more than 1 cm2 occurs or if the woman has sexual intercourse, or if it is a polyester prosthesis, partial mesh excision, either immediately or after local estrogen thera y, should be offered (EO). When symptomatic vaginal mesh exposure occurs, but without infectious complications, surgical removal of the exposed part of the mesh by the vaginal route is recommended (EO), and not systematic complete excision of the mesh. Following sacral colpopexy, complete removal of the mesh (by laparoscopy or laparotomy) is only required in the presence of an abscess or spondylodiscitis (EO). When vaginal mesh exposure recurs after a first reoperation, the patient should be treated by an experienced team specialized in this type of complication (EO). Suture thread vaginal exposure: For women presenting with vaginal exposure to non-absorbable suture thread following POP surgery with mesh reinforcement, the suture thread should be removed by the vaginal route (EO). Removal of the surrounding mesh is only recommended when vaginal mesh exposure or associated abscess is diagnosed. Bladder and ureteral mesh exposure: When bladder mesh exposure occurs, removal of the exposed part of the mesh is recommended (grade B). Both alternatives (total or partial mesh removal) should be discussed with the patient and should be debated during a multidisciplinary discussion group meeting (EO).Copyright © 2024 Elsevier B.V.

Degheili, J. A. and A. P. Dickson (2020). "Childhood and adolescent idiopathic urethritis: what does the current literature say?" Journal of Pediatric Urology 16(3): 276-283.
	Introduction: Idiopathic urethritis (IU) is a known entity in the childhood and adolescent age groups and is described as blood spotting of the underwear in these populations. Typically, IU presents clinically as terminal void haematuria or blood spotting, accompanied with dysuria, occasional suprapubic pain and rarely constitutional symptoms. Sometimes IU may progress to formation of urethral strictures. It carries a high morbidity because of its chronicity and recurrent course, which often persists to puberty. In spite of no single aetiology being confirmed, several treatment approaches have shown some efficacy. Although no consensus has yet been established, the consideration of previous authors' experience and expertise may contribute to the development of a possible unified algorithm. Aim(s): This article considers IU, collecting pertinent data and case series from the literature. The authors attempt to describe all presumptive aetiologies, endoscopic findings with established grading classifications and finally the various treatment modalities proposed. In addition, highlights from the senior's author experience regarding this entity including endoscopic, radiographic and histological images are mentioned. Method(s): Retrospective review and analysis of all relevant articles present on PubMed, SCOPUS and Cochrane Library from the time of inception to the date of first submission. Result(s): A total of 19 series concerning IU have been reported since year 1971 to present time (Table 1). Many aetiologies have been postulated, but some have been refuted, including infectious pathogens. Children with dysfunctional voiding and meatal stenosis are more prone to exhibit IU. A variation in the urethral milieu during the prepubertal period, secondary to systematic hormonal alteration, may lead to squamous cell metaplasia resulting in IU and possible urethral strictures. Grading classifications for IU are described. Up to 20% of IU may develop urethral strictures. Various treatment approaches are discussed. Conclusion(s): A summary of current understanding of the pathogenesis and spectrum of IU has been achieved. Successful treatment can be achieved with steroids and dysfunctional voiding protocols. It may be possible to develop a consensus unified management algorithm.Copyright © 2020 Journal of Pediatric Urology Company

Dekel, S., et al. (2023). "A Systematic Review of Interventions for Prevention and Treatment of Post-Traumatic Stress Disorder Following Childbirth." MedRxiv : the preprint server for health sciences.
	Objective: Postpartum women can develop post-traumatic stress disorder (PTSD) in response to complicated, traumatic childbirth; prevalence of these events remains high in the U.S. Currently, there is no recommended treatment approach in routine peripartum care for preventing maternal childbirth-related PTSD (CB-PTSD) and lessening its severity. Here, we provide a systematic review of available clinical trials testing interventions for the prevention and indication of CB-PTSD.; Data Sources: We conducted a systematic review of PsycInfo, PsycArticles, PubMed (MEDLINE), ClinicalTrials.gov, CINAHL, ProQuest, Sociological Abstracts, Google Scholar, Embase, Web of Science, ScienceDirect, and Scopus through December 2022 to identify clinical trials involving CB-PTSD prevention and treatment.; Study Eligibility Criteria: Trials were included if they were interventional, evaluated CB-PTSD preventive strategies or treatments, and reported outcomes assessing CB-PTSD symptoms. Duplicate studies, case reports, protocols, active clinical trials, and studies of CB-PTSD following stillbirth were excluded.; Study Appraisal and Synthesis Methods: Two independent coders evaluated trials using a modified Downs and Black methodological quality assessment checklist. Sample characteristics and related intervention information were extracted via an Excel-based form.; Results: A total of 33 studies, including 25 randomized controlled trials (RCTs) and 8 non-RCTs, were included. Trial quality ranged from Poor to Excellent. Trials tested psychological therapies most often delivered as secondary prevention against CB-PTSD onset (n=21); some examined primary (n=3) and tertiary (n=9) therapies. Positive treatment effects were found for early interventions employing conventional trauma-focused therapies, psychological counseling, and mother-infant dyadic focused strategies. Therapies' utility to aid women with severe acute traumatic stress symptoms or reduce incidence of CB-PTSD diagnosis is unclear, as is whether they are effective as tertiary intervention. Educational birth plan-focused interventions during pregnancy may improve maternal health outcomes, but studies remain scarce.; Conclusions: An array of early psychological therapies delivered in response to traumatic childbirth, rather than universally, in the first postpartum days and weeks, may potentially buffer CB-PTSD development. Rather than one treatment being suitable for all, effective therapy should consider individual-specific factors. As additional RCTs generate critical information and guide recommendations for first-line preventive treatments for CB-PTSD, the psychiatric consequences associated with traumatic childbirth could be lessened.; Competing Interests: Disclosure Statement: The authors report no conflict of interest.

Del Forno, S., et al. (2023). "Effects of Pelvic Floor Muscle Physiotherapy on Urinary, Bowel, and Sexual Functions in Women with Deep Infiltrating Endometriosis: A Randomized Controlled Trial." Medicina (Kaunas, Lithuania) 60(1).
	Background and Objectives : Endometriosis is a chronic and recurrent disease defined as the presence and proliferation of endometrial glands and stroma outside the uterine cavity. It affects up to 6-10% of women of reproductive age and can be classified into superficial, ovarian, and deep infiltrating endometriosis (DIE). Deep infiltrating endometriosis can be associated with pain symptoms and pelvic floor muscle hypertone. Moreover, it may be responsible of bowel, urinary, and sexual dysfunctions with impairment of women's quality of life. Few studies have investigated the role of physiotherapy in women with DIE. Here, we aimed first to evaluate the effects of pelvic floor physiotherapy (PFP) on urinary, bowel, and sexual functions. Secondly, we aimed to evaluate the effects of ultrasound visual feedback during PFP on pelvic floor and subjective modifications in the frequency of sexual intercourse. Materials and Methods : This randomized controlled trial was conducted between June 2018 and December 2019 at our tertiary center. Nulliparous women with DIE and superficial dyspareunia were enrolled. At first examination, levator hiatal area (LHA) assessed with 3D/4D transperineal ultrasound, pain symptoms, urinary, bowel, and sexual functions were evaluated. Then, women were randomly assigned to no intervention (control group) or treatment with five individual sessions of PFP (experimental group), and after four months women underwent a second examination. Urinary, bowel, and sexual functions were assessed with validated questionnaires at first and second examinations. In particular, the Bristol Female Lower Urinary Tract Symptoms questionnaire was used to evaluate urinary symptoms, the Knowles-Eccersley-Scott-Symptom questionnaire to assess the presence of constipation, and the Female Sexual Function Index to investigate sexual function. Study outcomes were the comparisons among groups in terms of differences in actual changes in median of questionnaire scores between first and second examinations. Results : Thirty women (17 in the experimental group and 13 in the control group) completed the study. No significant differences were found between the two groups regarding urinary, bowel, and sexual functions, although women in the experimental group showed a tendency towards an improvement in constipation symptoms. Conclusion : In women with DIE, PFP does not appear to affect urinary, bowel, and sexual functions. Therefore, despite the improvement in superficial dyspareunia, chronic pelvic pain, and PFM relaxation with high treatment satisfaction, women should be informed about the unclear impact of PFP on urinary, bowel, and sexual functions. Larger studies are necessary to further investigate the impact of PFP on these functions.

Del Mistro, A., et al. (2019). "Five-year risk of CIN3 after short-term HPV-DNA negativity in cytology-negative women: a population-based cohort study." BJOG : an international journal of obstetrics and gynaecology 126(11): 1365-1371.
	Objective: To assess the 5-year risk of high-grade lesions in women with a transient high-risk HPV infection.; Design: Population-based cohort study.; Setting: HPV primary testing within population-based organised cervical cancer screening programmes.; Population: Italian women enrolled in seven pilot projects and attending the second round.; Methods: On the basis of the cytology triage performed on HPV-positive women, immediate colposcopy or HPV repeat at 12 months was recommended. Data were collected at the subsequent round 3-4 years after HPV infection clearance.; Main Outcome Measures: Rates of HPV infection, CIN2+ and CIN3+ detection at subsequent round after HPV clearance, and relative risks (RR) in comparison with HPV-negative women (with 95% confidence interval).; Results: Data on 1230 women (1027 aged 25-64 years and 203 aged 35-64 years) have been analysed. Overall compliance with repeat HPV testing was 84%. In comparison with HPV-negative women, those with a transient HPV infection had higher proportions of HPV positivity (15% versus 3.7%) and of CIN2+ lesions (0.87% versus 0.23%) in round two; most of these (7/10) were CIN2; no cancers were detected, and CIN3 occurred in 3/1230 (0.24%).; Conclusions: HPV-based protocols for cervical cancer screening allow long intervals for HPV-negative women; it is important to monitor the clinical outcome in the women with transient high-risk HPV infection. CIN3 detection is similar to that observed in routine European cytology-based screening programmes (CIN3+: 2.7‰); 5-year intervals may provide reasonable protection but longer intervals are not recommended.; Tweetable Abstract: A screening interval of 5 years (but no longer) appears safe in women with transient HPV detection. (© 2019 Royal College of Obstetricians and Gynaecologists.)

Del Riccio, M., et al. (2023). "The clinical impact of continued smoking in patients with breast and other hormone-dependent cancer: A systematic literature review." Critical Reviews in Oncology/Hematology 184: 103951.
	We conducted a systematic review of studies that investigated whether quitting smoking at or around diagnosis improves survival of patients with hormone-dependent cancers (HDC). Nine studies published in 2013-2022 were included. Studies were very diverse in terms of design, definition of quitters and continued smokers, and prevalence of prognostic factors other than smoking cessation (e.g. patients' demographics, tumour characteristic, and treatments). For breast, ovarian, and endometrial cancer, all included studies found that quitters had better overall, disease specific, and disease-free survival than continued smokers. For prostate cancer, there was no evidence of an association of smoking cessation with improved survival. This literature review provided suggestive evidence that female smokers diagnosed with cancer of the breast, ovary, or endometrium may improve their chances of surviving by stopping smoking. Smoking cessation counselling should become part of standard oncological care for these patients and integrated into breast cancer screening programs. (Copyright © 2023 Elsevier B.V. All rights reserved.)

Delangle, R., et al. (2019). "The Use of microRNAs in the Management of Endometrial Cancer: A Meta-Analysis." Cancers 11(6).
	Introduction: Endometrial cancer (EC) is the most important gynecological cancer in terms of incidence. microRNAs (miRs), which are post-transcriptional regulators implicated in a variety of cellular functions including carcinogenesis, are particularly attractive candidates as biomarkers. Indeed, several studies have shown that the miR expression pattern appears to be associated with prognostic factors in EC. Our objective is to review the current knowledge of the role of miRs in carcinogenesis and tumor progression and their association with the prognosis of endometrial cancer. Materials and Method: We performed a literature search for miR expression in EC using MEDLINE, PubMed (the Internet portal of the National Library of Medicine) and The Cochrane Library, Cochrane databases "Cochrane Reviews" and "Clinical Trials" using the following keywords: microRNA, endometrial cancer, prognosis, diagnosis, lymph node, survival, plasma, FFPE (formalin-fixed, paraffin-embedded). The miRs were classified and presented according to their expression levels in cancer tissue in relation to different prognostic factors. Results: Data were collected from 74 original articles and 8 literature reviews which described the expression levels of 261 miRs in ECs, including 133 onco-miRs, 110 miR onco-suppressors, and 18 miRs with discordant functions. The review identified 30 articles studying the expression pattern of miR in neoplastic endometrial tissue compared to benign and/or hyperplastic tissues, 12 articles detailing the expression profile of miRs as a function of lymph node status, and 14 articles that detailed the expression pattern of miRs in endometrial tumor tissue according to overall survival or in the absence of recurrence. Conclusions: The findings presented here suggest that miR analysis merits a role as a prognostic factor in the management of patients with endometrial cancer.

Delangle, R., et al. (2020). "Anti-NMDA receptor encephalitis associated with ovarian tumor: the gynecologist point of view." Archives of Gynecology and Obstetrics 302(2): 315-320.
	Background: Anti-NMDA receptor antibody (anti-NMDAr) encephalitis, although still a rare condition, is well known to neurologists as it is the leading cause of non-infectious acute encephalitis in young women. However, this is less well known to gynecologists, who may have a decisive role in etiological management. Indeed, in 30-60% of cases in women of childbearing age, it is associated with the presence of an ovarian teratoma, whose removal is crucial in the resolution of symptomatology. Objective(s): Primary objective of our work was to present a review in a very schematic and practical way for gynecologists, about the data on anti-NMDAr encephalitis in terms of epidemiology, clinical symptomatology, treatment and prognosis. The second objective was to propose a decision tree for gynecologists to guide them, in collaboration with neurologists and anesthesiologists, after the diagnosis of NMDAr encephalitis associated with an ovarian mass. Method(s): We conducted an exhaustive review of existing data using PubMed and The Cochrane Library. Then, we illustrated this topic by presenting two typical cases from our experience. Result(s): Anti-NMDA antibody encephalitis association with an ovarian teratoma is common, especially in women of reproductive age. Complementary examinations in search of an ovarian teratoma must therefore be systematic to envisage a possible surgical excision that may improve patient prognosis. Conclusion(s): Anti-NMDA antibody encephalitis should not be ignored by gynecologists whose role in management is central.Copyright © 2020, Springer-Verlag GmbH Germany, part of Springer Nature.

Delara, R., et al. (2020). "Surgical or imaging lymph node assessment in locally advanced cervical cancer: a systematic review and meta-analysis." Journal of Gynecologic Oncology 31(6): e79.
	Objective: To evaluate the survival impact of imaging vs surgical nodal assessment in patients with cervical cancer stage IB2-IVA prior to definitive chemoradiotherapy (CRT).; Methods: PubMed, MEDLINE, Cochrane Library, and ClinicalTrials.gov were used to search for publications in English and Chinese over a 50-year period. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols was used to conduct this review. Inclusion criteria were studies that compared survival outcomes in International Federation of Gynecology and Obstetrics 2009 stage IB2-IVA cervical cancer patients with pre-therapy pelvic and/or aortic lymphadenectomy (LND) or imaging. One or more of the following modalities were used for nodal assessment: computed tomography (CT), magnetic resonance imaging, or positron emission tomography-CT. The National Institutes of Health Quality Assessment Tool was utilized to assess study quality.; Results: The initial search identified 65 studies, and five met the inclusion criteria. There were a total of 1,112 patients. Seven hundred and fifty-four underwent pelvic and/or aortic LND and 358 had imaging. When compared to LND, imaging had a sensitivity and specificity of 88.9% and 22.2% for pelvic lymph node (LN), and 33%-62.5% and 92%-95.5% for para-aortic LN. There were no differences in progression-free survival (PFS) (hazard ratio [HR]=1.13; 95% confidence interval [CI]=0.73-1.74; I²=75%; p<0.01) and overall survival (OS) (HR=1.06; 95% CI=0.66-1.69; I²=75%; p<0.01) between surgical and imaging nodal assessment.; Conclusions: Imaging and surgical nodal assessment has comparable PFS and OS in patients with cervical cancer stage IB2-IVA.; Trial Registration: PROSPERO Identifier: CRD42020155486.; Competing Interests: No potential conflict of interest relevant to this article was reported. (Copyright © 2020. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology.)

Delecourt, C., et al. (2022). "Benefits of AirSeal System in Laparoscopic Hysterectomy for Benign Condition: a Randomized Controlled Trial." Journal of Minimally Invasive Gynecology 29(8): 1003‐1010.
	STUDY OBJECTIVE: To compare the AirSeal insufflation system with the standard insufflation system for postoperative abdominal pain after laparoscopic hysterectomy for benign pathology. DESIGN: Randomized controlled trial. SETTING: Teaching Hospital La Conception, Marseille, France, February 2018 to July 2020. PATIENTS: A total of 80 patients scheduled for a laparoscopic hysterectomy for benign pathology (40 per group). INTERVENTION: Laparoscopic hysterectomy using the AirSeal insufflation system with a pneumoperitoneum between 8 and 10 mm Hg compared with the standard insufflation system with a pneumoperitoneum between 12 and 15 mm Hg. MEASUREMENTS AND MAIN RESULTS: The primary end point was abdominal pain at 6 hours after the end of surgery, assessed by a Simple Numerical Scale from 0 to 10. The secondary end points were intraoperative (operating time and difficulty of the surgery felt by the operator), early postoperative (intensity of abdominal and scapular pain at H0 [end of surgery], H2 [two hours after the end of surgery, H12 [twelve hour after the end of surgery], H24 [twenty four hours after the end of surgery], H48 [fourty eight hours after the end of surgery]), and late postoperative (late postoperative complication, estimated time to return to normal life, and overall patient satisfaction assessed by the SF‐12 general health survey). The median values for abdominal pain were not different between the 2 groups at 6 hours (AirSeal group median, 0; interquartile range, 2 vs standard laparoscopy group median, 1; interquartile range, 2; p = .41). The abdominal and scapular pain values were similar in both groups at all postoperative times. There were no differences between the groups regarding secondary end points. CONCLUSION: Use of the AirSeal insufflation system with low‐pressure pneumoperitoneum in laparoscopic hysterectomy for a benign indication did not reduce postoperative abdominal and scapular pain.

Deligiannidis, K., et al. (2023). "Improvement in HAMD-17 Subscale Scores with 14-Day Treatment Course of Zuranolone in Postpartum Depression: Results from the SKYLARK Study." Obstetrics and Gynecology 141(5 Supplement 1): 64S-65S.
	INTRODUCTION: Postpartum depression (PPD) is a serious perinatal complication. SKYLARK (phase 3, randomized, double-blind, placebo-controlled trial [NCT04442503]) evaluated zuranolone, an investigational, neuroactive steroid positive allosteric modulator of both synaptic and extrasynaptic GABA(A) receptors, in adult patients with PPD. The primary endpoint, change from baseline (CFB) in HAMD-17 total score at day 15, was met. Zuranolone was generally well tolerated. The HAMD-17 can be divided into subscales that group specific items from the HAMD-17 scale that measure different aspects of depression presentation. Here, we present HAMD-17 subscale data from SKYLARK. METHOD(S): Patients aged 18-45 years with severe PPD (HAMD 17 total score $26) were randomized 1:1 to oral, once-daily zuranolone 50 mg or placebo for 14 days. The secondary endpoint was day 15 CFB in HAMD-17 subscale (Core Depression, Anxiety, Bech-6, Maier) scores. Subscales were analyzed separately by a mixed-effects model for repeated measures. Institutional review board approval was obtained. RESULT(S): One hundred ninety-five patients (zuranolone, 98; placebo, 97) were randomized, received study drug, and had valid baseline and one or more post-baseline efficacy assessments. At day 15, patients receiving a 14-day treatment course of zuranolone showed nominally significant improvements across all HAMD-17 subscales versus placebo (least squares mean [SE] CFB treatment difference: Core Depression, 25.9 [2.4], P 5.0151; Anxiety, 25.7 [2.3], P 5.0123; Bech-6, 28.6 [3.0], P 5.0040; Maier, 27.6 [2.6], P 5.0041). Improvement in all subscales was observed starting at day 3. CONCLUSION(S): In SKYLARK, zuranolone was associated with rapid improvement in depressive and anxiety symptoms in patients with PPD across multiple domains, supporting its development as a potential oral, rapid-acting treatment option for PPD.

Deligiannidis, K., et al. (2021). "Rapid and Sustained Improvement in Concurrent Symptoms of Depression and Anxiety in a Post Hoc Analysis of Zuranolone Treatment in Postpartum Depression." Biological psychiatry 89(9): S157.
	Background: Zuranolone demonstrated improvements in depressive and anxiety symptoms versus placebo from a Phase 3 (NCT02978326; ROBIN) trial in postpartum depression (PPD). This post‐hoc analysis evaluated concurrent remission of depressive and anxiety symptoms. Methods: Women (n=151) ages 18‐45, ≤6 months postpartum, with PPD and Hamilton Rating Scale for Depression (HAMD‐17) total score ≥26, were randomized 1:1 to zuranolone 30mg or placebo for 2 weeks, with 4 weeks follow‐up. Change from baseline (CFB) in HAMD‐17 score (Day 15; primary endpoint), Montgomery‐Åsberg Depression Rating Scale (MADRS), Hamilton Rating Scale for Anxiety (HAM‐A) were evaluated. Concurrent anxiety and depression remission were defined two ways: (1) HAMD‐17≤7+HAM‐A≤7, or (2) MADRS≤10+HAM‐A≤7. Sustained remission was defined as meeting concurrent remission criteria on both Day 15 and Day 45. Adjusted odds ratios were calculated using generalized estimating equation models. Results: Zuranolone demonstrated statistically significant Day 15 CFB versus placebo in HAMD‐17 total score (primary endpoint: ‐17.8 vs. ‐13.6, p=0.0028). A significantly higher proportion of zuranolone‐treated patients achieved concurrent remission of anxiety and depression (all p<0.05) as early as Day 3 and sustained remission on Days 15 and 45. The likelihood of achieving concurrent remission was significantly higher among zuranolone‐treated patients at Day 15 and Day 45 (odds range: 2.35–3.45 times higher versus placebo). Sustained remission was also significantly higher among zuranolone‐treated patients (odds range: 3.71–6.21). Conclusions: Zuranolone demonstrated rapid (Day 3) and sustained (Day 45) improvements in core depression symptoms, as well as sustained concurrent remission of depression and anxiety symptoms at Days 3, 15, and 45. Supported By: This study was sponsored by Sage Therapeutics, Inc. Keywords: Zuranolone, Postpartum Depression, Neuroactive Steroid, Anxiety, Sleep Disorder

Deligiannidis, K., et al. (2021). "Evaluation of Insomnia Symptoms in a Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial of Zuranolone in Postpartum Depression." Biological psychiatry 89(9): S91.
	Background: Zuranolone is an investigational, oral neuroactive steroid GABAA receptor positive allosteric modulator with improvements in depressive and anxiety symptoms versus placebo from a Phase 3 (NCT02978326; ROBIN) trial in postpartum depression (PPD). This ROBIN trial post‐hoc analysis evaluated insomnia symptoms, a common comorbidity in PPD. Methods: Women (n=151) aged 18‐45 years, ≤6 months postpartum, with PPD (major depressive episode beginning in 3rd trimester or ≤4 weeks postpartum) and a 17‐Item Hamilton Rating Scale for Depression (HAMD‐17) total score ≥26, were randomized 1:1 to zuranolone 30 mg or placebo for 2 weeks, with 4 weeks follow‐up. Change from baseline (CFB) in HAMD‐17 total score (Day 15; primary endpoint) and the Montgomery‐Åsberg Depression Rating Scale (MADRS; secondary endpoint) were evaluated using a mixed‐effects model for repeated measures (MMRM). The HAMD‐17 insomnia subscale (HAMD‐17‐Ins) and MADRS individual insomnia item (MADRS‐Ins) scores were evaluated post‐hoc (not adjusted for multiplicity) using an MMRM. Results: Zuranolone demonstrated statistically significant Day 15 CFB versus placebo in HAMD‐17 total score (‐17.8 vs. ‐13.6, P=0.0028), MADRS (‐22.1 vs. ‐17.6, P=0.0180), and associated insomnia sub‐scales/items (difference zuranolone vs. placebo; HAMD‐17‐Ins: ‐1.003, P=0.0038; MADRS‐Ins: ‐0.773, P=0.0116). Significant CFB in insomnia sub‐scales/items favoring zuranolone were observed by Day 3 (HAMD‐17‐Ins: ‐0.841, P=0.0142; MADRS‐Ins: ‐0.710, P=0.017) and at Day 45 (HAMD‐17‐Ins: ‐0.730, P=0.0207; MADRS‐Ins: ‐0.636, P=0.0221). Most common (≥5%) adverse events were somnolence, headache, dizziness, upper respiratory tract infection, diarrhea, and sedation. Conclusions: Zuranolone demonstrated rapid (Day 3) and sustained (Day 45) improvements in insomnia‐related symptoms compared with placebo. Funding Source: This study was sponsored by Sage Therapeutics, Inc. Keywords: Zuranolone, Postpartum Depression, Neuroactive Steroid, Insomnia, Sleep Disorder

Deligiannidis Kristina, M., et al. (2023). "Effect of Zuranolone on Concurrent Anxiety and Insomnia Symptoms in Women With Postpartum Depression." The Journal of Clinical Psychiatry 84(1).
	Objective: Concurrent anxiety and/or insomnia symptoms in women with postpartum depression (PPD) are common and associated with more severe PPD. The effects of zuranolone on concurrent anxiety and/or insomnia symptoms and on patient-perceived functional health in women with PPD in the ROBIN study are reported.; Methods: The phase 3, double-blind, randomized, placebo-controlled trial (conducted January 2017-December 2018) included women aged 18-45 years, ≤ 6 months postpartum, with PPD (onset of DSM-5 -defined major depressive episode in the third trimester or ≤ 4 weeks postpartum) and baseline 17-item Hamilton Depression Rating Scale (HDRS-17) total score ≥ 26. Women were randomized 1:1 to once-daily oral zuranolone 30 mg (n = 77) or placebo (n = 76) for 14 days with follow-up through day 45. Concurrent remission of depressive and anxiety symptoms (Hamilton Anxiety Rating Scale total score ≤ 7 plus HDRS-17 total score ≤ 7 or Montgomery-Asberg Depression Rating Scale total score ≤ 10), improvement in insomnia symptoms, patient-perceived functional health, and treatment effect sizes described by number needed to treat (NNT) were assessed. Analyses were exploratory; P values are nominal.; Results: Rates of concurrent remission of depressive and anxiety symptoms were higher with zuranolone versus placebo (P < .05) at days 3, 15, and 45; the rate of sustained concurrent remission (ie, at both days 15 and 45) was also higher with zuranolone ( P < .05). Anxiety symptoms (assessed by HDRS-17 anxiety/somatization subscale and Edinburgh Postnatal Depression Scale anxiety subscale) improved with zuranolone versus placebo ( P < .05) at days 3 through 45. Potential benefits on insomnia symptoms and patient-perceived functional health were observed. Day 15 NNTs were 5 for both HDRS-17 response and remission.; Conclusions: Zuranolone was associated with concurrent improvements in depressive and anxiety symptoms, with beneficial effects on insomnia symptoms and patient-perceived functional health in adults with PPD.; Trial Registration: ClinicalTrials.gov identifier: NCT02978326. (© Copyright 2023 Physicians Postgraduate Press, Inc.)

Deligiannidis Kristina, M., et al. (2022). "Effect of transcutaneous auricular vagus nerve stimulation on major depressive disorder with peripartum onset: A multicenter, open-label, controlled proof-of-concept clinical trial (DELOS-1)." Journal of Affective Disorders 316: 34-41.
	Background: Postpartum depression has a high prevalence in the United States (~13 %) and often goes undertreated/untreated. We conducted a multicenter, open-label, proof-of-concept trial to assess the Nēsos wearable, non-invasive, transcutaneous auricular vagus nerve stimulation (taVNS) system for the treatment of major depressive disorder with peripartum onset (PPD).; Methods: Women (n = 25), ages 18 to 45, within 9 months postpartum, and diagnosed with PPD were enrolled at 3 sites. The study included 6 weeks open-label therapy and 2 weeks observation. Efficacy outcomes included change from baseline (CFB) in Hamilton Rating Scale for Depression (HAMD17) total scores, HAM-D17 response and remission, and patient and clinician global impression of change (PGIC, CGIC) scores. Analysis included descriptive statistics and mixed-effects models for repeated measures.; Results: The most common AEs (≥5 %) were discomfort (n = 5), headache (n = 3), and dizziness (n = 2); all resolved without intervention. No serious AEs or deaths occurred. Baseline mean HAM-D17 score was 18.4. Week 6 least squares (LS) mean CFB in HAM-D17 score was -9.7; 74 % achieved response and 61 % achieved remission. At week 6, at least some improvement was reported by 21 of 22 (95 %) clinicians on CGIC and 22 of 23 (96 %) participants on PGIC.; Limitations: This was a single-arm, open-label study, and enrollment was limited to participants with mild-to-moderate peripartum depression.; Conclusion: Results from this proof-of-concept study suggest that the Nēsos taVNS system is well tolerated and may be an effective non-invasive, non-pharmacological treatment for major depressive disorder with peripartum onset. Further evaluation in larger sham-controlled studies is needed.; Clinicaltrials: govNCT03972995. (Copyright © 2022 Elsevier B.V. All rights reserved.)

Della Corte, L., et al. (2023). "Is There Still a Place for Surgery in Patients with PCOS? A Review." Life (Basel, Switzerland) 13(6).
	OBJECTIVE: The surgical management of polycystic ovary syndrome (PCOS) represents an unclear option compared to medical therapy, and it is necessary to deepen the role of minimally invasive surgery, represented by laparoscopic ovarian drilling (LOD) and transvaginal hydrolaparoscopy (THL), for the treatment of PCOS in infertile women resistant to drug therapy and to establish its success in terms of ovulation and pregnancy rates. METHODS: A search was performed in the main electronic databases (MEDLINE, EMBASE, Web of Science, PubMed, and the Cochrane Library) from 1994 to October 2022 in order to evaluate the role of surgery in patients with PCOS resistant to pharmacological treatment. Only original scientific articles in English were included. RESULTS: Seventeen studies were analyzed in this review. In all analyzed studies, more than 50% of the population underwent spontaneous ovulation after surgical treatment without great differences between the two surgical techniques (LOD and THL). More than 40% of patients delivered, with a higher rate after LOD, although eight ectopic pregnancies and sixty-three miscarriages were reported. A lower risk of adhesion formation after THL has been reported. No clear data regarding the effect of surgery on the regularization of the menstrual cycle has been described. A reduction in LH and AMH serum levels as well as the LH/FSH ratio compared to preoperative levels for both surgical techniques has been described. CONCLUSIONS: Despite the scarcity and heterogeneity of data, surgical therapy could be considered an effective and safe approach in the management of PCOS patients with resistance to pharmacological treatment who desire to become pregnant.

Della Corte, L., et al. (2023). "Medical and Surgical Strategies in Vulvar Paget Disease: Let's Throw Some Light!" Journal of Personalized Medicine 13(1): 100.
	Background: Vulvar Paget's disease (VPD) is defined as a neoplasm of epithelial origin, mostly in postmenopausal women. Due to the extreme rarity of VPD, limited data about recommended treatment options are available. Surgical excision has been the treatment of choice although in the recent decade medical treatments have been proposed. Method(s): A systematic computerized search of the literature was performed in the main electronic databases (MEDLINE, EMBASE, Web of Science, PubMed, and Cochrane Library), from 2003 to September 2022, in order to analyze all medical and surgical strategies used for the treatment of VPD. Result(s): Thirty-four articles were included in this review with findings as follows: 390 patients were treated with medical or other conservative treatment while 2802 patients were treated surgically; 235/434 (54%) patients had a complete response, 67/434 (15%) a partial response, 10/434 (2.3%) a stable disease, 3/434 (0.7%) disease progress, 3/434 (0.7%) died of the disease, 55/434 (13%) died of other causes during follow up while 7/434 (1.6%) had to stop topical treatments with 5% imiquimod cream because of side effects; 239/434 patients (55%) had a recurrence and 11/434 (2.5%) were lost to follow-up. The length of follow-up was variable, according to the different studies analyzed. Conclusion(s): VPD is a chronic disease with a high recurrence rate and low mortality. There are no significant differences in recurrence rates in patients who undergo surgery and those who do not and the margin status at the time of primary surgery and recurrence. Several surgical and medical approaches providing both local control of the disease and minimal tissue damage have been developed. Clock mapping, a recent preoperative vulvo-vaginal workup tool, can predict the invasiveness and the extension of VPD. However, to date, due to the different treatment options available and in the absence of a global consensus, it is critical to tailor treatments to individual patient characteristics and biopsy histopathologic findings, to ensure the best type of therapy.Copyright © 2023 by the authors.

Della Corte, L., et al. (2023). "Hyperthermic Intraperitoneal Chemotherapy (HIPEC): New Approaches and Controversies on the Treatment of Advanced Epithelial Ovarian Cancer-Systematic Review and Meta-Analysis." Journal of Clinical Medicine 12(22).
	Background: Hyperthermic intraperitoneal chemotherapy (HIPEC) after cytoreductive surgery has been extensively studied in patients with peritoneal carcinomatosis, and it holds promise as a therapeutic strategy, but its role remains elusive. The aim of this study was to assess the existing evidence for the use or not of HIPEC in primary debulking surgery (PDS), interval debulking surgery (IDS), and recurrent ovarian cancer (ROC), evaluated in terms of survival rates and post-surgical morbidity.; Methods: Medline, Pubmed, Cochrane, and Medscape were systematically searched for any article comparing the use of HIPEC treatment with any other therapy in patients with ovarian cancer in PDS, IDS, and ROC. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines were followed. We only considered English-language published studies.; Results: We included 14 studies, including two RCTs with a total of 1813 women, published between 2003 and 2023 with a recruitment period between 1998 and 2020. In PDS, there were no differences in progression-free survival (PFS) between HIPEC and controls [MD -5.53 months [95% CI -19.91 to 8.84 months]; I 2 = 96%]. Conversely, in patients treated with NACT, pooled results showed a significant survival advantage in terms of progression-free survival (PFS) and overall survival (OS) in the combined HIPEC plus IDS group rather than surgery alone [PFS: MD 4.68 months (95% CI 3.49 to 5.86 months, I 2 = 95%); OS: MD 11.81 months (95% CI 9.34 to 14.27 months); I 2 = 97%]. Concerning ROC patients, pooled MD did not show either a significant PFS difference between intervention and controls [MD 2.68 months (95% CI 433 to 9.70 months); I 2 = 95%], and OS significant difference (MD 6.69 months [95% CI -9.09 to 22.47 months]; I 2 = 98%). Severe post-operative complications (≥grade 3) were available in 10 studies, accounting for 1108 women. Overall, there was a slightly but significantly increased risk with the combined approach compared to controls [RR 1.26 (95% CI 1.02 to 1.55); I 2 = 0%].; Conclusions: The combination of HIPEC with cytoreductive surgery prolongs OS and PFS in advanced epithelial ovarian cancer after NACT with acceptable morbidity. However, additional trials are still needed to determine the effectiveness of HIPEC in primary and recurrence settings. In the era of personalized medicine, the correlation between the efficacy of HIPEC and biological and molecular findings represents a challenge for the future of ovarian cancer.

Della Corte, L., et al. (2024). "The role of liquid biopsy in epithelial ovarian cancer: State of the art." Critical Reviews in Oncology/Hematology 194: 104263.
	The clinical implementation of liquid biopsy has dramatically modified the analytical paradigm for several solid tumors. To date, however, only circulating free DNA (cfDNA) has been approved in clinical practice to select targeted treatments for patients with colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and breast cancer (BC). Interestingly, emerging liquid biopsy analytes in peripheral blood, including circulating tumor cells (CTC), miRNA, and extracellular vesicles (EVs), have been shown to play a crucial role in the clinical management of solid tumor patients. Here, we review how these blood-based biomarkers may positively impact early diagnosis, prognosis, and treatment response in ovarian cancer (OC) patients.Copyright © 2024 Elsevier B.V.

Dellino, M., et al. (2022). ""Intestinal-Type" Vulvar Adenocarcinoma: A Review of the MITO Rare Tumors Group." Cancers 14(20).
	Intestinal-type adenocarcinoma (VAIt) represents a sporadic variant of vulvar carcinoma. It appears frequently localized to epithelial glands in the vulvar region, and it probably derives from cloacal remnants persisting in the adult. We performed a systematic review of the limited cases reported in the literature, with the intent to assess the specific peculiarities of this rare neoplasia and to state consistent management recommendations. The principal histological VAIt characteristic is that it resembles mucinous colonic carcinomas. Therefore, immunohistochemical workup, with different tumor markers including CK20, CDX2, and CK7 staining, is needed. To confirm vulvar origin, a thorough diagnostic, and radiological examination is required to rule out other primary malignancies. The gold standard of treatment for VAIt is surgery, with local excision with tumor-free margins. Lymph node staging is an option advised if the tumor size is >2 cm or if lymph node metastases are suspected on imaging. On the other hand, the role of neoadjuvant therapy is still in doubt, but a good response to adjuvant chemotherapy treatments has been described in both advanced and recurrent diseases. Sometimes, VAIt behavior can be unpredictable, with relapses even after many years, so more experiences and longer follow-up periods are needed to elucidate the best therapeutic management and its long-term prognosis.

dell'Insubria Università degli, S. and d. Verona Universita (2022). Effects of Oral Inositol Supplementation on Obstetrics Outcomes in PCOS Women.
	No Results Available Dietary Supplement: Inositol + Folic acid|Dietary Supplement: Folic acid Gestational diabetes prevalence|Preeclampsia prevalence|Birth weight|Weight gain in pregnancy Female Not Applicable 80 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment IPOSI-1 December 31, 2026

Dell'Orto, F., et al. (2019). "Feasibility of sentinel lymph node mapping of the ovary: a systematic review." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 29(7): 1209-1215.
	Pelvic and para-aortic lymphadenectomy is routinely performed in early ovarian cancer to define the stage of the disease. However, it may be associated with increased blood loss, operative time, and length of hospitalization. The sentinel lymph node technique has been shown to be safe and feasible in vulvar, uterine, and cervical cancer. Data detailing feasibility and outcomes of sentinel lymph node mapping in ovarian cancer are scarce.To summarize the studies evaluating the feasibility of sentinel lymph node detection from the ovary, examining the technique and detection rate.A systematic search of the literature was performed using PubMed and Embase from June 1991 to February 2019. Studies describing the sentinel lymph node technique and lymphatic drainage of the ovaries were incorporated in this review. Ten articles were selected, comprising a total of 145 patients. A variety of agents were used, but the primary markers were technetium-99m radiocolloid (Tc-99m), patent blue, or indocyanine green, and the most common injection site was the ovarian ligaments.The overall sentinel lymph node detection rate was 90.3%.We propose a standardized technique sentinel lymph node mapping in ovarian cancer, using indocyanine green, or Tc-99m and blue dye as alternative tracers, injected in both the suspensory and the infundibulopelvic ligament of the ovary.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Delomenie, M., et al. (2019). "The clinical implication of lymph nodes micrometastases and isolated tumor cells in patients with cervical cancer: A systematic review." European Journal of Obstetrics, Gynecology, and Reproductive Biology 241: 71-76.
	Lymph node macroscopic involvement in cervical cancer is a well-known prognostic factor, allows the gynecologic-oncologist to identify women at increased risk for recurrence. Since the development of sentinel node biopsy, micrometastases (MMs) and Isolated Tumor Cells (ICTs) have been increasingly identified in cervical cancer, however their prognostic value and treatment are still controversial. We reviewed the literature (MEDLINE and EMBASE database analysis) from inception up to January 2019, concerning the incidence of lymph nodes MMs and ITCs in cervical cancer, their controversial histologic and molecular biology definition, their anatomic distribution, the role of frozen section and the prognostic value and treatment options for women diagnosed with lymph nodes MMs/ITCs. (Copyright © 2019 Elsevier B.V. All rights reserved.)

DeMairo, J., et al. (2023). "Outcomes at the Motherhood Center: A Comparison of Virtual and On-Site Versions of a Specialized Perinatal Partial Hospitalization Program." Maternal and Child Health Journal.
	OBJECTIVES: Remotely administered mental health care is becoming increasingly common for treatment of a range of psychiatric disorders; however, there is a dearth of literature overviewing direct comparisons between remote and in-person interventions for treatment of Perinatal Mood and Anxiety Disorders (PMADs). The sudden advent of the Covid-19 pandemic in New York City forced an abrupt conversion for an intensive day treatment program for new mothers with PMADs, from an on-site to a remote program. METHODS: The current report compares outcomes of 81 women who completed the program in-person to those of 60 women who completed the program remotely. RESULTS: Improvement in depression scores was statistically superior in the remote program, and improvement in mother-infant bonding was statistically equivalent between the on-site and remote programs. DISCUSSION: These findings indicate that specialized partial hospitalization treatment for individuals with moderate to severe psychiatric illness can be effectively provided via telehealth, thus offering improved convenience, accessibility, and safety without compromising care. We conclude that remotely administered group psychotherapy is an effective intervention for women with moderate to severe PMADs.

Demian, G., et al. (2022). "Endometrial receptivity analysis (ERA) for a personalized embryo transfer (pET) in assisted reproductive technology: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Demir, E., et al. (2022). "Outcomes between non-IVF and IVF treatment after laparoscopic conservative surgery of advanced endometriosis with Endometriosis Fertility Index score >3." Medicine 101(37): e30602.
	Surgical excision of advanced endometriosis has been demonstrated to improve women's pain symptoms and quality of life in women in randomized placebo-controlled trials, but there is no strong evidence regarding the live birth rate. The revised American Fertility Society (r-AFS) classification for endometriosis has a limited predictive ability for fertility outcomes after surgery; therefore, EFI scoring has been advised for predicting conception after endometriosis surgery. No randomized controlled trials have investigated fertility outcomes in patients with advanced endometriosis after surgery. This study aimed to determine the outcomes of in vitro fertilization (IVF) or non-IVF treatments after conservative surgery for advanced endometriosis in patients with good prognosis Endometriosis Fertility Index (EFI) scores (>3). This prospective cohort study was conducted between April 2014 and April 2019 at a tertiary research hospital. In total, 113 women with suspected preoperative advanced endometriosis were enrolled in this study. A total of 90 women with advanced endometriosis underwent laparoscopic surgery. Fourteen patients with EFI score of ≤3 and 3 of them who had bilateral tubal occlusion were also excluded. Seventy-three women were included in this study. The remaining 30 women in the non-IVF group and 32 women in the IVF group were analyzed. The main outcome measures were cumulative pregnancy rates and live birth rates in both groups. Women who underwent IVF treatment were older than women (30 ± 3.41) who had non-IVF treatment (26.5 ± 3.07) after laparoscopic surgery (P < .001). The remaining baseline characteristics of the patients in both groups were similar. Clinical pregnancy, abortion, and live birth rates were similar in both the groups after 36 months of follow-up. This study demonstrated that cumulative pregnancy and live birth rates were similar to those of non-IVF or IVF treatments after conservative surgery for advanced endometriosis, if patients had good prognosis EFI scores. Furthermore, non-IVF treatments resulted in nearly the same clinical pregnancy results as IVF treatment within 1 year after surgery.; Competing Interests: The authors have no funding and conflicts of interests to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Demiralp, O., et al. (2023). "The effect of progressive muscle relaxation technique and myofascial release technique on premenstrual symptoms, blood circulation, and quality of life in women with premenstrual syndrome: A single-blind randomized controlled study." Medicine 102(27): e34223.
	Background: Premenstrual syndrome (PMS) is a common condition in women of reproductive age. It is characterized by a range of behavioral, physical, and psychological symptoms. The aim of this study is to investigate the effects of progressive relaxation and myofascial release technique (MRT) on premenstrual symptoms, blood flow rate, pain, sleep quality and quality of life, in women with PMS.; Method: The study will conduct as a single-blind randomized controlled trial. Study registered at the ClinicalTrial.gov Protocol ID: NCT05836454. The volunteers will be randomized using allocation software to be divided into 3 groups: the progressive muscle relaxation group, the MRT group, and the control group. Assessments will be conducted by another physical therapist who is blinded to the groups. The assessments will include the Premenstrual Syndrome Severity Score, Blood Flow Measurements, Short Form McGill Pain Questionnaire, the Pittsburgh Sleep Quality Index and Short Form-36 Health Survey.; Discussion: Since both methods provide relaxation, improve symptoms and quality of life, they have not been compared to each other in the literature. This prompt to us to plan this study.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.)

Demuytere, J., et al. (2023). "The transcriptomic effects of hyperthermia in cisplatin HIPEC: results from the OVIP trial." European Journal of Surgical Oncology 49(2): e193.
	Background: HIPEC with cisplatin in addition to cytoreductive surgery (CRS) can be a valuable treatment option in stage III epithelial ovarian cancer. Some studies report hyperthermic enhancement of tumor cell killing for cisplatin in vitro and in murine models, and we previously reported a potentially enhanced pharmacokinetic profile of hyperthermic chemoperfusion when compared with normothermic chemoperfusion of cisplatin. However, there is only a very limited amount of human in vivo data on the effects of hyperthermic chemoperfusion on tumor cells. Here, we report a transcriptomic analysis of epithelial ovarian cancer peritoneal metastasis samples post-chemoperfusion of patients enrolled in the OvIP study (NCT02567253), a multicenter randomized trial investigating tumor tissue platinum penetration after normothermic (37degreeC) versus hyperthermic (41degreeC) chemoperfusion with cisplatin at 75 or 120 mg/m2. Material(s) and Method(s): CRS + HIPEC was performed utilizing an open coliseum technique. Patients were randomized to receive normothermic (37degreeC) or hyperthermic (41degreeC) chemoperfusion with cisplatin at 75 or 120 mg/m2 for 90 minutes. Following optimal cytoreduction, two parietal peritoneal index nodules were left during chemoperfusion, and resected for analysis after perfusion. Resected samples were kept in RNALater preservative medium following surgery, and frozen to -80 degrees. All samples were shipped to BGI technologies, Hong Kong, where RNA extraction and RNA-Seq (DNBSeq) was performed. Reads were aligned to GRCh38 using STAR and genes quantified using featureCounts. Differential gene expression was performed using DESeq2 followed by geneset enrichment analyses. Immune cell deconvolution was performed using CIBERSORT. Result(s): We analyzed post-perfusion samples from 37 patients. In accordance with previous in vitro data, hyperthermia induced a clear heat shock response when compared to normothermic chemoperfusion, exemplified by significant upregulation of HSPB1, also known as Hsp27. Additionally an upregulation of genes associated with poor prognosis in several cancers such as FXR1, HIST1H2BK, CKS2 and FKBP4 was observed. Pathways upregulated by hyperthermia included those linked to cisplatin response such as the E2F pathway and the G2M/DNA Damage checkpoints. Relatedly, we observed upregulation of both the mitotic spindle pathway and MTORC1 signaling, both known to be associated with cisplatin resistance. Immune cell deconvolution indiccated a temperature-specific depletion of CD8+ and CD4+ memory cells, with no dose effect. Other cell types were not significantly affected. Conclusion(s): Our results suggest a putative tumor-promoting transcriptomic response to hyperthermia of 41degreeC in ovarian cancer cells, in addition to a possible immune cell depleting effect. These effects potentially outweigh the earlier described in vitro and pharmacokinetic effects of hyperthermia, requiring further investigation.Copyright © 2022

Deng, H., et al. (2023). "Effect of intrauterine infusion of platelet-rich plasma for women with recurrent implantation failure: a systematic review and meta-analysis." Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology 43(1): 2144177.
	This study evaluated the effect of intrauterine perfusion of autologous platelet-rich plasma (PRP) on pregnancy outcomes in women with recurrent implantation failure (RIF). Key biomedical databases were searched to identify relevant clinical trials and observational studies. Outcomes included clinical pregnancy rate, chemical pregnancy rate, implantation rate, live birth rate, and abortion rate. Data was extracted from ten studies (six randomised controlled trials, four cohort studies) involving 1555 patients. Pregnancy outcomes were improved in women treated with PRP compared to controls: clinical pregnancy rate (RR = 1.96, 95% CI [1.67, 2.31], p < 0.00001, I 2 = 46%), chemical pregnancy rate (RR = 1.79, 95% CI [1.54, 2.08], p < 0.00001, I 2 = 29%), implantation rate (RR = 1.90, CI [1.50, 2.41], p < 0.00001, I 2 = 0%), live birth rate (RR = 2.83, CI [1.45, 5.52], p = 0.0007, I 2 = 83%), abortion rate (RR = 0.40, 95% CI [0.18, 0.90], p = 0.03, I 2 = 59%). These data imply PRP has potential to improve pregnancy outcomes in women with RIF, suggesting a promising role in assisted reproductive technology.IMPACT STATEMENT What is already known on this subject? Platelet-rich plasma (PRP) is an autologous blood product that contains platelets, various growth factors, and cytokines at concentrations above the normal baseline level. Recent studies have shown that intrauterine infusion of autologous PRP can improve pregnancy outcomes in infertile women. What do the results of this study add? This systematic review and meta-analysis of data from ten studies ( n = 1555; 775 cases and 780 controls) investigated the effect of intrauterine perfusion of autologous PRP on pregnancy outcomes in women with recurrent implantation failure (RIF). Findings suggest that pregnancy outcomes, including clinical pregnancy rate, chemical pregnancy rate, implantation rate, live birth rate and abortion rate were improved in women treated with PRP compared to controls. What are the implications of these findings for clinical practice and/or further research? RIF remains a challenge for researchers, clinicians, and patients. Our study identified PRP as a potential intervention in assisted reproduction. As an autologous blood preparation, PRP eliminates the risk of an immune response and transmission of disease. PRP is low cost and effective and may represent a new approach to the treatment of patients with RIF.

Deng, J., et al. (2020). "Chinese herbal medicine for previous cesarean scar defect: A protocol for systematic review and meta-analysis." Medicine 99(50): e23630.
	Background: Previous cesarean scar defect (PCSD) is a gynecological disease that can cause bleeding after intercourse, prolonging menstrual period, intermenstrual bleeding, dysmenorrhea, and even lead to infertility. Chinese herbal medicine plays an important role in the treatment of gynecological diseases in China and East Asia. This study aims to assess the efficacy and safety of Chinese herbal medicine for PCSD.; Methods: We search the following databases: PubMed, the Cochrane Library, Chinese Biomedical Literature Database (CB), Chinese Science and Technique Journals Database (VIP), EMBASE, Chinese National Knowledge Infrastructure Database (CNKI), and the Wanfang Database. Other sources will also be searched like Google Scholar and gray literature. All databases mentioned above are searched from the start date to the latest version. Randomized controlled trials will be included which recruiting PCSD participants to assess the efficacy and safety of Chinese herbal medicines against controls (placebo or other therapeutic agents). Primary outcomes will include the size of PCSD, menstrual cycle, menstrual phase, menstrual volume, duration of disease, security index. Two authors will independently scan the searched articles, extract the data from attached articles, and import them into Endnote X8 and use Microsoft Excel 2013 to manage data and information. We will assess the risk of bias by Cochrane tool of risk of bias. Disagreements will be resolved by consensus or the participation of a third party. All analysis will be performed based on the Cochrane Handbook for Systematic Reviews of Interventions. The meta-analysis in this review will use RevMan 5.3 software.; Results: The study aims to evaluate the efficacy and safety of the treatment that Chinese herbal medicine for PCSD.; Conclusion: This study of the meta-analysis could provide evidence for clinicians and help patients to make a better choice.; Inplasy Registration Number: INPLASY202090080.

Deng, T. and Y. Dong (2023). "Effect of aerobic exercise on postoperative rehabilitation and life quality of patients with uterine leiomyoma." European Journal of Gynaecological Oncology 44(2): 130-131.
	Objectives: Uterine leiomyoma is a common benign tumor of women in clinical practice, which will cause a greater negative impact on the life quality of patients. Aerobic exercise can promote lung expansion and accelerate the recovery of the body. Therefore, this research explores the impact of aerobic exercise training on the postoperative rehabilitation and life quality of patients with uterine leiomyoma. Method(s): 88 patients with postoperative uterine leiomyoma admitted to our affiliated hospital from February 2021 to January 2022 were selected as the study subjects. The patients were randomly divided into observation group and control group, with 44 patients in each group. The patients in the observation group took appropriate aerobic exercise training, while the patients in the control group maintained routine treatment and nursing methods. Result(s): The postoperative rehabilitation of the two groups of patients is shown in Table 1. It can be seen that the time of getting out of bed, the first exhaust and the hospital stay in the observation group are shorter than those in the control group, and the difference is statistically significant (p < 0.05). The life quality of patients in the two groups is shown in Table 2. It can be found that the life quality scores in the observation group after aerobic exercise are higher than those in the control group, with a statistically significant difference (p < 0.05). Conclusion(s): The recovery effect of hysteromyoma after operation needs to be improved. Therefore, the effect of aerobic exercise on the postoperative rehabilitation and life quality of patients was explored. The results show that aerobic exercise training can effectively improve the life quality of patients, improve the postoperative rehabilitation effect, and has certain clinical application value..

Deng, T., et al. (2022). "Comparison of platinum monotherapy with concurrent chemoradiation therapy versus platinum-based dual drug therapy with concurrent chemoradiation therapy for locally advanced cervical cancer: a systematic review and meta-analysis." Infectious agents and cancer 17(1): 18.
	Objective: To compare the survival outcomes and adverse events of patients with locally advanced cervical cancer (LACC) who received platinum monotherapy with concurrent chemoradiation therapy (CCRT) versus platinum-based dual drug therapy with CCRT.; Method: All relevant literature was screened form the PubMed, EMBASE, Web of Science, The Cochrane Library and other databases from their establishment to October 2020. The main endpoint indicators included overall survival (OS) and progression-free survival (PFS). Grade 3 and above adverse events induced by chemotherapy were also compared.; Results: This study involved 17 literature and 4,106 patients. There were 2,066 patients treated with CCRT with platinum-based dual drug therapy and 2,040 patients received CCRT with platinum monotherapy. Meta-analysis results showed that, compared to CCRT with platinum monotherapy, OS (HR = 0.68, 95% CI 0.58-0.79) and PFS (HR = 0.67, 95% CI 0.58-0.77) of LACC patients were significantly improved by CCRT with platinum-based dual drug therapy. In addition, CCRT with platinum-based dual drug therapy led to more adverse reactions such as neutropenia (OR = 4.92, 95% CI 3.55-6.84), anemia (OR = 1.99, 95% CI 1.17-3.39), diarrhea (OR = 1.70, 95% CI 1.30-2.22), leukopenia (OR = 2.42, 95%CI 1.84-3.17), thrombocytopenia (OR = 2.87, 95%CI 1.44-5.72), etc. CONCLUSION: CCRT with platinum-based dual drug therapy improved OS and PFS of LACC patients relative to the CCRT with platinum monotherapy. But it also increased the adverse reactions caused by multiple chemotherapy drugs. Thus, it is crucial to select a proper chemotherapy regimen based on the actual tolerance of patients in clinical practice. (© 2022. The Author(s).)

Dengler, K. L., et al. (2021). "Preoperative pudendal block with liposomal and plain bupivacaine reduces pain associated with posterior colporrhaphy: a double-blinded, randomized controlled trial." American Journal of Obstetrics and Gynecology 225(5): 556.e551‐556.e510.
	Background: Pelvic reconstructive surgery may cause significant postoperative pain, especially with posterior colporrhaphy, contributing to a longer hospital stay and increased pain medication utilization. Regional blocks are being increasingly utilized in gynecologic surgery to improve postoperative pain and decrease opioid usage, yet preoperative pudendal blocks have not been used routinely during posterior colporrhaphy. Objective: This study aimed to compare the effect of preoperative regional pudendal nerve block using a combination of 1.3% liposomal and 0.25% plain bupivacaine vs 0.25% plain bupivacaine alone on vaginal pain after posterior colporrhaphy on postoperative days 1, 2, and 3. We hypothesized that there would be a reduction in vaginal pain scores for the study group vs the control group over the first 72 hours. Study Design: This was a double‐blinded, randomized controlled trial that included patients undergoing a posterior colporrhaphy, either independently or in conjunction with other vaginal or abdominal reconstructive procedures. Patients were block randomized to receive 20 mL of either a combination of 1.3% liposomal and 0.25% plain bupivacaine (study) or 20 mL of 0.25% plain bupivacaine (control) in a regional pudendal block before the start of surgery. Double blinding was achieved by covering four 5‐mL syringes containing the randomized local anesthetic. After induction of anesthesia, a pudendal nerve block was performed per standard technique (5 mL superiorly and 5 mL inferiorly each ischial spine) using a pudendal kit. The primary outcome was to evaluate postoperative vaginal pain using a visual analog scale on postoperative days 1, 2, and 3. Secondary outcomes included total analgesic medication usage through postoperative day 3, postoperative voiding and defecatory dysfunction, and impact of vaginal pain on quality of life factors. Results: A total of 120 patients were enrolled (60 in each group). There were no significant differences in demographic data, including baseline vaginal pain (P=.88). Postoperative vaginal pain scores were significantly lower in the combined liposomal and bupivacaine group at all time points vs the plain bupivacaine group. Median pain scores for the study and control groups, respectively, were 0 (0?2) and 2 (0?4) for postoperative day 1 (P=.03), 2 (1?4) and 3 (2?5) for postoperative day 2 (P=.05), and 2 (1?4) and 3 (2?5) for postoperative day 3 (P=.02). Vaginal pain scores increased from postoperative day 1 to postoperative days 2 and 3 in both groups. There was a significant decrease in ibuprofen (P=.01) and acetaminophen (P=.03) usage in the study group; however, there was no difference between groups in total opioid consumption through postoperative day 3 (P=.82). There was no difference in successful voiding trials (study 72%, control 82%, P=.30), return of bowel function (P>.99), or quality of life factors (sleep, stress, mood, and activity). Conclusion: Preoperative regional pudendal block with a combination of liposomal and plain bupivacaine provided more effective vaginal pain control than plain bupivacaine alone for reconstructive surgery that included posterior colporrhaphy. Given the statistically significant decrease in vaginal pain in the study group, this block may be considered as a potential adjunct for multimodal pain reduction in this patient population.

Denisiuk, P. and D. Rachon (2021). "Effects of 6 months treatment with different combined oral contraceptives on the selected metabolic parameters and markers of low-grade inflammation in women with polycystic ovary syndrome." European journal of translational and clinical medicine 4: 23.
	Introduction: Polycystic ovary syndrome (PCOS) apart from ovarian hyperandrogenism is also characterized by peripheral insulin resistance and hyperinsulinemia. The most common therapy of hyperandrogenism is combined oral contraceptive (COC) which apart from ethynylestradiol (EE) contain gestagens with anti‐androgenic properties. These in turn may also have unfavorable metabolic effects. Aim: The aim of study was to evaluate the effects of different COC on the selected metabolic parameters, hormones, lipid concentrations and markers of low grade inflammation (LGI). Subjects and methods: Sixty‐two women with PCOS (age range 17‐34 years) were randomly assigned to treatment with four COC preparations containing 20‐35 ug of EE and different types of progestins (2 mg of dienogest [DNG], 2 mg of cyproterone acetate [CPA], 250 ug of norgestimate [NGS] and 75 ug of gestodene [GSD]) for 6 months. Blood for the analyses was drawn at baseline and 6 months after intervention. Results: After 6 months the BMI, serum glucose, insulin and HOMA‐IR did not change in neither groups. Waist circumference was significantly lower with EE‐DNG (p < 0.05). Serum androgens and FAI decreased significantly in all the study groups (p < 0.05). Serum TSH concentrations increased only in the EE‐CPA group, as well as serum PRL (p < 0.05). Serum TCh increased significantly only in the EE‐DNG and EE‐CPA groups (p < 0.05). HDL‐Ch increased significantly in EE‐DNG, EE‐CPA and EE‐GSD (p < 0.05). Serum LDL‐Ch concentrations decreased significantly only in the EE‐DNG group (p = 0.011). Serum TG increased significantly in all the groups, as well as serum CRP (p < 0.05), whereas WBC increased significantly only in the EE‐NGS and EE‐GSD (p < 0.05). Conclusions: Six months treatment with studied COC do not have any significant effects on serum insulin, glucose and HOMA‐IR, but significantly increase serum TG, markers of LGI in women with PCOS. Some of them also increase serum HDL, TCh and reduce LDL‐Ch.

Dennis, C. L., et al. (2019). "Interventions (other than psychosocial, psychological and pharmacological) for treating postpartum depression." Cochrane Database of Systematic Reviews 2019(11): CD013460.
	This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:. The primary objective of this review is to assess the effects, on mothers and families, of interventions (other than psychosocial, psychological and pharmacological) compared with usual care in postpartum depression. Secondary objectives are to examine the effectiveness of:. specific types of physical therapies (e.g. bright light therapy, physical exercise, yoga, acupuncture, sleep deprivation); specific types of nutraceuticals (e.g. omega-3 fatty acids); specific types of herbal remedies (e.g. St. John's Wort).Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Dennis, C. L., et al. (2020). "Psychosocial and psychological interventions for treating postpartum depression: An updated Cochrane systematic review." Arch. Women's Ment. Health 23(2): 238-None.
	
Dennis, N. and G. Hobson (2023). "Working well: Mitigating the impact of menopause in the workplace - A narrative evidence review." Maturitas 177: 107824.
	review was used to screen initial returns before a subsequent full-text review determined the final studies included. Result(s): Twelve studies were selected for in-depth review: four conducted in the UK, seven in continental Europe and one in South America. The findings of the papers fell into five categories: work ability, improved symptom management, mental wellbeing and empowerment, increased openness about menopause in the workplace, and the impact of management/leadership. None of the included interventions were reported to give a significant improvement in measures of work ability. However, there were improvements in women's wellbeing, and their ability to manage symptoms. Interventions to improve workplace openness and managers' skills were well received by participants. Conclusion(s): The evidence for effective workplace interventions for women experiencing menopause symptoms is currently lacking. There is considerable need for further high-quality evaluations of interventions designed to support women in the workplace.Copyright © 2023 The Authors

Denschlag, D., et al. (2021). "Impact of co-medication on survival in patients with ovarian cancer a analysis of 4 prospective trials of the ago-ovar and engot/ GCIG collaborators." International Journal of Gynecological Cancer 31(SUPPL 1): A214‐A215.
	Introduction/Background There is poor evidence from mostly retrospective series whether co‐medication with metformin, statin or beta‐blocker have an impact on survival in patients with primary ovarian cancer. The aim of this study was to investigate the association of these medications with survival. Methodology Individual data from 3 prospective phase III randomized controlled trials (AGO‐OVAR 11/ICON 7, 12, 16) and one phase II trial (AGO‐OVAR 15) were pooled and analyzed. Patients were either classified as ever‐user if the specific co‐medication was documented at least once during the trial. In. contrast, never‐users served as controls. Data were adjusted for potential confounders (age, FIGO stage, histology, residual tumor after surgery, ECOG performance status, BMI, Charlson Comorbidity Index and assigned treatment within the trial) in multivariate Cox regression analyses. Result(s) Overall, 2.857 patients were included in the analyses. Ever‐users were: N=100 patients received metformin (3.5%), N=226 received statins (7.9%), and N=475 (16.6%) received beta‐blockers (BB) (N=391 selective (sBB); N=84 non‐selective (nsBB)) as co‐medication. There were no significant differences regarding the baseline characteristics (histology, FIGO stage, residual tumor after surgery, and chemotherapy‐schedule) between ever‐ and neverusers except that ever‐users were significantly older and more obese, compared to controls. Median progression‐free (PFS) and overall survival (OS) for the entire cohort was 18.7 months and 60.1 months, respectively Multivariate analyses for PFS and OS including age, BMI, Histology, FIGO stage, residual tumor after surgery, ECOG performance status and CCI revealed neither a significant impact of metformin on survival of ever‐users, compared to never‐users (PFS HR 0.94 95%‐CI 0.69‐1.29, p=0.7; OS HR 0.82 95%‐CI 0.58‐1.17, p=0.28), nor for statins (PFS HR 0.98 95%‐CI 0.82‐1.18, p=0.87; OS HR 0.91 95%‐CI 0.74‐1.12, p=0.37), respectively. In contrast, ever‐users of sBB had a significantly elevated risk for recurrence and death in multivariate analysis (PFS HR 1.22 95%‐CI 1.05‐1.41, p=0.009; OS HR 1.25 95%‐CI 1.06‐1.47, p=0.009). Conclusion In this large pooled analysis neither a co‐medication with metformin nor with statins had a significant impact on survival in patients with primary ovarian cancer. In contrast, co‐medication with a beta‐blocker was associated with worse survival. Further studies are warranted to confirm this observation.

Denys, P., et al. (2023). "AbobotulinumtoxinA is effective in patients with urinary incontinence due to neurogenic detrusor overactivity regardless of spinal cord injury or multiple sclerosis etiology: Pooled analysis of two phase III randomized studies (CONTENT1 and CONTENT2)." Neurourology and Urodynamics 42(1): 153-167.
	Background: Neurogenic detrusor overactivity incontinence (NDOI) is often inadequately managed with oral therapy. Objective(s): To assess efficacy and safety of abobotulinumtoxinA (aboBoNT-A; Dysport; Ipsen Ltd.) according to etiology of NDOI. Design, Setting, and Participant(s): Two phase III, randomized, double-blind studies (CONTENT1 [NCT02660138] conducted in Asia, Europe and North America; CONTENT2 [NCT02660359] conducted in the Americas, Asia, Europe and Oceania) both included patients with spinal cord injury (SCI) or multiple sclerosis (MS), with inadequately managed NDOI, regularly performing clean intermittent catheterization (CIC). Intervention(s): Patients in CONTENT1 and CONTENT2 received aboBoNT-A injections 600 U (n = 162)/800 U (n = 161), or placebo (n = 162) into the detrusor muscle. Outcome Measurements and Statistical Analysis: Primary endpoint: mean change from baseline in number of NDOI episodes/week at Week 6. Secondary endpoints: proportion of patients with no NDOI episodes; incontinence-related quality of life (I-QoL); urodynamic parameters; and time-to-retreatment. Safety was also assessed. Statistical analyses were conducted for pooled populations by etiology (aboBoNT-A doses vs. placebo). Results and Limitations: Of 485 randomized patients, 341 (70%) and 144 (30%) had SCI and MS etiologies, respectively. A significant reduction was observed in mean NDOI episodes/week at Week 6 with both aboBoNT-A doses versus placebo in the SCI (all p < 0.001) and MS (all p < 0.01) groups, as well as significant improvements in I-QoL and urodynamic parameters. Median time-to-retreatment was longer in patients with MS (48-62 weeks across doses) than those with SCI (39-44 weeks). Safety data were similar between etiologies. Urinary tract infection was the most frequent adverse event; similar numbers were reported across treatment groups. Conclusion(s): AboBoNT-A was well tolerated and significantly improved continence and bladder function, and QoL, in patients with SCI or MS with NDOI performing regular CIC. Patient Summary: AboBoNT-A injections improved QoL, symptoms, and bladder function in patients with SCI or MS with bladder muscle overactivity that causes incontinence.Copyright © 2022 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.

Deodato, M., et al. (2023). "Efficacy of manual therapy and pelvic floor exercises for pain reduction in primary dysmenorrhea: A prospective observational study." Journal of Bodywork and Movement Therapies 36: 185-191.
	Background: Primary dysmenorrhea represents one of the most common causes of pelvic and low back pain. Pharmacological treatment can present some side effects, and non-pharmacological treatments should be considered to improve the symptoms of primary dysmenorrhea. The aim of this study was to evaluate the efficacy of manual therapy (MT), pelvic floor exercises (PFE), and their combination (MT + PFE) to improve clinical outcomes and pain sensitivity in women with primary dysmenorrhea. Method(s): A prospective observational study was conducted. Thirty females (age 25.0 +/- 6.1 y) with history of primary dysmenorrhea participated to 8 sessions of 60 min of either MT, PFE or MT + PFE, twice per week. They participated to the different treatments according to the different services offered by the school of physiotherapy. A 0-10 numeric rating scale (NRS) was administered to assess subjective pain, while short-form 36 (SF-36) was used to evaluate quality of life. The pressure pain threshold (PPT) was assessed with a portable algometer on different pelvic and lumbar areas. Result(s): Independently from the treatment, significant improvements were reported for general pain NRS (p < 0.001; peta2 = 0.511), as well as most the domains of the SF-36, although the general health domain did not reach statistical significance (p = 0.613; peta2 = 0.010). PPT revealed a general improvement in all tested body areas, although on the quadratus lumborum, the PFE treatment did not induce a significant improvement compared to the MT and MT + PFE protocols (p = 0.039). Conclusion(s): These findings highlight the importance of proposing physiotherapy treatments to females with primary dysmenorrhea to improve symptoms, with manual therapy combined with active pelvic floor exercise providing the best outcomes including an improvement of lumbar pain thresholds.Copyright © 2023 Elsevier Ltd

Derby University, o. (2021). Developing an Evidence Base for the Use of Art Psychotherapy Within a Perinatal Mental Health Service.
	No Results Available Behavioral: Art Psychotherapy, Art Therapy|Behavioral: Wait List Measure any changes in mental wellbeing during the term of the Art Therapy intervention.|Monitor patient reported quality of life during the term of the Art Therapy intervention.|Monitor patient reported quality of life during the term of the Art Therapy intervention and during the wait-list period.|Monitor changes in mother-infant interaction during the term of the Art Therapy intervention and during the wait-list period.|Statistical analysis of change in mental wellbeing as assessed by the use of Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)|Statistical analysis of change in patient reported quality of life as assessed by the use of ReQol20 (Recovering Quality of Life)|Statistical analysis of change in patient reported quality of life as assessed by the use of ReQol10 (Recovering Quality of Life)|Statistical analysis of changes in mother-infant interaction as assessed by the use of the Bethlem Mother-Infant Interaction Scale.|Capture the participants lived experience of Art Therapy|Measure participant interaction with art materials during Art Therapy intervention Female Not Applicable 8 Other Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Stanhope 100491262 May 26, 2022

Dermofarm, S. A. U. (2023). Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness.
	No Results Available Device: Hidrante HA|Device: Cumlaude Hidrante Interno® Vaginal Health Index|Severity of subjective symptoms (investigator record)|Subjective symtomps (patient's notebook)|Objective signs of vulvovaginal atrophy|Vaginal pH|Sexual function|Global Symptom Score (GSS)|Adverse events as a measure of Safety and Tolerability|Overall Safety Assessment|Patient satisfaction Female Not Applicable 54 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment DFARM-HYDRA-HA-2022 October 18, 2023

Desaunay, P., et al. (2023). "Benefits and Risks of Antidepressant Drugs During Pregnancy: A Systematic Review of Meta-analyses." Paediatric drugs 25(3): 247-265.
	Background: The prescription of antidepressant drugs during pregnancy has been steadily increasing for several decades. Meta-analyses (MAs), which increase the statistical power and precision of results, have gained interest for assessing the safety of antidepressant drugs during pregnancy.; Objective: We aimed to provide a meta-review of MAs assessing the benefits and risks of antidepressant drug use during pregnancy.; Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a literature search on PubMed and Web of Science databases was conducted on 25 October, 2021, on MAs assessing the association between antidepressant drug use during pregnancy and health outcomes for the pregnant women, embryo, fetus, newborn, and developing child. Study selection and data extraction were carried out independently and in duplicate by two authors. The methodological quality of included studies was evaluated with the AMSTAR-2 tool. Overlap among MAs was assessed by calculating the corrected covered area. Data were presented in a narrative synthesis, using four levels of evidence.; Results: Fifty-one MAs were included, all but one assessing risks. These provided evidence for a significant increase in the risks for major congenital malformations (selective serotonin reuptake inhibitors, paroxetine, fluoxetine, no evidence for sertraline; eight MAs), congenital heart defects (paroxetine, fluoxetine, sertraline; 11 MAs), preterm birth (eight MAs), neonatal adaptation symptoms (eight MAs), and persistent pulmonary hypertension of the newborn (three MAs). There was limited evidence (only one MA for each outcome) for a significant increase in the risks for postpartum hemorrhage, and with a high risk of bias, for stillbirth, impaired motor development, and intellectual disability. There was inconclusive evidence, i.e., discrepant results, for an increase in the risks for spontaneous abortion, small for gestational age and low birthweight, respiratory distress, convulsions, feeding problems, and for a subsequent risk for autism with an early antidepressant drug exposure. Finally, MAs provided no evidence for an increase in the risks for gestational hypertension, preeclampsia, and for a subsequent risk for attention-deficit/hyperactivity disorder. Only one MA assessed benefits, providing limited evidence for preventing relapse in severe or recurrent depression. Effect sizes were small, except for neonatal symptoms (small to large). Results were based on MAs in which overall methodological quality was low (AMSTAR-2 score = 54.8% ± 12.9%, [19-81%]), with a high risk of bias, notably indication bias. The corrected covered area was 3.27%, which corresponds to a slight overlap.; Conclusions: This meta-review has implications for clinical practice and future research. First, these results suggest that antidepressant drugs should be used as a second-line treatment during pregnancy (after first-line psychotherapy, according to the guidelines). The risk of major congenital malformations could be prevented by observing guidelines that discourage the use of paroxetine and fluoxetine. Second, to decrease heterogeneity and bias, future MAs should adjust for maternal psychiatric disorders and antidepressant drug dosage, and perform analyses by timing of exposure. (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Deswal, R., et al. (2019). "Single nucleotide polymorphisms in treatment of polycystic ovary syndrome: a systematic review." Drug metabolism reviews 51(4): 612-622.
	As 15-20% of reproductive aged females are suffering from polycystic ovary syndrome (PCOS), a large number of pharmacological preparations are frequently available in the market for the treatment of PCOS; however, they seem to be ineffective and cause undesirable side effects. This has emphasized the need to optimize dosage regimens for individualized treatment. The objective of this systematic review is to review single nucleotide polymorphisms (SNPs) associated with drugs used for the treatment of PCOS to understand pharmacogenetics variability of patients to drug response there by helping clinicians in designing tailored treatments and possibly reducing adverse drug reactions. A comprehensive electronic literature search was conducted to highlight some clinically relevant SNPs that act to influence PCOS and associated co-morbidities. A total of 16 studies were included in this review. These genetic variations can be used as a potential target for pharmacotherapy and pharmacogenetic clinical trials for better diagnosis, management, and treatment planning.

Devi, N., et al. (2020). "N -acetyl-cysteine as adjuvant therapy in female infertility: a systematic review and meta-analysis." Journal of basic and clinical physiology and pharmacology 32(5): 899-910.
	Objectives: The objective of this study is to explore the efficacy and safety of N -acetyl-cysteine (NAC) as adjuvant therapy in female infertility.; Content: We performed a systematic literature search of PubMed, Cochrane Library, Embase, and Ovid databases through April 2019 for Randomized Controlled Trials (RCTs) evaluating the effectiveness and safety of NAC as adjuvant therapy in female infertility. The outcomes assessed were rates of ovulation, pregnancy, miscarriage and multiple pregnancy, presented as pooled odds ratio with 95% confidence interval (CI) using the random-effects model. Heterogeneity and inconsistency of the measurements were identified through Cochrane's Q statistic and I2 statistic. We also performed a sensitivity analysis, publication bias (using funnel plot and Begg's test), and subgroup analysis.; Summary: Fifteen RCTs recruiting 2330 female receiving NAC were included. The pooled estimate showed the statistically insignificant improvement in outcomes; clinical pregnancy rate 1.55 (95% CI 0.98-2.47; I2=68%; p<0.01), ovulation rate 1.77 (95% CI 0.76-4.14; I2=90%; p<0.01), multiple pregnancy rate 0.83 (95% CI 0.34-1.99; I2=10%; p=0.31) and miscarriage rate 0.76 (95% CI= 0.37, 1.53; I2=0%; p=0.69) . NAC was found less efficacious and safe than metformin in all outcomes. Overall, NAC showed statistically insignificant (OR=0.98-2.47).; Outlook: NAC can be an effective adjuvant in PCOS related and unexplained female infertility. The effect could be more profound in women with high BMI, insulin resistance, and oxidative stress. However, the findings need further confirmation in well-designed randomized controlled trials to examine clinical outcomes such as live birth rate in more extended follow-up periods. (© 2020 Walter de Gruyter GmbH, Berlin/Boston.)

Dewald Cornelia Lieselotte, A., et al. (2024). "Interventional Therapy of Pelvic Venous Disorders (PeVD)." RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin.
	Background: Pelvic venous disorders (PeVD) are an underdiagnosed cause of chronic pelvic pain in women. They are caused by venous insufficiency of the pelvic or ovarian veins, leading to the development of mainly periuterine and periovarian varices. It is a progressive disease if left untreated and can cause swelling, dyspareunia, dysmenorrhea, and other symptoms, some non-specific, that affect the patient's quality of life. Interventional therapies are a central component of the treatment of PeVD, with a variety of techniques available for both diagnosis and treatment.; Method: This review provides an overview of the pathophysiologic background, diagnosis, and, most importantly, interventional treatment options for PeVD.; Results: There is a lack of standardized nomenclature and internationally accepted diagnostic criteria for PeVD as well as randomized controlled trials demonstrating clinical success. However, in clinical trials, endovascular therapy for PeVD has been shown to be safe and effective. This review presents the various interventional techniques for the treatment of PeVD, including embolization, stenting, and sclerotherapy.; Conclusion: The importance of PeVD is receiving growing recognition. Recent advances, such as the development of the Symptoms-Varices-Pathophysiology (SVP) classification, provide an impetus to standardize nomenclature and are the first step toward systematizing disease management. Interventional therapies provide a safe and tailored minimally invasive treatment option for patients with PeVD.; Key Points: · Pelvic venous disorders are an underdiagnosed condition with frequently delayed diagnosis and debilitating symptoms.. · Until now, the PeVD nomenclature has been imprecise, with terms like May-Thurner syndrome/Nutcracker syndrome.. · Interventional approaches are effective and play a central role in PeVD treatment..; Citation Format: · Dewald CL, Becker LS, Meyer BC. Interventional Therapy of Pelvic Venous Disorders (PeVD). Fortschr Röntgenstr 2024; DOI: 10.1055/a-2229-4100.; Competing Interests: The authors declare that they have no conflict of interest. (Thieme. All rights reserved.)

Dhanis, J., et al. (2022). "Prehabilitation to Improve Outcomes of Patients with Gynaecological Cancer: A New Window of Opportunity?" Cancers 14(14): 3448.
	The literature evaluating the effect of prehabilitation programmes on postoperative outcomes and quality of life of patients with gynaecological cancer undergoing surgery was reviewed. Databases including Pubmed, Medline, EMBASE (Ovid) and PsycINFO were systematically searched to identify studies evaluating the effect of prehabilitation programmes on patients with gynaecological cancer. Both unimodal and multimodal prehabilitation programmes were included encompassing physical exercise and nutritional and psychological support. Primary outcomes were surgical complications and quality of life. Secondary outcomes were anthropometric changes and adherence to the prehabilitation programme. Seven studies fulfilled the inclusion criteria, comprising 580 patients. Included studies were nonrandomised prospective studies (n = 4), retrospective studies (n = 2) and one case report. Unimodal programmes and multimodal programmes were included. In patients with ovarian cancer, multimodal prehabilitation resulted in significantly reduced hospital stay and time to chemotherapy. In patients with endometrial and cervical cancer, prehabilitation was associated with significant weight loss, but had no significant effects on surgical complications or mortality. No adverse events of the programmes were reported. Evidence on the effect of prehabilitation for patients with gynaecological cancer is limited. Future studies are needed to determine the effects on postoperative complications and quality of life.Copyright © 2022 by the authors.

Dhatt, A., et al. (2022). "Fertility outcomes following treatment of chronic endometritis: a systematic review and meta-analysis." Human Reproduction 37(Supplement 1): i394.
	Study question: To determine if treatment of chronic endometritis (CE) impacts fertility outcomes Summary answer: Treatment of CE in women with infertility, recurrent pregnancy loss, or recurrent implantation failure, improves live birth outcomes What is known already: Chronic endometritis is an inflammatory condition that involves plasma cells invading the endometrial stroma. Prevalence of CE is high among patients with recurrent pregnancy loss (RPL), recurrent implantation failure (RIF), and infertility. Proposed treatment strategies include oral antibiotics, intrauterine antibiotic infusion, platelet-rich plasma, and hysteroscopic surgery, among others. Although treatment-associated CE cure rates have been high, few studies have reported on fertility outcomes following treatment of CE. Previously published systematic reviews have also yielded widely conflicting outcomes regarding the impact of CE treatment on fertility outcomes. Study design, size, duration: We conducted a systematic search of the literature until late December 2021 across the Cochrane, EMBASE, and Medline databases. We used a DerSimonian and Laird random-effects metaanalysis model for the quantitative analysis. Participants/materials, setting, methods: Clinical trials, prospective and retrospective observational studies that examined the treatment outcomes of CE were included. Study eligibility assessment, data extraction, and risk of bias assessment were independently performed by two reviewers. Comparisons were made between the groups of treated versus untreated CE, treated versus persistent CE, and between specific treatment strategies. Pooled risk ratios (RR) for the impact of CE treatment on outcomes such as live birth, clinical pregnancy, and miscarriage rates were assessed Main results and the role of chance: Twelve studies totalling 1,539 women were included in our systematic review(3 randomized controlled trials and 9 observational studies), and 5 studies were included in the quantitative meta-analysis. Patients all had confirmed CE and a history of infertility, RPL, or RIF. Cure rates ranged between 37.2-91.8%. Live birth rate in the treated CE group ranged from 27.1-84.6%, from 16.4-44.4% in the nontreated CE group, and from 6.7-30.8% in the persistent CE group. Clinical pregnancy rate in the treated CE group ranged from 29.3-76.3%, from 11.1- 30% in the non-treated CE group, and from 20-42.3% in the persistent CE group. Miscarriage rate in the treated CE group ranged from 6.7-23.8%, from 35.7-55.6% in the non-treated CE group, and from 27.3-66.7% in the persistent CE group. Risk ratio for the pooled effect of successful CE treatment compared to persistent CE on live birth was 2.98 (95% confidence ratio [CI] 1.51-5.91, I2=36.8%), on clinical pregnancy rate was 2.25 (95% CI 1.59-3.18, I2=40.1%), and on miscarriage rate was 0.55 (95% CI 0.28-1.10, I2=0.0%). Insufficient studies compared specific treatment subtypes to allow for any substantive qualitative or quantitative analysis. Limitations, reasons for caution: Our results are limited by significant between- study heterogeneity in the study design, patient population, and comparisons used. Subgroup analysis by categories of comparisons mitigates some of this heterogeneity Wider implications of the findings: Adequate treatment of CE significantly improves live birth rates in patients with RPL, RIF, and infertility. Assessment for CE should become part of routine fertility investigations, and resolution of CE must be confirmed prior to initiating fertility treatments.

Dholakia, J., et al. (2021). "Prehabilitation for medically frail patients undergoing surgery for epithelial ovarian cancer: a cost-effectiveness analysis." Journal of Gynecologic Oncology 32(6): e92.
	Objective: To assess the potential cost-effectiveness of prehabilitation in medically frail patients undergoing surgery for epithelial ovarian cancer (EOC). Method(s): We created a cost-effectiveness model evaluating the impact of prehabilitation on a cohort of medically frail women undergoing primary surgical intervention for EOC. Cost was assessed from the healthcare system perspective via (1) inpatient charges from 2018-2019 institutional Diagnostic Related Grouping data for surgeries with and without major complications; (2) nursing facility costs from published market surveys. Major complication and non-home discharge rates were estimated from the literature. Based on published pilot studies, prehabilitation was determined to decrease these rates. Incremental cost-effectiveness ratio for cost per life year saved utilized a willingness-to-pay threshold of $100,000/life year. Modeling was performed with TreeAge software. Result(s): In a cohort of 4,415 women, prehabilitation would cost $371.1 Million (M) versus $404.9 M for usual care, a cost saving of $33.8 M/year. Cost of care per patient with prehabilitation was $84,053; usual care was $91,713. When analyzed for cost-effectiveness, usual care was dominated by prehabilitation, indicating prehabilitation was associated with both increased effectiveness and decreased cost compared with usual care. Sensitivity analysis showed prehabilitation was more cost effective up to a cost of intervention of $9,418/patient. Conclusion(s): Prehabilitation appears to be a cost-saving method to decrease healthcare system costs via two improved outcomes: lower complication rates and decreased care facility requirements. It represents a novel strategy to optimize healthcare efficiency. Prospective studies should be performed to better characterize these interventions in medically frail patients with EOC.Copyright © 2021. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.

Di Biase, N., et al. (2019). "Review of general suggestions on physical activity to prevent and treat gestational and pre-existing diabetes during pregnancy and in postpartum." Nutrition, Metabolism and Cardiovascular Diseases 29(2): 115-126.
	The aim of this review is to provide general suggestions on physical activity (PA) in pre-gestational and gestational diabetes mellitus (GDM) and encourage women to take part in safe and effective activities throughout pregnancy, in the absence of other contraindications. PA before and during pregnancy and in postpartum has many positive effects on the mother, as it could reduce the risk of GDM, excessive weight gain and lower back pain and also prevents, in the postpartum, diabetes mellitus. It may also reduce the duration of labour and complications at childbirth, fatigue, stress, anxiety and depression, thereby leading to an improved sense of wellbeing. Clinically, it is thought to help prevent preeclampsia and premature birth even though RCTs provide conflicting evidence with regard to the prevention of GDM. The main reason for this rests on the fact that the majority of clinical trials have not been able to replicate the preventive effect of PA on the onset of GDM, such as the different adherence of the patient to PA. Herein, we survey the literature regarding exercise and PA on GDM prevention and treatment as well as on clinical outcomes in pre-GDM in pregnancy. On the basis of the current literature, we also present a series of general recommendations and suggestions on PA and exercise training in pregnancy among both diabetic patients and those at risk for GDM.Copyright © 2018 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University

Di Donato, V., et al. (2020). "Management of morbidity associated with pancreatic resection during cytoreductive surgery for epithelial ovarian cancer: A systematic review." European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology 46(4 Pt A): 694-702.
	Introduction: In ovarian cancer (OC), survival benefit in case of complete cytoreduction with absence of residual tumor has been clearly demonstrated; however, it often requires extensive surgery. Particularly, pancreatic resection during cytoreduction, may severely impact perioperative morbidity and mortality.; Objectives: The aim of this systematic review is to evaluate complication rates and related optimal management of ovarian cancer patients undergoing pancreatic resection as part of cytoreductive surgery.; Methods: Literature was searched for relevant records reporting distal pancreatectomy for advanced ovarian cancer. All cohorts were rated for quality. We focused our analysis on complications related to pancreatic surgical procedures evaluating the following outcomes: pancreatic fistula (PF), abdominal abscess, pancreatitis, iatrogenic diabetes, hemorrhage from splenic vessels and pancreatic-surgery-related mortality.; Results: The most frequent complication reported was PF. Similar rates of PF were reported after hand-sewn (20%) or stapled closure (24%). Continued drainage is the standard treatment, and often, the leak can be managed conservatively and does not require re-intervention. Abdominal abscess is the second most frequent complication and generally follows a non-adequately drained PF and often required re-laparotomy. Pancreatitis is a rare event that could be treated conservatively; however, death can occur in case of necrotic evolution. Cases of post-operative hemorrhage due to splenic vessel bleeding have been described and represent an emergency.; Conclusions: Knowledge of pancreatic surgery and management of possible complications ought to be present in the oncologic-gynecologic armamentarium. All patients should be referred to specialized, dedicated, tertiary centers in order to reduce, promptly recognize and optimally manage complications.; Competing Interests: Declaration of competing interest The authors declare no conflict of interest. (Copyright © 2019 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Di Donato, V., et al. (2022). "HPV Vaccination after Primary Treatment of HPV-Related Disease across Different Organ Sites: A Multidisciplinary Comprehensive Review and Meta-Analysis." Vaccines 10(2): 239.
	Objective: To assess evidence on the efficacy of adjuvant human papillomavirus (HPV) vaccination in patients treated for HPV-related disease across different susceptible organ sites. Method(s): A systematic review was conducted to identify studies addressing the efficacy of adjuvant HPV vaccination on reducing the risk of recurrence of HPV-related preinvasive diseases. Results were reported as mean differences or pooled odds ratios (OR) with 95% confidence intervals (95% CI). Result(s): Sixteen studies were identified for the final analysis. Overall, 21,472 patients with cervical dysplasia were included: 4132 (19.2%) received the peri-operative HPV vaccine, while 17,340 (80.8%) underwent surgical treatment alone. The recurrences of CIN 1+ (OR 0.45, 95% CI 0.27 to 0.73; p = 0.001), CIN 2+ (OR 0.33, 95% CI 0.20 to 0.52; p < 0.0001), and CIN 3 (OR 0.28, 95% CI 0.13 to 0.59; p = 0.0009) were lower in the vaccinated than in unvaccinated group. Similarly, adjuvant vaccination reduced the risk of developing anal intraepithelial neoplasia (p = 0.005) and recurrent respiratory papillomatosis (p = 0.004). No differences in anogenital warts and vulvar intraepithelial neoplasia recurrence rate were observed comparing vaccinated and unvaccinated individuals. Conclusion(s): Adjuvant HPV vaccination is associated with a reduced risk of CIN recurrence, although there are limited data regarding its role in other HPV-related diseases. Further research is warranted to shed more light on the role of HPV vaccination as adjuvant therapy after primary treatment.Copyright © 2022 by the authors. Licensee MDPI, Basel, Switzerland.

Di Donato, V., et al. (2021). "Preoperative frailty assessment in patients undergoing gynecologic oncology surgery: A systematic review." Gynecologic Oncology 161(1): 11-19.
	Objective: The aim of the present article was to discuss currently available evidence on the impact of frailty assessment on adverse postoperative outcomes and survival in patients undergoing surgery for gynecological cancer.; Methods: Systematic search of Medline (PubMed) and Embase databases until September 30, 2020. Key inclusion criteria were: (1) randomized or observational studies; (2) patients undergoing non-emergent surgery for gynecological malignancies; (3) preoperative frailty assessment.; Results: Through the process of evidence acquisition, twelve studies including 85,672 patients were selected and six tools were evaluable: 30-item frailty index, 40-item frailty index, modified frailty index (mFI), John Hopkins Adjusted Clinical Groups index, Fried frailty criteria, Driver's tool. The prevalence of frailty varied roughly from 6.1% to 60% across different series included. The mFI was the most adopted and predictive instrument. Pooled results underlined that frail patients were more likely to develop 30-day postoperative complications (OR:4.16; 95%CI 1.49-11.65; p:0.007), non-home discharge (OR:4.41; 95%CI: 4.09-4.76; p < 0.001), ICU admission (OR:3.99;3.76-4.24; p < 0.001) than the non-frail counterpart. Additionally, frail patients experienced worse oncologic outcomes (disease-free and overall survivals) than non-frail patients.; Conclusion: The present systematic review demonstrated that preoperative frailty assessment among gynecologic oncology patients is essential to predict adverse outcomes and tailor a personalized treatment. The mFI appeared as the most used and feasible tool in daily practice, suggesting that tailored therapeutic strategies should be considered for patients with 3 or more frailty-defining items.; Competing Interests: Declaration of Competing Interest All the authors declare that they have no conflict of interest. (Copyright © 2020 Elsevier Inc. All rights reserved.)

Di Donato, V., et al. (2021). "Adjuvant hpv vaccination to prevent recurrent cervical dysplasia after surgical treatment: A meta-analysis." Vaccines 9(5): 410.
	Objective: The aim of this meta-analysis was to discuss evidence supporting the efficacy of adjuvant human papillomavirus (HPV) vaccination in reducing the risk of recurrent cervical intraepithelial neoplasia (CIN) 2 or greater after surgical treatment. Method(s): A systematic literature search was performed for studies reporting the impact of HPV vaccination on reducing the risk of recurrence of CIN 2+ after surgical excision. Results were reported as mean differences or pooled odds ratios (OR) with 95% confidence intervals (95% CI). Result(s): Eleven studies met the inclusion criteria and were selected for analysis. In total, 21,310 patients were included: 4039 (19%) received peri-operational adjuvant HPV vaccination while 17,271 (81%) received surgery alone. The recurrence of CIN 2+ after treatment was significantly lower in the vaccinated compared with the unvaccinated group (OR 0.35; 95% CI 0.21-0.56; p < 0.0001). The recurrence of CIN 1+ after treatment was significantly lower in the vaccinated compared with the unvaccinated group (OR 0.51; 95% CI 0.31-0.83; p = 0.006). A non-significant trend of reduction rate of HPV persistence was observed in the vaccinated compared with the unvaccinated cohorts (OR was 0.84; 95% CI 0.61-1.15; p = 0.28). Conclusion(s): HPV vaccination, in adjuvant setting, is associated with a reduced risk of recurrent CIN 1+ and CIN 2+ after surgical treatment.Copyright © 2021 by the authors. Licensee MDPI, Basel, Switzerland.

Di Donato, V., et al. (2021). "Fertility-sparing surgery for women with stage I cervical cancer of 4 cm or larger: a systematic review." Journal of Gynecologic Oncology 32(6): e83.
	Objective: To investigate current evidence on oncological, fertility and obstetric outcomes of patients with stage I cervical cancer of 4 cm or larger undergoing fertility-sparing surgery (FSS).; Methods: Systematic review of studies including women affected by stage I cervical cancer ≥4 cm who underwent FSS. Main outcome measures: disease-free survival (DFS), overall survival (OS), pregnancy rate, live birth rate, premature delivery rate.; Results: Fifteen studies met all eligibility criteria for this systematic review, involving 48 patients affected by cervical cancer ≥4 cm who completed FSS. Three patients (6.3%) experienced a recurrence and one of them (2.1%) died of disease. The 5-year DFS rate was 92.4%. The 5-year OS rate was 97.6%. A significantly shorter 5-year DFS was reported for high-risk patients (G3, non-squamous histotype, diameter ≥5 cm) compared with low-risk (74.7% vs. 100%; log-rank test, p=0.024). Data about fertility outcomes were available for 12 patients. Five patients out of 12 (41.7%) attempted to conceive with an estimated pregnancy rate of 80%, a live birth rate of 83.3% and a premature delivery rate of 20%.; Conclusion: Women with high tumor grade, aggressive histology and tumor size ≥5 cm have a higher risk of recurrence. Oncologic outcomes are encouraging among low-risk patients; however, the lack of high-quality studies makes it difficult to draw any firm conclusions. Prospective multicentric clinical trials with a proper selection of inclusion/exclusion criteria should be conducted in women with low-risk factors, strong desire to preserve their fertility and high likelihood to conceive.; Competing Interests: No potential conflict of interest relevant to this article was reported. (Copyright © 2021. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.)

Di Donato, V., et al. (2019). "Uterine asymptomatic myomas: An overview from diagnosis to treatment." Giornale Italiano di Ostetricia e Ginecologia 41(2): 76-83.
	Objective. Uterine myomas represent the most common benign gynecological tumors and about 40-60% of patients with fibroids are asymptomatic. The diagnosis is often incidental and the treatment depends on patient's age, size of fibroids, estimated rate of growth, woman's fertility plans and risk of malignancy. Despite the prevalence, scientific research regarding asymptomatic fibroids is still underfunded compared with other nonmalignant diseases and actually, no guidelines are reported about management and treatment of themselves. Material and method We conducted a review of literature from February to May 2017. PubMed (MEDLINE), Web of Science databases, EMBASE, Cochrane Library and Scopus database were systematically searched for records reporting on asymptomatic fibroids. Results. Further large studies are needed to define the management of asymptomatic fibroids, real indications to treatment and risks and benefits of a waiting strategy when no treatment is needed can be drawn. Conclusion. No standard guidelines for the management of asymptomatic fibroids have been reported. Treatment is individualized and depends on patient s age, size of fibroids, woman s fertility plans and risk of malignancy.© Copyright 2019, CIC Edizioni Internazionali, Roma.

Di Donato, V., et al. (2020). "Does Hormone Replacement Therapy Impact the Prognosis in Endometrial Cancer Survivors? A Systematic Review." Oncology 98(4): 195-201.
	Purpose: The objective of this study was to evaluate the impact of hormone replacement therapy (HRT) on the prognosis in endometrial cancer (EC) survivors.; Methods: The research was conducted using the following electronic databases: MEDLINE (PubMed), Web of Science, ClinicalTrial.gov, and Cochrane Library. We performed a review of studies published from January 1986 to January 2019. We selected studies that included EC patients submitted to surgery with curative intent and postoperative use of HRT.; Result: Seven of 1,332 abstracts considered were eligible: 4 retrospective series, 1 prospective study, 1 randomized controlled trial, and 1 population study. Globally in the observed studies there was not a significant increase in the recurrence rate, measured by the relative risk, in the EC survivors using HRT compared with the controls in tumour stages I and II. The bias was that HRT was prescribed only to low-risk patients, who were young and had a low stage of disease.; Conclusion: This systematic review shows that HRT use had no negative effect on prognosis in EC survivors in tumour stages I and II. (© 2020 S. Karger AG, Basel.)

Di Donna Mariano, C., et al. (2022). "Conventional Laparoscopy versus Robotic-Assisted Aortic Lymph-Nodal Staging for Locally Advanced Cervical Cancer: A Systematic Review and Meta-Analysis." Journal of Clinical Medicine 11(12).
	Aortic lymph node metastases are a relative common finding in locally advanced cervical cancer. Minimally invasive surgery is the preferred approach to perform para-aortic lymph nodal staging to reduce complications, hospital stay, and the time to primary treatment. This meta-analysis (CRD42022335095) aimed to compare the surgical outcomes of the two most advanced approaches for the aortic staging procedure: conventional laparoscopy (CL) versus robotic-assisted laparoscopy (RAL). The meta-analysis was conducted according to the PRISMA guideline. The search string included the following keywords: "Laparoscopy" (MeSH Unique ID: D010535), "Robotic Surgical Procedures" (MeSH Unique ID: D065287), "Lymph Node Excision" (MeSH Unique ID: D008197) and "Aorta" (MeSH Unique ID: D001011), and "Uterine Cervical Neoplasms" (MeSH Unique ID: D002583). A total of 1324 patients were included in the analysis. Overall, 1200 patients were included in the CL group and 124 patients in the RAL group. Estimated blood loss was significantly higher in CL compared with RAL ( p = 0.02), whereas hospital stay was longer in RAL compared with CL ( p = 0.02). We did not find significant difference for all the other parameters, including operative time, intra- and postoperative complication rate, and number of lymph nodes excised. Based on our data analysis, both CL and RAL are valid options for para-aortic staging lymphadenectomy in locally advanced cervical cancer.

Di Donna Mariano, C., et al. (2023). "Detection of sentinel lymph node in vulvar cancer using 99m Tc-labeled colloid lymphoscintigraphy, blue dye, and indocyanine-green fluorescence: a meta-analysis of studies published in 2010-2020." Archives of Gynecology and Obstetrics 307(6): 1677-1686.
	Objectives: Sentinel lymph node (SLN) biopsy is widely accepted in the surgical staging of early vulvar cancer, although the most accurate method for its identification is not yet defined. This meta-analysis aimed to determine the technique with the highest pooled detection rate (DR) for the identification of SLN and compare the average number of SLNs detected by planar lymphoscintigraphy (PL), single-photon emission computed tomography/computed tomography (SPECT/CT), blue dye and indocyanine green (ICG) fluorescence.; Methods: The meta-analysis was conducted according to the PRISMA guideline. The search string was: "sentinel" and "vulv*", with date restriction from 1st January 2010 until Dec 31st, 2020. Three investigators selected studies based on: (1) a study cohort or a subset of a minimum of 10 patients with vulvar cancer undergoing either PL, SPECT/CT, blue-dye, or ICG fluorescence for the identification of SLN; (2) the possibility to extrapolate the DR or the average number of SLNs detected by a single technique (3) no evidence of other malignancies in the patient history.; Results: A total of 30 studies were selected. In a per-patient and a per-groin analysis, the DR for SLN of PL was respectively 96.13% and 92.57%; for the blue dye was 90.44% and 66.21%; for the ICG, the DR was 91.90% and 94.80%. The pooled DR of SPECT/CT was not calculated, since only two studies were performed in this setting. At a patient-based analysis, no significant difference was documented among PL, blue dye, and ICG (p = 0.28). At a per-groin analysis, PL and ICG demonstrated a significantly higher DR compared to blue dye (p < 0.05). The average number of SLNs, on a per-patient analysis, was available only for PL and ICG with a median number of 2.61 and 1.78 lymph nodes detected, respectively, and no significant statistical difference.; Conclusions: This meta-analysis favors the use of ICG and PL alone and in combination over blue dye for the identification of the SLN in vulvar cancer. Future studies may investigate whether the combined approach allows the highest DR of SLN in patients with vulvar cancer. (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Di Giorgio, A., et al. (2019). "From palliation to cure: PIPAC for peritoneal malignancies." Minerva Medica 110(4): 385-398.
	INTRODUCTION: Systemic chemotherapy offers poor control over peritoneal disease, maybe as a consequence of restricted drug availability within the abdominal cavity. Locoregional chemotherapy may overcome these shortcomings but its administration is limited to a few patients with confined peritoneal spread. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) emerged in the last years as a novel method of intraperitoneal drug administration. EVIDENCE ACQUISITION: We report a meta-analysis of published studies on PIPAC safety and pathological anti-tumoral efficacy on PC from various tumor entities, with the aim of providing more evidence to support further research. This systematic review and meta-analysis were designed, conducted and reported according to the PRISMA statement. EVIDENCE SYNTHESIS: An overall pathological response rate of 43.7% was calculated on a total of 668 patients who underwent 1480 PIPAC cycles across the 20 studies. Pooled severe adverse events rate (CTCAE grade 3-4) was 10% and seven deaths across all studies were reported, of which only four were related to PIPAC. CONCLUSION(S): PIPAC is a safe procedure which has a relevant anti-tumoral activity on peritoneal carcinomatosis. Further studies, even in the early stage of disease, are awaited to assess the clinical benefit of PIPAC. This review may serve as a reliable basis for future research.Copyright © 2019 EDIZIONI MINERVA MEDICA.

Di, M., et al. (2023). "Ovarian stimulation protocols for poor ovarian responders: a network meta-analysis of randomized controlled trials." Archives of Gynecology and Obstetrics 307(6): 1713-1726.
	Objective: To evaluate the efficacy of manifold ovarian stimulation protocols for patients with poor ovarian response.; Methods: PubMed, Embase, Cochrane Library and Web of Science were systematically searched until February 14, 2021. Primary outcomes included clinical pregnancy rate per initiating cycle and low risk of cycle cancellation. Secondary outcomes included number of oocytes retrieved, number of metaphase II (MII) oocytes, number of embryos obtained, number of transferred embryos, endometrial thickness on triggering day and estradiol (E 2 ) level on triggering day. The network plot, league table, rank probabilities and forest plot of each outcome measure were drawn. Therapeutic effects were displayed as risk ratios (RRs) or mean differences (MDs) with 95% confidence intervals (CIs).; Results: This network meta-analysis included 15 trials on 2173 participants with poor ovarian response. Delayed start GnRH antagonist was the best regimen in terms of clinical pregnancy rate per initiating cycle (74.04% probability of being the optimal), low risk of cycle cancellation (75.30%), number of oocytes retrieved (68.67%), number of metaphase II (MII) oocytes (97.98%) and endometrial thickness on triggering day (81.97%), while for E 2 level on triggering day, microdose GnRH agonist (99.25%) was the most preferred. Regarding number of embryos obtained and number of transferred embryos, no statistical significances were found between different ovarian stimulation protocols.; Conclusion: Delayed start GnRH antagonist and microdose GnRH agonist were the two superior regimens in the treatment of poor ovarian response, providing favorable clinical outcomes. Future investigation is needed to confirm and enrich our findings. (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Di Tucci, C., et al. (2019). "Immunotherapy in endometrial cancer: new scenarios on the horizon." Journal of Gynecologic Oncology 30(3): e46.
	This extensive review summarizes clinical evidence on immunotherapy and targeted therapy currently available for endometrial cancer (EC) and reports the results of the clinical trials and ongoing studies. The research was carried out collecting preclinical and clinical findings using keywords such as immune environment, tumor infiltrating lymphocytes, programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) expression, immune checkpoint inhibitors, anti-PD-1/PD-L1 antibodies and others' on PubMed. Finally, we looked for the ongoing immunotherapy trials on ClinicalTrials.gov. EC is the fourth most common malignancy in women in developed countries. Despite medical and surgical treatments, survival has not improved in the last decade and death rates have increased for uterine cancer in women. Therefore, identification of clinically significant prognostic risk factors and formulation of new rational therapeutic regimens have great significance for enhancing the survival rate and improving the outcome in patients with advanced or metastatic disease. The identification of genetic alterations, including somatic mutations and microsatellite instability, and the definition of intracellular signaling pathways alterations that have a major role in in tumorigenesis is leading to the development of new therapeutic options for immunotherapy and targeted therapy.

Di Vito, M., et al. (2020). "Is aromatherapy effective in obstetrics? A systematic review and meta-analysis." Phytotherapy research : PTR.
	The aim of this systematic review is to collect clinical trials conducted using essential oils (EOs) in obstetric symptoms by evaluating if and in which context the aromatherapy practice is effective in obstetrics. The research was conducted by using the databases of EMBASE, Medline, Biosis and Toxcenter, PubMed, and Google Scholar search engine, selecting articles from January 2004 to July 2020. This study was performed according to the MOOSE and PRISMA guidelines. Only the randomized clinical trials were considered, and in cases of multiple publications, it was considered the most up to date information. Biases were highlighted. In the presence of homogeneous data, pooling statistics and meta-analysis were applied. The research led to 71 articles, 17 of which were eligible. Among the trials selected, eight investigated the effectiveness of EOs on anxiety, depression, and stress. Two concerned the treatment of nausea and vomiting, six evaluated the application of EOs on labor for pain treatment, and two showed the effectiveness in the treatment of episiotomy. The heterogeneity of works carried out so far has made it possible to develop a meta-analysis only in the field of pain treatment during childbirth, identifying the effectiveness of the EOs Lavandula spp. and Rosa damascena.

Di, W. and H. Jianrong (2023). "Quality of life in ovarian cancer patients treated with bevacizumab: a meta-analysis."
	
Di Yuan, M., et al. (2019). "Clinical evidence of Chinese medicine therapies for depression in women during perimenopause and menopause." Complementary Therapies in Medicine 47: 102071.
	Background: Depression is common in women during perimenopause and menopause. Complementary therapies such as acupuncture and Chinese herbal medicine (CHM) are often utilized by these women. However, the efficacy and safety of these treatments have not been systematically evaluated.; Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs). Nine English and Chinese databases were searched and search terms included perimenopause, menopause, depression, Chinese herbal medicine, acupuncture, RCTs, and their synonyms. Methodological quality was assessed using the Cochrane Risk of Bias Tool.; Results: A total of 18 RCTs were identified (6 CHM, 11 acupuncture related therapies, 1 combination of CHM and acupuncture). For Hamilton Rating Scale of Depression (HRSD) and Kuppermans Index of Menopause, tuina-massage, combined therapy of CHM plus acupuncture showed significant benefits at end of treatment compared to antidepressants. Either CHM and acupuncture reduced HRSD scores, indicating less severe depression, showing comparable effects to antidepressants.; Conclusion: CHM and acupuncture treatment in perimenopause and menopausal women resulted in reduced severity of depression. Results should be interpreted with caution given the small number of studies included in this review and further RCTs are warranted to validate findings from this review. (Copyright © 2019. Published by Elsevier Ltd.)

Diakosavvas, M., et al. (2022). "Myomectomy during pregnancy; diagnostical dilemmas: two case reports and a systematic review of the literature." Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology 42(5): 757-765.
	Myomectomy in pregnancy, until this day, remains very controversial. We present two cases of successful antepartum myomectomies performed in the second trimester of gestation. In both cases, the initial suspected origin of these tumours was the ovaries. However, as it was shortly after confirmed, since both women underwent laparotomy, the diagnosis of these masses was uterine fibroids. Both cases resulted on the live birth of two healthy infants via caesarean section. Secondarily, we conducted a thorough review of current data of myomectomies performed during pregnancy, including the characteristics and diagnosis of the myomas of pregnant women, the surgical details and complications, along with the outcomes of these gestations. Overall, the analysis of cases published in international literature, suggests that the surgical removal of myomas during pregnancy can be considered safe, given certain indications and considerations. Our review comprises of 71 women undergoing excision of fibroids during pregnancy. Only three cases ended in a miscarriage while the remaining 68 resulted in a second or third trimester delivery. However, the data concerning the safety of the procedure are scarce and originate mostly from case reports. Thus, conclusions on the exact maternal and obstetrical complication rates cannot be drawn.

Diakosavvas, M., et al. (2020). "Controversies in preoperative bowel preparation in gynecologic and gynecologic oncology surgery: a review of the literature." Archives of Gynecology and Obstetrics 302(5): 1049-1061.
	Purpose: The purpose of this review is to assess the impact of mechanical and oral antibiotics bowel preparation on surgical performance and to investigate their role before gynecologic surgical procedures regarding the infection rates. We also aim to study the updated evidence regarding the use of these different types of bowel preparation, as well as the current preoperative practice applied.; Methods: An extensive search of the literature was conducted with Medline/PubMed, and the Cochrane Library Database of Systematic Reviews being used for our primary search.; Results: To date, due to the conflicting guidelines by the scientific societies, surgeons do not use a specific pattern of bowel preparation regimen. There are no strong evidence supporting mechanical bowel preparation, but instead, in many cases, patients' adverse effects, both physiological and psychological have been noted. On the other hand, the combined use of oral antibiotic and mechanical bowel preparation has been proven beneficial in colorectal surgery in reducing postoperative morbidities.; Conclusion: Based on current literature, in gynecologic surgeries with minimal probability of intraluminal entry, a regimen without any bowel preparation should be applied. The combined administration of both mechanical and oral antibiotic bowel preparation, or even the use of the oral antibiotics alone, should be preserved for cases of increased complexity, where bowel involvement is highly anticipated, such as in gynecologic oncology, as stated in the ERAS protocols. Nonetheless, further research specific to gynecologic surgery is required.

Diamond, M. P., et al. (2019). "A 12-month extension study to evaluate the safety and efficacy of asoprisnil in women with heavy menstrual bleeding and uterine fibroids." Human Reproduction Open 2019(4): hoz027.
	Study Question: What is the safety and efficacy profile during long-term (12-24 months) uninterrupted treatment with the selective progesterone receptor modulator asoprisnil, 10 and 25 mg in women with heavy menstrual bleeding (HMB) associated with uterine fibroids?; Summary Answer: Uninterrupted treatment with asoprisnil should be avoided due to endometrial safety concerns and unknown potential long-term consequences.; What Is Known Already: Asoprisnil was well tolerated in shorter-term studies and effectively suppressed HMB and reduced fibroid volume.; Study Design Size Duration: Women with uterine fibroids who had previously received placebo ( n = 87) or asoprisnil 10 mg ( n = 221) or 25 mg ( n = 215) for 12 months in two double-blind studies entered this randomized uncontrolled extension study and received up to 12 additional months of treatment followed by 6 months of post-treatment follow-up. Women who previously received placebo were re-randomized to either asoprisnil 10 or 25 mg for the extension study. This report focuses on the 436 women who received asoprisnil in the double-blind studies and this extension study. Results for women who previously received placebo in the double-blind studies are not described.; Participants/materials Setting Methods: Women ≥18 years of age who completed a 12-month, double-blind, placebo-controlled study, had estradiol levels indicating that they were not menopausal and had no endometrial hyperplasia or other significant endometrial pathology were eligible. The safety endpoints were focused on endometrial assessments. The composite primary efficacy endpoint was the proportion of women who demonstrated a response to treatment by meeting all three of the following criteria at the final month for participants who prematurely discontinued or at month 12 for those who completed the study: a reduction from initial baseline to final visit of ≥50% in the menstrual pictogram score, hemoglobin concentration ≥11 g/dl or an increase of ≥1 g/dl from initial baseline at the final visit, and no surgical or invasive intervention for uterine fibroids. Other efficacy endpoints included rates for amenorrhea and suppression of bleeding, changes in fibroid and uterine volume and changes in hematologic parameters. No statistical tests were planned or performed for this uncontrolled study.; Main Results and Role of Chance: Imaging studies revealed a progressive increase in endometrial thickness and cystic changes that frequently prompted invasive diagnostic procedures. Endometrial biopsy results were consistent with antiproliferative effects of asoprisnil. Two cases of endometrial cancer were diagnosed. At the final month of this extension study (total duration of uninterrupted treatment up to 24 months), the primary efficacy endpoint was achieved in 86 and 92% of women in the asoprisnil 10- and 25-mg groups, respectively. During each month of treatment, amenorrhea was observed in the majority of women (up to 77 and 94% at 10 and 25 mg, respectively). There was a progressive, dose-dependent decrease in the volume of the primary fibroid with asoprisnil 10 and 25 mg (-55.7 and -75.2% median decrease, respectively, from baseline [i.e. the beginning of the placebo-controlled study] to month 12 [cumulative months 12-24] of this extension study). These effects were associated with improvements in quality of life measures.; Limitations Reasons for Caution: This study was uncontrolled, which limits the interpretation of safety and efficacy findings. The study also had multiple protocol amendments with the addition of diagnostic procedures and, because no active comparator was included, the potential place of asoprisnil in comparison to therapies such as GnRH agonists and surgery cannot be determined.; Wider Implications of the Findings: Long-term, uninterrupted treatment with asoprisnil leads to prominent cystic endometrial changes that are consistent with the 'late progesterone receptor modulator' effects, which prompted invasive diagnostic procedures, although treatm nt effic cy is maintained. Although endometrial cancers were uncommon during both treatment and follow-up, these findings raise concerns regarding endometrial safety during uninterrupted long-term treatment with asoprisnil. This study shows that uninterrupted treatment with asoprisnil should be avoided due to safety concerns and unknown potential long-term consequences.; Study Funding/competing Interests: AbbVie Inc. (prior sponsor, TAP Pharmaceutical Products Inc.) sponsored the study and contributed to the design and conduct of the study, data management, data analysis, interpretation of the data and the preparation and approval of the manuscript. Financial support for medical writing and editorial assistance was provided by AbbVie Inc. M. P. Diamond received research funding for the conduct of the study paid to the institution and is a consultant to AbbVie. He is a stockholder and board and director member of Advanced Reproductive Care. He has also received funding for study conduct paid to the institution for Bayer and ObsEva. E. A. Stewart participated as a site investigator in the phase 2 study of asoprisnil and served as a consultant to TAP Pharmaceuticals during the time of design and conduct of the studies while on the faculty of Harvard Medical School and Brigham and Women's Hospital, Boston, MA. In the last 3 years, she has received support from National Institutes of Health grants HD063312, HS023418 and HD074711. She has served as a consultant for AbbVie Inc., Allergan, Bayer HealthCare AG and Myovant for consulting related to uterine leiomyoma and to Welltwigs for consulting related to infertility. She has received royalties from UpToDate and the Med Learning Group. A.R.W. Williams has acted as a consultant for TAP Pharmaceutical Products Inc. and Repros Therapeutics Inc. He has current consultancies with PregLem SA, Gedeon Richter, HRA Pharma and Bayer. B.R. Carr has served as consultant and received research funding from AbbVie Inc. and Synteract (Medicines360). E.R. Myers has served as consultant for AbbVie Inc., Allergan and Bayer. R.A. Feldman received compensation for serving as a principal investigator and participating in the conduct of the trial. W. Elger was a co-inventor of several patents related to asoprisnil.C. Mattia-Goldberg is a former employee of AbbVie Inc. and owns AbbVie stock or stock options. B.M. Schwefel and K. Chwalisz are employees of AbbVie Inc. and own AbbVie stock or stock options.; Trial Registration Number: NCT00156195 at clinicaltrials.gov. (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology.)

Dias Amanda Tamiris, B., et al. (2021). "Effectiveness of the use of Low Molecular Heparin in patients with repetition abortion history: Systematic review and meta-analysis." JBRA Assisted Reproduction 25(1): 10-27.
	Objective: To evaluate the efficacy and safety of using low molecular weight heparin (LMWH) in women with a history of recurrent abortion without an identified cause.; Methods: To develop a systematic review to select the studies. Total found 437 papers. Seven studies were completed or requested. The following variables were analyzed: clinical pregnancy, implantation rate, live births, abortion, premature birth, pregnancy, continuous pregnancy, beyond the 20th gestational week, congenital abnormality, hemorrhage, preeclampsia, placental premature detachment.; Results: The LMWH group had a higher incidence of continuous pregnancy after the 20th week of gestation and there was no significant difference between the LMWH group and the expectant management group in the analysis of other variables.; Conclusions: There was no data showing risk and/or less use of LMWH compared to expectant management; on the contrary, LMWH use increased the incidence of evolutionary pregnancy after the 20th gestational week. LMWH has some influence on prophylactic treatment of repeat abortion for unknown cause.

Dias Sávia Francisca, L., et al. (2019). "Scientific and technological prospection on transdermal formulations and complementary therapies for the treatment of primary dysmenorrhea." Expert opinion on therapeutic patents 29(2): 115-126.
	Introduction: Primary dysmenorrhea (PD) is another term for idiopathic menstrual cramps. Treatments include the use of oral non-steroidal anti-inflammatory drugs (NSAIDs). These drugs have several side effects. The objective of this study was to perform a systematic review on the transdermal administration of drugs and the use of alternative therapies for the treatment of PD.; Areas Covered: The article bases were Web of Science, PubMed and Sciencedirect and the patent bases were INPI, EPO and WIPO with publications on Primary Dysmenorrhea and associations with Transdermal Administration; Complementary Therapies and Medicinal Plants. 21 articles and 12 patents were analyzed. The results demonstrate the need for alternative therapies for the treatment of PD, with greater effectiveness and lower side effects, mainly in an attempt to reduce the intensity and duration of pain as well as reducing the continuous use of medications.; Expert Opinion: The study of technological prospection highlighted the relevant importance in seeking new methods for the relief of the symptoms provoked by this condition. The perspectives coexist in the discovery of new natural and biotechnological pharmacological applications, mainly in the development of new devices capable of facilitating and optimizing this form of administration in an attempt to reduce side effects.

Díaz-Álvarez, L., et al. (2022). "Does the Contractile Capability of Pelvic Floor Muscles Improve with Knowledge Acquisition and Verbal Instructions in Healthy Women? A Systematic Review." International Journal of Environmental Research and Public Health 19(15).
	Seventy percent of women with pelvic floor dysfunctions (PFDs) are estimated to present deficient consciousness of their pelvic floor muscles (PFMs) and poor ability to contract them. Improving the proprioception of PFMs, defined as the capacity to know the status and position of each body part, and adequately contracting them could be a protective factor to prevent the appearance of PFDs in the general female population. This study aimed to identify the effectiveness of educational interventions and verbal instructions on how to contract and exercise the PFMs to improve the proprioception of the PFMs in women. A systematic search of studies published in the last 20 years until March 2022 was conducted in the PubMed, Cochrane Library, Web of Science, Scopus, PEDro, Lilacs, and Dialnet databases. A meta-analysis could not be performed due to the heterogeneity in the types of studies and included populations. This review followed the PRISMA guidelines for the design, search, and reporting of studies. The methodological quality was analysed via the PEDro and the Newcastle-Ottawa scales in the case of randomised clinical trials and non-randomised studies, respectively, while the quality of evidence was determined using the SIGN grading system for evidence-based guidelines. Descriptive and experimental studies published in English, Spanish, or Portuguese that evaluated the contractile capability of the PFMs in healthy women or women without a previous diagnosis of PFD were included. Seven articles that included a total of 2507 women were found, three of which were clinical trials with PEDro scores between 5 and 9 points out of 10 and four of which were non-randomised studies with NOS scores between 6 and 8 points out of 10. The outcomes were measured through vaginal palpation, visual observation, questionnaires for PFD symptoms, and self-perception reports. This review discriminated between two types of intervention, educational programmes and verbal instructions, and evaluated the changes observed in PFM strength and knowledgeability and the symptoms of PFDs. The findings showed that educational interventions and verbal instructions improve the proprioception of PFMs in women of all ages that are healthy or without a previous diagnosis of PFDs as well as their knowledge about the pelvic floor, healthy lifestyle habits, and symptoms that are potentially indicative of PFDs. Further high-quality randomised clinical trials are warranted to draw definitive conclusions about the effectiveness of educational interventions to improve the proprioception of the PFMs in women considered healthy or with mild symptoms that may be indicative of PFDs.

Díaz-Feijoo, B., et al. (2022). "A multimodal prehabilitation program for the reduction of post-operative complications after surgery in advanced ovarian cancer under an ERAS pathway: a randomized multicenter trial (SOPHIE)." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society: 1463-1468.
	Background: Multimodal prehabilitation programs that combine exercise training, nutritional support, and optimize psychological status have demonstrated efficacy in reducing post-operative complications in non-gynecological abdominal surgeries; however, the benefit in advanced ovarian cancer is unclear.; Primary Objective: To compare the post-operative complications of a multimodal prehabilitation program in patients undergoing cytoreductive surgery for advanced ovarian cancer with standard pre-operative care.; Study Hypothesis: Multimodal prehabilitation reduces post-operative complications in patients undergoing cytoreductive surgery for advanced ovarian cancer and subsequently reduces the length of hospital stay and time to initiation of adjuvant therapy.; Trial Design: This prospective, multi-institutional, randomized clinical trial will randomize candidates for surgery to either the standard of care or multimodal prehabilitation consisting of (1) 2- or 3-weekly supervised high-intensity resistance training sessions and promotion of physical activity through a mobile phone application; (2) respiratory physiotherapy; (3) nutrition counseling with supplementation as needed; and (4) weekly psychological and cognitive behavioral sessions. Baseline, pre-operative and 1 month post-operative data will be collected. An independent blinded evaluator will collect intra- and post-operative surgical data.; Major Inclusion/exclusion Criteria: Women with advanced ovarian cancer International Federation of Gynecology and Obstetrics (2014) stage III or IV scheduled to undergo primary debulking surgery, interval debulking surgery,or secondary or tertiary cytoreductive surgery will be included. Women are eligible if they are able to undergo a minimum of 2 weeks of prehabilitation prior to surgery. Patients with <75% adherence to the total program will be excluded.; Primary Endpoint: Post-operative complications in patients with advanced ovarian cancer undergoing cytoreductive surgery according to the Comprehensive Complication Index.; Sample Size: 146 patients will be included, 73 in each group.; Estimated Dates for Completing Accrual and Presenting Results: Accrual should be completed in December 2024 with results reported soon thereafter.; Trial Registration Number: NCT04862325.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Díaz-Feijoo, B., et al. (2021). "Surgical complications comparing extraperitoneal vs transperitoneal laparoscopic aortic staging in early stage ovarian and endometrial cancer." Gynecologic Oncology 160(1): 83-90.
	OBJECTIVE: To determine whether the extraperitoneal approach for paraaortic staging lymphadenectomy results in a lower rate of surgical complications compared to the transperitoneal approach, without compromising oncological outcomes. METHODS: Prospective randomized multicenter study of patients with early endometrial or ovarian cancer undergoing paraaortic lymphadenectomy in 2010-2019. Patients were randomized to minimally invasive surgery (laparoscopy or robotic-assisted) using an extraperitoneal or a transperitoneal approach. The primary end point measure was a composite outcome that included developing one or more of the following surgical complications: bleeding during paraaortic lymphadenectomy ≥500 mL, any intraoperative complication related to paraaortic lymphadenectomy, severe postoperative complication (Dindo ≥ IIIA), impossibility to complete the procedure, or conversion to laparotomy. RESULTS: There were 103 patients in the extraperitoneal group and 100 in the transperitoneal group. Differences in the composite outcome (transperitoneal 26.0% vs, extraperitoneal 18.4%; P = 0.195) were not found. Differences in the operative time, conversion to laparotomy, intraoperative bleeding, or survival were not observed. A higher number of lymph nodes were retrieved through the extraperitoneal approached (median, interquartile range [IQR] 12 [7-17] vs, 14 [10-19]: P = 0.026). Older age and greater body mass index (BMI) or waist-to-hip ratio (WHR) increased the risk for surgical complications independently of the laparoscopic approach. CONCLUSIONS: The extraperitoneal approach did not show differences regarding surgical and oncological parameters compared with the transperitoneal approach, although the number of aortic nodes retrieved was higher. The decision to use one or another laparoscopic route is a matter of the surgeon preference. Trial registration ClinicalTrials.gov.identifier: NCT02676726.

DiCarlo-Meacham, A. M., et al. (2023). "Reduced versus standard intradetrusor OnabotulinumtoxinA injections for treatment of overactive bladder." Neurourology and Urodynamics 42(1): 366-374.
	Background: Intradetrusor onabotulinumtoxinA injection is an effective advanced treatment for overactive bladder. While the effective dosages have been well studied, very little data exist on treatment efficacy using differing injection techniques. The objective of this study was to determine whether the efficacy of a reduced injection technique of 5 injection sites was noninferior to the standard technique of 20 injection sites of intradetrusor onabotulinumtoxinA for treatment of overactive bladder. Method(s): In this randomized noninferiority trial, men and women seeking treatment of overactive bladder with intradetrusor onabotulinumtoxinA injections were randomized to receive 100 units administered via either a reduced injection technique of 5 injection sites or a standard injection technique of 20 injection sites. Subjects completed a series of standardized questionnaires at baseline and at 4-12 weeks postprocedure to determine symptom severity and treatment efficacy. The primary outcome was treatment efficacy as determined by Overactive Bladder Questionnaire-Short Form with a noninferiority margin of 15 points. Secondary outcomes were incidence of urinary tract infection and urinary retention requiring catheterization. Result(s): Data from 77 subjects were available for analysis with 39 in the control arm (20 injections) and 38 in the study arm (5 injections). There was a significant improvement in both arms from baseline to follow-up in Overactive Bladder Questionnaire-Short Form and International Consultation on Incontinence Questionnaire scores (p < 0.001). Overall treatment success was 68% with no statistically significant difference between arms. A significant difference between arms was found on the Overactive Bladder Questionnaire-Short Form quality of life survey favoring the control arm (confidence interval [CI]: 0.36-20.5, p = 0.04). However, there were no significant differences between arms in the remaining validated questionnaires. The study arm did not demonstrate noninferiority to the control arm. Subjects in the study arm were significantly more likely to express a willingness to undergo the procedure again (odds ratio = 3.8, 95% CI: 1.42-10.67, p = 0.004). Adverse events did not differ between arms. Conclusion(s): A reduced injection technique for administration of intradetrusor onabotulinumtoxinA demonstrates similar efficacy to the standard injection technique but did not demonstrate noninferiority. Subjects preferred the reduced injection technique over the standard technique. A reduced injection technique is a safe and effective alternative to the standard technique.Copyright © 2022 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.

Dickey, B. L., et al. (2021). "An updated systematic review of HPV genotype distribution by cervical disease grade in women living with HIV highlights limited findings from Latin America." Sexually Transmitted Diseases.
	Cervical cancer is five times more likely among women living with HIV (WHIV), likely due to higher prevalence of HPV. Despite evidence of higher rates with multiple HPV genotypes in WHIV, there are no recommendations for triage by HPV genotyping specific to WHIV. In Latin America/Caribbean (LAC) rates are high and vary significantly. To guide optimization of HPV-based cervical cancer screening among WHIV in LAC, review of current literature was completed to assess HPV genotype distribution by cervical disease grade in WHIV in this region; and further expanded globally for comparison across regions.A systematic review of the literature from June 2016 to January 2020 revealed 15 studies reporting HPV genotype distribution by cervical disease state (normal, low-grade disease, high-grade disease, and invasive cervical cancer) across different global regions.Across all studies, there were 6,928 WHIV from 4 global regions, 3,952 of whom were HPV-positive. Three studies from LAC were reviewed, with one providing enough detail to describe HPV genotypes by cervical disease grade and identified type 31 and 35 in high-grade cervical lesions. Of the studies included, 4 from Africa and Europe/North America each, and 1 from Asia included data that were able to be summarized.Latin America, a region which experiences high rates of HPV, HIV, and cervical disease, had few published studies reporting HPV genotypes by cervical disease grade, with one reporting individual HPV genotype and specific cervical disease grade. Identifying HPV types associated with CIN2+ in WHIV in this region has the potential to improve screening and treatment for cervical cancer prevention and should be the focus of future research.

Diebold, A., et al. (2021). "Testing the effects of a prenatal depression preventive intervention on parenting and young children's self-regulation and functioning (EPIC): protocol for a longitudinal observational study." BMC public health 21(1): 1368.
	Background: Perinatal depression is a pervasive public health concern that disproportionately affects low-income women and can have negative impacts on parenting and child developmental outcomes. Few interventions focus on preventing perinatal depression. Previous studies suggest that Mothers and Babies is efficacious in preventing the worsening of depressive symptoms and the onset of postpartum depression. This manuscript presents the protocol of the EPIC study (Effects of a Prenatal Depression Preventive Intervention on parenting and young children's Self-Regulation and Functioning) to test the effects of Mothers and Babies on parenting and child developmental outcomes through 54 months postpartum. EPIC is an observational study that builds on a completed cluster-randomized trial (CRT). Innovations of this study are direct observations of a subsample of mother-child dyads and the inclusion of fathers/caregivers' variables as moderators of maternal mental health.; Methods: For this study, we plan to enroll 738 women with children under 30 months old, ≥18 years old, and who speak English or Spanish. Additionally, 429 fathers, partners, or other adult caregivers will be recruited through women participating in the study. Women will be recruited through the parent study (intervention and control participants) or through one of 10 home visiting programs in Illinois (control participants). Data collection will take place through maternal self-report at five time points (when the child is 30, 36, 42, 48, and 54 months), paternal self-report at three time points (when the child is 30, 42, and 54 months), and through mother-child observations at three time points (when the child is 36, 42, and 48 months). Outcome domains include maternal mental health, cognitive-behavioral and parenting skills, and child self-regulation and functioning. Moderators include the contributions of fathers/caregivers, race-ethnicity, and socioeconomic disadvantage. Power and sample size were calculated assuming a two-sided 5% type I error rate and assumed analyses on the individual level.; Discussion: This study has several key strengths and innovations, as well as great potential significance to influence the long-term trajectories of parenting and child development via prenatal intervention.; Trial Registration: The study was retrospectively registered at ClinicalTrials.gov (Identifier: NCT04296734 ) on March 5, 2020. (© 2021. The Author(s).)

Diem, S. J., et al. (2020). "Effects of pharmacologic and nonpharmacologic interventions on menopause-related quality of life: A pooled analysis of individual participant data from four MsFLASH trials." Menopause 27(10): 1126-1136.
	Objective:The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected menopause-related quality of life (QOL) measures. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions' effects on menopause-related QOL relative to control in women with VMS. Method(s):We pooled individual-level data from 1,005 peri-and postmenopausal women with 14 or more VMS/week across the four RCTs. Interventions included escitalopram 10 to 20mg/d; yoga/aerobic exercise; 1.8g/d omega-3-fatty acids; oral 17-beta-estradiol 0.5mg/d; venlafaxine XR 75mg/d; and cognitive behavioral therapy for insomnia (CBT-I). Outcomes measures were the Menopause-specific Quality of Life scale and its subscales. Result(s):Significant improvements in total Menopause-specific Quality of Life from baseline were observed with estradiol, escitalopram, CBT-I, and yoga, with mean decreases of 0.3 to 0.5 points relative to control. The largest improvement in the vasomotor subscale was observed with estradiol (-1.2 points), with more modest but significant effects seen with escitalopram, yoga, and CBT-I. Significant improvements in the psychosocial subscale were observed for escitalopram, venlafaxine, and CBT-I. For the physical subscale, the greatest improvement was observed for CBT-I and exercise, whereas for the sexual subscale, the greatest improvement was observed for CBT-I, with yoga and estradiol demonstrating smaller effects. Conclusion(s):These results suggest that for menopause-related QOL, women have a variety of treatment strategies to choose from and can select an approach based on most bothersome symptoms and individual preferences.Copyright © 2020 Lippincott Williams and Wilkins. All rights reserved.

Dieter Alexis, A., et al. (2019). "Catheter burden following urogynecologic surgery." American Journal of Obstetrics and Gynecology 221(5): 507.e501-507.e507.
	Background: Data on the experience that women who undergo urogynecologic surgery have with postoperative catheterization are severely limited. As the importance of our patients' perioperative experience becomes more valued, assessment of the burden of postoperative catheterization, which has not yet been performed, is increasingly needed.; Objective: The aim of this study was to compare catheter burden in women who self-selected use of an indwelling Foley catheter vs clean intermittent self-catheterization for voiding dysfunction after reconstructive pelvic surgery.; Study Design: This is a nested study within a nonblinded randomized controlled trial of 2 different voiding trial protocols that was conducted from March to October 2017. Women who underwent pelvic organ prolapse and/or stress urinary incontinence surgery who were English speaking and ≥18 years old with a preoperative postvoid residual <100 mL were included. Participants who did not pass their voiding trial were discharged with an indwelling Foley catheter or self-catheterization per participant preference. Our primary outcome was catheter burden at 1 week after surgery assessed by the Short-Term Catheter Burden Questionnaire, which is a validated 6-item survey comprised of 2 subscales: difficulty of use and embarrassment. Scores range from 3-15 with higher scores indicating greater difficulty and/or embarrassment, and the sum of the 2 subscale scores measures total catheter burden with a higher score indicating greater burden. Secondary outcomes included the rate of urinary tract infection, the number of postoperative clinic visits, and the number of postoperative phone calls.; Results: Of 150 participants, 77 women (51%) did not pass their voiding trial; of those, 47 women (61%) were discharged home with an indwelling catheter and 30 women (39%) with self-catheterization. Baseline demographics were similar, except that women who chose an indwelling Foley catheter were older (62±11 vs 55±11 years; P<.01). There were no significant differences between indwelling Foley catheter and self-catheterization in total catheter burden score (18±5 vs 18±6; P=.77), difficulty of use subscale score (8±3 vs 9±3; P=.20), or embarrassment subscale score (10±4 vs 9±4; P=.12). For secondary outcomes, there were no significant differences in rate of urinary tract infection (23% indwelling vs 30% self-catheterization; P=.60). Consistent with study protocol, women who were discharged with an indwelling Foley catheter did have more postoperative clinic visits (2±1 vs 1±1 visits; P<.01), and those women who were discharged with self-catheterization had more postoperative phone calls (2±3 vs 5±3 phone calls; P<.01). Otherwise there was no significant difference in nonvoiding-related clinic visits (1±1 visits for indwelling and self-catheterization; P=.15) or postoperative phone calls (1±2 indwelling vs 2±3 self-catheterization calls; P=.31).; Conclusion: In women who used either an indwelling Foley catheter or clean intermittent self-catheterization for management of postoperative voiding dysfunction after pelvic reconstructive surgery, there were no differences in difficulty of use, embarrassment, or overall catheter burden. There were also no differences in nonvoiding-related postoperative phone calls or clinic visits, with similar rates of urinary tract infection between the 2 groups. (Copyright © 2019 Elsevier Inc. All rights reserved.)

Dietl, A., et al. (2020). "Tumor Handling of Early-stage Cervical Cancer: A Literature Analysis of Villoglandular Adenocarcinoma of the Cervix." Anticancer Research 40(6): 3049-3053.
	Background/aim: Recent studies have demonstrated the inferior overall survival outcomes of patients with early-stage cervical cancer who undergo minimally invasive surgery (MIS). One possible explanation for these unexpected results is intraoperative tumor manipulation.; Materials and Methods: Considering this hypothesis, we have reviewed the literature on the oncological outcomes of patients with villoglandular adenocarcinoma (VGA) of the cervix, an uncommon variant of cervical cancer that has an excellent prognosis.; Results: VGA generally presents as an exophytic mass arising from the endocervix. In a systematic review, we identified 221 patients treated surgically for VGA (FIGO stage Ia-Ib 1 ). Of these, 11 developed recurrence, and four died. The recurrence sites in 8 cases were the pelvis (n=3), vaginal cuff (n=3), episiotomy scar (n=1), and cervix (n=1). Furthermore, 23 VGA-patients were treated by MIS, four experienced recurrence, and one died. Three intraabdominal metastases after MIS were reported.; Conclusion: Excessive tumor-handling during MIS or manipulations, e.g. cervix-dilation (during delivery), can worsen the otherwise excellent prognosis. (Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Dietl Anna, K., et al. (2021). "Villoglandular adenocarcinoma of the uterine cervix: a systematic review and meta-analysis." Archives of Gynecology and Obstetrics 304(2): 317-327.
	Purpose: Villoglandular adenocarcinoma (VGA) of the uterine cervix has been classified as a rare subtype of cervical adenocarcinoma with good prognosis. A conservative surgical approach is considered feasible. The main risk factor is the presence of other histologic types of cancer. In this largest systematic review to date, we assess oncological outcomes associated with conservative therapy compared to those associated with invasive management in the treatment of stage Ia and Ib 1 VGA.; Methods: Case series and case reports identified by searching the PubMed database were eligible for inclusion in this review (stage Ia-Ib 1 ).; Results: A total of 271 patients were included in our literature review. 54 (20%) patients were treated by "conservative management" (conization, simple hysterectomy, and trachelectomy) and 217 (80%) by "invasive management" (radical hysterectomy ± radiation, hysterectomy, and radiation). Recurrences of disease (RODs) were found in the conservative group in two (4%) cases and in the invasive group in nine (4%) cases. There was no significant difference in disease-free survival (DFS) according to conservative or invasive treatment (p = 0.75). The histology of VGA may be complex with underlying usual adenocarcinoma (UAC) combined with VGA.; Conclusion: The excellent prognosis of pure VGA and the young age of the patients may justify the management of this tumor using a less radical procedure. The histological diagnosis of VGA is a challenge, and pretreatment should not be based solely on a simple punch biopsy but rather a conization with wide tumor-free margins. (© 2021. The Author(s).)

Dietz de Loos, A., et al. (2022). "Pregnancy Rate and Outcomes Following a Randomized Controlled Three-component Lifestyle Intervention in Women with PCOS." Human reproduction (Oxford, England) 37: i482‐i483.
	Study question: What is the impact of a three‐component lifestyle intervention on the pregnancy rate, time to pregnancy and pregnancy complications in women with polycystic ovary syndrome? Summary answer: A non‐significant positive trend in pregnancy outcomes was demonstrated in favor of the lifestyle intervention groups, in line with the weight loss achieved per group. What is known already: PCOS (polycystic ovary syndrome) is associated with overweight and obesity. Women with PCOS and overweight or obesity present with more pronounced reproductive derangements. Moreover, when pregnant, pregnancy complications such as gestational diabetes, hypertensive disorders and preterm birth seem to be more prevalent in this population. The first line treatment for women with PCOS and overweight or obesity is a multi‐component lifestyle intervention. Data on pregnancy outcomes after multi‐component lifestyle interventions in women with PCOS are scarce. Study design, size, duration: The present study is a one‐year randomized controlled trial to investigate the effect of a three‐component (cognitive behavioral therapy, healthy diet and physical therapy) lifestyle intervention (LSI) with or without Short Message Service (SMS) on pregnancy leading to live birth, pregnancy complications and outcomes within 24 months after the start of the lifestyle intervention compared to care as usual (CAU). Participants/materials, setting, methods: Women diagnosed with PCOS according to the Rotterdam 2003 criteria and a BMI above 25 kg/m2 were included. A total of 183 participants were randomly assigned to three groups: 1) three‐component lifestyle intervention with SMS (SMS+); 2) three‐component lifestyle intervention without SMS (SMS‐); 3) care as usual (CAU): encourage to lose weight autonomously (control group). Pregnancy and neonatal outcomes were collected from the Dutch Bureau of Statistics (CBS) combined with the Dutch Perinatal registry (Perined). Main results and the role of chance: Within 24 months after the start of the intervention the pregnancy rate leading to live birth was 41.7% (25/60) within SMS+, 38.1% (24/63) within SMS‐ and 38.3% (23/60) within CAU. This was non‐significant between the groups. Mean time to pregnancy for SMS+ was 18.3 months, 19.1 months for SMS‐ and 19.4 months for CAU (p=0.775). Gestational diabetes (LSI: 8.2% vs CAU: 21.7%, p=0.133), hypertensive disorders (LSI: 8.2% vs CAU: 13.0%, p=0.673) and preterm birth (LSI: 12.2% vs CAU: 17.4%, p=0.716) rates were all lower in the LSI groups (SMS+ and SMS‐ combined) compared to CAU. Limitations, reasons for caution: Although significantly less than the LSI groups, even the CAU group achieved weight loss, which may give an underestimation of the effect of the lifestyle intervention with regard to pregnancy outcomes. Wider implications of the findings: Weight loss overall seems to have a positive effect on pregnancy outcomes, and multi‐component lifestyle interventions are needed to achieve weight loss.

Dietz de Loos, A., et al. (2023). "Pregnancy Outcomes in Women with PCOS: Follow-Up Study of a Randomized Controlled Three-Component Lifestyle Intervention." Journal of Clinical Medicine 12(2).
	Women with polycystic ovary syndrome (PCOS) and excess weight often present with reproductive derangements. The first-line treatment for this population is a multi-component lifestyle intervention. This follow-up study of a randomized controlled trial based on data from the Dutch Perinatal registry was conducted to study the effect of a one-year three-component (cognitive behavioral therapy, healthy diet, and exercise) lifestyle intervention on pregnancy outcomes in women with PCOS and overweight or obesity. Women diagnosed with PCOS, a BMI ≥ 25 kg/m², and a wish to conceive were randomized to either three-component lifestyle intervention (LSI, n = 123), and care as usual (CAU, n = 60) where they were encouraged to lose weight autonomously. Conception resulting in live birth was 39.8% (49/123) within LSI and 38.3% (23/60) within CAU ( p = 0.845). In total, 58.3% conceived spontaneously. Gestational diabetes (LSI: 8.2% vs. CAU: 21.7%, p = 0.133), hypertensive disorders (LSI: 8.2% vs. CAU 13.0%, p = 0.673), and preterm birth (LSI: 12.2% vs. CAU: 17.4%, p = 0.716) rates were all lower in LSI compared to CAU. This follow-up study showed no significant differences in conception resulting in live birth rates between LSI and CAU. Nonetheless, a large proportion eventually conceived spontaneously. Moreover, after LSI, the number of uneventful pregnancies was lower compared to care as usual.

Digklia, A., et al. (2022). "Trabectedin and Durvalumab Combination Is Feasible and Active in Relapsing Ovarian Cancer." Clinical cancer research : an official journal of the American Association for Cancer Research 28(9): 1745-1747.
	The combination of chemotherapy and immune therapies still promises to synergize for prolonged tumor control. However, the quest for optimal combinations tailored for tumor histology remains ongoing. A recent study provides evidence on the feasibility of the trabectedin/durvalumab combination and reports on interesting preliminary efficacy. See related article by Toulmonde et al., p. 1765. (©2022 American Association for Cancer Research.)

Dikke, G. B., et al. (2023). "VAGINAL DILATERS IN THE PREVENTION AND TREATMENT OF STENOSIS AND VAGINAL PAIN SYNDROMES." Akusherstvo i Ginekologiya (Russian Federation) 2023(12): 181-188.
	This article presents up-to-date information on the use of vaginal dilators in gynecology, taking into account the indications for their use and effectiveness. The findings of 36 articles found in the databases Medline, Scopus, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar, eLibrary were analyzed over the period 2014-2023 using keywords. The results of the analysis showed that there are the following indications for the use of vaginal dilators: condition after radiation therapy for cancer of the vulva, cervix, uterus, anogenital area (high risk of vaginal stenosis); scars/stenosis after episiotomy or perineal rupture during childbirth, vaginoplasty surgery (neovagina, vaginal hypoplasia/agenesis, or Mayer-Rokitansky-Kuster-Hauser syndrome); dyspareunia, vaginismus, vulvodynia, sclerosing complications of skin diseases of the external genitalia (sclerotic lichen, lichen planus). The use of vaginal dilators is effective in 75-81% of patients for the prevention of vaginal stenosis after radiation therapy for cancer of the genitalia and anogenital area; it is effective in the treatment of hypoplasia/agenesis of the vagina in 75%, and is also effective in stenosis caused by sclerotic lichen and lichen planus. The success of therapy depends on informing and educating patients. Conclusion(s): The analysis of studies published over the past 10 years has shown the possibility of using vaginal dilators for various diseases, in particular for the prevention of vaginal stenosis after radiation therapy in patients treated for gynecological cancer, postpartum injuries, after gynecological operations on the vulva and vagina, as well as for stenosis caused by sclerotic lichen and lichen planus. Informing and educating patients influence the success of therapy. The use of vaginal dilators should become more widespread in clinical practice.Copyright © A group of authors, 2023.

Dikke, G. B., et al. (2021). "Immune-mediated mechanisms of the inflammatory response in women with combined infections of the lower genital tract." Obstetrics, Gynecology and Reproduction 15(3): 245‐257.
	Aim: to increase the effectiveness of combination therapy and reduce frequency of recurrences of inflammatory diseases in the lower genital tract of combined etiology. Materials and Мethods. There was conducted a prospective, randomized, blind, comparative clinical study. 80 women with vaginal microbiota disorders were examined randomized into 2 groups: group I (n = 40) ‐ antibiotic therapy was carried out in combination with the preparation Superlimph, group II (n = 40) ‐ a standalone antibacterial therapy; group III consisted of 20 patients lacking gynecological diseases considered to provide with control laboratory parameters. Clinical and laboratory methods were used: microscopy of vaginal smears, detection of viruses and sexually transmitted infections, measurement of serum cytokine levels ‐ interleukins (IL‐1β, IL‐2, IL‐4, IL‐6, IL‐8, IL‐10), tumor necrosis factor alpha, (TNF‐α), interferon gamma (IFN‐γ). Results. It was found that clinical recovery occurred in 90.0 and 70.0 % of patients in group I and group II (р = 0.02), respectively. Microbiological recovery was observed in 100.0 and 67.5 % of patients, respectively (р = 0.003). In group I, the isolation of herpes simplex virus type 2 was found in 80.0 and 45.2 % of patients before and after treatment (p < 0.001), respectively, whereas in group II ‐ in 82.5 and 77.5 %, respectively (p = 0.58), between groups ‐ p < 0.001. Before treatment the level of all cytokines, excepting IFN‐γ, was higher than the reference values in both groups: in group I, their magnitude decreased after treatment (p < 0.001) and corresponded to the reference values; in group II no changes occurred. Three months after treatment, no relapses were observed in group I, whereas frequency of relapses in group II was 22.5 %, within 1 year ‐ 0 and 35.1 %, respectively. Predictors of recurrent dysbiosis (IL‐2, IL‐6 and TNF‐α in increased concentrations after a course of treatment) were identified. Conclusion. Treatment with a combined broad‐spectrum antimicrobial drug along with topical immunomodulatory agent containing exogenous cytokines is an effective strategy for treating concomitant dysbiosis and preventing relapse.

Dikke, G. B., et al. (2021). "Cytokine profile in patients with chronic endometritis and reproductive disorders." Voprosy Ginekologii, Akusherstva i Perinatologii 20(6): 82‐91.
	Objective. To study the immune response in patients with chronic endometritis (CE) of viral and bacterial etiology based on the evaluation of cytokine status as well as the efficiency of local therapy using a complex of natural exogenous cytokines. Patients and methods. A prospective randomized clinical trial, which included 76 women with CE and infertility, who received etiotropic antibacterial therapy prior to inclusion in the study, is presented. In group I (n = 36), patients were treated with a daily intravaginal administration of Superlymph 25 U for 20 days; in group II (n = 40), patients were under observation. We used a vaginal wet mount test, real‐time polymerase chain reaction (RT‐PCR) (to estimate virus shedding), and an analysis of serum cytokine levels (interleukins IL‐1β, IL‐2, IL‐4, IL‐6, IL‐8, IL‐10, and tumor necrosis factor alpha (TNF‐α)). Results. The herpes simplex virus type 1 (HSV‐1) and type 2 (HSV‐2) (80.6% and 80.0%, respectively) was predominantly detected in both groups of patients in combination with other types of herpesviruses (50.0% and 42.5%, respectively) and/or human papillomavirus (HPV) (50%). After treatment with Superlymph, virus shedding ceased in 66.7% of patients (p < 0.001). Before treatment, the levels of all cytokines were higher than the reference values (p < 0.001) in both groups (IL‐1β – 1.8 times, IL‐6 – 1.6 times, IL‐2 and IL‐8 – 1.2 times, TNF‐α – 1.4 times). After treatment, their values decreased in group I (p < 0.001 for each indicator). In group II, the changes were insignificant. Pregnancy occurred within 12 months in 30 (83.3%) patients in group I and in 24 (60.0%) patients in group II, and this result was statistically significantly higher in group I (p = 0.047). Conclusion. The role of viral and bacterial infections accompanied by an imbalance of pro‐and anti‐inflammatory cytokines in patients with CE was revealed, which is the basis for prescribing not only antibacterial therapy, but also local immunomodulatory agents.

Dilawari, A., et al. (2023). "FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer." Clinical cancer research : an official journal of the American Association for Cancer Research 29(19): 3835-3840.
	On November 14, 2022, the FDA granted accelerated approval to mirvetuximab soravtansine-gynx for treatment of adult patients with folate receptor-α (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic therapies. The VENTANA FOLR1 (FOLR-2.1) RxDx Assay was approved as a companion diagnostic device to select patients for this indication. Approval was based on Study 0417 (SORAYA, NCT04296890), a single-arm, multicenter trial. In 104 patients with measurable disease who received mirvetuximab soravtansine-gynx, the overall response rate was 31.7% [95% confidence interval (CI), 22.9-41.6] with a median duration of response of 6.9 months (95% CI, 5.6-9.7). Ocular toxicity was included as a Boxed Warning in the U.S. Prescribing Information (USPI) to alert providers of the risks of developing severe ocular toxicity including vision impairment and corneal disorders. Pneumonitis and peripheral neuropathy were additional important safety risks included as Warnings and Precautions in the USPI. This is the first approval of a targeted therapy for FRα-positive, platinum-resistant ovarian cancer and the first antibody-drug conjugate approved for ovarian cancer. This article summarizes the favorable benefit-risk assessment leading to FDA's approval of mirvetuximab soravtansine-gynx. (©2023 American Association for Cancer Research.)

Dilbaz, B., et al. (2022). "The effect of hysteroscopic metroplasty on fertility in T-shaped and Y-shaped dysmorphic uterus." The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception 27(5): 384-389.
	Objective: T/Y-shaped dysmorphic uterus is frequently associated with subfertility, abortion, preterm delivery, and recurrent implantation failure. In this study, the impact of hysteroscopic metroplasty for a T/Y-shaped uterus on obstetric outcomes was investigated in patients with infertility and recurrent pregnancy loss (RPL) and compared the uterine anomaly subgroups.; Method: Cases with infertility and/or RPL diagnosed with T/Y-shaped uterus by hysterosalpingography (HSG) and 3D transvaginal ultrasonography (3D TVUSG) with no other male or female pathology have recruited the study. Medical history and the obstetric outcome after two years of follow-up were recorded.; Results: Out of the 92 cases recruited, T-shaped uteri (Group-1) were observed in 30, while 62 (67.3%) patients had Y-shaped uteri. Pregnancy was achieved in 50 (54.3%) of the cases, 28 (56%) of the pregnancies occurred spontaneously, and in 22 (44%) pregnancy was achieved through assisted reproductive techniques (ART). Term delivery occurred in 29 (76.3%) of the pregnancies while 9 (23.6%) had preterm deliveries and a total of 38 (76%) resulted in a live birth. Out of the 31 patients with previous RPL history, 13 (41.9%) achieved pregnancy and 11 out of 13 (84.6%) had a term pregnancy followed by live birth.; Conclusion: Spontaneous pregnancy, and term pregnancy rates after surgery were found to be promising in these uterine anomalies. The pregnancy outcome of the primary infertile patients was found the same in two groups (50%-46.1%), but the results of the RPL patients were found to be better in the T-shaped group than in the Y-shaped group (70%-28.5%).

Dilek, O., et al. (2022). "Impact of the individual counseling program for polycystic ovarya syndrome management among university students: A prospective randomized controlled trial." Nigerian journal of clinical practice 25(6): 809-816.
	Background: Polycystic ovary syndrome (PCOS) is common in women of reproductive age.; Aim: This study aimed to investigate the impact of individual counseling program which had been designed from the transtheoretical model (TM) for students diagnosed with PCOS.; Patients and Methods: The study is a prospective randomized controlled trial. The research was carried out in four stages as screening, diagnosis, randomization, selection, and counseling. The data for the analysis were drawn from a sample of 854 students at first and a total of 67 students were administered the scales. The control (n = 33) and experimental groups (n = 34) were formed based on the simple randomization technique. The sample characteristics were voluntary participation, absence of sexual activity for a minimum of 6 months, belonging to the age group of 19-24, an absence of chronic diseases or any physical disability, and a lack of mental disorders. Participants using medication and obtaining scores of above/below 18.5 and below/above 30 on the body mass index (BMI) were not included in the study.; Results: The prevalence of PCOS among university students was found to be 8.8%. The findings indicated that the majority of the students have been experiencing various physical symptoms such as being overweight, menstrual irregularity, hirsutism, alopecia, acne, and psychological symptoms such as uneasiness, irritability, anger, anxiety, and fatigue. Based on the pretest and posttest scores, it was observed that the anthropometric values and psychological indicators such as the feeling of uneasiness, irritability, anger, anxiety, and fatigue were significantly decreased in the group of PCOS that took the counseling program.; Conclusions: Individual counseling improved the anthropometric measurements and the clinical findings related to PCOS.; Competing Interests: None

Dillon Gabrielle, A., et al. (2022). "Seven days of statin treatment improves nitric-oxide mediated endothelial-dependent cutaneous microvascular function in women with endometriosis." Microvascular research 144: 104421.
	Introduction: Endometriosis is associated with systemic inflammation and increased risk of cardiovascular disease (CVD). Endothelial dysfunction is one of the first manifestations of CVD but is unexplored in women with endometriosis. HMG-CoA-reductase inhibitors (statins) exert potent anti-inflammatory effects, and have been proposed as an adjunctive therapy in women with endometriosis. We hypothesized that microvascular endothelial function would be impaired in otherwise healthy women with endometriosis mediated by reduced nitric oxide (NO)-dependent dilation and that short term statin administration would improve endothelial function.; Methods: In 8 healthy control (HC: 33 ± 9 yr) and 8 women with endometriosis (EN: 34 ± 9 yr), laser-Doppler flux (LDF) was measured continuously during graded intradermal microdialysis perfusion of the endothelium-dependent agonist acetylcholine (Ach: 10 -10 -10 -1 M) alone and in combination with the NO synthase inhibitor (L-NAME: 0.015 M). 6 EN repeated the microdialysis experiment following 7 days of oral atorvastatin treatment (10 mg). Cutaneous vascular conductance was calculated (CVC = LDF*mmHg -1 ) and normalized to site-specific maximum (28 mM sodium nitroprusside, 43 °C). The NO-dependent dilation was calculated as the difference between the areas under the dose response curves.; Results: Ach-induced vasodilation was blunted in women with endometriosis (main effect p < 0.01), indicating impaired endothelial function. NO-dependent vasodilation was also reduced in women with endometriosis (HC: 217 ± 120.3 AUC vs. EN: 88 ± 97 AUC, p = 0.03). Oral atorvastatin improved Ach-induced (main effect p < 0.01) and NO-dependent (295 ± 153 AUC; p = 0.05) vasodilation in women with endometriosis.; Conclusion: Microcirculatory endothelium-dependent vasodilation is impaired in women with endometriosis, mediated in part by reductions in NO. Short-term oral atorvastatin improved endothelium-dependent vasodilation, suggesting that statin therapy may be a viable intervention strategy to mitigate accelerated CVD risk in women with endometriosis.; Competing Interests: Declaration of competing interest None. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Dimas, A., et al. (2023). "The expression and possible role of corticotropin-releasing hormone family peptides and their corresponding receptors in gynaecological malignancies and premalignant conditions: a systematic review." Przeglad menopauzalny = Menopause review 22(4): 227-235.
	The aim of this systematic review is to investigate the impact of corticotropin-releasing hormone (CRH) family peptides and their corresponding receptors on human physiology and disease onset, with a specific focus on gynaecological malignancies such as breast, endometrial, ovarian, vulvar, and cervical cancer. A comprehensive systematic review of 3 medical databases was conducted by 2 independent reviewers. We reviewed studies that explored the expression and role of CRH peptides in various aspects of cancer biology, in the context of breast, endometrial, ovarian, vulvar, and cervical cancer. Our findings reveal that CRH family peptides and their receptors, CRHR1 and CRHR2, are expressed in diverse gynaecological tissues, including cancer cells. Notably, we observed differential expression patterns among different gynaecological cancer types and stages, indicating potential associations with tumour aggressiveness and patient prognosis. Furthermore, CRH peptides were found to exert significant influences on critical cellular processes, such as cell proliferation, migration, invasion, and immune response, in gynaecological cancers. These findings highlight the multifaceted roles of CRH family peptides in gynaecological malignancies and emphasize the need for further research in this field. Therefore, understanding the mechanisms underlying the involvement of CRH family peptides in tumourigenesis may open new avenues for targeted therapeutic strategies in gynaecological malignancies.; Competing Interests: The authors report no conflict of interest. (Copyright © 2023 Termedia.)

Dimitrios, R., et al. (2021). "Effect of vitamin D supplementation in endometriosis."
	
Ding, N., et al. (2020). "Chinese herbal medicine on treating obese women with polycystic ovary syndrome: A systematic review and meta-analysis protocol." Medicine 99(49): e22982.
	Introduction: Known as an endocrine disorder, Polycystic ovary syndrome (PCOS) has posed an influence on 6% to 20% reproductive females worldwide. The commonly used pharmaceutical agents currently are Oral Contraceptives (OCs) and insulin-sensitizing agents. However, OCs is not appropriate for females pursuing pregnancy. Furthermore, some of insulin-sensitizing agents are found to be related to a high incidence of gastrointestinal adverse effects. In this regard, the effectiveness of Chinese herbal medicine in handling reproductive and metabolic defects simultaneously has been proved by extensive evidence. In this research, the effectiveness and safety of Chinese herbal medicine for obese females with PCOS were examined.; Methods and Analysis: In the systematic review, we searched databases of AMED, Science Online, EMbase, WorldSciNet, the Cochrane Library, PubMed, Nature, MEDLINE, China National Knowledge Infrastructure, the Wanfang Databse and China Biology Medicine Disc and the Chongqing VIP Chinese Science and Technology Periodical Database, to find out the papers published in Chinese or English by September 25, 2020 in this field. In addition, potential reference lists, relevant conference proceedings, qualified studies, related system reviews and other resources were also considered. Two researchers were responsible for independently selecting the research papers, collecting data, and evaluating research quality. Moreover, the data were synthesized with the combination of a fixed-effects or random-effects model with the heterogeneity test. According to the objective and self-reported assessment, the primary outcomes will be Nausea and vomiting were primary outcomes. RevMan 5 software was used to analyze the collected data, the evidence level of which was evaluated by GRADE. The selection between the fixed-effects and random-effects models was determined by the heterogeneity level. In addition to the 95% Confidence Interval (CI), odds ratio (OR), or risk ratio (RR) was applied to the 2 categories. Moreover, 95% CI and standardized mean difference (SMD) or the weighted mean difference (WMD) were taken as the continuous variables. When existing meaningful heterogeneity could not be explained by any assessment such as subgroup analysis, we would not conduct a meta-analysis. During the subgroup analysis, each subgroup in specific cases should be comprehensively considered.; Ethics and Dissemination: The evaluation of rights or personal information of patients was not involved in the systematic review. Hence, we need not gain approval from ethical institutions. This paper will be present at related conferences for communication and published in journals.; Registration: Open Science Framework (OSF) Preregistration: osf.io/yp86h.

Dinoi, G., et al. (2023). "Minimally Invasive Compared With Open Surgery in High-Risk Endometrial Cancer: A Systematic Review and Meta-analysis." Obstetrics and Gynecology 141(1): 59-68.
	Objective: To compare outcomes between minimally invasive surgery and open surgery in patients with high-risk endometrial cancer.; Data Sources: A cohort study of all patients who underwent surgery for high-risk endometrial cancer between 1999 and 2016 at Mayo Clinic (Rochester, Minnesota) and a literature search of MEDLINE, EMBASE, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, and Scopus of all published studies until December 2020.; Methods of Study Selection: The systematic review identified 2,332 patients (14 studies, all retrospective except a subanalysis of a randomized comparison) and the cohort study identified 542 additional patients. Articles were included if reporting original data on overall survival and disease-free survival among patients with high-risk endometrial cancer, defined as International Federation of Gynecology and Obstetrics grade 3 endometrioid, serous, clear cell, mixed histology, or uterine carcinosarcoma. Studies that did not report at least one of the main outcomes, those in which one surgical technique (robotic or laparoscopic surgery) was missing in the comparison analysis with open surgery, and case reports were excluded. Additional data were extracted from a retrospective cohort of patients from Mayo. A random-effect model was used for meta-analysis.; Tabulation, Integration, and Results: This systematic review and meta-analysis was registered in PROSPERO. Literature search and data extraction were performed independently by two reviewers, as well as quality assessment using GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology, and the Newcastle-Ottawa Scale. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. Meta-analysis showed that disease-free survival and overall survival in patients with high-risk endometrial cancer who underwent minimally invasive surgery were not statistically different from those of patients who underwent open abdominal surgery (relative risk [RR] 0.93, 95% CI 0.82-1.05, I2 20%, P=.23; and RR 0.92, 95% CI 0.77-1.11, I2 31%, P=.12, respectively). Subgroup analysis by stage (early vs advanced) did not identify a difference between surgical approaches.; Conclusion: Minimally invasive surgery and open surgery had similar disease-free survival and overall survival in patients with high-risk endometrial cancer.; Systematic Review Registration: PROSPERO, CRD42021275535.; Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest. (Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Dioun, S., et al. (2022). "COST-EFFECTIVENESS OF HYSTERECTOMY AT THE TIME OF RISK-REDUCING BILATERAL SALPINGOOOPHORECTOMY FOR PATIENTS WITH BRCA1 MUTATIONS." International Journal of Gynecological Cancer 32(Supplement 3): A39.
	Objectives More recent data suggests that patients with BRCA1 are at an increased risk of developing uterine serous cancers. This raises the question of whether a hysterectomy should be done at time of rrBSO. We developed a decision model to compare the cost-effectiveness of rrBSO with or without hysterectomy for patients with BRCA1 mutations. Methods A Markov model was created to simulate the clinical trajectory of a hypothetical cohort of 10,000 women aged 40 years of age with BRCA1 mutations undergoing rrBSO. The initial decision point in the model was whether a hysterectomy was performed at the time of rrBSO. A time horizon of 60 years was used. Postoperative morbidity and mortality were included in the model as well as risk for subsequent hysterectomy and prolapse after hysterectomy. Model probabilities, cost and utility values were derived with assumptions drawn from published literature. The effectiveness was calculated in terms of average quality adjusted life years (QALYs). The primary outcome was incremental cost-effectiveness ratios (ICERs), expressed in 2018 US dollars/QALYs. One way sensitivity analyses were performed to vary the assumptions across a range of plausible values. Results RrBSO with hysterectomy was the least costly strategy at $13,628, followed by rrBSO alone ($14,630). Hysterectomy at time of rrBSO was cost-effective compared with rrBSO. rrBSO alone was subjected to absolute dominance because it was both more costly and less effective. Multiple one-way sensitivity analyses did not substantially impact the costeffectiveness. Conclusions Hysterectomy at time of rrBSO for BRCA1 patients constitutes a cost-effective management strategy.

Dioun, S., et al. (2021). "Cost-effectiveness of dostarlimab in advanced recurrent deficient mismatch repair endometrial cancer patients." International Journal of Gynecological Cancer 31(SUPPL 4): A16.
	Objectives Women with recurrent endometrial cancer who fail carboplatin and paclitaxel have a poor prognosis with few effective options. The recent GARNET Trial showed promising results for dostarlimab in these patients. We developed a decision model to compare the cost-effectiveness of dostarlimab to other treatment options in patients with progressive/recurrent deficient mismatch repair (dMMR) endometrial cancer who have failed first-line chemotherapy. Methods A Markov model was created to simulate the clinical trajectory of women with progressive/recurrent dMMR endometrial cancer who failed carboplatin and paclitaxel (figure 1). The initial decision point in the model was treatment with either dostarlimab, pembrolizumab or pegylated liposomal doxorubicin (PLD). Model probabilities, cost and utility values were derived with assumptions drawn from published literature. The effectiveness was measured in terms of quality adjusted life years (QALYs) gained. The primary outcome was incremental cost-effectiveness ratios (ICERs), expressed in 2018 US dollars/QALYs. One-way sensitivity analyses were performed to vary the assumptions across a range of plausible values. Results PLD was the least costly strategy at $54,307, followed by pembrolizumab ($160,780) and dostarlimab ($251,132). PLD was cost-effective compared with dostarlimab with an ICER of $199,621, while pembrolizumab was subjected to extended dominance (table 1). Multiple one-way sensitivity analyses did not substantially impact the cost-effectiveness. Conclusions Dostarlimab is associated with greater survival compared with other treatments for women with recurrent dMMR endometrial cancer. However, the agent is substantially more costly.

Dioun, S., et al. (2021). "Uptake and Outcomes of Sentinel Lymph Node Mapping in Women With Atypical Endometrial Hyperplasia." Obstetrics and Gynecology 137(5): 924-934.
	Objective: To examine the utilization, morbidity, and cost of sentinel lymph node mapping in women undergoing hysterectomy for complex atypical endometrial hyperplasia.; Methods: Women with complex atypical endometrial hyperplasia who underwent hysterectomy from 2012 to 2018 in the Perspective database were examined. Perioperative morbidity, mortality, and cost were examined based on performance of sentinel lymph node mapping, lymph node dissection or no nodal evaluation.; Results: Among 10,266 women, sentinel lymph node mapping was performed in 620 (6.0%), lymph node dissection in 538 (5.2%), and no lymphatic evaluation in 9,108 (88.7%). Use of sentinel lymph node mapping increased from 0.8% in 2012 to 14.0% in 2018, and the rate of lymph node dissection rose from 5.7% to 6.4% (P<.001). In an adjusted model, residence in the western United States, treatment by high-volume hospitals and use of robotic-assisted hysterectomy were associated with sentinel lymph node mapping (P<.05 for all). The complication rates were similar between the three groups. The median cost for sentinel lymph node mapping ($9,673) and lymph node dissection ($9,754) were higher than in those who did not undergo nodal assessment ($8,435) (P<.001).; Conclusion: Performance of sentinel lymph node mapping is increasing rapidly for women with complex atypical endometrial hyperplasia but is not associated with increased perioperative morbidity or mortality.; Competing Interests: Financial Disclosure Dr. Wright has served as a consultant for Clovis Oncology and received research support from Merck. Dr. Hou has served as a consultant for Foundation Medicine. Dr. Hur has served as a consultant for Kite Pharmaceuticals and has equity in Cambridge Biomedical Economic Consulting Group. The other authors did not disclose any potential conflicts of interest. (Copyright © 2021 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Dioun, S., et al. (2021). "Intraoperative Rupture of the Ovarian Capsule in Early-Stage Ovarian Cancer: A Meta-analysis." Obstetrics and Gynecology 138(2): 261-271.
	Objective: To examine the effects of intraoperative ovarian capsule rupture on progression-free survival and overall survival in women who are undergoing surgery for early-stage ovarian cancer.; Data Sources: MEDLINE using PubMed, EMBASE (Elsevier), ClinicalTrials.gov, and Scopus (Elsevier) were searched from inception until August 11, 2020.; Methods of Study Selection: High-quality studies reporting survival outcomes comparing ovarian capsule rupture to no capsule rupture among patients with early-stage epithelial ovarian cancer who underwent surgical management were abstracted. Study quality was assessed with the Newcastle-Ottawa Scale, and studies with scores of at least 7 points were included.; Tabulation, Integration, and Results: The data were extracted independently by multiple observers. Random-effects models were used to pool associations and to analyze the association between ovarian capsule rupture and oncologic outcomes. Seventeen studies met all the criteria for inclusion in the meta-analysis. Twelve thousand seven hundred fifty-six (62.6%) patients did not have capsule rupture and had disease confined to the ovary on final pathology; 5,532 (33.7%) patients had intraoperative capsule rupture of an otherwise early-stage ovarian cancer. Patients with intraoperative capsule rupture had worse progression-free survival (hazard ratio [HR] 1.92, 95% CI 1.34-2.76, P<.001), with moderate heterogeneity (I2=41%, P=.07) when compared with those without capsule rupture. Pooled results from these studies showed a worse overall survival (HR 1.48, 95% CI 1.15-1.91, P=.003), with moderate heterogeneity (I2=53%, P=.02) when compared with patients without intraoperative capsule rupture. This remained significant in a series of sensitivity analyses.; Conclusion: This systematic review and meta-analysis of high-quality observational studies shows that intraoperative ovarian capsule rupture results in decreased progression-free survival and overall survival in women with early-stage ovarian cancer who are undergoing initial surgical management.; Systematic Review Registration: PROSPERO, CRD42021216561.; Competing Interests: Financial Disclosure Dr. Hou has served as a consultant for Foundation Medicine. Dr. Tergas reports money was paid to her from Auro Vaccines. Dr. Matsuo received an honorarium from Chugai and investigator meeting attendance expense from VBL Therapeutics outside this study. Dr. Wright has served as a consultant for Clovis Oncology, received royalties from UpToDate, and received research support from Merck. The other authors did not report any potential conflicts of interest. (Copyright © 2021 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

DiSilvestro, P., et al. (2023). "Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial." Journal of clinical oncology : official journal of the American Society of Clinical Oncology 41(3): 609-617.
	Purpose: In SOLO1/GOG 3004 (ClinicalTrials.gov identifier: NCT01844986), maintenance therapy with the poly(ADP-ribose) polymerase inhibitor olaparib provided a sustained progression-free survival benefit in patients with newly diagnosed advanced ovarian cancer and a BRCA1 and/or BRCA2 (BRCA) mutation. We report overall survival (OS) after a 7-year follow-up, a clinically relevant time point and the longest follow-up for any poly(ADP-ribose) polymerase inhibitor in the first-line setting.; Methods: This double-blind phase III trial randomly assigned patients with newly diagnosed advanced ovarian cancer and a BRCA mutation in clinical response to platinum-based chemotherapy to maintenance olaparib (n = 260) or placebo (n = 131) for up to 2 years. A prespecified descriptive analysis of OS, a secondary end point, was conducted after a 7-year follow-up.; Results: The median duration of treatment was 24.6 months with olaparib and 13.9 months with placebo, and the median follow-up was 88.9 and 87.4 months, respectively. The hazard ratio for OS was 0.55 (95% CI, 0.40 to 0.76; P = .0004 [ P < .0001 required to declare statistical significance]). At 7 years, 67.0% of olaparib patients versus 46.5% of placebo patients were alive, and 45.3% versus 20.6%, respectively, were alive and had not received a first subsequent treatment (Kaplan-Meier estimates). The incidence of myelodysplastic syndrome and acute myeloid leukemia remained low, and new primary malignancies remained balanced between treatment groups.; Conclusion: Results indicate a clinically meaningful, albeit not statistically significant according to prespecified criteria, improvement in OS with maintenance olaparib in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation and support the use of maintenance olaparib to achieve long-term remission in this setting; the potential for cure may also be enhanced. No new safety signals were observed during long-term follow-up.

Dizavandi Fatemeh, R., et al. (2019). "An overview of the phytoestrogen effect on vaginal health and dyspareunia in peri- and post-menopausal women." Post Reproductive Health 25(1): 11-20.
	Objective: The aim of this overview was to evaluate the effectiveness of phytoestrogens on vaginal health and dyspareunia in peri- and post-menopausal women.; Material and Methods: Three databases including MEDLINE, Scopus and the Cochrane Central Register of Controlled Trials were from inception to August 2017.; Result: Two systematic reviews and 11 RCTs were included in the overview. According to the findings, isoflavones increased the maturation value and attenuated the vaginal atrophy in the post-menopausal women. Topical isoflavones had beneficial effects on the vaginal atrophy. Similar efficacy was found in Pueraria mirifica and conjugated estrogen cream on dryness ( p = 0.277), soreness ( p = 0.124) and irritation ( p = 0.469), as well as discharge ( p = 0.225) and dyspareunia ( p = 0.089). However, the conjugated estrogen cream was more effective compared to Pueraria mirifica ( p > 0.005) regarding maturation index improvement. Comparison of fennel 5% vaginal cream and placebo gel showed significant difference in superficial cells ( p < 0.01), parabasal cells ( p < 0.01) and intermediate cells ( p < 0.01), whereas no difference was found between the oral fennel and placebo in terms of superficial, parabasal and intermediate cells as well as Maturation value. Administration of 80 mg red clover oil had a significant effect on superficial ( p < 0.005), intermediate ( p < 0.005) and parabasal and vaginal dryness ( p < 0.005) compared to the placebo. Flaxseed had also a trivial effect on maturation value. Genistein had a more prominent effect on the genital score. The severity of dyspareunia decreased by 27%.; Conclusion: Phytoestrogens have various effects based on administration route and type on the vaginal atrophy.

Djusad, S., et al. (2024). "The Use of Vasopressor and Tourniquet to Reduce Hemorrhage during Myomectomy for Uterine Fibroid Removal: A Systematic Review." Open Access Macedonian Journal of Medical Sciences 12(1): 22-28.
	AIM: This review aims to evaluate the efficacy of vasopressin and tourniquet to reduce blood loss during myomectomy for uterine fibroids removal. BACKGROUND: Uterine fibroids and uterine leiomyomata, the most common benign tumors in women, can be difficult for women trying to conceive. Surgical therapy, such as hysterectomy or myomectomy, is one of the main treatment options. Excessive blood loss may occur during the procedure. Clamps or tourniquets around the uterine vessels are commonly used as anti-bleeding precautions during myomectomy. Intra-myometrial injection of vasopressin at the base of the largest fibroids and during hysteroscopic myomectomy is effective in reducing blood loss during laparoscopic myomectomy. METHOD(S): A literature search and computer-aided comprehensive electronic bibliographic search was performed using PubMed, Science Direct, SCOPUS, and Wiley for studies published from January 1997 to November 2017. RESULT(S): Ten studies met the eligibility criteria and were included in this review. Each study assessed and compared the effects of vasopressin to the control group that exerts a hormonal hemorrhagic effect during myomectomy procedures. About 50% of vasopressin hemostatic agents have better outcomes in reducing blood loss. However, the use of both vasopressin and tourniquet simultaneously failed to reduce blood loss. DISCUSSION: Intramyometrial vasopressin injection resulted in a higher efficacy to decrease blood loss during myomectomy. Despite deciding which methods provide the most effective way to decrease blood loss, the two techniques showed excellent outcomes for the quality of the myomectomy procedure itself. CONCLUSION(S): Hemostatic medications have shown to have positive effects on myomectomy patients. The predicted volume of blood loss significantly decreased by both the mechanical tourniquet approach and the injection of the hormone vasopressin.Copyright © 2024 Suskhan Djusad, Ario Bimo, Annisa Futihandayani, Hana Fathia Herianti.

Dmochowski, R. R., et al. (2023). "Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder." BMC Urology 23(1): 64.
	Background: Overactive bladder (OAB) is defined as urinary urgency accompanied by frequency and nocturia, with or without urge urinary incontinence (UUI). Vibegron, a selective beta3-adrenergic receptor agonist approved in the US in December 2020, demonstrated efficacy in reducing symptoms of OAB and was safe and well tolerated in the 12-week EMPOWUR trial and its 40-week, double-blind extension trial. The goal of the COMPOSUR study is to evaluate vibegron in a real-world setting to assess patient treatment satisfaction, tolerability, safety, duration of treatment, and persistence. Method(s): This is a 12-month, prospective, observational, real-world study, with an optional 12-month extension to 24 months, in the US assessing adults >= 18 years old starting a new course of vibegron. Patients must be previously diagnosed with OAB with or without UUI, symptomatic for >= 3 months before enrollment, and receive prior treatment with an anticholinergic, with mirabegron, or with a combination of an anticholinergic and mirabegron. Enrollment is performed by the investigator following exclusion and inclusion criteria guided by US product labeling, reinforcing a real-world approach. Patients complete the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q) monthly and the OAB Questionnaire short form (OAB-q-SF) and Work Productivity and Activity Impairment Questionnaire (WPAI:US) at baseline and monthly for 12 months. Patients are followed up via phone call, in-person visits, or telehealth (ie, virtual) visits. The primary endpoint is patient treatment satisfaction as determined by the OAB-SAT-q satisfaction domain score. Secondary endpoints include percent positive responses to individual OAB-SAT-q questions, additional OAB-SAT-q domain scores, and safety. Exploratory endpoints include adherence and persistence. Discussion(s): OAB leads to a significant decrease in quality of life, as well as impairment of work activities and productivity. Persistence with OAB treatments can be challenging, often due to lack of efficacy and adverse effects. COMPOSUR is the first study to provide long-term, prospective, pragmatic treatment data for vibegron in the US and the resultant effect on quality of life among patients with OAB in a real-world clinical setting. Trial registration ClinicalTrials.gov identifier: NCT05067478; registered: October 5, 2021.Copyright © 2023, The Author(s).

Do, K. T., et al. (2021). "Phase 1 Combination Study of the CHK1 Inhibitor Prexasertib and the PARP Inhibitor Olaparib in High-grade Serous Ovarian Cancer and Other Solid Tumors." Clinical Cancer Research 27(17): 4710‐4716.
	PURPOSE: Checkpoint kinase 1 (CHK1) plays a central role in the response to replication stress through modulation of cell‐cycle checkpoints and homologous recombination (HR) repair. In BRCA‐deficient cancers with de novo or acquired PARP inhibitor resistance, the addition of the CHK1 inhibitor prexasertib to the PARP inhibitor olaparib compromises replication fork stability, as well as HR proficiency, allowing for sensitization to PARP inhibition. PATIENTS AND METHODS: This study followed a 3+3 design with a 7‐day lead‐in of olaparib alone, followed by 28‐day cycles with prexasertib administered on days 1 and 15 in combination with an attenuated dose of olaparib on days 1‐5 and 15‐19. Pharmacokinetic blood samples were collected after olaparib alone and following combination therapy. Patients enrolled to the expansion phase of the study underwent paired tumor biopsies for pharmacodynamic (PD) assessments. RESULTS: Twenty‐nine patients were treated. DLTs included grade 3 neutropenia and grade 3 febrile neutropenia. The MTD/recommended phase 2 dose (RP2D) was prexasertib at 70 mg/m2 i.v. with olaparib at 100 mg by mouth twice daily. Most common treatment‐related adverse events included leukopenia (83%), neutropenia (86%), thrombocytopenia (66%), and anemia (72%). Four of 18 patients with BRCA1‐mutant, PARP inhibitor‐resistant, high‐grade serous ovarian cancer (HGSOC) achieved partial responses. Paired tumor biopsies demonstrated reduction in RAD51 foci and increased expression of γ‐H2AX, pKAP1, and pRPA after combination exposure. CONCLUSIONS: Prexasertib combined with olaparib has preliminary clinical activity in BRCA‐mutant patients with HGSOC who have previously progressed on a PARP inhibitor. PD analyses show that prexasertib compromises HR with evidence of induction of DNA damage and replication stress.

Doan, L., et al. (2023). "Ketamine Analgesia for Long Lasting Pain Relief after Surgery (KALPAS) Study." Cancer Research 83(5).
	Background: Post‐mastectomy pain syndrome (PMPS) affects up to 60% of women undergoing mastectomy. Standard perioperative multimodal analgesia remains only moderately effective in preventing PMPS, and many patients continue to rely on opioids for their chronic pain. In the context of the opioid overdose crisis, alternative interventions are urgently needed. Ketamine targets risks factors for PMPS including acute pain and negative mood, making it an ideal candidate for the prevention of PMPS. Trial Design: This is a multisite, three‐arm, double‐blind, RCT to test the effectiveness of ketamine in reducing PMPS in women undergoing mastectomy for oncologic indication. Arm 1 consists of continuous perioperative ketamine infusion that begins during surgery and continues for 2 hours in the post‐anesthesia care unit (PACU). Arm 2 consists of a single‐dose of ketamine in the PACU given over 50‐60 minutes. Arm 3 consists of placebo. Standard surgical and postsurgical care remain unchanged across all arms. Eligibility Criteria: Inclusion criteria are: women ≥18 years of age undergoing total mastectomy for oncologic indication +/‐ lymph node dissection and +/‐ immediate or delayed reconstruction with no distant metastases. Exclusion criteria include: (1) history of cognitive impairment (2) past ketamine or phencyclidine misuse or abuse, (3) schizophrenia or history of psychosis, (4) history of post‐traumatic stress disorder, (5) known sensitivity or allergy to ketamine, (6) liver or renal sufficiency, (7) uncontrolled hypertension, chest pain, cardiac arrhythmia, stroke, head trauma, intracranial mass or hemorrhage, glaucoma, porphyria, uncontrolled thyroid disease, or other contraindication to ketamine, (8) lamotrigine alfentanil, physostigmine, or 4‐aminopyridine use, (9) currently pregnant, (10) body mass index greater than 35, (11) non‐English or non‐Spanish speaker, (12) currently participating in another pain interventional trial, (13) patient has started or undergone hormone therapy for gender transition into male, or (14) patient is scheduled for bilateral (or greater) flap reconstruction. Specific Aims: The primary outcome is pain intensity on the Brief Pain Inventory short form scale at the surgical site three months after mastectomy. Secondary outcomes include pain severity and interference at the surgical site, incidence of PMPS, anxiety, and depression over 12 months after surgery. Tertiary outcomes include neuropathic symptoms, fatigue, sleep, physical function, and opioid use. Statistical Methods: We will test the differences in the primary outcome between 1) the continuous ketamine infusion and the control; and 2) the single‐dose ketamine and the control, each at 0.025 significance level (adjusted for multiple comparisons using the Bonferroni correction), based on the two‐sample t‐tests (allowing unequal variances) if outcome variables are approximately normal, or Wilcoxon's rank‐sum tests otherwise. Accrual: The target accrual for this study is ∼750. Recruitment began January 2022. Recruitment is expected to be complete by October 2025. As of July 14, 2022, 43 participants have been enrolled across all sites.

Dobberfuhl, A. D. (2019). "Evaluation and treatment of female stress urinary incontinence after pelvic radiotherapy." Neurourology and Urodynamics 38(S4): S59-S69.
	Introduction: Pelvic radiotherapy is associated with both acute and chronic voiding dysfunction. A review of the success and complications of surgical treatments for female stress urinary incontinence after pelvic radiotherapy has not been summarized in the published literature. Method(s): A systematic review of female stress urinary incontinence after pelvic radiotherapy was conducted using MeSH terminology (1988-2018). Result(s): There is limited published literature on the treatment of stress urinary incontinence in women following pelvic radiotherapy. Long term indwelling urethral catheter should be avoided in all women given the risk of iatrogenic hypospadias. Surgical treatments can be classified into those for the intact versus failed outlet. Urethral bulking injections have been studied in a prospective fashion specifically in women with stress urinary incontinence after radiotherapy and although not randomized, have the highest level of evidence. Patients should be screened for a history of prior radiotherapy before considering sling placement. Artificial urinary sphincter is associated with a high rate of erosion after prior radiotherapy. The role of Burch colposuspension in patients with prior radiotherapy is poorly defined. Urinary diversion should be considered for patients with a devastated outlet. Conclusion(s): Since the long-term effects of radiotherapy on lower urinary tract voiding function are typically irreversible and progressive, further research is needed to mitigate the adverse effects of irradiation and identify more durable treatment options for women with radiation induced bladder dysfunction and stress urinary incontinence.Copyright © 2018 Wiley Periodicals, Inc.

Dobo, N., et al. (2022). "The impact of NOSE colectomy and laparoscopic conventional segmental resection on bowel function and quality of life among patients with rectal endometriosis: prospective randomized trial." Human reproduction (Oxford, England) 37: i111‐i112.
	Study question: What is the impact of laparoscopic conventional or NOSE colorectal resection on bowel function in patients with deep endometriosis infiltrating the rectum one year postoperatively? Summary answer: Both conventional and NOSE colectomy improved the functional outcomes and quality of life among patients with deeply invasive rectal endometriosis one year after bowel surgery. What is known already: Conventional laparoscopic approach to the surgical management of deep endometriosis infiltrating the rectum appears to assure improved digestive functional outcomes. NOSE technique for colorectal disease can significantly reduce the duration of hospital stay, accelerate postoperative recovery with better cosmetic results, and in particular, result in less postoperative pain and fewer complications. However, long‐term solid data about gastrointestinal well‐being after segmental bowel or NOSE resection for deep endometriosis are still missing. Study design, size, duration: Between the 1st September 2019 ‐ 31th of December 2020 we performed a 2‐arm unblinded prospective randomized trial, enroling 91 patients with deep infiltrating rectal endometriosis up to 15 cm from the anal verge. Patients aged between 18 and 45 years, with deep endometriosis infiltrating at least the muscular layer in depth, and up to 50% of rectal circumference, complaining pain, bowel symptoms and/or infertility were included. The average follow up time was 14±2.6 months. Participants/materials, setting, methods: Patients were enroled at Semmelweis University, Department of Obstetrics and Gynecology, Budapest, Hungary and had either conventional laparoscopic bowel resection or NOSE resection. Randomization was performed preoperatively using the simple randomization method. The primary endpoint was to assess the bowel function and quality of life by using the Endometriosis Health Profile 30, the Gastrointestinal Quality of Life Index and the Low Anterior Resection Syndrome score preoperatively, 1 month, 6 months, 1 year after the surgery. Main results and the role of chance: A total of 91 patients were enroled. 39 patients were in the NOSE surgery arm, 49 were in the Conventional laparoscopic surgery arm. One patient was lost to follow‐up and we had two cases of drop out from the trial after randomization due to performing non intended disc resection. This cases were excluded from the study. There was no conversion to laparotomy.The overall scores on Gastrointestinal Quality of Life Index (GIQLI), Low Anterior Resection Syndrome scores (LARS) and Endometriosis Health Profile 30 (EHP30) scores did not reveal significant differences between the two groups. LARS scores were improved, but did not reveal significant differences 12 months (T3) after the operation compared with the preoperative (T0) values in both groups (Conventional surgery group: T0=21.41 T3= 17.90; p=0.934, NOSE surgery goup T0= 26.53 T3= 18.23; p=0.229). GIQLI scores were significantly improved 12 months after the operation compared with the baseline values in Conventional surgery group T0= 95.44 T3= 111.39 p=0.002. EHP30 scores were significantly improved concerning pain, emotion well‐being, control and powerlessness, self‐image, social support and sexuality scale 12 months after the operation compared with the preoperative values in both groups. Limitations, reasons for caution: An obvious bias of performance is the lack of blinding, however blinding was not feasible due to the clinical nature of our study. We report no imprecision in patient selection, but a potential source of attrition bias in our data occured in a total number of three cases in NOSE‐group. Wider implications of the findings: Our study does not show a statistically significant difference between conventional or NOSE surgery for short and mid‐term functional digestive outcomes. Occurrence of longterm bowel dysfunction does not appear to be related to a specific surgical technique.

Dobrindt, E. M., et al. (2021). "Insulinoma in pregnancy (a case presentation and systematic review of the literature)." Rare Tumors 13.
	Insulinomas are rare, benign and functional tumors that coincidentally may become overt during pregnancy or in the post-partum period. As the general symptoms of a pregnancy might cover the clinical presentation, diagnosing remains challenging. We present one additional case of a post-partum insulinoma, combined with a systematic review of the literature to sum up relevant details in diagnosis and treatment. A systematic request of Pubmed/Medline was conducted using the following terms: "insulinoma AND pregnancy" and "insulinoma" for a second request of ClinicalTrials.gov. All publications concerning pregnant or post-partum women with insulinoma were included. Thirty-six cases could be identified for analysis. Each publication was reviewed for demographic, diagnostic and therapeutic data. The most frequent clinical signs were unconsciousness and neurological symptoms. 64.9% were diagnosed during early pregnancy and 35.1% post-partum. 91.9% underwent surgery with a third resected during pregnancy without severe influence on fetal or maternal outcome. Three patients died of metastatic disease or misdiagnosing, two of them miscarried. Insulinoma in pregnancy is rare but should be considered in case of unclear hyperinsulinemic hypoglycemia. Surgery can be performed during the second trimester or post-partum with promising outcome.Copyright © The Author(s) 2021.

Dogra, S., et al. (2023). "Targeting doublecortin-like kinase 1 reveals a novel strategy to circumvent chemoresistance and metastasis in ovarian cancer." Cancer letters 578: 216437.
	Ovarian cancer (OvCa) has a dismal prognosis because of its late-stage diagnosis and the emergence of chemoresistance. Doublecortin-like kinase 1 (DCLK1) is a serine/threonine kinase known to regulate cancer cell "stemness", epithelial-mesenchymal transition (EMT), and drug resistance. Here we show that DCLK1 is a druggable target that promotes chemoresistance and tumor progression of high-grade serous OvCa (HGSOC). Importantly, high DCLK1 expression significantly correlates with poor overall and progression-free survival in OvCa patients treated with platinum chemotherapy. DCLK1 expression was elevated in a subset of HGSOC cell lines in adherent (2D) and spheroid (3D) cultures, and the expression was further increased in cisplatin-resistant (CPR) spheroids relative to their sensitive controls. Using cisplatin-sensitive and resistant isogenic cell lines, pharmacologic inhibition (DCLK1-IN-1), and genetic manipulation, we demonstrate that DCLK1 inhibition was effective at re-sensitizing cells to cisplatin, reducing cell proliferation, migration, and invasion. Using kinase domain mutants, we demonstrate that DCLK1 kinase activity is critical for mediating CPR. The combination of cisplatin and DCLK1-IN-1 showed a synergistic cytotoxic effect against OvCa cells in 3D conditions. Targeted gene expression profiling revealed that DCLK1 inhibition in CPR OvCa spheroids significantly reduced TGFβ signaling, and EMT. We show in vivo efficacy of combined DCLK1 inhibition and cisplatin in significantly reducing tumor metastases. Our study shows that DCLK1 is a relevant target in OvCa and combined targeting of DCLK1 in combination with existing chemotherapy could be a novel therapeutic approach to overcome resistance and prevent OvCa recurrence.; Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: C·W.H. is an inventor on a patent for nanoparticle-encapsulated DCLK1-targeted siRNAs. C.W.H. is the co-founder of COARE Holdings, Inc. The remaining authors declare that they have no competing interests. (Copyright © 2023 Elsevier B.V. All rights reserved.)

Doi Suhail, A. R., et al. (2020). "Metformin in pregnancy to avert gestational diabetes in women at high risk: Meta-analysis of randomized controlled trials." Obesity reviews : an official journal of the International Association for the Study of Obesity 21(1): e12964.
	Previous randomized and observational studies on the efficacy of metformin in pregnancy to reduce incident gestational diabetes mellitus (GDM) in women at high risk (obesity, polycystic ovary syndrome [PCOS], or pregestational insulin resistance) have been conflicting and several groups are planning further randomized controlled trials (RCTs) to answer this question conclusively. This work assesses the efficacy of metformin in pregnancy to avert one outcome-incident GDM in women at high risk. We included RCTs comparing metformin with usual care or placebo controls in terms of incident GDM and recruiting women at high risk during early pregnancy. Eleven eligible trials enrolled 2370 adult women whose intervention arm consisted of metformin started at conception or before 20 weeks of gestation. Risk of GDM was similar in intervention compared with controls (risk ratio [RR] 1.03; 95% confidence interval [CI], 0.85-1.24). The data were of sufficient quality meeting the criteria for consistency and directness. We conclude that metformin does not contribute to averting the GDM outcome in women at high risk when initiated in pregnancy. The evidence provided by this synthesis affirms that further broad clinical trials investigating this question are no longer needed. (© 2019 World Obesity Federation.)

Doi, T., et al. (2022). "A phase 1 trial of xentuzumab, an IGF-neutralizing antibody, in Japanese patients with advanced solid tumors." Cancer Science 113(3): 1010-1017.
	Xentuzumab is an insulin-like growth factor (IGF) ligand-neutralizing antibody. This phase 1 trial assessed xentuzumab in Japanese patients with solid tumors. Patients aged >=20 y old with solid tumors that were refractory or not amenable to standard therapy were enrolled. Patients received xentuzumab intravenously at a starting dose of 750 mg/wk. Dose escalation used a 3 + 3 design with dose de-escalation. The primary endpoint was to determine the maximum tolerated dose (MTD) of xentuzumab. Safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity were also assessed. Fifteen patients received xentuzumab in the dose escalation part (750 mg/wk [n = 6]; 1000 mg/wk [n = 3]; 1400 mg/wk [n = 6]). There were no dose-limiting toxicities at any dose; the MTD of xentuzumab was not reached. Xentuzumab 1000 mg/wk was recommended as the relevant biological dose. Six further patients received xentuzumab 1000 mg/wk in an expansion cohort. Of 21 patients, 13 (61.9%) experienced a drug-related adverse event, most commonly fatigue (23.8%), neutropenia (19.0%), diarrhea, nausea, white blood cell count decrease, and muscle spasms (14.3% each). No relevant deviations from dose linearity of xentuzumab exposure were observed during dose escalation. Total IGF-1 and IGF-2 levels increased and bioactive IGF levels decreased from baseline to 24 h after the first infusion in cycle 1. Partial response was observed in 2 (9.5%) patients with desmoid-type fibromatosis. Disease control was achieved in 6 (28.6%) patients (median duration 42.4 mo). Xentuzumab monotherapy was well tolerated in Japanese patients and showed evidence of anti-tumor activity. This study was registered with www.clinicaltrials.gov (NCT02145741).Copyright © 2021 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

Dol, J., et al. (2020). "Impact of mobile health interventions during the perinatal period on maternal psychosocial outcomes: a systematic review." JBI evidence synthesis 18(1): 30-55.
	Objective: The objective of this review was to evaluate the effectiveness of mother-targeted mobile health (mHealth) education interventions during the perinatal period on maternal psychosocial outcomes in high-income countries.; Introduction: The perinatal period is an exciting yet challenging period for mothers that requires physical, emotional and social adjustment to new norms and expectations. In recent years, there has been an increase in the use of mHealth by new mothers who are seeking health information through online or mobile applications. While there have been systematic reviews on the impact of mHealth interventions on maternal and newborn health in low- and middle-income countries, the impact of these interventions on maternal psychosocial health outcomes in high-income countries remains uncertain.; Inclusion Criteria: This review considered studies of mHealth education interventions targeting mothers in high-income countries (as defined by the World Bank) during the perinatal period. Interventions must have started between the antenatal period (conception through birth) through six weeks postpartum. All experimental study designs were included. Outcomes included self-efficacy, social support, postpartum anxiety and postpartum depression.; Methods: PubMed, CINAHL, PsycINFO and Embase were searched for published studies in English on December 16, 2018. Gray literature was also searched for non-peer reviewed articles, including Google Scholar, mHealth intelligence and clinical trials databases. Critical appraisal was undertaken by two independent reviewers using standardized critical appraisal instruments from JBI. Quantitative data were extracted from included studies independently by two reviewers using the standardized data extraction tool from JBI. All conflicts were solved through consensus with a third reviewer. Quantitative data were, where possible, pooled in statistical meta-analysis using RevMan. Where statistical pooling was not possible, findings were reported narratively.; Results: Of the 1,607 unique articles identified, 106 full-text papers were screened and 24 articles were critically appraised, with 21 included in the final review. Eleven were quasi-experimental and 10 were randomized controlled trials. The mHealth intervention approach varied, with text message and mobile applications being the most common. Length of intervention ranged from four weeks to six months. The topics of the mHealth intervention varied widely, with the most common topic being postpartum depression. Mothers who received an mHealth intervention targeting postpartum depression showed a decreased score on the Edinburgh Postnatal Depression Scale when measured post-intervention (odds ratio = -6.01, 95% confidence interval = -8.34 to -3.67, p < 0.00001). The outcomes related to self-efficacy, social support and anxiety showed mixed findings of effectiveness (beneficial and no change) across the studies identified.; Conclusions: This review provides insight into the effectiveness of mHealth interventions targeting mothers in high-income countries in the perinatal period to enhance four psychosocial outcomes: self-efficacy, social support, anxiety and depression. Despite a wide variety of outcome measurements used, the predominant findings suggest that there are insufficient data to conclude that mHealth interventions can improve self-efficacy and anxiety outcomes. Potential benefits on social support were related to interventions targeting postnatal behaviors. Postpartum depression was the mostly commonly reported outcome. Findings related to the comparison of pre-post outcomes and intervention versus control demonstrated that mHealth interventions targeting postpartum depression were associated with a reduction in postpartum depression.

Dolan, N., et al. (2022). "Are Mindfulness-Based Interventions as Effective as Cognitive Behavioral Therapy in Reducing Symptoms of Complicated Perinatal Grief? A Systematic Review." Journal of midwifery & women's health 67(2): 209-225.
	INTRODUCTION: Perinatal loss can be a devastating experience for parents that can result in complicated grief symptoms that include depression, anxiety, and posttraumatic stress. Perinatal bereavement care pathways have been developed internationally within health care services; however, there is an apparent lack of recommendations and guidance on grief-focused interventions specifically for complicated perinatal grief. Studies have analyzed the effectiveness of cognitive behavioral therapy (CBT) for perinatal grief, and more recent research has emerged on the use of mindfulness-based interventions (MBIs) for perinatal grief symptoms. The purpose of this study was to conduct a systematic review and present the effectiveness of CBT and MBIs for perinatal grief, to report patient experiences of the interventions, and to determine which intervention can be more effective in managing symptoms of complicated perinatal grief. METHODS: A systematic search was conducted of 5 academic databases: PsycINFO, CINAHL, MEDLINE, Social Science, and ASSIA. No limits on publication date, language, or geographic location were set because of the paucity of research published on this subject. Quality appraisal was conducted for each included study. Findings are reported in accordance with the PRISMA statement. RESULTS: This systematic review identified 8 eligible studies with a total of 681 bereaved participants. The results were examined for effectiveness of CBT and MBIs for grief; effectiveness of CBT and MBIs for depression, anxiety, and posttraumatic stress; and participant experiences. Both interventions produced favorable reductions of perinatal grief symptoms, depression, and posttraumatic stress. However, a true comparison between the 2 interventions' effect on complicated perinatal grief symptoms could not be made because of the limited studies in this area and the heterogeneity of the included studies' methods and outcomes. DISCUSSION: Both MBIs and CBT interventions can be effective in reducing symptoms of complicated perinatal grief. The findings of this review are heavily weighted in quantitative outcome measurements. More qualitative research and randomized controlled trials with larger sample sizes are needed in this area of perinatal bereavement care.

Dolitsky Shelley, N., et al. (2020). "Efficacy of progestin-only treatment for the management of menopausal symptoms: a systematic review." Menopause (New York, N.Y.) 28(2): 217-224.
	Importance: Menopause is associated with bothersome symptoms for many women, including mood changes, hot flushes, sleep problems, and fatigue. Progesterone is commonly prescribed in combination with estrogen therapy. Although monotherapy with progestins has been used as treatment of menopausal symptoms in women with contraindications to estrogens, the optimal route, and dosage of progestin monotherapy has not been established.; Objective: To assess whether progestin as a standalone treatment is effective for treating vasomotor and mood symptoms associated with menopause.; Evidence Review: We conducted a systematic review using PubMed and Embase databases from January 1980 to January 2020. We included randomized controlled trials (RCTs) that investigated different forms of progestin for the treatment of vasomotor or mood symptoms associated with menopause.; Findings: A systematic search of 892 studies identified seven RCTs involving a total of 601 patients. The available literature was heterogeneous in terms of formulation and dose of progesterone; administration ranged from 5 to 60 mg of transdermal progesterone, 10 to 20 mg oral medroxyprogesterone acetate, and 300 mg of oral micronized progesterone. Duration of treatment also differed between studies, ranging from 21 days to 12 months (median: 12 wks). Three of seven RCTs reported that progestin therapy led to an improvement of vasomotor symptoms (VMS) in postmenopausal women. The largest study administering oral progestin using 300 mg micronized progesterone reported a 58.9% improvement in VMS (vs 23.5% in placebo group, n = 133), whereas the largest study using transdermal progesterone reported no improvement (n = 230). No study reported an improvement of mood symptoms. Side effects, such as headaches and vaginal bleeding, were significant in five of seven RCTs and led to discontinuation of treatment in 6% to 21% of patients.; Conclusions and Relevance: A beneficial effect was reported in some trials with the transdermal route at longer duration and with oral treatment at higher doses for VMS for progesterone-only therapy. This report may help to inform future studies of progestin-only therapy for the treatment of menopausal symptoms.; Competing Interests: Financial disclosure/conflicts of interest: J.H.S. is active on the following boards: the American Society of Reproductive Medicine, The American Board of Obstetrics and Gynecology, the Society for Reproductive Investigation and the American Gynecological and Obstetrical Society. Dr. Segars has received sponsored research funding for clinical trials involving from Biospecifics, Bayer, Allergan, and Abbvie and served as a consultant for Myovant. All other authors have nothing to disclose. (Copyright © 2020 by The North American Menopause Society.)

Dolmans, M. M., et al. (2021). "Conservative management of uterine fibroid-related heavy menstrual bleeding and infertility: Time for a deeper mechanistic understanding and an individualized approach." Journal of Clinical Medicine 10(19): 4389.
	(1) Background: Uterine fibroids are the most common form of benign uterine tumors, causing heavy menstrual bleeding (HMB), pelvic pain, infertility and pressure symptoms. Almost a third of women with uterine fibroids seek treatment. The objective of this review is to understand the mechanisms linking fibroids to these symptoms and evaluate different options for their management, particularly the place of gonadotropin-releasing hormone (GnRH) antagonist. (2) Methods: We gathered the most recent and relevant papers on the main fibroid-related symptoms and medical and surgical therapy for their treatment. Those reporting use of oral GnRH antagonists were investigated in detail. (3) Results: The mechanisms explaining myoma-related HMB and infertility were reviewed, as they are essential to a deeper mechanistic understanding and oriented approach. The choice of treatment depends on the number, size, and location of fibroids, and is guided by the patient's age and desire to preserve her fertility. Economic impacts of myomas in terms of direct costs, lost workdays, and complications were found to be significant. Medical, surgical, and non-surgical strategies were analyzed in this context. Novel medical approaches with GnRH antagonist were explored and found to represent an effective new option. (4) Conclusion(s): The need for alternatives to surgical intervention is very real, especially for women seeking to preserve their fertility. New options now exist, with GnRH antagonists proven to treat fibroid symptoms effectively, opening the door to novel strategies for the management of myomas.Copyright © 2020 by the authors. Licensee MDPI, Basel, Switzerland.

Don Emma, E., et al. (2023). "Endometrial Angiogenesis of Abnormal Uterine Bleeding and Infertility in Patients with Uterine Fibroids-A Systematic Review." International Journal of Molecular Sciences 24(8).
	Uterine fibroids are the most common benign tumors in women, with abnormal uterine bleeding (AUB) as the main reported symptom. Additionally, an association between fibroids and infertility has been established, especially if the fibroid protrudes in the uterine cavity. Hormonal therapy is associated with side-effects and as well as hysterectomy, which is incompatible with a desire to conceive. To improve treatment, it is essential to unravel the etiology of fibroid-related symptoms. We aim to evaluate endometrial angiogenesis in women with fibroids, with and without AUB, and the influence of pharmaceutical therapies in these patients. Furthermore, we explore the possible role of altered angiogenesis in patients with fibroids and infertility. We performed a systematic review according to PRISMA-guidelines (PROSPERO: CRD42020169061), and included 15 eligible studies. Endometrial expression of vascular endothelial growth factor (VEGF) and adrenomedullin was increased in patients with fibroids. This suggests aberrant angiogenesis, potentially involving disturbed vessel maturation, resulting in immature and fragile vessels. Treatment with gonadotropin-releasing hormone agonist, ulipristal acetate, and continuous oral contraception pills reduced several angiogenic parameters, including VEGF. If infertile and fertile patients with fibroids were compared, a significant decreased expression of the bone morphogenetic protein/Smad-protein pathway was found, possibly caused by the increased expression of transforming growth factor-beta. For future therapeutic development, these different angiogenic pathways could be of interest as possible targets to treat fibroid-related symptoms.

Donadon, M. F., et al. (2021). "Oxytocin effects on the cognition of women with postpartum depression: a randomized, placebo-controlled clinical trial." Progress in neuro-psychopharmacology & biological psychiatry 111: 110098.
	Background: One of the most common mental disorders in the perinatal period is postpartum depression (PPD), which is associated with impaired emotional functioning due to alterations in different cognitive aspects including thought and facial emotion recognition (FER). Emotional impairments may affect the interaction and care offered to infants and their later development and therefore interventions with potential to minimize impairments associated with PPD are opportune. Oxytocin (OXT) was shown to have therapeutic properties associated with the promotion of affiliative and pro‐social behaviors in different mental disorders. Few studies have assessed its therapeutic potential in PPD. Objectives: To assess the effects of the acute administration of intranasal OXT (24 IU) on FER of baby faces and negative thoughts after delivery in mothers with and without PPD. Methods: We conducted a randomized double‐blind, placebo‐controlled trial with a crossover design involving mothers with PPD (N = 20) and without PPD (N = 35) in the puerperium. Participants completed a static task of FER of baby faces and a questionnaire of post‐natal negative thoughts. Results: Mothers with PPD had increased scores of negative thoughts about motherhood/infants, but no impairments in FER, when compared to healthy mothers. OXT had no effects on the rates of correct judgments or response times in the FER task, but was associated with response biases to facial happiness and the reduction of negative thoughts in mothers with PPD. Discussion/conclusion: OXT may have positive effects on maternal affiliative behavior, maternal care, and mother‐infant interactions as suggested by changes found in different cognitive aspects, thus minimizing the deleterious effects of PPD on child development.

Donatti, L., et al. (2022). "Cognitive Behavioral Therapy in Endometriosis, Psychological Based Intervention: A Systematic Review." Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia 44(3): 295-303.
	Introduction: Endometriosis is an inflammatory disease that affects women of reproductive age, causing pain and the possibility of infertility. Endometriosis was associated to low life quality and research shows the impact of endometriosis in several areas of life, justifying how these patients are more likely to develop depression, anxiety, and stress.; Objective: The aim of the present systematic review was to explore the field of psychology in endometriosis, identifying studies that used the cognitive behavioral therapy technique as a treatment for endometriosis and chronic pelvic pain.; Methods: The keywords used were Endometriosis and Behavioral Therapy; Behavioral Disciplines and Activities ; Cognitive Behavioral Therapy ; Mental Health ; Psychological Techniques ; Psychology ; Psychotherapy ; Mental Health Services ; and the search was performed in the following databases: PubMed/Medline, Scielo, Lilacs, and Capes. The study followed the PRISMA guidelines and all studies whose intervention strategy used was related to cognitive-behavioral therapy were considered.; Results: Of the 129 articles found, only 5 were selected, and it was possible to identify that the psychological intervention whose approach brought cognitive-behavioral therapy techniques promoted a decrease in the sensation of pain, improvements in the scores of depression and stress, and significant changes in aspects of quality of life such as vitality, physical and social functioning, emotional well-being, control, and autonomy.; Conclusion: Cognitive-behavioral therapy can be very promising to take care of the emotional side of those who have endometriosis However, the present systematic review highlights the need to develop more structured studies with consistent, clear and replicable methods to reach a psychological intervention protocol for patients who live with this gynecological-physical-emotional condition.; Competing Interests: The authors have no conflict of interests to declare. (Federação Brasileira de Ginecologia e Obstetrícia. This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).)

Donayeva, A., et al. (2023). "The effects of vitamin D and calcium on primary dysmenorrhea: a systematic review." Journal of medicine and life 16(11): 1597-1605.
	Dysmenorrhea, affecting approximately 80% of adolescents, significantly impairs quality of life, disrupts sleep patterns, and induces mood changes. Furthermore, its economic impact is substantial, accounting for an estimated $200 billion in the United States and $4.2 million in Japan annually. This review aimed to identify the effects of vitamin D and calcium on primary dysmenorrhea. We conducted a comprehensive literature search across Web of Science, PubMed, Scopus, and Science Direct, focusing on studies published from 2010 to 2020. Keywords included 'primary dysmenorrhea', 'vitamin D', '25-OH vitamin D3', 'cholecalciferol', and 'calcium'. The quality assessment of the articles was done using the Consolidated Standards of Reporting Trials (CONSORT) and the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklists, and the risk bias was assessed using the Cochrane assessment tool. Abnormal low Vit. D levels increased the severity of primary dysmenorrhea through increased prostaglandins and decreased calcium absorption. Vitamin D and calcium supplements could reduce the severity of primary dysmenorrhea and the need for analgesics. This systematic review found an inverse relation between the severity of dysmenorrhea and low serum Vit. D and calcium.. Vitamin D and calcium supplements could reduce the severity of primary dysmenorrhea and the need for analgesics.; Competing Interests: The authors declare no conflict of interest. (© 2023 The Author(s).)

Dondi, G., et al. (2021). "Uterine Preservation Treatments in Sarcomas: Oncological Problems and Reproductive Results: A Systematic Review." Cancers 13(22).
	Uterine sarcomas are rare cancers, sometimes diagnosed in women of childbearing age. Hysterectomy is the standard treatment in early stages. The option of lesion removal to save fertility is described in the literature, but it is still considered experimental. The objective of this systematic review is to report on the available evidence on the reproductive and oncological outcomes of fertility-sparing treatment in women with uterine sarcomas. PubMed, Scopus and Cochrane Central Register of Controlled Trials were searched between 1 January 2011 and 21 June 2021 for publications in English about women with uterine sarcoma treated with a fertility-sparing intervention. Thirty-seven studies were included for a total of 210 patients: 63 low-grade endometrial stromal sarcomas, 35 embryonal rhabdomyosarcomas of the cervix, 19 adenosarcomas, 7 leiomyosarcomas and 2 uterine tumors resembling an ovarian sex cord. Conservative treatment ensured pregnancy in 32% of cases. In terms of oncological outcomes, relapse was related to histology and the worst prognosis was reported for leiomyosarcoma, followed by low-grade endometrial stromal sarcoma, which relapsed in 71% and 54% of cases, respectively. The highest death rate was associated with leiomyosarcoma (57.1%). This study demonstrated that fertility-sparing treatments may be employed in selected cases of early stage uterine sarcoma.

Dong Allan, C., et al. (2020). "Subclinical hypothyroidism and thyroid autoimmunity in recurrent pregnancy loss: a systematic review and meta-analysis." Fertility and Sterility 113(3): 587.
	Objective: To determine whether overt/subclinical hypothyroidism and/or thyroid autoimmunity is associated with recurrent pregnancy loss (RPL) and whether treatment improves outcomes.; Design: Systematic review and meta-analysis.; Setting: University obstetrics and gynecology departments.; Patient(s): Women with RPL and overt/subclinical hypothyroidism, and/or thyroid autoimmunity.; Intervention(s): None.; Main Outcome Measure(s): Associations between RPL and overt/subclinical hypothyroidism and/or thyroid autoimmunity and any effects of treatment.; Result(s): After our review of articles from PubMed, EMBASE, Web of Science, and CENTRAL, we found two interventional studies in which levothyroxine did not improve the subsequent live-birth rate in women with subclinical hypothyroidism with or without thyroid antibodies. A meta-analysis of five studies revealed the prevalence of subclinical hypothyroidism in RPL to be 12.9% (95% confidence interval [CI], 0%-35.2%). A meta-analysis of 17 studies revealed a statistically significant association between RPL and thyroid autoimmunity (odds ratio 1.94; 95% CI, 1.43-2.64). However, a randomized study suggested that levothyroxine does not benefit euthyroid women with thyroid autoimmunity.; Conclusion(s): Based on the limited observational studies available, no association exists between RPL and subclinical hypothyroidism, nor does levothyroxine improve subsequent pregnancy outcomes. An association exists between RPL and thyroid autoimmunity, but levothyroxine does not improve subsequent pregnancy outcomes. Women with RPL should be screened/treated for overt thyroid disease but not thyroid autoimmunity. Thyroid antibody screening is not supported by the published studies, and further randomized studies are needed. No recommendation regarding the treatment of subclinical hypothyroidism can be made at this time; prospective and randomized studies are urgently needed. (Copyright © 2019 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Dong, H., et al. (2021). "Whether preoperative hysteroscopy increases the dissemination of endometrial cancer cells: A systematic review and meta-analysis." The Journal of Obstetrics and Gynaecology Research 47(9): 2969-2977.
	Aim: To determine whether hysteroscopy (HSC) increases the risk of intraperitoneal dissemination in endometrial cancer patients.; Methods: We conducted a comprehensive review of multiple databases. Quality assessments of eligible studies were performed using the Newcastle-Ottawa and Jadad scales. Positive peritoneal cytology (PPC) as the outcome of interest was compared between endometrial cancer patients with and without HSC. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated as a measure of effects.; Results: Three case-control studies and eight retrospective cohort studies included 3364 patients, of whom 1116 underwent preoperative HSC, which resulted in a significantly higher PPC rate (OR, 1.82; 95% CI, 1.31-2.54; p = 0.0004). I 2 was 11%, and the heterogeneity was acceptable. The difference between the groups with stages I-II was statistically insignificant (OR, 1.50; 95% CI, 0.75-2.99; p = 0.25). When liquid was used as the uterine distension medium during HSC and the intrauterine pressure was controlled under 80 mmHg, the difference between the two groups was also insignificant (OR, 1.18; 95% CI, 0.50-2.79; p = 0.71). However, when the intrauterine pressure exceeded 80 mmHg, the difference between the two groups was statistically significant (OR, 2.18; 95% CI, 1.28-3.73; p = 0.004).; Conclusion: This meta-analysis indicates that preoperative HSC in patients with endometrial cancer may increase the risk of intraperitoneal dissemination of malignant cells, which may be associated with intrauterine pressure >80 mmHg but not with stages I-II. There is no reason to avoid HSC for the diagnosis of endometrial cancer, especially in early stages, but intrauterine pressure should possibly be controlled below 80 mmHg. (© 2021 Japan Society of Obstetrics and Gynecology.)

Dong, P., et al. (2021). "Systematic review and meta-analysis of traditional Chinese medicine compound in treating infertility caused by endometriosis." Annals of Palliative Medicine 10(12): 12631-12642.
	Background: To perform meta-analysis to investigate the efficacy and safety of traditional Chinese medicine (TCM) compound in the treatment of endometriosis (EMS)-induced infertility.; Methods: The databases of PubMed, Embase, Cochrane Library, Chinese Journal Full-text Database (CNKI), VIP, Wanfang Science and Technology Journal Full-text Database, and Chinese Biomedical Literature (CBM) were used to search for articles on the treatment of EMS-induced infertility with TCM compound from database establishment to September 2021. Endnote X9 software was used to screen the articles. Stata 15.1 and RevMan 5.3 software were used to record the data, and a meta-analysis was performed on the effective rate, pregnancy rate, abortion rate, incidence of adverse reactions, luteinizing hormone (LH) level, and estradiol (E2) level of TCM compound in the treatment of EMS-induced infertility. Finally, the reliability of the results was assessed by sensitivity analysis. A funnel plot was used to evaluate the publication bias of the articles.; Results: A total of 11 articles were included. Meta-analysis showed that when TCM compound was used to treat EMS-induced infertility, the effective rate of the trial group was significantly higher than that in the control group [odds ratio (OR) =1.26; 95% confidence interval (CI): 1.00 to 1.60; P=0.049], and the difference was statistically significant; the pregnancy rate of the trial group was significantly higher than that in the control group (OR =1.94; 95% CI: 1.50 to 2.50; P<0.05), and the difference was statistically significant; the abortion rate of the trial group was significantly lower than that in the control group (OR =0.16; 95% CI: 0.06 to 0.48; P=0.01), and the difference was statistically significant; and the incidence of adverse reactions in the trial group was not significantly different from the control group (OR =0.48; 95% CI: 0.17 to 1.34; P=0.162); the LH level of the trial and control group [standardized mean difference (SMD) =0.51; 95% CI: -1.73 to 2.75; P=0.658], and the E2 level (SMD =1.65; 95% CI: -0.77 to 4.07; P=0.182) had no statistical difference.; Discussion: Chinese herbal compound is effective in the treatment of endometriotic infertility and has a positive effect on improving the pregnancy rate.

Dong, S., et al. (2019). "Comparative efficacy and safety of traditional Chinese patent medicine for endometriosis: A Bayesian network meta-analysis protocol." Medicine 98(29): e16473.
	Background: Endometriosis is a common disease of women of childbearing age. In recent years, the incidence of endometriosis has been on the rise. The main clinical manifestations are pelvic pain and infertility. In recent years, traditional Chinese patent medicine (TCMP) has played an important role in the treatment of endometriosis. So far, there is a lack of comparison among all the current common TCPMs for endometriosis. Consequently, it is indispensable to propose a network meta-analysis (NMA) protocol to discuss the strengths and weaknesses of different TCMPs.; Methods: We will comprehensively and systematically retrieve the relevant Chinese and English databases from their inceptions to the May 2019. All randomized controlled trials (RCTs) of TCMPs for Endometriosis will be included. Two researchers will independently screen literature, extract data and assess the risk of bias of included studies. We will conduct pairwise meta-analyses and Bayesian network meta-analyses to assess all the available evidence. Data will be analyzed using STATA and WinBUGS software.; Results: This work will compare and rank the relative efficacy of different TCPMs in the treatment of endometriosis in detail.; Conclusion: The results of this study will provide reliable evidence for the selection of clinical treatment program and guideline development.; Prospero Registration Number: CRD42019127781.

Dong, Y., et al. (2020). "A Meta-Analysis on Efficacy and Security of Nedaplatin Versus Cisplatin Combined with Concurrent Radiotherapy for Advanced Cervical Cancer." Anti-Tumor Pharma. 10(4).
	
Dong, Z., et al. (2020). "Immunodiagnosis and Immunotherapeutics Based on Human Papillomavirus for HPV-Induced Cancers." Frontiers in Immunology 11: 586796.
	Infection with human papillomavirus (HPV) is one of the main causes of malignant neoplasms, especially cervical, anogenital, and oropharyngeal cancers. Although we have developed preventive vaccines that can protect from HPV infection, there are still many new cases of HPV-related cancers worldwide. Early diagnosis and therapy are therefore important for the treatment of these diseases. As HPVs are the major contributors to these cancers, it is reasonable to develop reagents, kits, or devices to detect and eliminate HPVs for early diagnosis and therapeutics. Immunological methods are precise strategies that are promising for the accurate detection and blockade of HPVs. During the last decades, the mechanism of how HPVs induce neoplasms has been extensively elucidated, and several oncogenic HPV early proteins, including E5, E6, and E7, have been shown to be positively related to the oncogenesis and malignancy of HPV-induced cancers. These oncoproteins are promising biomarkers for diagnosis and as targets for the therapeutics of HPV-related cancers. Importantly, many specific monoclonal antibodies (mAbs), or newly designed antibody mimics, as well as new immunological kits, devices, and reagents have been developed for both the immunodiagnosis and immunotherapeutics of HPV-induced cancers. In the current review, we summarize the research progress in the immunodiagnosis and immunotherapeutics based on HPV for HPV-induced cancers. In particular, we depict the most promising serological methods for the detection of HPV infection and several therapeutical immunotherapeutics based on HPV, using immunological tools, including native mAbs, radio-labelled mAbs, affitoxins (affibody-linked toxins), intracellular single-chain antibodies (scFvs), nanobodies, therapeutical vaccines, and T-cell-based therapies. Our review aims to provide new clues for researchers to develop novel strategies and methods for the diagnosis and treatment of HPV-induced tumors.© Copyright © 2021 Dong, Hu, Du, Tan, Li, Du, Bai, Ma and Cui.

Donmez, M., et al. (2022). "Efficacy of bright light therapy in perinatal depression: A randomized, double-blind, placebo-controlled study." Journal of Psychiatric Research 149: 315-322.
	Background: Uncertainties and difficulties associated with the current treatment modalities for perinatal depression (PND) may cause some mothers to avoid treatment. Raising awareness about the effectiveness and safety of bright light therapy (BLT) may help to alleviate the challenges of PND. The main goal of this study was to evaluate the efficacy and safety of BLT versus placebo in PND.; Method: A total of 30 women who were either pregnant or in first year postpartum and diagnosed with major depressive disorder were enrolled; 23 completed the study. Patients were randomly assigned to either the BLT (10,000 lux) or placebo (<500 lux) group. BLT and placebo light were applied for 45 min in the morning every day for a 3-week period. The Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Depression Rating Scale (HAM-D), and Edinburgh Postnatal Depression Scale (EPDS) were administered weekly to evaluate response and remission rates and depression scores.; Results: There was no significant difference between the two groups in terms of baseline depression scores. At the end of the study, the response rates assessed according to MADRS were 75% for BLT and 18.2% for placebo (p = .006), and remission rates were 41.7% vs. 0% (p = .016), respectively. There was no significant difference between the groups (p > .05) in terms of treatment-related side effects. The main limitation of this study is its small sample size, which limits the generalizability of the study's findings.; Conclusion: The results indicate that BLT is more effective than placebo and is reliable in terms of side effects in PND patients. In order to expand the use of BLT in PND, new studies with larger sample sizes are needed. (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Donmez, S., et al. (2023). "Analgesic Efficacy of Ibuprofen in Dysmenorrhea." Bezmialem Science 11(2): 163-169.
	Objective: Non-steroidal anti-inflammatory drugs (NSAIDs) are used routinely and as first choice in the analgesic treatment of abdominal pain caused by primary dysmenorrhea (PD). In our study, we aimed to compare the analgesic efficacy of 400 mg and 800 mg ibuprofen doses administered intravenously (iv) in the treatment of patients presenting with abdominal pain due to PD. Method(s): The study was conducted in emergency department over a period of 4 months in a prospective, randomized, controlled and single-blind design. Females aged between 18-50 years were included in the study. The patients were randomly divided into two groups as those who received ibuprofen 400 mg and those who received 800 mg. In these two groups, the pain scores of the patients at 0, 30 and 60 min were determined and analyzed using the 10-unit Numeric Rating Scale (NRS). Result(s): A total of 54 patients, 27 in each group were included in the study. Age, weight and body mass index parameters of the groups were statistically similar. There was no statistically significant difference between the two groups in terms of the degree of pain at admission and at the 30th-60th min of follow-up. In the 400 mg and 800 mg treatment groups, the NRS score differences between 0 and30 min periods [median [interquartile range (IQR): 4 (3-5) and 4 (3-4); p=0.224] and between 0 and 60 min periods [median (IQR): 4 (3-5) and 4 (3-4); p=0.224] were statistically similar. There was no difference between the two groups in terms of need for rescue medication and side effects. Conclusion(s): Similar efficacy is observed in reducing pain intensity between 400 mg and 800 mg doses of iv ibuprofen. According to these findings, it can be concluded that 400 mg of ibuprofen.Copyright © 2023 by the Bezmialem Vakif University.

Donnelly, J., et al. (2022). "Vitamin E in Cancer Treatment: A Review of Clinical Applications in Randomized Control Trials." Nutrients 14(20): 4329.
	Vitamin E, along with other vitamins and micronutrients play a range of physiologic roles in the homeostasis of the body. Moreover, they also have postulated therapeutic roles that are often incompletely studied and understood. In this scoping review, we explored the recent randomized control trials (RCTs) of Vitamin E in the context of cancer, to investigate whether Vitamin E has a therapeutic role. We searched major bibliographic electronic databases to identify sixteen RCTs studying the role of Vitamin E in cancer management that have been published in the last ten years. These studies had different methodological qualities, including some that used Vitamin E in combination with other treatments. Furthermore, due to the heterogenous results, it is difficult to make a consensus statement on the effectiveness of Vitamin E in cancer therapeutics. In some cases, there were even suggestion of detriment with Vitamin E supplementation. Therefore, well designed, large, prospective RCTs are needed studying pure isoforms of Vitamin E to establish the safety and efficacy of this dietary supplement.Copyright © 2022 by the authors.

Donnelly, L. and G. Balneaves Lynda (2022). "Fact or Fiction? The Role of Regulated Body-Identical Hormone Therapy for Menopausal Women." Nursing for women's health 26(2): 143-151.
	Many menopausal women use hormone therapy, including regulated body-identical hormone therapy (rBHT), to relieve vasomotor symptoms and prevent cardiovascular disease. Despite growing interest in rBHT, there is uncertainty regarding potential benefits and risks. With this narrative review, we aimed to synthesize the literature regarding the efficacy of these therapies for managing vasomotor symptoms and preventing cardiovascular disease. Thirteen articles were identified, with authors of several studies showing rBHT and combination therapy (rBHT with synthetic hormone therapy) to be efficacious in managing vasomotor symptoms when compared to placebo. Conflicting evidence exists regarding the efficacy of rBHT in the prevention of cardiovascular disease, with some studies demonstrating improved cardiovascular biomarkers, particularly among women who are at the beginning of the menopausal journey and experiencing symptoms. In summary, rBHT may have a role in the care of women trying to manage vasomotor symptoms and in protecting against cardiovascular disease among menopausal women; however, larger, more rigorously designed randomized controlled trials are required.; Competing Interests: Author Disclosures The authors report no conflicts of interest or relevant financial relationships. (Copyright © 2022. Published by Elsevier Inc.)

Donnez, J., et al. (2022). "Linzagolix With and Without Hormonal Add-Back Therapy for the Treatment of Symptomatic Uterine Fibroids: Two Randomized, Placebo-Controlled, Phase 3 Trials." Obstetrical and Gynecological Survey 77(12): 741-742.
	
Donnez, J., et al. (2022). "Linzagolix with and without hormonal add-back therapy for the treatment of symptomatic uterine fibroids: two randomised, placebo-controlled, phase 3 trials." Lancet (London, England) 400(10356): 896-907.
	Background: Uterine fibroids are common non-cancerous neoplasm that cause heavy menstrual bleeding and other signs. Linzagolix is an oral gonadotropin-releasing hormone receptor antagonist taken once per day that dose-dependently suppresses gonadal steroids and might reduce uterine-fibroid-associated signs. Two phase 3 trials were conducted to confirm the efficacy and safety of linzagolix at full-suppression (200 mg) and partial-suppression (100 mg) doses with or without hormonal add-back therapy (1 mg oestradiol and 0·5 mg norethisterone acetate) compared with placebo for the treatment of symptomatic uterine fibroids.; Methods: PRIMROSE 1 and PRIMROSE 2 were identical 52-week, randomised, parallel, double-blind, placebo-controlled, phase 3 trials conducted at clinics in the USA (PRIMROSE 1) and Europe and the USA (PRIMROSE 2). Eligible women with uterine fibroid-associated heavy menstrual bleeding (menstrual blood loss >80 mL per cycle) were randomly assigned in a 1:1:1:1:1 ratio to one of five masked treatments: (1) placebo, (2) 100 mg linzagolix per day alone, (3) 100 mg linzagolix per day with once-per-day hormonal add-back therapy (1 mg oestradiol and 0·5 mg norethisterone acetate), (4) 200 mg linzagolix per day alone, or (5) 200 mg linzagolix per day with once-per-day hormonal add-back therapy (1 mg oestradiol and 0·5 mg norethisterone acetate). The primary endpoint was a response (menstrual blood loss ≤80 mL and ≥50% reduction from baseline) at 24 weeks in women who received at least one dose of treatment and did not meet any exclusion criteria based on predosing assessments. These trials are registered with ClinicalTrials.gov (NCT03070899 and NCT03070951). The trials have been completed.; Findings: Between May, 2017, and October, 2020, in PRIMROSE 1, 574 women were enrolled, of which 48 discontinued and 15 were excluded; therefore, 511 women were included in the full analysis set; and in PRIMROSE 2, 535 women were enrolled, of which 24 did not receive the study drug and ten women were excluded from the study, resulting in 501 women being included in the full analysis set. In both trials, a significantly higher proportion of women had a reduction in heavy menstrual bleeding in all linzagolix (with or without add-back therapy) treatment groups compared with the placebo group (p≤0·003). In PRIMROSE 1, the response rates were 56·4% (95% CI 45·8-66·6%) in the 100 mg group, 66·4% (56·6-75·2%) in the 100 mg plus add-back therapy group, 71·4% (61·8-79·8%) in the 200 mg group, and 75·5% (66·0-83·5%) in the 200 mg plus add-back therapy group, compared with 35·0% (25·8-45·0%) in the placebo group. In PRIMROSE 2, the response rates were 56·7% (46·3-66·7%) in the 100 mg group, 77·2% (67·8-85·0%) in the 100 mg plus add-back therapy group, 77·7% (68·4-85·3%) in the 200 mg group, and 93·9% (87·1-97·7%) in the 200 mg plus add-back therapy group, compared with 29·4% (20·8-39·3%) with placebo. The most common adverse events up to 24 weeks were hot flushes (35% of participants in PRIMROSE 1 and 32% in PRIMROSE 2 with linzagolix [200 mg] alone and 3-14% in all other groups).; Interpretation: Linzagolix (100 mg or 200 mg) with or without add-back therapy significantly reduced heavy menstrual bleeding. Partial suppression with once-per-day linzagolix (100 mg) without add-back therapy potentially provides a unique option for the chronic treatment of symptomatic uterine fibroids in women who cannot or do not want to take concomitant hormonal add-back therapy.; Funding: ObsEva.; Competing Interests: Declaration of interests JD is a member of the scientific advisory board of ObsEva and Preglem. EAS reports institutional grants from the National Institutes for Health related to adenomyosis and from Agency for Healthcare Research and Quality related to uterine fibroids; royalties or licenses from UpToDate; consulting fees from AbbVie, Bayer, Myovant, and ObsEva; honoraria for Continuing Medical Education course presentations from MED-IQ, Physicians’ Education Resource, and WEB MD; and for writt n work from the American College of Obstetricians and Gynecologists and Massachusetts Medical Society; an issued patent (6440445) with no commercial activity; participation in a phase 3 advisory board for Myovant; and is an unpaid advisory board member of the Fibroid Foundation, outside the current work. EM reports National Institute for Health grants paid to the institution; consulting fees from the University of Washington, Pfizer, and Myovant Sciences; and payments or honoraria for MED-IQ, StartART nursing, and Prime Education Continuing Medical Education. DA reports payments to institution from ObsEva and Abbvie; and payments to self from ObsEva and Vindico Medical Education. AA-H reports funding from the National Institutes for Health and consulting fees from Abbvie, Bayer, Myovant, Novartis, ObsEva, and Pfizer, outside the current work. NW reports consulting payments from Abbvie and ObsEva. J-PG is a full-time employee and a stockholder of ObsEva. EB is a full-time employee and a stockholder of ObsEva. AH is a full-time employee and a stockholder of ObsEva. EG is a full-time employee and a stockholder of ObsEva. EL is the founder, a board member, and a stockholder of ObsEva. PT is contracted by Cytel, who received fees from ObsEva for statistical services for the current work and other work. All other authors declare no competing interests. (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Donohoe, F., et al. (2021). "The menopause after cancer study (MACS) - A multimodal technology assisted intervention for the management of menopausal symptoms after cancer - Trial protocol of a phase II study." Contemporary clinical trials communications 24: 100865.
	Aims: This study will aim to assess if a composite intervention which involves a specific evidence-based intervention for management of insomnia and non-hormonal pharmacotherapy to manage vasomotor symptoms (VMS) of menopause can improve quality of life for patients experiencing troublesome VMS after cancer who are not eligible for standard systemic menopausal hormone therapy (MHT). Participants will be asked to nominate a partner or companion to support them during this process as an additional form of support.; Background: The menopause transition and its symptoms represent a significant challenge for many patients after cancer treatment, particularly those for whom conventional MHT is contraindicated. These symptoms include hot flushes, night sweats, urogenital symptoms as well as mood and sleep disturbance. These symptoms can exacerbate the consequences of cancer and its treatment.; Methods: We will recruit 205 women who meet inclusion criteria and enrol them on a composite intervention which consists of four parts: (1) use of non-hormonal pharmacotherapy for the management of troublesome vasomotor symptoms of menopause tailored to the timing of predominant symptoms, (2) digital cognitive behavioural therapy for insomnia through the web based Sleepio service, (3) access to information regarding self-management strategies for the common symptoms of menopause and their consequences and (4) identification of a partner or other support person who commits to providing support during the study period.; Outcomes: The primary outcome will be cancer specific quality of life measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30). Secondary outcomes will include sleep quality, bother/interference of vasomotor symptoms and communication between couples about their cancer diagnosis and their menopause experience. Sleep will be measured using the Sleep Condition Indicator (SCI) tool, bother/interference of vasomotor symptoms will be measured by the Hot Flush Rating Scale (HFRS) and communication will be measured using the Couples' Illness Communication Scale (CICS). These validated scales will be administered at baseline, four weeks, three months and six months.; Registration: This study is registered on ClinicalTrials.gov with number NCT04766229.; Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2021 Published by Elsevier Inc.)

Dorfman, T., et al. (2024). "Proprietary Delivery System Increases Serum Estradiol Levels and Reduces Vasomotor Symptoms in Menopausal Women." Journal of Neurosurgical Anesthesiology 36(1): 1277-1278.
	Objective: Objective: The objective of the study is to demonstrate the benefit of a novel nutraceutical with a proprietary delivery system in decreasing hot flashes in a menopausal population. Initially, two pilot studies were performed in menopausal women utilizing a new supplement regimen delivered by a lozenge using Directline technology. The first study focused on the efficacy of the Directline technology compared to leading competitors. The study showed a greater than 300% peak serum level and a 60% longer peak blood level compared to the market leader's gummy delivery system. The second pilot study demonstrated a significant reduction in the negative symptoms of menopause including hot flashes, insomnia, and irritability. Additionally, serum estradiol levels increased by over 360% in 2 months. Patients also experienced an improvement in dayto- day physical and mental function. Consequently, a much larger IRB-approved and third-party governed study was launched to establish if the supplement system could decrease the incidence of vasomotor symptoms in menopausal women. Design(s): Design: An IRB-approved, open-label study was conducted to evaluate the effectiveness of the supplement system in reducing hot flashes. We included females who had not used hormone therapy in the past 12 months and were currently experiencing hot flashes. The participants were given a 90-day supply of the supplement system, consisting of three lozenges per day. They reported the number of hot flashes and provided feedback on a daily questionnaire. Participants who consented also had four separate blood draws taken (before starting the supplement and every 30 days until the study ended) measuring a variety of hormones and other menopausal parameters. Result(s): Results: The study involves 101 women with a mean age of 53 years old, from various ethnic and socioeconomic backgrounds. To date, 90% of participants reported a reduction in menopausal symptoms, 80% of participants reported a significant reduction in hot flashes and other menopausal symptoms, and 25% of participants reported a complete elimination of hot flashes. Participants also reported improved quality and duration of sleep and increased energy levels. To date, no serious adverse events have been reported. Blood serum is still being collected and analyzed and the study will be completed by September 2023. Conclusion(s): Conclusion(s): In a large population of menopausal women from a multitude of ethnic and socioeconomic backgrounds who utilized our proprietary nutraceutical, hot flashes, and other menopausal symptoms were significantly reduced based on our preliminary data. Additionally, a preliminary assessment of serum estradiol levels shows a significant increase over time as women continue to take the supplement system. The initial data demonstrate a statistically significant benefit based on subjective questionnaire responses and blood serum levels of estradiol proving the efficacy of both the Directline delivery system and the ingredient profile of the supplements.

D'Oria, O., et al. (2024). "Pharmacotherapy for the treatment of recurrent cervical cancer: an update of the literature." Expert Opinion on Pharmacotherapy 25(1): 55-65.
	Introduction: Cervical cancer is the fourth most common cause of cancer-related death worldwide. High-risk locally advanced or recurrent/metastatic cervical cancers have a poor prognosis with routine treatments. The objective of this study is to analyze the data available in the literature on therapies and molecules currently in use to improve the prognosis of recurrent cervical cancer.; Areas Covered: An extensive literature search was conducted by authors to identify relevant trials on various databases. Articles in English published until September 2023 that investigate different pharmacotherapy strategies for the treatment of recurrent cervical cancer, were included. Results of various pharmacological regimens including different combinations of chemotherapy, immune checkpoint inhibitors, DNA damage repair inhibitors and antibody-drug conjugates were analyzed.; Expert Opinion: In recent years, there have been significant improvements in the outcomes of recurrent/metastatic cervical cancer. However, these improvements do not address the unmet need in terms of oncological outcomes. The introduction of immunotherapy and targeted therapies showed advantages in cervical cancer patients. New therapies and combination strategies must be implemented. Centralization of care and enrollment in clinical trials are of paramount importance. Primary and secondary prevention remains the fundamental goal to reduce the burden of cervical cancer.

D'Oria, O., et al. (2022). "The role of preoperative frailty assessment in patients affected by gynecological cancer: a narrative review." Italian Journal of Gynaecology and Obstetrics 34(2): 76-83.
	The following article aims to highlight the importance of the assessment of frailty in patients affected by gynecological cancer and to discuss current data available on scores commonly used to predict adverse postoperative outcomes and overall survival in this group of patients. A narrative review was performed in Medline (PubMed) and Embase database until February 28, 2022. This study includes randomized and observational studies about patients undergoing non-emergent surgery for gynecological malignancies with preoperative frailty assessment. Fourteen studies, for a total of 85957 women, were included. The Modified Frailty Index (mFI) is the most commonly used tool for definition of frail patient. Results highlighted that frail patients had lower disease-free survival rates and overall survival rates than non-frail patients. Additionally, frail patients were more at risk of developing 30-day postoperative complications, non-home discharge and Intensive Care Unit admission than the other group. In gynecologic oncology, the assessment of the state of women's frailty is fundamental to predict adverse outcomes and to customize treatment strategies. Modified Frailty Index is the most used tool to assess the frailty state of gynecologic oncologic patients. We advise that this index should be part of the patients' standard evaluation and that it may be used in the daily practice to aid in shared decision making for tailored therapeutic strategies. In this manuscript we provide an update on the importance of the use of preoperative frailty scores to predict complications among patients treated for gynecological cancer.Copyright © The Authors.

D'Oria, O., et al. (2022). "Fractional Co2 laser for vulvo-vaginal atrophy in gynecologic cancer patients: A valid therapeutic choice? A systematic review." European Journal of Obstetrics, Gynecology, and Reproductive Biology 277: 84-89.
	Introduction: One of the most common adverse events reported by gynecological cancer survivors with spontaneous or iatrogenic menopause is vulvo-vaginal atrophy (VVA). An increasing number of women have this kind of discomfort related to the menopause induced by different cancer therapies. In this regard, fractional CO2 laser may be a valid therapeutic choice for these patients.; Methods: We performed a literature search of PubMed, EMBASE, SCOPUS and Web of Science databases with search terms of laser CO2 treatment of vulvovaginal atrophy and gynecologic cancer survivors and reviewed major US Society Guidelines to create this narrative review of this topic. Breast, ovarian endometrial and cervical cancers were included.; Results: Nine studies were included. Fractional CO2 laser improves clinical symptoms and sexual function, in terms of VHI (vaginal health index) and FSFI (female sexual function index). Non severe adverse event occurred.; Conclusion: According to the best evidence available, fractional CO2 laser treatment for VVA is an effective and safe therapeutic option for gynecological cancer survivors, improving sexual life and quality of life (QoL).; Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2022 Elsevier B.V. All rights reserved.)

Dorigo, O., et al. (2023). "Maveropepimut-S, a DPX-Based Immune-Educating Therapy, Shows Promising and Durable Clinical Benefit in Patients with Recurrent Ovarian Cancer, a Phase II Trial." Clinical cancer research : an official journal of the American Association for Cancer Research 29(15): 2808-2815.
	Purpose: Patients with platinum-resistant ovarian cancer respond poorly to existing therapies. Hence there is a need for more effective treatments.; Patients and Methods: The DeCidE1 trial is a multicenter, randomized, open-label, single-arm phase II study to evaluate the safety and effectiveness of maveropepimut-S with cyclophosphamide in patients with recurrent ovarian cancer. Median follow-up for evaluable subjects was 4.4 months. Data were collected from March 2019 to June 2021. Subjects received two injections of 0.25 mL maveropepimut-S 3 weeks apart, followed by one 0.1-mL doses, every 8 weeks up to progression. Oral cyclophosphamide, 50 mg twice daily, was administered in repeating weekly on and off cycles.; Results: Twenty-two patients were enrolled. Median age was 58 years (38-78 years). Among the evaluable population, the objective response rate (ORR) was 21% [90% confidence interval (CI), 7.5%-41.9%], with a disease control rate (DCR) of 63% (90% CI, 41.8%-81.3%), including 4 (21%) patients with partial responses, 8 (42%) stable disease, and 7 (37%) progressive disease. The ORRs were consistent across subgroups based on platinum sensitivity, and DCR was higher in the platinum-resistant subpopulation. Four SD patients maintained clinical benefit up to 25 months. Most treatment-related adverse events (TRAE) were grade 1 and 2 (87% of unique events). Most common AEs were injection site reactions. Eight subjects reported grade 3 and no grade 4 AEs. Survivin-specific T-cell responses were observed in treated patients with clinical benefit.; Conclusions: Maveropepimut-S with intermittent low-dose cyclophosphamide is well-tolerated, with clinical benefit for patients with recurrent ovarian cancer. Observed responses are irrespective of the platinum status. (©2023 The Authors; Published by the American Association for Cancer Research.)

Dorina, G., et al. (2021). "Comparing the efficacy and safety of metformin and inositols in polycystic ovary syndrome: a systematic review and meta-analysis."
	
Dormuth Colin, R., et al. (2021). "Comparison of Pregnancy Outcomes of Patients Treated With Ondansetron vs Alternative Antiemetic Medications in a Multinational, Population-Based Cohort." JAMA Network Open 4(4): e215329.
	Importance: Ondansetron is frequently used to treat nausea and vomiting during pregnancy. Although some studies reported important safety signals, few studies have been sufficiently large to assess rare pregnancy outcomes.; Objective: To study the association between ondansetron exposure during pregnancy and the risks of spontaneous abortion, stillbirth, and major congenital malformations.; Design, Setting, and Participants: This is a cohort study conducted in 3 countries, with a meta-analysis. Participants included women and girls aged 12 to 55 years who experienced spontaneous abortion, induced abortion, stillbirth, or live birth between April 2002 and March 2016, as recorded in administrative data from 5 Canadian provinces (British Columbia, Alberta, Saskatchewan, Manitoba, and Ontario), the US IBM MarketScan Research Databases, and the UK Clinical Practice Research Datalink. The statistical analysis was completed in October 2020.; Exposures: Exposure to ondansetron during pregnancy was compared with exposure to other commonly used antiemetics to minimize confounding by indication.; Main Outcomes and Measures: The primary outcome was fetal death, defined as either spontaneous abortion or stillbirth. Secondary outcomes were the 2 components of the primary outcome and major congenital malformations identified during the year after a live birth. Adjusted hazard ratios were estimated using Cox proportional hazards models with time-dependent drug exposures and were adjusted using high-dimensional propensity scores. For major congenital malformations, adjusted odds ratios were estimated from logistic models. Site-level results were pooled using random-effects meta-analysis. Sensitivity analyses considered second-line antiemetic exposure and exposure specifically during 4 to 10 weeks of gestation.; Results: Data from 456 963 pregnancies were included in this study of fetal death (249 787 [54.7%] in Canada, 197 913 [43.3%] in the US, and 9263 [2.0%] in the UK; maternal age, ≤24 years, 93 201 patients [20.4%]; 25-29 years, 149 117 patients [32.6%]; 30-34 years, 142 442 patients [31.2%]; and ≥35 years, 72 203 patients [15.8%]). Fetal death occurred in 12 907 (7.9%) of 163 810 pregnancies exposed to ondansetron, and 17 476 (5.7%) of 306 766 pregnancies exposed to other antiemetics. The adjusted hazard ratios were 0.91 (95% CI, 0.67-1.23) for fetal death with time-dependent ondansetron exposure during pregnancy, 0.82 (95% CI, 0.64-1.04) for spontaneous abortion, and 0.97 (95% CI, 0.79-1.20) for stillbirth. For major congenital malformations, the estimated odds ratio was 1.06 (95% CI, 0.91-1.22). Results of sensitivity analyses were generally consistent with those of the primary analyses.; Conclusions and Relevance: In this large, multicenter cohort study, there was no association between ondansetron exposure during pregnancy and increased risk of fetal death, spontaneous abortion, stillbirth, or major congenital malformations compared with exposure to other antiemetic drugs.

dos Santos, S., et al. (2024). "Effects of health education on women with urinary incontinence: systematic review and meta-analysis." International Urogynecology Journal 35(2): 273-289.
	Introduction and hypothesis: The objective was to investigate the effects of health education (HE) on urinary symptoms and quality of life in women with urinary incontinence (UI). Method(s): A systematic review and meta-analysis of trials evaluating HE for women with UI. The risk of bias was assessed using the revised Cochrane risk-of-bias tool for randomized trials. Result(s): The search identified 5,118 articles. Eighteen papers were considered eligible. The interventions investigated included health education (HE), combined intervention, self-management (SM), and structured training (ST). Outcomes included quality of life (QoL), UI frequency, UI severity, impression of improvement, incontinence symptoms, urine leakage, fear of leakage, urgency, and incontinence impact. Compared with the control group there was a significant improvement in the frequency, severity, and impact on the QoL for women with UI (assessed by the total score of the International Consultation on Incontinence Questionnaire Short Form (ICIQ SF); RR = -1.47, 95% CI [-2.07, -0.88]; two trials; low certainty of the evidence). Conclusion(s): This review shows that HE seems to be beneficial in the treatment of women with UI when compared with control women (no treatment or general health care), improving the frequency, severity, and impact on QoL assessed by the ICIQ SF total score. However, the certainty of this evidence is low.Copyright © The International Urogynecological Association 2023.

Doty, M. S., et al. (2022). "Daily meditation program for anxiety in individuals admitted to the antepartum unit: a multicenter randomized controlled trial (MEDITATE)." American Journal of Obstetrics & Gynecology MFM 4(3): 100562.
	BACKGROUND: Inpatient antepartum women have higher levels of anxiety than outpatient. Former randomized trials using mindful meditation programs to decrease maternal anxiety have conflicting results; some studies showed a considerable decrease in anxiety levels, whereas others showed no difference. A paucity of trials exist using mindful meditation for maternal anxiety in the inpatient antepartum population; most studies focus on the outpatient clinic population. Because of inpatient acuity and anxiety factors, we conducted a randomized trial to target this population. OBJECTIVE: This study aimed to compare anxiety levels on day 4 of either routine care or routine care plus a twice-daily application-based mindful meditation program in women admitted to the antepartum unit. STUDY DESIGN: In a multisite randomized trial (ClinicalTrials.gov Identifier: NCT03737279), women admitted to the antepartum units were randomized to either routine care plus educational pamphlets (control arm) or routine care plus a twice-daily application-based mindful meditation program (intervention arm). The inclusion criteria were age of at least 18 years, gestational age of at least 23 weeks, planned inpatient care for >3 days from randomization, and care by our university physician team. The primary outcome was maternal state anxiety level (measured using the validated State-Trait Anxiety Inventory) on day 4 (randomization being day 1). The secondary outcomes included stress (measured using the Perceived Stress Scale) and depression (measured using the Edinburgh Depression Scale) on day 4, latency period from randomization to delivery, patient experience, number of meditation sessions, and total meditation time. A total of 56 women were needed for 90% power to detect a decrease in the primary outcome by 30% in the intervention group, compared with the control group. All women were observed using an intention-to-treat analysis. We compared the continuous variables using the Wilcoxon rank-sum test or t test and the categorical variables using the chi-squared test or the Fisher exact test. RESULTS: From March 4, 2019, to December 20, 2019, 412 women were screened for eligibility, 77 women (18.7%) were found eligible, and 56 women (72.7%) were randomized with 28 women in each group. Of note, 96.4% of women completed at least 1 meditation session, and 39.3% of women completed all meditation sessions. The mean score of the anxiety level using the State-Trait Anxiety Inventory on day 4 was not significantly different (P=.24) between the control group (42.0±10.8) and meditation group (37.5±13.1). A decreased anxiety score from day 1 to day 4 was seen in both the control group and meditation group (-4.7 vs -9.4, respectively; P=.12). The rate of abnormal State-Trait Anxiety Inventory scores on day 4 was not significantly different between the control group and meditation group (62% vs 45%, respectively; P=.28). When asked about the experience with the research trial, 88.8% of women in the control group and 89.5% of women in the meditation group reported a positive experience. CONCLUSION: Compared with the control group, a twice-daily application-based mindful meditation program for women admitted to the antepartum unit did not considerably decrease the anxiety score on day 4. However, >88% of women in both groups had a positive experience with the nonpharmacologic intervention.

Dou, P.-H., et al. (2019). "Electrical stimulation on adverse events caused by chemotherapy in patients with cervical cancer: A protocol for a systematic review of randomized controlled trial." Medicine 98(7): e14609.
	Background: This protocol of systematic review aims to investigate the effectiveness of electrical stimulation (ES) on adverse events (AEs) caused by chemotherapy in patients with cervical cancer (CC).; Methods: This systematic review of randomized controlled trials will be identified through searchers of PUBMED, PsycINFO, Scopus, Opengrey, Cochrane Central Register of Controlled Trials, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Web of Science, Allied and Complementary Medicine Database, and Chinese Biomedical Literature Database. All the sources will be searched from the inception to the date of study search ran. Additionally, websites of clinical trials registry and reference lists provided in relevant studies and reviews will also be searched. Two independent reviewers will evaluate the eligibility criteria of all potential literature, extract the data, and determine the risk of bias for each included study. RevMan 5.3 software will be used to pool the data and to conduct a meta-analysis.; Results: This systematic review will assess the effectiveness of ES on AEs caused by chemotherapy in patients with CC.; Conclusion: The findings of this study may summarize the latest evidence for the ES on AEs following chemotherapy for CC.; Prospero Registration Number: PROSPERO CRD42019120191.

Dou, Y., et al. (2024). "Long-term outcome and risk factors of reintervention after high intensity focused ultrasound ablation for uterine fibroids: a systematic review and meta-analysis." International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group 41(1): 2299479.
	Objectives: To quantify the reintervention rate and analyze the risk factors for reintervention after high-intensity focused ultrasound (HIFU) ablation of uterine fibroids.; Methods: Eighteen studies were selected from the seven databases. A meta-analysis was applied to synthesize the reintervention rates for fibroids across various follow-up durations. Subgroup-analysis was conducted based on the year of surgery, sample size, guide methods, and non-perfusion volume ratio (NPVR). Signal intensity of T2-weighted imaging (T2WI) was independently evaluated for reintervention risk.; Results: The study enrolled 5216 patients with fibroids treated with HIFU. There were 3247, 1239, 1762, and 2535 women reaching reintervention rates of 1% (95% confidence interval (CI): 1-1), 7% (95% CI: 4-11), 19% (95% CI: 11-27), and 29% (95% CI: 14-44) at 12, 24, 36, and 60-month after HIFU. The reintervention rates of patients treated with US-guided HIFU (USgHIFU) were significantly lower than those of patients treated with MR-guided focused ultrasound surgery (MRgFUS). When the NPVR of fibroids was over 50%, the reintervention rates at 12, 36 and 60-month after HIFU were 1% (95% CI: 0.3-2), 5% (95% CI: 3-8), and 15% (95% CI: 9-20). The reintervention risk for hyper-intensity fibroids on T2WI was 3.45 times higher (95% CI: 2.7-4.39) for hypo-/iso-intensity fibroids.; Conclusion: This meta-analysis showed that the overall reintervention rates after HIFU were acceptable and provided consultative suggestions regarding treatment alternatives for patients with fibroids. Subgroup-analysis revealed that USgHIFU, NPVR ≥ 50%, and hypo-/iso-intensity of fibroids on T2WI were significant factors in reducing reintervention.; Systematic Review Registration: PROSPERO, CRD42023456094.

Douglas, M. L., et al. (2021). "Efficacy of Advance Care Planning Videos for Patients: A Randomized Controlled Trial in Cancer, Heart, and Kidney Failure Outpatient Settings." Medical decision making : an international journal of the Society for Medical Decision Making 41(3): 292-304.
	BACKGROUND: Patient videos about advance care planning (ACP; hereafter "Videos"), were developed to support uptake of provincial policy and address the complexity of patients' decision-making process. We evaluate self-administered ACP Videos, compare the studies' choice of outcomes, show correlations between the patients' ACP actions, and discuss implications for health care policy. OBJECTIVE: To test the efficacy of the Videos on patients' ACP/goals of care designation conversations with a health care provider. DESIGN, SETTING, AND PARTICIPANTS: Using a 2-arm, 1:1 randomized controlled trial, we recruited outpatients with a diagnosis of kidney failure, heart failure, metastatic lung, gastrointestinal, or gynecological cancer from 22 sites. Analysis followed the intention-to-treat principle. INTERVENTIONS: Videos describing the ACP process and illustrating the resuscitative, medical, and comfort levels of care. MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of participants who reported having an ACP/goals of care designation (GCD) conversation with a health care provider by 3 mo. Outcomes were measured using the Behaviours in Advance Care Planning and Actions Survey, an online survey capturing ACP attitudes, processes, and actions. RESULTS: We analyzed 241 and 217 participants at baseline and 3 mo, respectively. The proportion of participants who had an ACP/GCD conversation with a health care provider by 3 mo was significantly different between study arms (46% intervention; 32% control; adjusted odds ratio, 1.83; P = 0.032). Adjusted for the quality of conversations, there was no significant difference. CONCLUSIONS: Videos as stand-alone tools do not engage individuals in high-quality ACP. Pragmatic trials are necessary to evaluate their impact on downstream outcomes when integrated into intentional, comprehensive conversations with a health care provider. Considering the strong correlation between 2 activities (physicians discussing options, patients telling health care providers preferences), policy should focus on empowering patients to initiate these conversations.

Doulgeraki, T., et al. (2023). "The genetic background of female reproductive disorders: a systematic review." Current opinion in obstetrics & gynecology 35(5): 426-433.
	Purpose of Review: Reproductive function is the interplay between environmental factors and the genetic footprint of each individual. The development in genetic analysis has strengthened its role in the investigation of female reproductive disorders, potential treatment options and provision of personalized care. Despite the increasing requirement of genetic testing, the evidence of the gene-disease relationships (GDR) is limited. We performed a systematic review exploring the associations between the most frequent female reproductive endocrine disorders associated with subfertility [including polycystic ovaries syndrome (PCOS), premature ovarian failure (POI) and hypogonadotropic hypogonadism] and their genetic background in order to summarize current knowledge.; Methods: A systematic review of relevant literature in accordance with PRISMA guidelines was conducted until July 2022. Data sources that were used are PubMed and Embase.; Recent Findings: A total of 55 studies were included from the 614 articles identified in the original search. We identified 384 genes associated with one or more of the included female reproductive disorders. The highest number of genes was found to be associated with POI ( N = 209), followed by hypogonadotropic hypogonadism ( N = 88) and PCOS ( N = 87). Four genes, including FSHR , LHβ , LEPR and SF1 were associated with multiple reproductive disorders implying common pathways in the development of those diseases.; Summary: We provide an up-to-date summary of the currently known genes that are associated with three female reproductive disorders (PCOS, POI and hypogonadotropic hypogonadism). The role of genetic analysis in the field of impaired female reproduction may have a role in the diagnosis of female reproductive disorders and personalized patient care. (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Douligeris, A., et al. (2023). "The Effect of Postoperative Gum Chewing on Gastrointestinal Function Following Laparoscopic Gynecological Surgery. A Meta-analysis of Randomized Controlled Trials." Journal of Minimally Invasive Gynecology 30(10): 783-796.
	Objective: To assess the effect of postoperative gum chewing on gastrointestinal function in women following laparoscopic gynecological surgery for benign indications. Data Sources: We screened 5 major databases (Medline, Scopus, Google Scholar, Cochrane Central Register of Controlled Trials, and Clinicaltrials.gov) from inception till February 2023. Methods of Study Selection: No language restrictions were applied. We included randomized controlled trials comparing the postoperative bowel function between patients who chewed and patients who did not chew gum postoperatively after laparoscopic gynecological procedures for benign indications. Tabulation, Integration, and Results: Data from 5 studies on 670 patients were extracted and analyzed by 3 independent reviewers. Meta-analysis was performed with RevMan 5.4 software (Copenhagen: The Nordic Cochrane Center, The Cochrane Collaboration, 2020), with mean differences (MDs), pooled risk ratios, and random-effects model. Postoperative gum chewing significantly reduced the time to first bowel sounds and the time to first passage of flatus (MD -2.58 hours 95% confidence interval (CI) -4.12 to -1.04 p = .001 and MD -3.97 hours 95% CI -6.26 to -1.68 p <.001, respectively). The time to first defecation, the time to first postoperative patients' mobilization, the length of hospital stay, and the risk of postoperative bowel obstruction showed no statistically significant difference between the 2 groups. When subgroup analysis was performed according to the type of the laparoscopic procedure, it failed to reveal a positive impact of postoperative gum chewing in both the times to first passage of flatus and first defecation following laparoscopic hysterectomies (MD -5.35 hours 95% CI -10.93 to 0.23 p = .06 and MD -15.93 hours 95% CI -40.13 to 8.28 p = .20, respectively). Conclusion(s): The results of the present meta-analysis support that postoperative gum chewing following laparoscopic gynecological procedures seems to have a positive effect on the early mobilization of the gastrointestinal tract. However, these results should be interpreted with caution due to the small number of the included randomized controlled clinical trials.Copyright © 2023 AAGL

Doumouchtsis, S. K., et al. (2019). "A systematic review on outcome reporting in randomised controlled trials on surgical interventions for female stress urinary incontinence: a call to develop a core outcome set." BJOG: An International Journal of Obstetrics and Gynaecology 126(12): 1417-1422.
	Background: Several meta-analyses have identified methodological limitations in female stress urinary incontinence (SUI) trials, precluding the synthesis of primary studies and high-quality evidence. Objective(s): Evaluation of outcome measure selection and outcome reporting in randomised controlled trials (RCTs) on surgery for SUI. Search strategy: Systematic review of RCTs identified from bibliographical databases, including Medline, Cochrane, and EMBASE. Selection Criteria: Randomised controlled trials evaluating the efficacy and safety of surgical interventions for the management of female SUI. Data Collection and Analysis: Two researchers independently assessed the included studies and documented outcomes. Main Result(s): Overall, 108 studies were identified that included 422 reported outcomes and 119 outcome measures. The three most common outcomes were cure rates (87 studies), quality of life (85 studies), and overactive bladder (78 studies). The median methodological quality rating was 3 (range 0-3) and the outcome reporting quality rating was 3 (range 0-5). Multinomial logistic regression analysis revealed that the methodological quality and use of validated questionnaire were significant predictors of the quality of outcome reporting (beta = 0.538, P < 0.001; beta = 0.218, P = 0.011, respectively). Conclusion(s): Outcome reporting in SUI trials is highly variable. Until a core outcome set is developed and implemented, we propose an interim use of three commonly reported outcomes in each domain (treatment success rate - complete cure, partial improvement, or failure of response; urodynamic evaluation outcomes - overactive bladder (OAB), voiding dysfunction, and urodynamic stress incontinence; patient-reported outcomes - quality of life, sexual dysfunction, and patient satisfaction) with the use of validated questionnaires for patient-reported outcomes and subjective success rates. Complications should be also explicitly and comprehensively reported using validated outcome measures. Tweetable abstract: There is significant variation in outcome reporting in SUI trials. Our systematic review findings aim to form the basis for the development of a core outcome set.Copyright © 2019 Royal College of Obstetricians and Gynaecologists

Dovnik, A. and F. Dovnik Nina (2020). "Vitamin D and Ovarian Cancer: Systematic Review of the Literature with a Focus on Molecular Mechanisms." Cells 9(2).
	Vitamin D is a lipid soluble vitamin involved primarily in calcium metabolism. Epidemiologic evidence indicates that lower circulating vitamin D levels are associated with a higher risk of ovarian cancer and that vitamin D supplementation is associated with decreased cancer mortality. A vast amount of research exists on the possible molecular mechanisms through which vitamin D affects cancer cell proliferation, cancer progression, angiogenesis, and inflammation. We conducted a systematic review of the literature on the effects of vitamin D on ovarian cancer cell.; Competing Interests: The authors declare no conflict of interest.

Doxford-Hook Elizabeth, A., et al. (2023). "Management of levator ani avulsion: a systematic review and narrative synthesis." Archives of Gynecology and Obstetrics 308(5): 1399-1408.
	Purpose: Levator ani muscle (LAM) avulsion affects up to 35% of women. Unlike obstetric anal sphincter injury, LAM avulsion is not diagnosed immediately after vaginal delivery, however, has a profound impact on quality of life. The management of pelvic floor disorders is in growing demand yet the significance of LAM avulsion in the context of pelvic floor dysfunction (PFD) is poorly understood. This study collates information on success of treatment for LAM avulsion to establish the best options for management of women.; Methods: MEDLINE ® , MEDLINE ® In-Process, EMBASE, PubMed, CINAHL and The Cochrane Library were searched for articles that evaluated the management techniques used to treat LAM avulsion. The protocol was registered with PROSPERO (CRD42021206427).; Results: Natural healing of LAM avulsion occurs in 50% of women. Conservative measures, including pelvic floor exercises and pessary use are poorly studied. Pelvic floor muscle training for major LAM avulsions was of no benefit. Post-partum pessary use was only of benefit in the first three months for women. Surgeries for LAM avulsion are poorly researched but studies suggest they may provide benefit for 76-97% of patients.; Conclusions: Whilst some women with PFD secondary to LAM avulsion improve spontaneously, 50% continue to have pelvic floor symptoms 1 year following delivery. These symptoms result in a significant negative impact on quality of life, however, it is not clear whether conservative or surgical methods are helpful. There is a pressing need for research to find effective treatments and explore appropriate surgical repair techniques for women with LAM avulsion. (© 2023. Crown.)

Drakopoulou, E., et al. (2022). "Gene Therapy for Malignant and Benign Gynaecological Disorders: A Systematic Review of an Emerging Success Story." Cancers 14(13).
	Despite the major advances in screening and therapeutic approaches, gynaecological malignancies still present as a leading cause of death among women of reproductive age. Cervical cancer, although largely preventable through vaccination and regular screening, remains the fourth most common and most lethal cancer type in women, while the available treatment schemes still pose a fertility threat. Ovarian cancer is associated with high morbidity rates, primarily due to lack of symptoms and high relapse rates following treatment, whereas endometrial cancer, although usually curable by surgery, it still represents a therapeutic problem. On the other hand, benign abnormalities, such as fibroids, endometriosis, placental, and embryo implantation disorders, although not life-threatening, significantly affect women's life and fertility and have high socio-economic impacts. In the last decade, targeted gene therapy approaches toward both malignant and benign gynaecological abnormalities have led to promising results, setting the ground for successful clinical trials. The above therapeutic strategies employ both viral and non-viral systems for mutation compensation, suicide gene therapy, oncolytic virotherapy, antiangiogenesis and immunopotentiation. This review discusses all the major advances in gene therapy of gynaecological disorders and highlights the novel and potentially therapeutic perspectives associated with such an approach.

Drexler, U., et al. (2023). "Fasting during cancer treatment: a systematic review." Quality of Life Research 32(5): 1427-1446.
	Background: Clinical data on the modern topic fasting among cancer patients are rare. This review aimed to summarise published clinical data on fasting and its effects on patients undergoing chemotherapy and therefore to give some directions in advising patients with the desire to fast. Method(s): A systematic search was conducted searching five electronic databases (Embase, Cochrane, PsychInfo, CINAHL and Medline) to find studies concerning the use, effectiveness and potential harm of fasting during therapy on cancer patients. The main endpoints were quality of life, side effects and toxicities of the fasting intervention. Result(s): The search results totaled 3983 hits. After systematic sorting according to standardised pre-defined criteria, nine publications which covered eight studies with 379 patients were included in this systematic review. The majority of the patients included were diagnosed with breast- and gynaecological cancers. Fasting duration and timepoints ranged significantly (24-140 h before, and on the day of, chemotherapy to 56 h after chemotherapy). In one study patients were fasting before cancer surgery. The studies were mostly low to moderate quality and reported heterogeneous results. Overall, the studies were insufficiently powered to detect significant effects on the predefined endpoints. Conclusion(s): Fasting for short periods does not have any beneficial effect on the quality of life of cancer patients during treatment. Evidence on fasting regimes reducing side effects and toxicities of chemotherapy is missing. In contrast, as the negative effects of unintentional weight loss are known to impact clinical outcomes severely, fasting is not indicated in this context.Copyright © 2022, The Author(s).

Dreyer, H., et al. (2022). "The Impact of Suppressing Estradiol During Ovarian Stimulation on the Unsupported Luteal Phase: A Randomized Controlled Trial." The Journal of Clinical Endocrinology and Metabolism 107(9): e3633-e3643.
	Context: Supraphysiological sex steroid levels at the follicular-luteal phase transition are implicated as the primary cause of luteal insufficiency after ovarian stimulation (OS) for in vitro fertilization.; Objective: We aimed to determine the impact of suppressing estradiol levels during OS of multiple dominant follicles on the unsupported luteal phase and markers of endometrial maturation.; Methods: At 2 university hospitals, 25 eligible egg donors were randomized to undergo OS using exogenous gonadotropins with or without adjuvant letrozole 5 mg/day. Final oocyte maturation was triggered with a GnRH agonist. No luteal support was provided. The primary outcome was the duration of the luteal phase. Secondary outcomes were luteal phase hormone profiles and the endometrial transcriptomic signature 5 days after oocyte pick up (OPU + 5).; Results: The median (interquartile range [IQR]) luteal phase duration was 8.0 (6.8-11.5) days compared with 5.0 (5.0-6.8) days in the intervention and control group, respectively (P < 0.001). Estradiol levels were effectively suppressed in the letrozole group with a median of 0.86 (0.23-1.24) nmol/L at OPU compared to 2.82 (1.34-3.44) nmol/L in the control group. Median (IQR) progesterone levels at OPU + 5 were 67.05 (15.67-101.75) nmol/L in the letrozole group vs 2.27 (1.05-10.70) nmol/L in the control group (P < 0.001). In the letrozole group, 75% of participants revealed endometrial transcriptomic signatures interpreted as post-receptive. In the control group, 40% were post-receptive and 50% noninformative.; Conclusion: Suppressing estradiol levels in the follicular phase with adjuvant letrozole significantly reduces the disruption of the unsupported luteal phase after OS. (© The Author(s) 2022. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Drks (2021). "„Better with dad" Process and outcome of inpatient-mother-child therapies for postpartum mental disorders: prozess und Outcome stationärer Mutter-Kind: contributing factors and predictors in the field of maternal and paternal relationships." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention 1: Intervention Group (fathers are included in the treatment) The intervention group includes participation in a weekly program (6 sessions of 60‐75 minutes each), accompanying the mothers' treatment on the ward. Part of the intervention are 4 sessions of psychoeducation, an open group session, a father‐child video interaction training, furthermore a 30‐minute individual conversation at the beginning and at the end of the intervention as well as a couple session with the reference therapist of the mother in treatment. Intervention 2: Treatment‐as‐usual (fathers are not included in the treatment) Treatment as usual includes a couple's interview during the course of treatment by the reference therapist of the mother in treatment and participation in a monthly open group for relatives, otherwise no further involvement of fathers in therapy CONDITION: F32.2 ‐ Severe depressive episode without psychotic symptoms F32.3 ‐ Severe depressive episode with psychotic symptoms F33.2 ‐ Recurrent depressive disorder, current episode severe without psychotic symptoms F33.3 ‐ Recurrent depressive disorder, current episode severe with psychotic symptoms F53.1 ‐ Severe mental and behavioural disorders associated with the puerperium, not elsewhere classified F53.8 ‐ Other mental and behavioural disorders associated with the puerperium, not elsewhere classified F53.9 ‐ Puerperal mental disorder, unspecified Mental illness in the postpartum period (0‐2 yrs postpartum) PRIMARY OUTCOME: 1. maternal psychological symptoms compared from start to end of treatment (measured by the Symptom Check List 90); 2. change in mother‐child bonding from start to end of treatment (measured by the CARE Index and the Parental Bonding Questionnaire); 3. change in child developmental age from start to end of treatment (measured by Largo's landmarks); 4. change in paternal distress compared from start to end of treatment (measured by the Gender Sensitive Depression Screening GSDS‐25); 5. change in father‐child bonding (measured by the Parental Bonding Questionnaire). SECONDARY OUTCOME: 1. change in maternal and paternal mentalizing ability (measured by the Parental Reflective Functioning Questionnaire); 2. change of partnership quality from the perspective of mothers as well as fathers (measured by the Partnership Questionnaire PFB‐K); 3. change in parenthood from the perspective of mothers as well as fathers (measured by the "Partnership Questions"); 4. change in social support (measured by the "Fsoz‐U‐K"). INCLUSION CRITERIA: Mothers: ‐ Mental disorder according to ICD‐10 ‐ Indication for mother‐child treatment according to OPS 9‐643 (determined by the ward physician/psychologist) ‐ Birth of a child no longer than 24 months ago ‐ Sufficient German language skills ‐ Written informed consent (DvH, ICH‐GCP), including consent to audio recording of scientific interviews and video recording of mother‐child interactions. Fathers: ‐ Birth of a child no more than 24 months ago. ‐ Admission of the partner with the common child for inpatient mother‐child treatment ‐ Sufficient German language skills ‐ Written informed consent (DvH, ICH‐GCP), including consent to audio recording of scientific interviews and video recording of mother‐child interactions. Children: INCLUSION CRITERIA: ‐ Joint admission with mother for inpatient mother‐child treatment. ‐ Not older than 24 months ‐ No acute stress or illness at the time of videodiagnostic recording

Drks (2021). "Embryo transfer with intrauterine application of human chorionic gonadotropin (hCG) to improve implantation- and pregnancy rates - a randomized controlled study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention 1: Intrauterine application of 500 IU hCG (Pregnyl, ORGANON, Netherlands) dissolved in 40 µl embryo culture medium G‐2™ PLUS (Vitrolife, Sweden) on day 3 after ovum pick up. Intervention 2: Intrauterine application of 500 IU hCG (Pregnyl, ORGANON, Netherlands) solved in 40 µl culture medium (G‐2™ PLUS (Vitrolife, Sweden) on day 5 before embryo transfer Intervention 3: Application of 40µl embryo culture medium without hCG either on day 3 after OPU or on day 5 before embryo transfer (control group) CONDITION: N46 ‐ Male infertility N97 ‐ Female infertility PRIMARY OUTCOME: Implantation rate (number implanted embryos/ number transfered embryos; pregnancy rate: number positive pregnancy tests (beta‐hCG) / number embryo transfers, clinical pregnancy rate: number of verified pregnancy tests by fetal heart beat / number embryo transfers; miscarriage rates: miscarriages/ number of embryo transfers; Live birth rates: number of deliveries / embryo transfers SECONDARY OUTCOME: Miscarriage rate after foetal heartbeat (miscarriages /verfied ckinical pregnancies); Live birth rate (Live birth / embryos transferred) INCLUSION CRITERIA: Included were all fresh blastocyst transfers on day 5 after ovum pick up

Drks (2021). "Influence of additional pelvic floor muscle trainig postpartum on the sexual- and pelvic floor function in primiparous women." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention 1: 6 months after delivery additional, professional pelvic floor training for 6 weeks once a week Intervention 2: No additional pelvic floor muscel training CONDITION: O34.8 ‐ Maternal care for other abnormalities of pelvic organs PRIMARY OUTCOME: Influence of pelvic floor training on the pelvic floor, sexuality.; ; Two validated questionnaires 6 and 12 months after delivery in our urogynecology department:; "Female Sexual Function Index ‐ questionnaire" and the "German Pelvic Floor Questionnaire for pregnant women and women after childbirth" SECONDARY OUTCOME: Influence of additional pelvic floor muscle training on clincial parameters, including an evaluation of the degree of a pelvic organ prolaps and the muscel strenght of the pelvic floor muscle. Besides, a gerneral development of pelvic floor function and sexual function in primiparous women after delivery. ; ; Clinical examination with speculum to show a possible pelvic organ prolapse with the help of the POP Q score as well as palpation of the pelvic floor muscle with the help of the Oxford score 6 and 12 months after delivery. INCLUSION CRITERIA: Primiparous women; singleton pregnancy; knowledge of German.

Drks (2021). "Removal of fibromata pendulantia: scissor excision vs. 532 nm-laser." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention 1: excision by scissors We will use both treatment methods on each subject. We will always start with the left side of the body (neck or armpits). The randomised allocation of which procedure we will start with which subject will be done with a computer‐based app called a "random number generator". We will carry out this draw anew for each study participant, so that the persons carrying out the treatment cannot influence which procedure we treat first. Intervention 2: Non‐ablative 532‐nm LBO‐laser CONDITION: D23.9 ‐ Benign neoplasm: Skin, unspecified PRIMARY OUTCOME: Hypothesis: Treatment by the 532 nm LBO laser shows the highest acceptance among the subjects ("Which procedure would you prefer if you were treated again?"). SECONDARY OUTCOME: 1. The treatment with scissors is more painful than the treatment with the LBO laser.; ; 2. The subjects find it an advantage that there is no bleeding with laser therapy and no bandages are needed. ; ; 3. The laser therapy causes less pigment displacement and scars. The cosmetic result is objectively better after 3 months. INCLUSION CRITERIA: 1. The clinical diagnosis is clearly fibromata pendulantia. 2. The patient is at least 18 years old. 3. The patient should be under sixty so that no high‐risk patients have to be called into the doctor's office in times of the COVID‐19 pandemic. 4. The patient is able to understand and sign the patient information sheet and informed consent form. 5. The patient is able to follow all study instructions and attend all study appointments. 6. The patient is not pregnant and does not breastfeed. 7. The patient is in good general health and is free from disease or physical complaints, e.g. other skin diseases, which, in the opinion of the investigator, might interfere with the evaluation of a target lesion or would expose the subject to unacceptable risk by participating in the study.

Drks (2021). "What is the benefit of biofeedback training of the pelvic floor with ACTICORE1® for urinary incontinence?" International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention 1: Biofeedback training with the ACTICORE1 6 minutes a day after inclusion in the study Intervention 2: Biofeedback training with the ACTICORE1 6 minutes a day for 12 weeks after inclusion in the study CONDITION: N39.3 ‐ Stress incontinence N39.4 ‐ Other specified urinary incontinence PRIMARY OUTCOME: ICIQ‐Score 12 weeks after study enrollment SECONDARY OUTCOME: Quality of life according to the EQ‐5D‐3L questionnaire 4 weeks after enrollment; ; Feeling of prolapse 4 weeks after inclusion in the study; ; Impairment of sexuality due to incontinence (VAS) 4 weeks after inclusion in the study; ; Wearing a diaper (yes / no) 4 weeks after enrollment; ; Quality of life according to the EQ‐5D‐3L questionnaire 8 weeks after inclusion in the study; ; Feeling of prolapse 8 weeks after inclusion in the study; ; Impairment of sexuality by the Incontinence (VAS) 8 weeks after Study inclusion; ; Wearing a diaper (yes / no) 8 weeks after enrollment in the course; ; Quality of life according to the EQ‐5D‐3L questionnaire 12 weeks after inclusion in the study; ; Feeling of prolapse 12 weeks after inclusion in the study; ; Impairment of sexuality due to incontinence (VAS) 12 weeks after inclusion in the study; ; Wearing a diaper (yes / no) 12 weeks after enrollment; ; ICIQ‐Score 365 days after study enrollment; ; Quality of life according to the EQ‐5D‐3L questionnaire 365 days after inclusion in the study; ; Feeling of prolapse 365 days after inclusion in the study; ; Impairment of sexuality due to incontinence (VAS) 365 days after inclusion in the study; ; Wearing a diaper (yes / no) 365 days after enrollment INCLUSION CRITERIA: All urinary incontinent patients with subjective impairment and an ICIQ score of greater than or equal to 5 ‐ Vulnerable individuals are also included: Patients with mental illnesses, People with illnesses or disabilities that impair their ability to understand and / or significantly impair their ability to cope with everyday life; pregnant women, patients under 18 years of age (2‐11, 12‐17) and> 65 years of age signed informed consent

Drks (2022). "Evaluation of an app-based self-help training (PandaMom Plus) for the prevention of peripartum mood disorders in women at risk." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention 1: PandaMom Plus: PandaMom Plus is a guided, internet‐based self‐help training offered during the last trimester of pregnancy (> 30th week of pregnancy) and in the first weeks postpartum. The program consists of 12 sessions with the recommendation to use one session per week. Intervention 2: Meine Entspannung (ME): ME is an internet‐based self‐help training focussing on relaxation. CONDITION: Peripartum depression and anxiety PRIMARY OUTCOME: Depression and anxiety scores (EPDS, DASS‐P, Mini‐DIPS) SECONDARY OUTCOME: Program acceptance, adherence INCLUSION CRITERIA: ‐ pregnancy (> 30th week of pregnancy) ‐ EPDS score = 10 (Edinburgh Postnatal Depression Scale; Co Xet al., 1987; German version: Bergant et al., 1998)

Drks (2022). "ViSu - Virtual Reality and Sound Intervention under Chemotherapy." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention 1: active intervention with VR mindfulness practice of gynecologic and senologic oncology patients while their chemotherapy (ca. 20 minutes each for two cheomtherapy sessions) Intervention 2: receptive music intervention of gynecologic and senologic oncology patients while their chemotherapy (ca. 20 minutes each for two cheomtherapy sessions) Intervention 3: standard care of gynecologic and senologic oncology patients while their chemotherapy (control group) CONDITION: Anxiety, cancer‐related fear of progression C50 ‐ Malignant neoplasm of breast C51 ‐ Malignant neoplasm of vulva C52 ‐ Malignant neoplasm of vagina C53 ‐ Malignant neoplasm of cervi Xuteri C54 ‐ Malignant neoplasm of corpus uteri C55 ‐ Malignant neoplasm of uterus, part unspecified C56 ‐ Malignant neoplasm of ovary C57 ‐ Malignant neoplasm of other and unspecified female genital organs C58 ‐ Malignant neoplasm of placenta PRIMARY OUTCOME: STAI‐State (Staite‐Trait‐Anxiety Questionnaire, Spielberger et al., 1970), before and after intervention SECONDARY OUTCOME: Physiological sympathetic stress response (heart rate/pulse via pulse oximeter in beats per minutes), HPA axis activity (salivary cortisol), progression anxiety (PA‐F‐KF; Mehnert et al., 2006), symptom distress (MIDOS‐2; Stiel et al., 2010), anxiety via visual analog scale (0=not at all anxious to 100=maximally anxious), satisfaction (0=not at all satisfied to 100=maximally satisfied), self‐efficacy expectancy via General Self‐Efficacy Short Scale (ASKU; Beierlein et al., 2014), STAI‐Trait (Grimm, 2009), Demographic & disease‐related data (adapted from PO Bado, Herschbach et al., 2008), Experiences with mindfulness and music, Usability assessment (7 items from the PSSUQ, Lewis, 1995 & self‐created items). INCLUSION CRITERIA: Presence of a confirmed senological and/or gynecological cancer diagnosis Intravenous chemotherapy with an application duration incl. irrigation of at least 60 minutes At least the second chemotherapy session at the time of the intervention Legal capacity Minimum age = 18 years Sufficient knowledge of the German language

Drks (2023). "Adhesion prevention with 4DryField® PH in hysteroscopic surgery." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group 1: Adhesion prevention is performed using 4DryField® PH. The investigational device 4DryField® PH will be applied surgically invasive. The application will be carried out at the end of the intervention. For this purpose, 3 g 4DryField® PH powder will be mixed with 24 ml sterile saline solution, until a uniform gel has been created. Gel will be inserted until the uterine cavity is filled, 24 ml are not necessarily required. Group 2: Untreated control group CONDITION: ; D25 ; N85.6 ; Q51.9 Congenital malformation of uterus and cervix, unspecified Intrauterine synechiae Leiomyoma of uterus N85.6 Q51.9 PRIMARY OUTCOME: The primary endpoint is the adhesion score at second look hysteroscopy. For this purpose, the establish classification system for intrauterine adhesions published by the American Fertility Society (AFS) will be used. SECONDARY OUTCOME: ‐ Individual evaluation of subcategories of primary endpoint ; ‐ Pregnancy rate (in the subgroup of patients wishing to conceive) ; ‐ Frequency of re‐interventions for adhesiolysis ; ‐ Dysmenorrhea ; ‐ If and when normal cycle reoccurs ; ‐ Rate of complications INCLUSION CRITERIA: 1. Hysteroscopic surgery for treatment of intrauterine lesions (septa, myoma, adhesions) with second look hysteroscopy 2. Written consent to participate in the study

Drks (2023). "Hilotherapy for prevention of chemotherapy-induced peripheral polyneuropathy - A unicentric, prospective-controlled, randomized clinical trial for comparison of local hilotherapy vs. no therapy to prevent peripheral polyneuropathy during Taxan-based chemotherapy regimen." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group 1: no hilotherapy of hands and feet Group 2: hilotherapy of hands and feet CONDITION: ; G62.0 ; C50.9 ; C54 ; C56 ; C53 Breast, unspecified C50.9 Drug‐induced polyneuropathy G62.0 Malignant neoplasm of cervi Xuteri Malignant neoplasm of corpus uteri Malignant neoplasm of ovary PRIMARY OUTCOME: The primary endpoint of this study is the comparison of the incidence of a peripheral polyneuropathy (clinical Total Neuropathy Score cTNS = 11) in patients with gynecologic malignoma that are undergoing Taxan‐based chemotherapy regimen with or without a preventive hilotherapy of hands and feet.; Study visits will take place at the beginning, in the middle and at the end of the planned chemotherapy regimen.; Additionally, two follow‐up visits will take place six months and twelve months after the end of chemotherapy. SECONDARY OUTCOME: * Subjective extent of CIPN as measured with the EORTC QLQ‐CIPN20 questionnaire. ; * Changes in the result of electrophysical examinations before and after chemotherapy. ; * Acceptance of hilotherapy measured as the amount of patinets that have to stop local cold application during a session (> 5 miutes) or terminate earlier ir stop the treament completely for the rest of chemotherapy. ; * Adverse effects of hilotherapy documented as any adverse event. ; * Tolerance of chemotherapy measured as the proportion of patient with dose reduction or premature end of chemotherapy. ; * Quality of Life of patients measured with the EORTC QLQ‐C30 questionnaire ; * Comparison of the time of regression, cTNS score of persisting symptoms and amount of patients without residues after end of chemotherapy and follow‐up between patients with and without preventive hilotherapy. INCLUSION CRITERIA: * Written consent for participation in this trail * Age =18 years * Female * Breast or genital cancer of the woman * Planned application of a Taxan‐based chemotherapy regimen (Paclitaxel, Nac‐Paclitaxel) independent of the therapy line * Taxan‐ and Platin‐naivity * Sufficient knowledge of the German language to assure an adequat survey of patient's history

Drks (2023). "PET-guided Radiosurgery of Oligometastatic Cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group 1: A planning CT with a PET/CT or integrating a PET/MRI is obtained. Patients with 2 to 5 extracranial metastases with or without 1 to 3 cerebral metastases are treated with a single fraction per lesion of radiotherapy on 1 to 3 working days with 20 to 24 Gy. Systemic chemotherapy starts within three weeks after the end of radiotherapy according to guidelines. Group 2: A planning CT with a PET/CT or integrating a PET/MRI is obtained. Patients with 2 to 5 extracranial metastases with or without 1 to 3 cerebral metastasis are treated with three fractions of 10 to 14 Gy per lesion within a maximum of eight working days. The mean dose to the GTV should exceed 100 BED. Systemic chemotherapy starts within 2 weeks after the end of radiotherapy according to guidelines. CONDITION: Oligometastasis wth two to five extracranial and not more than three ZNS lesions PRIMARY OUTCOME: progression‐free survival SECONDARY OUTCOME: overall survival ; time to retreatment INCLUSION CRITERIA: ICD‐10: C00‐25, C30‐34(NSCLC only), C37, C39, C44‐45, C48, C50 (hormone‐resistant only), C51‐58, C60‐61 (castration‐resistant only), C63‐69, C73‐74, and C80 oligometastatic disease with =5 extracranial lesions and =3 intrecebral lesions wihtout presious treatment, after relapse after complete remission or partial remission patient qualifies for cytotoxic systemic therapy normal blood counts (Hb>8g/dl, ANC>1500/mm³, thrombocytes >100 000/mm³) normal liver function tests (ASAT/ALAT/AP=2.5*ULN), if liver metastatic and to be treated: <5*ULN Bilirubin <1,5*ULN Creatinin clearance (Cockroft‐Gault) > 50 ml/min ability to understand research protocol and willing to comply with reassessments and follow‐ups consent to have the patient’s case re‐discussed in interdisciplinary tumor boards. negative pregnancy test for female patients aged <50 yrs. if sexually active, ability to use pregnancy prevention methods until 12 months after endin

Drost Larissa, E., et al. (2023). "A web-based decision aid for shared decision making in pelvic organ prolapse: the SHADE-POP trial." International Urogynecology Journal 34(1): 79-86.
	Introduction and Hypothesis: Among women worldwide, pelvic organ prolapse (POP) is a common problem. There are three different treatment options for POP: pelvic floor muscle therapy, pessary treatment and prolapse surgery. As none of the three treatment options is clearly superior, shared decision making (SDM) is very important. A decision aid (DA) is known to facilitate patient participation and SDM. We hypothesise that the use of a web-based DA for POP increases patients' satisfaction with information and care and reduces decisional conflict.; Methods: This two-arm, multicentre, cluster randomised controlled trial was performed in women with POP in five different Dutch hospitals. The control group received usual care (UC) and the intervention group received the DA in addition to UC. Primary outcome measures were satisfaction with treatment decision making and satisfaction with information. Analyses were performed using independent sample t tests, Chi-squared tests, and multilevel linear regression analyses.; Results: Between the DA group (n=40) and the UC group (n=56) no differences were found concerning patients' satisfaction with information, with scores of 45.63 and 46.14 out of 50 respectively (p=0.67). Also, no differences were found concerning the perceived role in decision making, as patients scored 46.83 in the DA group and 46.41 in the UC group, out of a maximum of 54 (n=0.81).; Conclusions: No differences were found concerning patients' satisfaction with information and treatment decision making between the DA and UC. However, both groups scored high on the questionnaires, which suggests that the decision process is already of high quality. (© 2022. The Author(s).)

Du, H. L., et al. (2021). "Meta-analysis of Kushen Gel combined with antifungal drugs in treatment of vulvovaginal candidiasis." Chinese Traditional and Herbal Drugs 52(16): 4973-4985.
	Objective: To systematically evaluate the clinical efficacy and safety of Kushen Gel () combined with antifungal drug in the treatment of vulvovaginal candidiasis (VVC). Method(s): The PubMed, Web of Science, Embase, Cochrane Library, Chinese Journal Full-text Database (CNKI), Chinese Biomedical Literature Database (CBM), VIP, Wanfang Database were electronically searched to collect randomized controlled trials (RCTs) on Kushen Gel combined with antifungal drug in the treatment of VVC. The retrieval time was from database establishment to May 31, 2021. The literatures, extracting data, the quality of the included studies were screened and evaluated based on Cochrane's systematic evaluation principles. RevMan 5.3 software was used for Meta-analysis. Result(s): A total of 34 RCTs involving 3272 subjects were included. Meta-analysis results showed that in the patients with VVC, compared with antifungal drug alone, combination of Kushen Gel with antifungal drug can significantly increase the negative conversion rate of Candida [RR=1.20, 95% CI (1.17, 1.24), P < 0.000 01], reduce the recurrence rate of VVC [RR=0.25, 95% CI (0.17, 0.35), P < 0.000 01]. In additon, combination with Kushen Gel is superior to monotherapy with antifungal drug in improving vaginal itching [MD=-3.34, 95% CI (-3.54, -3.15), P < 0.000 01], vaginal pain [MD=-2.66, 95% CI (-3.16, -2.17), P < 0.000 01], abnormal leucorrhea [MD=-2.87, 95% CI (-3.13, -2.67), P < 0.000 01], and vaginal mucosal hyperemia [MD=-3.60, 95% CI (-4.02, -3.18), P < 0.000 01] symptoms. Otherwise, no statistically significant difference in adverse reactions rate were found between the two groups [RR=0.86, 95% CI (0.29, 2.49), P=0.78]. Conclusion(s): In the patients of VVC, Kushen Gel combined with antifungal drug can effectively increase the negative conversion rate of pathogenic bacteria, reduce the recurrence rate, and accelerate the relief of clinical symptoms, which is superior to that of antifungal drug alone. And the combination regimen is safe in clinical application.Copyright © 2021, Editorial Office of Chinese Traditional and Herbal Drugs. All right reserved.

Du, J., et al. (2020). "The effect of icariin for infertile women with thin endometrium: A protocol for systematic review." Medicine 99(12): e19111.
	Background: Thin endometrium, defined as <7 mm of the endometrial thickness around ovulation period, had been identified as a negative factor on pregnancy rate of infertile women. It was considered to be the toughest part in treatment of infertility, because there was a lack of significant effect, although many drugs had been already used. Icariin was one of the major bioactive pharmaceutical constituent extracted from the Chinese herb "Ying Yang Huo," in the genus of Epimedium, and some randomized controlled trials reported its application for thin endometrium. There is no systematic review focusing on the effective of icariin in treating infertile women with thin endometrium, so our review aims to explore it.; Methods: The bibliographic database and electronic library will be systematically searched online, such as MEDLINE, EMBASE, Web of Science, Clinicaltrails.org., China National Knowledge Infrastructure Database (CNKI), Wan fang Database, China Biology Medicine Database (CBM), VIP Science Technology Periodical Database, and Cochrane Library. And the reference listed for potential literatures of included studies will be scanned additionally. Related randomized controlled trials (RCTs) will be collected and selected before January 4, 2020. Trials will be screened by independent reviewers, and the literature will be search in English or Chinese, with the search terms as "Icariin," "Epimedium," "infertile women," "female infertility," "endometrium," "pregnancy rate." The software for Systematic review and Meta-analysis is RevMan 5.3. The protocol and the systematic review will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement.; Result and Conclusion: The efficacy of icariin to treat thin endometrium will be evaluated, and the conclusion will be published to help clinicians determine treatment strategy for infertile women with thin endometirum by providing medical evidence.; Registration Information: PROSPERO CRD42019148977.

Du, J., et al. (2020). "Efficacy and safety of platelet-rich plasma for the treatment of thin endometrium: A protocol for systematic review and meta-analysis." Medicine 99(3): e18848.
	Background: Endometrial thickness has been identified as a prognostic factor for pregnancy rate for patients with female infertility. Thin endometrium is defined as <7 mm on the day of ovulation, or on the day of human chorionic gonadotrophin (HCG) injection in fresh in vitro fertilization (IVF) cycles, or the day to start progesterone in frozen-thaw embryo transfer cycles, as stated in the guideline of thin endometrium from the Canadin Fertility and Andrology Society and Chinese expert consensus from the Society of Reproductive Medicine, Chinese Medical Association. Many medicines are used for improving the endometrial thickness and embryo implantation rate of the patients with thin endometirum, but thin endometrium remains a major troublesome clinical problem with limited efficacy.Platelet-rich plasma (PRP), as a growing and robust therapeutic option in musculoskeletal medicine, is a preparation of autologous plasma with a high concentration of platelets, and the therapeutic mechanism is based on the capacity to supply supra physiologic amounts of essential growth factors to provide a regenerative stimulus for promoting repair in tissues with low healing potential. Some randomized controlled trials have reported the application of PRP for patients with thin endometrium with satisfactory effect. However, there is no systematic review on efficacy and safety of PRP as a treatment of thin endometrium.; Methods: The data and information will be retrieved from the databases of MEDLINE, Embase, Web of Science, Clinicaltrials.org., Cochrane Library, China Biology Medicine Database, Wan Fang Database, China National Knowledge Infrastructure Database, VIP Science Technology Periodical Database, and OpenGrey for gray literature. The randomized controlled clinical trials are going to be selected before December 20, 2019, in English or Chinese language, with the search terms including "thin endometrium,""platelet-rich plasma," "endometrial thickness," "hemorheology of endometrium," "pregnancy rate," and "adverse reactions." RevMan 5.3 will be used for systematic review and meta-analysis. This protocol will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement, and the systematic review will be reported with the PRISMA statement.; Results and Conclusion: The efficacy and safety of PRP for the treatment of thin endometrium will be evaluated, and the conclusion will be published to provide medical evidence for a better clinical decision of patients with thin endometirum.

Du, S., et al. (2023). "Systematic review and meta-analysis of moxibustion on urinary incontinence among women." World Journal of Acupuncture - Moxibustion 33(4): 314-324.
	Background: Urinary incontinence (UI) is a common condition that bothers women's lives, including stress urinary incontinence (SUI), urgency urinary incontinence (UUI) and mixed urinary incontinence (MUI). The current non-surgical treatment of Western medicine includes pelvic floor muscle training (PFMT), medication, electric stimulation, etc., all of which have varied limitations. For instance, the patients are poor in compliance with PFMT and medication results in frequent adverse effects. Being one of the featured treatments of TCM, moxibustion has several merits including safety, low cost and simple operation. In recent years, the clinical evidences prove increasingly that moxibustion may be effective for women with UI. However, there is no high-quality systematic review of moxibustion for this disease. Objective(s): To evaluate the effect and safety of moxibustion on UI (including SUI, UUI and MUI) among women. Method(s): From the inception to October 13, 2022, the data of the randomized controlled trials (RCTs) of moxibustion on UI among women were collected from CNKI, WanFang Data, VIP, SinoMed, Web of Science, Pubmed, EMBASE and Cochrane Library databases. Two investigators screened the articles independently and extracted the data according to the inclusion and exclusion criteria developed in advance. Using the risk of bias assessment tool of Cochrane Handbook, the included RCTs were evaluated. With RevMan 5.3 software, meta-analysis was performed, and the GRADE tool was adopted to assess evidence certainty of different outcomes. Result(s): A total of 1176 articles were retrieved and 19 of them with 1397 patients were eligible and included in the review. In experimental groups, moxibustion combined with PFMT was used, while in control groups PFMT was applied alone. And the subjects were all women with SUI. Meta-analysis showed that compared with PFMT alone, moxibustion combined with PFMT reduced the urine leakage volume (1-hour pad test) (MD = -1.95g, 95%CI [-2.32, -1.57], P < 0.001), the frequency of UI in 24-hour (MD = -0.64, 95%CI [-0.88, -0.40], P < 0.001) and the score of the short form of International Consultation on Incontinence Questionnaire (ICIQ-SF) of women with SUI (MD = -2.53, 95%CI [-3.43, -1.63], P < 0.001); and this combined intervention measure did not increase significantly the adverse events (RR = 0.82, 95%CI [0.15, 4.6], P = 0.82). GRADE assessment showed that the UI frequency in 24-hour and the incidence of adverse events were rated as low quality, the urine leakage volume of 1-hour pad test and ICIQ-SF score were very low quality. Conclusion(s): Compared with PFMT alone, the intervention combined with moxibustion greatly reduced the urine leakage volume and UI frequency and improved the quality of life (QoL) among women with SUI with favorable safety. Moxibustion could be effective supplementary therapy on SUI among women. However, due to the high risk of bias of the included trials and low certainty of evidence, more high-quality clinical studies are needed to verify the above findings. Registration: Registered on PROSPERO: CRD42022297643.Copyright © 2023

Du, X., et al. (2024). "Clinical Study of Deep Hyperthermia Combined with Computational Medicine of Platinum Chemotherapy in the Treatment of Ovarian Cancer." Alternative Therapies in Health and Medicine.
	Objective: Deep hyperthermia combined with platinum-based chemotherapy (DHCT) might lead to the development of better therapeutic strategy for patients with malignant tumor. This study aimed to analyze the computational medical differences in ovarian cancer patients treated with DHCT compared with platinum-based chemotherapy alone. Method(s): 78 patients with advanced ovarian cancer admitted from November 2017 to November 2021 were randomly selected as subjects. Overall survival analysis and CA125 clinical efficiency evaluation were performed to explore the effect of DHCT on cis-platinum therapy. All patients were informed and consented, and approved by the hospital committee. The data were systematically analyzed by chi-squared test to analyze clinical effect and safety observation, and the Kaplan-Meier method and log-rank test were used for survival analysis. Result(s): Survival analysis showed that DHCT was strongly associated with improved overall survival (OS) in the platinum treatment of ovarian cancer patients (Hazard Ratio = 1.57, 95% CI: 0.93-2.44, P = .017). For ovarian cancer patients receiving lobaplatin treatment, DHCT could also elevate their survival (Hazard Ratio = 1.52, 95% CI :1.02-2.25, P = .013). The study also showed a statistically significant difference in clinical outcomes between the two groups (P < .001), and the opposite is true for adverse reactions. Conclusion(s): Our results suggest that DHCT is expected to be combined with platinum chemotherapy, which is helpful for the molecular classification of ovarian cancer patients. More studies are needed to further verified the clinical significance.

Duan, X., et al. (2021). "Effect of metformin on adiponectin in PCOS: A meta-analysis and a systematic review." European Journal of Obstetrics, Gynecology, and Reproductive Biology 267: 61-67.
	Background: Conflicting results have been reported regarding the effect of metformin on adiponectin levels in women with polycystic ovary syndrome (PCOS). This meta-analysis reviewed all studies comparing adiponectin levels before and after metformin treatment in PCOS women. Additionally, changes in other indicators, including long-term complications associated with PCOS, such as inflammatory, metabolism factors and hormonal profile, were investigated following metformin treatment. We conducted subgroup analysis based on body mass index (BMI) stratification and appropriate pooling.; Methods: We searched literature in PUBMED, EMBASE, the Cochrane Library, and CNKI databases. The main meta-analysis included 11 studies containing data on 353 subjects.; Results: Metformin treatment was associated with significantly increased serum adiponectin concentrations [10 studies, random-effects SMD (95% CI) -0.58 [-1.03, -0.13]; I 2 = 86%; P = 0.01]. Additionally, the meta-analysis revealed that circulating tumor necrosis factor-α(TNF-α) and C-reactive protein (CRP) concentrations were significantly decreased after metformin treatment, with corresponding SMDs of 1.01 (95% CI: 0.74-1.28, P＜0.00001) and 0.48(95% CI: 0.35-0.60, P＜0.00001).; Conclusion: Following metformin administration, serum adiponectin concentrations of PCOS women were found to be significantly increased, accompanied by a significant improvement in other indicators. Further investigation with a larger sample size should be conducted to validate optimal dose and duration of metformin.; Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2021 Elsevier B.V. All rights reserved.)

Duarte Pablo, R., et al. (2022). "Quality of life analysis measured with the Cervantes 16 scale in treated menopausal women with genitourinary syndrome." Journal of comparative effectiveness research 11(18): 1365-1374.
	Aim : To assess the quality of life of menopausal women with genitourinary syndrome receiving local drugs (prasterone, estriol or promestriene). Methods : Prospective, longitudinal, randomized study in which quality of life was assessed using the 16-item Cervantes scale (EC16) before and after treatment. Results : A total of 45 women were assessed (35.6% received prasterone, 33.3% estriol and 31.1% promestriene). After treatment, statistically significant mean score differences were observed in EC16, mainly with prasterone. Improvement in EC16 score only shows a statistically significant relationship with age and drug use. Conclusion : The EC16 is an affordable and quick-to-apply tool that allows physicians and patients to know patients' self-perceived quality of life. Local treatment has been shown to improve the quality of life of menopausal patients with genitourinary syndrome.

Dube, R. and S. Kar Subhranshu (2022). "Genital Microbiota and Outcome of Assisted Reproductive Treatment-A Systematic Review." Life (Basel, Switzerland) 12(11).
	The balance between different bacterial species is essential for optimal vaginal health. Microbiome includes the host genome along with microorganism genomes and incorporates the biotic and abiotic factors, reflecting the habitat as a whole. A significant difference exists in the composition and number of the human microbiota in healthy individuals. About one-tenth of the total body microbiota exists in the urogenital tract and these can be identified by microscopy and culture-based methods, quantitative PCR, next generation and whole genome sequencing. The trend of delaying the planning of pregnancy to a later age nowadays has resulted in magnifying the use of assisted reproductive treatment (ART). Hence, genital microbiota and its impact on fertility has generated immense interest in recent years. In this systematic review, we searched the available evidence on the microbiota of the genital tract in women undergoing ART and studied the outcomes of IVF in different microbial compositions. Despite the inconsistency of the studies, it is evident that vaginal, cervical and endometrial microbiota might play a role in predicting ART outcomes. However, there is no clear evidence yet on whether the diversity, richness, quantity, or composition of species in the maternal genital tract significantly affects the outcomes in ARTs.

Dubinskaya, A., et al. (2023). "Is it time for doctors to Rx vibrators? A systematic review of pelvic floor outcomes." Sexual Medicine Reviews 11(1): 15-22.
	Introduction: Vibrators and similar devices are an underutilized treatment modality in pelvic and sexual medicine, likely because of the limited knowledge on the health benefits of their use. Objective(s): The aim of this study was to review available data regarding the effect of vibrator use on sexual function, pelvic floor function, and chronic unexplained vulvar pain. Method(s): We performed a systematic literature review of PubMed, Embase, and MEDLINE from inception to March 2021 per the PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-analyses). The search was based on the following sex toy woman, pelvic vibrator, sexual stimulation vibrator, vaginal vibrator, vibrator pelvic floor, vibrator incontinence, and vulvar pain vibrator. An overall 586 articles were identified. Studies that met inclusion criteria were reviewed: original research, sample of women, vibrator use, and application to the pelvic/genital area. Exclusion criteria included case reports, unrelated content, vibrator not applied to the pelvic/genital area, male participants, or conditions of interest not addressed. A total of 17 original studies met the criteria and were reviewed in depth. Result(s): After review of the literature and identification of articles appropriate for the study, there were 8 studies surrounding sexual function, 8 on pelvic floor function (muscle strength/urinary incontinence), and 1 on vulvar pain. Among the identified studies, vibrators were considered an accepted modality to enhance a woman's sexual experience, improve pelvic floor muscle function, and facilitate treatment of vulvar pain. Conclusion(s): Vibrators are not well studied, and given the promising benefits demonstrated in the articles identified, future research efforts should be directed toward investigating their utility. Considering the potential pelvic health benefits of vibrators, their recommendation to women could be included in our pelvic floor disorder treatment armamentarium.Copyright © The Author(s) 2023.

Dubol, M., et al. (2020). "Neuroimaging premenstrual dysphoric disorder: A systematic and critical review." Frontiers in Neuroendocrinology 57: 100838.
	Endocrine organizational and activational influences on cognitive and affective circuits are likely critical to the development of premenstrual dysphoric disorder (PMDD), a sex-specific hormone-dependent mood disorder. An overview of the anatomical and functional neural characterization of this disorder is presented here by means of neuroimaging correlates, identified from eighteen publications (n = 361 subjects). While white matter integrity remains uninvestigated, greater cerebellar grey matter volume and metabolism were observed in patients with PMDD, along with altered serotonergic and GABAergic neurotransmission. Differential corticolimbic activation in response to emotional stimuli distinguishes the PMDD brain, namely enhanced amygdalar and diminished fronto-cortical function. Thus far, the emotional distress and dysregulation linked to PMDD seem to be defined by structural, chemical and functional brain signatures; however, their characterization remains sparsely studied and somewhat inconsistent. Clear and well-replicated neurobiological features of PMDD are needed to promote timely diagnoses and inform development of prevention and treatment strategies. (Copyright © 2020 Elsevier Inc. All rights reserved.)

Dubol, M., et al. (2021). "Neuroimaging the menstrual cycle: A multimodal systematic review." Frontiers in Neuroendocrinology 60.
	Increasing evidence indicates that ovarian hormones affect brain structure, chemistry and function of women in their reproductive age, potentially shaping their behavior and mental health. Throughout the reproductive years, estrogens and progesterone levels fluctuate across the menstrual cycle and can modulate neural circuits involved in affective and cognitive processes. Here, we review seventy-seven neuroimaging studies and provide a comprehensive and data-driven evaluation of the accumulating evidence on brain plasticity associated with endogenous ovarian hormone fluctuations in naturally cycling women (n = 1304). The results particularly suggest modulatory effects of ovarian hormones fluctuations on the reactivity and structure of cortico-limbic brain regions. These findings highlight the importance of performing multimodal neuroimaging studies on neural correlates of systematic ovarian hormone fluctuations in naturally cycling women based on careful menstrual cycle staging. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

DuBose, L. E., et al. (2022). "Role of BH4 Deficiency as a Mediator of Oxidative Stress-Related Endothelial Dysfunction in Menopausal Women." American journal of physiology. Heart and circulatory physiology 323(5): H975‐H982.
	Endothelial function (brachial artery flow‐mediated dilation [FMD]) is reduced in estrogen‐deficient postmenopausal women, mediated, in part, by reduced nitric oxide (NO) bioavailability, secondary to tetrahydrobiopterin (BH4) deficiency and oxidative stress. FMD is increased, but not fully restored, in postmenopausal women after acute intravenous vitamin C (VITC; superoxide scavenger) or oral BH4 supplementation. In vitro studies demonstrate that coadministration of VITC with BH4 prevents endothelial nitric oxide synthase (eNOS) uncoupling and reductions in NO by peroxynitrite. To investigate mechanisms of endothelial dysfunction in women, we assessed the separate and combined effects of VITC and BH4 to determine whether coadministration of VITC + BH4 improves FMD in healthy postmenopausal women (n = 19, 58 ± 5 yr) to premenopausal (n = 14, 36 ± 9 yr) levels, with exploratory testing in perimenopausal women (n = 8, 51 ± 3 yr). FMD was measured during acute intravenous infusions of saline (control) and VITC (∼2‐3 g) ∼3 h after a single dose of oral BH4 (KUVAN, 10 mg/kg body wt) or placebo (randomized crossover, separated by ∼1 mo). Under the placebo condition, FMD was reduced in postmenopausal compared with premenopausal women during the saline infusion (5.6 ± 0.7 vs. 11.6 ± 0.9%, P < 0.001) and increased in postmenopausal women during VITC (+3.5 [1.4, 5.6]%, P = 0.001) and acute BH4 (+1.8 [0.37, 3.2]%, P = 0.01) alone. Coadministration of VITC + BH4 increased FMD in postmenopausal women (+3.0 [1.7, 4.3]%, P < 0.001), but FMD remained reduced compared with premenopausal women (P = 0.02). Exploratory analyses revealed that VITC + BH4 did not restore FMD in perimenopausal women to premenopausal levels (P = 0.045). Coadministration of VITC + BH4 does not restore FMD in menopausal women, suggesting that additional mechanisms may be involved.NEW & NOTEWORTHY Endothelial function is reduced across the menopausal stages related to increased oxidative stress associated with estrogen deficiency. In vitro studies demonstrate that coadministration of VITC with BH4 prevents endothelial nitric oxide synthase (eNOS) uncoupling and reductions in NO by peroxynitrite; however, this remains untested in humans. We demonstrate that the coadministration of BH4 + VITC does not restore endothelial function in perimenopausal and postmenopausal women to the level of premenopausal women, suggesting that other mechanisms contribute.

Duenas-Gonzalez, A. and A. Gonzalez-Fierro (2019). "Pharmacodynamics of current and emerging treatments for cervical cancer." Expert Opinion on Drug Metabolism and Toxicology 15(8): 671-682.
	Introduction: Beyond early stages of cervical cancer (1A1, IA2, IB1, IIA1,), locally advanced disease (IB2, IIA2, IIA2, IIB, IIIA, IIIB, IIIC, IVA) and advanced (metastatic, recurrent or persistent disease) patients require drug therapy either as radiosensitizer, adjuvant or as palliative systemic chemotherapy. Areas covered: This review briefly discusses the achievements in treating cervical cancer. Expert opinion: Two studies are ongoing to optimize treatment after radical hysterectomy. These studies compare chemoradiation versus radiation in intermediate-risk patients or increasing treatment intensity (chemoradiation plus adjuvant chemotherapy versus chemoradiation) for high-risk and locally advanced cervical cancer. Concerning advanced disease, bevacizumab increased median survival for only 3.5 months when added to a cisplatin-doublet. Although this increase is slightly superior to the 2.9 months gained with cisplatin topotecan versus cisplatin, (0.6 months of difference), the doublet plus bevacizumab is considered the standard of care. Recently, pembrolizumab became an alternative for advanced disease that progresses to first-line treatment. Beyond that, the number of phase II and phase III trials in advanced disease is limited but on the increase. HPV E6/E7 oncoproteins are the Achilles Heel of cervical cancer, and there is cautious optimism that antagonists of these oncoproteins will be further developed.Copyright © 2019, © 2019 Informa UK Limited, trading as Taylor & Francis Group.

Duffy, J., et al. (2020). "A core outcome set for future endometriosis research: an international consensus development study." BJOG : an international journal of obstetrics and gynaecology 127(8): 967-974.
	Objective: To develop a core outcome set for endometriosis.; Design: Consensus development study.; Setting: International.; Population: One hundred and sixteen healthcare professionals, 31 researchers and 206 patient representatives.; Methods: Modified Delphi method and modified nominal group technique.; Results: The final core outcome set includes three core outcomes for trials evaluating potential treatments for pain and other symptoms associated with endometriosis: overall pain; improvement in the most troublesome symptom; and quality of life. In addition, eight core outcomes for trials evaluating potential treatments for infertility associated with endometriosis were identified: viable intrauterine pregnancy confirmed by ultrasound; pregnancy loss, including ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy; live birth; time to pregnancy leading to live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital abnormalities. Two core outcomes applicable to all trials were also identified: adverse events and patient satisfaction with treatment.; Conclusions: Using robust consensus science methods, healthcare professionals, researchers and women with endometriosis have developed a core outcome set to standardise outcome selection, collection and reporting across future randomised controlled trials and systematic reviews evaluating potential treatments for endometriosis. TWEETABLE ABSTRACT: @coreoutcomes for future #endometriosis research have been developed @jamesmnduffy. (© 2020 Royal College of Obstetricians and Gynaecologists.)

Duffy James, M. N., et al. (2019). "Tackling poorly selected, collected, and reported outcomes in obstetrics and gynecology research." American Journal of Obstetrics and Gynecology 220(1): 71.e71-71.e74.
	Clinical research should ultimately improve patient care. To enable this, randomized controlled trials must select, collect, and report outcomes that are both relevant to clinical practice and genuinely reflect the perspectives of key stakeholders including health care professionals, researchers, and patients. Unfortunately, many randomized controlled trials fall short of this requirement. Complex issues, including a failure to take into account the perspectives of key stakeholders when selecting outcomes, variations in outcome definitions and measurement instruments, and outcome reporting bias make research evidence difficult to interpret, undermining the translation of research into clinical practice. Problems with poor outcome selection, measurement, and reporting can be addressed by developing, disseminating, and implementing core outcome sets. A core outcome set represents a minimum data set of outcomes developed using robust consensus science methods engaging diverse stakeholders including health care professionals, researchers, and patients. Core outcomes should be routinely utilized by researchers, collected in a standardized manner, and reported consistently in the final publication. They are currently being developed across our specialty including infertility, endometriosis, and preeclampsia. Recognizing poorly selected, collected, and reported outcomes as serious hindrances to progress in our specialty, more than 80 journals including the Journal, have come together to support the Core Outcomes in Women's and Newborn Health (CROWN) initiative. The consortium supports researchers to develop, disseminate, and implement core outcome sets. Implementing core outcome sets could make a profound contribution to addressing poorly selected, collected, and reported outcomes. Implementation should ensure future randomized controlled trials hold the necessary reach and relevance to inform clinical practice, enhance patient care, and improve patient outcomes. (Copyright © 2018 Elsevier Inc. All rights reserved.)

Duffy, J. M. N., et al. (2020). "Top 10 priorities for future infertility research: an international consensus development study† ‡." Human reproduction (Oxford, England) 35(12): 2715-2724.
	Study Question: Can the priorities for future research in infertility be identified?; Summary Answer: The top 10 research priorities for the four areas of male infertility, female and unexplained infertility, medically assisted reproduction and ethics, access and organization of care for people with fertility problems were identified.; What Is Known Already: Many fundamental questions regarding the prevention, management and consequences of infertility remain unanswered. This is a barrier to improving the care received by those people with fertility problems.; Study Design, Size, Duration: Potential research questions were collated from an initial international survey, a systematic review of clinical practice guidelines and Cochrane systematic reviews. A rationalized list of confirmed research uncertainties was prioritized in an interim international survey. Prioritized research uncertainties were discussed during a consensus development meeting. Using a formal consensus development method, the modified nominal group technique, diverse stakeholders identified the top 10 research priorities for each of the categories male infertility, female and unexplained infertility, medically assisted reproduction and ethics, access and organization of care.; Participants/materials, Setting, Methods: Healthcare professionals, people with fertility problems and others (healthcare funders, healthcare providers, healthcare regulators, research funding bodies and researchers) were brought together in an open and transparent process using formal consensus methods advocated by the James Lind Alliance.; Main Results and the Role of Chance: The initial survey was completed by 388 participants from 40 countries, and 423 potential research questions were submitted. Fourteen clinical practice guidelines and 162 Cochrane systematic reviews identified a further 236 potential research questions. A rationalized list of 231 confirmed research uncertainties was entered into an interim prioritization survey completed by 317 respondents from 43 countries. The top 10 research priorities for each of the four categories male infertility, female and unexplained infertility (including age-related infertility, ovarian cysts, uterine cavity abnormalities and tubal factor infertility), medically assisted reproduction (including ovarian stimulation, IUI and IVF) and ethics, access and organization of care were identified during a consensus development meeting involving 41 participants from 11 countries. These research priorities were diverse and seek answers to questions regarding prevention, treatment and the longer-term impact of infertility. They highlight the importance of pursuing research which has often been overlooked, including addressing the emotional and psychological impact of infertility, improving access to fertility treatment, particularly in lower resource settings and securing appropriate regulation. Addressing these priorities will require diverse research methodologies, including laboratory-based science, qualitative and quantitative research and population science.; Limitations, Reasons for Caution: We used consensus development methods, which have inherent limitations, including the representativeness of the participant sample, methodological decisions informed by professional judgment and arbitrary consensus definitions.; Wider Implications of the Findings: We anticipate that identified research priorities, developed to specifically highlight the most pressing clinical needs as perceived by healthcare professionals, people with fertility problems and others, will help research funding organizations and researchers to develop their future research agenda.; Study Funding/competing Interest(s): The study was funded by the Auckland Medical Research Foundation, Catalyst Fund, Royal Society of New Zealand and Maurice and Phyllis Paykel Trust. G.D.A. reports research sponsorship from Abbott, personal fees from Abbott and LabCorp, a financial interest in Advanced Reproductive Care, committee membership of the FIGO Committee on Reproductive Me icine, International Committee for Monitoring Assisted Reproductive Technologies, International Federation of Fertility Societies and World Endometriosis Research Foundation, and research sponsorship of the International Committee for Monitoring Assisted Reproductive Technologies from Abbott and Ferring. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and editor for the Cochrane Gynaecology and Fertility Group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. A.W.H. reports research sponsorship from the Chief Scientist's Office, Ferring, Medical Research Council, National Institute for Health Research and Wellbeing of Women and consultancy fees from AbbVie, Ferring, Nordic Pharma and Roche Diagnostics. M.L.H. reports grants from Merck, grants from Myovant, grants from Bayer, outside the submitted work and ownership in Embrace Fertility, a private fertility company. N.P.J. reports research sponsorship from AbbVie and Myovant Sciences and consultancy fees from Guerbet, Myovant Sciences, Roche Diagnostics and Vifor Pharma. J.M.L.K. reports research sponsorship from Ferring and Theramex. R.S.L. reports consultancy fees from AbbVie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. E.H.Y.N. reports research sponsorship from Merck. C.N. reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring and retains a financial interest in NexHand. J.S. reports being employed by a National Health Service fertility clinic, consultancy fees from Merck for educational events, sponsorship to attend a fertility conference from Ferring and being a clinical subeditor of Human Fertility. A.S. reports consultancy fees from Guerbet. J.W. reports being a statistical editor for the Cochrane Gynaecology and Fertility Group. A.V. reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and the journal Reproduction. His employing institution has received payment from Human Fertilisation and Embryology Authority for his advice on review of research evidence to inform their 'traffic light' system for infertility treatment 'add-ons'. N.L.V. reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the present work. All authors have completed the disclosure form.; Trial Registration Number: N/A. (© The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Duffy, J. M. N., et al. (2021). "Top 10 priorities for future infertility research: an international consensus development study." Fertility and Sterility 115(1): 180-190.
	Study Question: Can the priorities for future research in infertility be identified?; Summary Answer: The top 10 research priorities for the four areas of male infertility, female and unexplained infertility, medically assisted reproduction, and ethics, access, and organization of care for people with fertility problems were identified.; What Is Known Already: Many fundamental questions regarding the prevention, management, and consequences of infertility remain unanswered. This is a barrier to improving the care received by those people with fertility problems.; Study Design, Size, Duration: Potential research questions were collated from an initial international survey, a systematic review of clinical practice guidelines, and Cochrane systematic reviews. A rationalized list of confirmed research uncertainties was prioritized in an interim international survey. Prioritized research uncertainties were discussed during a consensus development meeting. Using a formal consensus development method, the modified nominal group technique, diverse stakeholders identified the top 10 research priorities for each of the categories male infertility, female and unexplained infertility, medically assisted reproduction, and ethics, access, and organization of care.; Participants/materials, Setting, Methods: Healthcare professionals, people with fertility problems, and others (healthcare funders, healthcare providers, healthcare regulators, research funding bodies and researchers) were brought together in an open and transparent process using formal consensus methods advocated by the James Lind Alliance.; Main Results and the Role of Chance: The initial survey was completed by 388 participants from 40 countries, and 423 potential research questions were submitted. Fourteen clinical practice guidelines and 162 Cochrane systematic reviews identified a further 236 potential research questions. A rationalized list of 231 confirmed research uncertainties were entered into an interim prioritization survey completed by 317 respondents from 43 countries. The top 10 research priorities for each of the four categories male infertility, female and unexplained infertility (including age-related infertility, ovarian cysts, uterine cavity abnormalities, and tubal factor infertility), medically assisted reproduction (including ovarian stimulation, IUI, and IVF), and ethics, access, and organization of care, were identified during a consensus development meeting involving 41 participants from 11 countries. These research priorities were diverse and seek answers to questions regarding prevention, treatment, and the longer-term impact of infertility. They highlight the importance of pursuing research which has often been overlooked, including addressing the emotional and psychological impact of infertility, improving access to fertility treatment, particularly in lower resource settings, and securing appropriate regulation. Addressing these priorities will require diverse research methodologies, including laboratory-based science, qualitative and quantitative research, and population science.; Limitations, Reasons for Caution: We used consensus development methods, which have inherent limitations, including the representativeness of the participant sample, methodological decisions informed by professional judgement, and arbitrary consensus definitions.; Wider Implications of the Findings: We anticipate that identified research priorities, developed to specifically highlight the most pressing clinical needs as perceived by healthcare professionals, people with fertility problems, and others, will help research funding organizations and researchers to develop their future research agenda.; Study Funding/ Competing Interest(s): The study was funded by the Auckland Medical Research Foundation, Catalyst Fund, Royal Society of New Zealand, and Maurice and Phyllis Paykel Trust. Geoffrey Adamson reports research sponsorship from Abbott, personal fees from Abbott and LabCorp, a financial interest in Advanced Reproductive Care, committee membership of the FI O Committee on Reproductive Medicine, International Committee for Monitoring Assisted Reproductive Technologies, International Federation of Fertility Societies, and World Endometriosis Research Foundation, and research sponsorship of the International Committee for Monitoring Assisted Reproductive Technologies from Abbott and Ferring. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and editor for the Cochrane Gynaecology and Fertility Group. Hans Evers reports being the Editor Emeritus of Human Reproduction. Andrew Horne reports research sponsorship from the Chief Scientist's Office, Ferring, Medical Research Council, National Institute for Health Research, and Wellbeing of Women and consultancy fees from Abbvie, Ferring, Nordic Pharma, and Roche Diagnostics. M. Louise Hull reports grants from Merck, grants from Myovant, grants from Bayer, outside the submitted work and ownership in Embrace Fertility, a private fertility company. Neil Johnson reports research sponsorship from Abb-Vie and Myovant Sciences and consultancy fees from Guerbet, Myovant Sciences, Roche Diagnostics, and Vifor Pharma. José Knijnenburg reports research sponsorship from Ferring and Theramex. Richard Legro reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. Ben Mol reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. Ernest Ng reports research sponsorship from Merck. Craig Niederberger reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. Jane Stewart reports being employed by a National Health Service fertility clinic, consultancy fees from Merck for educational events, sponsorship to attend a fertility conference from Ferring, and being a clinical subeditor of Human Fertility. Annika Strandell reports consultancy fees from Guerbet. Jack Wilkinson reports being a statistical editor for the Cochrane Gynaecology and Fertility Group. Andy Vail reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and of the journal Reproduction. His employing institution has received payment from HFEA for his advice on review of research evidence to inform their 'traffic light' system for infertility treatment 'add-ons'. Lan Vuong reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the present work. All authors have completed the disclosure form.; Trial Registration Number: Not applicable. (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Duffy, J. M. N., et al. (2020). "Developing a core outcome set for future infertility research: an international consensus development study† ‡." Human reproduction (Oxford, England) 35(12): 2725-2734.
	Study Question: Can a core outcome set to standardize outcome selection, collection and reporting across future infertility research be developed?; Summary Answer: A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCTs) and systematic reviews evaluating potential treatments for infertility.; What Is Known Already: Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret.; Study Design, Size, Duration: A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries).; Participants/materials, Setting, Methods: Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus science methods.; Main Results and the Role of Chance: The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable.; Limitations, Reasons for Caution: We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition and an arbitrary consensus threshold.; Wider Implications of the Findings: Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Fertility and Sterility and Human Reproduction, have committed to implementing this core outcome set.; Study Funding/competing Interest(s): This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund and Maurice and Phyllis Paykel Trust. The funder had no role in the design and conduct of the study, the collection, management, analysis or interpretation of data, or manuscript preparation. B.W.J.M. is supported by a National Health and Medical Research Council Practitioner Fellowship (GNT1082548). S.B. was supported by University of Auckland Foundation Seelye Travelling Fellowship. S.B. reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. J.M.L.K. reports research sponsorship from Ferring and Theramex. R.S.L. reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.J.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. C.N. reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. A.S. reports consultancy fees from Guerbet. E.H.Y.N. reports research sponsorship from Merck. N.L.V. reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have completed the disclosure form.; Trial Registration Number: Core Outcome Measures in Effectiveness Trials Initiative: 1023. (© The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Duffy, J. M. N., et al. (2021). "Developing a core outcome set for future infertility research: an international consensus development study." Fertility and Sterility 115(1): 191-200.
	Study Question: Can a core outcome set to standardize outcome selection, collection, and reporting across future infertility research be developed?; Summary Answer: A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCT) and systematic reviews evaluating potential treatments for infertility.; What Is Known Already: Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions, and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret.; Study Design, Size, Duration: A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries).; Participants/materials, Setting, Methods: Healthcare professionals, researchers, and people with fertility problems were brought together in an open and transparent process using formal consensus science methods.; Main Results and the Role of Chance: The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin, and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth, and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable.; Limitations, Reasons for Caution: We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition, and an arbitrary consensus threshold.; Wider Implications of the Findings: Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection, and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Ferility and Sterility, and Human Reproduction, have committed to implementing this core outcome set.; Study Funding/competing Interest(s): This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund, and Maurice and Phyllis Paykel Trust. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. Hans Evers reports being the Editor Emeritus of Human Reproduction. José Knijnenburg reports research sponsorship from Ferring and Theramex. Richard Legro reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. Ben Mol reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. Craig Niederberger reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. Annika Strandell reports consultancy fees from Guerbet. Ernest Ng reports research sponsorship from Merck. Lan Vuong reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have completed the disclosure form.; Trial Registration Number: Core Outcome Measures in Effectiveness Trials Initiative: 1023. (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Duffy, J. M. N., et al. (2020). "Standardizing definitions and reporting guidelines for the infertility core outcome set: An international consensus development study." Human Reproduction 35(12): 2735-2745.
	STUDY QUESTION: Can consensus definitions for the core outcome set for infertility be identified in order to recommend a standardized approach to reporting? SUMMARY ANSWER: Consensus definitions for individual core outcomes, contextual statements and a standardized reporting table have been developed. WHAT IS KNOWN ALREADY: Different definitions exist for individual core outcomes for infertility. This variation increases the opportunities for researchers to engage with selective outcome reporting, which undermines secondary research and compromises clinical practice guideline development. STUDY DESIGN, SIZE, DURATION: Potential definitions were identified by a systematic review of definition development initiatives and clinical practice guidelines and by reviewing Cochrane Gynaecology and Fertility Group guidelines. These definitions were discussed in a face-to-face consensus development meeting, which agreed consensus definitions. A standardized approach to reporting was also developed as part of the process. PARTICIPANTS/MATERIALS, SETTING, METHODS: Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus development methods. MAIN RESULTS AND THE ROLE OF CHANCE: Forty-four potential definitions were inventoried across four definition development initiatives, including the Harbin Consensus Conference Workshop Group and International Committee for Monitoring Assisted Reproductive Technologies, 12 clinical practice guidelines and Cochrane Gynaecology and Fertility Group guidelines. Twenty-seven participants, from 11 countries, contributed to the consensus development meeting. Consensus definitions were successfully developed for all core outcomes. Specific recommendations were made to improve reporting. LIMITATIONS, REASONS FOR CAUTION: We used consensus development methods, which have inherent limitations. There was limited representation from low- and middle-income countries. WIDER IMPLICATIONS OF THE FINDINGS: A minimum data set should assist researchers in populating protocols, case report forms and other data collection tools. The generic reporting table should provide clear guidance to researchers and improve the reporting of their results within journal publications and conference presentations. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials statement, and over 80 specialty journals have committed to implementing this core outcome set. STUDY FUNDING/COMPETING INTEREST(S): This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund and Maurice and Phyllis Paykel Trust. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility Group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. R.S.L. reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. C.N. reports being the Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and a financial interest in NexHand. E.H.Y.N. reports research sponsorship from Merck. A.S. reports consultancy fees from Guerbet. J.W. reports being a statistical editor for the Cochrane Gynaecology and Fertility Group. A.V. reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and of the journal Reproduction. His employing institution has received payment from Human Fertilisation and Embryology Authority for his advice on review of research evidence to inform their 'traffic light' system for infertility treatment 'add-ons'. N.L.V. reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have comple ed the disclosure form.Copyright © The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.

Dufour, S., et al. (2023). "Technical Update No. 433: eHealth Solutions for Urinary Incontinence Among Women." Journal of Obstetrics and Gynaecology Canada 45(2): 150-159.e151.
	Objective: The purpose of this technical update is to establish the state of the science regarding emerging and novel electronic health (eHealth) and mobile health (mHealth) solutions for urinary incontinence among women. Target population: Women over 18 years with urinary incontinence. Options: Websites and mobile health applications are useful in the conservative care of urinary incontinence. Relevant care providers should be familiar with such tools, particularly those that use motivational principles for behaviour change, which can be used as adjunct tools for urinary incontinence care. Telemedicine is an effect mode to provide services for the conservative care of urinary incontinence. Outcome(s): Use of eHealth and mHealth solutions has potentially significant health outcomes for patients, providers, and global health systems. Broader use of telemedicine, in and of itself, could improve care access and reduce costs incurred by patients and the health care system. Benefits, Harms, and Costs: Evidence for the efficacy of eHealth and mHealth technologies and applications for urinary incontinence ranges from weak to strong. However, the research landscape for many of these novel solutions is developing rapidly. Furthermore, these options have minimal or no harm and confer an established cost benefit and care access benefit. Evidence: The Cochrane Library, Medline, EMBASE, CENTRAL databases (from January 2014 to April 2019) were searched to find articles related to conservative care of urinary incontinence in women (over 18 years) and studies on eHealth and mHealth interventions for urinary incontinence. Articles were appraised, and the collective evidence was graded. Validation methods: The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and conditional [weak] recommendations). Intended audience: Relevant primary care providers and medical specialists, including physicians, nurses, midwives, and pelvic health physiotherapists. SUMMARY STATEMENTS: 1. Electronic and mobile health interventions for urinary incontinence are growing, both in their availability in the health care market and in the science to support their use (moderate). 2. Electronic health interventions offered in conjunction with pelvic floor muscle training, either self-directed or directed by a health care provider (physiotherapist), may provide a marginal benefit in symptom improvement for stress urinary incontinence among women (low). 3. Application- and web-based programming for urinary incontinence should include traditional components of self-management programs, including motivational strategies to support behavioural interventions (high). 4. Bladder diaries are the most studied electronic health tool for overactive bladder and urge urinary incontinence. The acceptability and feasibility of these mobile health solutions has been established (low). 5. There is limited research on how electronic health interventions improve urge urinary incontinence and overactive bladder (low). 6. Telehealth can be an effective platform for patient education and counselling on conservative and surgical management of uncomplicated stress urinary incontinence (high). RECOMMENDATIONS: 1. Mobile health solutions, such as applications that incorporate evidence-based, motivational, behavioural intervention principles, should be recommended to women with stress urinary incontinence if tailored in-person care is not available or accessible (strong, high). 2. There is currently insufficient evidence to recommend the routine use of electronic health interventions that include a physical device to improve stress urinary incontinence symptoms (conditional, very low). 3. Electronic health interventions may be recommended to complement stress urinary incontinence treatment, but providers should familiarize themselves with the specific interventions recommended, since they va y significantly in terms of composition, cost, and benefit (conditional, very low). 4. Health care providers remain the key knowledge translators and advisors on overactive bladder and urge urinary incontinence; they should not assume that patients will get the information they need from a website (strong, moderate). 5. Health care providers may recommend web-based self-management programs that incorporate evidence-based motivational behavioural intervention principles if tailored in-person care is not available or accessible to patients (strong, low). 6. Application-based bladder diaries may be used as an alternative to traditional bladder diaries as a self-monitoring tool (conditional, low). 7. Follow-up visits for uncomplicated stress urinary incontinence may be considered in women who are comfortable with this platform (strong, low). 8. Although there is insufficient evidence to recommend virtual or telehealth consultation for routine pessary care instructions, these platforms can be considered on a case-by-case basis depending on the patient's comfort with pessary self-care (conditional, very low). 9. Surgical counselling for stress urinary incontinence via telehealth or virtual platforms may be considered for women who are comfortable with shared decision-making on these platforms (strong, moderate). 10. Post-operative virtual visits may be offered as an alternative to in-person visits after uncomplicated surgery for stress urinary incontinence (strong, moderate).Copyright © 2022 The Society of Obstetricians and Gynaecologists of Canada/La Societe des obstetriciens et gynecologues du Canada

Dumbala, S., et al. (2020). "Effect of Yoga on Psychological Distress among Women Receiving Treatment for Infertility." International journal of yoga 13(2): 115-119.
	BACKGROUND: Infertility among women has been associated with significant psychological distress, anxiety, and depression. yoga therapy has been found to be useful in the management of anxiety, depression and psychological distress. AIM: To review studies on the effectiveness of yoga in reducing psychological distress and improving clinical outcomes among women receiving treatment for infertility. METHODOLOGY: PubMed, ScienceDirect, and Google Scholar databases were searched for studies using the following inclusion criteria: studies published in English, those published between 2000 and 2018, published in peer-reviewed journals, and those with Yoga as an intervention. Review articles, studies without any yoga interventions for infertility, and male infertility were excluded. The keywords included for the literature search were: Yoga, Mindfulness, Relaxation technique, Stress, Distress, Anxiety, Infertility, In Vitro Fertilization (IVF), and Assisted Reproductive Technology (ART). RESULTS: Three studies satisfied the selection criteria. Two studies involved Hatha yoga intervention and one study used structured yoga program. The variables assessed in these studies were: (1) anxiety, (2) depression, (3) emotional distress, and (4) fertility-related quality of life. All the studies reported an improvement in the anxiety scores after yoga intervention. CONCLUSION: Yoga therapy may be potentially useful in improving anxiety scores among women suffering from infertility. More studies are needed in this area to establish role of yoga as an adjuvant during the treatment of infertility.

Dumesic Daniel, A., et al. (2023). "Randomized clinical trial: effect of low-dose flutamide on abdominal adipogenic function in normal-weight women with polycystic ovary syndrome." Fertility and Sterility 119(1): 116-126.
	Objective: To examine whether low-dose flutamide administration to normal-weight women with polycystic ovary syndrome (PCOS) reduces abdominal fat deposition, attenuates accelerated lipid accumulation in newly formed adipocytes derived from subcutaneous (SC) abdominal adipose stem cells (ASCs), and/or alters glucose-lipid metabolism.; Design: A double-blind, placebo-controlled randomized clinical trial.; Setting: An academic medical center.; Patient(s): Twelve normal-weight women with PCOS and 12 age- and body mass index-matched controls.; Intervention(s): Women underwent circulating hormonal and metabolic determinations, intravenous glucose tolerance testing, total body dual-energy roentgenogram absorptiometry, and SC abdominal fat biopsy. Interventions were repeated in women with PCOS after 6-month administration of flutamide (125 mg orally daily) vs. placebo.; Main Outcome Measure(s): Clinical parameters and lipid accumulation in newly formed adipocytes derived from SC abdominal ASCs in vitro were compared between controls and the women with PCOS receiving flutamide vs. placebo.; Results: Serum luteinizing hormone and androgen levels as well as lipid accumulation in newly formed SC abdominal adipocytes were greater in the women with PCOS than controls. Flutamide vs. placebo reduced percent android fat, lowered serum log low-density lipoprotein and log non-high-density lipoprotein levels, and increased fasting circulating glucose levels. In all women with PCOS, changes in percent android fat positively correlated with serum log non-high-density lipoprotein and log low-density lipoprotein levels, with correlations influenced by serum free testosterone levels. Flutamide vs. placebo also attenuated lipid accumulation in newly-formed PCOS SC abdominal adipocytes in vitro relative to controls, which was unrelated to serum lipid levels.; Conclusion: Low-dose flutamide administration to normal-weight PCOS women reduces preferential abdominal fat deposition, attenuates accelerated lipid accumulation in newly-formed adipocytes derived from SC abdominal ASCs in vitro, and alters glucose-lipid homeostasis.; Clinical Trial Registration Number: NCT01889199 (URL, clinicaltrials.gov; date of registration, 6/28/2013; enrollment date of first subject, 6/28/2013). (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Duncan-Lothamer, C., et al. (2022). "The Use of Dye-Less Cystoscopy in Assessing Urinary-Tract Integrity During Hysterectomy." Journal of Gynecologic Surgery 38(5): 348-353.
	Objective: The goal of this research was to determine if dye can be omitted without affecting the accuracy of urinary-tract injury assessment during cystoscopy at the time of hysterectomy. Material(s) and Method(s): This prospective randomized study was performed at a gynecologic oncology service in a tertiary-care center from July 2018 to June 2019. All patients undergoing hysterectomy for either benign and malignant indications were included. The study focused on the routine cystoscopy given to each patient per protocol. Patients were randomized into 2 main groups: (1) dye versus (2) no-dye, and then into 4 subgroups based on the distending media that was used (water or saline). A linear, continuous visual scale was used to grade ureteral jet strength. The time to visualization of ureteral jets was documented. The primary outcome measure was the degree of agreement between 2 observers' ratings of ureteral jet strengths when urinary dye was used or when it was not used. Result(s): According to Cronbach's alpha, the correlation between 2 observers was 85.3% agreement for the strength of the right-side ureteral jets and 85.8% for the left side ureteral jets. The difference in jet strength between the dye and no-dye groups was statistically significant for evaluation of the right-side ureter but not clinically significant. No statistical significance for assessment of ureteral jet strength was noted between water and saline distension media nor was there a difference between the groups for time until first jet visualization. Conclusion(s): Cystoscopy can be performed without using dye for ureter and bladder assessment during gynecologic surgeries. (J GYNECOL SURG 38:348)Copyright © 2022, Mary Ann Liebert, Inc.

duPont Nefertiti, C., et al. (2022). "Prognostic significance of ethnicity and age in advanced stage epithelial ovarian cancer: An NRG oncology/gynecologic oncology group study." Gynecologic Oncology 164(2): 398-405.
	Background: Age and ethnicity are among several factors that influence overall survival (OS) in ovarian cancer. The study objective was to determine whether ethnicity and age were of prognostic significance in women enrolled in a clinical trial evaluating the addition of bevacizumab to front-line therapy.; Methods: Women with advanced stage ovarian, primary peritoneal, or fallopian tube cancer were enrolled in a phase III clinical trial. All women had surgical staging and received adjuvant chemotherapy with one of three regimens. Cox proportional hazards models were used to evaluate the relationship between OS with age and race/ethnicity among the study participants.; Results: One-thousand-eight-hundred-seventy-three women were enrolled in the study. There were 280 minority women and 328 women over the age of 70. Women age 70 and older had a 34% increase risk for death when compared to women under 60 (HR = 1.34; 95% CI 1.16-1.54). Non-Hispanic Black women had a 54% decreased risk of death with the addition of maintenance bevacizumab (HR = 0.46, 95% CI:0.26-0.83). Women of Asian descent had more hematologic grade 3 or greater adverse events and a 27% decrease risk of death when compared to non-Hispanic Whites (HR = 0.73; 95% CI: 0.59-0.90).; Conclusions: Non-Hispanic Black women showed a decreased risk of death with the addition of bevacizumab and patients of Asian ancestry had a lower death rate than all other minority groups, but despite these clinically meaningful improvements there was no statistically significant difference in OS among the groups. (Copyright © 2021. Published by Elsevier Inc.)

Dupuit, M., et al. (2020). "Effect of high intensity interval training on body composition in women before and after menopause: a meta-analysis." Experimental physiology 105(9): 1470-1490.
	New Findings: What is the topic of this review? A meta-analysis of the efficacy of high intensity interval training (HIIT) in reducing weight, total fat mass (FM) and (intra)-abdominal FM in normal-weight and overweight/obese women before and after menopause. What advances does it highlight? HIIT programmes in women significantly decrease body weight and total and abdominal FM. Their effects are more evident in pre- than in postmenopausal women. Cycling HIIT seems more effective than running, especially in postmenopausal women, and training interventions longer than 8 weeks comprising three sessions a week should be promoted.; Abstract: High-intensity interval training (HIIT) is a stimulating modality for reducing body weight and adipose tissue. The purpose of this meta-analysis was to assess the efficacy of HIIT in reducing weight, total fat mass (FM) and (intra)-abdominal FM in normal-weight and overweight/obese women before and after menopause. A structured electronic search was performed to find all publications relevant to our review. Stratified analyses were made of hormonal status (pre- vs. postmenopausal state), weight, HIIT modalities (cycling vs. running), programme duration (< or ≥8 weeks) and the methods used to measure body composition (dual-energy X-ray absorptiometry vs. computed tomography, Magnetic Resonance Imaging and others). A total of 38 studies involving 959 subjects were included. Our meta-analysis showed that overall HIIT programmes significantly decrease weight, total and abdominal FM in women. Both normal weight and overweight/obese women lost total FM after HIIT protocols whereas HIIT was only effective in decreasing abdominal FM in women with excess adiposity. When pre- and postmenopausal women were considered separately, the effect of HIIT on weight, total and abdominal FM were only significant before menopause. Cycling HIIT seemed more effective than running, especially in postmenopausal women, and training interventions longer than 8 weeks comprising three sessions were more efficient. HIIT is a successful strategy to lose weight and FM in normal weight and overweight/obese women. However, further studies are still needed to draw meaningful conclusions about the real effectiveness of HIIT protocols in postmenopausal women. (© 2020 The Authors. Experimental Physiology © 2020 The Physiological Society.)

Duralde Erin, R., et al. (2023). "Management of perimenopausal and menopausal symptoms." BMJ (Clinical research ed.) 382: e072612.
	Most women worldwide experience menopausal symptoms during the menopause transition or postmenopause. Vasomotor symptoms are most pronounced during the first four to seven years but can persist for more than a decade, and genitourinary symptoms tend to be progressive. Although the hallmark symptoms are hot flashes, night sweats, disrupted sleep, and genitourinary discomfort, other common symptoms and conditions are mood fluctuations, cognitive changes, low sexual desire, bone loss, increase in abdominal fat, and adverse changes in metabolic health. These symptoms and signs can occur in any combination or sequence, and the link to menopause may even be elusive. Estrogen based hormonal therapies are the most effective treatments for many of the symptoms and, in the absence of contraindications to treatment, have a generally favorable benefit:risk ratio for women below age 60 and within 10 years of the onset of menopause. Non-hormonal treatment options are also available. Although a symptom driven treatment approach with individualized decision making can improve health and quality of life for midlife women, menopausal symptoms remain substantially undertreated by healthcare providers.; Competing Interests: Competing interests: We have read and understood the BMJ policy on declaration of interests and declare the following interests: none. (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Duran-Retamal, M., et al. (2020). "Live birth and miscarriage rate following intracytoplasmic morphologically selected sperm injection vs intracytoplasmic sperm injection: An updated systematic review and meta-analysis." Acta Obstetricia et Gynecologica Scandinavica 99(1): 24-33.
	Introduction: Intracytoplasmic morphologically selected sperm injection (IMSI) is one of the sperm selection techniques used for assisted reproduction which has been applied for a variety of indications including previously failed fertilization with intracytoplasmic sperm injection (ICSI). A Cochrane review 1 found no difference in outcomes between either modality of sperm selection. Since the Cochrane review was published there have been a further two randomized controlled trials comparing IMSI and ICSI. This systematic review and meta-analysis aims to compare IMSI with ICSI as insemination methods regarding live birth rate and miscarriage rate.; Material and Methods: Systematic review of randomized controlled trials, observational studies and similar reviews in electronic databases published before January 2018.; Results: We found nine randomized controlled trials, evaluating 1610 cycles of in vitro fertilization and 15 observational studies evaluating 1243 cycles of in vitro fertilization. Meta-analysis of the included randomized controlled trials showed no difference in the live birth rate or miscarriage rate between the ICSI and IMSI groups. Meta-analysis of five observational studies showed a significantly higher number of live births in the IMSI group than ICSI group (live birth rate odds ratio 1.47, 95% confidence interval 1.16-4.07), with a moderate degree of heterogeneity (I 2 = 41%). Additionally, from six observational studies, a significantly lower miscarriage rate was observed in the IMSI group than in the ICSI group (odds ratio 0.51, 95% confidence interval 0.37-0.70, I 2 = 0%).; Conclusions: Meta-analysis of randomized studies comparing IMSI to ICSI has not shown any difference in live birth rate and miscarriage rate. Meta-analysis of observational studies, which must be interpreted with caution, revealed an increased live birth rate and decreased miscarriage rate with IMSI vs ICSI. (© 2019 Nordic Federation of Societies of Obstetrics and Gynecology.)

Durmaz, A. and G. Kakaşçı Ç (2022). "THE EFFECTS OF WOMAN-CENTERED CARE ON VITAL SIGNS, ANXIETY AND COMFORT LEVELS: a RANDOMIZED CONTROLLED TRIAL." Karya journal of health science 3(2): 133‐139.
	
Dursun, M., et al. (2024). "The effect of transobturator tape surgery on female sexual function: a systematic review and meta-analysis." Archives of Gynecology and Obstetrics.
	Purpose: We aimed to review the literature regarding the effects of trans obturator tape surgery (TOT) on sexual functions in women with stress urinary incontinence (SUI) to reveal compact data and to reach more consistent and reliable results. Method(s): PRISMA statement was used in the current review. The databases of PubMed (Medline), Science Direct, and Cochrane Central Register of Controlled Trials were detected independently. We evaluated the studies comparing the preoperative and postoperative sexuality parameters related to the TOT procedure in females. Studies presenting the mean and standard deviation(SD) of global and sub-item Female Sexual Function Index(FSFI) were included in the current study. Result(s): We identified 783 studies in full publications or abstract forms using the methodology above and the search terms. Finally, eight studies were included in the meta-analysis. The pooled analysis of the mean difference demonstrated that the total sexual function scores of the patients improved after TOT surgery. Conclusion(s): The data collected from the current meta-analysis suggest that TOT surgery improves female sexual function.Copyright © 2024, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Duska Linda, R., et al. (2023). "Phase IIa Study of PLX2853 in Gynecologic Cancers With Known ARID1A Mutation and Phase Ib/IIa Study of PLX2853/Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer." JCO precision oncology 7: e2300235.
	Purpose: The Bromodomain and Extra-Terminal (BET) domain proteins facilitate the development of many human cancers via epigenetic regulation. BET inhibitors may be effective in reversing platinum resistance in ovarian cancer (OC) and may generate synthetic lethality with ARID1A loss. PLX2853 is an orally active, small-molecule inhibitor of BET bromodomain-mediated interactions that exhibits low nanomolar potency in blocking all four BET family members.; Methods: We conducted a multicenter and open-label study with two parallel arms: a phase IIa study of PLX2853 monotherapy in patients with advanced gynecologic malignancies with an ARID1A mutation and a phase Ib/IIa combination study of PLX2853 plus carboplatin in women with platinum-resistant OC. The primary objectives were safety and tolerability for phase Ib and efficacy for both phase IIa portions. Thirty-four of 37 enrolled patients completed at least one post-baseline response assessment.; Results: Of the 14 evaluable patients on the monotherapy arm, 1 (7.1%) achieved a best overall response of partial response (PR), 5 (35.7%) had stable disease (SD), and 8 (57.1%) had progressive disease (PD). Of the 20 evaluable patients on the combination arm, 1 (5.0%) had PR, 9 (45.0%) had SD, and 10 (50%) had PD.; Conclusion: This study confirmed the safety profile of PLX2853 and demonstrated the feasibility of combination with carboplatin. Although these results did not meet the prespecified response criteria, evidence of clinical activity highlights the rationale for further exploration of BET inhibitors in patients with ARID1A -mutated gynecologic malignancies, possibly in combination with agents targeting potential feedback mechanisms such as the PI3K pathway.

Duska, L. R., et al. (2021). "A Surgical Window Trial Evaluating Medroxyprogesterone Acetate with or without Entinostat in Patients with Endometrial Cancer and Validation of Biomarkers of Cellular Response." Clinical Cancer Research 27(10): 2734‐2741.
	Purpose: This surgical window of opportunity (window) study assessed the short‐term effect of medroxyprogesterone acetate (MPA) alone versus MPA plus the histone deacetylase (HDAC) inhibitor entinostat on regulation of progesterone receptor (PR) in women with newly diagnosed endometrioid endometrial adenocarcinoma. Patients and Methods: This multisite, randomized, open‐label surgical window study treated women intramuscularly on day 1 with 400 mg MPA. Entinostat given 5 mg by mouth on days 1, 8, and 15 was randomly assigned with equal probability. Surgery followed on days 21–24. Pretreatment and posttreatment tissue was assessed for PR H‐scores, Ki‐67 levels, and histologic response. Results: Fifty patients were accrued in 4 months; 22 and 20 participants had PR evaluable pretreatment and posttreatment slides in the MPA and MPA/entinostat arms, respectively. Median posttreatment PR H‐scores were significantly lower than pretreatment H‐scores in both arms but did not differ significantly (MPA: 247 vs. 27, MPA/entinostat 260 vs. 23, respectively, P ¼ 0.87). Decreased Ki‐67 was shown in 90% treated with MPA/entinostat compared with 68% treated with MPA alone (P ¼ 0.13). Median PR H‐score decreases were larger when Ki‐67 was decreased (208) versus not decreased (45). The decrease in PR pretreatment versus posttreatment was associated with loss of Ki‐67 nuclear staining, consistent with reduced cellular proliferation (P < 0.008). Conclusions: This surgical window trial rapidly accrued in a multisite setting and evaluated PR as its primary endpoint and Ki‐67 as secondary endpoint. Despite no immediate effect of entinostat on PR in this short‐term study, lessons learned can inform future window and treatment trials.

Duska, L. R., et al. (2021). "A phase Ib/II and pharmacokinetic study of EP0057 (formerly CRLX101) in combination with weekly paclitaxel in patients with recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer." Gynecologic Oncology 160(3): 688-695.
	BACKGROUND: EP0057 (formerly CRLX101) is an investigational nanoparticle-drug conjugate (NDC) of a cyclodextrin-based polymer backbone plus camptothecin, a topoisomerase-1 inhibitor. Prior studies showed efficacy in recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC). METHODS: This phase Ib/2 trial assessed safety and efficacy of EP0057 Q2W plus weekly paclitaxel in patients with EOC. The recommended phase 2 dose (RP2D) was identified using a 3+3 design. The single-arm phase 2 assessed overall response (ORR) per RECIST 1.1 in patients previously treated with bevacizumab. Secondary objectives included progression free survival (PFS) and duration of response. RESULTS: The RP2D was established as 15 mg/m2 EP0057 Q2W plus 80 mg/m2 paclitaxel administered 3 weeks on/1 week off. Nine patients enrolled on phase 1b, with no DLTs; 21 additional patients enrolled on phase 2. All completed >1 cycle. Median age was 62 (44-76) years, 57% ≥3 prior therapies. For the primary analysis, 6/19 patients with prior bevacizumab had confirmed responses (ORR=31.6% (95% CI: 15.4% to 54.0%)) including one complete response (CR). Median PFS was 5.4 months. Most common grade 3/4 adverse events attributed to treatment were decreased neutrophil count (13, 43%) and anemia (3, 10%). CONCLUSIONS: Although the observed ORR was not statistically better than the historical control rate, EP0057 remains an interesting option for treatment of recurrent EOC. EP0057 exhibits high plasma drug retention, slow clearance, and controlled slow release of CPT from the polymer when administered alone and with paclitaxel. (NCT02389985) 242 words.

Dutra, L., et al. (2021). "Transcranial direct current electrical stimulation for the treatment of interstitial cystitis: a study protocol." European Journal of Obstetrics, Gynecology, and Reproductive Biology 262: 198‐202.
	Background: Interstitial cystitis or painful bladder syndrome is a chronic disorder that presents an unknown etiology, with no generally accepted treatment. Although there is no gold standard treatment, transcranial direct current stimulation (tDCS) has shown efficacy in several chronic pain syndromes with decrease in pain, and improved functionality and mood. tDCS could be a safe, ease to use, and low‐cost complementary intervention for patients with interstitial cystitis. Aim: This study will investigate the effects of a tDCS protocol on pain, functionality, and mood in patients with interstitial cystitis. Methods: A randomized controlled clinical trial with two arms. Women will be randomized into two groups: active or sham. Anodal tDCS over the primary motor cortex will be performed for 5 consecutive days with an intensity of 2 mA for 20 min. Participants will be evaluated five times: 1 week before intervention; on the 5th day of tDCS; and 1, 6, and 12 months after the last day of tDCS. The outcomes will be assessed using the numeric rating scale, McGill pain questionnaire, positive and negative affect scale, international consultation on incontinence questionnaire for female lower urinary tract symptoms, Hamilton anxiety scale, six‐minute walk test, patient global impression of change, and voiding diary. Discussion: Only the active group will be expected to show decreased pain. The results of this trial will be the first step in the use of neuromodulation in interstitial cystitis and will provide additional data to support new studies with tDCS.

Dutra, P., et al. (2021). "Comparison of topical fractional CO2 laser and vaginal estrogen for the treatment of genitourinary syndrome in postmenopausal women: a randomized controlled trial." Menopause (New York, N.Y.) 28(7): 756‐763.
	OBJECTIVE: To compare the efficacy of fractional CO2 laser therapy with topical estrogen therapy for the treatment of postmenopausal genitourinary syndrome of menopause. METHODS: We conducted a randomized controlled clinical trial involving 25 postmenopausal women. Participants were aged between 50 and 65 years with at least 1 year of amenorrhea and follicle‐stimulating hormone levels of >40 IU/L. The women were randomized into two groups: the laser therapy group (n = 13) and the vaginal topical estrogen therapy group (n = 12). Changes in the vaginal epithelium thickness, Frost index, and cell maturation were analyzed in both the groups. The female sexual quotient of each woman was also evaluated. Subjective evaluation was performed through a physical examination. RESULTS: Histological analysis showed a significant increase in the vaginal epithelium thickness at the end of treatment in females in both the laser therapy (P < 0.001) and topical estrogen therapy (P = 0.001) groups. The topical estrogen therapy group tended to present a higher maturation index at the end of treatment when compared with that of the other group. Sexual function increased significantly over time in both the topical estrogen therapy (P < 0.001) and laser therapy (P < 0.001) groups. Subjective evaluation through physical examination showed a significant improvement in atrophy in both the groups. CONCLUSION: Despite the nonequivalence with topical estrogen therapy, our data suggest that laser therapy is an effective method for the treatment of vulvovaginal atrophy.

Dutta, R., et al. (2022). "Safety and economics of an enhanced recovery after surgery protocol in pelvic reconstructive surgery." International Urogynecology Journal 33(7): 1875-1880.
	Introduction and Hypothesis: We hypothesized that an enhanced recovery after surgery (ERAS) protocol for patients undergoing female pelvic reconstructive surgery would conserve hospital resources without compromising patient safety.; Methods: In June 2020, an ERAS protocol designed to promote same-day discharge was initiated that included pre-operative hydration, a urinary anesthetic, non-narcotic analgesia, perineal ice, a bowel regimen, enrollment of the family to assist with care, and communication regarding planned same-day discharge. We compared demographic, operative, hospital stay, complications, and cost data in patients undergoing pelvic organ prolapse or incontinence surgery over 4 sequential months pre (PRE; N = 82) and post (POST; N = 91) ERAS implementation using univariate statistics.; Results: There were no differences in demographics, operative details, or complications (p > 0.05). There were no significant differences in overall revenues or expenses (p > 0.05), but bed unit cost was significantly lower in the POST group ($210 vs $533, p < 0.0001). There was a trend toward an increased operating margin in POST patients ($4,554 vs $2,151, p = 0.1163). Significantly more POST surgeries were performed in an ambulatory setting (73.6% vs 48.8%, p = 0.0008) and resulted in same-day discharge (80.2% vs 50.0%, p = 0.0003). There were no differences in the rates of emergency room or unexpected clinic visits (p > 0.05). Prescribed post-operative opiate dose was significantly reduced in POST patients (p < 0.0001).; Conclusions: In patients undergoing female pelvic reconstructive surgery, an ERAS protocol facilitated transfer of procedures to an ambulatory surgical site and permitted same-day discharge without increasing complications, clinic visits, or emergency room visits. It also reduced bed unit cost and may improve operating margins. (© 2021. The International Urogynecological Association.)

Dweck, A., et al. (2024). "Efficacy of a Nonhormonal Neurokinin B Inhibiting Supplement for Reducing Vasomotor Symptoms." Journal of Neurosurgical Anesthesiology 36(1): 1302-1303.
	Objective: The primary objective was to evaluate the effects of a nonhormonal, botanical blend (VMS-BH02; ThermellaTM), on hot flashes and night sweats in women who experience menopausal vasomotor symptoms (VMS). Preclinical studies showed that the combination of these ingredients synergistically inhibited the neurokinin B pathway and did not raise estrogen levels nor induce cell proliferation in MCF-7 cells. This was the first clinical study conducted to evaluate clinical benefits. Design(s): This is an ongoing open-label study in women 45-65 years of age. Thirty peri- and post-menopausal women were recruited if they reported a daily average of 5 or more VMS, regardless of severity. Participants were instructed to consume 2 capsules of the supplement daily. To date, participants have completed 8 weeks. The primary endpoint was the percent change in total VMS, collected using daily diaries. Secondary endpoints were assessed using various validated monthly questionnaires including the Menopause Specific Quality of Life (MENQOL), the Hot Flash Related Daily Interference Scale (HFRDIS), the Greene Climacteric Scale (GCS), and the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS). Participants completed all questionnaires at Baseline, and weeks 2, 4, and 8, with the exception of the MENQOL, which was not administered at week 2. Result(s): Thirty women completed 8 weeks (55.5 +/-3.7 yrs) of supplementation. There was a significant decrease in self-reported total VMS occurrences (all severities) noted across the time points (Baseline: 10.7 +/-6.0; Week 4: 6.2 +/-4.2; Week 8: 5.1 +/-4.4; p < 0.01). Combined, moderate and severe hot flashes were significantly decreased at all weeks when compared to baseline (Baseline: 5.1 +/-2.6; Week 4: 2.9 +/-2.6; Week 8: 2.5 +/-2.9; p < 0.01). Night sweats significantly decreased from baseline at weeks 4 and 8 (Baseline: 2.9 +/-2.1; Week 4: 1.5 +/-1.2, p = 0.002; Week 8: 1.4 +/-1.3, p < 0.01). Significant improvements were also noted in the MENQOL total sum at weeks 4 and 8 compared to baseline (Baseline: 3.8 +/-1.2; Week 4: 3.0 +/-1.1; Week 8: 2.7 +/-1.4; p < 0.01), the HFRDIS total sum at all timepoints compared to baseline (Baseline: 42.7 +/-18.2; Week 2: 31.03 +/-18.3; Week 4: 26.1 +/-20.4; Week 8: 18.4 +/-18.4; p < 0.001), and the GCS total sum at weeks 2, 4, and 8 compared to baseline (Baseline: 20.3 +/-8.6; Week 2: 16.3 +/-8.3, p < 0.001; Week 4: 14.1 +/-8.5, p = 0.001; Week 8: 12.5 +/-10.3, p < 0.001). There were also significant improvements in PROMIS total score at weeks 2, 4, and 8 compared to baseline (Baseline: 30.3 +/-7.0; Week 2: 26.4 +/-8.3; Week 4: 25.5 +/-8.1; Week 8: 23.4 +/-8.3; p < 0.01). Conclusion(s): The eight-week daily supplementation with ThermellaTM, which has a high affinity for inhibition of the NK3 receptor, resulted in significant and consistent reductions in vasomotor symptoms, including hot flashes and night sweats. These improvements were observed as early as two weeks into the study and continued throughout the investigation period. Notably, the frequency and severity of these symptoms decreased over time. Supplementation also showed positive effects on menopause-specific quality of life related outcomes and sleep disturbances. Overall, these findings underscore the promising clinical efficacy of this novel botanical blend in effectively managing vasomotor symptoms experienced by women throughout their menopausal transition.

Dwyer, L., et al. (2022). "Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse." Trials 23(1): 742.
	Background: Pelvic organ prolapse (POP) is a common condition in women, where the downward descent of pelvic organs into the vagina causes symptoms which impacts quality of life. Vaginal pessaries offer an effective alternative to surgery for the management of POP. However, the need for regular follow-up can be burdensome for women and requires significant healthcare resources. The TOPSY study is a randomised controlled trial which aims to determine the clinical and cost-effectiveness of self-management of vaginal pessaries. This paper describes the theoretical and practical development of the self-management intervention.; Methods: The intervention was developed using the MRC complex intervention framework, normalisation process theory (NPT) and self-management theory. The intervention aims to boost perceived self-efficacy in accordance with Bandura's social cognitive theory and is guided by the tasks and skills Lorig and Hollman describe as necessary to self-manage a health condition.; Results: The TOPSY intervention was designed to support women to undertake the medical management, role management and emotional management of their pessary. The six self-management skills described by Lorig and Hollman: problem-solving, decision-making, resource utilisation, formation of a patient-provider partnership role, action planning and self-tailoring, are discussed in detail, including how women were supported to achieve each task within the context of pessary self-management. The TOPSY intervention includes a self-management support session with a pessary practitioner trained in intervention delivery, a follow-up phone call 2 weeks later and ongoing telephone or face-to-face support as required by the woman initiated by contacting a member of the research team.; Conclusions: The TOPSY study intervention was developed utilising the findings from a prior service development project, intervention development and self-efficacy theory, relevant literature, clinician experience and feedback from pessary using women and members of the public. In 2022, the findings of the TOPSY study will provide further evidence to inform this important aspect of pessary management.; Trial Registration: ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017. (© 2022. The Author(s).)

Dybeck, M.-M., et al. (2022). "Can supervised group-based multimodal exercise improve health-related quality of life in women with ovarian cancer undergoing chemotherapy?" European journal of cancer care 31(4): e13607.
	
Eberle, A., et al. (2024). "Medical Management of Ovarian Endometriomas: A Systematic Review and Meta-analysis." Obstetrics and Gynecology 143(1): 53-66.
	OBJECTIVE:To estimate the effect of medical management on the size of ovarian endometriomas.DATA SOURCE:Online databases were searched from inception to October 2022, including Ovid MEDLINE, Ovid EMBASE, PubMed, EBM Reviews - Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov, and Web of Science.METHODS OF STUDY SELECTION:Following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we included all English-language, full-text articles that reported on change in endometrioma size (either diameter or volume) after medical interventions. Studies evaluating surgical interventions or postoperative recurrence were excluded. All screening and data extraction were performed independently by two authors. Risk of bias assessment was performed with either the Cochrane Risk of Bias Tool for randomized controlled trials or a modified Newcastle-Ottawa Scale for observational studies.TABULATION, INTEGRATION, AND RESULTS:After removal of duplicates, 9,332 studies were screened, with 33 full-text articles deemed eligible for inclusion. In the meta-analysis, dienogest showed significant reduction in cyst diameter (reduction 1.32 cm, 95% CI, 0.91-1.73, eight studies, n=418 cysts) and volume (mean difference of log-transformed volume 1.35, 95% CI, 0.87-1.83, seven studies, n=282 cysts). Similarly, significant reductions were seen with the oral contraceptive pill (OCP) (1.06 cm, 95% CI, 0.59-1.53, nine studies, n=455), gonadotropin-releasing hormone (GnRH) agonists (1.17 cm, 95% CI, 0.42-1.92, four studies, n=128 cysts), norethindrone acetate (0.6 cm, 95% CI, 0.27-0.94, two studies, n=88 cysts), and danazol (1.95 cm, 95% CI, 1.18-2.73, two studies, n=34 cysts). Norethindrone acetate with aromatase inhibitor was also effective in reducing endometrioma volume (mean difference of log-transformed volume 1.47, 95% CI, 0.16-2.78, two studies, n=34 cysts). CONCLUSION(S):Medical management with dienogest, OCPs, GnRH agonists, norethindrone acetate, norethindrone acetate with aromatase inhibitor, or danazol can reduce the size of ovarian endometriomas.SYSTEMATIC REVIEW REGISTRATION:PROSPERO, CRD 42022363319.Copyright © 2024 Lippincott Williams and Wilkins. All rights reserved.

Ebner, F., et al. (2019). "Results of an internal audit on the survival of patients with uterine sarcoma." Journal of the Turkish German Gynecological Association 20(1): 15-22.
	Objective: In the last 5 years there has been much discussion about the surgical procedure for uterine fibroids, and essentially, also uterine sarcoma. Still there exists no reliable presurgical diagnostic tool to differentiate between benign fibroids and uterine sarcomas. The aim of this study was to confirm the suspected association between intraoperative spread of tumor by morcellation and impaired outcomes in patients with sarcoma.; Material and Methods: After the local ethics commission positively reviewed the study protocol, the oncologic database of our university hospital was retrospectively reviewed for patients with uterine sarcomas over a time period of 13 years (2002-2015). Data was extracted from the medical files and survival information was collected by contacting the patient’s general practitioners if last follow-up-status was older than 6 months. For the analysis, patients were split into two groups with either intrasurgical morcellation (M+) or no morcellation (M-) regarding information provided by the surgical report.; Results: Data on 57 patients with uterine sarcoma were available for further analysis. The median age and body mass index of the patients was 63 years and 27 kg/m², respectively. The sarcoma subtypes were 25 leiomyosarcoma, 19 carcinosarcoma, 9 endometrioid stroma sarcoma, 3 adenosarcoma, and one case without further differentiation. In the majority, no morcellation was performed (M- group, n=44) and 51 patients received open surgery (3 laparoscopic, 1 vaginal, and 2 incomplete surgeries). The median time of follow-up was 31 months. The disease-free survival was 50.5 months and the Cox regression analysis showed a hazard ratio of 3.06 [no significant difference between the two subgroups (p=0.079; 95% confidence interval (CI): 0.9-10.6)]. The overall survival was found as 62.2 months and the Cox regression analysis showed a hazard ratio of 3.216 with a statistically significant difference between the two subgroups (p=0.013; 95% CI: 1.3-8.1).; Conclusion: Despite the efforts to find a pre-surgical diagnostic tool, the clinical situation remains unsatisfactory. Overall sarcoma prevalence is low during the last 13 years at our university center, but morcellation occurred in a relevant portion of patients (13 of 57). If sarcoma is suspected or diagnosed then en-bloc resection of the uterus can prolong survival. Thus, morcellation of the uterus and not the surgical technique (en-bloc resection) is the prognostic factor and should be avoided in any suspicious case.

Ebrahimi, A., et al. (2020). "Investigation of the role of herbal medicine, acupressure, and acupuncture in the menopausal symptoms: An evidence-based systematic review study." Journal of family medicine and primary care 9(6): 2638-2649.
	Background: Menopause is an important physiological phenomenon in women's lives. Women's concern about taking the hormone treatment to ease menopausal symptoms is increasing. Over the past decade, the use of complementary and alternative medicine for the treatment of menopausal problems instead of hormone therapy has increased.; Objective: This study aimed to investigate the role of herbal medicine, acupressure, and acupuncture in the menopausal symptoms.; Methods: Data source: related articles were searched from internal scientific databases and external databases of "Web of Scopus, Cochrane, PubMed, Science Direct, Ovid, and Google scholar."; Study Eligibility Criteria: The keywords such as menopause, menopausal symptoms, complementary menopausal medicine, acupuncture in menopause, herbal medicine in menopause, and acupuncture in menopause were searched in the studies from 1987 to 2019. Exclusion criteria were inadequate information in the study, lack of access to full-text articles, animal studies, and reports. At the end of the search, 145 articles out of a total of 400 articles were reviewed.; Results: In various studies, different herbs such as licorice, valerian, soy, sage, ginseng, etc., were used to improve menopausal symptoms. In addition, acupuncture and acupressure were used to reduce menopausal symptoms.; Conclusion: The efficacy and use of complementary and alternative medicine, along with other classical medicine care, can be a new model for improving menopausal symptoms in women. It is recommended that further clinical and review studies be conducted to develop complementary and alternative medicine.; Competing Interests: There are no conflicts of interest. (Copyright: © 2020 Journal of Family Medicine and Primary Care.)

Eccles, H. and V. Sharma (2023). "The association between premenstrual dysphoric disorder and depression: A systematic review." Journal of Affective Disorders Reports 12: 100504.
	Background: Due to the high comorbidity of premenstrual dysphoric disorder (PMDD) with other psychiatric conditions, it is important to understand the relationship between PMDD and major depression. In this study we aim to review studies that investigated the prevalence of PMDD and in those with major depression and vice versa. Method(s): A systematic review was completed December 2021 using PubMed, PsychINFO, CINAHL and EMBASE. The inclusion criteria used included: (1) original research studies, (2) a diagnosis of current or past history of depression, (3) a diagnosis of late luteal phase disorder (LLPD) as per DSM-III-R or PMDD as defined in DSM-IV or DSM-5, and (4) published in English. The authors screened the titles and abstracts of papers that were original research with participants who had a history of depression and a diagnosis of PMDD or late luteal phase disorder. The reference lists of review papers were searched for other relevant literature. Result(s): After 90 articles were screened for relevance and inclusion criteria, 10 articles were included in the study. They were published from 2001 to 2018 and varied across demographic areas. All but one study found a positive association between PMDD and history or current depression. Many studies found that a history of depression (no current depression) was associated with PMDD. Limitation(s): The way the studies diagnosed PMDD and depression was heterogeneous. More than half the studies did not use daily prospective ratings, which is a necessary step for a final confirmed diagnosis of PMDD. Therefore, it is possible that at least some of these participants did not have PMDD. Conclusion(s): PMDD is a prevalent disorder that affects women across the world. People with PMDD should be monitored for future development of depression and vice versa. Treatment of depression should consider this association. More studies are needed to understand the mechanisms responsible for the association.Copyright © 2023 The Author(s)

Economics Izmir University, o. (2023). 360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence.
	This study was planned to examine and compare the effects of standard diaphragm exercises with Pelvic floor muscle exercises (PFME) and 360-degree expanded diaphragm exercises with PFME on urinary symptoms, PFM functions and quality of life in women with stress urinary incontinence. Priary measure: Change of Pelvic floor muscle contraction during Valsalva; 9 secondary measures: Conditions: Stress Urinary Incontinence Diaphragmatic Breathing Pelvic Floor Muscle Exercise Intra-abdominal Pressure

Edey Katharine, A., et al. (2019). "Interventions for the treatment of Paget's disease of the vulva." The Cochrane Database of Systematic Reviews 6: CD009245.
	Background: This is an updated version of the original Cochrane Review published in Issue 10, 2013.Extramammary Paget's disease is a rare form of superficial skin cancer. The most common site of involvement is the vulva. It is seen mainly in postmenopausal white women. Paget's disease of the vulva often spreads in an occult fashion, with margins extending beyond the apparent edges of the lesion. There is a range of interventions from surgical to non-invasive techniques or treatments. The challenges of interventions are to remove or treat disease that may not be visible, without overtreatment and with minimisation of morbidity from radical surgery. There is little consensus regarding treatment. Surgery, by default, is the most common treatment, but it is challenging to excise the disease adequately, and recurrence is common, leading to repeated operations, and destruction of anatomy. Alternative treatments of photodynamic therapy, laser therapy, radiotherapy, topical treatments or even chemotherapy have been mooted, and it is important to evaluate the available evidence. It is essential to assess whether newer cell-specific treatments, such as photodynamic therapy and imiquimod, can reduce the need for radical surgery.; Objectives: To evaluate the benefits and harms of different treatment modalities for the management of Paget's disease of the vulva.; Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via Ovid) and Embase (via Ovid) up to 8 May 2018. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of review articles.; Selection Criteria: We searched for randomised controlled trials (RCTs) and well-designed non-randomised studies that compared different interventions in women with Paget's disease of the vulva, DATA COLLECTION AND ANALYSIS: Two review authors independently assessed whether potentially relevant studies met the inclusion criteria. We found no trials and, therefore, analysed no data.; Main Results: The search for the original version of the review identified 635 unique references. We found 31 references (which reported on 30 studies) in full text after inspection of titles and abstracts, but we excluded them all as they did not meet the inclusion criteria. However, we have included a comprehensive narrative account of studies where we identified an analysis of more than 10 women, as this forms the only evidence base in this rare disease. Surgery continues to be the mainstay of treatment in the current literature, with other treatments limited to case reports or treatment of inoperable or recurrent disease.This update between September 2013 and May 2018 identified 35 new studies. None of these met the inclusion criteria. There was only one prospective study of 5% imiquimod in recurrent Paget's disease of the vulva, which although of good quality only included eight women.; Authors' Conclusions: Since the last version of the review was published there are many more cases in the literature reporting a clinical response to 5% imiquimod cream. There is one prospective study of eight women treated with 5% imiquimod for recurrent Paget's disease of the vulva, and one prospective trial of 20 women was due to be reported. This increasing evidence for the safety and efficacy of 5% imiquimod will be helpful for women and clinicians alike. Ideally, a multicentre RCT of reasonable size is needed, but ongoing publications of high-quality non-randomised prospective studies will enhance the current available literature.

Edinoff, A. N., et al. (2021). "Brexanolone, a GABAA Modulator, in the Treatment of Postpartum Depression in Adults: A Comprehensive Review." Frontiers in Psychiatry 12: 699740.
	Postpartum depression (PPD) is one of the three major categories on the spectrum of postpartum psychiatric syndromes. Postpartum psychiatric syndromes are classified as either postpartum blues, postpartum depression, or postpartum psychosis. Postpartum depression is important to recognize clinically because of the effect it can have on the mother-child bond. The neurosteroid allopregnanolone, a progesterone derivative, is important for its role in positively modulating GABAA receptors. GABA-mediated signaling has been previously implicated in major depressive disorder. Allopregnanolone-mediated signaling has been identified as an important therapeutic target. Treatment with an allopregnanolone-analog, brexanolone, has been shown to improve depression scores in trials for the treatment of PPD. Brexanolone is a positive allosteric modulator of GABAA and is the first drug approved by the FDA to treat postpartum depression. Brexanolone enhances the inhibitory effects of GABAA, restores dysfunctional GABAA transmembrane channels, and mimics a naturally produced progesterone metabolite that fluctuates during pregnancy and postpartum. One open-label study and two phase two studies have some significant reduction in HAM-D scores after treatment and that the effect was still there 30 days post-treatment. Per the data reported, intravenous infusion of brexanolone could be efficacious and safe for the treatment of women suffering from postpartum depression.© Copyright © 2021 Edinoff, Odisho, Lewis, Kaskas, Hunt, Cornett, Kaye, Kaye, Morgan, Barrilleaux, Lewis, Viswanath and Urits.

Edmed Shannon, L., et al. (2022). "Sleep and health-related quality of life in women following a cancer diagnosis: results from the Women's Wellness after Cancer Program in Australia." Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 30(12): 10243-10253.
	Purpose: Sleep disturbance after cancer treatment could compromise recovery. This paper examined the associations between post-treatment sleep problems and health-related quality of life (HRQoL), and the effectiveness of an e-enabled lifestyle intervention on sleep outcomes.; Methods: The Women's Wellness after Cancer Program (WWACP) was examined in a single blinded, multi-centre randomised controlled trial. Data were collected from 351 women (M age = 53.2, SD = 8.8; intervention n = 175, control group n = 176) who had completed surgery, chemotherapy and/or radiotherapy for breast, gynaecological or blood cancers within the previous 24 months. Participants completed the Pittsburgh Sleep Quality Index (PSQI) at baseline (prior to intervention randomisation), and at 12 and 24 weeks later. Sociodemographic information, menopausal symptoms (Greene Climacteric Scale) and HRQoL (36-Item Short Form Health Survey; SF-36) were also collected. Linear panel regression was used to examine the association between sleep variables and SF36 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. A difference-in-difference regression model approach was used to examine the intervention effect on the sleep outcomes.; Results: After adjustment for potential confounders, the sleep variables (except sleep duration) significantly predicted physical, but not mental, HRQoL. There was no statistically significant effect of the intervention on sleep outcomes at 12 or 24 weeks.; Conclusion: Women who have completed treatment for cancer experience sleep problems that are associated with decreased physical HRQoL. Improving sleep through targeted interventions should improve their physical HRQoL. Improved targeting of the sleep components of the WWACP should be explored. (© 2022. The Author(s).)

Edmonds, K., et al. (2023). "Apical support after laparoscopic hysterectomy for benign conditions: a randomized controlled trial comparing vaginal cuff closure techniques." American Journal of Obstetrics and Gynecology 228(3 Supplement): S821.
	Objectives: As the approximately 600,000 women that undergo minimally invasive hysterectomy per year age, they are at increased risk for pelvic organ prolapse. The route of vaginal cuff closure after total laparoscopic hysterectomy has not been standardized and can be performed laparoscopically or vaginally. This study was designed to compare pelvic floor support between these closure techniques after laparoscopic hysterectomy. Material(s) and Method(s): This randomized controlled trial included adult female patients scheduled to undergo a total laparoscopic hysterectomy for benign indication. Exclusion criteria included a planned concurrent prolapse procedure, malignancy, and a pelvic organ prolapse quantitation system (POPQ) C Point greater than -4. Preoperative (preop) POPQ exams were performed by blinded Urogynecologists to assess pelvic support within 1 month of surgery. Subjects were randomized to vaginal or laparoscopic cuff closure on the day of surgery. Vaginal closure was performed vertically with absorbable suture and laparoscopic closure was performed horizontally with delayed-absorbable suture. POPQ exams were then repeated by blinded Urogynecologists at 6-8 weeks and 1 year postoperatively (postop). The study was powered to detect a 1.75cm difference, with an estimated effect size of 0.97. Alpha was set at 0.025 to correct an alpha of 0.05 for two primary study timepoints. Attrition was set at 30% to account for patient dropout before the last measurement point at 1 year. Power was set at 0.8. These assumptions resulted in a required sample size of up to 31 patients per group, or 62 patients in total. Result(s): 57 subjects were enrolled in the study; 44 subjects completed 6-8 week follow-up, and 33 subjects were evaluated at 1 year. Subject enrollment and retention were impacted by the COVID-19 Pandemic resulting in a small sample size. Baseline demographics were similar between groups except for a significant difference between surgeon training status with laparoscopic closures performed mostly by fellows (82.6%) and vaginal closures performed mostly by residents (95.2%, p<0.001). The primary outcome of the mean difference of Point C (preop - postop value) between laparoscopic and vaginal closure was 0.98 cm and 1.24 cm, respectively at 6-8 weeks postop (p = 0.55), and 1.22 cm and 1.63 cm, respectively at 1 year postop (p = 0.48, Figure 1). These positive mean differences indicate increased apical support for both study groups and timepoints. Mean differences for all other points of the POPQ (Table 1) and postop complication rates were non-significant between groups at all timepoints. Conclusion(s): There is no significant difference in post-hysterectomy apical support after total laparoscopic hysterectomy between laparoscopic and vaginal cuff closure techniques at 6-8 weeks and 1 year postop. [Formula presented] [Formula presented]Copyright © 2022

Education Poznan University of, P. (2021). Effect of Time-restricted Eating on Cognitive Function and Other Biopsychosocial Factors in Menopausal Women Undertaking a 12-week Exercise Programme.
	No Results Available Behavioral: Exercise and Time-Restricted Eating|Behavioral: Exercise only Brain-derived neurotrophic factor|Glial cell derived neurotrophic factor|Insulin|Glucose|LDL-cholesterol|Muscle mass|Fat mass|Stroop test|N-back test|Electroencephalography|One-repetition maximum test|Ruffier test|Menopause Rating Scale|The Menopause-Specific Quality of Life Questionnaire Female Not Applicable 80 Other Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention BJozwiak_PhD July 1, 2023

Education Poznan University of, P., et al. (2023). Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology.
	No Results Available Other: Visceral therapy|Other: Placebo NRS|platforms|postural pattern by Halla-Wernhama-Littlejohna|pelvic type assessment|CromWell (measurement of oral dilation)|standarised questonarie by Kulesa-Morawiecka et al.|According to the Polish version of the questionnaire, the highest point value, i.e. 171, indicates the lowest rank in the quality of life assessment, while the lowest point value indicates the highest level of quality of life.|Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.|visceral techniques and placebo Female Not Applicable 200 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 305/23 September 1, 2026

Education Prof Dr. Cemil, T. and H. Organization Research (2023). Comparison of Vaginal Axis on MRI in Alternative Apical Prolapse Surgeries to Sacrocolpopexy.
	No Results Available Procedure: laparoscopic lateral suspension|Procedure: laparoscopic pectopexy|Procedure: Sacrospinous ligament fixation Vaginal axis|Vaginal distances|Prolapse symptoms, Colorectal-Anal Impact Questionnaire|Prolapse symptoms|Urinary Symptoms|Postoperative de novo dyspareunia|Sexual functions|Quality of life measures|Patient Global Impression of Improvement (PGI-I) Female Not Applicable 60 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Other E-10840098-772.02-4704 December 27, 2023

Education Prof Dr. Cemil, T. and H. Organization Research (2023). Vaginal Axis on Magnetic Resonance Imaging After Laparoscopic Pectopexy Surgery: a Controlled Study.
	No Results Available Procedure: laparoscopic pectopexy Anatomic Success|Urge Symptoms stres incontinence|Sexual functions Female Not Applicable 21 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 77 July 1, 2023

Edwards, L. M., et al. (2021). "A Systematic Review and Meta-Analysis of Risk Factors for Postpartum Depression Among Latinas." Maternal and Child Health Journal.
	OBJECTIVES: The purpose of this article was to describe the findings from a systematic review, quality review, and meta-analysis of risk factors for postpartum depression among adult Latinas in the United States. METHODS: Databases were searched from inception to May 2020 for studies published in English related to Latina/Hispanic mothers and risk factors of postpartum depression. Of 115 abstracts screened, 10 met the inclusion criteria for the review and meta-analysis. Eleven risk factors from these studies were included: acculturation, age, economic stress, education, marital status, number of children, prenatal depression, recent and remote intimate partner violence (IPV), general social support, and partner/father's social support. RESULTS: Partner/father's social support had a large effect size. Prenatal depression and recent IPV had medium effect sizes, while education, economic stress, general social support and remote IPV had small effect sizes. Negligible effect sizes were found for age, marital status, number of children, and acculturation. CONCLUSIONS: Prenatal depression, IPV, social support (general and from partner/father), economic stress and education are risk factors that should be screened for when working with perinatal Latinas. Future directions for clinical practice and research are discussed.

Edwin, A., et al. (2023). "Cost effectiveness of female overactive bladder syndrome therapy." Journal of Obstetrics and Gynaecology Research 49(Supplement 1): 135-136.
	Overactive bladder (OAB) syndrome is a chronic condition that has an impact on patients' daily activities and health-related quality of life (HRQL). First to fourth line therapy are often used following insufficient results with high rates of discontinuation. We aim to discuss how cost can be the cause of low persistence of the treatment of female OAB. This study systematically reviewed persistence/ adherence data in female OAB therapy. A search focused on the intersection of OAB therapy, persistence / adherence, and cost was conducted in MEDLINE along with Scopus and Google Scholar that published after 2010. Inclusion criteria are original articles of full-text length. Exclusion criteria are abstracts, review articles, and chapters from books. A total of 50 articles were included in the review. Results showed high rates of discontinuation, from 4%-40%, with 43%-83% discontinuing within the first 30 days and rise over time. The estimated average annual direct cost of OAB per patient are $500 to $3395. In addition, nursing home costs were estimated at $5.1 billion/year and it was estimated that work absenteeism related to OAB costs $1.2 billion/year. The low levels of persistence documented in this review reveal cause for concern about the balance of the cost effectiveness OAB therapy, especially in low resource country with limited coverage of health insurance. Strategies should be identified to increase persistence including the use of artificial intelligence to gain more cost effectiveness and minimal side effects over any existing traditional methods.

Efficace, F., et al. (2021). "Patient-Reported Outcomes as Independent Prognostic Factors for Survival in Oncology: Systematic Review and Meta-Analysis." Value in Health 24(2): 250-267.
	Objectives: Assessment of patient-reported outcomes (PROs) in oncology is of critical importance because it provides unique information that may also predict clinical outcomes. Method(s): We conducted a systematic review of prognostic factor studies to examine the prognostic value of PROs for survival in cancer. A systematic literature search was performed in PubMed for studies published between 2013 and 2018. We considered any study, regardless of the research design, that included at least 1 PRO domain in the final multivariable prognostic model. The protocol (EPIPHANY) was published and registered in the International Prospective Register of Systematic Reviews (CRD42018099160). Result(s): Eligibility criteria selected 138 studies including 158 127 patients, of which 43 studies were randomized, controlled trials. Overall, 120 (87%) studies reported at least 1 PRO to be statistically significantly prognostic for overall survival. Lung (n = 41, 29.7%) and genitourinary (n = 27, 19.6%) cancers were most commonly investigated. The prognostic value of PROs was investigated in secondary data analyses in 101 (73.2%) studies. The EORTC QLQ-C30 questionnaire was the most frequently used measure, and its physical functioning scale (range 0-100) the most frequent independent prognostic PRO, with a pooled hazard ratio estimate of 0.88 per 10-point increase (95% CI 0.84-0.92). Conclusion(s): There is convincing evidence that PROs provide independent prognostic information for overall survival across cancer populations and disease stages. Further research is needed to translate current evidence-based data into prognostic tools to aid in clinical decision making.Copyright © 2020 ISPOR-The Professional Society for Health Economics and Outcomes Research

Eftekhar, M., et al. (2024). "Effectiveness of Autologous Platelet-Rich Plasma Therapy in Women with Repeated Implantation Failure: A Randomized Clinical Trial." International Journal of Fertility and Sterility 18(2): 162-166.
	Background: Platelet-rich plasma (PRP) therapy has been shown to enhance tissue regeneration by expressing sev-eral cytokines and growth factors (GFs). This study investigated the effect of intrauterine infusion of PRP as a non-invasive autologous GF on pregnancy outcomes in women with repeated implantation failure. Material(s) and Method(s): This randomized clinical trial was conducted to compare the pregnancy rates between two groups of women who were candidates for the frozen-thawed embryo transfer with a history of two or more implantation failures. The PRP group (n=33) was treated with hormone replacement therapy+0.5 cc to 1 cc PRP infused into the uterine cavity two days before the embryo transfer. The control group (n=33) was only treated with hormone replacement therapy. The endometrial preparation process was done similarly in both groups. The chemical, clinical, and ongoing pregnancy, and implantation rates were compared between the two groups. Result(s): Our results showed that the chemical pregnancy rate was not statistically higher in the PRP group in compari-son with the control group (36.4 vs. 24.2%). In addition, the clinical pregnancy, ongoing pregnancy, and implantation rates were higher in the PRP group than the control group; however, the difference between the two groups was not statistically significant. Conclusion(s): Administration of intrauterine PRP before embryo transfer in women with repeated implantation failure (RIF) does not affect assisted reproductive technology (ART) outcomes (registration number: IRCT2016090728950N3).Copyright © 2024, Royan Institute (ACECR). All rights reserved.

Egawa-Takata, T., et al. (2022). "Adjuvant Chemotherapy for Endometrial Cancer (ACE) trial: A randomized phase II study for advanced endometrial carcinoma." Cancer Science 113(5): 1693-1701.
	This study evaluated the feasibility and efficacy of three postoperative adjuvant chemotherapy regimens for endometrial cancer. Endometrioid cancer patients with intermediate-risk stage I and II or high-risk stage III and IV disease were randomly assigned to receive six cycles of either paclitaxel-epirubicin-carboplatin (TEC), paclitaxel-anthracycline (doxorubicin)-carboplatin (TAC), or dose-dense paclitaxel-carboplatin (ddTC). The primary end-point was the completion rate (CRate) of six cycles of treatment. The secondary end-points were progression-free survival (PFS) and overall survival (OS). One hundred and one patients were treated as follows: 33 received TEC, 33 TAC, and 35 ddTC. The CRates for TEC, TAC, and ddTC were 94%, 64%, and 69%, respectively (P =.005). The TEC CRate was significantly higher than for the other two groups. However, the PFS and OS outcomes were not statistically different between the three groups. The 2-year survival rates were 94%, 97%, and 97% for TEC, TAC, and ddTC, respectively. When compared to the current standard treatments for endometrial cancer, TEC is a promising candidate for a phase III trial based on its significantly superior CRate and equivalent PFS and OS. This study is registered with UMIN Clinical Trials Registry (UMIN000008911).Copyright © 2022 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

Eichler, S., et al. (2023). "A potent non-hormonal option for the treatment of postmenopausal vaginal dryness with high tolerability." Maturitas 173: 95-96.
	Genitourinary syndrome of menopause (GSM) is considered a chronic condition with urogenital implications caused by estrogen deficiency typically after onset of menopause. Vaginal dryness accompanied by burning and itching is one of the most prevalent and bothersome symptoms of GSM. Affected women suffer from reduced lubrication and, those who are sexually active, also from dyspareunia. Non-hormonal therapies, such as vaginal moisturizers or lubricants, are recommended as first-line treatments to achieve the relief of symptoms, while improving the quality of life. Due to emerging demand for pessary formulations, we evaluated the efficacy and tolerability of a non-hormonal pessary containing nourishing lipids and lactic acid. Therefore, a prospective, open-label clinical trial was performed, including 79 postmenopausal women with symptoms of vaginal dryness. The patients applied one pessary daily within the first week followed by two pessaries per week for the next 31 days. After 38 days of treatment, a treatment free period of 6 days completed the trial. Subjective symptoms of vaginal dryness, such as feeling of dryness, itching, burning and pain (unrelated and related to sexual intercourse), were assessed at every visit, while the objective vaginal health index (VHI) was only examined at beginning and end of treatment. Data regarding the impact on patients' quality of life, efficacy and tolerability were evaluated using various questionnaires. Our data show that symptoms of vulvovaginal dryness, itching, burning and pain as well as dyspareunia significantly decreased from baseline to end of treatment (day 38) and beyond. Quality of life assessed by DIVA (day-to day impact of vaginal aging) questionnaire, and VHI also clearly improved over the study period. The tolerability was rated as 'good' or 'very good' by most of the patients and by the investigator. No serious adverse events and only a low number of mild adverse events rated as related to the vaginal pessary were reported. Overall, this study identifies the investigated non-hormonal pessary as a potent option for the treatment of postmenopausal symptoms of vaginal dryness with a high tolerability. It can therefore be recommended as a first-line treatment that contributes to maintaining a healthy vaginal environment in postmenopausal women.Copyright © 2023

Eijkenboom, L., et al. (2022). "Strategies to safely use cryopreserved ovarian tissue to restore fertility after cancer: a systematic review." Reproductive Biomedicine Online 45(4): 763-778.
	Ovarian tissue cryopreservation and subsequent autotransplantation is a successful technique for fertility preservation in oncological patients. However, there are concerns regarding safety, as the graft may contain malignant cells that could lead to the reintroduction of cancer. To circumvent this problem several experimental strategies are being pursued. This systematic review was conducted to provide an overview of the strategies aiming to safely use cryopreserved human ovarian tissue to restore fertility after cancer. Thirty-one studies were included, covering five different experimental strategies: (i) in-vitro maturation of oocytes, (ii) constructing an artificial ovary as a scaffold for reseeding pre-antral follicles, (iii) purging strategies aimed at the eradication of contaminating malignant cells, (iv) maturation of oocytes by xenotransplantation, and (v) stem cell-based oogenesis. These strategies to circumvent the reintroduction of cancer cells through ovarian tissue autotransplantation are being developed, but so far have not reached the stage of clinical trials. Further research is required to establish their risks and effectiveness while the ethical aspects associated with these strategies also need to be discussed. Despite the fact that these experimental procedures are still under development, they might provide safe fertility restoration options for oncological patients in the future. (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Eisenberg, N., et al. (2021). "Short- and Long-Term Complications of Intraoperative Benign Ovarian Cyst Spillage: A Systematic Review and Meta-analysis." Journal of Minimally Invasive Gynecology 28(5): 957-970.
	Objective: To review short- and long-term complications associated with intraoperative rupture of benign ovarian cysts. Data Sources: The Cochrane Central Register of Controlled Trials, BIOSIS, Medline (Ovid), Web of Science, ClinicalTrials.gov, and Google Scholar were searched using the following terms and their combinations: "spillage," "rupture," "leakage," "ovarian cyst," "teratoma," "dermoid," "operative," "surgery," "outcome." Methods of Study Selection: Randomized controlled and observational studies evaluating the operative outcomes of surgical treatment of ovarian cysts with intraoperative spillage compared with those of surgical treatment of ovarian cysts without spillage were included. A systematic review and meta-analysis following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was performed. Tabulation, Integration, and Results: A total of 28 studies were included in the qualitative analysis and 12 in the quantitative analysis. Ovarian cyst diameter was not found to be associated with the risk for spillage (relative risk [RR] 0.75; 95% confidence interval [CI], -0.33 to 1.82). Intraoperative benign ovarian cyst rupture was not associated with adverse short- and long-term outcomes such as reoperation (RR 1.16; 95% CI, 0.39-3.48), infertility (RR 0.73; 95% CI, 0.15-3.63), transient fever (RR 3.22; 95% CI, 0.83-12.51), and readmission (RR 1.00; 95% CI, 0.33-2.98). However, intraoperative spillage was found to be associated with increased risk for benign recurrence (RR 3.1; 95% CI, 1.05-9.14). A subgroup analysis of the studies that included only dermoid cysts showed an association between intraoperative cyst rupture and postoperative chemical peritonitis (RR 9.36; 95% CI, 1.20-73.28). Conclusion(s): Intraoperative ovarian cyst spillage of a benign cyst is associated with limited adverse clinical outcomes. Although the surgical approach (minimally invasive vs open) should not be affected by the concern regarding an intraoperative cyst rupture, maximal efforts should be made to prevent intra-abdominal spillage.Copyright © 2020

Eisenlohr-Moul Tory, A., et al. (2022). "Effects of acute estradiol and progesterone on perimenstrual exacerbation of suicidal ideation and related symptoms: a crossover randomized controlled trial." Translational psychiatry 12(1): 528.
	Female suicide attempts peak peri-menstrually-around the onset of menses-when the ovarian steroids estradiol (E2) and progesterone (P4) fall rapidly. Given preclinical evidence that withdrawal from either E2 or P4 can provoke behaviors consistent with elevated suicide risk, we hypothesized that withdrawal from one or both of these steroids contributes to perimenstrual exacerbation of suicidal ideation (SI) and related symptoms. In a randomized, controlled, double-blind crossover experiment (NCT03720847), a transdiagnostic sample of naturally cycling, medically healthy psychiatric outpatients reporting past-month SI completed two conditions during two different 14-day experimental intervals (days 7-20 where the luteinizing hormone surge = day 0), separated by a monthlong washout cycle. In the E2 and P4 (EP) condition, participants received transdermal E2 (0.1 mg/day) plus oral micronized P4 (200 mg/day as 100 mg twice daily) to buffer perimenstrual steroid withdrawal. A matched placebo (PBO) condition allowed natural perimenstrual steroid withdrawal. Participants reported daily SI and planning (primary outcomes) and indices of depression (low mood, hopelessness), threat sensitivity (anxiety, perceived stress), executive functioning (difficulty concentrating, impulsivity), and social cognitive bias (rejection sensitivity, perceived burdensomeness). In baseline cycles, no participant met prospective criteria for DSM-5 premenstrual dysphoric disorder, but 59% met all criteria except full follicular symptom remission, and 93% showed the highest SI in the perimenstrual phase. Of 29 randomized, 28 were analyzed (14 EP-PBO, 14 PBO-EP). Experimental administration of E2 and P4 (relative to PBO) reduced perimenstrual exacerbation of SI, suicide planning, depression, hopelessness, perceived stress, rejection sensitivity, and perceived burdensomeness, particularly in the perimenstrual (natural E2 and P4 withdrawal) days. Further, delayed withdrawal from experimental E2 and P4 (but not PBO) recapitulated SI, hopelessness, and rejection sensitivity. Acute perimenstrual withdrawal from ovarian steroids may play a causal role in perimenstrual worsening of depression and SI. (© 2022. The Author(s).)

Ejaz, K., et al. (2022). "Use of gonadotropin-releasing hormone agonists for ovarian preservation in patients receiving cyclophosphamide for systemic lupus erythematosus: A meta-analysis." Lupus 31(14): 1706-1713.
	Background: Cyclophosphamide (CYC) has known cytotoxic effects on ovarian reserve and has been linked to premature ovarian failure (POF) in systemic lupus erythematosus (SLE). The concurrent use of gonadotropin-releasing hormone agonists (GnRHas) is postulated to preserve ovarian function by reducing the number of follicles exposed to CYC, but there is paucity of data to establish its efficacy. We conducted a meta-analysis to summarize the effect of concurrent GnRHa use in persevering ovarian function and pregnancy.; Methods: English language databases of PubMed, Embase, and Cochrane were searched to include studies published between 2000 and 2021. Studies in females with rheumatic diseases receiving concurrent GnRHa and CYC therapy to evaluate ovarian preservation as defined by amenorrhea, follicle stimulating hormone (FSH), anti-mullerian hormone (AMH), or estradiol levels or successful pregnancy were included. We used a fixed effect, exact, Mantel-Haenszel approach to estimate the overall odds ratio (OR) and associated 95% confidence intervals (95% CIs).; Results: Seven studies with 218 female patients were included. The ovarian function was preserved in 125/132 (94.6%) of women who received GnRHa concurrently with CYC compared to 50/86 (58%) of women who did not receive GnRHa (OR = 10.3, CI = 4.83-36.29). The OR for pregnancy with GnRHa use = 2.94 (CI = 1.04-9.89).; Conclusion: Our results based on limited published studies suggest that concurrent GnRHa use preserves ovarian function and increase odds of pregnancy. It can be considered for premenopausal SLE females receiving CYC . Long-term follow-up studies are needed to establish the efficacy and safety of GnRHa use for ovarian preservation.

El Hajj, H., et al. (2021). "Rationale and study design of the CHIPPI-1808 trial: a phase III randomized clinical trial evaluating hyperthermic intraperitoneal chemotherapy (HIPEC) for stage III ovarian cancer patients treated with primary or interval cytoreductive surgery." ESMO Open 6(2): 100098.
	BACKGROUND: Ovarian cancer remains the most lethal gynecologic malignancy with high recurrence rates. Because recurrence involves primarily the peritoneum, intraperitoneal chemotherapy is being evaluated as a new approach to treat microscopic peritoneal disease. One trial showed that cisplatin-paclitaxel intraperitoneal chemotherapy with intravenous paclitaxel improved survival but increased morbidity. Another trial reported a significant improvement in overall survival (OS) and disease-free survival (DFS) without increasing the morbidity (P = 0.76) or mortality rates (hazard ratio 0.67, P = 0.02) after adding hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreduction. The current trial aims to evaluate the impact of adding HIPEC to primary or interval cytoreductive surgery for epithelial ovarian cancer (EOC) on the efficacy, safety, treatment feasibility, and quality of life. PATIENTS AND METHODS: This is an international, multicenter, open-label, randomized (1 : 1), two-arm, phase III clinical trial that will enroll 432 patients with newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage III EOC. Patients are randomized to receive or not HIPEC with the standard of care. Inclusion criteria include patients with FIGO stage III EOC, Fallopian tube carcinoma or primary peritoneal cancer who undergo complete primary or interval cytoreduction. The primary objective is to assess DFS of the addition of HIPEC. Secondary objectives are the assessment of OS, safety, return to intended oncologic treatment, quality of life and the trade-off between efficacy and morbidity. CONCLUSIONS: The results might help extend the indications of HIPEC to include patients undergoing primary cytoreduction, providing a standardized protocol for HIPEC in EOC management and reliable information on the quality of life after adding HIPEC.

El Moujahed, L., et al. (2023). "Response to Ovarian Stimulation for Urgent Fertility Preservation before Gonadotoxic Treatment in BRCA -Pathogenic-Variant-Positive Breast Cancer Patients." Cancers 15(3).
	BRCA 1/2 pathogenic variants increase the risk of developing early and aggressive breast cancers (BC). For these patients, fertility potential can be directly affected by oncologic treatments. In addition, evidence indicates that BRCA -mutated women had a significant reduction in their ovarian reserve. In order to improve their chances of conception after the completion of cancer treatments, fertility preservation should be proposed before the administration of gonadotoxic drugs, ideally by oocyte vitrification after controlled ovarian hyperstimulation (COH). The present investigation aims to assess the ovarian response to COH in BRCA 1/2 -pathogenic-variant carriers diagnosed with BC. Patient characteristics and COH outcomes were compared between BRCA -positive ( n = 54) and BRCA -negative ( n = 254) patients. The number of oocytes recovered did not differ between the two groups. However, the oocyte maturation rate and the number of mature oocytes obtained (7 (4.5-11.5) vs. 9 (5-14) oocytes, p = 0.05) were significantly lower in the BRCA -mutated patients. Although individualized COH protocols should be discussed, BRCA -mutated patients would benefit from FP before BC occurs, in order to cope with the potential accelerated decline of their ovarian reserve, optimize the success rate of FP by repeating COH cycles, and to preserve the feasibility of PGT-M by collecting a large amount of eggs.

El Sabeh, M., et al. (2021). "Simvastatin Inhibits Wnt/β-Catenin Pathway in Uterine Leiomyoma." Endocrinology 162(12).
	The Wnt/β-catenin pathway is upregulated in uterine leiomyomas, the most common benign tumors in the female reproductive tract. Simvastatin is an antihyperlipidemic drug, and previous in vitro and in vivo reports showed that it may have therapeutic effects in treating leiomyomas. The objective of this study was to examine the effects of simvastatin on the Wnt/β-catenin signaling pathway in leiomyoma. We treated primary and immortalized human leiomyoma cells with simvastatin and examined its effects using quantitative real-time polymerase chain reaction, Western blotting, and immunocytochemistry. We also examined the effects using human leiomyoma tissues from an ongoing randomized controlled trial in which women with symptomatic leiomyoma received simvastatin (40 mg) or placebo for 3 months prior to their surgery. The results of this study revealed that simvastatin significantly reduced the expression of Wnt4 and its co-receptor LRP5. After simvastatin treatment, levels of total β-catenin and its active form, nonphosphorylated β-catenin, were reduced in both cell types. Additionally, simvastatin reduced the expression of Wnt4 and total β-catenin, as well as nonphosphorylated β-catenin protein expression in response to estrogen and progesterone. Simvastatin also inhibited the expression of c-Myc, a downstream target of the Wnt/β-catenin pathway. The effect of simvastatin on nonphosphorylated-β-catenin, the key regulator of the Wnt/β-catenin pathway, was recapitulated in human leiomyoma tissue. These results suggest that simvastatin may have a beneficial effect on uterine leiomyoma through suppressing the overactive Wnt/β-catenin pathway.

Elansary, M., et al. (2023). "Effect of Immediate Referral vs a Brief Problem-solving Intervention for Screen-Detected Peripartum Depression: A Randomized Clinical Trial." JAMA Network Open 6(5): E2313151.
	Importance: The US Preventive Services Task Force recommends screening adults for depression in settings with programs in place to ensure receipt of appropriate care. Best practices regarding how to ensure such care are unknown, particularly for pregnant and postpartum persons. Objective(s): To compare the effectiveness of 2 strategies for the initial management of screen-detected peripartum depressive symptoms. Design, Setting, and Participant(s): This randomized comparative effectiveness trial was performed from February 1, 2018, to June 30, 2020, at the prenatal clinic, postpartum unit, and pediatric clinic within an urban safety-net hospital. Participants included peripartum persons with positive depression screen results. Data were analyzed from July 6, 2020, to September 21, 2022, based on intention to treat. Intervention(s): Engagement-focused care coordination (EFCC), which used shared decision-making and motivational techniques to refer patients to outside mental health services, and problem-solving education (PSE), a brief cognitive-behavioral program delivered at the screening site. Main Outcomes and Measures: The primary outcome consisted of severity of depressive symptoms; secondary outcomes included severity of anxiety symptoms and engagement with care, each measured bimonthly over 12 months. Rates of symptom elevations were modeled using negative binomial regression; rates of symptom trajectories were modeled using treatment x time interactions. Result(s): Among the 230 participants (mean [SD] age, 29.8 [5.8] years), 125 (54.3%) were Black and 101 (43.9%) were Hispanic or Latina. At baseline, 117 participants (50.9%) reported at least moderately severe depressive symptoms (Quick Inventory of Depressive Symptomatology score >=11), and 56 (24.3%) reported clinically significant anxiety symptoms (Beck Anxiety Inventory score >=21). Across 6 assessment time points, the mean (SD) number of moderately severe depressive symptom episodes in EFCC was 2.2 (2.2), compared with 2.2 (2.1) in PSE, for an adjusted rate ratio (aRR) of 0.95 (95% CI, 0.77-1.17). The mean (SD) number of anxiety symptom elevations in EFCC was 1.1 (1.8), compared to 1.1 (1.6) in PSE, for an aRR of 0.98 (95% CI, 0.69-1.39). There were significant treatment x time interactions relative to mean depressive symptom scores (-0.34 [95% CI, -0.60 to -0.08]; P =.009 for interaction term), favoring EFCC. There were no differences in engagement with care. Conclusions and Relevance: In this randomized comparative effectiveness trial, there were no differences in depressive or anxiety symptom burden across comparators; however, the evidence suggested improved depressive symptom trajectory with immediate referral. Further work is necessary to guide approaches to management following depression screening for peripartum persons. Trial Registration: ClinicalTrials.gov Identifier: NCT03221556.Copyright © 2023 American Medical Association. All rights reserved.

Elassall Gena, M., et al. (2022). "Levonorgestrel-releasing intrauterine system versus systemic progestins in management of endometrial hyperplasia: A systemic review and meta-analysis." Journal of Gynecology Obstetrics and Human Reproduction 51(8): 102432.
	Introduction: Endometrial hyperplasia is associated with varying risk of endometrial cancer. The aim of this review is to assess effectiveness of levonorgestrel-releasing intrauterine system (LNG-IUS), compared to systemic progestins, in management of endometrial hyperplasia MATERIALS AND METHODS: A search on studies comparing LNG-IUS to systemic progestins was conducted on Scopus, Web of science, Cochrane, PubMed and Embase databases, from the date of inception to September 20 th , 2020. Studies were excluded if they were non-comparative, animal studies, review articles, case reports, case series, and conference papers. Primary outcomes include resolution/regression rate, failure rate, and hysterectomy rate. Analysis was pooled using random effect model and was expressed as pooled odds ratios (OR) and 95% confidence interval (CI). Quality assessment was performed using Cochrane Risk of Bias Tool and the Newcastle-Ottawa Scale (NOS) assessment tool. MOGGE Meta-analysis Matrix was used to illustrate multiple subgroup analyses.; Results: Out of 341 studies retrieved from literature search, 12 were eligible. LNG-IUS yielded significantly higher resolution/regression rate (91.3% vs 68.6%, OR 3.42, 95% CI 1.86-6.30). Failure and hysterectomy rates were significantly lower in LNG-IUS group compared to systemic progestins' group (19.2% vs. 32.3%, OR 0.34, 95% CI 0.20-0.57 and 9.3% vs. 24.1%, OR 0.41, 95% CI 0.29-0.57, respectively). Subgroup analysis of studies including complex hyperplasia only did not show significant difference in resolution/regression rate was not statistically significant.; Conclusion: LNG-IUS is associated with high success rate in management of women with endometrial hyperplasia. However, specific effectiveness of LNG-IUS on more advanced histologic subtypes is less studied.; Competing Interests: Declaration of Competing Interest None (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

Elasy, A. N., et al. (2022). "Vaginal misoprostol versus combined intracervical foley's catheter and oxytocin infusion for second trimester pregnancy termination in women with previous caesarean sections: a randomised control trial." Journal of Obstetrics and Gynaecology 42(7): 2962‐2969.
	Second trimester pregnancy termination has been reported to be associated with 3–5 times higher maternal morbidity and mortality risks more than first trimester termination. Medical methods had been thoroughly assessed and it is considered the anchor of the safe abortion care. Howevere, there is no global agreement regarding the ideal method for induction of the second trimester abortion in a scarred uterus. The aim of this study was to achieve vaginal expulsion in an expeditious manner with less maternal complications. A total of 158 women having, a history of previous caesarean section undergoing second trimester pregnancy termination, were randomly allocated into group (1) vaginal misoprostol group (n = 79) or group (2) combined intracervical foley’s catheter plus intravenous oxytocin infusion group (n = 79). The primary endpoint was complete fetal expulsion. Meanwhile, secondary outcomes were the rates of maternal complications, in terms of the need for surgical evacuation of retained product of conception (ERPOC), severe haemorrhage, uterine rupture, blood transfusion, cervical laceration, diarrhoea, vomiting and fever. The registration number of this trial https://clinicaltrials.gov/ct2/show/NCT04501809. This study showed that the combined use of intracervical foley’s catheter and oxytocin is an effective, and safe alternative to vaginal misoprostol for termination of the second trimester pregnancy in women having a previous caesarean delivery.Impact statementWhy was this study conducted? The purpose of this study is to achieve an expeditious delivery for second trimester pregnancy termination in a scarred uterus by combined mechanical and pharmacological methods without significant morbidity. Physicians should balance the benefit of achieving vaginal exlpusion in an expeditious manner versus the risk of uterine rupture or any other maternal complications. What does this add to what is known? This study showed that a combined mechanical and pharmacolohical approach for second trimester termination of pregnancy has comparable efficacy and safety to vaginal misoprostol which is more affordable to the low resources countries where termination of pregnancy in a scarred uterus still has an increased maternal morbidity. What is the implication of this study on clinical practice? The combined use of intracervical foley’s catheter with intravenous oxytocin infusion is a safer option than vaginal misoprostol with less serious maternal complications.

El-Azab Ahmed, S. and W. Siegel Steven (2019). "Sacral neuromodulation for female pelvic floor disorders." Arab Journal of Urology 17(1): 14-22.
	Objective : To systematically review available studies on the effectiveness and safety of sacral neuromodulation (SNM) in women with various pelvic floor disorders not responding to more conservative treatment, as SNM is indicated in such women. Methods : Data source: We did a systematic review through the PubMed and the Cochrane Library according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement from 1998 to 2018 in English using the keywords 'Sacral Neuromodulation' and 'Sacral Nerve Stimulation'. Study selection : Randomised controlled trials and prospective studies were selected, with a minimum sample size of 20 patients and ≥6 months of follow-up. Results : We identified 19 articles. A ≥50% reduction in symptoms qualifies the patient for a permanent implant. Several advances have been introduced into SNM to decrease the invasiveness of the procedure, including a smaller implantable pulse generator battery (improved comfort) and better localisation of the lead wire (improved outcome). The literature reports success for overactive bladder (OAB) to range between 56% and 68% (up to 80%). We report a 5-year therapeutic success rate of 67%. In our previous studies, 38% of our patients with urge urinary incontinence achieved complete continence at 60-months follow-up, with a therapeutic response rate of 57%. Effectiveness in patients with urinary retention and faecal incontinence are about 70% and 85%, respectively. Effectiveness in interstitial cystitis/bladder pain syndrome appears to be lower compared with OAB. Conclusion : SNM is a safe and effective therapy for women with various pelvic floor disorders. Abbreviations: BONT: botulinum toxin; FDA: USA Food and Drug Administration; FS: Fowler's syndrome; FI: faecal incontinence; IC/BPS: interstitial cystitis/bladder pain syndrome; ICIQ-OABqol: International Consultation on Incontinence Modular Questionnaire-Overactive Bladder Symptoms Quality of Life; INS: implantable neurostimulator; OAB: overactive bladder; PET: positron emission tomography; PNE: peripheral nerve evaluation; PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses; PTNM: posterior tibial nerve modulation; PVR: post-void residual urine; QoL: quality of life; RCT: randomised controlled trial; SNM: sacral neuromodulation; (U)UI: (urgency) urinary incontinence.

Elderbashy, M. S., et al. (2021). "High intensity interval training for cardiometabolic disease prevention in polycystic ovarian syndrome females: Literature review." Journal of Cardiovascular Disease Research 12(5): 937-943.
	Aims: Thisnarrative review aims to examine the effect of high intensity interval training (HIIT) for prevention ofcardiometabolic disease in females with polycystic ovarian syndrome (PCOS). Also,itaims to provide a framework for future research to be able to formulate more comprehensive, lifestyle-centered guidelines intreating women with PCOS. Method(s): A literature search was elicited in PEDro, Cochrane library, PubMed, and Google Scholar databases with the keywords"Physical therapy modalities", "PCOS", "HIIT", "Exercise protocol","Cardiometabolic Risk", "Insulin Resistance (IR)" and "Metabolic syndrome".Reviewed literature was analyzed and summarizeddescriptively. Result(s): HIIT can lower IR and improve metabolic syndrome when performed in regular basis. Conclusion(s): HIIT is effective in prevention of cardiometabolic disease in polycystic ovarian females.Copyright © 2021 EManuscript Technologies. All rights reserved.

Eleftheria, K., et al. (2021). "The role of maternal physical activity on in vitro fertilization outcomes: a systematic review and meta-analysis."
	
Eleje George, U., et al. (2020). "Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies." The Cochrane Database of Systematic Reviews 9: CD012871.
	Background: Preterm birth (PTB) remains the foremost global cause of perinatal morbidity and mortality. Thus, the prevention of spontaneous PTB still remains of critical importance. In an attempt to prevent PTB in singleton pregnancies, cervical cerclage, in combination with other treatments, has been advocated. This is because, cervical cerclage is an intervention that is commonly recommended in women with a short cervix at high risk of preterm birth but, despite this, many women still deliver prematurely, as the biological mechanism is incompletely understood. Additionally, previous Cochrane Reviews have been published on the effectiveness of cervical cerclage in singleton and multiple pregnancies, however, none has evaluated the effectiveness of using cervical cerclage in combination with other treatments.; Objectives: To assess whether antibiotics administration, vaginal pessary, reinforcing or second cerclage placement, tocolytic, progesterone, or other interventions at the time of cervical cerclage placement prolong singleton gestation in women at high risk of pregnancy loss based on prior history and/or ultrasound finding of 'short cervix' and/or physical examination. History-indicated cerclage is defined as a cerclage placed usually between 12 and 15 weeks gestation based solely on poor prior obstetrical history, e.g. multiple second trimester losses due to painless dilatation. Ultrasound-indicated cerclage is defined as a cerclage placed usually between 16 and 23 weeks gestation for transvaginal ultrasound cervical length < 20 mm in a woman without cervical dilatation. Physical exam-indicated cerclage is defined as a cerclage placed usually between 16 and 23 weeks gestation because of cervical dilatation of one or more centimetres detected on physical (manual) examination.; Search Methods: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (26 September 2019), and reference lists of retrieved studies.; Selection Criteria: We included published, unpublished or ongoing randomised controlled trial (RCTs). Studies using a cluster-RCT design were also eligible for inclusion in this review but none were identified. We excluded quasi-RCTs (e.g. those randomised by date of birth or hospital number) and studies using a cross-over design. We also excluded studies that specified addition of the combination therapy after cervical cerclage because the woman subsequently became symptomatic. We included studies comparing cervical cerclage in combination with one, two or more interventions with cervical cerclage alone in singleton pregnancies.; Data Collection and Analysis: Two review authors independently screened titles and abstracts of all retrieved articles, selected studies for inclusion, extracted data, assessed risk of bias, and evaluated the certainty of the evidence for this review's main outcomes. Data were checked for accuracy. Standard Cochrane review methods were used throughout.; Main Results: We identified two studies (involving a total of 73 women) comparing cervical cerclage alone to a different comparator. We also identified three ongoing studies (one investigating vaginal progesterone after cerclage, and two investigating cerclage plus pessary). One study (20 women), conducted in the UK, comparing cervical cerclage in combination with a tocolytic (salbutamol) with cervical cerclage alone in women with singleton pregnancy did not provide any useable data for this review. The other study (involving 53 women, with data from 50 women) took place in the USA and compared cervical cerclage in combination with a tocolytic (indomethacin) and antibiotics (cefazolin or clindamycin) versus cervical cerclage alone - this study did provide useable data for this review (and the study authors also provided additional data on request) but meta-analyses were not possible. This study was generally at a low risk of bias, apart from issues relating to blinding. We downgraded the certainty of evidence for serious risk of bias and imprecision (few participants, few events and wide 95% confidence intervals). Cervical cerclage in combination with an antibiotic and tocolytic versus cervical cerclage alone (one study, 50 women/babies) We are unclear about the effect of cervical cerclage in combination with antibiotics and a tocolytic compared with cervical cerclage alone on the risk of serious neonatal morbidity (RR 0.62, 95% CI 0.31 to 1.24; very low-certainty evidence); perinatal loss (data for miscarriage and stillbirth only - data not available for neonatal death) (RR 0.46, 95% CI 0.13 to 1.64; very low-certainty evidence) or preterm birth < 34 completed weeks of pregnancy (RR 0.78, 95% CI 0.44 to 1.40; very low-certainty evidence). There were no stillbirths (intrauterine death at 24 or more weeks). The trial authors did not report on the numbers of babies discharged home healthy (without obvious pathology) or on the risk of neonatal death.; Authors' Conclusions: Currently, there is insufficient evidence to evaluate the effect of combining a tocolytic (indomethacin) and antibiotics (cefazolin/clindamycin) with cervical cerclage compared with cervical cerclage alone for preventing spontaneous PTB in women with singleton pregnancies. Future studies should recruit sufficient numbers of women to provide meaningful results and should measure neonatal death and numbers of babies discharged home healthy, as well as other important outcomes listed in this review. We did not identify any studies looking at other treatments in combination with cervical cerclage. Future research needs to focus on the role of other interventions such as vaginal support pessary, reinforcing or second cervical cerclage placement, 17-alpha-hydroxyprogesterone caproate or dydrogesterone or vaginal micronised progesterone, omega-3 long chain polyunsaturated fatty acid supplementation and bed rest. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

El-Ghazzi, N., et al. (2023). "[New drug arrival : Pembrolizumab as second-line treatment in MSI-H/dMMR endometrial, colorectal, gastric, intestinal and biliary cancers]." Bulletin du cancer 110(1): 11-13.
	Nouvelles AAM : pembrolizumab en deuxième ligne des tumeurs métastatiques MSI-H/dMMRNew drug arrival : Pembrolizumab as second-line treatment in MSI-H/dMMR endometrial, colorectal, gastric, intestinal and biliary cancers Le système de réparation des mésappariements (ou MisMatch Repair, MMR ) maintient l’intégrité de l’ADN en corrigeant avec une haute fidélité les erreurs de réplication de l’ADN telles que les insertions, les délétions et les mésappariements de bas...

El-Hashimi, D. and M. Gorey Kevin (2019). "Yoga-specific enhancement of quality of life among women with breast cancer: Systematic review and exploratory meta-analysis of randomized controlled trials." Journal of Evidence-Based Integrative Medicine 24.
	Physical activities during and after cancer treatment have favorable psychosocial effects. Increasingly, yoga has become a popular approach to improving the quality of life (QoL) of women with breast cancer. However, the extant synthetic evidence on yoga has not used other exercise comparison conditions. This meta-analysis aimed to systematically assess yoga-specific effects relative to any other physical exercise intervention (eg, aerobics) for women with breast cancer. QoL was the primary outcome of interest. Eight randomized controlled trials with 545 participants were included. The sample-weighted synthesis at immediate post-intervention revealed marginally statistically and modest practically significant differences suggesting yoga's potentially greater effectiveness: d = 0.14, P = .10. However, at longer term follow-up, no statistically or practically significant between-group difference was observed. This meta-analysis preliminarily demonstrated that yoga is probably as effective as other exercise modalities in improving the QoL of women with breast cancer. Both interventions were associated with clinically significant improvements in QoL. Nearly all of the yoga intervention programs, however, were very poorly resourced. Larger and better controlled trials of well-endowed yoga programs are needed. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

Elias, M. H., et al. (2023). "HOXA10 DNA Methylation Level in the Endometrium Women with Endometriosis: A Systematic Review." Biology 12(3).
	Endometriosis is an inflammatory chronic systemic disease resulting in pelvic pain and infertility. However, despite a high prevalence of endometriosis, disease identification is still insufficient, and a high percentage of misdiagnosing was observed. Hence, a comprehensive study needs to be done to improve our understanding of the pathogenesis of endometriosis. Aberrant hypermethylation of HOXA10 has been reported to play a role in endometriosis. Thus, a comprehensive literature search was conducted to identify the DNA methylation level of HOXA10 among endometriosis patients across populations. The literature search was done using PubMed, Scopus, EBSCOhost, and Science Direct applying (HOXA10 OR "homeobox A10" OR "HOXA-10" OR HOX1) AND ("DNA methylation" OR methylation) AND (endometriosis OR endometrioma) as keywords. From 491 retrieved studies, five original articles investigating the DNA methylation level of HOXA10 from endometrium tissues among endometriosis women were included. All five included studies were classified as high-quality studies. High HOXA10 DNA methylation level was observed in the endometrium tissue of women with endometriosis in all the included studies. The secretory phase was identified as the best sampling time for HOXA10 DNA methylation study in endometriosis, and the most studied DNA methylation site is the promoter region of the HOXA10. However, more studies are needed to expose the HOXA10 mechanism in the pathogenesis of endometriosis.

Eliezer, D., et al. (2019). "Alpha blockers for treating functional daytime urinary incontinence in children." Cochrane Database of Systematic Reviews(4).
	This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects of alpha blockers for treating functional daytime urinary incontinence in children.

Elkind-Hirsch, K. E., et al. (2021). "Exenatide, dapagliflozin or phentermine/topiramate differentially affect metabolic profiles in polycystic ovary syndrome." The Journal of Clinical Endocrinology and Metabolism 106(10): 3019-3033.
	CONTEXT: Glucagon-like peptide-1 receptor agonists and sodium-glucose co-transporter-2 inhibitors reduce weight and improve insulin sensitivity via different mechanisms. OBJECTIVE: The efficacy of once-weekly exenatide (EQW) and dapagliflozin (DAPA) alone and co-administered (EQW/DAPA), DAPA/extended release metformin (DAPA/MET), and phentermine topiramate extended release (PHEN/TPM) on metabolic parameters, body composition, and sex hormones were examined in obese women with PCOS. RESEARCH DESIGN AND METHODS: Non-diabetic women (n=119; 18-45y) with BMI>30 <45 and PCOS (NIH criteria) were randomized in a single-blind fashion to EQW (2 mg weekly); DAPA (10 mg daily), EQW/DAPA (2 mg weekly/10 mg daily), DAPA (10 mg)/MET (2000mg XR daily) or PHEN (7.5 mg)/TPM (46mg ER daily) treatment for 24 weeks. Study visits at baseline and 24 weeks included weight, blood pressure (BP), waist (WC) measures and body composition evaluated by dual-energy X-ray absorptiometry (DXA). Oral glucose tolerance tests (OGTT) were done to assess glycemia, mean blood glucose (MBG), and compute insulin sensitivity (SI) and secretion (IS) measures. Sex steroids, free androgen index (FAI) and lipid profiles were measured in the fasting sample. RESULTS: EQW/DAPA and PHEN/TPM resulted in the most loss of weight, total body fat by DXA, and WC. Despite equivalent reductions in BMI and WC with PHEN/TPM, only EQW/DAPA and EQW resulted in significant improvements in MBG, SI and IS. Reductions in fasting glucose, testosterone, FAI and BP were seen with all drugs. CONCLUSION: Dual therapy with EQW/DAPA was superior to either alone, DAPA/MET and PHEN/TPM in terms of clinical and metabolic benefits in this patient population.

Elliott, J., et al. (2023). "Guideline No. 444: Hirsutism: Evaluation and Treatment." Journal of Obstetrics and Gynaecology Canada 45(12): 102272.
	Objective: This guideline reviews the etiology, diagnosis, evaluation, and treatment of hirsutism. Target Population: Women with hirsutism. Options: Three approaches to management include: 1) mechanical hair removal; 2) suppression of androgen production; and 3) androgen receptor blockade. Outcome(s): The main limitations of the management options include the adverse effects, costs, and duration of treatment. Benefits, Harms, and Costs: Implementation of the recommendations in this guideline may improve the management of hirsutism in women with this condition. Adverse effects and a potential long duration of treatment are the main drawbacks to initiating treatment, as is the possibility of significant financial costs for certain treatments. Evidence: A comprehensive literature review was updated to April 2022, following the same methods as for the prior Society of Obstetricians and Gynaecologists of Canada (SOGC) Hirsutism guidelines. Results were restricted to systematic reviews, randomized controlled trials, controlled clinical trials, and observational studies. There were no date limits, but results were limited to English- or French-language materials. Validation Methods: The authors rated the quality of evidence and strength of recommendations using the modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, along with the option of designating a recommendation as a "good practice point." See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and conditional [weak] recommendations). Intended Audience: Primary care providers, family medicine physicians, obstetricians and gynaecologists, reproductive endocrinologists and others who manage the care of patients with hirsutism. Tweetable Abstract: Management of hirsutism involves a 3-pronged approach of mechanical hair removal, suppression of androgen production, and androgen receptor blockade. SUMMARY STATEMENTS: 1. The modified Ferriman-Gallwey score can be used in the assessment of hirsutism to help quantify the problem and assess the response to treatment. Cut-off scores defining hirsutism will vary by racial background. Modified Ferriman-Gallwey scores from 3 to 15 represent mild hirsutism, 16-25 represent moderate hirsutism, and >25 indicate severe hirsutism (moderate). 2. Hyperandrogenism in women with polycystic ovary syndrome may result from several mechanisms, including insulin resistance, hyperinsulinemia, elevated luteinizing hormone-related increases in theca cell androgen production, and increased adrenal androgen output. (high). 3. Non-classical congenital adrenal hyperplasia often presents with hirsutism and has a similar clinical picture as polycystic ovary syndrome. However, the prevalence of non-classical congenital adrenal hyperplasia is very low outside of specific high-risk ethnic groups (high). 4. Hirsutism can be classified into 1 of 3 groups based on etiology: hyperandrogenic hirsutism (including polycystic ovarian syndrome, non-classical congenital adrenal hyperplasia, or androgen-secreting tumours), non-androgenic hirsutism (including medication-induced hirsutism), and idiopathic hirsutism (moderate). 5. Polycystic ovary syndrome is the most common cause of hirsutism, with idiopathic hirsutism being the second most common (high). 6. Most patients with hirsutism have normal androgen levels. That said, high androgen levels should be investigated immediately, as some impacts will be permanent, such as voice changes and clitoromegaly (high). 7. Hirsutism is not a diagnosis, but a symptom or sign, and an underlying etiology should be sought (high). 8. The most effective therapy for hirsutism is multimodal and combines physical hair removal techniques with medical therapies. At least six months of medical therapy is required to see a significant improvement in hirsutism. Unfortunately, many permanent physical hair removal procedures are considered cosmetic and the costs can be a barrier to treatment (moderate). 9. Hair growth tends to recur after stopping medical therapy, while laser hair removal, intense pulsed light, and electrolysis produce permanent hair reduction (moderate). RECOMMENDATIONS: 1. Patients presenting with hirsutism should be evaluated with a focused history taking, physical examination with anthropometric measurements, and appropriate investigations to differentiate between the possible etiologies (strong, moderate). 2. Patients with moderate to severe hirsutism should undergo blood testing to determine total testosterone and sex hormone-binding globulin levels; however, the benefit of testing in mild hirsutism is questionable. Additional testing is indicated for patients with irregular cycles and signs of hyperandrogenism or other endocrinopathies (conditional, low). 3. Patients with hyperandrogenic hirsutism should have serum levels of dehydroepiandrosterone sulfate and 17-hydroxyprogesterone measured (strong, moderate). 4. Referral for evaluation by a medical or reproductive endocrinologist (or another practitioner with similar expertise) is indicated in the presence of 1) virilization; 2) serum testosterone or dehydroepiandrosterone sulfate levels more than twice the upper limit of normal; 3) signs or symptoms of Cushing syndrome; or 4) early follicular phase serum 17-hydroxyprogesterone levels >6 nmol/L (strong, high). 5. Therapy should be offered to all patients with hirsutism who desire treatment (good practice point). 6. Combined hormonal contraceptives should be offered as first-line therapy if there are no contraindications (strong, high). 7. Mechanical hair removal and/or topical treatments can be offered as first-line therapy or as an adjuvant to medical therapy (strong, high). 8. Antiandrogens can be considered as monotherapy or in addition to combined hormonal contraceptives to enhance efficacy (strong, high). 9. Patients on antiandrogens require an effective method of contraception and should be counselled regarding the risk of feminization of a male fetus if pregnancy were to occur (good practice point).Copyright © 2023 The Society of Obstetricians and Gynaecologists of Canada/La Societe des obstetriciens et gynecologues du Canada

Elsan (2021). Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Immediate Post-partum Situation.
	In this study, the investigators propose to evaluate the benefit of an innovative analgesic treatment in the immediate postpartum period using photobiomodulation (PBM) by evaluating pain using a Visual Analog Scale. PBM, discovered in the 1950s, uses the properties of light. The PBM corresponds to all the non-thermal and non-cytotoxic biological effects caused by the exposure of tissues to light sources in the visible and near-infrared range. More precisely, certain wavelengths of the light spectrum (red-infrared) lead to a cascade of biological effects within the cell: reduction of pain, regulation of inflammation and acceleration of the healing process. The objective of this study is to analyze the possibility of replacing chemical medication by a non-invasive, painless technology in patients who have just given birth. This technology is already used for anti-inflammatory and analgesic actions in indications such as stomatology, rheumatology, post-operation and traumatology. This is part of the field of NMIs (non-medicinal interventions).

Elsea, D., et al. (2022). "Correction to: Cost-Effectiveness Analysis of Olaparib in Combination with Bevacizumab Compared with Bevacizumab Monotherapy for the First-Line Maintenance Treatment of Homologous Recombination Deficiency-Positive Advanced Ovarian Cancer." PharmacoEconomics - open 6(6): 899.
	
El-Swaify Seif, T., et al. (2023). "Can fluorescence-guided surgery improve optimal surgical treatment for ovarian cancer? A systematic scoping review of clinical studies." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 33(4): 549-561.
	Background: The predicament of achieving optimal surgical intervention faced by surgeons in treating ovarian cancer has driven research into improving intra-operative detection of cancer using fluorescent materials.; Objective: To provide a literature overview on the clinical use of intra-operative fluorescence-guided surgery for ovarian cancer, either for cytoreductive surgery or sentinel lymph node (SLN) biopsy.; Methods: The systematic review included studies from June 2002 until October 2021 from PubMed, Web of Science, and Scopus as well as those from a search of related literature. Studies were included if they investigated the use of fluorescence-guided surgery in patients with a diagnosis of ovarian cancer. Authors charted variables related to study characteristics, patient demographics, baseline clinical characteristics, fluorescence-guided surgery material, and treatment details, and surgical, oncological, and survival outcome variables. After screening 2817 potential studies, 24 studies were included.; Results: Studies investigating the role of fluorescence-guided surgery to visualize tumor deposits or SLN biopsy included the data of 410 and 118 patients, respectively. Six studies used indocyanine green tracer with a mean SLN detection rate of 92.3% with a pelvic and para-aortic detection rate of 94.8% and 96.7%, respectively. The sensitivity, specificity, and positive predictive value for micrometastases detection of OTL38 and 5-aminolevulinc acid at time of cytoreduction were 92.2% vs 79.8%, 67.3% vs 94.8%, and 55.8% vs 95.8%, respectively.; Conclusion: Fluorescence -guided surgery is a technique that may improve the detection rate of micrometastases and SLN identification in ovarian cancer. Further research is needed to establish whether this will lead to improved patient outcomes.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Elterman, D., et al. (2021). "A prospective, multicenter, international study to explore the effect of three different amplitude settings in female subjects with urinary urge incontinence receiving interstim therapy." Neurourology and Urodynamics 40(3): 920‐928.
	AIMS: The aim of this study is to evaluate the effect of sub‐sensory amplitude settings of sacral neuromodulation therapy on overactive bladder symptoms in subjects with urinary urge incontinence. METHODS: Subjects who qualified for a neurostimulator device implant were randomized to one of three amplitude settings (50% of sensory threshold [ST], 80% of ST, and ST). Subjects completed urinary voiding diaries (3‐day), International consultation on incontinence modular questionnaire‐overactive bladder symptoms quality of life questionnaire, and patient global impression of improvement (PGI‐I) to assess change in voiding symptoms and quality of life (QoL) from baseline through 12 weeks. RESULTS: Forty‐eight subjects had a successful test stimulation, 46 were implanted with a neurostimulator device and 43 completed the 12‐week follow‐up visit. The change from baseline to 12 weeks is ‐3.0 urinary incontinence (UI) episodes/day (95% confidence interval [CI]: ‐4.4 to ‐1.7) for the 50% of sensory threshold group, ‐2.9 UI episodes/day (95% CI: ‐4.7 to ‐1.2) for 80% of sensory threshold group, and ‐3.6 UI episodes/day (95% CI: ‐5.2 to ‐1.9) for the sensory threshold group. In each randomized group, improvements were observed in health‐related QoL, its subscales, and symptom interference. Subjects across all three randomization groups reported on the PGI‐I that their bladder condition was better at 12 weeks compared to before they were treated with InterStim therapy. CONCLUSION: These findings provide insights into possible advancements in the postimplantation phase of therapy with potential for improved patient comfort and increased device longevity.

Elterman, D., et al. (2022). "Prospective, multicenter study to evaluate performance and safety of a re-engineered temporary lead for InterStimTM therapy evaluation." Neurourology and Urodynamics 41(8): 1731-1738.
	Aims: The basic evaluation or percutaneous nerve evaluation (PNE) is a method to assess pre-implantation therapeutic response in patients considering sacral neuromodulation for the treatment of refractory overactive bladder. A new PNE lead with a more robust design and greater distensibility designed to reduce the possibility of lead migration has recently been introduced to the market. The aim of this prospective, multicenter, global, postmarket study was to evaluate the clinical performance and safety of the new InterStim PNE lead with the foramen needle. Method(s): Patients with overactive bladder were enrolled in this study. The primary objective of this study was to determine the proportion of subjects who demonstrated motor or sensory response(s) during lead placement using the InterStim PNE lead. Additional measures included the Patient Global Impression of Improvement (PGI-I), patient satisfaction at the end of therapy evaluation, and change in bladder symptoms from baseline to the end of therapy evaluation (1-week follow-up visit). Result(s): One-hundred and ten subjects met the inclusion and exclusion criteria and underwent a lead implant procedure. Of those, 108 had a successful procedure and 107 completed the 1-week follow-up visit. Ninety-nine percent of subjects (109/110) had a motor or sensory response during needle placement (95% confidence interval [CI]: 95%-100%) and 97% of subjects (107/110) had a motor or sensory response during lead placement (95% CI: 92%-99%). The majority of subjects (88%, 95/108) reported their bladder condition was better at the follow-up visit compared to before the PNE implant procedure, as reported in PGI-I. Subjects reported being satisfied with how the therapy impacted their voiding symptoms (82%, 88/108) and that they would recommend this therapy (87%, 94/108) to other patients. Symptom improvement was demonstrated with urinary urge incontinence subjects having an average of 4.2 +/- 3.4 urinary incontinence episodes/day at baseline and 2.2 +/- 2.5 at follow-up, and urinary frequency subjects having an average of 12.5 +/- 4.4 voids/day at baseline and 10.5 +/- 4.3 voids/day at follow-up. Lead removal was deemed to be easy and safe by the implanting physician, with a total of three adverse device effects in 3/110 subjects. No event was categorized as serious and all were resolved without sequelae. Conclusion(s): The updated InterStim PNE lead with a more robust design and greater distensibility designed to reduce migration was shown to have a high rate of motor or sensory response during lead placement. Furthermore, subjects reported high rates of global improvements and amelioration of symptoms, and the lead was easy to remove with minimal morbidity.Copyright © 2022 Wiley Periodicals LLC.

Elwood, P. C., et al. (2021). "Aspirin and cancer survival: A systematic review and meta-analyses of 118 observational studies of aspirin and 18 cancers." ecancermedicalscience 15: 1258.
	Background: Despite the accumulation of research papers on aspirin and cancer, there is doubt as to whether or not aspirin is an acceptable and effective adjunct treatment of cancer. The results of several randomised trials are awaited, and these should give clear evidence on three common cancers: colon, breast and prostate. The biological effects of aspirin appear likely however to be of relevance to cancer generally, and to metastatic spread, rather than just to one or a few cancers, and there is already a lot of evidence, mainly from observational studies, on the association between aspirin and survival in a wide range of cancers. Aim(s): In order to test the hypothesis that aspirin taking is associated with an increase in the survival of patients with cancer, we conducted a series of systematic literature searches to identify clinical studies of patients with cancer, some of whom took aspirin after having received a diagnosis of cancer. Result(s): Three literature searches identified 118 published observational studies in patients with 18 different cancers. Eighty-one studies report on aspirin and cancer mortality and 63 studies report on all-cause mortality. Within a total of about a quarter of a million patients with cancer who reported taking aspirin, representing 20%-25% of the total cohort, we found aspirin to be associated with a reduction of about 20% in cancer deaths (pooled hazard ratio (HR): 0.79; 95% confidence intervals: 0.73, 0.84 in 70 reports and a pooled odds ratio (OR): 0.67; 0.45, 1.00 in 11 reports) with similar reductions in all-cause mortality (HR: 0.80; 0.74, 0.86 in 56 studies and OR: 0.57; 0.36, 0.89 in seven studies). The relative safety of aspirin taking was examined in the studies and the corresponding author of every paper was written to asking for additional information on bleeding. As expected, the frequency of bleeding increased in the patients taking aspirin, but fatal bleeding was rare and no author reported a significant excess in fatal bleeds associated with aspirin. No author mentioned cerebral bleeding in the patients they had followed. Conclusion(s): There is a considerable body of evidence suggestive of about a 20% reduction in mortality in patients with cancer who take aspirin, and the benefit appears not to be restricted to one or a few cancers. Aspirin, therefore, appears to deserve serious consideration as an adjuvant treatment of cancer, and patients with cancer, and their carers, have a right to be informed of the available evidence.Copyright: © the authors; licensee ecancermedicalscience. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Elyashiv, O., et al. (2024). "The Poor Prognosis of Acquired Secondary Platinum Resistance in Ovarian Cancer Patients." Cancers 16(3).
	Objective: The goal of this study was to evaluate response to treatment and survival in epithelial ovarian cancer patients with acquired secondary platinum resistance (SPR) compared to patients with primary platinum resistance (PPR).; Methods: Patients were categorized as PPR (patients with disease recurrence occurring during or <6 months after completing first-line platinum-based chemotherapy) and SPR (patients with previously platinum-sensitive disease that developed platinum resistance on subsequent treatments). Clinico-pathological variables and treatment outcomes were compared.; Results: Of the 118 patients included in this study, 60 had PPR and 58 developed SPR. The SPR women had a significantly higher rate of optimal debulking during their upfront and interval operations, significantly lower CA-125 levels during their primary treatment, and a significantly higher complete and partial response rate to primary chemotherapy. Once platinum resistance appeared, no significant difference in survival was observed between the two groups. The median PFS was 2 months in the PPR group and 0.83 months in the SPR group ( p = 0.085). Also, no significant difference was found in post-platinum-resistant relapse survival, with a median of 17.63 months in the PPR and 20.26 months in the SPR group ( p = 0.515).; Conclusions: Platinum resistance is an important prognostic factor in women with EOC. Patients with SPR acquire the same poor treatment outcome as with PPR. There is a great need for future research efforts to discover novel strategies and biological treatments to reverse resistance and improve survival.

Elyashiv, O., et al. (2021). "ICON 9-an international phase III randomized study to evaluate the efficacy of maintenance therapy with olaparib and cediranib or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 31(1): 134-138.
	BACKGROUND: Two novel biological agents-cediranib targeting angiogenesis, and olaparib targeting DNA repair processes-have individually led to an improvement in ovarian cancer control. The aim of ICON9 is to investigate the combination of cediranib and olaparib maintenance in recurrent ovarian cancer following platinum-based therapy. PRIMARY OBJECTIVE: To assess the efficacy of maintenance treatment with olaparib in combination with cediranib compared with olaparib alone following a response to platinum-based chemotherapy in women with platinum-sensitive ovarian, fallopian tube or peritoneal cancer during first relapse. STUDY HYPOTHESIS: Maintenance therapy with cediranib and olaparib in combination is associated with improved patient outcomes compared with olaparib alone. TRIAL DESIGN: International phase III randomized controlled trial. Following a response to platinum-based chemotherapy patients are randomized 1:1 to either oral olaparib and cediranib (intervention arm) or oral olaparib alone (control arm). MAJOR INCLUSION CRITERIA: Patients with a known diagnosis of high grade serous or endometrioid carcinoma of the ovary, fallopian tube or peritoneum, progressing more than 6 months after first-line platinum-based chemotherapy, who have responded to second-line platinum-based chemotherapy. PRIMARY ENDPOINTS: Progression-free and overall survival. Co-primary endpoints to be assessed using a fixed-sequence gatekeeping approach: (1) progression-free survival, all patients; (2) progression-free survival, BRCA wild type; (3) overall survival, all patients; (4) overall survival, BRCA wild type. SAMPLE SIZE: 618 patients will be recruited. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Accrual is expected to be completed in 2024 with presentation of results in 2025. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03278717.

Embaby, A., et al. (2023). "WEE1 inhibitor adavosertib in combination with carboplatin in advanced TP53 mutated ovarian cancer: A biomarker-enriched phase II study." Gynecologic Oncology 174: 239-246.
	Objective: In the first part of this phase II study (NCT01164995), the combination of carboplatin and adavosertib (AZD1775) was shown to be safe and effective in patients with TP53 mutated platinum-resistant ovarian cancer (PROC). Here, we present the results of an additional safety and efficacy cohort and explore predictive biomarkers for resistance and response to this combination treatment.; Methods: This is a phase II, open-label, non-randomized study. Patients with TP53 mutated PROC received carboplatin AUC 5 mg/ ml·min intravenously and adavosertib 225 mg BID orally for 2.5 days in a 21-day cycle. The primary objective is to determine the efficacy and safety of carboplatin and adavosertib. Secondary objectives include progression-free survival (PFS), changes in circulating tumor cells (CTC) and exploration of genomic alterations.; Results: Thirty-two patients with a median age of 63 years (39-77 years) were enrolled and received treatment. Twenty-nine patients were evaluable for efficacy. Bone marrow toxicity, nausea and vomiting were the most common adverse events. Twelve patients showed partial response (PR) as best response, resulting in an objective ORR of 41% in the evaluable patients (95% CI: 23%-61%). The median PFS was 5.6 months (95% CI: 3.8-10.3). In patients with tumors harboring CCNE1 amplification, treatment efficacy was slightly but not significantly better.; Conclusions: Adavosertib 225 mg BID for 2.5 days and carboplatin AUC 5 could be safely combined and showed anti-tumor efficacy in patients with PROC. However, bone marrow toxicity remains a point of concern, since this is the most common reason for dose reductions and dose delays.; Competing Interests: Declaration of Competing Interest A list with conflicts of interest of all authors will be provided. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Emerson, M., et al. (2023). "A systematic review and exploration of smartphone app interventions for perinatal depression with case study." Current Treatment Options in Psychiatry 10(3): 136-166.
	Purpose of review: In this review, we aim to summarize the availability and features of smartphone apps in both the commercial marketplace and academic literature for perinatal depression with the goal of informing patients and clinicians along with giving clinical recommendations related to the integration of mobile apps into perinatal care. Recent findings: There are few apps targeted towards perinatal depression, and of those that exist, most lack evidence and a robust privacy policy. Recent reviews have also highlighted the dearth of quality apps for perinatal mental health care. Summary: Using keywords, searches of the academic literature and Android and Apple App Stores were conducted to identify perinatal depression apps. Notably, there were only six apps included from the app stores, and 18 publications were included from academic literature. Of the commercially available apps, most had concerning privacy policies and contained a paywall to access its features. The academic literature results had small sample sizes and heterogenous outcomes. Additionally, there was a disconnect between the academic apps and those found in app stores; only five of the apps in the academic literature were available commercially yet only one was found in the initial commercial app search. Due to these results, we present a case study of an alternate app, mindLAMP, to illustrate how to incorporate a mobile app into perinatal mental health care. (PsycInfo Database Record (c) 2024 APA, all rights reserved)

Emídio, V.-F., et al. (2021). "Follicular fluid composition and reproductive outcomes of women with polycystic ovary syndrome undergoing in vitro fertilization: a systematic review."
	
Emile Sameh, H., et al. (2019). "Outcome of laparoscopic ventral mesh rectopexy for full-thickness external rectal prolapse: a systematic review, meta-analysis, and meta-regression analysis of the predictors for recurrence." Surgical Endoscopy 33(8): 2444-2455.
	Background: Laparoscopic ventral mesh rectopexy (LVMR) has proved effective in the treatment of internal and external rectal prolapse. The present meta-analysis aimed to determine the predictive factors of recurrence of full-thickness external rectal prolapse after LVMR.; Methods: An organized, systematic search of electronic databases including PubMed/Medline, Embase, Scopus, and Cochran library was conducted in adherence to PRISMA guidelines. Studies that reported the outcome of LVMR in patients with full-thickness external rectal prolapse were included according to predefined criteria. A meta-regression analysis and sub-group meta-analyses were performed to recognize the patient and technical factors that were associated with higher recurrence rates.; Results: Seventeen studies comprising 1242 patients of a median age of 60 years were included. The median operation time was 122.3 min. Conversion to open surgery was required in 22 (1.8%) patients. The weighted mean complication rate across the studies was 12.4% (95% CI 8.4-16.4) and the weighted mean rate of recurrence of full-thickness external rectal prolapse was 2.8% (95% CI 1.4-4.3). The median follow-up duration was 23 months. Male gender (SE = 0.018, p = 0.008) and length of the mesh (SE = - 0.007, p = 0.025) were significantly associated with full-thickness recurrence of rectal prolapse. The weighted mean rates of improvement in fecal incontinence and constipation after LVMR were 79.3% and 71%, respectively.; Conclusion: LVMR is an effective and safe option in treatment of full-thickness external rectal prolapse with low recurrence and complication rates. Male patients and length of the mesh may potentially have a significant impact on recurrence of rectal prolapse after LVMR.

Emily, E.-H., et al. (2021). "Physical activity and/or dietary interventions in infertile women with overweight or obesity prior to infertility treatment - a systematic review and individual participant data meta-analysis (IPDMA)."
	
Emily, W., et al. (2021). "The use of uterine artery embolization (UAE) compared with myomectomy for the management of uterine fibroids: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Emma, S., et al. (2022). "Surgical outcomes of robotic single-site vs. multiport hysterectomy for the treatment of endometrial malignancy: a systematic review and meta-analysis."
	
Emons, G. and C. Gründker (2021). "The Role of Gonadotropin-Releasing Hormone (GnRH) in Endometrial Cancer." Cells 10(2).
	Endometrial cancer (EC) is one of the most common gynecological malignancies. Gonadotropin releasing hormone (GnRH) is a decapeptide first described to be secreted by the hypothalamus to regulate pituitary gonadotropin secretion. In this systematic review, we analyze and summarize the data indicating that most EC express GnRH and its receptor (GnRH-R) as part of an autocrine system regulating proliferation, the cell cycle, and apoptosis. We analyze the available data on the expression and function of GnRH-II, its putative receptor, and its signal transduction. GnRH-I and GnRH-II agonists, and antagonists as well as cytotoxic GnRH-I analogs, have been shown to inhibit proliferation and to induce apoptosis in human EC cell lines in pre-clinical models. Treatment with conventional doses of GnRH-agonists that suppress pituitary gonadotropin secretion and ovarian estrogen production has become part of fertility preserving therapy of early EC or its pre-cancer (atypical endometrial hyperplasia). Conventional doses of GnRH-agonists had marginal activity in advanced or recurrent EC. Higher doses or more potent analogs including GnRH-II antagonists have not yet been used clinically. The cytotoxic GnRH-analog Zoptarelin Doxorubicin has shown encouraging activity in a phase II trial in patients with advanced or recurrent EC, which expressed GnRH-R. In a phase III trial in patients with EC of unknown GnRH-R expression, the cytotoxic GnRH doxorubicin conjugate was not superior to free doxorubicin. Further well-designed clinical trials exploiting the GnRH-system in EC might be useful.

Emons, G., et al. (2021). "Endometrial Cancer Lymphadenectomy Trial (ECLAT) (pelvic and para-aortic lymphadenectomy in patients with stage I or II endometrial cancer with high risk of recurrence; AGO-OP.6)." International Journal of Gynecological Cancer 31(7): 1075‐1079.
	Background The impact of comprehensive pelvic and para‐aortic lymphadenectomy on survival in patients with stage I or II endometrial cancer with a high risk of recurrence is not reliably documented. The side effects of this procedure, including lymphedema and lymph cysts, are evident. Primary Objective Evaluation of the effect of comprehensive pelvic and para‐aortic lymphadenectomy in the absence of bulky nodes on 5 year overall survival of patients with endometrial cancer (International Federation of Gynecology and Obstetrics (FIGO) stages I and II) and a high risk of recurrence. Study Hypothesis Comprehensive pelvic and para‐aortic lymphadenectomy will increase 5 year overall survival from 75% (no lymphadenectomy) to 83%, corresponding to a hazard ratio of 0.65. Trial Design Open label, randomized, controlled trial. In arm A, a total hysterectomy plus bilateral salpingo‐oophorectomy is performed. In arm B, in addition, a systematic pelvic and para‐aortic lymphadenectomy up to the level of the left renal vein is performed. For all patients, vaginal brachytherapy and adjuvant chemotherapy (carboplatin/paclitaxel) are recommended. Major Inclusion Criteria Patients with histologically confirmed endometrial cancer stages pT1b‐pT2, all histological subtypes, and pT1a endometrioid G3, serous, clear cell, or carcinosarcomas can be included when bulky nodes are absent. When hysterectomy has already been performed (eg, for presumed low risk endometrial cancer), study participation is also possible. Exclusion Criteria Patients with pT1a, G1 or 2 of type 1 histology or uterine sarcomas (except for carcinosarcomas), endometrial cancers of FIGO stage III or IV (except for microscopic lymph node metastases) or visual extrauterine disease. Primary Endpoint Overall survival calculated from the date of randomization until death. Sample Size 640 patients will be enrolled in the study. Estimated Dates for Completing Accrual and Presenting Results At present, 252 patients have been recruited. Based on this, accrual should be completed in 2025. Results should be presented in 2031. Trial Registration NCT03438474.

Emons, G., et al. (2023). "Endometrial Cancer. Guideline of the DGGG, DKG and DKH (S3-Level, AWMF Registry Number 032/034-OL, September 2022). Part 1 with Recommendations on the Epidemiology, Screening, Diagnosis and Hereditary Factors of Endometrial Cancer, Geriatric Assessment and Supply Structures." Geburtshilfe und Frauenheilkunde 83(8): 919-962.
	Summary The S3-guideline on endometrial cancer, first published in April 2018, was reviewed in its entirety between April 2020 and January 2022 and updated. The review was carried out at the request of German Cancer Aid as part of the Oncology Guidelines Program and the lead coordinators were the German Society for Gynecology and Obstetrics (DGGG), the Gynecology Oncology Working Group (AGO) of the German Cancer Society (DKG) and the German Cancer Aid (DKH). The guideline update was based on a systematic search and assessment of the literature published between 2016 and 2020. All statements, recommendations and background texts were reviewed and either confirmed or amended. New statements and recommendations were included where necessary. Aim The use of evidence-based risk-adapted therapies to treat women with endometrial cancer of low risk prevents unnecessarily radical surgery and avoids non-beneficial adjuvant radiation therapy and/or chemotherapy. For women with endometrial cancer and a high risk of recurrence, the guideline defines the optimum level of radical surgery and indicates whether chemotherapy and/or adjuvant radiation therapy is necessary. This should improve the survival rates and quality of life of these patients. The S3-guideline on endometrial cancer and the quality indicators based on the guideline aim to provide the basis for the work of certified gynecological cancer centers. Methods The guideline was first compiled in 2018 in accordance with the requirements for S3-level guidelines and was updated in 2022. The update included an adaptation of the source guidelines identified using the German Instrument for Methodological Guideline Appraisal (DELBI). The update also used evidence reviews which were created based on selected literature obtained from systematic searches in selected literature databases using the PICO process. The Clinical Guidelines Service Group was tasked with carrying out a systematic search and assessment of the literature. Their results were used by interdisciplinary working groups as a basis for developing suggestions for recommendations and statements which were then modified during structured online consensus conferences and/or additionally amended online using the DELPHI process to achieve a consensus. Recommendations Part 1 of this short version of the guideline provides recommendations on epidemiology, screening, diagnosis, and hereditary factors. The epidemiology of endometrial cancer and the risk factors for developing endometrial cancer are presented. The options for screening and the methods used to diagnose endometrial cancer are outlined. Recommendations are given for the prevention, diagnosis, and therapy of hereditary forms of endometrial cancer. The use of geriatric assessment is considered and existing structures of care are presented.; Competing Interests: Conflict of Interest/Interessenkonflikt The conflicts of interest of the authors are listed in the long German-language version of the guideline./Die Interessenkonflikte der Autoren sind in der Langfassung der Leitlinie aufgelistet. (© Thieme Medical Publishers.)

Ems (2022). Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis.
	No Results Available Drug: Venus 20 + 0,064|Drug: Venus 20 + 1|Drug: Venus 20 + 4|Drug: Butoconazole nitrate Time to first relief of symptoms|Adverse events Female Phase 2 0 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment EMS1819 - VENUS March 2024

Energin, H. and H. Eric (2023). "Effect of anterior repair on sexual function in heterosexual couples." International Urogynecology Journal 34(11): 2833-2838.
	Introduction and hypothesis: Little is known about the impact of native tissue repair techniques on heterosexual intercourse. This study was aimed at investigating the effect of anterior colporrhaphy on women's and their partners' sexual function. Method(s): Sexually active women with a male partner who were diagnosed with anterior wall prolapse without any incontinence were prospectively recruited from a single academic center. Demographic data were collected and a Pelvic Organ Prolapse Quantification examination was performed. Before and 3 months post-operatively, women completed two validated questionnaires to assess sexual function, the International Consultation on Incontinence Questionnaire Vaginal Symptoms short form (ICIQ-VS SF) 55, and the Female Sexual Function Index (FSFI), and their male partners completed the International Index of Erectile function-5. Pre- and post-operative results were compared using a paired t test. Result(s): This study was conducted in the gynecology department of a university hospital between May 2022 and June 2023, where 50 heterosexual couples were enrolled and underwent isolated anterior repair. The mean age of women and their partners were 44.3 +/- 5.12 and 48.1 +/- 5.81 respectively. Overall, female sexual function improved significantly from pre- to 3 months postoperatively with a decrease in ICIQ-VS SF scores from 13.3 +/- 3.27 to 1.7 +/- 1.1 (p < 0.05) and an increase in FSFI scores from 21.74 +/- 9.37 to 29.28 +/- 9.97 (p < 0.05). The only domain that did not improve was sexual pain. For their male partners, there was a similar significant improvement in sexual function with an increase in scores from 48.71 +/- 8.71 to 60.68 +/- 8.63 (p < 0.05). Conclusion(s): Isolated anterior repair was associated with improved short-term sexual function amongst heterosexual couples.Copyright © 2023, The International Urogynecological Association.

English, M., et al. (2022). "Fezolinetant for Treatment of Moderate-to-severe Vasomotor Symptoms Associated with Menopause: Results from a 52-week Study (Skylight 2)." Journal of the Endocrine Society 6(Supplement 1): A678-A679.
	Background: SKYLIGHT 2 (NCT04003142) investigated safety and efficacy of fezolinetant (a neurokinin-3 receptor antagonist) on frequency and severity of moderate-to-severe vasomotor symptoms (VMS) and sleep disturbance. In this analysis, persistence of fezolinetant efficacy was investigated over 52 weeks. Method(s): This double-blind Phase 3 study randomized women aged >=40-65 years with moderate-to-severe VMS associated with menopause (average of >=7 hot flashes/day) to once-daily placebo or fezolinetant 30mg or 45mg for 12 weeks. Women completing 12 weeks entered an extension period, with those on placebo re-randomized to fezolinetant 30mg or 45mg (placebo/fezolinetant), and those originally on fezolinetant remaining on their dose for an additional 40-weeks. Fezolinetant efficacy was evaluated vs placebo for 12- weeks through change in VMS frequency, VMS severity, and Patient-reported Outcomes Measurement Information System Sleep Disturbance-Short Form 8b (PROMIS) Total Score. Persistence of efficacy for fezolinetant was evaluated descriptively (without statistical comparisons) over the extension period. Result(s): The analysis comprised 484 women (fezolinetant 30mg n=166, fezolinetant 45mg n=167, placebo/fezolinetant 30mg n=76, placebo/fezolinetant 45mg n=75). Improvement in VMS frequency and severity observed through week 12 (statistically significant differences vs placebo) was maintained throughout the 52-week total study period for those receiving fezolinetant. Fezolinetant demonstrated further reductions in VMS frequency and severity from baseline to beyond week 12. For VMS frequency, there was a least squares (LS) mean (SE) baseline-to-week 12 reduction of -6.83 (0.39) VMS/day for fezolinetant 30mg and -7.50 (0.39) for 45mg, and a mean (SD) baseline-to-week 52 reduction of -8.03 (4.53) for fezolinetant 30mg and -8.48 (3.98) for 45mg. For VMS severity, LS mean (SE) baseline-toweek 12 reduction was -0.64 (0.06) for 30mg and -0.77 (0.06) for 45mg, and mean (SD) baseline-to-week 52 reduction was -0.83 (0.82) for fezolinetant 30mg, and - 0.95 (0.78) for 45mg. Women re-randomized from placebo to fezolinetant experienced a reduction in frequency and severity of VMS consistent with that in women receiving fezolinetant throughout the study. Fezolinetant also reduced PROMIS-assessed sleep disturbance, with a LS mean (SE) baseline-to-week 12 reduction of -4.1 (0.5) for fezolinetant 30mg and -5.5 (0.5) for 45mg (statistically significant difference vs placebo for fezolinetant 45mg) and a mean (SD) baseline-to-week 52 reduction of - 6.3 (7.3) for fezolinetant 30mg and -5.7 (7.9) for 45mg. The safety profile observed for the 40-week extension period was consistent with that of the 12-week placebo-controlled period. Conclusion(s): Fezolinetant 30mg and 45mg once daily were efficacious for treatment of moderate-to-severe VMS associated with menopause. Efficacy was persistent and reductions in VMS frequency were maintained during the extension period, at levels consistent with weeks 1 through 12. Fezolinetant 45mg improved sleep at week 12 and improvement was maintained through the active treatment extension period. No safety signals of concern were apparent for either fezolinetant dose.

Engmann, L., et al. (2021). Microfluidics Versus Gradient Centrifugation Effect on Euploidy Rates.
	No Results Available Device: Microfluidics chamber|Other: Density Gradient Centrifugation Euploidy rate of resulting embryos|Pregnancy rates after transfer of euploid embryos Female Not Applicable 150 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 21-106R-1 December 31, 2022

Ensrud Kristine, E., et al. (2022). "Changes in serum endogenous estrogen concentrations are mediators of the effect of low-dose oral estradiol on vasomotor symptoms." Menopause (New York, N.Y.) 29(9): 1014-1020.
	Objectives: The aim of this study was to quantify changes in serum total estradiol (E2) and estrone (E1) concentrations with initiation of low-dose oral estradiol treatment and evaluate whether changes in concentrations mediate the effect of treatment in reducing vasomotor symptom (VMS) frequency.; Methods: We analyzed baseline and week 8 (W8) data from 171 perimenopausal and postmenopausal women with VMS enrolled in low-dose 17β estradiol ( n = 72) and placebo ( n = 99) groups of a randomized clinical trial.; Results: From baseline to W8, women in the low-dose estradiol group had a fourfold increase in E2, resulting in a W8 E2 of 23 pg/mL, and a fivefold increase in E1, resulting in a W8 E1 of 110.7 pg/mL. In contrast, E2 and E1 among women in the placebo group were unchanged from baseline to W8. Changes in E2 and E1 from baseline to W8 met criteria for mediating the effect of low-dose estradiol treatment on VMS frequency. With change in estrogen concentration added to treatment assignment in a regression model predicting W8 VMS frequency, the effect of treatment with low-dose estradiol versus placebo was attenuated, with change in E2 representing a 44.1% reduction ( P = 0.03) and change in E1 representing a 69.5% reduction ( P = 0.02) in total intervention effect.; Conclusion: Among perimenopausal and postmenopausal women with VMS, treatment with low-dose oral estradiol versus placebo results in four- to fivefold increases in serum E2 and E1. The increases in serum E2 and E1 with low-dose oral estradiol treatment seem to mediate in part the effect of treatment in reducing VMS frequency.; Competing Interests: Financial disclosure/conflicts of Interest: S.D.R. reports research funding from Bayer and royalties from UpToDate. S.B. reports his institution has received research grants from MIB, AbbVie, and Transition Therapeutics, on which he is the PI. These grants are unrelated to the work. C.M.M. reports grant support from Merck Inc and consultant and advisory fees from Scynexis and UpToDate. H.J. reports grant support from Merck, Pfizer, NeRRe/KaNDy, and Que Oncology, and consultant and advisory fees from Bayer, Eisai, and Jazz. H.J.'s spouse is an employee of Arsenal Biosciences and has an equity stake in Merck Research Labs and Tango Therapeutics. The other authors declare no conflict of interest. (Copyright © 2022 by The North American Menopause Society.)

Eoh Kyung, J., et al. (2023). "Clinical Relevance of Uterine Manipulation on Oncologic Outcome in Robot-Assisted versus Open Surgery in the Management of Endometrial Cancer." Journal of Clinical Medicine 12(5).
	In this study, we investigated the impact of uterine manipulation on endometrial cancer survival outcomes. We analyzed patients with endometrial cancer who underwent robot-assisted staging and open staging surgery between 2010 and 2020. Either uterine manipulators or vaginal tubes were utilized in robot-assisted staging. Propensity score matching was performed to correct baseline characteristics. Progression-free survival (PFS) and overall survival (OS) were analyzed using Kaplan-Meier curve analysis. In total, 574 patients, including those undergoing robot-assisted staging with a uterine manipulator ( n = 213) or vaginal tube ( n = 147) and staging laparotomy ( n = 214), were analyzed. Propensity score matching was performed for age, histology, and stage as covariates. Before matching, Kaplan-Meier curve analysis showed that PFS and OS were significantly different among the three groups ( p < 0.001 and p = 0.009, respectively). In the propensity-matched cohorts of 147 women, the previously suggested differences in PFS and OS were not observed in patients undergoing robot-assisted staging with a uterine manipulator or vaginal tube or open surgery. In conclusion, robotic surgery using a uterine manipulator or vaginal tube did not compromise survival outcomes in endometrial cancer management.

Epperson, C. N., et al. (2023). "Effect of brexanolone on depressive symptoms, anxiety, and insomnia in women with postpartum depression: Pooled analyses from 3 double-blind, randomized, placebo-controlled clinical trials in the HUMMINGBIRD clinical program." Journal of Affective Disorders 320: 353-359.
	Background: Brexanolone is currently the only treatment specifically approved for postpartum depression (PPD) in the United States, based on the results from one Phase 2 and two Phase 3 double-blind, randomized, controlled trials in the HUMMINGBIRD program.; Methods: Adults with PPD randomized to a 60-h infusion of brexanolone 90 μg/kg/h (BRX90) or placebo from the 3 trials were included in these post hoc analyses. Data on change from baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, HAMD-17 Anxiety/Somatization and Insomnia subscales, and Clinical Global Impression of Improvement (CGI-I) scale were pooled. Response rates for HAMD-17 (≥50 % reduction from baseline) and CGI-I (score of 1 or 2) scales and time to response were analyzed.; Results: Patients receiving BRX90 (n = 102) versus placebo (n = 107) achieved a more rapid HAMD-17 response (median, 24 vs 36 h; p = 0.0265), with an Hour-60 cumulative response rate of 81.4 % versus 67.3 %; results were similar for time to CGI-I response (median, 24 vs 36 h; p = 0.0058), with an Hour-60 cumulative response rate of 81.4 % versus 61.7 %. CFB in HAMD-17 Anxiety/Somatization and Insomnia subscales also favored BRX90 versus placebo, starting at Hour 24 through Day 30 (all p < 0.05), and response rates for both subscales were higher with BRX90.; Limitations: The study was not powered to assess exploratory outcomes.; Conclusions: Brexanolone was associated with rapid improvement in depressive symptoms and symptoms of anxiety and insomnia compared with placebo in women with PPD. These data continue to support the use of brexanolone to treat adults with PPD.; Competing Interests: Declaration of competing interest C. Neill Epperson serves on an advisory board for Asarina Pharma and Babyscripts; reports grants awarded to the University of Colorado from Sage Therapeutics, Inc. and HealthRhythms; and receives consulting fees/honoraria from Sage Therapeutics, Inc. David R. Rubinow serves as a consultant and a clinical advisory board co-chair for Sage Therapeutics, Inc.; receives consulting fees and travel/meeting support from Sage Therapeutics, Inc.; and reports grants awarded to University of North Carolina from Sage Therapeutics, Inc. Dr. Rubinow also holds stock options from Sage Therapeutics, Inc. Samantha Meltzer-Brody reports grants awarded to University of North Carolina from Sage Therapeutics, Inc. Dr. Meltzer-Brody also received honoraria from Sage Therapeutics, Inc. Kristina M. Deligiannidis serves as a consultant to Sage Therapeutics, Inc., Brii Biosciences, Inc., and GH Research Ireland Limited, and as a council/board member for Society of Biological Psychiatry and American Society of Clinical Psychopharmacology. Dr. Deligiannidis reports grants awarded to Zucker Hillside Hospital/Feinstein Institutes for Medical Research from Sage Therapeutics, Inc. during the conduct of the brexanolone injection and zuranolone clinical trials. Dr. Deligiannidis also received grants from NIH and Vorso Corporation, royalties from an NIH employee invention outside of the submitted work, payments/honoraria from Platform Q Health Education CME and Peer View Institute for Medical Education, and travel/meeting support from Sage Therapeutics, Inc. and Vorso Corporation. Robert Riesenberg has no conflict of interest to declare. Andrew D. Krystal participates on a data safety monitoring board/advisory board for Idorsia and Neurocrine Biosciences; receives payments/honoraria from Eisai and Idorsia and consulting fees from Adare, Axsome Therapeutics, Big Health, Eisai, Evecxia, Ferring Pharmaceuticals, Galderma, Harmony Biosciences, Idorsia, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Millenium Pharmaceuticals, Merck, Neurocrine Biosciences, Neurawell, Pernix, Otsuka Pharmaceuticals, Sage Therapeutics, Inc., Takeda, and Angelini; and reports grants from Janssen Pharmaceuticals, Axsome Pharmaceutics, Reveal Biosensors, The Ray and Dagmar Dolby Family Fund, and NIH. Dr. Krystal also holds stock options from Big Health. Kemi Bankole, ng-Yi Huang, Colville Brown, and Robert Lasser are employees of Sage Therapeutics, Inc. and hold stock and/or stock options. Haihong Li and Stephen J. Kanes are former employees of Sage Therapeutics, Inc. and may hold stock and/or stock options. Dr. Kanes is also an inventor of the patent entitled “Neuroactive steroids, compositions, and uses thereof” (US10940156B2), which relates to methods of using brexanolone to treat certain diseases. (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Erciyestepe, S. G., et al. (2023). "Can an apparent diffusion coefficient of uterine fibroid before uterine artery embolization predict potential fibroid response?" Ginekologia polska.
	OBJECTIVES: ACOG guidance confirms the use of uterine artery embolisation (UAE) as an alternative to hysterectomy or myomectomy. The main objective of this article is to evaluate the ability of preoperative magnetic resonance imaging (MRI) to study the relationship between uterine fibroid reduction and diffusion coefficient (ADC) value after UAE. This is a relevant topic with the growing interest in using ADC as a noninvasive imaging biomarker for monitoring tissue changes and predicting uterine fibroid response to UAE over the past years. MATERIAL AND METHODS: In this prospective controlled non-randomized trial; uterine fibroid volume, fibroid diameter, uterine volume, fibroid ADC and normal myometrium ADC were recorded before and after UAE. Wilcoxon test was used in the analysis of the dependent quantitative data. Pearson correlation coefficients were calculated between post-UAE uterine volume, fibroid volume, and average fibroid diameter reduction and the patient's age, parity, gravidity, fibroid ADC and myometrial ADC before UAE. RESULT(S): The mean fibroid volume reduction was 36.0% (range between 17.3-77.7%). Mean fibroid diameter, fibroid volume, uterine volume, and myometrium ADC values after UAE were significantly lower than before the procedure (p = 0.002, < 0.001, 0.001, 0.006 respectively), but the decrease in fibroid ADC is not significant. As a result decrease in fibroid volume was greater as pre-UAE fibroid ADC values increased, and that finding may contribute to the selection of the patients for the procedure. CONCLUSION(S): The ADC value before UAE was positively correlated with fibroid volume reduction.

Erdemoğlu, Ç. and D. Aksoy (2022). "The effect of hypnofertility on fertility preparedness, stress, and coping with stress in women having in vitro fertilization: A randomized controlled trial." Journal of Reproductive and Infant Psychology: 1-12.
	BACKGROUND: In vitro fertilisation is a stressful process for women. Hypnofertility is a method that can be used to relieve stress during in vitro fertilisation. It is based on an effective and strong body-mind interaction, as well as balancing the brain and body via positive words and thoughts. OBJECTIVE: This study aimed to investigate the effects of hypnofertility on fertility preparedness, stress, and coping with stress in women undergoing in vitro fertilisation. METHODS: This study was conducted with a randomised controlled trial design. Hypnofertility-based relaxation, visualisation, imagination, and affirmation techniques were applied to the intervention group at four stages, and no initiative was applied to the women in the control group. The Clinical Trial Registration number of the study is NCT04755270. RESULTS: After the hypnofertility method, the mean score of the intervention group in the positive feelings and thoughts subscale of the Fertility Preparedness Scale was higher than that of the control group (p < 0.05). The hypnofertility method caused a significant decrease in the level of infertility stress in the intervention group, and the intervention group used the active-confronting and passive-avoidance methods more than control group did (p < 0.05). CONCLUSION: The hypnofertility method increased the levels of preparedness for fertility, reduced stress levels and provided effective strategies to cope with stress.

Erdogan, O., et al. (2023). "Is adjuvant chemotherapy necessary for 2014 FIGO stage IC adult granulosa cell tumor?: Multicentric Turkish study." Asia-Pacific Journal of Clinical Oncology.
	Aim: The aim of our study is to examine the clinical, surgical, and pathological factors of stage 1C adult granulosa cell tumor (AGCT) patients and to investigate the effects of adjuvant therapy on recurrence and survival rates in this patient group. Method(s): Out of a total of 415 AGCT patients treated by 10 tertiary oncology centers participating in the study, 63 (15.2%) patients with 2014 FIGO stage IC constituted the study group. The FIGO 2014 system was used for staging. Patient group who received adjuvant chemotherapy was compared with patient group who did not receive adjuvant chemotherapy in terms of disease-free survival (DFS), and disease-specific survival. Result(s): The 5-year DFS of the study cohort was 89%, and the 10-year DFS was 85%. Those who received adjuvant chemotherapy and those who did not were similar in terms of clinical, surgical and pathological factors, except for peritoneal cytology. In the univariate analysis, none of the clinical, surgical or pathological factors were significant for DFS. Adjuvant chemotherapy and type of treatment protocol had no impact on DFS. Conclusion(s): Adjuvant chemotherapy was not associated with improved DFS and overall survival in stage IC AGCT. Multicentric and randomized controlled studies are needed for early stage AGCT in order to confirm these results and reach accurate conclusions.Copyright © 2023 John Wiley & Sons Australia, Ltd.

Erekson, E., et al. (2021). "The Design of a Prospective Trial to Evaluate the Role of Preoperative Frailty Assessment in Older Women Undergoing Surgery for the Treatment of Pelvic Organ Prolapse: The FASt Supplemental Trial." Female Pelvic Medicine & Reconstructive Surgery 27(1): e106-e111.
	OBJECTIVE: We present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP. METHODS: The selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification. CONCLUSIONS: This trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications.

Erel, C. T. and I. B. Ozcivit (2021). "Re: vaginal Er: YAG LASER application in the menopausal ewe model: a randomised estrogen and sham-controlled trial." BJOG 128(6): 1098.
	
Ergun-Longmire, B. and E. Greydanus Donald (2024). "Ovarian tumors in the pediatric population: An update." Disease-a-month : DM: 101691.
	Research reveals that 1% of neoplasms in females under 17 years of age are ovarian neoplasms and though usually benign, malignant tumors may occur in the pediatric age group. This review considers various current concepts of these tumors including the epidemiology, risk factors, clinical presentations, diagnosis, differential diagnosis, and treatment options including the need to provide fertility-sparing surgery as well as their potential impacts on the psychological well-being of children and adolescents. We gathered data from the published articles ranging from studies, meta-analyses, retrospective studies, and reviews. We focused on the articles published in English between January 1, 2000, and August 31, 2023. Only a few articles published prior to 2000 were included for historical perspective. (Copyright © 2024. Published by Elsevier Inc.)

Erguven, M. and T. Irez (2023). "Hyaluronidase used in oocyte denudation inhibits the proliferation and the viability of cumulus cells through the inhibition of midkine." Human Reproduction 38(Supplement 1): i274.
	Study question: Does hyaluronidase (HAse) have possible negative or positive effects on cumulus cells (CCs) during oocyte denudation before ICSI by altering midkine (MK) levels? Summary answer: Hyaluronidase inhibits the proliferation of CCs via the inhibition of MK activity which may result in poor embryo quality and low ICSI success. What is known already: MK is abundantly expressed in ovarian follicles. MK secreted from the cumulus-granulosa cells that surround oocytes was shown to promote the cytoplasmic maturation of oocytes. This effect of MK could be mediated via its' anti-apoptotic effect and some other mechanisms. The removal of CCs during oocyte denudation (OD) is done in order to select and grade the oocytes before ICSI. HAse is applied for ICSI to break down hyaluronic acid, which is present at high levels in the cumulus-oocyte complex during OD. To date, there have only been a few reported cases of the toxic effects of hyaluronidase on oocytes. Study design, size, duration: This study is a prospective, randomized study done with 90 healthy women between September 2017 and September 2018. Participants/materials, setting, methods: This study was done with women diagnosed as a male factor between the ages of 21 and 40 who underwent ICSI. HAse was applied to the cultured CCs at concentrations of 0.1 IU/ml, 1 IU/ml, and 10 IU/ml. The proliferation and apoptosis indices (Flow cytometry), structures [Transmissive electron microscopy (TEM)], and MK levels (ELISA) of CCs were evaluated every 24 hours for 48 hours. One way-Anova was used and p<0.05 was considered statistically significant. Main results and the role of chance: The application of HAse at all concentrations decreased cumulus cell numbers for 48 hours (p<0.05). The highest decrease in cell number and cell viability with the highest number of apoptotic cells were detected at the 48th hour at the application of the highest concentration of HAse (p<0.05). The highest concentration of HAse application caused the highest decrease in MK levels at the end of 48 hours (p<0.05). Limitations, reasons for caution: The effect of HAse on the CCs of women aged below 21 and above 40 could not be evaluated. Therefore, the overall resistance and fragility of CCs to these HAse concentrations could not be evaluated. In addition, the HAse effects should be evaluated in female infertility cases such as PCOS. Wider implications of the findings: This is the first report to examine the effect of HAse on MK activity. 2-3 lines of CCs are commonly left during oocyte denudation in order to protect the oocyte from stress-induced reactions. The low number of CCs means low MK levels resulting in a loss in oocyte competence.

Erin, R., et al. (2021). "Comparison of Urodynamics Parameters with Intrafascial or Extrafascial Hysterectomy Techniques." Journal of Gynecologic Surgery 37(2): 139‐143.
	Objectives: The aim of this study was to compare urodynamics parameters at pre‐and postoperative periods in patients undergoing intrafascial or extrafascial abdominal hysterectomy. Background: Hysterectomy carries the risk of damage to the pelvic splanchnic nerve, which leads to the development of urinary incontinence. Materials and Methods: Women scheduled for total abdominal hysterectomy were randomized to intrafascial (n = 24) and extrafascial (n = 27). All of the 10 urodynamics parameters investigated in the two techniques at pre‐and postoperative periods were compared. p < 0.05 was chosen to represent the statistical significance for each of the variables. Results: We observed by urodynamics investigation at preoperative and sixth month postoperative periods no urinary incontinence in patients subjected to intrafascial or extrafascial total abdominal hysterectomy. There was no difference between the two techniques with respect to maximum detrussor pressure, maximum abdominal pressure, strong micturition requirement, vesical compliance, detrusor compliance, maximum vesical pressure, first sensation of bladder filling, first desire to void, and strong desire to void (p > 0.05). Maximum bladder capacity in the intrafascial technique was significantly higher than in the extrafascial technique (p < 0.05). Conclusion: No significant relationship was found between the two groups with respect to increase of stress or urge urinary incontinence symptoms and subsequent incontinence after hysterectomy.

Ersahin, S., et al. (2022). "High serum AMH inhibits pathological growth of the low biomass endometrial microbiome." European Review for Medical and Pharmacological Sciences 26(20): 7600-7604.
	Objective: Although host microbiome play a role in both hormonal status and fertility, this issue has not yet been clarified. Since the endometrium is a sterile tissue, it is accepted that microbiota does not grow under normal conditions. The aim of the study was to reveal the characteristics of endometrial microbiota according to serum AMH levels in women with implantation failure.; Patients and Methods: Forty-five women aged 20-30 years with two or more implantation failures were included in the study. They were divided into 3 groups according to their serum AMH values: Group 1 -AMH <1.3 ng/ml; Group 2 - AMH between 1.3-2.6 ng/ml; Group 3 - AMH >2.6 ng/ml. Twenty-two healthy fertile women who were the same age as the infertile group and applied for cervical smear screening were accepted as the control group. Following the embryo transfer, the tip of the catheter was inserted into the transport medium under sterile conditions. Sowing was carried out by touching the tips of the catheter to the blood agar medium. After the evaluation of the petri dishes at the end of 48 hours of incubation, colonies were stained with Gram stain. Microorganisms in the colonies were identified with the Vitek-2 device according to their gram-staining characteristics and their antibiograms were made.; Results: A negative correlation was detected between low AMH values and the microbiome detection rates in endometrial cultures. In patients with low serum AMH levels, the chance of endometrial microbiota growth was higher in the endometrial culture medium. The most common bacteria were found to be MSSA, MRKNS and lactobacillus. Clinical pregnancy rates were found to be significantly higher in the group with high AMH levels. As AMH levels increased, positive flora detection rates decreased, while clinical pregnancy rates increased.; Conclusions: Low serum AMH level increases the rate of positive endometrial microbiome in culture and decreases clinical pregnancy rates.

Erzincan, M. and Hospital (2021). "The Effect of Hot Pack Application on Postoperative Ileus Undergoing Surgery for Gynecologic Malignancies." ClinicalTrials.gov.
	Postoperative ileus (POI), is an extensively known complication characterized by an impairment of normal gastrointestinal motor activity after abdominal surgery and may also occur after surgery at other sites due to non‐mechanical causes. [1]. This clinical asset has been linked to prominent perioperative morbidity with the following financial burden owing to extended hospitalization [1]. Furthermore, POI can postpone adjuvant treatments, such as chemotherapy in patients who went through surgery for cancers. Abdominal tenderness and distension, nausea and vomiting, delay in the passage of flatus and stool, and intolerance to solid food are the prime symptoms of POI [1‐3]. It is generally transient, but if prolonged, can cause surgical incision dehiscence, intestinal anastomotic fistula, abdominal cavity infection, intestinal ischemia, aspiration pneumonia, and other serious complications [4‐6]. Hence, many clinicians have focused on averting POI. Many studies have analyzed preventive methods, such as preoperative mobilization of the patient, adequate pain control, gum chewing, epidural anesthesia, coffee consumption, and motility agents such as metoclopramide and alvimopan [7‐15]. For all the manifold remedy approaches, POI maintains a difficult clinical challenge that compromises the rapid improvement of patients who underwent abdominal surgery. Recently, thermal attempts have been employs for several situations such as inflammatory bowel disease, chronic pelvic pain, and abdominal pain [16]. It may be used in two different ways; whole body or local. Local thermal therapy can be carried out by hot pack or paraffin [17]. It has been demonstrated that local thermotherapy abate myotonia, enhances circulation, and eases pain by expediting the removal of the pain‐producing substance. Local thermal therapy is widely used for a number of conditions such as pain, nausea, vomiting, and some bowel diseases in traditional Chinese medicine [18]. Only one study has shown that hot pack therapy at the postoperative period has a positive effect on bowel motility. However, this study has a lot of weaknesses. Moreover, until now, no study has specifically investigated the effect of the hot pack on gynecological oncology surgery. The investigators hypothesized that using a hot pack during the early postoperative period would accelerate the return of gastrointestinal motility. Therefore, investigators performed a randomized controlled trial (RCT) to assess whether using hot pack whips up the recovery of gut function after gynecological oncology surgery

Escarcega-Bordagaray, J. A., et al. (2024). "Basal characteristics of patients who responded to Ovarian Fragmentation for Follicular Activation (OFFA) or In Vitro Activation (IVA): a systematic review and meta-analysis." Journal of Assisted Reproduction and Genetics.
	A systematic review and meta-analysis were performed to identify if there is a subset of patients with POI who are more likely to show follicular growth after ovarian fragmentation for follicular activation (OFFA) or in vitro activation (IVA). Five studies met inclusion criteria for meta-analysis with a total of 164 patients. Forty-three patients showed follicle development (26.21%). Of those, the pregnancy rate was 35.58% (11/43) and the live birth rate was 20.93% (9/43). Our meta-analysis showed that age was not associated with follicle growth. However, lower baseline FSH, lower duration of amenorrhea/diagnosis, and presence of follicles remaining in biopsy were statistically significant for follicle development. Patients with basal characteristics mentioned before may have more chances to show follicle growth after OFFA or IVA. Taking into account that approximately 20% of patients with follicle growth had live birth, these results are very promising. Given the overall certainty of evidence, future studies are needed to confirm said results.

Eskander Ramez, N. (2024). "Revisiting immunotherapy in endometrial cancer." Clinical advances in hematology & oncology : H&O 22(1): 28-30.
	
Eskander Ramez, N., et al. (2023). "Overcoming the challenges of drug development in platinum-resistant ovarian cancer." Frontiers in Oncology 13: 1258228.
	The definition of "platinum-resistant ovarian cancer" has evolved; it now also reflects cancers for which platinum treatment is no longer an option. Standard of care for platinum-resistant ovarian cancer is single-agent, non-platinum chemotherapy with or without bevacizumab, which produces modest response rates, with the greatest benefits achieved using weekly paclitaxel. Several recent phase 3 trials of pretreated patients with prior bevacizumab exposure failed to meet their primary efficacy endpoints, highlighting the challenge in improving clinical outcomes among these patients. Combination treatment with antiangiogenics has improved outcomes, whereas combination strategies with immune checkpoint inhibitors have yielded modest results. Despite extensive translational research, there has been a lack of reliable and established biomarkers that predict treatment response in platinum-resistant ovarian cancer. Additionally, in the platinum-resistant setting, implications for the time between the penultimate dose of platinum therapy and platinum retreatment remain an area of debate. Addressing the unmet need for an effective treatment in the platinum-resistant setting requires thoughtful clinical trial design based on a growing understanding of the disease. Recent cancer drug approvals highlight the value of incorporating molecular phenotypes to better define patients who are more likely to respond to novel therapies. Clinical trials designed per the Gynecologic Cancer InterGroup recommendations-which advocate against relying solely upon the platinum-free interval-will help advance our understanding of recurrent ovarian cancer response where platinum rechallenge in the platinum-resistant setting may be considered. The inclusion of biomarkers in clinical trials will improve patient stratification and potentially demonstrate correlations with biomarker expression and duration of response. With the efficacy of antibody-drug conjugates shown for the treatment of some solid and hematologic cancers, current trials are evaluating the use of various novel conjugates in the setting of platinum-resistant ovarian cancer. Emerging novel treatments coupled with combination trials and biomarker explorations offer encouraging results for potential strategies to improve response rates and prolong progression-free survival in this population with high unmet need. This review outlines existing data from contemporary clinical trials of patients with platinum-resistant ovarian cancer and suggests historical synthetic benchmarks for non-randomized trials.; Competing Interests: RE reports receiving institution research support from AstraZeneca, Clovis Oncology, Eisai, Merck, and Novocure; and consulting and advisory fees from AstraZeneca; Cardiff Oncology; Clovis Oncology; Eisai; Elevar; Genentech/Roche; GSK/Tesaro; ImmunoGen, Inc; Merck; Mersana; and Myriad. KM reports advisory board participation for Addi; Alkermes; Aravive, Inc; AstraZeneca; Blueprint Pharma; Caris; Celsion Corporation; Clovis; Eisai Co, Ltd; Eli Lilly and Company; EMD Serono; Genentech, Inc/Roche; GlaxoSmithKline plc/Tesaro; I-MAB Biopharma Co, Ltd; ImmunoGen, Inc; InxMed Co, Ltd; Jiangsu Hengrui Pharmaceuticals Company Ltd; Merck & Co, Inc; Mereo Biopharma Group plc; Mersana Therapeutics, Inc; Myriad Genetics, Inc; Novartis Pharmaceuticals Corporation; Novocure GmbH; Onconova Therapeutics, Inc; OncXerna Therapeutics, Inc; Tarveda Therapeutics; VBL Therapeutics; and Verastem, Inc; research funding from Eli Lilly and Company; GlaxoSmithKline plc/Tesaro; Merck & Co, Inc; PTC Therapeutics; and Verastem, Inc; and employment by GOG Partners, NRG Ovarian Cancer Committee Chair, and employment by The GOG Foundation Inc uncompensated. BM reports receiving speaker and/or consultant fees from Acrivon; Adaptimmune; Amgen; Aravive; AstraZeneca; Bayer; Clovis; Eisai; Elevar; Genmab/Seagen; the GOG Foundation; Gradalis; Heng Rui; ImmunoGen, Inc; Laekna; MacroGenics; Merck; Mersana; Myriad; Novartis; Novocure; OncoC4; Panavance; Pieris; Pfizer; Roche/Genentech; Sorrento; TESARO/GSK; L; Verastem; and Zentalis; and consultant and/or investigator fees from US Oncology Research. TH reports advisory board participation for AstraZeneca; Caris; Clovis; Eisai Co, Ltd; Epsilogen Ltd; Genentech, Inc; GlaxoSmithKline plc; Johnson & Johnson; Merck & Co, Inc; Mersana Therapeutics, Inc; and Seagen Inc. CA reports nothing to disclose. DO reports receiving institutional funds from AbbVie; Advaxis; Agenus, Inc; Alkermes; Aravive, Inc; Arcus Biosciences, Inc; AstraZeneca; BeiGene USA, Inc; Boston Biomedical; Bristol Myers Squibb; Clovis Oncology; Deciphera Pharma; Eisai; EMD Serono, Inc; Exelixis; Genentech, Inc; Genmab; GlaxoSmithKline; GOG Foundation; Hoffmann-La Roche, Inc; ImmunoGen, Inc; Incyte Corporation; IOVANCE Biotherapeutics; Karyopharm; Leap Therapeutics, Inc; Ludwig Institute for Ca; Merck & Co, Inc; Merck Sharp & Dohme Corp; Mersana Therapeutics, Inc; NCI; Novartis; Novocure; NRG Oncology; OncoC4, Inc; OncoQuest, Inc; Pfizer, Inc; Precision Therapeutics, Inc; Prelude Therapeutics; Regeneron Pharmaceuticals, Inc; RTOG; Rubius Therapeutics; Seattle Genetics Seagen; Sutro Biopharma; SWOG; TESARO; and Verastem, Inc; and consultant and/or advisory board personal fees from AbbVie; Adaptimmune; Agenus, Inc; Arquer Diagnostics; Arcus Biosciences, Inc; AstraZeneca; Atossa Therapeutics; Boston Biomedical; Cardiff Oncology; Celcuity; Clovis Oncology; Corcept Therapeutics; Duality Bio; Eisai; Elevar; Exelixis; Genentech, Inc; Genelux; GlaxoSmithKline; GOG Foundation; Hoffmann-La Roche, Inc; ImmunoGen, Inc; Imvax; InterVenn; INXMED; IOVANCE Biotherapeutics; Janssen; Jazz Pharmaceuticals; Laekna; Leap Therapeutics, Inc; Luzsana Biotechnology; Merck & Co, Inc; Merck Sharp & Dohme Corp; Mersana Therapeutics, Inc; Myriad; Novartis; Novocure; OncoC4, Inc; Onconova; Regeneron Pharmaceuticals, Inc; Replimmune; R-PHARM US, LLC; Roche Diagnostics; Seattle Genetics Seagen; Sorrento; Sutro Biopharma; Tarveda Therapeutics; Toray; Trillium; Umoja; Verastem, Inc; VBL Therapeutics; Vincerx Pharma; Xencor; and Zentalis. RC reports research funding from AbbVie Inc; AstraZeneca; Clovis; Genmab A/S; ImmunoGen, Inc; Merck & Co, Inc; Mersana Therapeutics, Inc; Roche/Genentech, Inc; and Toray; and scientific steering committee participation with AbbVie Inc; Agenus Inc; Aravive, Inc; AstraZeneca; Clovis; Deciphera Pharmaceuticals, Inc; Epsilogen Ltd; Genentech, Inc; Genmab A/S/Seagen Inc; GlaxoSmithKline plc; ImmunoGen, Inc; Karyopharm Therapeutics Inc; Merck & Co, Inc; Mirati Therapeutics, Inc; Novocure GmbH; OncXerna Therapeutics, Inc; and Toray. (Copyright © 2023 Eskander, Moore, Monk, Herzog, Annunziata, O’Malley and Coleman.)

Eskew Ashley, M., et al. (2019). "Letrozole Compared With Clomiphene Citrate for Unexplained Infertility: A Systematic Review and Meta-analysis." Obstetrics and Gynecology 133(3): 437-444.
	Objective: To estimate the clinical effectiveness, as determined by positive pregnancy test, of letrozole compared with clomiphene citrate for ovarian stimulation in patients with unexplained infertility.; Data Sources: We conducted a systematic review and meta-analysis of data from electronic databases including Ovid-MEDLINE, EMBASE, Scopus, Cochrane Database of Systematic Reviews, Cochrane Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and ClinicalTrials.gov.; Methods: We searched for concepts of unexplained infertility, letrozole, clomiphene citrate, and clinical outcomes including pregnancy and live birth. Studies were included if they were randomized controlled trials (RCTs) comparing clomiphene citrate with letrozole in patients with unexplained infertility. Eight RCTs including 2,647 patients with unexplained infertility were included. Primary outcome was positive pregnancy test per patient. Secondary outcomes included positive pregnancy test per cycle, clinical pregnancy, live birth, spontaneous miscarriage, twin gestation, mean serum estradiol (E2), endometrial thickness, and number of dominant follicles. The Cochrane Q test and Higgin's I were used to assess heterogeneity. Random effects models were used to obtain pooled relative risks (RR) and 95% CIs.; Tabulation, Integration, and Results: In analysis per patient, there was no significant difference in positive pregnancy test between patients treated with letrozole compared with clomiphene citrate (24% vs 23%, pooled RR 1.08, 95% CI 0.85-1.36). Significant heterogeneity was noted between studies (I=60.8%). There were no significant differences in clinical pregnancy (pooled RR 1.15, 95% CI 0.71-1.85), live birth (pooled RR 0.94, 95% CI 0.83-1.08), spontaneous miscarriage (pooled RR 0.92, 95% CI 0.61-1.38), or twin gestation (pooled RR 0.81, 95% CI 0.39-1.68). Mean serum E2 was significantly lower in the letrozole group than in the clomiphene citrate group.; Conclusion: Although limited by heterogeneity, studies of ovarian stimulation in women with unexplained infertility show no difference in clinical outcomes between letrozole and clomiphene citrate.

Esmaeilian, Y., et al. (2023). "IVF characteristics and the molecular luteal features of random start IVF cycles are not different from conventional cycles in cancer patients." Human reproduction (Oxford, England) 38(1): 113-124.
	Study Question: Are the IVF parameters and the steroidogenic luteal characteristics of random-start IVF cycles different from conventional cycles in cancer patients?; Summary Answer: No; controlled ovarian stimulation cycles randomly started at late follicular phase (LFP) and luteal phase (LP) are totally comparable to those conventional IVF cycles started at early follicular phase (EFP) in terms of the expression of the enzymes involved in cholesterol utilization and steroid hormone biosynthesis pathways, gonadotropin receptor expression and, estradiol (E2) and progesterone (P4) production in addition to the similarities in ovarian response to gonadotropin stimulation, oocyte yield, fertilization rate and embryo development competency in cancer patients.; What Is Known Already: Random start ovarian stimulation protocols are commonly employed for oocyte and embryo freezing for fertility preservation in cancer patients with time constraints who do not have sufficient time to undergo ovarian stimulation initiated conventionally at EFP of the next cycle. No data is available regarding the molecular steroidogenic features of these cycles analyzed together with the clinical IVF characteristics in cancer patients. We aimed to address this question in this study to help understand how similar the random start cycles are to the conventional start ones.; Study Design, Size, Duration: A clinical translational research study conducted in 62 cancer patients undergoing IVF for fertility preservation between the years 2017 and 2022.; Participants/materials, Setting, Methods: Sixty-two patients who were diagnosed with different types of cancer and underwent ovarian stimulation for oocyte (n = 41) and embryo (n = 21) cryopreservation using GnRH antagonist protocol and human menopausal gonadotropins before receiving cancer treatment/surgery were enrolled in the study. For patients with breast cancer and endometrial cancer the aromatase inhibitor letrozole was used with gonadotropin stimulation. Ovarian stimulation was initiated conventionally at EFP in 22 patients and served as control while it was started at LFP in 20, and mid-LP in the other 20 patients. The luteinized granulosa cells (GCs) were recovered from follicular aspirates during oocyte retrieval procedure and used for the experiments separately for each individual patient. The expression of the enzymes involved in sex steroid biosynthesis (StAR, 3β-HSD, Aromatase) and cholesterol synthesis (3-hydroxy 3-methylglutaryl Co-A reductase (HMG-Co-A reductase)), utilization (hormone sensitive lipase (HSL)), and storage (Acetyl-Coenzyme A acetyltransferase 1 (ACAT-1)), and gonadotropin receptor expression status were analyzed using immunoblotting and RT-PCR methods. Laser confocal immunofluorescence imaging was applied to analyze and compare the expression patterns of the steroidogenic enzymes and their relation with mitochondria. In vitro E2 and P4 production by the cells were compared among the groups.; Main Results and the Role of Chance: Baseline demographic and IVF characteristics of the patients undergoing the conventional start and random start IVF cycles were similar. Duration of gonadotropin stimulation was significantly longer in LFP and LP start cycles in comparison to the conventional ones. Ovarian response to gonadotropin stimulation, mature and total oocyte yield, fertilization and Day 5 blastulation rates of the embryos were comparable between the conventional versus random start cycles. When the luteal GCs of these random start cycles were analyzed we could not find any gross differences between these cycles in terms of the viability index and gross light microscopic morphologic features. More detailed analysis of the molecular luteal characteristics of the cells using RT-PCR, immunoblotting methods revealed that the expression profiles of the gonadotropin receptors, and the enzymes involved in sex steroid biosynthesis and cholesterol synthesis/utilization, and the steroidogenic activity of the luteal GCs of the random start cycles are almost identical to those of the conventional start cycles. Confocal image analysis demonstrated similar patterns in the signal expression profiles of the steroidogenic enzymes and their co-localization within mitochondria.; Large Scale Data: N/A.; Limitations, Reasons for Caution: Caution should be exercised when interpreting our data and counseling cancer patients seeking fertility preservation because it is still unclear if previous exposure to cancer drugs, different ovarian pathologies or infertility etiologies, previous ovarian surgery and/or any other underlying diseases that are concomitantly present with cancer may cause a difference between conventional and random start stimulation protocols in terms of IVF parameters, luteal function and reproductive outcome. Relatively low number of patients in each stimulation protocol and pooling of luteal GCs for each patient rather than individual analysis of each follicle and oocyte are additional limitations of our study.; Wider Implications of the Findings: Our findings provide reassurance that random start protocol offers cancer patients an equally good prospect of fertility preservation as conventional IVF.; Study Funding/competing Interest(s): Funded by the School of Medicine, the Graduate School of Health Sciences of Koc University and Koç University Research Center for Translational Medicine (KUTTAM), equally funded by the Republic of Turkey Ministry of Development Research Infrastructure Support Program. All authors declare no conflict of interest.; Trial Registration Number: N/A. (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Espitalier, F., et al. (2021). ""Impact of Nociception Level (NOL) index intraoperative guidance of fentanyl administration on opioid consumption, postoperative pain scores and recovery in patients undergoing gynecological laparoscopic surgery. A randomized controlled trial"." Journal of Clinical Anesthesia 75: 110497.
	Study objective: The Nociception Level (NOL) index uses a multiparametric approach to measure the balance between sympathetic and parasympathetic systems activity. Recently, a strong correlation between the NOL index response to nociceptive stimuli and the level of opioid analgesia during surgery was reported. Others observed that intraoperative doses of remifentanil and sufentanil were reduced when the NOL index was used. So far, no study has evaluated the impact of NOL‐guided fentanyl antinociception in laparoscopic gynecological surgery. The primary hypothesis of this present study was to evaluate whether intraoperative NOL‐guided fentanyl administration would reduce intra‐operative opioid consumption. Secondary hypotheses were to assess whether this would lead to lower postoperative opioid consumption and pain scores, as well as improved postoperative outcomes. Setting: University hospital, operating room. Patients: 70 adult patients, ASA 1–3, scheduled for total laparoscopic hysterectomy. Interventions: Patients were randomized into 2 groups: SOC (standardization of care) and NOL (using the NOL index to guide the administration of fentanyl). The depth of anesthesia was monitored with BIS™. Intraoperative fentanyl boluses were administered based on heart rate and mean arterial pressure variations in the SOC group, and NOL index for the NOL group. Measurements: Fentanyl total intraoperative dose administered was collected and also averaged per hour. Pain scores and hydromorphone consumption were assessed in the post‐anesthesia care unit and up to 24 h. Main results: Sixty‐six patients completed the study, 33 in each group. Total intraoperative fentanyl administration was not different between the two groups (217 (70) in the NOL group vs 280 (210) in the SOC group (P = 0.11)). Nevertheless, intraoperative fentanyl administration per hour was reduced by 25% in the NOL‐guided group compared to the SOC group: 81 (24) vs 108 (66) μg.h−1, respectively (P = 0.03). Hydromorphone consumption and pain scores in the post‐anesthesia care unit and at 24 h were not significantly different between the two groups. Conclusion: NOL‐guided analgesia allowed for a 22% reduction of the total amount of intraoperative fentanyl which was not significant. Nevertheless, results reported a significant reduction by 25% in the doses of fentanyl averaged per hour of surgery and administered in the NOL‐guided group compared with the standardized practice in laparoscopic gynecological surgery. The pain measured postoperatively was similar in the two groups while the average postoperative consumption of opioids to achieve the same level of pain scores in post‐anesthesia care unit and at 24 h was not significantly reduced. Further larger multicenter studies centered towards postoperative outcomes are needed.

Estevez, S. L., et al. (2022). "OBSTETRIC OUTCOMES OF FERTILITY PATIENTS WITH PELVIC PAIN DISORDERS." Fertility and Sterility 118(4 Supplement): e95-e96.
	Objective: Previous research has shown vaginismus to be an independent risk factor for cesarean delivery (CD).1 CD is associated with increased maternal and neonatal morbidity compared with vaginal deliveries; despite this, the rate of CD continues to rise. The American College of Obstetricians and Gynecologists has proposed strategies to help reduce the rate of CD. Most of which focus on the peripartum and intrapartum periods. Therefore, an opportunity exists for reproductive endocrinology and infertility (REI) providers to identify patients at risk for CD based on a history of pelvic pain disorders (PPDs). Material(s) and Method(s): The study included all nulliparous patients undergoing assisted reproductive technology (ART) treatment at a single academic fertility center who had a live birth from 2012-2020. Cases included all patients diagnosed with PPDs. A 3:1 ratio propensity score matched population of patients without PPDs was included as a control group. Patients were matched by age, body mass index (BMI), and anti-Mullerian hormone (AMH). Baseline demographics were collected and included age, BMI, marital status, duration of infertility, AMH, history of anxiety disorders, use of anxiolytics, and obstetrical outcomes. Exclusion criteria were pregnancy outside of treatment, fibroids, Mullerian anomalies, and prior uterine surgery. Comparative statistics were performed using chi-square and students t-test where appropriate. A multivariate regression analysis was conducted to evaluate the association between PPDs and mode of delivery. A total sample size of 170 patients per group was calculated in order to detect a 15% difference is CD rates with an 80% power (alpha=0.05). Result(s): 174 patients who reported a history of a PPD were compared to 575 controls. Demographic characteristics were comparable among groups. Significant differences were found in the duration of infertility among groups with PPD patients reporting a longer duration of infertility (18.9+/-20 vs 14.0+/-14 vs. p=0.003). Patients in the PPD group had significantly higher diagnosis of anxiety disorders (115+/-21.9 vs. 55+/-31.6, p< 0.009) and use of anxiolytics (17+/-3.2 vs. 12+/-6.9, p< 0.03) as compared to controls. The prevalence of chronic hypertension was significantly higher in patients with PPDs (6+/-3.4 vs 5+/-1 p<0.02). Patients with a history of PPD had a higher rate of CD compared with controls (59.8% vs. 49.2% p=0.01). Additionally, after adjusting for age, BMI, AMH, duration of infertility, and fertility diagnosis, there was a significant association between having a diagnosis of PPD and increased odds of having a CD (aOR= 1.5, CI 95%; 1.06-2.20). Conclusion(s): Patients with PPDs have significantly greater odds of CD, higher rates of anxiety disorders, and increased use of anxiolytics compared to patients without a history of pelvic pain. Impact Statement: REIs could serve as a point of intervention and referral for patients with PPDs. Pelvic physical therapy, emotional support, and insertion training may be beneficial in improving patient experience and outcomes, and reducing the risk of CD. Support: None REFERENCES:: 1. Moller L, Josefsson A, Bladh M, Lilliecreutz C, Sydsjo G. Reproduction and mode of delivery in women with vaginismus or localised provoked vestibulodynia: a Swedish register-based study. BJOG. 2015 Feb;122(3):329-34. Epub 2014 Jul 3. PMID:.Copyright © 2022

Ethier, J.-L., et al. (2022). "State of the Biomarker Science in Ovarian Cancer: A National Cancer Institute Clinical Trials Planning Meeting Report." JCO precision oncology 6: e2200355.
	Purpose: Despite therapeutic advances in the treatment of ovarian cancer (OC), 5-year survival remains low, and patients eventually die from recurrent, chemotherapy-resistant disease. The National Cancer Gynecologic Cancer Steering Committee identified the integration of scientifically defined subgroups as a top strategic priority in clinical trial planning.; Methods: A group of experts was convened to review the scientific literature in OC to identify validated predictive biomarkers that could inform patient selection and treatment stratification. Here, we report on these findings and their potential for use in future clinical trial design on the basis of hierarchal evidence grading.; Results: The biomarkers were classified on the basis of mechanistic targeting, including DNA repair and replication stress, immunotherapy and tumor microenvironment, oncogenic signaling, and angiogenesis. Currently, BRCA mutations and homologous recombination deficiency to predict poly (ADP-ribose) polymerase inhibitor response are supported in OC by the highest level of evidence. Additional biomarkers of response to agents targeting the pathways above have been identified but require prospective validation.; Conclusion: Although a number of biomarkers of response to various agents in OC have been described in the literature, high-level evidence for the majority is lacking. This report highlights the unmet need for identification and validation of predictive biomarkers to guide therapy and future trial design in OC.

Etrusco, A., et al. (2024). "Efficacy, safety, and feasibility of the treatment of intrauterine pathologies with the mini-resectoscope: A systematic review." International Journal of Gynecology and Obstetrics.
	Background: Hysteroscopy represents the gold standard for the diagnosis and treatment of intrauterine pathologies. The advent of the mini-resectoscope heralded a new era in intrauterine surgery, both in inpatient and outpatient settings. Objective(s): To evaluate the effectiveness, safety, and feasibility of the mini-resectoscope for the treatment of intrauterine pathologies. Search Strategy: Electronic databases were searched for English-language trials describing surgical procedures for uterine pathologies performed with a mini-resectoscope until 30 April 2023. Selection Criteria: Retrospective or prospective original studies reporting the treatment of uterine pathologies with mini-resectoscope were deemed eligible for the inclusion. Data Collection and Analysis: Data about study features, characteristics of included populations, surgical procedures, complications, and results/outcomes were collected. Result(s): Seven papers that met the inclusion criteria were included in this systematic review. Quantitative analysis was not possible due to data heterogeneity. A descriptive synthesis of the results was provided accordingly to the pathology hysteroscopically removed/corrected: polyps and myomas, uterine septum, intrauterine synechiae, and isthmocele. Conclusion(s): The mini-resectoscope is poised to play a leading role in hysteroscopic surgery for many pathologies, both in inpatient and outpatient settings. Since some applications of the mini-resectoscope have not yet been thoroughly investigated, future studies should address current knowledge gaps, designing high-quality comparative trials on specific applications.Copyright © 2024 International Federation of Gynecology and Obstetrics.

Eubanks, A. (2023). "Hormone Therapy: Menopausal Hormone Therapy." FP essentials 531: 15-21.
	The marked decrease in estrogen levels in menopausal women can cause bothersome symptoms that affect daily life. More than 75% of women experience menopausal symptoms, which can include vaginal dryness, itching, discharge, dyspareunia, mood changes, hot flushes, and night sweats. Menopausal hormone therapy (MHT) is the most effective treatment for vasomotor symptoms. Benefits include decreased risk of osteoporotic fractures and vaginal atrophy, improved glycemic control, and decreased vasomotor symptoms. However, recent research on risks associated with MHT has shown increased risk of venous thromboembolism and breast cancer. MHT typically is an option for patients younger than 60 years or within 10 years of menopause onset with bothersome vasomotor symptoms. The decision to start MHT should be made on an individual basis after a thorough evaluation and counseling. Oral, intramuscular, transdermal, and intravaginal formulations are available. The goal of therapy is use of the lowest dose for the shortest time that effectively manages symptoms. The patient and physician should regularly assess the risks and benefits associated with MHT and ensure that the benefits of its use continue to outweigh the risks. (Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.)

Euctr, A. T. (2021). "The trial assesses the efficacy and safety of a vaginalgel for dryness." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: Estrokad 0.03 Vaginalzäpfchen Product Name: Estrokad 0.03mg Vaginalzäpfchen Pharmaceutical Form: Suppository INN or Proposed INN: ESTRIOL CAS Number: 50‐27‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.03‐ CONDITION: ; MedDRA version: 21.1 Level: LLT Classification code 10047782 Term: Vulvovaginal atrophy System Organ Class: 100000004872 Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] PRIMARY OUTCOME: Main Objective: To assess the efficacy of the investigational medical device on vaginal dryness symptoms in adult subjects; To assess the safety of the investigational medical device in adult subjects; Primary end point(s): Efficacy:; Improvement in vaginal dryness estimated with the VAS ; Safety:; Amount of adverse events occurred since baseline estimated via reports and interviews ; Amount of serious adverse events occurred since baseline estimated via reports and interviews ; Secondary Objective: To assess user’s experience with the product under investigation (usability, customer satisfaction, package information leaflet / instruction for use) Timepoint(s) of evaluation of this end point: Week 3 SECONDARY OUTCOME: Secondary end point(s): Efficacy:; Improvement in vaginal dryness estimated with the VAS ; Improvement in vaginal burning estimated with the VAS ; Improvement in vaginal itching estimated with the VAS ; Satisfaction with the treatment method estimated with a questionnaire ; Timepoint(s) of evaluation of this end point: Week 3 and week 12 INCLUSION CRITERIA: • Informed consent • Biological sex: female (women only) • Women with moderate or severe vaginal dryness • Age > 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Euctr, B. E. (2021). "Study to Evaluate the Efficacy and Safety of Miconazole Nitrate 2% + Domiphen Bromide Vaginal cream in the Treatment of Subjects with Acute Vulvovaginal Candidiasis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Miconazole Nitrate Pharmaceutical Form: Vaginal cream INN or Proposed INN: DOMIPHEN BROMIDE CAS Number: 538‐71‐6 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 0.14‐ Trade Name: Gyno‐Daktarin Pharmaceutical Form: Vaginal cream Product Name: Miconazole Nitrate Pharmaceutical Form: Vaginal cream INN or Proposed INN: DOMIPHEN BROMIDE CAS Number: 538‐71‐6 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 0.29‐ CONDITION: acute vulvovaginal candidiasis Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: The primary objectives of this study are to evaluate the efficacy of vaginal miconazole nitrate 2% + domiphen bromide cream in the treatment of VVC compared to miconazole nitrate 2% based on the cure rate of VVC at Day 15, and to determine the most optimal dose of domiphen bromide (0.14% or 0.29%) for the treatment of VVC through Week 12.; Primary end point(s): Primary efficacy endpoints :; •The proportion of subjects with clinical cure at the first follow‐up visit (Day 15); •The proportion of subjects with mycological eradication at the first follow‐up visit (Day 15); •The proportion of subjects with overall therapeutic success at the first follow‐up visit (Day 15); Secondary Objective: The secondary objectives of this study are to:; •Evaluate the safety and tolerability of the two formulations of vaginal miconazole nitrate + domiphen bromide cream through Week 12.; •Evaluate the efficacy of vaginal miconazole nitrate + domiphen bromide cream in the treatment of VVC compared to miconazole nitrate 2% based on the cure rate of VVC at Day 29, Day 57 and Day 85.; •Evaluate the efficacy of the two formulations of vaginal miconazole nitrate + domiphen bromide treatment on patient reported outcomes through Week 12. ; Timepoint(s) of evaluation of this end point: Day 15 SECONDARY OUTCOME: Secondary end point(s): Secondary efficacy endpoints :; • The proportion of subjects with clinical cure at the first follow‐up visit through Week 12.; • The proportion of subjects with mycological eradication at the first follow‐up visit through Week 12.; • The proportion of subjects with overall therapeutic success (defined as clinical cure and mycological eradication) through Week 12.; • Change from Baseline through Week 12 in vulvovaginitis symptom questionnaire total score.; • Change from Baseline through Week 12 in the EQ‐5D questionnaire total score.; Secondary safety endpoints :; • Change from Baseline in clinical laboratory parameters on Follow‐Up Visits; (Serum chemistry, hematology and urinalysis through Week 12); • Frequency and severity of Adverse Events during treatment period as well as post‐treatment (AEs); • Change from Baseline in vital signs on Follow‐Up Visits through Week 12 Timepoint(s) of evaluation of this end point: through Week 12, including follow‐up visits on Day 15, Day 29, Day 57 and Day 85 INCLUSION CRITERIA: Subjects must be generally healthy, non‐pregnant females 18‐50 years of age at Screening Visit. Subjects must have an acute VVC episode at Screening Visit, defined as a total signs and symptoms score of =3 and a positive KOH wet mount preparation or Gram stain from a vaginal smear revealing filamentous hyphae/pseudohyphae and/or budding yeast cells. Subjects of childbearing potential must have a negative pregnancy test before randomization and may not be lactating or planning to become pregnant during the study period. Subjects of childbearing potential must agree to use highly effective methods of contraception or to abstain from sexual intercourse. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 95 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Euctr, D. E. (2021). "A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VACCINE CANDIDATE BNT162b2 IN IMMUNOCOMPROMISED PARTICIPANTS =2 YEARS OF AGE." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: COMIRNATY Product Name: BNT162b2 Product Code: RBP020.2 (PF‐07302048) Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: NAP Current Sponsor code: BNT162b2 Other descriptive name: Tozinameran Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 500‐ CONDITION: Protection against COVID‐19 ; MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] SECONDARY OUTCOME: Secondary end point(s): Not Applicable Timepoint(s) of evaluation of this end point: Not Applicable INCLUSION CRITERIA: Participants are eligible to be included in the study only if all of the following criteria apply: Age and Sex: 1.Male or female participants who are =2 years of age at the time of enrollment (Visit 1). 2.Participants or participants’ parent(s)/legal guardians, as age appropriate, who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3.Life expectancy =12 months (365 days) in the opinion of the investigator at enrollment (Visit 1). 4.Participants or participant’s parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period. 5.Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnan PRIMARY OUTCOME: Main Objective: To describe the immune response to prophylactic BNT162b2 in participants =18 years of age without serological or virological evidence of past SARS‐CoV‐2 infection and with:; • Asymptomatic CLL without treatment and undergoing observation, or CLL on BTK inhibitor or anti‐CD20 monoclonal antibodies; • Diagnosed with NSCLC and on chemotherapy, checkpoint inhibitors, or targeted agents for oncogene‐driven tumors; • Maintenance hemodialysis treatment due to end‐stage renal disease; • Immunomodulator therapy for an autoimmune inflammatory disorder; To describe the immune response to prophylactic BNT162b2 in participants =2 to <18 years of age without serological or virological evidence of past SARS‐CoV‐2 infection and either:; • Are on immunomodulator therapy for an autoimmune inflammatory disorder; • Are on immunosuppression therapy after solid organ transplant ; • Underwent bone marrow or stem cell transplant at least 6 months before enrollment ; Full information in Section 3 of Protocol Primary end point(s): In participants complying with the key protocol criteria (evaluable participants) and no serological or virological evidence of past SARS CoV‐2 infection in each disease subset: ; • GMTs at 1 month after Dose 2 ; In participants complying with the key protocol criteria (evaluable participants) and no serological or virological evidence of past SARS CoV‐2 infection in each age group (=2 to <5, =5 to <12, and =12 to <18 years) and disease subset: ; • GMTs at 1 month after Dose 2; In participants receiving at least 1 dose of study intervention in each disease subset, the percentage of participants reporting:; • Local reactions for up to 7 days following each dose; • Systemic events for up to 7 days following each dose; • AEs from Dose 1 through 1 month after Dose 2; • AEs from Dose 3 through 1 month after Dose 3; • from Dose 1 through the duration of the study ; In participants receiving at least 1 dose of study intervention in each age group (=2 to <5, =5 to <12, and =12 to <18 years) and disease subset, the percentage of participants reporting:; • Local reactions for up to 7 days following each dose; • Systemic events for up to 7 days following each dose; • AEs from Dose 1 through 1 month after Dose 2; • AEs from Dose 3 through 1 month after Dose 3; • SAEs from ose 1 through the duration of the study; ; • Incidence rate of confirmed COVID 19 per 1000 person‐years of follow‐up; • Incidence rate of confirmed MIS‐C cases Secondary Objective: Not Appllicable Timepoint(s) of evaluation of this end point: Please see Section 3 of full clinical Protocol

Euctr, D. K. (2021). "The effect of bladder installed local anesthetic solution prior to Botox injections in the bladder." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: Lidokain SAD Pharmaceutical Form: Injection INN or Proposed INN: Lidokain Other descriptive name: LIDOCAINE HYDROCHLORIDE PHEUR Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravesical use Trade Name: Natriumbikarbonat SAD Pharmaceutical Form: Injection INN or Proposed INN: Sodium hydrogen carbonat Other descriptive name: SODIUM HYDROGEN CARBONATE PHEUR Concentration unit: mmol/ml millimole(s)/millilitre Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravesical use Trade Name: Natriumklorid "Fresenius Kabi" 9 mg/ml Pharmaceutical Form: Solvent for parenteral use INN or Proposed INN: Sodium Chloride Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% Concentration unit: g/l gram(s)/litre Concentration type: equal Concentration number: 9‐ CONDITION: The effect of intravesical Lidocaine solution versus placebo on pain perception during intravesical injection of Onabotulinum toxin A. ; MedDRA version: 21.1 Level: LLT Classification code 10046495 Term: Urge incontinence syndrome System Organ Class: 100000004857 ; MedDRA version: 21.1 Level: LLT Classification code 10002321 Term: Anesthesia System Organ Class: 100000004852 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: The purpose of this study is to investigate the effect of lidocaine‐solution versus placebo (isotonic NaCl) disposed inside the urinary bladder as intravesical anesthesia prior to onabotulinum toxin A injections in the treatment of urgency urinary incontinence.; Primary outcome is the maximum pain score reported by using the 100 mm visual analogue scale (VAS) immediately after the injection procedure. Primary end point(s): Primary end point is to reduce discomfort associated with onabotulinum toxin A injections and; ; Secondary Objective: Secondary outcome is adverse events: Post‐void residual requiring clean intermittent catherization (CIC), signs of urinary tract infection (UTI), hematuria, patient’s satisfaction on a 5‐point scale. Timepoint(s) of evaluation of this end point: 2021‐2024 SECONDARY OUTCOME: Secondary end point(s): Perform onabotulinum toxin A injections in outpatient clinics Timepoint(s) of evaluation of this end point: 2021‐2024 INCLUSION CRITERIA: • Female, age =18 years • Admitted to treatment with BTX‐A injections at the Urogynecological Clinic at Herlev Hospital due to UUI • Able to read and understand Danish • The female accepts to receive BTX‐A injection as an outpatient treatment without the option of receiving sedative drugs Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Euctr, D. K. (2021). "Glucocorticoids during robotoc-assisted hysterectomy." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: Dexavit Product Name: Dexavit Product Code: H02AB02 Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: Dexavit CAS Number: 312‐93‐6 Other descriptive name: DEXAMETHASONE PHOSPHATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 24‐ Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use CONDITION: robotic‐ assisted hysterectomy Therapeutic area: Body processes [G] ‐ Physical Phenomena [G01] PRIMARY OUTCOME: Main Objective: Gucocorticoid treatment to amelirate surgical stress parameters Primary end point(s): The primary endpoint is reduction of postoperative c‐reactive protein (crp) after robotic hysterectomy as an objective measurement of the stress amelioration by the given steroid. Secondary Objective: The hypothesis is that women undergoing robotic hysterectomy would benefit from peroperative glucocorticoid treatment on important life qualities like pain, fatigue, freedom of medications and resuming work and sexual activities. Timepoint(s) of evaluation of this end point: 24‐48 hours after surgery SECONDARY OUTCOME: Secondary end point(s): other inflammatory markers based on transcriptional profiling, pain and the medication needed during hospital stay and after discharge, and when work and sexual function could be resumed. Timepoint(s) of evaluation of this end point: Transcriptional factors: 2 days post surgery; Pain and medication before admittance by hosptal cahrst 24‐28 hours; Pain, medication, work sexual function fours weeks after discharge by questionnaires and diary INCLUSION CRITERIA: women who are having a robotic hysterectomy for benign indications: Meno‐metrorrhagia, dysmenorrhea, fibroma, dysplasia, dysmenorrhea, and ability in Danish writing Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Euctr, D. K. (2022). "Clinical research study to learn about the effect and safety of different doses of FE 999302 when given as a single dose for final development of the eggs after ovarian stimulation." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Code: FE 999302 Pharmaceutical Form: Solution for injection INN or Proposed INN: Choriogonadotropin beta Current Sponsor code: FE 999302 Other descriptive name: HUMAN CHORIONIC GONADOTROPIN Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 500‐ Trade Name: NOVAREL Product Name: NOVAREL Product Code: FE 999086 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Choriogonadotropin beta Current Sponsor code: FE 999086 Other descriptive name: HUMAN CHORIONIC GONADOTROPIN Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 5000‐ Trade Name: OVITRELLE Product Name: OVITRELLE Pharmaceutical Form: Solution for injection in pre‐filled pen INN or Proposed INN: Choriogonadotropin alfa CAS Number: 177073‐44‐8 Other descriptive name: CHORIOGONADOTROPIN ALFA Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 250‐ Trade Name: OVITRELLE Product Name: OVITRELLE Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed INN: Choriogonadotropin alfa CAS Number: 177073‐44‐8 Other descriptive name: choriogonadotropin alfa Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 500‐ CONDITION: Infertility ; MedDRA version: 20.1 Level: LLT Classification code 10016398 Term: Female infertility System Organ Class: 100000004872 Therapeutic area: Body processes [G] ‐ Reproductive physiologi cal processes [G08] PRIMARY OUTCOME: Main Objective: To compare the effect of 150, 200, and 250 µg of FE 999302 with 250 µg OVITRELLE and 10,000 IU NOVAREL on oocyte maturity when administered for triggering of final follicular maturation in women undergoing controlled ovarian stimulation Primary end point(s): Number of metaphase II (MII) oocytes Secondary Objective: 1. To compare the effect of 150, 200, and 250 µg of FE 999302 with 250 µg OVITRELLE and 10,000 IU NOVAREL on fertilisation, blastocyst quality, endocrine profile during the luteal phase, and pregnancy, when administered for triggering of final follicular; maturation in women undergoing controlled ovarian stimulation; 2. To compare the safety of 150, 200, and 250 µg of FE 999302 with 250 µg OVITRELLE and 10,000 IU NOVAREL when administered for triggering of final follicular maturation in women undergoing controlled ovarian stimulation; 3. To investigate the impact of body weight on FE 999302 exposure and assess the population pharmacokinetics of FE 999302 when administered for triggering of final follicular maturation in women undergoing controlled ovarian stimulation; Timepoint(s) of evaluation of this end point: 36 hours (+/‐ 2h) after triggering of final follicular maturation SECONDARY OUTCOME: Secondary end point(s): 1. Secondary Efficacy Endpoints; 1.1 Number of oocytes retrieved; 1.2 Number of fertilised (2 pronuclei) oocytes; 1.3 Number and quality of embryos; 1.4 Number and quality of blastocysts ; 1.5 Serum hormone concentrations of progesterone, 17‐OH‐progesterone, estradiol, follicle‐stimulating hormone (FSH), and luteinising hormone (LH) ; 1.6 Positive ßhCG (positive serum ßhCG test) ; 1.7 Clinical pregnancy (at least one gestational sac) ; 1.8 Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat); 1.9 Ongoing pregnancy (at least one intrauterine viable fetus) ; ; 2. Secondary Pharmacokinetics Endpoint; 2.1 Serum hCG concentrations ; ; 3. Secondary Safety Endpoints; 3.1 Ovarian hyperstimulation syndrome (OHSS), overall and by grade and severity; 3.2 Injection site reactions (redness, pain, itching, swelling, and bruising) assessed by the; subject following administration of investigational medicinal product (IMP); 3.3 Treatment‐induced anti‐hCG antibodies, overall as well as with neutralising capacity; 3.4 Multi‐fetal gestation, biochemical pregnancy, spontaneous abortion, ectopic pregnancy; (with and without medical/surgical intervention), and vanishing twins; ; 4. x loratory Endpoint; 4.1 Biomarkers of oocyte maturation and/or OHSS in follicular fluid and granulosa cells Timepoint(s) of evaluation of this end point: 1.3 on day 3 after oocyte retrieval; 1.4 on day 5 after oocyte retrieval; 1.5 at end‐of‐stimulation, the day after triggering, at oocyte retrieval, on day 5 after oocyte retrieval (transfer), on day 7‐9 after oocyte retrieval (mid‐luteal phase), and 13‐15 days after transfer; 1.6 13‐15 days after transfer; 1.7 5‐6 weeks after transfer; 1.8 5‐6 weeks after transfer; 1.9 10‐11 weeks after transfer; 2.1 at end‐of‐stimulation, the day after triggering, at oocyte retrieval, on day 5 after oocyte retrieval (transfer), and on day 7‐9 after oocyte retrieval (mid‐luteal phase); 3. Secondary Safety Endpoints ongoing throughout the trial INCLUSION CRITERIA: 1. Subject informed consent form signed prior to any trial‐related activities. 2. Parental informed consent form signed prior to start of stimulation in the trial. 3. In good physical and mental health as judged by the investigator. 4. Pre‐menopausal women between the ages of 18 and 42 years. The subjects must be at least 18 years (including the 18th birthday) and no more than 42 years (up to the day before the 43rd birthday) when they sign the informed consent. 5. Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor. 6. Infertility for at least 1 year before screening for subjects <35 years or for at least 6 months for subjects =35 years (not applicable in case of tubal or severe male f

Euctr, D. K. (2023). "ACSE-ESMART." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Ribociclib Product Code: LEE011 Pharmaceutical Form: Capsule, hard INN or Proposed INN: RIBOCICLIB Current Sponsor code: LEE011 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ INN or Proposed INN: RIBOCICLIB Current Sponsor code: LEE011 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Product Name: Temozolomide Pharmaceutical Form: Capsule INN or Proposed INN: Temozolomide Other descriptive name: TEMOZOLOMIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ INN or Proposed INN: Temozolomide Other descriptive name: TEMOZOLOMIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ INN or Proposed INN: Temozolomide Other descriptive name: TEMOZOLOMIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ INN or Proposed INN: Temozolomide Other descriptive name: TEMOZOLOMIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250‐ Product Name: Olaparib Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Olaparib CAS Number: 763113‐22‐0 Other descriptive name: OLAPARIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ INN or Proposed INN: Olaparib CAS Number: 763113‐22‐0 Other descriptive name: OLAPARIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ INN or Proposed INN: Olaparib CAS Number: 763113‐22‐0 Other descriptive name: OLAPARIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Trade Name: KISQALI Product Name: Ribociclib Product Code: LEE011 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: RIBOCIC CONDITION: Relapsed or refractory tumors in children Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: Phase I: To define or validate that the adult single agent RP2D of the selected drug or combination of drugs is safe in children/adolescents and/or that the PK profile is equivalent to that seen in adults, in pediatric/adolescent patients with malignancies which are recurrent or refractory to standard therapy. ; ; Phase II: To determine the preliminary activity (as measured by objective tumor response) of these agents in patients harboring specific molecular alterations or tumor types that may be associated with the mechanism of action of these drugs (i.e. molecularly enriched patient cohorts, where possible). Primary end point(s): The recommended phase II dose (RP2D) will be defined as the adult recommended dose (adjusted for weight or BSA) if toxicity and PK profiling are similar in children and in adults, or a higher dose, providing it is below the maximum tolerated dose (MTD).; The maximum tolerate dose (MTD) will be defined as the dose associated with or closest to 25% of DLTs in cycle 1.; Dose Limiting Toxicities (DLT) will be defined using CTC‐AE v4.03. Secondary Objective: Secondary:; 1.To characterize the toxicity profile of the agent(s) in pediatric/ adolescent patients.; 2.To characterize single or multiple‐dose PK of the agent(s).; 3.To evaluate the progression free survival and incidence of long responders (>6 months) and duration of response. ; 4.To evaluate whether the response rate is higher in the enriched population as compared to the non‐enriched population overall, by targeted treatment and by arm. ; ; Exploratory:; 1. To explore, define and/or validate pharmacodynamic (Pd) biomarkers of target inhibition or immune markers, where possible and potentially relevant.; 2. To explore relationships between measures of tumor expression of the molecular target(s), circulating tumor DNA and tumor growth. Timepoint(s) of evaluation of this end point: Cycle 1 SECONDARY OUTCOME: Secondary end point(s): Overall response rate (ORR), duration of response (DOR), progression‐free survival (PFS) ; ; Adverse Events ; ; PK parameters, including but not limited to pl ma concentration time profiles, AUClast, AUCtau, Cmin, Cmax, Tmax, Clearance, Half‐life time.; ; Relationship between the molecular profile of the tumor samples and tumor growth measured as modification of the sum of the diameters of the target lesions over time. Timepoint(s) of evaluation of this end point: Overall response rate (ORR), duration of response (DOR) will be defined as the time period between the first documented response (PR or CR) and the time of progression. Duration of response for patients free of progression at the cut‐off date will be censored at the last Imaging response scan date; progression‐free survival (PFS) will be defined as the time from treatment initiation until the date of first documented progression or death from any cause. Patients alive and free of progression at the cut‐off date will be censored at the last assessment date. INCLUSION CRITERIA: 1. Patients must be diagnosed with hematologic or solid tumor malignancy that has progressed or relapsed despite standard therapy, or for which no effective standard therapy exists. 2. Age <18 years at inclusion. 3. Patient must have had advanced molecular profiling (i.e. WES/WGS +/‐ RNAseq) of their recurrent or refractory tumor i.e. at the time of disease progression/relapse; exceptionally patients with advanced molecular profiling at diagnosis may be allowed. 4. Evaluable or measurable disease as defined by standard imaging criteria for the patient’s tumor type. 5. Performance status: Karnofsky performance status (for patients >12 years of age) or Lansky Play score (for patients =12 years of age) =70%. 6. Life expectancy =3 months. 7. Adequate organ function 8. Able to comply with scheduled follow‐up and with management of toxicity. 9. Females of childbearing potential must have a negative serum or urine pregnancy test within 7

Euctr, E. S. (2021). "Assessment of Conventional Dosing in Women undergoing ART with Follitropin Delta Treatment." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: REKOVELLE Pharmaceutical Form: Solution for injection in pre‐filled pen INN or Proposed INN: FOLLITROPIN DELTA CAS Number: 146479‐72‐3 Current Sponsor code: FE 999049 Other descriptive name: human recombinant follicle‐stimulating hormone Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 33.3‐ Trade Name: GONAL‐F Pharmaceutical Form: Solution for injection in pre‐filled pen INN or Proposed INN: follitropin alfa CAS Number: 56832‐30‐5 Other descriptive name: FOLLITROPIN ALFA Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 600‐ CONDITION: Infertility in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle ; MedDRA version: 20.0 Level: PT Classification code 10021928 Term: Infertility female System Organ Class: 10038604 ‐ Reproductive system and breast disorders Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] PRIMARY OUTCOME: Main Objective: • To compare a starting dose of 15 µg REKOVELLE to a starting dose of 225 IU GONAL F in conventional regimens with respect to ovarian response in women undergoing controlled ovarian stimulation Primary end point(s): Number of oocytes retrieved Secondary Objective: • To compare the follicular development, endocrine profile and embryo development associated with conventional dosing of REKOVELLE and GONAL‐F; • To compare the treatment efficiency associated with conventional dosing of REKOVELLE and GONAL‐F; • To compare the safety profile associated with conventional dosing of REKOVELLE and GONAL‐F Timepoint(s) of evaluation of this end point: Oocyte retrieval will take place 36h (±2h) after triggering of final follicular maturation SECONDARY OUTCOME: Secondary end point(s): • Number of follicles (total and by size category) at end‐of‐stimulation; • Serum concentrations of estradiol and progesterone at end‐of‐stimulation; • Number of fertilised oocytes and fertilisation rate; • Number of embryos and blastocysts (total and by quality) ; • Total gonadotropin dose and number of stimulation days; • Early OHSS (overall and by grade) and/or preventive interventions for early OHSS Timepoint(s) of evaluation of this end point: Timepoint is included in the relevant endpoint INCLUSION CRITERIA: 1. Informed Consent Form signed prior to screening evaluations. 2. In good physical and mental health. 3. Pre‐menopausal females between the ages of 18 and 40 years. The subjects must be at least 18 years (including the 18th birthday) when they sign the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomisation. 4. Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor. 5. Infertility for at least one year before randomisation for subjects =37 years or for at least 6 months for subjects =38 years (not applicable in case of tubal or severe male factor infertility). 6. Regular menstrual cycles of 21‐35 days (both inclusive), presumed to b

Euctr, E. S. (2021). "INTEnsity of ovariaN Stimulation and Embryo Quality." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: Ovaleap 900 UI/1,5 ml solucion inyectable Pharmaceutical Form: Solution for injection in pre‐filled pen Trade Name: Ovaleap 900 UI/1,5 ml solucion inyectable Pharmaceutical Form: Solution for injection in pre‐filled pen Trade Name: Ovaleap 450 UI/0,75 ml solucion inyectable Pharmaceutical Form: Solution for injection in pre‐filled pen Trade Name: Ovaleap 450 UI/0,75 ml solucion inyectable Pharmaceutical Form: Solution for injection in pre‐filled pen Trade Name: Ovaleap 300 UI/0,5 ml solucion inyectable Pharmaceutical Form: Solution for injection in pre‐filled pen Trade Name: Ovaleap 300 UI/0,5 ml solucion inyectable Pharmaceutical Form: Solution for injection in pre‐filled pen Trade Name: Orgalutran 0,25 mg/0,5 ml solución inyectable Pharmaceutical Form: Solution for injection Trade Name: Orgalutran 0,25 mg/0,5 ml solución inyectable Pharmaceutical Form: Solution for injection Trade Name: Ovitrelle 250 microgramos solución inyectable en pluma precargada. Pharmaceutical Form: Solution for injection in pre‐filled pen Trade Name: Ovitrelle 250 microgramos solución inyectable en pluma precargada. Pharmaceutical Form: Solution for injection in pre‐filled pen Trade Name: Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable Pharmaceutical Form: Solution for injection Trade Name: Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable Pharmaceutical Form: Solution for injection Trade Name: utrogestan 200 mg cápsulas blandas Pharmaceutical Form: Capsule, soft Trade Name: utrogestan 200 mg cápsulas blandas Pharmaceutical Form: Capsule, soft Trade Name: Omifin 50 mg comprimidos Pharmaceutical Form: CONDITION: Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] To compare the number of GQB and the morphokinetic parameters of early embryo development in infertile suboptimal patients undergoing two different intensities of ovarian stimulation, a milder approach ( Clomiphene Citrate (CC) 50mg/day plus 150IU daily dose of rFSH) and a more intense approach (300IU daily dose of rFSH). ; MedDRA version: 20.0 Level: PT Classification code 10021928 Term: Infertility female System Organ Class: 10038604 ‐ Reproductive system and breast disorders ; MedDRA version: 21.0 Level: PT Classification code 10021926 Term: Infertility System Organ Class: 10038604 ‐ Reproductive system and breast disorders ; MedDRA version: 20.0 Level: LLT Classification code 10021930 Term: Infertility NOS System Organ Class: 10038604 ‐ Reproductive system and breast disorders ; MedDRA version: 20.0 Level: PT Classification code 10021929 Term: Infertility male System Organ Class: 10038604 ‐ Reproductive system and breast disorders ; MedDRA version: 20.1 Level: LLT Classification code 10016399 Term: Female infertility (primary) System Organ Class: 10038604 ‐ Reproductive system and breast disorders ; MedDRA version: 21.1 Level: LLT Classification code 10039843 Term: Secondary infertility (female) System Organ Class: 10038604 ‐ Reproductive system and breast disorders PRIMARY OUTCOME: Main Objective: To compare the two stimulation groups of Clomiphene Citrate (CC) 50mg/day plus rFSH 150IU vs. 300IU regarding the number of GQB according to the Istanbul Consensus criteria Primary end point(s): The primary efficacy endpoint is the number of GQB, according to the Istanbul Consensus Criteria . Secondary Objective: To compare the two stimulation groups of Clomiphene Citrate (CC) 50mg/day plus rFSH 150IU vs. 300IU regarding the morphokinetic parameters of early embryo development Timepoint(s) of evaluation of this end point: 5‐7 days from oocytes insemination procedure SECONDARY OUTCOME: Secondary end point(s): The key secondary endpoints are: ; 1. Time of pronuclei appearance; 2. Time of pronuclei disappearance; 3. The total number of embryos; 4. Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8); 5. Time of compactation; 6. Time of morula; 7. Time of cavitation/early blast; 8. Time of full blastul ion; 9. Time of expanded blastocyst ; 10. Time of hatching blastocyst; 11. Blastocyst formation rate; 12. Cycle cancelation rate Timepoint(s) of evaluation of this end point: 1‐7 days from oocytes insemination procedure INCLUSION CRITERIA: • AFC = 5 and = 10 • AMH =1.5 ng/ml (AMH result of up to one year will be valid) • Age = 35 years and =40 years • BMI >=18.5 and <25 kg/m2 • Willing to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Euctr, E. S. (2021). "Trial of different schemes of PM14 alone and in combination with radiotherapy in soft tissue sarcomas and other solid tumors." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: PM14 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: PM14 Other descriptive name: PM14 Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 1‐ CONDITION: Advanced soft tissue sarcoma and other solid tumors Therapeutic area: Diseases [C] ‐ Cancer [C04] SECONDARY OUTCOME: Secondary end point(s): COHORTS A AND B; Phase I: ; ; ‐ Toxicity will be assessed by adverse events related to study drugs, detected through physical examinations and laboratory tests, and graded according to CTCAE v5.0.; ; • Overall response rate (ORR) (according to central radiology review): Efficacy measured by ORR, which is defined as the number of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable patients (according to RECIST v1.1).; ; ‐ mPFS (according to central radiology review): Efficacy measured by mPFS, which is defined as the median of time in months from date of enrollment to date of radiological progression according to RECIST v1.1 or to date of death due to any cause, whatever occurs first.; ; ‐ Quality of life: Assessed by using the EORTC QLQ‐C30 questionnaire.; ; ‐ The clinical study will provide tumor and blood samples for the translational research program.; ; ‐ The clinical study will provide blood samples for the measurement of PM14 concentration and baseline a‐1‐acid glycoprotein (AAG) levels.; ; COHORTS E AND F; Phase II:; ‐ Overall response rate (ORR) (according to central radiology review): Efficacy measured by ORR, which is defined as the number of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable patients (according to RECIST v1.1).; ; ‐ mOS: Efficacy measured by mOS, which is defined as the median of time in months from date of enrollment to date of death due to any cause. OS will be censored on the last date a patient was known to be alive. ; ; ‐ Quality of life: Assessed by using the EORTC QLQ‐C30 questionnaire.; ; ‐ Toxicity will be assessed by adverse events related to study drugs, detected through physical examinations and laboratory tests, and graded according to CTCAE v5.0.; ; ‐ The clinical study will provide tumor and blood samples for the translational research program.; ; COHORT C; Phase I:; ‐ Toxicity will be assessed by adverse events related to study drugs, detected through physical examinations and laboratory tests, and graded according to CTCAE v5.0.; ; ‐ Overall response rate (ORR) (according to central radiology review): Efficacy measured by ORR, which is defined as the number of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable patients (according to RECIST v1.1).; ; ‐ Median of progression‐free survival (mPFS) (according to central radiology review): Efficacy measured by mPFS, which is defined as the median of time in months from date of enrollment to date of radiological progression according to RECIST v1.1 or to date of death due to any cause, whatever occurs first.; ; ‐ Quality of life: Assessed by using the EORTC QLQ‐C30 questionnaire.; ; ‐ The clinical study will provide tumor and blood samples for the translational research program.; ; Phase II:; • Changes in pain: Variations in pain will be measured by the Brief Pain Inventory – Short Form (BPI‐SF). ; ‐ This will be at least measured at baseline, an early assessment 1 week after RT completion, a delayed assessment on days 1 of cycles 2 and 3; and ultra‐delayed assessment at 6 months from the first day of treatment.; ‐ Worst pain (2‐point decrease or increase from baseline, respectively). ; ‐ The time to clinically relevant increase or decrease in worst pain (2‐point increase or decrease from baseline, respectively). ; ‐ The proportions of patients with moderate or severe worst pain at baseline (worst pain scor 4 points) who shifted to no or mild pain (worst pain score = 4 points) during the study. ; • Changes in analgesic use: Variations in analgesic use will be measured by the Analgesic Quantification Algorithm (AQA). ; ‐ This will be at least measured at baseline, an early assessment 1 week after RT completion, a delayed assessment on days 1 of cycles 2 and 3; and ultra‐delayed assessment at 6 months from the first day of treatment.; ‐ The proportion of patients with a shift from strong opioid use (score = 3) to no/low analgesic use (score = 2). ; ‐ The proportion of patients with a shift from no/low analgesic use to strong opioid use.; ‐ The proportion of patients with a low analgesic use (scores 1‐2) to no analgesic use (score 0). ; • Changes in quality of life: Variations in quality of life will be measured by the QLQ‐C30 EORTC v3.0 questionnaire. ; ‐ This will be at least measured at baseline, an early assessment 1 week after RT completion, a delayed assessment on days 1 of cycles 2 and 3; and ultra‐delayed assessment at 6 months from the first day of treatment.; ‐ The proportions of patients showing little (5‐10 points), moderate (11‐20 points) or high changes (> 20) in the physical, emotional, social and role functioning scales over time.; ; ; (INSUFFICIENT SPACE TO INCLUDE ALL THE INFORMATION. IT IS AVAILABLE IN THE SYNOPSIS.) Timepoint(s) of evaluation of this end point: ‐ ORR: central radiology review (end of treatment visit, 3 weeks after surgery); ‐ mPFS: median of time in months from date of enrollment to date of radiological progression according to RECIST v1.1 or to date of death due to any cause, whatever occurs first.; ‐ Biological samples for translational study: baseline and cycle 1 day 2 or 3; ‐ mOS: median of time in months from date of enrollment to date of death due to any cause; ‐ Changes in pain, in analgesic use and in quality of life: at least measured at baseline, an early assessment 1 week after RT completion, a delayed assessment on days 1 of cycles 2 and 3; and ultra‐delayed assessment at 6 months from the first day of treatment.; ; (INSUFFICIENT SPACE TO INCLUDE ALL THE INFORMATION. IT IS AVAILABLE IN THE SYNOPSIS.) INCLUSION CRITERIA: All the cohorts: ‐ The patient must voluntarily sign the informed consent before any study test is conducted that is not part of routine patient care. ‐ Age: 18‐75 years. ‐ Measurable disease according to RECIST v1.1 criteria. ‐ Performance status =1 (ECOG). ‐ Men or women of childbearing potential must be using an effective method of contraception before entry into the study and throughout the same and for 3 months (men) and 6 months (women) after ending study treatment. Women of childbearing potential must have a negative serum or urine pregnancy test before study entry. ‐ Normal cardiac function with a LVEF = 50% by echocardiogram or MUGA. ‐ HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lam PRIMARY OUTCOME: Main Objective: COHORTS A (24‐h IV PM14 in advanced sarcomas) and B (3‐h IV PM14 3 consecutive days in advanced sarcomas); Phase I: To determine the maximum tolerated dose (MTD) of PM14 to be used as recommended phase 2 dose (RP2D).; ; COHORTS E (24‐h IV PM14 or 3‐h IV PM14 3 consecutive days ‐ Expanded to advanced L‐sarcomas) and F (24‐h IV PM14 or 3‐h IV PM14 3 consecutive days ‐ Expanded to other advanced STS: non L‐sarcomas); Phase II: To evaluate the progression‐free survival rate (PFSR) at 6 months.; ; COHORT C (Best scheme of PM14 plus RTP (3 Gy x 10 days = 30 Gy) in advanced solid tumors: sarcoma, head and neck, and others); Phase I: To determine the MTD of PM14 to be used as RP2D.; Phase II: To evaluate the ORR in irradiated nodules only. This objective is considered as a surrogate of palliative relief. ; ; COHORT D (Best schem o PM14 + RTP (1.8 Gy x 25 days = 45 Gy) in localized intermediate sarcoma); Phase I: To determine the MTD of PM14 to be used as RP2D.; Phase II: To evaluate the ORR. Primary end point(s): COHORTS A AND B; Phase I: The MTD will be determined by assessing adverse events according to CTCAE v5.0 and they will be used as a rule for escalating or diminishing dose levels according to the dose‐limiting toxicities detailed in the protocol.; ; COHORTS E AND F; Phase II: PFSR‐6m (according to central radiology review): Efficacy measured by the PFSR at 6 months, which is defined as the percentage of patients who did not experience radiological progression according to RECIST v1.1 or death due to any cause since the date of enrollment until month 6 after date of enrollment.; ; COHORT C; Phase I: The MTD will be determined by assessing adverse events according to CTCAE v5.0 and they will be used as a rule for escalating or diminishing dose levels according to the dose‐limiting toxicities detailed in the protocol.; ; Phase II: Overall response rate (ORR) (according to central radiology review): Efficacy measured by ORR, which is defined as the number of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable patients (according to RECIST v1.1). Only nodules included in the radiation field will be considered. Secondary Objective: COHORTS A AND B; Phase I:; ‐ To evaluate the safety profile.; ‐ To evaluate the overall response rate (ORR).; ‐ To evaluate the median of progression‐free survival (mPFS).; ‐ To evaluate quality of life.; ‐ To contribute to translational studies.; ‐ To characterize the PK of PM14 in the explored regimens; ; COHORTS E AND F; Phase II:; ‐ To evaluate the overall response rate (ORR).; ‐ To evaluate the median of overall survival (mOS).; ‐ To evaluate quality of life.; ‐ To evaluate the safety profile.; ‐ To contribute to translational studies.; ; COHORT C; Phase I:; ‐ To evaluate the safety profile.; ‐ To evaluate the overall response rate (ORR).; ‐ To evaluate the median of progression‐free survival (mPFS).; ‐ To evaluate quality of life.; ‐ To contribute to translational studies.; ; Phase II:; ‐ To evaluate variations in pain. /‐ To evaluate variations in analgesic use. ; ; (INSUFFICIENT SPACE TO INCLUDE ALL THE INFORMATION. IT IS AVAILABLE IN THE SYNOPSIS.) Timepoint(s) of evaluation of this end point: PFSR: since the date of enrollment until month 6 after date of enrollment.; ORR: central radiology review (end of treatment visit, 3 weeks after surgery)

Euctr, E. S. (2021). "Umbilical cord plasma for treating endometrial pathologies (thin endometrium / Ash erman’s syndrome/ endometria atrophy)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Platelet‐rich plasma from umbilical cord. Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: platelet rich plasma, allogenic Other descriptive name: HUMAN PLATELET, ALLOGENIC Concentration unit: ml millilitre(s) Concentration type: range Concentration number: 2‐6 CONDITION: Endometrial pathologies (Thin endometrium/ Asherman's syndrome/ Endometrial atrophy) Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] PRIMARY OUTCOME: Main Objective: Study of endometrial regeneration and/or improvement, in the form of tissue thickening, in patients with endometrial pathologies ; (thin endometrium/Asherman's syndrome/endometrial atrophy) treated with platelet‐rich plasma from the umbilical cord. Primary end point(s): Increase in endometrial thickness after application of PRP treatment, calculated as the difference between the endometrium after application of the treatment and the thickness of the patient's initial endometrium (in mm) Secondary Objective: Evaluation of the proof of concept in the 3 arms of the group of patients with premature ovarian failure (group A).; Study of the rates of implantation, pregnancy, abortion and live newborn after injection of the investigational drug (platelet‐rich plasma from umbilical cord) in the group of patients with endometrial pathology (group B).; Evaluation at the genetic and protein level of the endometrial biopsies collected from both groups (A and B).; Study of the molecular composition of the different plasma fractions obtained from the collected umbilical cord samples; Adverse events collection Timepoint(s) of evaluation of this end point: After application of PRP treatment SECONDARY OUTCOME: Secondary end point(s): Proof of concept.; Implementation rate.; Pregnancy rate.; Abortion rate.; Live birth rate.; Evaluation at the genetic and protein level of the endometrial biopsies collected from both groups (A and B).; Study of the molecular composition of the different plasma fractions obtained from the collected umbilical cord samples; Adverse events collection Timepoint(s) of evaluation of this end point: Proof of concept._Comparisons of endometrial thickness growth before and after PRP treatment, according to subgroups (grupo A) at the end of study; ; Study of the rates of implantation, pregnancy, abortion and live newborn after injection of the investigational drug (platelet‐rich plasma from umbilical cord) in the group of patients with endometrial pathology (group B), will be analized at the end of the study.; ; Composition molecular of the plasma fractions of the PRP samples of the umbilical cord used, Protein and genetic pattern of the collected endometrial biopsies before and after applying the PRP treatment, will be analysed at the end of the study.; ; Adverse effects, during all study. INCLUSION CRITERIA: Umbilical cord blood donors: information and informed consent of the parent(s), umbilical cord blood from live births in the obstetrics and gynaecology department of the HUP La Fe; the same criteria for collecting umbilical cord blood as standardised in the HUP La Fe will be followed for the donation of this biological product. Patients group A: information and signed informed consent; woman, acting voluntarily, aged between 18 and 48 at the time of recruitment; body mass index (BMI): = 18 kg/m2 and = 35 kg/m2; patients with premature ovarian failure (amenorrhea before age 40 and FSH > 40 IU/L). Group B patients: information and signed informed consent; female, acting voluntarily, aged between 18 and 48 years at the time of recruitment; body mass index (BMI): = 18 kg/m2 and = 35 kg/m2; patients undergoing a cycle of assisted reproduction; endometrial thickness < 5mm despite the administration of oestrogens for more than 10 days and/or evidence of Asherman'

Euctr, F. I. (2021). "Infections after hysterectomy - a double blinded placebo controlled study comparing the profylactic use of azithromycin and cefuroxime with single cefuroxime." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: AZITHROMYCIN Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: AZITHROMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Post‐hysterectomy infections Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: Primary outcome of the study is to assess whether azithromycin + cefuroxime decreases post‐hysterectomy deep infections (wound infections beneath fascia + deep pelvic area infections) as compared to cefuroxime only prophylaxis during 30 days after hysterectomy. Primary end point(s): All infection episodes will be reported up to 30 days postoperatively:; ; 1. Deep wound and pelvic organ infections; ; 2. Surficial infections; ; 3. Other infections, such has urine tract infections, fever over 38 ? over 2 days. Secondary Objective: Secondary outcomes are to assess whether azithromycin + cefuroxime decreases post‐hysterectomy superficial infections, urinary tract infections, or post‐operative fever as compared to cefuroxime only, and to report possible side‐effects of the used antibiotics.; ; In addition, the study finds out a possible role of BV and microbiome in post‐hysterectomy infections. Timepoint(s) of evaluation of this end point: 30 days after the operation. SECONDARY OUTCOME: Secondary end point(s): No. Timepoint(s) of evaluation of this end point: No. INCLUSION CRITERIA: Women undergoing hysterectomy for benign indication in University Hospitals (Helsinki University Hospital, Turku University Hospital, Tampere University Hospital, Oulu University Hospital and Kuopio University Hospital) who have not any contraindications for azithromycin or cefuroxime. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 1550 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 700

Euctr, F. I. (2021). "Pembrolizumab/placebo plus paclitaxel with or without bevacizumab for platinum-resistant recurrent ovarian cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: KEYTRUDA® (Pembrolizumab, MK‐3475) Product Code: MK‐3475 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Pembrolizumab CAS Number: 1374853‐91‐4 Current Sponsor code: MK‐3475 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Platinum‐resistant Recurrent Ovarian Cancer ; MedDRA version: 21.1 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression‐free survival (PFS) per RECIST 1.1 as assessed by the investigator Primary end point(s): 1. Progression‐free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator Secondary Objective: 1. To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab with respect to overall survival (OS) ; 2. To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab with respect to PFS per RECIST 1.1 by blinded independent central review (BICR) for PD‐L1+ (CPS =1) and all participants; 3. To evaluate safety and tolerability of pembrolizumab plus paclitaxel with or without bevacizumab; 4. To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to Global Health Status/Quality of Life (GHS/QoL) score using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ‐C30) and abdominal/gastrointestinal (GI) symptoms using EORTC Ovarian Cancer‐Specific Quality of Life Questionnaire (QLQ‐OV28) for PD‐L1+ (CPS =1) and all participants Timepoint(s) of evaluation of this end point: 1. Up to 38 months 64 months; 2. Up to 38 months; 3. Up to 64 months; 4. Up to 64 months; 5. Baseline and up to 64 months; 6. Up to 64 months; 7. Baseline and up to 64 months; 8. Up to 64 months SECONDARY OUTCOME: Secondary end point(s): 1. Overall Survival (OS); 2. PFS per RECIST 1.1 by Blinded Independent Central Review (BICR); 3. Number of Participants who Experience an Adverse Event (AE); 4. Number of Participants who Discontinue Study Treatment due to an AE; 5. Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire‐Core 30 (EORTC QLQ‐C30) ; 6. Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ‐C30; 7. Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire‐Ovarian Cancer (QLQ‐OV28) Abdominal/GI Symptom Scale; 8. TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ‐OV28 Abdominal/GI Symptom Scale Timepoint(s) of evaluation of this end point: 1. Up to INCLUSION CRITERIA: A participant will be eligible for inclusion in the study if the participant meets the following criteria: 1. Has histologically confirmed epithelial (including high‐grade serous or predominantly serous, low‐grade serous, any‐grade endometrioid, malignant mixed Müllerian tumors [carcinosarcoma], or clear cell) ovarian, fallopian tube, or primary peritoneal carcinoma. 2. Has received 1 or 2 prior lines of systemic therapy for OC, including at least 1 prior platinum‐based therapy. – Participants must have received at least 4 cycles of platinum‐based therapy in first line. – Adjuvant ± neoadjuvant therapy is considered 1 line – Participants may have received a pri PARPi; this will not be considered a separate line of therapy if received in maintenance – Participants may have received a prior anti‐PD‐1/anti‐PD‐L1 therapy or bevacizumab; these will not be considered a separate line of therapy – Any chemotherapy regimen change due to toxicity in

Euctr, F. R. (2021). "Evaluation of an initial treatment with bevacizumab in combination with chemotherapy and then in combination with niraparib in maintenance in patients with advanced ovarian cancer after complete initial surgery." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: ZEJULA Product Name: NIRAPARIB Pharmaceutical Form: Capsule, hard INN or Proposed INN: Niraparib CAS Number: 1038915‐60‐4 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 200 ‐300 Trade Name: MVASI Product Name: Bevacizumab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Bevacizumab CAS Number: 216974‐75‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐ CONDITION: Advanced ovarian, tubal or peritoneal cancer ; MedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: Determine whether paclitaxel – carboplatin followed by maintenance with niraparib compared to paclitaxel – carboplatin – Bevacizumab followed by maintenance Niraparib + Bevacizumab following a Front‐Line Complete Cytoreductive Surgery improves the progression‐free survival rate at 24 months in patients with advance ovarian cancer, primary peritoneal cancer and/or fallopian‐tube cancer. Primary end point(s): Progression‐free survival rate at 24 months Secondary Objective: ‐ Evaluate Progression Free Survival (PFS); ‐ Evaluate Progression Free Survival 2 (PFS2); ‐ Evaluate Safety (assessed based on CTCAE version 5); ‐ Evaluate Time to First Subsequent Treatment (TFST); ‐ Evaluate Time to Second Subsequent Treatment (TSST); ‐ Evaluate Overall survival (OS) at 5 years; ‐ Confirm the predictive value (overall chemo‐sensitivity) of the KELIM (CA‐125 Elimination rate constant K) Timepoint(s) of evaluation of this end point: 24 months after randomization of the last patient (estimated date: Q4 2025) SECONDARY OUTCOME: Secondary end point(s): ‐ Progression Free Survival (PFS); ‐ Progression Free Survival 2 (PFS2); ‐ Safety (assessed based on CTCAE version 5); ‐ Time to First Subsequent Treatment (TFST); ‐ Time to Second Subsequent Treatment (TSST); ‐ Overall survival (OS) at 5 years; ‐ Confirm the predictive value (overall chemo‐sensitivity) of the KELIM (CA‐125 Elimination rate constant K) Timepoint(s) of evaluation of this end point: PFS, PFS2, OS (estimated date: Q4 2028) INCLUSION CRITERIA: 1. Female patient = 18 years of age. 2. Signed informed consent and ability to comply with treatment and follow‐up. 3. Patient with newly diagnosed, a. Ovarian cancer, primary peritoneal cancer and/or fallopian‐tube cancer, b. Histologically confirmed (based on local histopathological findings): • high grade serous or • high grade endometrioid (grade 2 and 3) or • other epithelial non mucinous and non‐clear cell ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation, c. At an advanced stage: FIGO stage IIIA to IIIC of the 2018 FIGO classification. 4. Patient having undergone frontline, complete cytoreductive surgery (i.e. no visible residual disease): The patient will be considered eligible once the ESGO Quality Assurance in Ovarian Cancer Surgery will have been filled out and validated 5. Eastern Cooperative Oncology Group (ECOG) performance status 0‐1. 6. Patient must have received one cycle of carboplat

Euctr, F. R. (2021). "A Multicenter, Open-Label Phase 1/2 Trial to Assess the Safety, Tolerability and the Efficaciousness of MORAb-202, which is a type of drug called antibody-drug conjugate (ADC) that targets folate receptor alpha (FRa) in subjects with selected tumor types." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Code: MORAb‐202 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Not assigned CAS Number: 2407465‐18‐1 Current Sponsor code: MORAb‐202 Other descriptive name: Farletuzumab‐[Mal‐PEG2‐Val‐Cit‐pAB‐eribulin] Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ CONDITION: Solid tumors expressing folate receptor alpha in 4 tumor types: platinum resistant ovarian cancer, triple‐negative breast cancer (TNBC), endometrial cancer (EC), and non‐small cell lung cancer adenocarcinoma; NSCLC). ; MedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 20.0 Level: PT Classification code 10075566 Term: Triple negative breast cancer System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 21.0 Level: PT Classification code 10014733 Term: Endometrial cancer System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non‐small cell lung cancer System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] SECONDARY OUTCOME: Secondary end point(s): The secondary efficacy endpoints of the study are DOR, DCR, CBR, PFS by RECIST 1.1, and OS. ; Other secondary endpoints of the study include safety endpoints, PK profile, and the relationship between FRA expression levels and clinical outcome: ; Safety Endpoints: clinical laboratory tests, vital signs, oxygen saturation, body weight, 12‐lead ECGs, ECOG PS, and serum ADA titer (semi‐quantitative test) (not identified in an ongoing manner, identified during study analyses). ; The PK profile of MORAb‐202/total antibody/released eribulin in serum and plasma, and the assessment of potential ADA to MORAb‐202. ; The relationship between FRA expression levels and clinical outcome. Timepoint(s) of evaluation of this end point: DOR:From the 1st date of documented CR or PR to the date of disease progression or death, whichever occurs first. Calculated for subjects whose BOR is CR or PR. ; DCR:Proportion of subjects with BOR of CR, PR, or SD. ; CBR:Proportion of subjects with BOR of CR, PR, or durable SD (=23 weeks). SD is defined as the time from the date of 1st dose to the date of the 1st documentation of disease progression or death, whichever occurs first. Calculated for subjects whose BOR is SD. ; PFS:From the date of 1st dose to the date of the 1st documentation of disease progression or death, whichever occurs first. ; OS:From the date 1st dose to the date of death or for the subjects alive or lost to follow up, date of last known alive or the date of data cutoff, whichever comes first. ; PRIMARY OUTCOME: Main Objective: Primary Objectives; Dose‐Escalation Part primary objective:; (1) To evaluate safety, tolerability and to determine the recommended Phase 2 dose (RP2D) of MORAb‐202 in subjects with selected tumor types (ovarian cancer [OC], endometrial cancer [EC], non‐small cell lung carcinoma [NSCLC], triple‐negative breast cancer [TNBC]).; Dose‐Confirmation Part primary objectives:; To further evaluate the safety and tolerability of MORAb‐202.; To evaluate preliminary efficacy measured by objective response rate (ORR) of MORAb‐202 in subjects with OC and EC at selected doses.; ; ; Primary end point(s): The primary endpoints are:; RP2D of MORAb‐202 (Dose‐Escalation Part only).; ORR: defined as the proportion of subjects achieving a best overall response (BOR) of complete response (CR) or partial response (PR) (BOR ‐ are CR, PR, SD, PD, and not evaluable (NE), where SD has to be achieved at =5 weeks after the first dose 24 weeks after C1D1. All responses of CR and PR must be confirmed no less than 28 days following the initial achievem t of the response.; Safety Endpoints: DLTs, AEs,(SAEs, AEs leading to treatment discontinuation) and AEIs (including ILD incidence, severity, duration and outcome, and deaths). Secondary Objective: Secondary Objectives:; ‐ To evaluate duration of response (DOR), disease control rate (DCR), and clinical benefit rate (CBR).; ‐ To evaluate progression‐free survival (PFS) and overall survival (OS).; ‐ To determine the pharmacokinetic (PK) profiles of MORAb‐202, total antibody, and released eribulin in serum or plasma. ; ‐To evaluate the relationship between folate receptor alpha (FRA) expression levels and clinical outcome measures to support the identification of an appropriate FRA cut off point.; ; ; Timepoint(s) of evaluation of this end point: Efficacy analyses will be conducted based on the Efficacy Analysis Set. The primary efficacy analysis for a tumor type will be performed when all subjects in the cohort have completed the Week 24 tumor assessment or discontinued study treatment or when the study is terminated by the sponsor. INCLUSION CRITERIA: 1. Aged =18 years 2. For Dose‐Escalation: Females (TNBC, EC and OC) or males/females (NSCLC adenocarcinoma). Subjects with the following disease characteristics: a. TNBC: Histologically confirmed diagnosis of metastatic TNBC (ie, estrogen receptor (ER) negative/progesterone receptor negative/ human epidermal growth factor receptor 2 (HER2) negative (defined as IHC <2+ or fluorescence in situ hybridization (FISH) negative) breast cancer). Previously treated with at least one line of systemic anticancer therapy (cytotoxic or targeted anticancer agents) in the metastatic setting. b. NSCLC adenocarcinoma: Histologically or cytologically confirmed metastatic NSCLC adenocarcinoma: subjects who have failed previous treatment for metastatic disease, are not indicated or failed epidermal growth factor receptor (EGFR)‐, ALK‐, BRAF‐ or ROS1‐targeted therapy, and for whom no alternative standard therapy exists c. EC: Histologically confirmed diag

Euctr, G. R. (2023). "A Phase 1/2a Study Evaluating Allocetra-OTS on its own or together with Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Allocetra‐OTS Pharmaceutical Form: Suspension for injection INN or Proposed INN: Allocetra‐OTS Other descriptive name: Allogeneic mononuclear cells induced to an apoptotic state Concentration unit: Other Concentration type: equal Concentration number: 2500000000‐ Trade Name: OPDIVO Product Name: Opdivo Product Code: Sterile Concentrate Pharmaceutical Form: Sterile concentrate INN or Proposed INN: Nivolumab CAS Number: 946414‐94‐4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ CONDITION: Advanced Solid Tumor Malignancy ; MedDRA version: 21.1 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864 Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: 1. To assess the safety and to identify the MTD of Allocetra‐OTS as monotherapy when repeatedly administered via IV or IP infusion in patients with advanced solid tumor malignancy (applicable to Stage 1).; 2. To assess the safety and to identify the MTD of Allocetra‐OTS administered via IV or IP infusion in combination with nivolumab in patients with advanced solid tumor malignancy (applicable to Stage 2). Primary end point(s): 1. Stage 1: Characterize the safety of Allocetra‐OTS from the first infusion of Allocetra‐OTS up to Day 21, based on the DLTs and MTD (or MAD if no MTD is defined) of Allocetra‐OTS as monotherapy.; 2. Stage 2: Characterize the safety of Allocetra‐OTS from the first infusion of Allocetra‐OTS up to Day 35, based on the DLTs and MTD (or MAD if no MTD is defined) of Allocetra‐OTS in combination with nivolumab. Secondary Objective: 1. To assess preliminary efficacy parameters following IV or IP administration of Allocetra‐OTS as monotherapy in patients with advanced solid tumor malignancy (applicable to Stage 1).; 2. To assess preliminary efficacy parameters following IV or IP administration of Allocetra‐OTS in combination with nivolumab in patients with advanced solid tumor malignancy (applicable to Stage 2) Timepoint(s) of evaluation of this end point: Day 21 and Day 35 SECONDARY OUTCOME: Secondary end point(s): 1. Overall Response Rate (ORR)/Best Overall Response Rate (BORR) (percentage of patients who achieve best response of complete response [CR] or partial response [PR]).; 2. Clinical benefit rate (CBR) (percentage of patients who achieve best response of CR, PR or stable disease [SD] =6 months). (Stage 1 and 2); 3. Duration of response (DoR), defined as the time from first documented evidence of CR or PR until disease progression or death.; 4. Time to response (TTR), defined as the time from first infusion of AllocetraOTS to the first documented CR or PR.; 5. Kaplan‐Meier estimated median progression‐free survival (PFS), defined as the time from the first infusion of Allocetra‐OTS to disease progression or death due to any cause, whichever occurs first.; 6. Kaplan‐Meier estimated median overall survival (OS) defined as the time from the first infusion of Allocetra‐OTS to death due to any cause.; Note: All secondary endpoints are applicable to both Stage 1 and Stage 2 of the study, unless otherwise specified Timepoint(s) of evaluation of this end point: 12 months INCLUSION CRITERIA: 1. Patients must have histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumors, that have relapsed or have been refractory to available approved therapies specific to their cancer type, based upon standard clinical practice guidelines, with agents that are approved and available to them in their country. Patients who are either not eligible for or have specifically declined additional standard of care systemic therapy may also be enrolled. Patients with peritoneal carcinomatosis with no or minimal extraperitoneal disease (as per Investigator discretion) can be eligible for treatment with IP Allocetra‐OTS if an appropriate IP catheter (e.g. PleurX) or port is in place or can be placed. 2. Patients must have measurable disease per esponse Evaluation Criteria in Solid Tumors (RECIST v1.1), assessed within 28 days prior to study treatment. 3. Age =18 years old at the time of signing the ICF. 4. Patients who have

Euctr, H. U. (2021). "A Phase II, Randomized, Parallel design, Open label, Dose ranging Study to evaluate the efficacy and safety of Furazidin vaginal tablets in women with bacterial vaginosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Furazidin, vaginal tablets, 5 mg Pharmaceutical Form: Vaginal tablet INN or Proposed INN: Furazidin CAS Number: 1672‐88‐4 Other descriptive name: FURAZIDINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Product Name: Furazidin, vaginal tablets, 25mg Pharmaceutical Form: Vaginal tablet INN or Proposed INN: Furazidin CAS Number: 1672‐88‐4 Other descriptive name: FURAZIDINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Product Name: Furazidin, vaginal tablets, 50mg Pharmaceutical Form: Vaginal tablet INN or Proposed INN: Furazidin CAS Number: 1672‐88‐4 Other descriptive name: FURAZIDINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Product Name: Furazidin, vaginal tablets, 100mg Pharmaceutical Form: Vaginal tablet INN or Proposed INN: Furazidin CAS Number: 1672‐88‐4 Other descriptive name: FURAZIDINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: Dalacin 2% Vaginal Cream Product Name: Dalacin 2% Vaginal Cream Pharmaceutical Form: Vaginal cream INN or Proposed INN: clindamycin phosphate CAS Number: 24729‐96‐2 Other descriptive name: CLINDAMYCIN PHOSPHATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ CONDITION: Bacterial Vaginosis (BV) ; MedDRA version: 20.1 Level: PT Classification code 10004055 Term: Bacterial vaginosis System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] SECONDARY OUTCOME: Secondary end point(s): 1. Day 5 assessment of clinical cure rate based on the Amsel criteria (vaginal pH > 4.5, presence of clue cells, KOH test as well as greyish white, malodorous discharge), where clinical cure is defined as: the resolution of the abnormal vaginal discharge, a negative whiff test, and the presence of clue cells at less than 20% of the total epithelial cells on microscopic examination of the saline wet mount.; 2. Percentage of subjects with Nugent score of less than 4 (Day 21‐30); 3. Percentage of responders with outcome defined as a clinical cure plus Nugent score of less than 4 (Day 21‐30); 4. Assessment of patient quality of life with 5 treatments modalities (from the baseline visit to the end of the treatment); 5. Assessment of the patients’ compliance; 6. The percentage of Bacterial Vaginosis recurrences within 12 weeks of follow‐up; Timepoint(s) of evaluation of this end point: Day 5 PRIMARY OUTCOME: Main Objective: To evaluate the safety and efficacy of Furazidin vaginal tablets in patients with Bacterial Vaginosis.; To perform a proof of concept study to establish the most appropriate dosage (dosage regimen and treatment duration) to take forth into a phase III trial. Four different doses of study drugs as well as the comparator (Clindamycin cream 2%) will be applied vaginally to adult women with clinical signs and symptoms of vaginal infections caused by Bacteria spp.; In addition, the safety and local tolerability of four tested doses of the study drug will be assessed.; Primary end point(s): 1. Safety and local tolerability – incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related and unrelated to IMP.; Safety and local tolerability assessment based on Likert scale of the signs/symptoms:; • Assessed by physician:; Verbal evaluation of local symptoms and naked eye inspection of visible epithelial surface will be performed. Patients will be questioned and clinician will verify the following symptomps according to the Likert like scale (NO, MILD, MODERATE, MODERATE TO SEVERE, SEVERE):; o Discharge (normal/abnormal); o Dysuria; o Irritation; o Puffiness ; o Hyperemia of the mucosa ; ; • Reported by patient; Self‐reporting evaluations will be performed by patients according to the Likert like scale (NO, MILD, MODERATE, MODERATE TO SEVERE, SEVERE):; o Burning; o Discharge (normal/abnormal); o Dysuria; o Discomfort; I ritation; o Itching; o Pain; ; 2. Clinical endpoint – the Day 8 assessment of clinical cure rate based on the Amsel criteria (vaginal pH > 4.5, presence of clue cells, KOH test as well as greyish white, malodorous discharge), where clinical cure is defined as: the resolution of the abnormal vaginal discharge, a negative whiff test, and the presence of clue cells at less than 20% of the total epithelial cells on microscopic examination of the saline wet mount. Secondary Objective: not applicable Timepoint(s) of evaluation of this end point: Day 8 INCLUSION CRITERIA: 1. A written informed consent signed before any study‐specific evaluation is performed. 2. Female patients with age = 18 and = 50 years. 3. Patients requiring treatment for bacterial vaginosis. 4. Papanicolaou (Pap) smear/tests will be performed for subjects who do not have a negative test for intraepithelial lesion or malignancy or atypical squamous cells of undetermined significance in the past 24 months; in circumstances where the results of the Pap smear are pending at the time of randomization, eligible subjects may be randomized. 5. Women of childbearing potential must have a negative pregnancy test before randomization and may not be lactating or planning to become pregnant during the study period (up to Follow Up Visit 4 – Day 21‐30). 6. Agreement of female subject of childbearing potential to use highly effective methods of contraception (progestin intrauterine device, all oral contraceptives, transdermal hormonal contraceptives) or to a

Euctr, I. T. (2021). "Clinical study, involving Italian clinical sites, comparing the activity of Paclitaxel (weekly administration) to the activity of Cediranib-Olaparib with continuous administration or to Cediranib-Olaparib with intermittent administration, in patients with advanced ovarian cancer, resistant to previous platinum treatment." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Cediranib Product Code: [Not Applicable] Pharmaceutical Form: Tablet INN or Proposed INN: 8764 CAS Number: 288383‐20‐0 Current Sponsor code: AZD2171 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Product Name: Olaparib Product Code: [Not applicable] Pharmaceutical Form: Tablet INN or Proposed INN: Olaparib, 8685 CAS Number: 763113‐22‐0 Current Sponsor code: AZD2281‐KU‐0059436 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ Trade Name: PACLITAXEL MYLAN GENERICS ‐ 6 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO DI VETRO DA 16.7 ML Product Name: Paclitaxel Product Code: [n.a.] Pharmaceutical Form: Solution for infusion INN or Proposed INN: Paclitaxel, 7052 CAS Number: 33069‐62‐4 Current Sponsor code: n.a. Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 80‐ CONDITION: resistant high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer. ; MedDRA version: 21.1 Level: PT Classification code 10070907 Term: Ovarian cancer stage III System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 21.1 Level: PT Classification code 10070908 Term: Ovarian cancer stage IV System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] PRIMARY OUTCOME: Main Objective: The main objective of the trial is to evaluate and to compare the efficacy of the combination of Olaparib and Cediranib to the efficacy of weekly Paclitaxel administration, in terms of time to disease progression.; The study has also as main objective the safety evaluation of the new intermittent schedule of Cediranib compared to the administration of Cediranib with continuous schedule in terms of gastro‐intestinal toxicity. ; ; ; Primary end point(s): The study primary endpoint will be the progression free survival (PFS) defined as the time from randomization to the date of first progression or death for any cause, whichever comes first.; Progression will be established as the radiological disease progression according to RECIST 1.1 or to clinical assessment in case radiological evaluation is not feasible due to clinical condition.; The primary endpoint for safety will be the number of evacuations per day.; ; Secondary Objective: Secondary efficacy objectives will be the evaluation of treatment response, the prolongation of the time to second progression, overall survival and quality of life.; Other study aims will be to assess the safety and tolerability of combination of Olaparib and Cediranib vs. paclitaxel as single agent chemotherapy and the compliance to the study treatments.; Timepoint(s) of evaluation of this end point: Disease progression will be evaluated at the end of every 8 weeks (+/‐ 1 week) from randomisation for 48 weeks and every 12 weeks (+/‐ 1 week) thereafter. Safety primary endopoint: number of evacuations will be recorded by the patients every day during whole treatment period. SECONDARY OUTCOME: Secondary end point(s): Secondary endpoints will be: ; ‐ Objective Response Rate (ORR), defined as the percentage of patients with an objective response as determined by RECIST 1.1; ‐ PFS2 defined as time from randomization to second disease progression according to RECIST 1.1 or to clinical assessment, or death by any cause. ; ‐ Overall Survival (OS), defined in each patient as the time from randomization to the date of death for any cause.; ‐ Quality of Life evaluated by the Functional Assessment of Cancer Therapy‐Ovarian (FACT‐O) questionnaire.; ; ; Secondary endpoints of safety will be: ; ‐ the maximum toxicity grade experienced by each patient, for each toxicity, according to NCI‐CTCAE v. 4.0; ; ‐ the number of patients experiencing grade 3‐4 toxicity for each toxicity; ; ‐ type, frequency and ature of SAEs; ; ‐ patients with at least a SAE; patients with at least a SADR; ; ‐ patients with at least a SUSAR.; ; The endpoints for compliance will be: number of administered cycles, reasons for discontinuation and treatment modification and dose intensity.; Timepoint(s) of evaluation of this end point: Efficacy: second disease progression evaluated every 12 weeks from first progression. ORR according to radiological disease assessment, performed every 8 weeks from random until the end of treatment and every 12 weeks thereafter. ; Survival evaluated every 12 weeks from the first disease progression until overall survival analysis. ; Quality of life data recorded during baseline visit and every 4 weeks for the first 6 months or until treatment discontinuation whichever come first.; Safety: toxicities occurred during treatment period and the fist 30 days from the date of last treatment administration; Compliance endopoints will be recorded during whole treatment period. INCLUSION CRITERIA: 1.Patients affected by pathologically confirmed high‐grade epithelial ovarian, fallopian tube, or primary peritoneal cancer. 2.Relapsed/progressive disease within 6 months from last platinum‐based chemotherapy (platinum resistant/refractory disease) 3.Any line of treatment (after the first). 4.Any “last” chemotherapy line, including Paclitaxel that should have been administered at least 6 months before the study beginning. 5.Patients must be women > 18 years of age. 6.Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below: ‐ Haemoglobin = 10.0 g/dL and no blood transfusions in the 28 days prior to entry/randomisation ‐ Absolute neutrophil count (ANC) = 1.5 x 109/L ‐ White blood cells (WBC) > 3x109/L ‐ Platelet count = 100 x 109/L ‐ Total bilirubin = 1.5 x institutional upper limit of normal (ULN) ‐ AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper

Euctr, I. T. (2021). "Impact on Disease Relapse of HPV Vaccination in Women Treated With electrosurgical excision with diathermic loop (LEEP) for Cervical Intraepithelial Neoplasia." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: GARDASIL9 0,5 ml ‐ sospensione iniettabile ‐ uso intramuscolare – siringa pre‐riempita (vetro) ‐ 1 siringa preriempita + 2 aghi Product Name: GARDASIL9 0,5 ml ‐ sospensione iniettabile ‐ uso intramuscolare – siringa pre‐riempita (vetro) ‐ 1 s Product Code: [GARDASIL9 0, 5 ml ‐ sospensione iniettabile ‐ uso Pharmaceutical Form: Suspension for injection INN or Proposed INN: Papillomavirus (tipi umani 6,11,16,18,31,33, 45,52,58) Current Sponsor code: Proteina L1 tipi 6,11,16,18,31,33, 45,52,58 di Papillomavirus umano Concentration unit: DF dosage form Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Solvent for parenteral use Route of administration of the placebo: Intramuscular use CONDITION: Prevention of recurrence after a first episode of high‐grade cervical intraepithelial neoplasia (CIN2 +) up to initially invasive cervical cancer (FIGO IA1) ; MedDRA version: 21.1 Level: LLT Classification code 10008229 Term: Cervical cancer System Organ Class: 100000004864 ; MedDRA version: 21.1 Level: LLT Classification code 10056576 Term: Cervical intraepithelial neoplasia System Organ Class: 100000004872 ; MedDRA version: 21.1 Level: PT Classification code 10064328 Term: Human papilloma virus test positive System Organ Class: 10022891 ‐ Investigations Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: To evaluate the impact of pre‐surgical HPV 9‐valent vaccination in patients subjected to conization for the management of high‐grade cervical intraepithelial neoplasia (CIN2 +) and initially invasive cervical cancer in terms of possible reduction of recurrent post‐surgical disease. Primary end point(s): ‐ evaluation of the reduction of disease recurrence (cervical intraepithelial neoplasia up to microinvasive cervical cancer) by comparing the number of recurrences in the two arms. Secondary Objective: 1. Analysis of the possible impact of the 9‐valent vaccine on the post‐surgical natural history of HPV infection.; 2. Evaluation of 9‐valent HPV vaccination in patients treated for CIN2 + in terms of possible reduction of the follow‐up scheme in the cervical screening program (investigation on the possible temporal reduction of post‐surgical surveillance). Timepoint(s) of evaluation of this end point: During the entire duration of the study SECONDARY OUTCOME: Secondary end point(s): Analysis of the impact of the vaccine on prevalent post‐surgery infections by comparing the prevalence of persistent HPV infections (duration greater than 12 months after surgery) in the two arms.; Analysis of the impact of the vaccine in the post‐surgical surveillance times, comparison of the viral wash‐out times (negativity of the HPV test), times of negativization of the pap test and of the colposcopic exam in the post‐operative period: comparison of the overexposed times of negativization in the two arms. Timepoint(s) of evaluation of this end point: During the entire duration of the study; During the entire duration of the study INCLUSION CRITERIA: 1. Patients = 18 years old and ecog performance status = 1 2. Patients diagnosed with high‐grade cervical intraepithelial neoplasia or initially invasive cervical cancer (histological findings = CIN2 + and = Ia1 according to the FIGO staging of cervical cancer) 3. No fever at the time of vaccination 4. No previous HPV vaccination 5. Ability to understand and write in Italian 6. Signature of informed consent and consent to personal data Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 1200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Euctr, I. T. (2021). "Metal Allergen Patch Test." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Ammoniated Mercury Product Code: Panel 1 Pharmaceutical Form: Transdermal patch INN or Proposed INN: AMMONIO CLORURO CAS Number: 10124‐48‐8 Current Sponsor code: Pannl 1 Other descriptive name: Dose Range: 0.013, 0.040, 0.12, 0.36 mg/cm² Other Names Ammoniated mercuric chloride, Ammoniated mercury,Hydrargyrum ammoniatum, Hydrargyrum praecipitatum album, Hydrargyrum precipitatum album, Mercuric amidochloride, Mercuric ammonium chloride, Mercuric chloride, ammoniated, Mercury amine chloride, Mercury ammoniated, Mercury ammonium chloride, Mercury(II) chloride ammonobasic, Mercury, ammoniated, Mercury, ammonobasic Quecksilber(II)‐amid‐chlorid, Concentration unit: mg milligram(s) Concentration type: range Concentration number: 0‐0 Route of administration of the placebo: Cutaneous use Product Name: Aluminum chloride hexahydrate Product Code: Panel 2 Pharmaceutical Form: Transdermal patch INN or Proposed INN: ALLUMINIO CLORURO CAS Number: 7784‐13‐6 Current Sponsor code: Panel 2 Other descriptive name: Dose Range: 0.040, 0.12, 0.36, 0.72 mg/cm² Other Names:I3‐01918, Aluminum chloride, Aluminum chloride hexahydrate, Aluminum trichloride hexahydrate, Aluminum(III) chloride, hexahydrate, Concentration unit: mg milligram(s) Concentration type: range Concentration number: 0‐0 Route of administration of the placebo: Cutaneous use Product Name: Aluminum lactate Product Code: Panel 2 Pharmaceutical Form: Transdermal patch INN or Proposed INN: ALLUMINIO LATTATO CAS Number: 18917‐91‐4 Current Sponsor code: Panel 2 Other descriptive name: Dose Range: 0.047, 0.14, 0.42, 0.84 mg/cm² Other Names: Aluminium lactate, Aluminium lacticum, Aluminium‐(RS)‐lactat, Aluminum lactate, Aluminum lactate (Al(O3C3H5)3), Aluminum tris (alpha‐hydroxypropionate), Aluminum, tris (2‐hydro CONDITION: Diagnosis of Allergic Contact Dermatitis ; MedDRA version: 20.0 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 ‐ Immune system disorders Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Diagnosis [E01] SECONDARY OUTCOME: Secondary end point(s): ¿ The frequencies (total and by scored character) of late reactions, persistent reactions, and tape irritation will be determined for the entire study population, and by gender and race. The frequencies of late reactions and persistent reactions will also be calculated according to allergen dose tested.; ¿ The frequency of adverse events will be calculated for the entire study population, according to gender and race and to the allergen dose tested.; ¿ Serious adverse events will be described in detailed case reports for each subject.; Timepoint(s) of evaluation of this end point: Late or persistent reactions‐ days 4‐21, tape irritation‐ day 2, adverse and serious events‐ days 2‐21 PRIMARY OUTCOME: Main Objective: To evaluate the diagnostic performance and safety of mercury, aluminum and palladium proposed for inclusion in a T.R.U.E. TEST Metal Patch Test Panel. Primary end point(s): ¿ Determination of optimal test allergen dose as the lowest concentration eliciting either 1+ or 2+ or 3+ positive reaction in 70‐90% of subjects with the fewest number of 3+ reactions;; ¿ Overall concordance and discordance compared to the reference allergen.; ¿ The frequency of ranked skin responses‐ positive (1+, 2+, 3+); negative, doubtful and irritant reactions, will be calculated for each investigational and reference allergen dose tested. Statistical differences between the dose‐related frequencies will be evaluated within each allergen using the Generalized Estimation Equations (GEE) approach, which is based on probability distributions. ; ¿ Skin reaction concordance and discordance between the investigational allergen (mercury, aluminum and palladium) and the corresponding reference allergen will be determined in the total population tested. ; ¿ The frequencies of positive skin reactions to the investigational allergens will be calculated by gender and r e. ; Secondary Objective: No Secondary Objective Timepoint(s) of evaluation of this end point: Day 0‐21 INCLUSION CRITERIA: a. 18 years of age or older. b. History of contact dermatitis; c. Positive patch results to 1) mercury (elemental), 2) aluminum (aluminum chloride hexahydrate, aluminum hydroxide and/or aluminum lactate), 3) palladium (sodium tetrachloropalladate and/or palladium chloride), and/or 4) itching, subcutaneous nodules or excoriated papules at the sites of vaccination injections within the past 10 years; d. Unable to become pregnant or willing to use an acceptable method of contraception to prevent pregnancy if female of childbearing potential; ¿ Inability to become pregnant would include all male subjects and female subjects who are postmenopausal for at least 1 year, or surgically sterile‐ have had a hysterectomy, bilateral ovariectomy, uterine ablation or bilateral tubal ligation. ¿ Acceptable methods of contraception include: 1) systemic birth control; 2) double barrier method (condom with spermicide or diaphragm with spermicide); 3) IUD; 4) vasect

Euctr, I. T. (2021). "A MULTICENTER TRIAL OF A NEW CUSTOMIZED DOSING (RATIONAL ADJUSTMENT OF DOSE TO REDUCE ADVERSE REACTIONS “RADAR” DOSING) OF NIRAPARIB AS MAINTENANCE THERAPY IN PLATINUM SENSITIVE OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL RECURRENT CANCER PATIENTS." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Niraparib Product Code: [Niraparib] Pharmaceutical Form: Capsule, hard INN or Proposed INN: Niraparib tosilato monoidrato CAS Number: 1038915‐60‐4 Current Sponsor code: na Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Product Name: Niraparib Product Code: [Niraparib] Pharmaceutical Form: Capsule, hard INN or Proposed INN: Niraparib tosilato monoidrato CAS Number: 1038915‐60‐4 Current Sponsor code: na Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ CONDITION: Ovarian, fallopian tube or primary peritoneal recurrent cancer ; MedDRA version: 20.0 Level: LLT Classification code 10006888 Term: Ca ovary System Organ Class: 100000004864 ; MedDRA version: 20.0 Level: LLT Classification code 10006888 Term: Ca ovary System Organ Class: 100000004864 Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: The primary objectives of the study are: ; • to compare the safety profile of niraparib RADAR dosing in terms of occurrence of grade = 3 thrombocytopenia in the first three cycles versus the SmPC approved dosing in patients who either have a baseline body weight =58 and <77kg, or have a baseline body weight =77kg and baseline platelet count <150,000/µL (restricted population);; • to evaluate the improvement in the safety profile of niraparib RADAR dosing in terms of occurrence of grade = 3 thrombocytopenia in the first three cycles. Primary end point(s): Rate of patients experiencing a grade =3 thrombocytopenia during the first three cycles. Secondary Objective: • to compare the safety profile of RADAR dosing in terms of occurrence of grade = 3 thrombocytopenia in the first six cycles versus the SmPC approved dosing; • to evaluate the improvement in the safety profile of niraparib RADAR dosing in terms of occurrence of grade = 3 thrombocytopenia in the first six cycles; o to compare the efficacy of niraparib RADAR dosing vs. the SmPC dosing (300 mg); o to compare the safety profile of RADAR dosing compared with the SmPC dosing (300 mg); o to evaluate the safety of niraparib RADAR; • Compliance: to evaluate patients adherence to the two treatment regimens of niraparib (RADAR and SmPC) under study in terms of average administered dose in the first 6 cycles; • Pharmacokinetic: to assess the minimum level of niraparib at the steady state, i.e. trough level concentration and the peak level at two hours after the daily dose Timepoint(s) of evaluation of this end point: During the first three cycles SECONDARY OUTCOME: Secondary end point(s): Rate of patients experiencing a grade =3 thrombocytopenia during the first six cycles; Maximum toxicity grade experienced by each patient, for each toxicity, according to NCI‐CTCAE v. 4.03; Patients experiencing grade 3‐4 toxicities for each toxicity; Type, frequency and nature of SAEs; Patients with at least a SAE; Patients with at least a SADR; Patients with at least a SUSAR; PFS‐6: PFS rate at 6 months, defined as the proportion of patients alive and free from progression at 6 months after randomization.; PFS, defined as the time from the date of treatment randomization to the date of first documentation of progression or death whichever occurs first.; OS at 24 months, defined as the rate of patients who are alive at 24 months from randomization; Pharmacokinetics: Trough level of niraparib concentration at steady state (Css) and peak level at 2 hours after dosing.; Compliance; o Number of administered cycles; o Frequency and reasons for drug discontinuation and treatment modification (suspension, dose reduction).; o Dose intensity Timepoint(s) of evaluation of this end point: During the first six cycles; During the study; During the study; During the study; During the study; During the study; During the study; Six months after randomization; As clinical practice; 24 months from randomization; Cycle 1 at day 1 and 15; cycle 2 and 3 at day 1;c ycle 4 at day 1 and 15 only if dose escalated; on day 1 of any cycle in which the dose s reduced for the first time and on day 1 of the subsequent cycle.; During the study INCLUSION CRITERIA: 1. 18 years of age or older, female, any race 2. Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer 3. High grade (or grade 3) serous histology or known to have gBRCAmut 4. Has received at least 2 previous lines of platinum‐containing therapy (not necessarily consecutive), and has disease that was considered platinum sensitive following the penultimate platinum line (more than 6‐months period between penultimate platinum regimen and progression of disease) 5. Has responded to the last platinum line (PR or CR) 6. No more than 8 weeks have elapsed from completion of the last platinum regimen and the patient is still not progressing after response 7. Eastern Cooperative Oncology Group (ECOG) performance status of = 1 8. Adequate bone marrow, kidney and liver function, defined as follows: a. Absolute neutrophil count = 1,500/µL b. Platelets = 100,000/µL c. Hemoglobin = 9 g/dL d. Serum creatin

Euctr, I. T. (2021). "Olaparib beyond progression compared to platinum chemotherapy after secondary cytoreductive surgery in recurrent ovarian cancer patients. The phase III randomized, open label MITO 35b study: a project of the MITO-MANGO groups." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: CARBOPLATINO Product Code: [CARBOPLATINO] Pharmaceutical Form: Concentrate for solution for infusion CAS Number: 41575‐94‐4 Current Sponsor code: CARBOPLATINO Other descriptive name: CARBOPLATINO Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Trade Name: LYNPARZA ‐ 100 MG ‐ COMPRESSA RIVESTITA CON FILM ‐ USO ORALE ‐ BLISTER (ALU/ALU) ‐ 56 COMPRESSE Product Name: LYNPARZA Product Code: [LYNPARZA] Pharmaceutical Form: Film‐coated tablet CAS Number: 763113‐22‐0 Current Sponsor code: AZD2281 Other descriptive name: LYNPARZA®, olaparib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Product Name: Cisplatino Product Code: [Cisplatino] Pharmaceutical Form: Concentrate for solution for infusion CAS Number: 15663‐27‐1 Current Sponsor code: Cisplatino Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ Product Name: Gemcitabina Product Code: [Gemcitabina] Pharmaceutical Form: Concentrate for solution for infusion CAS Number: 95058‐81‐4 Current Sponsor code: GEMCITABINA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 38‐ Product Name: Paclitaxel Product Code: [Paclitaxel] Pharmaceutical Form: Concentrate for solution for infusion CAS Number: 33069‐62‐4 Current Sponsor code: Paclitaxel Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6‐ Trade Name: LYNPARZA ‐ 150 MG ‐ COMPRESSA RIVESTITA CON FILM ‐ USO ORALE ‐ BLISTER (ALU/ALU) ‐ 56 COMPRESSE Product Name: LYNPARZA Product Code: [LYNPARZA] Pharmaceutical Form: Film‐coated tablet CAS Number: 763113‐22‐0 Current Sponsor code: AZD2281 Other descriptive name: AZD2281, LYNPARZA CONDITION: Recurrent ovarian cancer patients ; MedDRA version: 21.1 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: • To determine the efficacy (in terms of progression‐free survival) of olaparib maintenance beyond progression when compared to standard chemotherapy in patients with recurrent ovarian cancer undergone secondary cytoreductive surgery for recurrent or progressive disease.; • To determine the efficacy of the experimental therapies on subsequent treatment (in terms of progression‐free survival 2) after progression. Primary end point(s): 1) progression‐free survival; 2) progression‐free survival 2 Secondary Objective: To compare the two arms in terms of: ; ; • Overall Survival; • Safety and tolerability (CTCAE 5.0 version and PRO‐CTCAE questionnaire); • Quality of Life (EORTC QLQ‐C30 questionnaire); • Financial toxicity (PROFFIT questionnaire) Timepoint(s) of evaluation of this end point: Every 12 weeks from C1D1± 7 days SECONDARY OUTCOME: Secondary end point(s): 1) Overall Survival; 2) Safety and tolerability (CTCAE 5.0 version and PRO‐CTCAE questionnaire); 3) Quality of Life (EORTC QLQ‐C30 questionnaire); 4) Financial toxicity (PROFFIT questionnaire Timepoint(s) of evaluation of this end point: 1)time from enrollement to death for any cause; 2) At screening (within 7 days prior to randomization), on Day 1 of each Cycle (during treatment) until 6 months, then at 9 and 12 months, from randomization for both arms or until progression; 2)At screening (within 7 days prior to randomization), on Day 1 of each Cycle (during treatment) until 6 months, then at 9 and 12 months, from randomization for both arms or until progression; 3) At screening (within 7 days prior to randomization), on Day 1 of each Cycle (during treatment) until 6 months, then at 9 and 12 months, from randomization for both arms or until progression INCLUSION CRITERIA: • Signed informed consent prior to any study specific procedures; • Female, age = 18 years at time of signing n ormed consent; • Patients with high‐grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer recurrent or progressive after first line PARPi maintenance are allowed; • Patients must have received only one previous line of a platinum containing regimen not containing bevacizumab; • Patient must have received a first‐line maintenance therapy with a PARPi for at least 6 months; if the prior PARPi used was olaparib then patients must have received treatment without significant toxicity or the need for a permanent dose reduction. Patients who experience disease relapse after the end of the 24 months maintenance therapy are eligible; • Patients must have undergone secondary cytoreductive surgery. The cytoreduction must result in complete resection (absence of macroscopic residual tumor) or at least resection of the

Euctr, I. T. (2021). "A Phase 2 Study of VS-6766 Alone and In Combination with Defactinib in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 201)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: ‐‐‐‐‐ Product Code: [VS‐6766] Pharmaceutical Form: Capsule, hard CAS Number: 946128‐90‐1 Current Sponsor code: VS‐6766 Other descriptive name: 3‐[[2‐[(Methylaminosulfonyl)amino]‐3‐fluoropyridin‐4‐yl]methyl]‐4‐methyl‐7‐ [(pyrimidin‐2‐yl)oxy]‐2H‐1‐benzopyran‐2‐one Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 800‐ Product Name: Defactinib Product Code: [VS‐6063] Pharmaceutical Form: Tablet INN or Proposed INN: DEFACTINIB HCl CAS Number: 1073160‐26‐5 Current Sponsor code: VS‐6063 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ CONDITION: Recurrent Low‐Grade Serous Ovarian Cancer (LGSOC) ; MedDRA version: 21.1 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: Part A:; To determine the optimal regimen, either VS‐6766 monotherapy or VS6766 in combination with defactinib, for subsequent evaluation for efficacy in the expansion phase (Part B); Part B:; To determine the efficacy of the optimal regimen identified from Part A Primary end point(s): Part A:; Confirmed overall response rate (ORR; partial response [PR] + complete; response [CR] defined according to RECIST 1.1) as assessed by the blinded independent radiology review committee (BIRC); Part B:; Confirmed ORR defined according to RECIST 1.1 as assessed by the BIRC Secondary Objective: 1) To characterize the safety and toxicity profile of VS‐6766 as a monotherapy and in combination with defactinib in LGSOC; 2); Part A:; To evaluate additional efficacy parameters for VS‐6766 monotherapy; and in combination with defactinib; Part B:; To evaluate additional efficacy parameters for the optimal regimen; identified in Part A; 3) To characterize the pharmacokinetics (PK) of VS‐6766, defactinib, and; relevant metabolites Timepoint(s) of evaluation of this end point: thorough the study SECONDARY OUTCOME: Secondary end point(s): Part A and B:; 1) Adverse events (AEs), serious AEs (SAEs), physical examinations,; clinical laboratory values and tolerability (dose; interruptions/reductions); 2) ; ‐ Duration of response (DOR) as assessed by the BIRC; ‐ ORR as assessed by the Investigator; ‐ Progression free survival (PFS), defined as the time from first dose of; study treatment to the first documentation of PD, or death from any; cause; ‐ Disease control rate (DCR), defined as CR+PR+ stable disease (SD); ‐ Overall survival (OS); 3) PK parameters derived from plasma concentrations of VS‐6766,; defactinib, and relevant metabolites Timepoint(s) of evaluation of this end point: thorough the study INCLUSION CRITERIA: Subjects may be eligible for inclusion in the study if they meet the following criteria: 1. Female subjects >= 18 years of age 2. Histologically proven LGSOC (ovarian, peritoneal) a. The Sponsor's Medical Monitor must review the pathology report prior to the start of treatment b. Adequate pathology material (as defined in the lab manual) must be available prior to enrollment to be used for central confirmation. Central pathological confirmation does not need to be completed prior to enrollment. 3. Tumor with known KRAS mutational status using a validated testing method (blood or tissue) prior to treatment assignment. Adequate archival tumor tissue less than 5 years old or fresh biopsy tissue samples (as defined in the lab manual) must be available for central confirmation prior to treatment assignment. 4. Progression (radiographic or clinical) or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease. Below a

Euctr, I. T. (2021). "A phase II trial of short-course versus long-course pre-operative chemotherapy with mFOLFIRINOX or PAXG regimen for stage I-III pancreatic ductal adenocarcinoma (PDAC." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: CISPLATINO SANDOZ ‐ 1 FLAC 100 ML CONCENTRATO PER INFUSIONE 0.5 MG/ML Product Name: Cisplatino Product Code: [15663‐27‐1] Pharmaceutical Form: Concentrate for solution for injection/infusion CAS Number: 15663‐27‐1 Current Sponsor code: ND Concentration unit: mg/ml milligram(s)/millilitre Concentration type: up to Concentration number: 100‐ Trade Name: ABRAXANE ‐ 5 MG/ML ‐ POLVERE PER SOSPENSIONE PER INFUSIONE ‐ USO ENDOVENOSO‐ 100 MG ‐ FLACONCINO(VETRO) 1 FLACONCINO Product Name: abraxane Product Code: [ABI‐007] Pharmaceutical Form: Powder for solution for injection/infusion CAS Number: 33069‐62‐4 Current Sponsor code: ND Other descriptive name: NAB‐PACLITAXEL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 3‐12 Trade Name: XELODA ‐ 500 MG 120 COMPRESSE FILMRIVESTITE IN BLISTER USO ORALE Product Name: XELODA Product Code: [154361‐50‐9] Pharmaceutical Form: Tablet CAS Number: 154361‐50‐9 Current Sponsor code: ND Other descriptive name: XELODA Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 500‐ Trade Name: GEMZAR ‐ 200 MG POLVERE PER SOLUZIONE PER INFUSIONE 1 FLACONCINO DA 200 MG Product Name: Gemcitabina Product Code: [95058‐81‐4] Pharmaceutical Form: Concentrate for solution for injection/infusion CAS Number: 95058‐81‐4 Current Sponsor code: ND Other descriptive name: GEMZAR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Trade Name: IRINOTECAN HOSPIRA ‐ 20MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 100MG/5ML Product Name: irinotecan Product Code: [37037025] Pharmaceutical Form: Concentrate for solution for injection/infusion CAS Number: 100286‐90‐6 Current Sponsor code: ND Other descriptive name: CAM CONDITION: Patients with pancreatic ductal adenocarcinoma ; MedDRA version: 21.0 Level: LLT Classification code 10033602 Term: Pancreatic adenocarcinoma resectable System Organ Class: 100000004864 Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: to compare in terms of 1yr‐EFS the efficacy of PAXG to that of mFOLFIRINOX.; to compare in terms of 1yr‐EFS the efficacy of 4 months pre‐operative and 2 months postoperative chemotherapy to that of 6 months of pre‐operative chemotherapy Primary end point(s): EFS,; CA19‐9 failure ; recurrence; ; preoperative or intraoperative unresectability; intraoperative evidence of metastases; death for any cause; whichever occurs first. Secondary Objective: OS, RECIST response rate, CA19.9 response rate, and complete pathologic response, resectability rate, surgical mortality and morbidity rate, intra‐ and post‐operative metastasis rate, N0 and R0 resections rate, patients reported outcomes, and treatment toxicity Timepoint(s) of evaluation of this end point: EFS, defined as the time from randomization to: RECIST progression [At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression]; CA19‐9 failure (defined as 2 consecutive increases of serum level =20%, separated by at least 4 weeks); recurrence; preoperative or intraoperative unresectability; intraoperative evidence of metastases; death for any cause; whichever occurs first. R1 resections will NOT be considered as events whereas R2 resections will be. SECONDARY OUTCOME: Secondary end point(s): EFS,; CA19‐9 failure ; recurrence; ; preoperative or intraoperative unresectability; intraoperative evidence of metastases; death for any cause; whichever occurs first. Timepoint(s) of evaluation of this end point: EFS, defined as the time from randomization to: RECIST progression [At least a 20% increase in the sum of diameters of target lesions, t ing as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression]; CA19‐9 failure (defined as 2 consecutive increases of serum level =20%, separated by at least 4 weeks); recurrence; preoperative or intraoperative unresectability; intraoperative evidence of metastases; death for any cause; whichever occurs first. R1 resections will NOT be considered as events whereas R2 resections will be. INCLUSION CRITERIA: 1. Cyto/histological diagnosis of pancreatic ductal adenocarcinoma*; 2. Clinical stage I‐III disease according to TNM 8th Ed. 2017 [appendix 1]; 3. Resectable or borderline resectable disease, as anatomically defined according to NCCN Guidelines Version 1.2020 4. Karnofsky Performance Status > 60% [appendix 3]; 5. Age ¿ 18 and = 75 years; 6. Adequate bone marrow function (GB = 3500/mm3, neutrophils =1500/mm3, platelets = 100000/mm3, Hb =10 g/dl); 7. Adequate kidney function (serum creatinine < 1.5 mg/dL); 8. Adequate liver function (ALT and AST < 3 ULN and Serum total bilirubin = 1.5 ULN); 9. No prior treatment (chemotherapy, radiotherapy and/or surgery) for pancreatic cancer; 10. Women must not be on pregnancy or lactation; 11. Patient of child‐bearing potential must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for 4 months after the last study tr

Euctr, I. T. (2021). "Prospective randomized trial comparing corifollitropin alfa (CF-alfa) late start (day 4) vs. CF-alfa standard start (day2) in poor, normal and potential high-responders undergoing IVF/ICSI." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: ELONVA ‐ 150 MCG ‐ SOLUZIONE INIETTABILE ‐ USO SOTTOCUTANEO ‐ SIRINGA PRERIEMPITA(VETRO) ‐ 0.5 ML 1 SIRINGA PRERIEMPITA + 1 AGO Product Name: Elonva Pharmaceutical Form: Solution for injection CONDITION: Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] Women with low reproductive capacity ; MedDRA version: 20.0 Level: LLT Classification code 10002658 Term: Anovulation System Organ Class: 100000004860 ; MedDRA version: 20.1 Level: LLT Classification code 10016398 Term: Female infertility System Organ Class: 100000004872 ; MedDRA version: 20.0 Level: LLT Classification code 10071102 Term: Controlled ovarian hyperstimulation System Organ Class: 100000004865 PRIMARY OUTCOME: Main Objective: compare the number of retrieved oocytes in the late start CF‐alfa vs. early start CF‐alfa in patients undergoing IVF Primary end point(s): Number of retrieved oocytes at US guided puncture Secondary Objective: Compare the two protocols with regard to the oocyte morphology (assessed by polarized light microscopy) the rate of clinical pregnancy to six weeks, the incidence of side effects and the degree of satisfaction of the patient Timepoint(s) of evaluation of this end point: 12 months SECONDARY OUTCOME: Secondary end point(s): Pregnancy rate with either applied protocol; Safety and undesired effects of applied protocols Timepoint(s) of evaluation of this end point: 12 months; 12 months INCLUSION CRITERIA: Age 18‐43 years Tubal infertility or male infertility referred for IVF Willingness to undergo randomization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Euctr, N. L. (2021). "RAINBO: refining Adjuvant treatment IN endometrial cancer Based On molecular features, The MMRD-GREEN trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: IMFINZI Product Name: Durvalumab Pharmaceutical Form: Solution for infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use CONDITION: Endometrial Cancer Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: 3 year recurrence free survival (RFS), in patients with MMRd HREC Primary end point(s): 3 year recurrence free survival.; RFS is defined as time from randomization until date of any recurrence (local or distant) or date of death due to any cause, whichever occurred first.; Secondary Objective: • RFS (median and at 5 years); • OS (median, 3yr, 5yr); • HRQoL; • Safety & tolerability (NCI‐CTC grade 3‐5); • Exploratory translational research (TR), including PD‐L1 testing using SP263 assay and TIP algorithm (>1% and 5%) on biopsy or resections of EC samples.; Timepoint(s) of evaluation of this end point: 3 years SECONDARY OUTCOME: Secondary end point(s): 1. Investigator assessed 5 yr RFS; 2. Overall Survival (OS) (median, 3yr, 5yr): will be determined from the date of registration to the date of death from any cause. Subjects who have not died at the time of the data freeze for the final analysis will be censored at the date the patient was last known to be alive.; 3. HRQoL (EORTC QLQC30 and QLQEN24) ; 4. Safety: Safety and tolerability endpoints will consist of the evaluation of side‐effects according to the NCI‐CTCAE version 5, AEs, withdrawals due to AEs, dose reductions or interruptions.; 5. Immune markers Timepoint(s) of evaluation of this end point: ad 1) at 5 years; ad2) At mortality ; ad 3) at baselinine and months 2,6,12,18, 24 and 36.; ad 4) During theray and till 30 days thereafter; ad 5) between year 3 and 5 INCLUSION CRITERIA: Key inclusion criteria for RAINBO program: • Histologically confirmed diagnosis of EC (all grades and all histologic subtypes, including: including endometrioid, serous endometrial carcinoma, uterine clear cell carcinoma, de‐ /undifferentiated carcinoma, uterine carcinosarcoma). • Molecular classification performed following the diagnostic algorithm described in WHO2020 (adapted from Vermij et al.) • TLH‐BSO or TAH‐BSO with or without lymphadenectomy and/or full surgical staging, without macroscopic residual disease after surgery • No distant metastases as determined by pre‐surgical or post‐surgical imaging (CT scan of chest, abdomen and pelvis or PET‐CT scan) • Written informed consent • Age > 18 years • Patients must be accessible for treatment and follow‐up • Written informed consent according to the local Ethics Committee requirements. Inclusion criteria specific for MMRD‐GREEN Trial: • WHO Performance score 0‐1 • Hist

Euctr, N. L. (2022). "A study investigating the dosing strategy for heated chemotherapy-lavage in the abdominal cavity (hyperthermic intraperitoneal chemotherapy, or HIPEC) during cytoreductive surgery in patients with advanced ovarian cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: Cisplatin Product Name: Cisplatin Product Code: L01XA Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Cisplatin Other descriptive name: NDC 16729‐288 Concentration unit: mg/m2 milligram(s)/square meter Concentration type: up to Concentration number: 100‐ Trade Name: Cisplatin Product Name: Cisplatin Product Code: L01XA Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Cisplatin Other descriptive name: NDC 16729‐288 Concentration unit: mg/l milligram(s)/litre Concentration type: up to Concentration number: 40‐ CONDITION: FIGO stage III high grade serous ovarian cancer, peritoneal cancer, or fallopian tube carcinoma Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: To evaluate BSA‐based versus concentration‐based OVHIPEC with cisplatin in patients with advanced‐stage ovarian cancer Secondary Objective: To assess the pharmacokinetics and safety Primary end point(s): The primary endpoint is the platinum concentration in the tumor nodule at the end of the HIPEC procedure. Timepoint(s) of evaluation of this end point: After the cytoreductive surgery plus HIPEC procedure SECONDARY OUTCOME: Secondary end point(s): Secondary endpoints:; ‐ Toxicity evaluation (CTCAE 5.0); ‐ Platinum concentration in normal tissue (in ng/mg wet tissue); ‐ Platinum concentration in tumor tissue after 30 min and 60 min of perfusion (in ng/mg wet tissue); ‐ Concentration versus time curve and AUC of intra‐peritoneal Pt during perfusion; ‐ Cmax, tmax, terminal t ½ in perfusate, clearance from perfusate ate the end of perfusion; ‐ Overall survival (OS) Timepoint(s) of evaluation of this end point: Pharmacokinetic parameters: after the cytoreductive surgery plus HIPEC procedure; Safety: 4‐5 weeks following surgery plus HIPEC INCLUSION CRITERIA: 1. signed and written informed consent 2. age = 18 years 3. patients eligible for interval cytoreductive surgery a. histological proven FIGO stage III primary high grade serous ovarian, fallopian tube, or extra‐ovarian cancer b. when only cytology is performed to confirm the diagnosis ovarian carcinoma, immunohistochemistry should be performed including keratin 7, keratin 20, p53, PAX8 c. neo‐adjuvant chemotherapy consists of (at least) 3 courses of carboplatin/paclitaxel d. following 2 cycles of chemotherapy no progression should occur 4. treated with optimal or complete interval cytoreductive surgery 5. fit for major surgery, WHO performance status 0‐2 6. adequate bone marrow function (hemoglobin level >5.5 mmol/L; leukocytes >3 x 109/L; platelets >100 x 109 /L) 7. adequate hepatic function (ALT, AST and bilirubin <2.5 times upper limit of normal) 8. adequate renal function (creatinine clearance = 60 ml/min using Cockcroft‐

Euctr, P. L. (2022). "Master Protocol of Dato-DXd as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Code: AZD5305 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: N/A CAS Number: 2589531‐76‐8 Current Sponsor code: AZD5305 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5‐ Product Name: Durvalumab Product Code: MEDI4736 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Durvalumab CAS Number: 1428935‐60‐7 Current Sponsor code: MEDI4736 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Product Name: Datopotamab deruxtecan Product Code: DS‐1062a Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Datopotamab deruxtecan CAS Number: 2238831‐60‐0 Current Sponsor code: DS‐1062a Other descriptive name: Anti‐trophoblast cell surface protein 2 (TROP2) antibody‐drug conjugate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Product Name: Capecitabine Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Capecitabine CAS Number: 154361‐50‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Product Name: Flourouracil (5‐FU) Pharmaceutical Form: Solution for injection INN or Proposed INN: fluorouracil CAS Number: 51‐21‐8 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Product Name: Bevacizumab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Bevacizumab CAS Number: 216974‐75‐3 Current Sponsor code: FKB238 Other descriptive name: A recombinant, humanized IgG1 mAb specific for VEGF Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25‐ Product Name: Carboplatin Pharmaceutical Form: Concen CONDITION: Therapeutic area: Diseases [C] ‐ Cancer [C04] various Advanced/Metastatic solid tumour types ‐ Endometrial Cancer ‐ Gastric Cancer ‐ Ovarian Cancer ‐ Metastatic castration‐resistant prostate cancer ‐ Colorectal cancer ; MedDRA version: 12.0 Level: HLGT Classification code 10007129 Term: Cancer‐related morbidities System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) PRIMARY OUTCOME: Main Objective: ‐To assess the efficacy of Dato‐DXd as monotherapy and in combination with anticancer agents by assessment of ORR; ; ‐To assess the safety and tolerability of Dato‐DXd as monotherapy and in combination with anticancer agents Primary end point(s): ‐ Objective response rate (ORR); ‐ AEs/SAEs, ECOG performance status, changes from baseline in laboratory findings,ECGs, vital signs, physical examinations, and ophthalmologic assessments; ‐ PSA50 response; ‐ Progression‐free survival (PFS) Secondary Objective: ‐ To further assess the efficacy of Dato‐DXd as monotherapy and in combination with anticancer; agents by assessment of PFS, DoR, DCR at 12 and 24 weeks, Best percentage change in tumour size (where applicable); ; ‐ To assess the PK of Dato‐DXd, total anti‐TROP2 antibody, and MAAA‐1181a in plasma; ; ‐ To investigate the immunogenic potential of Dato‐DXd Timepoint(s) of evaluation of this end point: ‐ ORR, PSA50, PFS: data obtained from first dose up until progression per RECIST 1.1 as assessed by the investigator or death, or the last evaluable assessment in the absence of an event (regardless of whether the participant withdraws from therapy); ; ‐ Safety: during the study treatment or the safety follow‐up period (defined as 28 days after last dose of study intervention, or if durvalumab, nivolumab, or bevacizumab is given, 90 days after the last dose will be reported) but prior to subsequent cancer therapy SECONDARY OUTCOME: Secondary end point(s): ‐ Progression‐free survival (PFS); ‐ Duration of response (DoR); ‐ Disease control rate (DCR); ‐ Best percentage change in tumour size; ‐ Overall survival (OS); ‐ Radiographic Progression‐free survival (rPFS); ‐ CA‐125 res nse; ‐ Plasma concentrations and PK parameters, total anti‐TROP2 antibody, and MAAA‐1181a; ‐ Presence of ADAs for Dato‐DXd Timepoint(s) of evaluation of this end point: ‐ PFS, DoR, DCR, Best percentage change in tumour size, rPFS, CA‐125 response: data obtained from first dose up until progression per RECIST 1.1 as assessed by the investigator or death, or the last evaluable assessment in the absence of an event (regardless of whether the participant withdraws from therapy); ‐ OS: data obtained from first dose up until death, or the last evaluable assessment in the absence of an event; ‐ PK and Immunogenicity: blood samples will be taken for specific drugs at limited time points INCLUSION CRITERIA: 1‐ Male and female, = 18 years at the time of screening 2‐Histologically or cytologically documented advanced or metastatic malignancy. 3‐ Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing. Archival FFPE tumour samples must be < 12 months old from the time of collection to the time of start of protocol screening. The exception is for gastric Substudy Cohorts 2A and 2B, where prospective PD‐L1 central testing is required for enrolment, archival FFPE tumour samples must be < 6 months old from the time of collection to the time of start of protocol. 4‐ At least 1 lesion not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline and can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes, which must have short axis = 15 mm) with CT or MRI and is suitable for accurate repeated measure

Euctr, R. O. (2022). "Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: Nplate Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: ROMIPLOSTIM CAS Number: 267639‐76‐9 Other descriptive name: ROMIPLOSTIM Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 500‐ Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: non‐small cell lung cancer (NSCLC), ovarian cancer, or breast cancer ; MedDRA version: 21.1 Level: PT Classification code 10029519 Term: Non‐small cell lung cancer stage III System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 21.1 Level: PT Classification code 10029522 Term: Non‐small cell lung cancer stage IV System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 21.1 Level: PT Classification code 10059515 Term: Non‐small cell lung cancer metastatic System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 21.1 Level: PT Classification code 10057529 Term: Ovarian cancer metastatic System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 21.1 Level: PT Classification code 10070907 Term: Ovarian cancer stage III System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 21.1 Level: PT Classification code 10070908 Term: Ovarian cancer stage IV System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 20.0 Level: PT Classification code 10006201 Term: Breast cancer stage III System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 20.0 Level: PT Classification code 10006202 Term: Breast cancer stage IV System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 20.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] SECONDARY OUTCOME: Timepoint(s) of evaluation of this end point: ‐The primary analysis will be performed at the primary completion date. The primary completion date is defined as the date when the last subject is assessed or receives an intervention for the final collection of data for the primary endpoint for the purposes of conducting the primary analysis, whether the study concluded as planned in the protocol or was terminated early. ; ; ‐When the last subject in the trial completes LTFU at 1 year after the last dose of investigational product, the final database will be locked and unblinded for the final analysis. In the final analysis, the secondary endpoints assessment, and all the exploratory endpoints will be evaluated Secondary end point(s): ‐ the depth of the platelet count nadir from the start of the first on‐study chemotherapy cycle through the end of the treatment period ; ‐the time to first platelet response, defined by platelet count 100 x 109/L in the absence of platelet transfusions during the preceding 7 days ; ‐the duration‐adjusted event rate of grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale ; ‐overall survival ; ‐platelet transfusion(s) during the treatment period PRIMARY OUTCOME: Main Objective: to evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer measured by the ability to administer on‐time, full‐dose chemotherapy Timepoint(s) of evaluation of this end point: ‐The primary analysis will be performed at the primary completion date. The primary completion date is defined as the date when the last subject s assessed or receives an intervention for the final collection of data for the primary endpoint for the purposes of conducting the primary analysis, whether the study concluded as planned in the protocol or was terminated early. Primary end point(s): no thrombocytopenia‐induced modification of any myelosuppressive agent in the second and third cycles of the planned on‐study chemotherapy regimen. Thrombocytopenia‐induced; modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 109/L. Secondary Objective: ‐to compare the treatment effect of romiplostim with that of placebo on the depth of platelet nadir; ‐to compare the treatment effect of romiplostim with that of placebo on the time to first platelet response; ‐to compare the treatment effect of romiplostim with that of placebo on the incidence of > grade 2 bleeding events; ‐to compare the treatment effect of romiplostim with that of placebo on overall survival; ‐to compare the treatment effect of romiplostim with that of placebo on the incidence of platelet transfusions; ‐to compare the treatment effect of romiplostim with that of placebo on the proportion of patients achieving platelet response; ‐overall safety of romiplostim ; ‐achieving a platelet count 100 x 109/L at any time after study day 1 to week 4 (i.e. 7 days after the planned third dose of investigational product) and in the absence of platelet transfusions during the preceding 7 days ; ‐adverse events, including treatment‐emergent adverse events, fatal ; adverse events, serious adverse events,and clinically significant changes in laboratory values ; ‐anti‐romiplostim antibodies and antibodies to thrombopoietin (TPO) ; ‐myelodysplastic syndromes and secondary malignancies INCLUSION CRITERIA: 1. Subject has provided informed consent prior to initiation of any study‐specific activities/procedures or subject’s legally acceptable representative has provided informed consent prior to any study‐specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent. 2. Males or females > 18 years of age at signing of the informed consent. 3. Documented active stage III or IV locally advanced or metastatic NSCLC, breast cancer, or ovarian cancer, or any stage recurrent disease. •patients with documented locally advanced (stage III) NSCLC should not be amenable to definitive treatment with chemoradiation and/or surgery. 4. Subjects must be receiving cancer treatment with 21‐ or 28‐day cycles, using one of the following carboplatinum‐based combination chemotherapy regimens: carboplatin/gemcitabine based, carbo

Eugonia (2022). Value of Follicular Flushing. Randomised Controlled Trial.
	No Results Available Procedure: Experimental: Follicular aspiration with addition of follicular flushing. Number of oocytes retrieved|Oocyte recovery rate|Oocyte maturation rate|Fertilization rate|Percentage of good quality embryos on day 2/3 Female Not Applicable 105 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Flushing RCT December 31, 2022

Eun, T., et al. (2023). "Therapeutic outcome of folate receptor alpha targeting antibody-drug conjugates in relapsed ovarian cancer: a meta-analysis."
	
Evangelia, K., et al. (2024). "Effect of autologous platelet-rich plasma on women undergoing IVF with a history of three unsuccessful embryo transfers under the age of 35, four unsuccessful embryo transfers between the ages of 35 and 39, or six unsuccessful embryo transfers at the age of 40 and above: a systematic review and meta-analysis."
	
Evangelia, K., et al. (2024). "Effect of intrauterine infusion of autologous platelet-rich plasma on women with repeated implantation failure undergoing IVF: a systematic review and meta-analysis."
	
Evans, D. (2021). "Regarding "Optimal Dose of Pituitrin in Laparoscopic Uterine Myomectomy: a Prospective, Double-Blinded, Randomized Controlled Trial"." Journal of Minimally Invasive Gynecology 28(11): 1956.
	
Evans, K., et al. (2022). "Remotely Delivered Interventions to Support Women With Symptoms of Anxiety in Pregnancy: Mixed Methods Systematic Review and Meta-analysis." Journal of Medical Internet Research 24(2): e28093.
	BACKGROUND: Symptoms of anxiety are common in pregnancy, with severe symptoms associated with negative outcomes for women and babies. Low-level psychological therapy is recommended for women with mild to moderate anxiety, with the aim of preventing an escalation of symptoms and providing coping strategies. Remotely delivered interventions have been suggested to improve access to treatment and support and provide a cost-effective, flexible, and timely solution. OBJECTIVE: This study identifies and evaluates remotely delivered, digital, or web-based interventions to support women with symptoms of anxiety during pregnancy. METHODS: This mixed methods systematic review followed a convergent segregated approach to synthesize qualitative and quantitative data. The ACM Digital Library, Allied and Complementary Medicine Database, Applied Social Sciences Index and Abstracts, Centre for Reviews and Dissemination database, the Cochrane Central Register of Controlled Trials, the Cochrane Library, CINAHL, Embase, Health Technology Assessment Library, IEEE Xplore, Joanna Briggs Institute, Maternity and Infant Care, MEDLINE, PsycINFO, and the Social Science Citation Index were searched in October 2020. Quantitative or qualitative primary research that included pregnant women and evaluated remotely delivered interventions reporting measures of anxiety, fear, stress, distress, women's views, and opinions were included. RESULTS: Overall, 3 qualitative studies and 14 quantitative studies were included. Populations included a general antenatal population and pregnant women having anxiety and depression, fear of childbirth, insomnia, and preterm labor. Interventions included cognitive behavioral therapy, problem solving, mindfulness, and educational designs. Most interventions were delivered via web-based platforms, and 62% (8/13) included direct contact from trained therapists or coaches. A meta-analysis of the quantitative data found internet-based cognitive behavioral therapy and facilitated interventions showed a beneficial effect in relation to the reduction of anxiety scores (standardized mean difference -0.49, 95% CI -0.75 to -0.22; standardized mean difference -0.48, 95% CI -0.75 to -0.22). Due to limitations in the amount of available data and study quality, the findings should be interpreted with caution. Synthesized findings found some evidence to suggest that interventions are more effective when women maintain regular participation which may be enhanced by providing regular contact with therapists or peer support, appropriate targeting of interventions involving components of relaxation and cognitive-based skills, and providing sufficient sessions to develop new skills without being too time consuming. CONCLUSIONS: There is limited evidence to suggest that women who are pregnant may benefit from remotely delivered interventions. Components of interventions that may improve the effectiveness and acceptability of remotely delivered interventions included providing web-based contact with a therapist, health care professional, or peer community. Women may be more motivated to complete interventions that are perceived as relevant or tailored to their needs. Remote interventions may also provide women with greater anonymity to help them feel more confident in disclosing their symptoms.

Evans, S. K. L., et al. (2021). "A Novel Injection Technique for Extended-Release Local Anesthetic After Posterior Colporrhaphy and Perineorrhaphy: a Randomized Controlled Study." Female Pelvic Medicine & Reconstructive Surgery 27(6): 344‐350.
	OBJECTIVES: To evaluate the effect of vaginal intraoperative infiltration of liposomal bupivacaine on vaginal pain among patients undergoing posterior colporrhaphy and perineorrhaphy. METHODS: This was a randomized, placebo‐controlled trial offered to women undergoing posterior colporrhaphy and perineorrhaphy with concomitant pelvic reconstructive procedures. Liposomal bupivacaine or normal saline placebo (30 mL) was injected into the posterior vaginal compartment and perineal body in 2‐ to 3‐mL increments, using a systematic technique. All participants received 10‐mL 0.25% bupivacaine with epinephrine prior to incision. Perioperative care was standardized. The primary outcome was vaginal pain as measured by a visual analog scale. RESULTS: One hundred twenty‐six women were screened, and 72 were included. Demographic characteristics were similar. Median visual analog scale was not different at any time point (P = 0.81). There were no differences in secondary outcomes, including narcotic use (37.5 vs 37.5 mg morphine equivalents, P = 0.51; placebo vs liposomal bupivacaine), time to first opioid (68 vs 89.5 minutes, P = 0.56), antiemetic doses (3 vs 2, P = 0.07), hospital length of stay (24 vs 21.9 hours, P = 0.98), length of stay in postanesthesia care unit (93 vs 100 minutes, P = 0.32), proportion of patients who had a bowel movement within the first 3 postoperative days (65.7 vs 59.5% P = 0.36), or successful voiding trials (45.7 vs 59.5%, P = 0.24). There were no differences in patient satisfaction or postoperative adverse events. CONCLUSIONS: In this study of pelvic reconstructive surgeries with posterior colporrhaphy and perineorrhaphy, there were no differences in pain scores or any secondary outcomes between liposomal bupivacaine and placebo injected into the posterior vaginal compartment.

Evelyne, R., et al. (2021). "The Effect of Post-Operative Suppressive Treatment on the Fertility Prognosis of Women with Endometriosis: a Systematic Review and Meta-Analysis."
	
Everhoj, C., et al. (2022). "Effects of early maternal cancer and fertility treatment on the risk of adverse birth outcomes." EClinicalMedicine 46: 101369.
	Background: Early maternal cancer and fertility treatment each increase the risk for adverse birth outcomes, but the joint effect of these outcomes has not yet been reported. Thus, the aim was to assess the individual and joint effect of maternal cancer and fertility treatment on the risk for adverse birth outcomes. Method(s): This population-based cohort study included 5487 live-born singletons identified in the Danish Medical Birth Register (1994-2016) of mothers with previous cancer (<40 years) recorded in the Danish Cancer Registry (1955-2014). We randomly selected 80,262 live-born singletons of mothers with no cancer <40 years matched to mothers with cancer by birth year and month. We calculated odds ratios (ORs) for preterm birth, low birth weight (LBW) (<2500 g) and small for gestational age (SGA), mean differences in birth weight in grams, and additional cases of preterm birth (gestational age<259 days) per 100,000 person-years. Multiplicative and additive interaction of maternal cancer and fertility treatment was compared with outcomes of children conceived naturally to mothers with no maternal cancer (reference group). Finding(s): Among 84,332 live-born singletons, increased ORs for preterm birth were observed among children born to mothers with previous cancer (1.48, 95% confidence interval [CI] 1.33-1.65) or after fertility treatment (1.43, 95% 1.28-1-61), with 22 additional cases of preterm birth among both group of children (95% CI 15-29; 95% CI 14-30). In the joint analyses, the OR for SGA for children born after fertility treatment to mothers with previous cancer was similar to that of the reference group (OR 1.02, 95% CI 0.72-1.44, P for interaction=0.52). Children with both exposures had increased ORs for LBW (1.86, 95% CI 1.17-2.96, P for interaction=0.06) and preterm birth (2.31, 955 CI 1.66-3.20, P for interaction = 0.56), with 61 additional cases of preterm birth (95% CI 27-95, P for interaction=0.26) over that of children in the reference group. The mean birth weight was also lower in children born to mothers with both exposures (-140 g, 95% CI -215; -65) (P for interaction=0.06) but decreased to -22 g (95% CI -76; 31) after adjustment for GA. Interpretation(s): Although we did not find any statistically significant additive interaction between maternal cancer and fertility treatment, children born after fertility treatment of mothers with previous cancer were at increased risk for adverse birth outcomes. Thus, pregnant women with both exposures need close follow-up during pregnancy. Funding(s): The Danish Cancer Society and the Danish Childhood Cancer Foundation.Copyright © 2022 The Author(s)

evgeniya, s. and I. Sapiyat (2023). "The value of cell-based therapy in women with thin endometrium and Asherman syndrome: systematic review."
	
Ewerton, F., et al. (2023). "Efficacy and Safety of Eliapixant in Overactive Bladder: The 12-Week, Randomised, Placebo-controlled Phase 2a OVADER Study." European Urology Focus.
	Background: Effective, well-tolerated novel treatments for overactive bladder (OAB) are lacking. The P2X3 receptor antagonist eliapixant demonstrated potential to reduce OAB symptoms in preclinical studies. Objective(s): To evaluate the safety, tolerability, and efficacy of eliapixant in patients with OAB with urgency urinary incontinence (UUI). Design, setting and participants: OVADER was a 12-wk, randomised, placebo-controlled, double-blind, parallel-group, multicentre, phase 2a study (NCT04545580) conducted between 2020 and 2022 in private and institutional clinical practices. Eligible patients were aged >=18 yr with wet OAB symptoms (urgency, urinary frequency, and urinary incontinence) for >=3 mo before screening. Intervention(s): Randomisation (1:1 ratio) to oral eliapixant 125 mg or placebo twice daily. Outcome measurements and statistical analysis: The primary endpoint was the mean change from baseline in the mean number of UUI episodes/24 h over weeks 4, 8, and 12 according to an electronic bladder diary, evaluated using a repeated-measurement model in a Bayesian framework. Results and limitations: Of 202 patients enrolled, 85 were valid for per-protocol analysis. The primary efficacy endpoint was not met. The posterior probability for eliapixant superiority over placebo was 40% (point estimate 0.05, 95% credible interval - to 0.38), which did not meet the predefined criterion of >=90% probability. Secondary and exploratory endpoints were not met. The incidence of adverse events was similar in the eliapixant (n = 32, 63%) and placebo (n = 27, 56%) groups; most were mild and five led to discontinuation of eliapixant. Conclusion(s): OVADER did not meet its clinical efficacy endpoints. Potential reasons include the nonspecific OAB symptom complex, the poorly understood pathophysiology, and the coinciding COVID-19 pandemic. Patient Summary: We tested whether a new drug called eliapixant would reduce symptoms of overactive bladder in comparison to placebo. We found that the drug did not work. More knowledge on how overactive bladder occurs is needed to find new drugs to treat this condition.Copyright © 2023

Eyck, B., et al. (2022). "OUTCOME OF NEOADJUVANT CHEMORADIOTHERAPY PLUS SURGERY FOR ESOPHAGEAL SQUAMOUS CELL CARCINOMA IN EAST ASIA VERSUS WESTERN EUROPE." Diseases of the Esophagus 35(Supplement 2): 106.
	Patients with different ethnic and genetic backgrounds may respond differently to specific anticancer therapies. The present study aimed to assess whether patients with esophageal squamous cell carcinoma (ESCC) who are treated with neoadjuvant chemoradiotherapy (nCRT) according to the CROSS regimen in East Asia have an inferior response compared to patients treated in Western Europe. Patients with ESCC who completed >=80% of nCRT according to CROSS (five weekly cycles of carboplatin [AUC of 2 mg/mL/min] and paclitaxel [50 mg/m2] with concurrent 41.4 Gy radiotherapy in 23 daily fractions of 1.8 Gy) followed by esophagectomy between June 2012 and April 2020 were identified from Asian and Dutch databases. Primary endpoint was pathologically complete response (pCR), defined as ypT0N0. Asian and Dutch patients were compared with nearest-neighbor propensity score matching, adjusting for confounding factors: gender, Charlson comorbidity index, tumor location, cT and cN stage, interval from start of nCRT to surgery, and number of resected lymph nodes. In total, 839 patients were included (Asian: 175, Dutch: 664). After matching, 154 remained in each group. Confounding factors were all significantly different before matching and 26% in the Asian versus 42% in the Dutch cohort had a pCR (p<0.001), which became 27% versus 42% after matching (p=0.008), respectively. Both ypT and ypN stage were significantly higher in the Asian cohort. R0 resection rate was comparable (Asian: 92% vs. Dutch: 95% resp., p=0.29). Asian patients more often had a cervical anastomosis (p=0.001) and less complications including pulmonary complications (21%- 38%, p=0.002), chyle leakage (2%-10%, p=0.006) and anastomotic leakage (10%-21% resp., p=0.02). The present study shows that after adjusting for patient and tumor characteristics, East Asian patients with ESCC have a poorer response to nCRT according to the CROSS regimen than Western European patients. The poorer response did not seem to have a negative effect on surgical outcome. Future studies investigating anticancer therapy for esophageal cancer should take into account ethnic and genetic differences in response to these regimens.

Ezzat, R. S., et al. (2021). "Impact of bariatric surgery on androgen profile and ovarian volume in obese polycystic ovary syndrome patients with infertility." Saudi journal of biological sciences 28(9): 5048-5052.
	Obesity has major adverse effects on reproductive performance and fertility potential especially in women with polycystic ovary syndrome. In this study, we aimed to evaluate the consequences of excess weight reduction by bariatric surgery on androgen levels, and ovarian volume by ultrasonography in obese polycystic ovary patients. This one year Cohort study was carried out in Zagazig university hospitals. The study included 36 infertile women with PCOS and obesity, who underwent bariatric surgery(sleeve gastrectomy or gastric bypass). Patients were evaluated for free and total serum testosterone levels, Sex hormone binding globulin (SHBG), free androgen index (FAI) and also ovarian volume by ultrasound pre-operatively, 6 months and 1 year after surgery. The results showed significant reduction in Body Mass Index, free and total serum testosterone levels and rise in SHBG and regulation of menstrual cycle at 6 and 12 months after operation. Free androgen index and ovarian volume by ultrasound also significantly decreased (p < 0.001) .As a conclusion, Bariatric surgery results in durable loss of weight and restores the normal physiological balance of androgenic milieu and ovarian morphology by ultrasound, in infertile women who have Polycystic ovary syndrome.

f2fgkn, R. B. R. (2023). "Comparison of the application of Current Therapy to the unilateral versus bilateral tibial nerve in women with Urine Leakage." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: This is a randomized, controlled, two‐arm, parallel, blinded clinical trial. Women who meet the inclusion criteria and do not meet the exclusion criteria will be randomized into 2 groups. The randomization sequence will be generated using a computer‐based randomization program in blocks of 10. The randomization group will be placed in opaque envelopes. The investigator responsible for the initial assessment will allocate women to the randomized group following a recruitment order. Women will be blind as to which group they will belong to: Unilateral Tibial Group or Bilateral Tibial Group. Unilateral group (G1) will consist of 50 participants diagnosed with overactive bladder syndrome or mixed urinary incontinence with predominance of urinary urgency, which will indicate the intervention to apply transcutaneous electrical stimulation in the region of the tibial nerve in the left lower limb, but will have the patient apply to both limbs to maintain blinding. The women will be isolated to 1 initial evaluation + 12 sessions of electrostimulation application (frequency twice a week, totaling 12 weeks and duration of 30 minutes each session), using the DualPe X961 TENS device with the following parameters: pulse width of 200µs, 1Hz frequency to find the motor point and increase the intensity as needed, finally, increase the frequency to 10Hz + 1 final assessment and reassessment at 1, 3 and 6 months for follow‐up. Bilateral group (G2): 50 participants diagnosed with overactive bladder syndrome or mixed urinary incontinence with predominance of urinary urgency, awaiting the application of transcutaneous electrical stimulation in the region of the tibial nerve in the left and right lower limbs, which will be attended to 1 evaluation initial + 12 sessions of electrostimulation a CONDITION: C12.050.351 Overactive Urinary Bladder; Urinary Incontinence PRIMARY OUTCOME: Expected outcome 1: improvement in urinary symptoms in both groups, but greater in the bilateral group. Urinary symptoms will be assessed using questionnaires validated for Portuguese (QUID, ICIQ‐SF and OAB), voiding diary carried out before and after the 12 intervention sessions and subjective report of the woman (question with LIKERT scale) INCLUSION CRITERIA: Women aged 18 or over; diagnosed with overactive bladder syndrome or mixed urinary incontinence with predominance of urgency; women who voluntarily accept the informed consent form (ICF); know how to read and write SECONDARY OUTCOME: Impact on sleep quality. We expect improvement in sleep quality in both groups, but higher in the bilateral group. Sleep quality will be assessed with a questionnaire validated for Portuguese (Patient‐Reported Outcomes Measurement Information System (PROMIS) Impact on symptoms of anxiety and depression. We expect improvement in psychological symptoms in both groups, but greater in the bilateral group. Psychological symptoms will be evaluated with a questionnaire validated for Portuguese (DASS‐21) Improvement in quality of life. We expect improvement in both groups, but greater in the bilateral group. Quality of life will be assessed using questionnaires validated for Portuguese (Incontinence Quality of life Questionnaire (I‐QOL) Improvement in sexual função. We expect improvement in both groups, but greater in the bilateral group. Sexual function will be assessed using a questionnairevalidated for Portuguese (FSFI)

Fabbi, M., et al. (2022). "Analysis of A Disintegrin and Metalloprotease 17 (ADAM17) Expression as a Prognostic Marker in Ovarian Cancer Patients Undergoing First-Line Treatment Plus Bevacizumab." Diagnostics (Basel, Switzerland) 12(9).
	To find prognostic factors for advanced ovarian cancer patients undergoing first-line therapy with carboplatin, paclitaxel and bevacizumab, we investigated the expression of a disintegrin and metalloprotease 17 (ADAM17) in cancer tissues. ADAM17 has been involved in ovarian cancer development, progression and cell resistance to cisplatin. Tissue microarrays from 309 ovarian cancer patients enrolled in the MITO16A/MANGO-OV2 clinical trial were analyzed by immunohistochemistry for ADAM17 protein expression. Intensity and extent of staining were combined into a semi-quantitative visual grading system (H score) which was related to clinicopathological characteristics of cases and the clinical outcome of patients by univariate and multivariate Cox regression models. ADAM17 immunostaining was detected in most samples, mainly localized in the tumor cells, with variable intensity across the cohort. Kaplan-Meier survival curves, generated according to the best cut-off value for the ADAM17 H score, showed that high ADAM17 expression was associated with worse prognosis for PFS and OS. However, after the application of a shrinkage procedure to adjust for overfitting hazard ratio estimates, the ADAM17 value as prognostic factor was lost. As subgroup analysis suggested that ADAM17 expression could be prognostically relevant in cases with no residual disease at baseline, further studies in this patient category may be worth planning.

Fabbro, M., et al. (2022). "EE493 Cost-Effectiveness of Pembrolizumab+Lenvatinib for Treatment of Advanced Endometrial Carcinoma in Women Who Have Progressed Following Prior Systematic Therapy and Are Not Candidates for Curative Surgery or Radiation in France." Value in Health 25(12 Supplement): S152-S153.
	Objectives: To evaluate cost-effectiveness of pembrolizumab plus lenvatinib for treatment of advanced endometrial carcinoma in women who have progressed following prior systematic therapy and are not candidate for curative surgery or radiation, from the French healthcare system perspective. Method(s): A three-state partitioned survival model (pre-progression, post-progression and death) was developed to estimate costs, effectiveness, and incremental cost-effectiveness ratio (ICER) of pembrolizumab + lenvatinib versus chemotherapy (doxorubicin or paclitaxel). Clinical and quality of life data were derived from the phase 3 study KEYNOTE-775. Progression-free survival, overall survival and time on treatment were extrapolated over a 10-year time horizon based on parametric functions. EQ-5D-5L data estimated by a regression model were converted to French population-based utilities using the French value set. Only direct medical costs were considered, based on public sources. Costs and health outcomes were discounted at 2.5% per year. ICER was calculated as cost per quality-adjusted life year (QALY) gained and per life year gained (LYG). Deterministic and probabilistic sensitivity analyses and scenarios analyses were conducted to assess robustness of results. Result(s): The model projected that pembrolizumab + lenvatinib is associated with 1.25 LYG and 1.04 additional QALY versus chemotherapy as well as incremental costs of 131,293 (discounted). ICERs were 126 246/QALY and 104 607/LY respectively. Results were mostly sensitive to parametric survival functions chosen to extrapolate overall survival, with an ICER varying from 107 532/QALY (-15%) with Log-normal to 144 565/QALY (+14%) with Weibull. Pembrolizumab plus lenvatinib has more than 80% probability of being cost-effective beyond the willingness-to-pay (WTP) threshold of 160,000/QALY. Conclusion(s): Model-based analysis suggests that pembrolizumab + lenvatinib improves life expectancy and is likely to be cost-effective versus chemotherapy for treatment of advanced endometrial carcinoma in women who have progressed following prior systematic therapy and are not candidate for curative surgery or radiation in France, assuming a WTP under 160,000/QALY.Copyright © 2022

Faber, M. A., et al. (2021). "Transobturator Versus Single-Incision Sling for Predominant Stress Urinary Incontinent (SUI) Women: a Randomized Controlled Trial." Journal of Minimally Invasive Gynecology 28(11): S153.
	Study Objective: To assess whether single‐incision sling (SIS) is non‐inferior to transobturator (TOT) sling regarding efficacy for treating women with confirmed stress‐predominant urinary incontinence (SUI). Design: Prospective, parallel, non‐blinded, multicenter, randomized controlled study. Setting: Two tertiary, academic hospitals. Patients or Participants: Ninety‐nine patients were followed 6 and 12 months after surgery. Interventions: Mid‐urethral TOT sling (Obtryx II® – Halo; n=50) with regional anesthesia or SIS (Solyx®; n=49) with local anesthesia. Intention‐to‐treat analysis was performed. Measurements and Main Results: The primary outcome was improvement in the Patient Global Improvement (PGI‐I) and Kings Health Questionnaire (KHQ) instruments after treatment. Secondary outcomes were subjective improvement (improved/cured), number of reoperations, estimated blood loss (EBL), operative room (OR) time, post‐op complications. Both groups were homogeneous (p=NS) regarding age(p=0.728), race(p=0.112), body mass index(p=0.082), menopausal status(p=0.359), vaginal deliveries(p=0.839), tobacco use(p=0.385) and sexual activity(p=0.605). There was no difference in the PGI after 6(p=0.067) and 12 months(p=0.128) of treatment between the groups. KHQ scores were better improved in the TOT group for the following domains: role limitations(p=0.049), physical limitations(p=0.0105) and severity measures(p=0.0416). The other domains (general health, incontinence impact, personal relationships, emotions, sleep/energy) were not different between the groups. After 12 months, TOT group was only superior to SIS in the general health domain(p=0.0189). However, the TOT group presented higher subjective improvement after 6 months (93.62 vs 75%; p=0.013) than SIS group, with no significant difference after 12 months. Six patients from the SIS group were reoperated versus three from the TOT group(p=0.309). The SIS group presented a smaller EBL (17.95 vs 33.9 ml; p=<0.005) and shorter OR time (16 vs 40.3 min; p<0.005) than the TOT group. Erosion rate was higher in the SIS group(p=0.059). No major complications occurred in both groups. Conclusion: TOT and SIS groups were equally effective after 6 and 12 months after treatment according to the PGI‐I and KHQ instruments. Subjective improvement was higher in the TOT group after 6 months, with no difference after 12 months.

Fabi, A., et al. (2022). "The immersive experience of virtual reality during chemotherapy in patients with early breast and ovarian cancers: The patient's dream study." Frontiers in Oncology 12: 960387.
	Background: A virtual reality experience (VRE) could represent a viable non-pharmacological intervention to reduce and better manage the main factors of psychophysical distress related to the diagnosis and treatment of cancer.; Aim: The "Patient's Dream" study was a two-arm randomized controlled trial conducted at the Regina Elena National Cancer Institute - IRCCS (Rome, Italy) from April 2019 to January 2020 to evaluate VRE impact in patients affected by breast or ovarian cancer. Before starting the first cycle of chemotherapy (CT), patients were randomized to receive the VRE (VRE arm) as "distraction therapy" or to entertain themselves with conventional means (control arm). The primary aims were the assessment of psychological distress, anxiety and quality of life between the two study arms. Secondary endpoints were the perceived time during the first course of CT and the acute and late toxicity.; Results: Fourty-four patients were enrolled, 22 patients were randomly assigned to the VRE arm and 22 to the control arm. Collected data underline the absence of prevalent disturbs of anxiety and depression in both groups. Nevertheless, even if the state anxiety values before and after CT decreased in both groups, this reduction was statistically significant over time only in the VRE arm. The duration of therapy perceived by patients undergoing distraction therapy was significantly shorter when compared to the control group. The use of VRE during the first CT cycle appeared to reduce asthenia outcomes.; Conclusion: Obtained data suggest that the VRE positively influenced the levels of state anxiety among cancer patients and support the continuous research on VRE as a distraction intervention, with the aim to meet the clinical need for effective nonpharmacologic adjunctive therapies.; Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT05234996, identifier NCT05234996.; Competing Interests: Authors FG, AG and GG are funders of Twiceout. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Fabi, Fotia, Giuseppini, Gaeta, Falcicchio, Giuliani, Savarese, Taraborelli, Rossi, Malaguti, Giannarelli, Pugliese and Cognetti.)

Fabiana, C. and P. Veronique (2022). "Impact of endometriosis surgery on Lower Urinary Tract."
	
Fabiani, C., et al. (2022). "Female fertility preservation: Impact of cancer on ovarian function and oocyte quality." International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 156(1): 166-171.
	Objective: To evaluate the influence of cancer on ovarian response and oocyte quality in controlled ovarian hyperstimulation (COH).; Methods: This prospective study conducted at the Physiopathology of Reproduction and Andrology Unit of Sandro Pertini Hospital enrolled 82 cancer patients undergoing controlled ovarian stimulation (COH) cycles for fertility preservation, and age- and date-matched controls undergoing COH for in vitro fertilization for male-factor infertility from June 2016 to November 2019. The interventions performed were COH, oocyte retrieval, and quality evaluation. Main outcome measures were maximal estradiol levels on the day of human chorionic gonadotropin administration, duration of stimulation, total amount of gonadotropins administered, number of oocytes retrieved, and rates of metaphase 2 oocytes and abnormal oocytes. All data were analyzed using the Statistical Package for the Social Sciences (IBM Corp., Armonk, NY, USA) 22.0.; Results: Intergroup comparisons (82 cancer patients and 180 patients in control group) showed a significant difference in ovarian response, especially for a significant higher number of abnormal oocytes in cancer patients (P < 0.0001). Regression analysis to assess the influence of the neoplastic process, regardless of the type, on ovarian response showed an effect on the main outcome measured due to cancer itself.; Conclusion: Cancer influences the ovarian response, particularly the oocyte quality, during COH performed for fertility preservation. (© 2021 International Federation of Gynecology and Obstetrics.)

Fabio, B. and F. Simone (2021). "A systematic review on the clinical use of indocyanine green in Endometriosis Surgery."
	
Fachini, A. M. D., et al. (2021). "Long-term outcomes of concomitant cisplatin plus radiotherapy versus radiotherapy alone in patients with stage IIIB squamous cervical cancer: A randomized controlled trial." Gynecologic Oncology 160(2): 379-383.
	OBJECTIVE: The present analysis determined the disease free survival (DFS) and overall survival (OS) at up to 14 years of follow-up in women who participated in our previous phase 3 randomized controlled clinical trial, in which women with stage IIIB squamous cervical cancer received either cisplatin plus RT or RT alone for treatment. The first study showed that the addition of cisplatin to RT offered a significant benefit in DFS, but not in OS. METHODS: The present analysis examined DFS and OS in 146 women from the original cohort (72 patients in the CRT arm and 74 patients in the RT-only arm) with follow-up of up to 14 years. RESULTS: Longer term follow-up showed that treatment with CRT offers a significant benefit in DFS and OS compared with treatment with RT only. Patients who received RT alone had significantly worse OS (HR, 1.88; 95% CI, 1.09-3.24) and DFS (HR, 1.82; 95% CI, 1.07-3.08) compared with patients who received CRT. The multivariate analyses also showed that the patients with baseline Karnofsky performance status (KPS) <90% showed significantly worse OS (HR, 3.11; 95% CI, 1.78-5.43), as did those with hemoglobin <10 mg/dL (HR, 4.32; 95% CI, 2.23-8.36). Patients with baseline KPS < 90% showed significantly worse DFS (HR, 2.83; 95% CI, 1.60-5.01), as did those with hemoglobin <10 mg/dL (HR, 4.16; 95% CI, 2.17-7.95). CONCLUSIONS: For stage IIIB cervical cancer, treatment with CRT offers a significant benefit in DFS and OS compared with treatment with RT only.

Factor, P. A. and K. Pasamba (2023). "METFORMIN AS AN ADJUNCT TO PROGESTIN THERAPY IN ENDOMETRIAL HYPERPLASIA AND EARLY-STAGE ENDOMETRIAL CANCER: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS." International Journal of Gynecological Cancer 33(Supplement 4): A52.
	Introduction Metformin has been studied for its anti-proliferative effects in endometrial cells, and it is hypothesized to have a synergistic effect with progestin therapy in suppressing endometrial cell proliferation. This systematic review and metaanalysis aimed to determine the efficacy of adjunctive metformin in the clinical regression of endometrial hyperplasia and early-stage endometrial carcinoma. Methods This meta-analysis followed the Cochrane methodology and adhered to the PRISMA 2020 guidelines. Randomized controlled trials (RCTs) were included if they enrolled reproductive-aged women with endometrial hyperplasia (with and without atypia) and endometrial carcinoma who were treated with progestin and metformin. The primary outcome was the complete response rate at 12-16 weeks, and secondary outcomes included relapse rate, clinical pregnancy rate, and live birth rate. Odds ratios (ORs) and 95% confidence intervals (CIs) were used for dichotomous data. Results Six RCTs were included. The addition of metformin to progestin therapy may increase the complete response rate of endometrial hyperplasia without atypia (OR 5.12, 95% CI 1.17 to 22.41; n=102) and live birth rates (OR 2.51, 95% CI 1.34 to 4.69; n=188) compared to progestin therapy alone, but the certainty of the evidence is low. Metformin did not have a significant effect on the clinical response of endometrial hyperplasia with atypia and endometrial carcinoma, relapse rates, and clinical pregnancy rates. Conclusion/Implications Current evidence is uncertain on the potential benefit of metformin with progestin in endometrial hyperplasia and carcinoma. Future high-quality randomized controlled trials with larger sample sizes and longer follow-up periods are needed to support practice recommendations.

Fader, A. N., et al. (2021). "A randomized phase III, two-arm trial of paclitaxel, carboplatin, and maintenance letrozole versus letrozole monotherapy in patients with stage II-IV, primary low-grade serous carcinoma of the ovary or peritoneum." Journal of Clinical Oncology 39(15 SUPPL).
	Background: Low‐grade serous carcinoma of the ovary or peritoneum (LGSOC) is a rare subtype of epithelial carcinoma. Differences in epidemiology, pathogenesis, disease presentation, and clinical outcomes have been characterized between women diagnosed with LGSOC and those with the p53‐driven highgrade serous carcinoma (HGSOC). Ultimately, patients with LGSOC should be treated differently than those with HGSOC. Several studies suggest that LGSOC is relatively chemoresistant and that most tumors robustly express estrogen and progesterone receptors. Recently, retrospective reports suggest that utilization of the aromatase inhibitor, letrozole, as monotherapy or in addition to platinum/taxane‐based chemotherapy in those with primary advanced‐stage LGSOC results in preliminarily promising survival outcomes. Methods: This study is a two‐arm, randomized, open‐label, Phase III clinical trial. The primary objective is to assess whether letrozole monotherapy (2.5 mg po daily) is non‐inferior to carboplatin (AUC 5‐6) and paclitaxel (175 mg/m2 ) followed by letrozole maintenance therapy with respect to progression free survival in women with primary, Stage II‐IV LGSOC who have undergone an attempt at maximal surgical cytoreduction. Secondary endpoints include incidence of adverse events, objective response rate in those with measurable disease after surgery, response duration, overall survival, and adherence to letrozole maintenance therapy. Study subjects must have undergone a bilateral salpingooophorectomy, and p53 IHC testing of tumors is required to rule out those with aberrant p53 expression commonly observed in HGSOC tumors. Study strata include residual disease status and country of enrollment. Four hundred and fifty patients will be enrolled in the United States, Canada and South Korea through the NRG Oncology trials network. Correlative aims include analyzing the association of ER/PR tumoral expression with aromatase inhibitor therapy response and determining ESR1 mutational status in those who develop letrozole resistance. The study includes two interim analyses; at 20% information time, a futility analysis will be conducted, and at 40% information time, both efficacy and futility will be assessed. This is one of the first randomized trials performed in women with primary, advanced LGSOC, and the study is open with 71 patients enrolled at the time of abstract submission.

Fadlalmola, H. A., et al. (2023). "Digital cognitive behavioural therapy (D.CBT) for pregnancy-related depression and sleep disturbances: a systematic review and meta-analysis." Italian Journal of Gynaecology and Obstetrics 35(3): 291-308.
	Objective. Between 5% and 30% of women during the pregnancy and postpartum periods may suffer from depression. The management modalities are ranging from coping and support to medications and electroconvulsive therapy. Our study aimed to assess whether digital cognitive behavioural therapy (D.CBT) can improve pregnancy-related mood and sleep disorders. Materials and Methods. We combed four databases, Web of Science, PubMed, Scopus, and Cochrane Library. Randomized control trials comparing D.CBT with any control group for pregnancy-related depression and sleep disorders were selected for this study. Results. We included 14 studies based on the original data of 12 trials. D.CBT significantly decreased the Patient Health Questionnaire-9 (PHQ-9) after eight weeks compared to the control (MD =-2.77; 95%CI-4.01 to-1.53; p < 0.0001); however, no significant difference after four weeks of intervention or after six weeks of delivery. After eight weeks, D.CBT significantly decreased Inventory of Depression and Anxiety Symptoms (IDAS) (SMD =-0.48; 95%CI-0.78 to-0.18; p = 0.002), while after only four weeks, D.CBT was associated with higher IDAS than the control (SMD = 0.56; 95%CI 0.26 to 0.86; p = 0.0002). Also, D.CBT significantly decreased Generalized Anxiety Disorder Scale (GAD-7) (MD =-1.73; 95%CI-2.63 to-0.83; p = 0.0002), and Insomnia Severity Index (ISI) (MD =-3.45; 95%CI-5.66 to-1.24; p = 0.002) when compared to the control. Conclusions. D.CBT shows some promising outcomes in treating pregnant women's depression and sleep difficulties as decreasing Patient Health Questionnaire-9 (PHQ-9), Depression and Anxiety Symptoms (IDAS), Generalized Anxiety Disorder Scale (GAD-7), and Insomnia Severity Index (ISI), especially after eight weeks of the intervention.Copyright © 2023, EDRA S.p.A. All rights reserved.

Fadoul, R., et al. (2022). "The Modulatory Effect of Adipose-Derived Stem Cells on Endometrial Polyp Fibroblasts." Stem Cells and Development 31(11-12): 311-321.
	Endometrial polyps (EPs) are benign overgrowths of the endometrium, with the potential to cause severe complications, ranging from discomfort to inflammation and infertility. Dysfunction of endometrial fibroblasts may be a critical component leading to the development of polyps. Although surgical intervention is the common remedy for severe cases, it comes with drawbacks, including infection, bleeding, and risk of damage to the cervix and adjacent tissues. Adipose-derived mesenchymal stromal cells (ASCs) are at the focus of modern medicine, as key modulators of tissue homeostasis, inflammation, and tissue repair, rendering them prime candidate agents for tissue regeneration and cell-based therapies. In this study, EPs were isolated from patients admitted to the OB/GYN department at the Galilee Medical Center and extracted fibroblasts (endometrial polyp fibroblasts, EPFs) were isolated and characterized. ASCs were isolated from healthy patients. The effect of EPF- and ASC-conditioned media (CM) on polyp-derived fibroblasts was evaluated, in both 2D and 3D assays, as well as on the expression of matrix-related gene expression. Herein, EPFs exposed to ASC-CM exhibited reduced migration, invasion, contraction of hydrogels, and extracellular matrix deposition, compared with those exposed to EPF-CM. Altogether, this study suggests that ASCs may have a modulating effect on fibroblasts involved in forming EPs and may serve as the basis for conservative treatment strategies aimed at treating severe cases of EPs.© Copyright 2022, Mary Ann Liebert, Inc., publishers 2022.

Fagbemi, F. (2019). "Impact of social support on postnatal depression among adolescent mothers: a systematic literature review." MIDIRS Midwifery Digest 29(1): 20-26.
	BACKGROUND: Postnatal depression (PND) is an important public health issue which affects mother and child. The National Institute of Clinical Excellence (NICE) (2014) suggests that PND is a common problem affecting one in ten women with in a year of giving birth. Studies have discussed the impact of social support on postnatal depression amongst inexperienced mothers such as adolescent women (Kim et al 2014), suggesting that a lack of social support can be a risk factor for postnatal depression in this group of mothers (Brown et al 2012). However, there were no systematic reviews found on this topic. AIM: The aim of this review is to explore the impact of social support on adolescent mothers' postpartum depressive symptoms. Study selection: A database search was carried out across two search engines, EBSCOhost and OVID. The research involved searching for articles that discuss the impact of social support on the psychological health of adolescent mothers. FINDINGS: All the studies identified suggest that social support has an inverse relationship with PND amongst adolescent mothers. CONCLUSION: There is some evidence that receiving social support after birth is important for adolescent mothers, to reduce the risk of postpartum depression.

Fagotti, A., et al. (2021). "Randomized Trial of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy for Advanced Epithelial Ovarian Cancer (SCORPION-NCT01461850)." Obstetrical & gynecological survey 76(2): 90‐91.
	
Fahrni, A. C., et al. (2022). "A new titanium-covered transobturator tape for surgical treatment of stress urinary incontinence." International Urogynecology Journal 33(4): 911-918.
	Introduction and hypothesis: To assess the long-term satisfaction, cure rate and safety of a new titanium-covered transobturator tape compared to polypropylene tape for the treatment of stress urinary incontinence (SUI). Method(s): A prospective study was conducted with 151 patients. Seventy patients underwent transobturator sling surgery with titanium tape from 2011 to 2019, and a historical control group (CG) of 81 patients was treated with a noncoated tape and underwent incontinence surgery from 1999 to 2009. We compared patient-reported outcome measures (PROMs) with the incontinence outcome questionnaire (IOQ). Result(s): The median follow-up was 21/2 years in both groups. Based on responses to the IOQ, a statistically significantly shorter time of recovery (IOQ 15: 21.3 +/- 26.4 [TG], 40.2 +/- 38.5 [CG], p = 0.02), improvement of sex life (IOQ 13: 34.1 +/- 29.4 [TG] vs. 65.3 +/- 35.6 [CG], p = 0.01) and less voiding dysfunction (IOQ 19: 30.9 +/- 28.1 [CG], 9.3 +/- 18.6 [TG], p = 0.01) were observed in the TG. Objectively, no postoperative urinary retention was observed in the TG, but four cases were described in the CG. Ten patients needed a reoperation for SUI in the CG compared to three in the TG (p = 0.03). Conclusion(s): The titanium-covered transobturator sling had superior recovery time, improved sexual function and reduced reoperation rate compared to a historical polypropylene group.Copyright © 2021, The Author(s).

Fahy, M. R. (2024). "A review of functional and surgical outcomes of gynaecological reconstruction in the context of pelvic exenteration." Surgical Oncology 52: 101996.
	Background: Radical surgical excision may be the only curative option for patients with advanced pelvic malignancy, but concerns surrounding the functional outcomes and survivorship of patients undergoing exenterative surgery remain. This is especially important in the context of vulvovaginal resection, where patients are often younger and surgery can have a profoundly negative impact on quality of life, body image and overall wellbeing. Reconstructive procedures are an important means of mitigating these adverse effects but outcomes are poorly described. Aim(s): To define the outcomes associated with gynaecological reconstructive procedures following pelvic exenterative surgery and to compare them with the outcomes of those patients who did not undergo reconstruction. Method(s): An international, multicentre retrospective investigation comparing the outcomes of reconstruction with no reconstruction. The protocol was prospectively registered (NCT05074069). Result(s): 334 patients were included. 77 patients had a neovagina reconstructed, 139 patients underwent flap reconstruction and 118 were not reconstructed. Patients who underwent reconstruction had a longer operative time and hospital stay with an increased risk of minor perineal complications. Reconstruction did not confer an increased risk of surgical reintervention, and overall complication rates were equivalent. Procedure-specific major morbidity was 5.2 % and 11.5 % for neovaginal and flap reconstruction, respectively. 66 % of patients undergoing neovaginal reconstruction experienced no long term morbidity. 7 % developed neovaginal stenosis and 12 % suffered disease recurrence. Conclusion(s): Neovaginal reconstruction is safe in carefully selected patients and offers specific advantages over alternative techniques, with few patients requiring reoperation. Primary closure does not increase perineal morbidity.Copyright © 2023 The Authors

Fairclough, E., et al. (2024). "Does variation of surgical technique affect native tissue anterior pelvic organ prolapse repair outcomes?" International Urogynecology Journal 35(1): 51-58.
	Introduction and hypothesis: The Variation in Surgical Technique study (VaST), demonstrated the large variation in surgical techniques used in native tissue (NT) anterior pelvic organ prolapse (POP) repairs. However, there are few comparative studies of different surgical techniques. This study was aimed at exploring whether surgical technique influenced the outcomes of NT anterior POP repairs. Method(s): The surgical techniques of 22 consultant surgeons performing NT anterior POP repairs were filmed and categorised. These surgeons performed 809 anterior repairs within the PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trial (PROSPECT). Logistical regression models were used to determine the influence of the different surgical techniques on subjective and objective outcomes, using data collected during PROSPECT. Result(s): In adjusted multivariate linear regression models, fascial-flap repair was associated with an improved subjective outcome (POP-SS) compared with midline plication (beta = -2.50 [-4.42 to -0.57]; p = 0.01). At 12 months, separate fascial defect repair was associated with a poorer objective outcome than midline plication (OR 6.06 [1.82-3.52], p = 0.006). At 24 months, deep dissection was associated with a poorer POP-SS than superficial dissection (0.32-2.60, p = 0.0). Continuous-locking closure of the skin was also associated with improved POP-SS compared with continuous non-locking closure (12 months: beta = -1.94 [-3.42 to -0.45], p = 0.01). Conclusion(s): Surgical technique may influence the outcome of native tissue anterior POP repairs. Our results should not change practice but inform future research; to develop methods of explicitly recording surgical techniques and allow confirmation of the effect of these aspects of technique on outcome.Copyright © 2023, The Author(s).

Fait, T., et al. (2023). "Treatment of Vulvovaginal Laxity by Electroporation: The Jett Plasma Medical for Her II Study." Journal of Clinical Medicine 12(19): 6234.
	Introduction: Vaginal laxity is a widespread and undertreated medical condition associated especially with vaginal parity. Aim(s): To evaluate the efficacy and safety of electroporation therapy treatment of vulvovaginal laxity by the Jett Plasma for Her II device. Method(s): The Jett Plasma for Her II Study is a multicentric, prospective, randomized, single-blinded, and controlled study. Women presenting with vaginal laxity were randomized to receive electroporation therapy delivered to the vaginal tissue (active-82 patients) vs. therapy with zero intensity (placebo-9 patients). Result(s): A total of 91 subjects whose average age was 48.69 +/- 10.89 were included. Due to the results of a one-way analysis of variance, it may be concluded that in the case of the vaginal laxity questionnaire (VLQ), there is a statistically significant difference between actively treated patients and the placebo group (F1,574 = 46.91; p < 0.001). In the case of the female sexual function index (FSFI), a one-way ANOVA test also showed a statistically significant difference between the actively treated patients and the placebo group (F1,278 = 7.97; p = 0.005). In the case of the incontinence impact questionnaire-7 (IIQ-7), a one-way ANOVA test showed a statistically significant difference between the actively treated patients and the placebo group (F1,384 = 15.51; p < 0.001). It confirms that improvement of vaginal laxity is conjoined with benefits in symptoms of urinary incontinence. Biopsy performed after the end of the treatment shows an increase in the vaginal mucosa thickness by an average of 100.04% in the active group. The treatment was well tolerated with no adverse events. No topical anesthetics were required. Conclusion(s): Treatments of vulvovaginal laxity by electroporation therapy achieved significant and sustainable 12-month effectiveness. Responses to the questionnaires also suggest subjective improvement in self-reported sexual function, incontinence, sexual satisfaction, and urogenital distress.Copyright © 2023 by the authors.

Faith, J., et al. (2022). "Bacterial vaginosis among pregnant women attending antenatal care in LMICs from 2000 to 2020."
	
Fakhri, M., et al. (2023). "Effects of Herbal Products on Menorrhagia: A Systematic Review and Meta-analysis." Journal of Nursing and Midwifery Sciences 10(3).
	Context: Menorrhagia is an important healthcare challenge. Complementary and alternative medicine therapies are strategies with potential positive effects on menorrhagia. Objectives: The aim of this study was to systematically assess the effects of herbal products on menorrhagia. Methods: This was a systematic review and meta-analysis. PubMed, Scopus, Web of Science, Embase, Cochrane Library, Barekat Gostar, Scientific Information Database (SID), Magiran, and IranDoc international and Iranian databases, in addition to the Google Scholar search engine, were searched without any time or language limitation (updated until 02.07.2022). Eligible studies were combined through the random-effects model based on their sample sizes, mean scores, and standard deviations. Data analysis was performed at a significance level of less than 0.05 using STATA software (version 14.0). Results: Nineteen trials on 1715 women (856 and 859 subjects in the control and intervention groups, respectively) were reviewed. After the intervention, menstrual bleeding severity in the first, second, and third cycles (P < 0.001) and the number of menstrual days in the first (P < 0.001), second (P < 0.001), and third (P = 0.487) menstrual cycles significantly decreased in the herbal products group. There were no significant between-group differences regarding the bleeding severity at the pretest (P < 0.001) and in the third cycle (P < 0.001) and the number of menstrual days at the pretest (P = 0.131) and in the second (P < 0.001) and third cycles (P = 0.014). However, the bleeding severity in the intervention group was significantly less than the control group in the first (P < 0.001) and second cycles (P < 0.001), and the number of menstrual days in the intervention group was significantly less than the control group in the first cycle (P = 0.004). Conclusions: Herbal products are effective in significantly reducing bleeding severity and the number of menstrual days among women with menorrhagia, and their effects reduce over time.

Fakhri, S., et al. (2022). "Modulation of TLR/NF-kappaB/NLRP Signaling by Bioactive Phytocompounds: A Promising Strategy to Augment Cancer Chemotherapy and Immunotherapy." Frontiers in Oncology 12: 834072.
	Background: Tumors often progress to a more aggressive phenotype to resist drugs. Multiple dysregulated pathways are behind this tumor behavior which is known as cancer chemoresistance. Thus, there is an emerging need to discover pivotal signaling pathways involved in the resistance to chemotherapeutic agents and cancer immunotherapy. Reports indicate the critical role of the toll-like receptor (TLR)/nuclear factor-kappaB (NF-kappaB)/Nod-like receptor pyrin domain-containing (NLRP) pathway in cancer initiation, progression, and development. Therefore, targeting TLR/NF-kappaB/NLRP signaling is a promising strategy to augment cancer chemotherapy and immunotherapy and to combat chemoresistance. Considering the potential of phytochemicals in the regulation of multiple dysregulated pathways during cancer initiation, promotion, and progression, such compounds could be suitable candidates against cancer chemoresistance. Objective(s): This is the first comprehensive and systematic review regarding the role of phytochemicals in the mitigation of chemoresistance by regulating the TLR/NF-kappaB/NLRP signaling pathway in chemotherapy and immunotherapy. Method(s): A comprehensive and systematic review was designed based on Web of Science, PubMed, Scopus, and Cochrane electronic databases. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed to include papers on TLR/NF-kappaB/NLRP and chemotherapy/immunotherapy/chemoresistance by phytochemicals. Result(s): Phytochemicals are promising multi-targeting candidates against the TLR/NF-kappaB/NLRP signaling pathway and interconnected mediators. Employing phenolic compounds, alkaloids, terpenoids, and sulfur compounds could be a promising strategy for managing cancer chemoresistance through the modulation of the TLR/NF-kappaB/NLRP signaling pathway. Novel delivery systems of phytochemicals in cancer chemotherapy/immunotherapy are also highlighted. Conclusion(s): Targeting TLR/NF-kappaB/NLRP signaling with bioactive phytocompounds reverses chemoresistance and improves the outcome for chemotherapy and immunotherapy in both preclinical and clinical stages.Copyright © 2022 Fakhri, Moradi, Yarmohammadi, Narimani, Wallace and Bishayee.

Falahati-Pour Soudeh, K., et al. (2023). "Ovarian Endocrine Status and ART 0utcomes in Women within PCOS Based on Different Testosterone Levels." Indian journal of endocrinology and metabolism 27(5): 440-444.
	Background: It is estimated that in women at reproductive age, the risk of polycystic ovary syndrome (PCOS) is about 5-21%. In PCOS cases with ovulation dysfunction, assisted reproductive techniques (ART) are useful for infertility treatment.; Objective: This study aimed to evaluate the ART outcome in infertile PCOS women based on different testosterone levels. Finally, the relationships between testosterone in different levels and reproductive parameters including endocrine status, the response of ovaries, and pregnancy outcomes were assessed.; Methods: In this retrospective study, 352 infertile PCOS women were examined. The women were categorised into five groups according to their testosterone levels: A = T < 0.4, B = 0.4 < T > 0.6, C = 0.6 < T > 0.8, D = 0.8 < T > 1.0 and E = T > 1.0 ng/dL. All study cases were in similar hyper-stimulation protocol and finally, hormonal profile and ART outcomes were compared between testosterone levels. P value ≤ 0.05 was statistically significant.; Results: In testosterone levels >1.0, the levels of anti-mullerian hormone (AMH) and luteinising hormone (LH) were higher than in other testosterone level groups. AMH ( P = 0.05) and LH ( P = 0.001) levels showed significant differences. No correlation was present between testosterone levels and ART outcomes, including stimulation duration, endometrial thickness, oocyte numbers, numbers of matured oocytes, number of obtained embryos, fertilisation rate, implantation rate clinical pregnancy and abortion rate.; Conclusions: Serum testosterone levels did not show any correlation with pregnancy outcomes in ART cycles of PCOS. However, basal testosterone levels are a good predictor for ovarian reserve and ovarian response. Consequently, we suggest that some prospective studies must be designed to approve the role of testosterone in the prediction of the outcome of pregnancy in ART cycles.; Competing Interests: There are no conflicts of interest. (Copyright: © 2023 Indian Journal of Endocrinology and Metabolism.)

Falandry, C., et al. (2021). "Efficacy and Safety of First-line Single-Agent Carboplatin vs Carboplatin Plus Paclitaxel for Vulnerable Older Adult Women With Ovarian Cancer: A GINECO/GCIG Randomized Clinical Trial." JAMA Oncology 7(6): 853-861.
	IMPORTANCE: Single-agent carboplatin is often proposed instead of a conventional carboplatin-paclitaxel doublet in vulnerable older patients with ovarian cancer. Such an approach could have a detrimental effect on outcomes for these patients. OBJECTIVE: To compare the feasibility, efficacy, and safety of single-agent carboplatin every 3 weeks, weekly carboplatin-paclitaxel, or conventional every-3-weeks carboplatin-paclitaxel in vulnerable older patients with ovarian cancer. DESIGN, SETTING, AND PARTICIPANTS: This international, open-label, 3-arm randomized clinical trial screened 447 women 70 years and older with newly diagnosed stage III/IV ovarian cancer by determining their Geriatric Vulnerability Score; 120 patients with a Geriatric Vulnerability Score of 3 or higher were stratified by country and surgical outcome. Enrollment took place at 48 academic centers in France, Italy, Finland, Denmark, Sweden, and Canada from December 11, 2013, to April 26, 2017. Final analysis database lock April 2019. Data analysis was performed from February 1 to December 31, 2019. INTERVENTIONS: Patients were randomized to receive 6 cycles of (1) carboplatin, area under the curve (AUC) 5 mg/mL·min, plus paclitaxel, 175 mg/m2, every 3 weeks; (2) single-agent carboplatin, AUC 5 mg/mL·min or AUC 6 mg/mL·min, every 3 weeks; or (3) weekly carboplatin, AUC 2 mg/mL·min, plus paclitaxel, 60 mg/m2, on days 1, 8, and 15 every 4 weeks. MAIN OUTCOMES AND MEASURES: The primary outcome was treatment feasibility, defined as the ability to complete 6 chemotherapy cycles without disease progression, premature toxic effects-related treatment discontinuation, or death. RESULTS: A total of 120 women were randomized. The mean and median age was 80 (interquartile range, 76-83; range, 70-94) years; 43 (36%) had a Geriatric Vulnerability Score of 4 and 13 (11%) had a Geriatric Vulnerability Score of 5; 40 (33%) had stage IV disease. During its third meeting, the independent data monitoring committee's recommendation led to the termination of the trial because single-agent carboplatin was associated with significantly worse survival. Six cycles were completed in 26 of 40 (65%), 19 of 40 (48%), and 24 of 40 (60%) patients in the every-3-weeks combination, single-agent carboplatin, and weekly combination groups, respectively. Treatment-related adverse events were less common with the standard every-3-weeks combination (17 of 40 [43%]) than single-agent carboplatin or weekly combination therapy (both 23 of 40 [58%]). Treatment-related deaths occurred in 4 patients (2 of 40 [5%] in each combination group). CONCLUSIONS AND RELEVANCE: This randomized clinical trial shows that compared with every-3-weeks or weekly carboplatin-paclitaxel regimens, single-agent carboplatin was less active with significantly worse survival outcomes in vulnerable older patients with ovarian cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02001272.

Falcão, P., et al. (2021). "Parasacral versus tibial transcutaneous electrical stimulation to treat urinary urgency in adult women: randomized controlled clinical trial." European Journal of Obstetrics, Gynecology, and Reproductive Biology 267: 167‐173.
	INTRODUCTION: Urinary urgency is a very strong urge to urinate that is difficult to postpone and control. One of the physiotherapeutic resources that can be used in the treatment of urinary urgency is electrical nerve stimulation. The objective of this study is to investigate the effects of parasacral and tibial nerve transcutaneous electrical stimulation in improving urinary urgency in adult women. MATERIAL AND METHODS: Single‐blinded randomized controlled clinical trial. PARTICIPANTS: Ninety‐nine adult women with urgency. INTERVENTIONS: Transcutaneous electrostimulation for 12, 20‐min sessions, twice a week. The tibial and parasacral groups received a current of F = 10 Hz and 200 μs pulse duration, while the sham group received a current of F = 100 Hz and 100 μs pulse duration, the active electrode placed over the scapula. Primary and secondary outcome measures: The primary outcome measure was urinary urgency, measured by the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ‐OAB) and Overactive Bladder questionnaire‐Validated 8‐Question Awareness Tool (OAB‐V8). Secondary outcomes were quality of life with the King's Health Questionnaire (KHQ) and voiding habits with the 24‐h voiding diary. Assessments occurred pretreatment, after the sixth and 12th post‐treatment sessions and at the 30‐day follow‐up. RESULTS: Both parasacral and tibial groups in the post‐treatment presented fewer episodes of urgency than the sham group. The parasacral group showed better results than the sham group post‐treatment for ICIQ‐OAB scores, and in KHQ domains Impact of Incontinence and task limitations. Parasacral group participants had OAB‐V8 score lower than 8 in the post‐treatment and follow‐up. CONCLUSION: Both tibial and parasacral groups had a positive and similar effect on reducing urinary urgency in adult women. Relative to the quality of life, transcutaneous parasacral electrostimulation was superior to transcutaneous tibial electrostimulation. CLINICAL TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (ReBEC), http://ensaiosclinicos.gov.br, protocol RBR‐9rf33n.

Falchook, G., et al. (2024). "A Relative Bioavailability, Bioequivalence, and Food Effect Study of Niraparib Tablets in Patients with Advanced Solid Tumors." Clinical therapeutics.
	PURPOSE: The poly (ADP-ribose) polymerase inhibitor niraparib is indicated as maintenance treatment in patients with certain subtypes of advanced ovarian cancer, and is being investigated in patients with other solid tumors. Niraparib is available in 100-mg capsules with a starting dosage of 200 or 300 mg/d. This study assessed the relative bioavailability (BA) and bioequivalence (BE) between a 1 x 300-mg tablet relative to 3 x 100-mg niraparib capsules. In addition, the food effect (FE) of a high-fat meal on the pharmacokinetic (PK) properties of tablet-formulated niraparib was investigated. METHOD(S): This was a US-based, 3-stage, open-label, multicenter, single-crossover, randomized-sequence study. Enrolled patients were 18 years and older, with histologically or cytologically confirmed advanced solid tumors (metastatic or local) and disease progression despite standard therapy. Patients were randomly assigned 1:1 to receive niraparib 1 x 300-mg tablet or 3 x 100-mg capsules in the BA and BE stages or 1 x 300-mg tablet in a fasted or fed (high-fat meal) state in the FE stage. Across all study stages, PK parameters were assessed for 7 days after each dose (tablet or capsule) or prandial state (fasted or fed). In the BA stage, patients crossed over to the other treatment after a 7-day washout period, which was extended to 14 days in the BE and FE stages. Tolerability was assessed for patients who received any amount of niraparib. FINDINGS: The BA-, BE-, and FE-evaluable populations comprised 23, 108, and 19 patients, respectively, who completed both treatment periods in each study stage, had sufficient concentration data to accurately estimate PK parameters without niraparib carryover, and did not experience disqualifying events. PK parameters were similar after dosing with tablet or capsule formulations; the 90% CIs of the geometric least square means for Cmax, AUC0-t, and AUC0- were within the 0.80 to 1.25 BE limits. In the FE stage, Cmax, AUC0-t, and AUC0- were 11%, 32%, and 28% higher, respectively, in the fed versus fasted state. The safety population included 29, 168, and 28 patients in the BA, BE, and FE stages, respectively, who received niraparib. No new safety signals were identified. IMPLICATIONS: Niraparib tablets were found to be bioequivalent to capsules. A modest (<=32%) FE was observed with a high-fat meal, but was not considered to be clinically meaningful, given niraparib's PK variability. CLINICALTRIALS: gov identifier: NCT03329001. (Clin Ther. 2024;46:XXX-XXX) © 2024 Elsevier HS Journals, Inc.Copyright © 2024 GSK. Published by Elsevier Inc. All rights reserved.

Falchook Gerald, S., et al. (2023). "A phase Ib study of adavosertib, a selective Wee1 inhibitor, in patients with locally advanced or metastatic solid tumors." Investigational New Drugs 41(3): 493-502.
	Adavosertib selectively inhibits Wee1, which regulates intra-S and G2/M cell-cycle checkpoints. This study investigated dosing schedules for adavosertib monotherapy, determining the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) in patients with advanced solid tumors.Patients received oral adavosertib qd or bid on a 5/9 schedule (5 days on treatment, 9 days off) in 14-day cycles, or qd on one of two 5/2 schedules (weekly, or for 2 of 3 weeks) in 21-day cycles. Safety, efficacy, and pharmacokinetic analyses were performed.Sixty-two patients (female, 64.5%; median age, 61.5 years; most common primary tumors: lung [24.2%], ovary [21.0%]) received treatment (qd schedules, n = 50; bid schedules, n = 12) for 1.8 months (median). Median time to maximum adavosertib concentration was 2.2-4.1 h; mean half-life was 5-12 h. Adverse events (AEs) caused dose reductions, interruptions and discontinuations in 17 (27.4%), 25 (40.3%) and 4 (6.5%) patients, respectively. Most common grade ≥ 3 AEs were anemia, neutropenia (each n = 9, 14.5%) and diarrhea (n = 8, 12.9%). Seven (11.3%) patients experienced 10 treatment-related serious AEs (pneumonia n = 2 [3.2%], dehydration n = 2 [3.2%], anemia n = 1 [1.6%], febrile neutropenia n = 1 [1.6%], and thrombocytopenia n = 1 [1.6%]). Overall objective response rate was 3.4% (2/58); disease control rate was 48.4% (30/62); median progression-free survival was 2.7 months.MTDs were 125 mg (bid 5/9) and 300 mg (qd 5/9 and 5/2 for 2 of 3 weeks); RP2D was 300 mg (qd 5/2 for 2 of 3 weeks). The safety profile was manageable, acceptable, and generally concordant with the known safety profile. (© 2023. The Author(s).)

Falchook, G. S., et al. (2021). "A phase 1a/1b trial of CSF-1R inhibitor LY3022855 in combination with durvalumab or tremelimumab in patients with advanced solid tumors." Investigational New Drugs 39(5): 1284-1297.
	Background LY3022855 is a recombinant, immunoglobulin, human monoclonal antibody targeting the colony-stimulating factor-1 receptor. This phase 1 trial determined the safety, pharmacokinetics, and antitumor activity of LY3022855 in combination with durvalumab or tremelimumab in patients with advanced solid cancers who had received standard anti-cancer treatments. Methods In Part A (dose-escalation), patients received intravenous (IV) LY3022855 25/50/75/100 mg once weekly (QW) combined with durvalumab 750 mg once every two weeks (Q2W) IV or LY3022855 50 or 100 mg QW IV with tremelimumab 75/225/750 mg once every four weeks. In Part B (dose-expansion), patients with non-small cell lung cancer (NSCLC) or ovarian cancer (OC) received recommended phase 2 dose (RP2D) of LY3022855 from Part A and durvalumab 750 mg Q2W. Results Seventy-two patients were enrolled (median age 61 years): Part A = 33, Part B = 39. In Part A, maximum tolerated dose was not reached, and LY3022855 100 mg QW and durvalumab 750 mg Q2W was the RP2D. Four dose-limiting equivalent toxicities occurred in two patients from OC cohort. In Part A, maximum concentration, area under the concentration-time curve, and serum concentration showed dose-dependent increase over two cycles of therapy. Overall rates of complete response, partial response, and disease control were 1.4%, 2.8%, and 33.3%. Treatment-emergent anti-drug antibodies were observed in 21.2% of patients. Conclusions LY3022855 combined with durvalumab or tremelimumab in patients with advanced NSCLC or OC had limited clinical activity, was well tolerated. The RP2D was LY3022855 100 mg QW with durvalumab 750 mg Q2W. ClinicalTrials.gov ID: NCT02718911 (Registration Date: May 3, 2011).

Falcinelli, M., et al. (2023). "Propranolol reduces IFN-γ driven PD-L1 immunosuppression and improves anti-tumour immunity in ovarian cancer." Brain, behavior, and immunity 110: 1-12.
	The immune system plays an important role in controlling epithelial ovarian cancer (EOC). EOC is considered to be a "cold tumour," a tumour that has not triggered a strong response by the immune system. However, tumour infiltrating lymphocytes (TILs) and the expression of programmed cell death ligand (PD-L1) are used as prognostic indicators in EOC. Immunotherapy such as PD-(L)1 inhibitors have shown limited benefit in EOC. Since the immune system is affected by behavioural stress and the beta-adrenergic signalling pathway, this study aimed to explore the impact of propranolol (PRO), a beta-blocker, on anti-tumour immunity in both in vitro and in vivo EOC models. Noradrenaline (NA), an adrenergic agonist, did not directly regulate PD-L1 expression but PD-L1 was significantly upregulated by IFN-γ in EOC cell lines. IFN-γ also increased PD-L1 on extracellular vesicles (EVs) released by ID8 cells. PRO significantly decreased IFN-γ levels in primary immune cells activated ex vivo and showed increased viability of the CD8 + cell population in an EV-immune cell co-incubation. In addition, PRO reverted PD-L1 upregulation and significantly decreased IL-10 levels in an immune-cancer cell co-culture. Chronic behavioural stress increased metastasis in mice while PRO monotherapy and the combo of PRO and PD-(L)1 inhibitor significantly decreased stress-induced metastasis. The combined therapy also reduced tumour weight compared to the cancer control group and induced anti-tumour T-cell responses with significant CD8 expression in tumour tissues. In conclusion, PRO showed a modulation of the cancer immune response by decreasing IFN-γ production and, in turn, IFN-γ-mediated PD-L1 overexpression. The combined therapy of PRO and PD-(L)1 inhibitor decreased metastasis and improved anti-tumour immunity offering a promising new therapy.; Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Falerina, P., et al. (2023). "Cost-effectiveness of postpartum depression screening: A Systematic Review of Economic Evaluation."
	
Fallah, P., et al. (2023). "Improving health equity among ovarian cancer patients enrolled in an Enhanced Recovery After Surgery (ERAS) pathway (2212)." Gynecologic Oncology 176(Supplement 1): S264-S265.
	Objectives: It is unknown whether Enhanced Recovery After Surgery (ERAS) protocols may improve health equity among ovarian cancer patients through standardizing preoperative counseling and establishing standards of care. Method(s): A cohort study was performed among stage III and IV ovarian cancer patients undergoing surgery at one academic institution from January 2010 to December 2021. The ERAS program was implemented in March 2017. The pre-ERAS period was defined as January 2010 to July 2015, and the post-ERAS period was defined as March 2017 to December 2021, excluding the transitional period between 2015 and 2017 when ERAS was starting to be implemented. A chart review was performed on surgical complications (within 30 days of surgery), including reoperations, readmissions, ICU admissions, blood transfusions during the primary stay, pneumonia, wound infections, etc. (Table 1). chi2 and Fisher's exact analyses were performed to compare outcomes by race during the pre-ERAS and post-ERAS periods. Result(s): Among 794 ovarian cancer patients (42.9% pre-ERAS, 57.1% post-ERAS), 86 patients (10.8%) were non-White overall, and the percentage of non-White patients increased over time (7.9% pre-ERAS, 13.0% post-ERAS). Before ERAS was implemented, 22.2% of non-White women versus 9.6% of White women were readmitted within 30 days of surgery (P = 0.040, Table 1). Non-White women also experienced a higher rate of receiving blood transfusions compared to non-White women (48.1% vs 29.6%, P = 0.046), with no other significant differences in complications noted during the pre-ERAS period. In the post-ERAS period, readmissions were reduced by half among non-White women, which were no longer noted to be significantly different by race (11.9% vs 9.9%, P = 0.641). Similarly, there was no significant difference in blood transfusions by race in the post-ERAS period. However, the rate of ICU admissions was significantly higher among non-White women post-ERAS (8.5% vs 2.0%, P = 0.018), which was similar to pre-ERAS data, although not statistically significant during that period (7.4% vs 3.2%, P = 0.244). There were no other significant differences in complications in the post-ERAS period. Conclusion(s): ERAS programs may improve health equity by reducing the need for blood transfusions and reducing readmissions by half among non-white women with ovarian cancer. The reduction in readmissions merits further investigation with a larger cohort, as this has potentially far-reaching implications in reducing healthcare expenditures. Future studies should also focus on specific aspects of ERAS programs that may reduce the chances of readmission among minority women with ovarian cancer. [Formula presented]Copyright © 2023

Fallon, V., et al. (2021). "Psychosocial experiences of postnatal women during the COVID-19 pandemic. A UK-wide study of prevalence rates and risk factors for clinically relevant depression and anxiety." Journal of Psychiatric Research 136: 157-166.
	BACKGROUND: When the vulnerabilities of the postnatal period are combined with the impact of the COVID-19 pandemic, psychosocial outcomes are likely to be affected. Specifically, we aim to: a) explore the psychosocial experiences of women in the early postnatal period; b) describe prevalence rates of clinically relevant maternal anxiety and depression; and c) explore whether psychosocial change occurring as a result of COVID-19 is predictive of clinically relevant maternal anxiety and depression. METHODS: A sample of UK mothers (N = 614) with infants aged between birth and twelve weeks were recruited via convenience sampling. A cross-sectional survey design was utilised which comprised demographics, COVID-19 specific questions, and a battery of validated psychosocial measures, including the EPDS and STAI-S which were used to collect prevalence rates of clinically relevant depression and anxiety respectively. Data collection coincided with the UK government's initial mandated "lockdown" restrictions and the introduction of social distancing measures in 2020. FINDINGS: Descriptive findings from the overall sample indicate that a high percentage of mothers self-reported psychological and social changes as a result of the introduction of social distancing measures. For women who reported the presence of psychosocial change, these changes were perceived negatively. Whilst seventy women (11.4%) reported a current clinical diagnosis of depression, two hundred and sixty-four women (43%) reported a score of ≥13 on the EPDS, indicating clinically relevant depression. Whilst one hundred and thirteen women (18.4%) reported a current clinical diagnosis of anxiety, three hundred and seventy-three women (61%) reported a score of ≥40 on STAI-S, indicating clinically relevant anxiety. After accounting for current clinical diagnoses of depression or anxiety, and demographic factors known to influence mental health, only perceived psychological change occurring as a result of the introduction of social distancing measures predicted unique variance in the risk of clinically relevant maternal depression (30%) and anxiety (33%). INTERPRETATION: To our knowledge, this is the first national study to examine the psychosocial experiences of postnatal women during the COVID-19 pandemic in the UK. Prevalence rates of clinically relevant maternal depression and anxiety were extremely high when compared to both self-reported current diagnoses of depression and anxiety, and pre-pandemic prevalence studies. Perceived psychological changes occurring as a result of the introduction of social distancing measures predicted unique variance in the risk for clinically relevant maternal depression and anxiety. This study provides vital information for clinicians, funders, policy makers, and researchers to inform the immediate next steps in perinatal care, policy, and research during COVID-19 and future health crises.

Fameli, A. L., et al. (2022). "Assessment of childbirth-related post traumatic stress disorder in Australian mothers: Psychometric properties of the City Birth Trauma Scale." Journal of Affective Disorders.
	BACKGROUND: The City Birth Trauma Scale (BiTS; Ayers, Wright & Thornton, 2018) is self-report measure of Post-Traumatic Stress Disorder (PTSD) symptoms following childbirth, based on DSM-5 criteria. We report on the first study of the psychometric properties of the BiTS in the Australian population. METHOD(S): Participants were mothers of infants aged 0-12months (N=705), who completed the BiTS and measures of related constructs. Confirmatory factor analysis was performed to assess the factor structure of the BiTS. Examination of the reliability, convergent, divergent and discriminant validity and acceptability of the BiTS was also examined. RESULT(S): Confirmatory factor analysis supported a bi-factor model of Birth-related Symptoms (BRS) and General Symptoms (GS) of post-partum PTSD as well as a global CB-PTSD factor. Internal consistency was found for the BiTS total scale and two proposed subscales (BRS and GS). BiTS total scores were significantly associated with an established measure of PTSD, providing support for convergent validity. Evidence of discriminant validity was examined by comparing the BiTS to an established measure of postpartum depression. LIMITATIONS: The present sample may over-represent participants with traumatic birth experiences in comparison to the general public. Furthermore, use of self-report measures limits the capacity to confirm the diagnostic status of participants. CONCLUSION(S): These findings suggest that the BiTS is a valid and reliable measure of childbirth-related PTSD, suited for use in postpartum populations. Total scores on the measure may be informative for clinical and research purposes, while evidence suggests strong support for interpretation of subscale scores.Copyright © 2022. Published by Elsevier B.V.

Fan, C., et al. (2022). "Vascular endothelial growth factor (VEGF) targeting therapy for persistent, recurrent, or metastatic endometrial cancer."
	
Fan Chi, W., et al. (2022). "Systematic Review of Black Cohosh ( Cimicifuga racemosa ) for Management of Polycystic Ovary Syndrome-Related Infertility." Journal of pharmacy practice 35(6): 991-999.
	Polycystic ovary syndrome (PCOS) is a common cause of female infertility. To conduct a systematic review assessing the efficacy and safety of black cohosh for ovulation-induction through hormone regulation and increased endometrial thickness to improve pregnancy rates in women with PCOS-related infertility. Preferred Reporting Items for Systematic Reviews and Meta-Analyses was used. A search of Medline, Embase, International Pharmaceutical Abstracts, Science Direct, and Cumulative Index of Nursing and Allied Health Literature spanning origin to December 19, 2020 was conducted using keywords and permutations of "black cohosh" and "PCOS." A search for "PCOS" in the National Clinical Trials database and International Clinical Trials Registry Platform was conducted in December 2020 to identify additional records. Eligibility criteria included reported efficacy or safety outcomes; studies in women with PCOS; English language; and primary literature. Eligible records were evaluated using applicable risk-of-bias tools. A total of 181 records were screened after deduplication from 207 results. Two randomized controlled trials (RCT) met inclusion criteria. Review of 1386 records from clinical trial registries and subsequent scoping searches resulted in identification of 4 additional records (3 published). Improvement in hormone regulation and endometrial thickness were found for black cohosh groups compared to clomiphene citrate (CC). Three RCTs reported improved pregnancy rates using black cohosh plus CC. There were no differences in adverse events. Studies demonstrated several risk-of-bias concerns. There is a lack of high-quality evidence supporting the effectiveness of black cohosh for improving pregnancy rates in PCOS-related infertility. Short-term use of black cohosh appears to be safe.

Fan, H., et al. (2021). "Differences in the individual curative effect of acupuncture for obese women with polycystic ovary syndrome based on metagenomic analysis: study protocol for a randomized controlled trial." Trials 22(1): 454.
	Background: Polycystic ovary syndrome is a common cause of infertility and shows a high incidence in women of reproductive age. Acupuncture is an appropriate adjunctive treatment for PCOS. However, the add-on effect of acupuncture as an adjunctive treatment for obese women with PCOS has not been studied, and previous studies indicate that there are individual differences in the curative effect of acupuncture, while deeper research on the mechanism of differences in the individual curative effect of acupuncture for obese women with PCOS is still lacking. This trial aims to assess the add-on treatment efficacy of acupuncture for obese women with PCOS and to explore the role of the gut microbiome on the differences in the individual curative effect of acupuncture based on metagenomic analysis.; Methods/design: This is an open-label, randomized, controlled trial. A total of 86 obese women with PCOS will be recruited. Subjects will be randomly assigned to a study group and a control group in a 1:1 ratio, with 43 subjects in each group (10 patients from each group who meet the study criteria will participate in the metagenomic analysis). An additional 10 subjects who meet the study criteria will be recruited to a healthy control group. The study group will receive acupuncture and clomiphene citrate treatment; the control group will only receive clomiphene citrate. Acupuncture treatment will be conducted three times a week from the fifth day of menstruation or withdrawal bleeding until the start of the next menstruation, for up to three menstrual cycles. The primary outcome will be LH/FSH. The secondary outcomes will comprise biometric features, hormone biomarkers, metabolic biomarkers, inflammatory biomarkers, Self-Rating Anxiety Scale, Self-Rating Depression Scale, and metagenomic analysis. The outcomes will be measured at baseline and post-intervention. Data will be analyzed using SPSS 19.0, and the gut microbiome will be analyzed using metagenomic analysis.; Discussion: In this study, we are evaluating the add-on effects of acupuncture and exploring the mechanism of the differences in the individual curative effect of acupuncture based on the gut microbiome, which may provide evidence to explain the different outcomes of different trials on acupuncture for PCOS and hopefully to provide a new aspect to study the mechanism of acupuncture's treatment effect.; Trial Registration: Chinese Clinical Trial Registry ChiCTR2000029882 . Registered on 16 February 2020. (© 2021. The Author(s).)

Fan, J., et al. (2021). "Anesthesia effect of ketorolac tromethamine combined with dezocine for painless induced abortion and its effect on stress response and postoperative uterine contraction pain." 中国计划生育学杂志 29(5): 889‐894.
	Objective: To investigate the anesthesia effect of ketorolac tromethamine combined with dezocine in painless induced abortion and its effect on women's stress response and postoperative uterine contraction pain. Methods: A total of 240 women who chose to undergo voluntary painless induced abortion in our hospital from October 2019 to March 2020 were selected and divided into dezocine group (group A) and ketorolac group (group B) by random number table. , Dezocine combined with ketorolac group (group C) and control group with 60 cases each. Group A was given intravenous injection of 0.1 mg/kg dezocine 15 minutes before operation, group B was given intravenous injection of 30 mg ketorolac tromethamine 30 minutes before operation, and group C was given a combination of 0.1 mg/kg dezocine and 30 mg ketorolac tromethamine. alcohol, and the control group was injected with 1 μg/kg fentanyl. The anesthesia effect and related clinical indexes including operation time, propofol dosage, orientation recovery time, postoperative recovery time, and blood oxygen saturation (SpO2) value after anesthesia were compared in each group. Hemodynamic indexes at different time points during operation included Mean arterial pressure (MAP), heart rate (HR) and stress hormone levels, uterine pain scores and adverse reactions at different time points after waking up. Results: The excellent and good rate of anesthesia effect in group C (91.7%) was higher than that in the other three groups (P<0.05). The dosage of propofol (134.3±16.4 mg) in group C was less than that in the other three groups, and the recovery time (4.4±1.2min) and orientation recovery time (4.3±1.1min) were shorter than those in the other three groups. SpO2 (98.6±1.1min) after anesthesia 2.3%) higher than the other 3 groups (P<0.05). HR, MAP and levels of stress hormones at 5 min after surgery (T1) and 5 min after surgery (T2) in each group were higher than those before surgery (T0), and group C < group A < group B < control group, and 1 min after waking up, The 10‐min pain visual analogue scale score in group C (3.2±0.7 points, 2.5±0.6 points) was lower than that in the other three groups, and the incidence of adverse reactions in group C (11.7%) was lower than that in the other three groups (all P<0.05). Conclusion: The prophylactic application of dezocine and ketorolac tromethamine before analgesic abortion to assist anesthesia is effective, can effectively reduce the dosage of propofol, reduce the body's hemodynamic fluctuation and stress response, and improve the operation efficiency. Post‐analgesia effect and resuscitation quality, and safety is also higher.

Fan, L., et al. (2022). "Biomarker testing to guide first-line PARP inhibitor maintenance for patients with advanced ovarian cancer after response to first- line platinum chemotherapy: A cost-effectiveness study (382)." Gynecologic Oncology 166(Supplement 1): S195.
	Objectives: Multiple poly-ADP ribose polymerase inhibitor (PARPi) maintenance treatment (mTx) options are available for patients with advanced ovarian cancer after response to first-line platinum chemotherapy (PSaOC). Olaparib (O) is an option as monotherapy for patients with BRCA1/2 mutations or in combination with bevacizumab (O+B) for Homologous Recombination Deficiency (HRD+) patients. Meanwhile, niraparib (N) is approved irrespective of biomarker status. This study aimed to evaluate the cost-effectiveness of biomarker testing and treatment with PARP inhibitor mTx in PSaOC patients from the perspective of a US payer. Method(s): Ten testing and treatment strategies (Table 1) were evaluated, representing common biomarker testing (none, BRCA or HRD) and mTx (O, O+B, N, B) in approved populations. PAOLA-1 trial data were used to build a lifetime horizon partitioned survival model with four health states, including progression-free (PFS), post 1st progression (PP1), post 2nd progression (PP2), and death. PFS was modeled through parametric mixture survival modeling to a landmark survival point at five years. Patients who remain PFS at year five are assumed to be long-term survivors. Time to PP2 and OS was modeled by fitting standard parametric models, and time on treatment data was informed by respective trials (up to 24m for O, 15m for B, treat to progression for N). The hazard ratio (HR) of PFS for O+B versus N (0.57 for HRD+/ITT; 0.46 for BRCA+) and O+B versus O (0.71 for BRCA+) were obtained from matching adjusted indirect comparison (MAIC) between PAOLA1 and PRIMA, and PAOLA1 and SOLO1. The HRs for OS are informed by PFS benefits and published OS data. The incremental cost-effectiveness ratios (ICERs) were calculated. Result(s): Strategy 2 (S2, no testing, B) had the lowest cost while S10 (HRD testing, O+B for HRD+ and B for HRD-) had the greatest life- years (LYs) and quality-adjusted life-years (QALYs). All of the niraparib strategies were dominated (i.e., had higher cost, lower LY/ QALYs), compared to at least one other strategy (Table 1). When compared to S2, S8 had lower ICERs than S4 ($41,204 per LY and $48,211 per QALY for S8 vs S2). S10 had an ICER of $66,588 per LY and $82,321 per QALY compared to S8. Conclusion(s): HRD testing followed by O+B for BRCA-/HRD+, O for BRCA+ and B for HRD- (S8) is highly cost-effective, dominating six strategies (all except 2, 4 &10) and having ICERs < $50,000/QALY compared to the least costly strategy (S2). Replacing O with O+B in BRCA+ patients (S10) improves outcomes, with ICER < 100,000/QALY compared to S8. All strategies involving niraparib were dominated by other approaches. An HRD biomarker-guided approach followed with O+/-B treatment in HRD+ patients provides the greatest LY and QALYs with good economic value.Copyright © 2022 Elsevier Inc.

Fan, L., et al. (2021). "Olaparib in combination with bevacizumab compared to bevacizumab monotherapy for the first-line maintenance treatment of advanced ovarian cancer: a cost-effectiveness analysis." Gynecologic Oncology 162(Supplement 1): S216-S217.
	Objectives: The addition of maintenance olaparib to bevacizumab (OLAP+BEV) demonstrated significant progression-free survival (PFS) benefit vs BEV alone in the randomized trial PAOLA-1 in advanced ovarian cancer patients with homologous recombination deficiency (HRD)-positive tumors. We aim to quantify the health and economic impact by evaluating the US cost-effectiveness of OLAP+BEV relative to BEV as a maintenance treatment for women with advanced ovarian cancer who had partial or complete response to first-line platinum-based chemotherapy and whose cancer is associated with HRD-positive status Methods: Our economic model was a cohort-level four state partitioned survival model with a lifetime horizon. States were progression-free, post first progression, post second progression, and death, modelled using first PFS (PFS1), second PFS (PFS2) and overall survival (OS) outcomes from the PAOLA-1 trial. This approach captured multiple progressions, and the differing health state utility after each progression. PFS1 was modelled through parametric mixture survival modeling to a landmark survival point at 5 years, beyond which, patients who have not progressed are assumed to experience all-cause mortality as the general population. PFS2 and OS were modelled by fitting standard parametric models, and time on treatment data was used directly from PAOLA-1, with a treatment cap of 24 months for OLAP and 15 months for BEV. The cost of HRD testing was calculated as unit cost divided by prevalence and was included as a one-time cost for OLAP+BEV arm. US-based health state utility values were analyzed by applying the methods developed by Pickard. The analyses were conducted from a US healthcare payer perspective, with an annual discount rate of 3%. We also explored the robustness of results using deterministic (DSA) and probabilistic sensitivity analysis. Result(s): At year 5, 45.1% and 16.9% patients remained PFS from OLAP+BEV and BEV arm, respectively. The results showed that compared with bevacizumab alone, OLAP+BEV led to a gain in quality-adjusted life years (2.89 QALYs gain) and life years (3.43 Lys gain) but resulted in higher costs, leading to a deterministic incremental cost-effectiveness ratio (ICER) of $75,276 per QALY. OLAP+BEV had an 87.5% probability of being cost-effective at a willingness-to-pay threshold of $100,000 per QALY. DSA identified efficacy (PFS and OS parameters), subsequent treatment and utility values as key model drivers. [Formula presented] Conclusion(s): OLAP+BEV is associated with LY and QALY gain, and is cost effective for US payers relative to BEV monotherapy for the treatment of women with advanced, HRD-positive ovarian cancerCopyright © 2021 Elsevier Inc.

Fan, L., et al. (2021). "Effectiveness of non-pharmacological interventions for postpartum depression:an umbrella review protocol."
	
Fan, L., et al. (2020). "Traditional uses, botany, phytochemistry, pharmacology, separation and analysis technologies of Euonymus alatus (Thunb.) Siebold: A comprehensive review." Journal of Ethnopharmacology 259: 112942.
	Ethnopharmacological relevance: Euonymus alatus (Thunb.) Siebold (E. alatus), a well-known medicinal plant, has been widely used thousands of years in China for the treatment of various diseases such as urticaria, dysmenorrhea, wound, dysentery, blood stasis, rheumatism and arthritis. Due to the extensive application of E. alatus in the fields of ethnopharmacological usage, the pharmaceutical researches of E. alatus keeps deepening. Aim of the study: This paper reviewed and summarized the integrated research progress of this medicinal plant. A comprehensive summary and comparison of traditional usages, botany, phytochemistry, pharmacology, toxicology, separation and analysis technologies of the E. alatus highlight recent scientific advances, which provides new insights into the research and development of this medicinal plant and would be helpful to promote the research situation of underlying pharmacological mechanisms and further utilizations of E. alatus. Material(s) and Method(s): Literature survey was carried out via classic books of herbal medicine, PhD. and MSc. Dissertations. Online scientific databases including Pubmed, SciFinder, Science Direct, Scopus, the Web of Science, Google Scholar, China National Knowledge Infrastructure (CNKI) and others were searched up to February 2020 to identify eligible studies. All literatures of the research subject are analyzed and summarized in this review. Result(s): The E. alatus has been widely used in traditional practice in China, Korea and other Asian Countries. In the study of phytochemistry, more than 230 chemical constituents have been isolated and identified from E. alatus, including sesquiterpenoids, diterpenoids, triterpenoids, flavonoids, phenylpropanoids, lignans, steroids, alkaloids and other compounds. Among them, literature reports show that flavonoids and steroids are the most important bioactive substances found in this plant. A number of researches also have shown that extracts and compounds from E. alatus exert a wide spectrum of pharmacological effects, including antidiabetic effect, anti-tumor effects, anti-inflammatory effects, hepatoprotective effects, antioxidant effects, antibacterial effects, as well as other effects. However, most of the studies without clinical research. Research into plant's toxicological effects has also been limited. In addition, this review also summarizes and compares the separation and analysis technologies of E. alatus. Conclusion(s): E. alatus has potential for the treatment of many diseases, especially tumors and diabetes. But many traditional uses of E. alatus have not been validated by current investigations. Additionally, modern studies haven't gone far enough into its pharmacological effects and the corresponding chemical constituents, more efforts should be made to illuminate the underlying mechanisms of E. alatus for treatment of tumors and diabetes. Moreover, the toxicological effects of this plant can be further studied. Currently, there are limited studies on its side effects and toxicological effects, which should provide further guidance for the safety of clinical use.Copyright © 2020 Elsevier B.V.

Fan, L., et al. (2022). "Cost comparison of adverse event management among breast and ovarian cancer patients treated with poly (ADP-ribose) polymerase inhibitors: analysis based on phase 3 clinical trials." Journal of market access & health policy 10(1): 2078474.
	Background: The economic impact of adverse events (AEs) for poly (ADP-ribose) polymerase inhibitors (PARPis) in ovarian or breast cancer has not been widely evaluated.; Objective: Compare PARPi-related AE management costs from a US payer perspective.; Methods: The frequency of treatment-related grade 3-4 AEs was obtained from published clinical trials of PARPis for the treatment of advanced ovarian cancer (AOC), platinum-sensitive recurrent ovarian cancer (PSROC), and metastatic breast cancer (MBC). AE management costs per patient (2020 USD) per treatment course were calculated by multiplying the AE unit costs by the frequency of AEs for each arm of each trial. Sensitivity analyses were conducted according to the lower and upper limits of the 95% confidence interval for AE rates and unit costs, respectively. Scenarios were also performed to explore the uncertainty of outcomes.; Results: Total AE management costs in AOC were: $3,904, olaparib; $5,595, olaparib plus bevacizumab; and $12,215, niraparib. In PSROC, total costs were: $3,894, olaparib; $6,001, rucaparib; and $11,492, niraparib, and in MBC: $3,574, olaparib; and $9,489, talazoparib. Hematological toxicities were the key drivers of AE management costs for PARPis.; Conclusions: The main AEs among PARPis were hematological. Olaparib was associated with lower AE costs compared to other PARPis.; Competing Interests: LF, DM, MM and JRE are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. YZ and PM are employed by Wickenstones Ltd, a company that received consultancy fees from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. AM and PG are employees of AstraZeneca PLC. (© 2022 PM and I are employed by Wickenstones Ltd, who was contracted by Merck Sharp & Dohme LLC to perform the research reported in this paper. Authors LF, DM, MM and JRE are employees of Merck Sharp & Dohme LLC while AM and PG are employees of AstraZeneca PLC ,. Published by Informa UK Limited, trading as Taylor & Francis Group.)

Fan, L. X., et al. (2022). "Cx32 promotes autophagy and produces resistance to SN-induced apoptosis via activation of AMPK signalling in cervical cancer." International journal of oncology 60(1): 5300.
	The roles of gap junctions (GJs) and its components, connexins, in the autophagy of cervical cancer cells have been rarely investigated. Our previous study demonstrated that connexin 32 (Cx32) exerted an anti-apoptotic effect on cervical cancer. However, as an important regulator of apoptosis, whether the autophagy is involved in the function of Cx32 on cervical cancer cells is not well defined. The present study aimed to investigate the role of Cx32 on autophagy and apoptosis inhibition in cervical cancer cells. The expression levels of Cx32 and the autophagy-associated protein LC3-II in paracancerous cervical tissues (n=30) and cervical cancer (n=50) tissues were determined via western blotting. In total, 45 cervical cancer specimens were used to evaluate the clinical relevance of Cx32 and LC3-II. It was found that both Cx32 and LC3-II were upregulated in cervical cancer tissues compared with those in paracancerous cervical tissues. The effect of Cx32 on autophagy was examined by detecting the change of LC3-II using western blotting, transfection with enhanced green fluorescent protein-LC3 plasmid and transmission electron microscopy analysis. Overexpression of Cx32 significantly enhanced autophagy in HeLa-Cx32 cells, whereas knockdown of Cx32 suppressed autophagy in C-33A cells. The flow cytometry results demonstrated that Cx32 inhibited the apoptosis of cervical cancer cells by promoting autophagy. Moreover, Cx32 triggered autophagy via the activation of the AMP-activated protein kinase (AMPK) signalling, regardless of the presence or absence of GJs. Collectively, it was identified that Cx32 exerted its anti-apoptotic effect by activating autophagy via the AMPK pathway in cervical cancer, which demonstrates a novel mechanism for Cx32 in human cervical cancer progression.Copyright © 2022 Spandidos Publications. All rights reserved.

Fan, P., et al. (2023). "Parent-Performed Infant Massage for Improving Parental Mental State Within 18 Months Postpartum: A Systematic Review." Journal of psychosocial nursing and mental health services 61(4): 52-59.
	The aim of the current review was to assess whether parent-performed infant massage (PPIM) could effectively improve the mental state of parents during the postpartum period. Several international electronic databases were thoroughly searched for relevant articles. Included studies observed the influence of PPIM on the mental state of parents of healthy full-term infants within 18 months postpartum or medically stable preterm infants during hospitalization after birth. Nine studies were included, which observed one or more aspects of parental mental state, including depression, anxiety, parental stress, or general mood state. Characteristics of participants, massage protocols, and outcome measures were heterogenous; hence, results regarding the influence of PPIM on parental mental state were inconsistent. Upon further investigation, 10-minute, home-based PPIM for at least 4 weeks is advisable for maternal depression within 5 months postpartum. Moreover, PPIM in a neonatal intensive care unit is advisable for improving the general mood of mothers of preterm infants. Additional methodologically rigorous studies are needed to provide stronger evidence. [Journal of Psychosocial Nursing and Mental Health Services, 61(4), 52-59.].

Fan, Y., et al. (2022). "Metformin anticancer: Reverses tumor hypoxia induced by bevacizumab and reduces the expression of cancer stem cell markers CD44/CD117 in human ovarian cancer SKOV3 cells." Frontiers in Pharmacology 13: 955984.
	Background: The occurrence and development of solid tumors depend on the blood supply in the tumor microenvironment (TME). Blocking angiogenesis is a new therapeutic strategy to inhibit tumor growth. The anti-angiogenic drug bevacizumab has been approved for gynecological malignancies, especially for advanced recurring cervical cancers and recurring ovarian cancers (OC). Studies in OC have shown a limited effect of bevacizumab in the general population, with a slight improvement in progression-free survival (PFS) and no effect on overall survival (OS). This might be related to the bevacizumab's role in aggravating the hypoxia in the TME, which helps maintain the stemness of ovarian cancer stem cells (CSCs) and promotes the invasion and metastasis of cancer cells. Drugs that target CSCs, such as metformin, may enhance the efficacy of anti-vascular therapies. Therefore, this study aimed to evaluate the effect of metformin combined with bevacizumab on the proliferation of OC cells both in vitro and in vivo , as well as on tumor hypoxia and tumor stem cell markers of human ovarian cancer SKOV3 cells. Methods: The OC cell model SKOV3 was treated with metformin, bevacizumab, and cisplatin alone or in combinations. Cell Counting Kit-8 (CCK-8) was used to measure the rate of cell proliferation. Metformin and bevacizumab were studied in vivo in nude mice. SKOV3 cells were transplanted subcutaneously in nude mice, and different drug interventions were performed after tumor formation, including blank control, bevacizumab alone, metformin alone, cisplatin alone, bevacizumab + metformin, bevacizumab + cisplatin, metformin + cisplatin, and bevacizumab + metformin + cisplatin treatments. The growth of transplanted tumors was routinely monitored and visualized by the tumor growth curve. We used flow cytometry to examine the proportion of CD44 + /CD117 + CSCs in each group. The immunohistochemistry (IHC) method was applied to detect expressions of vascular endothelial growth factor (VEGF), hypoxia-inducible factor 1α (HIF-1α), and microvascular density-associated factor CD34 in tumor cells. The limit dilution method was used to re-inject tumor cells in nude mice to examine the tumor recurrence rate. Results: Combination therapy of metformin and bevacizumab significantly reduced the proliferation rate of SKOV3 cells and the growth rate of transplanted tumors in nude mice compared with the monotherapy effects. In vivo results showed that metformin significantly reduced the proportion of CD44 + /CD117 + CSCs ( p < 0.01). Although bevacizumab increased the proportion of CD44 + /CD117 + CSCs, the addition of metformin did offset this fluctuating trend. The combination of bevacizumab, metformin, and cisplatin efficiently decreased the proportion of CSCs in the OC animal model. IHC results exhibited that expressions of VEGF, CD34, and HIF-1α in transplanted tumors were decreased by metformin alone compared with the control ( p < 0.05). In the bevacizumab treatment, VEGF, and CD34 expressions were decreased, while that of HIF-1α was increased, suggesting that the degree of hypoxia was differentially aggravated after the bevacizumab treatment. The VEGF, CD34, and HIF-1α expressions in the bevacizumab + metformin + cisplatin group were the lowest among all other treatment groups ( p < 0.05). Subcutaneous statistics of nude mice reseeded by the limit dilution method showed that the tumor recurrence rate in the bevacizumab + metformin + cisplatin group was relatively lower. Conclusion: Metformin, bevacizumab combined with platinum-based chemotherapy can significantly inhibit the growth of ovarian cancer cells and transplanted tumors, which is due to the reduction of the proportion of CD44 + /CD117 + CSCs and the alleviation of hypoxia in the tumor microenvironment. Therefore, this may be a reasonable and promising treatment regimen.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 22 Fan, Cheng, Liu, Liu, Lowe, Li, Bentley, King, Tuason, Zhou, Sun and Zhang.)

Fan, Z., et al. (2023). "Ovarian cancer treatment and natural killer cell-based immunotherapy." Frontiers in Immunology 14: 1308143.
	Background: Ovarian cancer (OC) is one of the malignant tumors that poses a serious threat to women's health. Natural killer (NK) cells are an integral part of the immune system and have the ability to kill tumor cells directly or participate indirectly in the anti-tumor immune response. In recent years, NK cell-based immunotherapy for OC has shown remarkable potential. However, its mechanisms and effects remain unclear when compared to standard treatment.; Methods: To explore the value of NK cell-based immunotherapy in the treatment of OC, we conducted a literature review. In comparison to standard treatment, our focus was primarily on the current anti-tumor mechanisms, the clinical effect of NK cells against OC, factors affecting the structure and function of NK cells, and strategies to enhance the effectiveness of NK cells.; Results: We found that NK cells exert their therapeutic effects in OC through mechanisms such as antibody-dependent cell cytotoxicity, perforin release, and granule enzyme secretion. They also secrete IFN-γ and TNF-α or engage in Fas/FasL and TRAIL/TRAILR pathways, mediating the death of OC cells. In clinical trials, the majority of patients experienced disease stability with mild side effects after receiving NK cell-based immunotherapy, but there is still a lack of high-quality research evidence regarding its clinical effectiveness. OC and prior experience with standard treatments have an effect on NK cells, and it may be considered to maximize NK cell effects through the modulation of the tumor microenvironment or combination with other therapies.; Conclusions: In this review, we have summarized the current evidence of NK cell applications in the treatment of OC. Furthermore, factors and strategies that influence and enhance the role of NK cell immunotherapy are discussed.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2023 Fan, Han, Fan and Zhao.)

Fanfani, F. (2023). "Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer." ClinicalTrials.gov.
	No Results Available Procedure: Robot-assisted surgery|Procedure: Laparoscopic surgery Conversion rate|Difference in overall duration of surgery|Difference in perioperative complications|Adherence to sentinel lymph node MSKCC algorithm|Ergonomics of the two different surgical approach|Quality of life (QoL) at baseline, 1 and 4 weeks (early), and 3 and 6 months (late) after surgery|Adherence to ESGO surgical Quality Index|Difference in overall survival and disease-free survival Female Not Applicable 566 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 5798 September 1, 2029

Fang, Q., et al. (2022). "Effect of peer support intervention on perinatal depression: A meta-analysis." General Hospital Psychiatry 74: 78-87.
	Background: To assess the effect of peer support on preventing or treating perinatal depression. Method(s): Eight databases (Wanfang, VIP, CNKI, CBM, Pubmed, Embase, PsycINFO, and Cochrane) were systematically searched for eligible randomized controlled trials from inception to July 2021. Two reviewers critically and independently assessed the risk of bias using Cochrane Collaboration criteria and extracted correlated data using the designed extraction form. Result(s): A total of 16 studies (including 3154 participants, peer support group: 1568, control group: 1586) were included in this meta-analysis. The intervention group (peer support) had significantly better effect on preventing or treating perinatal depression than the control group [SMD = -0.39, 95% CI (-0.54, -0.24), P < 0.00001, I2 = 78%]. The results of subgroup analyses showed that peer support interventions provided in the perinatal period [SMD = -0.51, 95% CI (-0.93, -0.09), P = 0.02] or only in the postpartum period could improve the depression of mothers [SMD = -0.44, 95% CI (-0.62, -0.26), P < 0.00001]. Face-to-face interventions [SMD = -0.28, 95% CI (-0.40, -0.15), P < 0.0001] and telephone/internet-based interventions [SMD = -0.73, 95% CI (-0.95, -0.50), P < 0.00001] were both effective for perinatal depression. As for form of intervention, the combination of individual and group sessions had the best effect on improving perinatal depression [SMD = -0.63, 95% CI (-1.04, -0.23), P = 0.002]. Peer support with the frequency of at least once a week had a significant effect on perinatal depression [SMD = -0.88, 95% CI (-1.32, -0.44), P < 0.0001]. Interventions with a length of <=3 months [SMD = -2.20, 95% CI (-3.35, -1.04), P = 0.0002] worked better than those lasting for 3-36 months [SMD = -1.64, 95% CI (-2.38, -0.90), P < 0.0001] in perinatal depression management. Peer support could improve perinatal depression both in low- and middle-income countries [SMD = -0.70, 95% CI (-0.95, -0.45), P < 0.00001] and high-income countries [SMD = -0.15, 95% CI (-0.28, -0.02), P = 0.03]. Conclusion(s): Providing peer support during the perinatal period or only postpartum period, using Internet or telephone approaches, a combination of group and individual, at least once a week can be regarded as an effective measure to manage perinatal depression.Copyright © 2021

Fang Qing, Y., et al. (2023). "Evidence for the role of multidisciplinary team care in people with pelvic pain and endometriosis: A systematic review." The Australian & New Zealand Journal of Obstetrics & Gynaecology.
	Background: Endometriosis is a chronic, inflammatory condition characterised by the presence of endometrial-like tissue outside the uterine cavity. Given the multi-system nature of the disease and the potential for significant negative impact on quality of life, there has been a long-standing recognition of the need for multidisciplinary care for people with endometriosis. However, there is paucity to the data supporting this approach, and much of the evidence is anecdotal.; Aim: This systematic review aims to describe recent evidence-based models and patient-centred perspectives of multidisciplinary care for endometriosis, to improve understanding of the role of an integrated, multidisciplinary team in effectively addressing patients' care needs.; Materials and Methods: PubMed, Medline, Embase and Web of Science were searched for relevant articles published between 1 January 2010 to 7 July 2022.; Results: Nineteen studies met the inclusion and exclusion criteria and pinpointed a multidisciplinary team consisting of gynaecologists, pain specialists, nurses, physiotherapists, psychologists, sex therapists, nutritionists, complementary medicine practitioners, and social workers to be most commonly utilised in holistically managing people with pelvic pain and endometriosis. Furthermore, patient perspectives on care highlighted the need for reliable information, respect and validation of experiences or preferences, discussion of long-term treatment plans and social and emotional supports.; Conclusion: The trend for multidisciplinary team care for people with endometriosis is growing. Further consumer-driven clinical studies and outcome evaluations need to be conducted to determine the effect of multidisciplinary care on improvements to quality of life for people living with endometriosis and or pelvic pain. (© 2023 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Fang-fang, H., et al. (2022). "Study on moxibustion in the treatment of uterine fibroids and its related brain changes based on rs-fMRI: a protocol for a systematic reviews and meta-analysis."
	
Fani, M., et al. (2023). "The effect of trunk-stabilizing muscles training in women with stress urinary incontinence: A Randomized Controlled Trial." PM & R : the journal of injury, function, and rehabilitation.
	INTRODUCTION: There is little evidence regarding the effect of trunk-stabilizing muscles training on the improvement of stress urinary incontinence (SUI) symptoms. OBJECTIVE: To investigate the effect of trunk-stabilizing muscles training on trans-abdominal ultrasonography (TAUS) and clinical urological indices, and on the quality of life (QoL) in women with SUI. DESIGN: Randomized controlled trial. SETTING: A university hospital. PARTICIPANTS: Forty-six women with SUI, aged 20-55 years, were randomly assigned to experimental (n =23) and control group (n =23). INTERVENTIONS: The experimental group performed trunk stabilization exercises according to the Sapsford protocol, while the control group performed pelvic floor muscle (PFM) exercises for eight weeks. MAIN OUTCOME MEASURES: The primary outcome measure was bladder base displacement (BBD), assessed by TAUS during PFM contraction (PFMC), Valsalva, and abdominal curl. The secondary outcome measures were PFM strength, the severity of urinary incontinence (UI), voiding diary, and QOL, assessed by the Modified Oxford Grading System, the severity index, frequency chart, and lower urinary tract symptoms-QOL questionnaire respectively. All variables were assessed at baseline and after 8-weeks of interventions. RESULTS: The interaction of group and time wasn't significant for BBD during PFMC (p=0.98), Valsalva (p=0.28), abdominal curl (p=0.34), and secondary variables (p>0.05). The main effect of time was significant in both groups for BBD during PFMC, PFM strength, the severity of UI, voiding diary, and QoL (p<0.001), with effect size (d) of 0.30, 0.80, 2.05, 1.07, 1.03 in the control; and 0.49, 0.52, 1.75, 0.66, 0.88 in the experimental group respectively. The main effect of the group wasn't significant for BBD during PFMC (p=0.68), Valsalva (p=0.22), abdominal curl (p=0.53), and secondary variables (p>0.05). CONCLUSIONS: Trunk-stabilizing muscles training and PFM exercise are equally effective in the improvement of PFM function, UI symptoms, and QOL in women with SUI. Both methods can be used interchangeably by physical therapists. This article is protected by copyright. All rights reserved.

Fankam Aimé, G., et al. (2023). "Guttiferone BL from the Fruits of Allanblackia gabonensis Induces Mitochondrial-Dependent Apoptosis in PA-1 Ovarian Cancer Cells." BioMed Research International 2023: 8981430.
	Despite the recent advancement of treatment strategies, cancer ranks 2 nd among the causes of death globally. Phytochemicals have gained popularity as an alternate therapeutic strategy due to their nontoxic nature. Here, we have investigated the anticancer properties of guttiferone BL (GBL) along with four known compounds previously isolated from Allanblackia gabonensis . The cytotoxicity was assessed by 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) assay. The study was extended for the assessment of the effect of GBL in PA-1 cells apoptosis induction, cell cycle distribution, and change in mitochondrial membrane potential using flow cytometry, Western blot analysis, and real-time PCR. Among the five tested compounds, GBL displayed significant antiproliferative effects against all tested human cancer cells (IC 50 < 10 μ M). Moreover, GBL exhibited no significant cytotoxicity towards normal ovarian epithelial cell line (IOSE 364) up to 50 μ M. GBL induced sub-G 0 cell cycle arrest and significant upregulation of cell cycle regulatory proteins of ovarian cancer cell PA-1. Furthermore, GBL induced its apoptosis as depicted by the accumulation of cells both at the early and late apoptotic phase in Annexin V/PI assay. In addition, it decreased the PA-1 mitochondrial membrane potential and promoted upregulation of caspase-3, caspase-9, and Bax and downregulation of Bcl-2. GBL also showed a dose-dependent inhibition of PA-1 migration. Altogether, this study reveals that guttiferone BL, studied herein for the first time, exhibits efficient antiproliferative activity by the induction of apoptosis through the mitochondrial-dependent pathway. Its investigation as a therapeutic agent against human cancers especially ovarian cancer should be envisaged.; Competing Interests: The authors declare that they have no known competing interests. (Copyright © 2023 Aimé Gabriel Fankam et al.)

Fanourgiakis, A., et al. (2022). "Manchester-Fothergill Operation Compared to Vaginal Hysterectomy for Uterine Prolapse." International Urogynecology Journal 33(Supplement 2): S432-S433.
	Introduction: Symptomatic uterine prolapse is a common indication for pelvic floor surgery. The surgical options include uterine conserving procedures or hysterectomy. Recently, uterine conserving surgery has become limited due to the reported complications of synthetic meshes and many women are declining mesh implants. The optimal choice of procedure should be based on low recurrence rates and complications. Although there are several surgical methods described to conserve the uterus, there is a lack of strong evidence supporting a superior technique. Objective(s): Our aim was to evaluate the effectiveness and peri/post operative outcomes of the uterine-sparing Manchester-Fothergill repair (MR) compared to vaginal hysterectomy (VH), which is the most common procedure for uterine prolapse. The impact of severity of prolapse and increased BMI (>30) on the surgical outcome was also assessed. Method(s): We have retrospectively evaluated the data from the perioperative period and the 6-week follow-up appointment of 48 patients, who underwent a Manchester repair in a single centre from 2010 to 2018. All procedures were performed by the same surgeon. Result(s): The mean age was 62.3 years. 95% of patients were multiparous and 89.6% post-menopausal. The mean BMI was 27.8. 89.6% presented with concurrent cystocele and 83.3% with rectocele. The mean operating time was 105+/-22 minutes and the average hospital stay was 2.51 days. 2 patients did not attend the post-operation follow- up review. 5 patients (10.4%) had EBL>1000ml, none had organ injury and 1 (2.1%) patient required antibiotics due to post-operative infection. In follow-up review, cervical stenosis was noted in 3 (6.3%) patients and recurrence of apical prolapse in only 1 (2.1%) patient. We identified 11 patients with severe prolapse (ie stage 3 and 4). Of those, 3 (27.3%) had major haemorrage >1000ml [RR 4.2, 95%CI (0.77-22.4), p 30, major haemorrhage occurred in 2 (15.4%). The mean operating time (103 minutes) and average hospital stay (3.5 days) did not differ significantly from patients with BMI below 30. No patients had recurrence in follow-up. In comparison, the literature on VH suggests a 2.9-10% risk of major bleeding, 5-13% risk of infection. 0.2-2% risk of bladder or ureteric injury. The recurrence rates of apical prolapse in the literature range from 1-13% for VH and 0.3-9.5% for MR. Conclusion(s): The Manchester repair should be considered a good alternative to VH, even for stage 3-4 prolapse. Our data demonstrates good medium-term results and low complication rates. Additionally, the uterus is preserved, which is an important consideration for many women. Severe prolapse and high BMI appear to increase the risk of intra-operative blood loss but do not affect the recurrence rate. The sample size, however, was small and further longer term follow up data will be collected.

Farahbod, F., et al. (2022). "Effectiveness of phosphodiesterase type 5 inhibitors on the treatment of thin endometrium and pregnancy outcomes: An systematic review." Journal of Endometriosis and Pelvic Pain Disorders 14(3): 132-142.
	Phosphodiesterase type 5 (PDE5) inhibitors are thought to play a role in increasing endometrial thickness and increasing the success rate of pregnancy outcomes. This study was done to investigate the effects of PDE5 inhibitors on infertile women with thin endometrium and pregnancy outcomes. In this systematic review, all randomized controlled trials (RCTs) and observational studies were retrieved from databases including Institute for Scientific Information (ISI), PubMed, and Scopus by interesting keywords. A checklist was designed to collect necessary data and pregnancy outcomes, and the required items were recorded. PDE5 inhibitors through various mechanisms such as induction of vasodilatory effect through the effect on NO/cGMP signaling on vascular smooth muscle, through regulating cells proliferation and induction angiogenesis by increasing the expression of tumor suppressor factor (p53), and vascular endothelial growth factor A (VEGF-A) and downregulating inflammation by downregulating proinflammatory cytokines, affect endometrial thickness that eventually increases and pregnancy outcomes. Although PDE5s inhibitors increase endometrial thickness by different mechanisms, especially in women with thin endometrial, this does not necessarily mean that they induce a positive effect in all situations. However, their positive effects on pregnancy outcome may be affected by the time of administration, type of infertility treatment, underlying diseases such as pelvic disorders and inflammation. So in this regard, there are still ambiguous aspects that required further RCTs study in this area.Copyright © The Author(s) 2022.

Farewell, C. V., et al. (2021). "Maternal mental health and early childhood development: Exploring critical periods and unique sources of support." Infant mental health journal 42(4): 603-615.
	BACKGROUND: The objective of this study was to explore associations between maternal depression and anxiety during early sensitive periods, child social-emotional and behavioral problems and the moderating roles of financial, instrumental, and partner emotional support. METHODS: Analyses was conducted using data from the Fragile Families and Child Wellbeing Study. Hierarchical linear regression modeling was used to explore associations between maternal depression and anxiety at 1- and 3-years postpartum, three unique types of social support, and childhood behavioral problems at 5-years of age (n = 2,827). RESULTS: Mothers who were depressed at one or both timepoints, compared to nondepressed mothers, reported higher externalizing behavioral problems scores of 1.96 and 2.90, and internalizing behavioral problems scores of 1.16 and 2.20, respectively, at 5-years of age (both p < .01), after controlling for covariates. Financial, instrumental, and partner emotional support were independently and inversely associated with behavioral problems (p < .05); however, none of these types of support moderated the relationship between maternal depression and behavioral problems, after controlling for covariates. IMPLICATIONS: Promoting maternal mental health as well as different sources of support throughout the first five years of life, instead of one critical period, may help to reduce the burden of chronic disease in the next generation.

Farhud, D. D., et al. (2021). "In-Vitro Fertilization Impact on the Risk of Breast Cancer: A Review Article." Iranian Journal of Public Health 50(3): 438-447.
	BACKGROUND: Due to the increasing prevalence of infertility, the number of referrals to infertility treatment centers has also increased. Nowadays, assisted reproductive technology (ART), including in vitro fertilization (IVF), is a treatment for infertility or genetic problems. Considering the possible consequences of this method among women undergoing in vitro fertilization (IVF) and kids conceived by IVF, extensive research has been conducted in this regard. METHODS: Overall, 100 articles were entered into the study, and relevant articles were searched and extracted from PubMed, Springer, and Google Scholar databases. In IVF procedure, medications such as Clomiphene citrate and gonadotropins are used to stimulate and mature follicles and thus increase ovulation. RESULTS: There are conflicting opinions on this issue. Some findings report a slight increase in cancer risk for hormone-sensitive cancers including breast cancer. The long-term use of IVF medications can increase estrogen hormones and cause excessive expression of genes, resulting in an increased risk of breast cancer, which is one of the most frequent cancers among women. CONCLUSION: There are some risks to be aware of, which followed the hypothesis that long IVF treatment process may lead to breast cancer among IVF candidates. Furthermore, the risk of breast cancer may be increased in those women with a positive family history and related inherited genes. Therefore, women candidates for IVF should be informed of the probable implications of the reproductive therapy techniques.

Farid-Kapadia, M., et al. (2023). "Comparison of tumor-agnostic and tumor-specific clinical oncology trial designs: A systematic review and meta-analysis." Future Oncology 19(25): 1741-1752.
	Aim: To examine whether tumor-specific and tumor-agnostic oncology trials produce comparable estimates of objective response rate (ORR) in BRAF-altered cancers. Material(s) and Method(s): Electronic database searches were performed to identify phase I-III clinical trials testing tyrosine kinase inhibitors from 2000 to 2021. A random-effects model was used to pool ORRs. A total of 22 cohorts from five tumor-agnostic trials and 41 cohorts from 27 tumor-specific trials had published ORRs. Result(s): There was no significant difference between pooled ORRs from either trial design for multitumor analyses (37 vs 50%; p = 0.05); thyroid cancer (57 vs 33%; p = 0.10); non-small-cell lung cancer (39 vs 53%; p = 0.18); or melanoma (55 vs 51%; p = 0.58). Conclusion(s): For BRAF-altered advanced cancers, tumor-agnostic trials do not yield substantially different results from tumor-specific trials.Copyright © 2023 Roche Canada.

Farkas, W., et al. (2023). "Perioperative hormone treatment of endometriosis." Current opinion in obstetrics & gynecology 35(5): 434-439.
	Purpose of Review: The use of hormonally suppressive medication to reduce levels of reproductive hormones around the time of surgery is widely used in the management of endometriosis. This review summarizes the current evidence concerning the perioperative use of hormonal treatment in the management of endometriosis.; Recent Findings: European Society of Human Reproduction and Embryology (ESHRE) guidanceSurgical Outcomes and Complications of Laparoscopic Hysterectomy for Endometriosis: A Multicentre Cohort StudyPre and postsurgical medical therapy for endometriosis surgery. Cochrane 2020Postoperative hormonal treatment for prevention of endometrioma recurrence after ovarian cystectomy: a systematic review and network meta-analysis. BJOG 2021.; Summary: The literature highlights the importance of hormonal treatment for symptom relief, reduced surgical complications and postoperative benefits, including a reduction in pain, disease recurrence and improved pregnancy rates. The treatment of endometriosis can be broadly categorized into medical, commonly using hormonal suppression medications and surgical, in which endometriosis tissue is excised or ablated. This review aims to outline current management strategies and examines the relationship between the two treatment modalities. (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Farley John, H., et al. (2022). "A phase II evaluation of temsirolimus with carboplatin and paclitaxel followed by temsirolimus consolidation in clear cell ovarian cancer: An NRG oncology trial." Gynecologic Oncology 167(3): 423-428.
	Objective: The primary objective of the study was to estimate the 12-month progression-free survival (PFS) for carboplatin/paclitaxel + temsirolimus in women with newly diagnosed clear cell ovarian cancer (CCOC), compared to historical controls in this patient population.; Methods: Patients with Stage III or IV CCOC were treated with Paclitaxel 175 mg/m2 on Day 1, Carboplatin AUC 6 Day 1, and temsirolimus (CCI-779) 25 mg IV Days 1 and 8 every 3 weeks for Cycles 1-6 or disease progression, followed by consolidation therapy with temsirolimus 25 mg Days 1, 8, and 15 every 3 weeks cycles 7-17 or until disease progression.; Results: Ninety patients were accrued to the study: 45 in the US and Korea (US/Korea) and 45 in Japan. Twenty-two percent received ≤6 cycles of therapy while 28% completed all 17 cycles of chemotherapy. Median PFS (OS) was 11 (23) months for US/Korea and 12 (26) months for Japan. In the US, none of suboptimally debulked patients had PFS >12 months, and 49% of optimal patients did, compared to 25% and 59% in Japan. Most common grade 3-4 adverse events were neutropenia, leukopenia, anemia, thrombocytopenia, hypertension, hypertriglyceridemia, and oral mucositis.; Conclusion: The carboplatin/paclitaxel + temsirolimus regimen was well tolerated. In optimally debulked patients, 54% had a PFS >12 months. This regimen did not statistically significantly increase PFS at 12 months compared to historical controls. No statistically significant differences in PFS or OS were observed between US/Korea vs Japan, or Asians vs non-Asians.; Competing Interests: Conflicts of interest With the exception of Dr. Gershenson, Secord and Yonemari (see details below), the co-authors have no conflicts of interest to declare. Dr. David Gershenson who reports grants received from Novartis in support of GOG-0281 to his Institution. Dr. Gershenson also reports that he received personal payments from Elsevier and UpToDte as well as personal consulting fees received from Genentech and Springworks. Dr. Gershenson also reports receiving stocks from Biogen, Inc., Johnson & Johnson and Bristol Myers Squibb. Dr. Secord reports receiving grant funding from the National Cancer Trial Network to her institution. She also reports clinical trial grants from Abbvie, Amgen, AstraZeneca, Boehringer Ingelheim, Clovis, Eisai, Immutep Ltd., Merck, Oncoquest PharmaMar, Roche/Genentech, Seagen Inc., Tesaro/GSK and VBL Therapeutics. Dr. Secord additionally reports receiving consulting fees from AstraZeneca, Clovis, Cordgenics, Eisai, Merck and Myriad as well as support for travel to attend Advisory Board meetings from AbbVie, Eisai and Tesaro. Dr. Secord served on the SGO Board of Directors, GOG Foundation Board of Directors and AAOGF Board of Trustees. Further to that, Dr. Secord reports receiving an experimental agent from Genentech for preclinical studies and participated on uncompensated advisory boards for Abbvie, Aravive, GSK, Regeneron and Tesaro as well as uncompensated Clinical Trial Steering Committees for Genentech/Roche, VBL Therapeutics and Oncoquest. Dr. Yonemori reports he received consulting fees from Novartis and Eisai. He also received honoraria for lectures from AstraZeneca, Eisai, Chugai, Takeda, Pfizer, and Eli Lilly. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Farrell, R., et al. (2022). "Clinical Trial Protocol for HyNOVA: Hyperthermic and Normothermic intraperitoneal chemotherapy following interval cytoreductive surgery for stage III epithelial OVArian, fallopian tube and primary peritoneal cancer (ANZGOG1901/2020)." Journal of Gynecologic Oncology 33(1): e1.
	Background: Ovarian cancer is the most lethal gynecological cancer, causing over 200,000 deaths worldwide in 2020. Initial standard treatment for primary ovarian cancer is optimal cytoreductive surgery (CRS) preceded and/or followed by intravenous platinum-based chemotherapy. However, most women develop recurrence within the peritoneal cavity and die of disease. Results of the OVIHIPEC 1 trial (2018) showed improved survival of 34% when hyperthermic intraperitoneal chemotherapy (HIPEC) was given immediately following interval-CRS in women with stage III disease. However, it is unknown if the effect of HIPEC is due to hyperthermia, one extra cycle of intraperitoneal (IP) chemotherapy, or other factors. There is also concern that hyperthermia might be associated with an increase in adverse events (AEs) due to a heightened systemic inflammatory response. HyNOVA is a seamless, multi-stage randomized study that attempts to answer these questions by comparing HIPEC to normothermic intraperitoneal chemotherapy (NIPEC), focusing on safety (stage 1), then assessing activity (stage 2) and effectiveness (stage 3). In this initial study, we hypothesize that NIPEC will result in a lower rate of severe AEs compared to HIPEC.; Methods: This initial stage of HyNOVA is a phase II study of 80 women with International Federation of Gynaecology and Obstetrics stage III epithelial ovarian cancer, with at least stable disease following 3-4 cycles of neoadjuvant chemotherapy, achieving interval-CRS to <2.5 mm residual disease. Participants are randomized 1:1 to receive IP cisplatin 100 mg/m² for 90 minutes either as HIPEC, heated to 42°C (41.5°C-42.5°C), or NIPEC, at 37°C (36.5°C-37.5°C). The primary outcome is the proportion of AEs ≥ grade 3 occurring within 90 days. Secondary outcomes are AE of interest, surgical morbidity, patient reported outcomes, resource allocation, feasibility, progression-free survival and overall survival. AEs are measured using both CTCAE v5.0 and Clavien-Dindo classification, particularly infection, pain, bowel dysfunction, and anemia. Tertiary outcomes are potential predictive biomarkers measured before and after HIPEC/NIPEC including circulating cell-free tumor DNA, tissue factors, and systemic inflammatory markers. There are 4 participating Australian sites with experience in CRS and HIPEC for peritoneal malignancy. HyNOVA is funded by an MRFF grant (APP1199155).; Trial Registration: ANZCTR Identifier: ACTRN12621000269831.; Competing Interests: No potential conflict of interest relevant to this article was reported. (Copyright © 2022. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.)

Farvid Maryam, S., et al. (2020). "Fiber consumption and breast cancer incidence: A systematic review and meta-analysis of prospective studies." Cancer 126(13): 3061-3075.
	Background: Associations between fiber intake and breast cancer risk have been evaluated in prospective studies, but overall, the evidence is inconsistent. The authors performed a systematic review and meta-analysis of prospective studies to investigate the relation between intake of total and types of fiber with breast cancer incidence.; Methods: The MEDLINE and Excerpta Medica dataBASE (EMBASE) databases were searched through July 2019 for prospective studies that reported on the association between fiber consumption and incident breast cancer. The pooled relative risk (RR) and 95% confidence intervals (95% CI) were estimated comparing the highest versus the lowest category of total and types of fiber consumption, using a random-effects meta-analysis.; Results: The authors identified 17 cohort studies, 2 nested case-control studies, and 1 clinical trial study. Total fiber consumption was associated with an 8% lower risk of breast cancer (comparing the highest versus the lowest category, pooled RR, 0.92; 95% CI, 0.88-0.95 [I 2 = 12.6%]). Soluble fiber was found to be significantly inversely associated with risk of breast cancer (pooled RR, 0.90 [95% CI, 0.84-0.96; I 2 = 12.6%]) and insoluble fiber was found to be suggestively inversely associated with risk of breast cancer (pooled RR, 0.93 [95% CI, 0.86-1.00; I 2 = 33.4%]). Higher total fiber intake was associated with a lower risk of both premenopausal and postmenopausal breast cancers (pooled RR, 0.82 [95% CI, 0.67-0.99; I 2 = 35.2%] and pooled RR, 0.91 [95% CI, 0.88-0.95; I 2 = 0.0%], respectively). Furthermore, the authors observed a nonsignificant inverse association between intake of total fiber and risk of both estrogen and progesterone receptor-positive and estrogen and progesterone receptor-negative breast cancers.; Conclusions: A random-effects meta-analysis of prospective observational studies demonstrated that high total fiber consumption was associated with a reduced risk of breast cancer. This finding was consistent for soluble fiber as well as for women with premenopausal and postmenopausal breast cancer. (© 2020 American Cancer Society.)

Farzaneh, F., et al. (2022). "THE VALUE OF NON HORMONAL HERBAL COMPLEMENTARY ON REDUCING MENOPAUSAL HOT FLASHES." International Journal of Gynecological Cancer 32: A215.
	Objectives Hot flashes is a bothering symptom in perimenopause women as well as in women after cancer treatment. Present study aimed to investigate the effects of a non‐hormonal herbal complementary(NHHC) in the treatment of hot flashes. Methods This study is the preliminary result of an ongoing large clinical research assessing the effect of NHHC on reducing hot flashes particularly when hormonal treatment is contraindicated. A randomized, double‐blind, placebo‐controlled clinical trial was performed on 70 postmenopause women with symptoms of hot flashes (no history of cancer). The cases(n=35) were given 2 capsules/daily of EstroG‐100 (extracts of Cynanchum wilfordii Hemsley, Phlomis umbrosa Turczaninow, Angelica gigas Nakai) for 12 weeks. The controls( n=35) were given placebo. The consent form, demographic questionnaire were completed. The severity of hot flashes recorded weekly for 12 weeks. Statistical tests were performed using SPSS 22.0. Results The mean age was 51.1±0.4 and 50.3±0.4 in cases and controls respectively. The mean duration of menopause was < 2 years. No significant differences found in the demographic factors. Among all the laboratory tests, just the Alkaline phosphatase value in the cases was significantly higher than the controls (p‐value = 0.047). In the cases the reduction of the severity of hot flashes at 30, 60, and 90 days after treatment and the trend of reduction, were significantly reduced(P<0.001). The severity of hot flashes in the control group did not change significantly during the study. Conclusions In this study the use of herbal extract (EstroG‐ 100) significantly reduced the severity of hot flashes in postmenopause women, without significant adverse effects.

Farzaneh, R., et al. (2021). "The Effect of Hypnosis Therapy on Dysmenorrhea: A Systematic Review." PROSPERO International prospective register of systematic reviews.
	
Fasanghari, M., et al. (2023). "The Effect of Aromatherapy Massage with Lavender Oil on the Severity of Primary Dysmenorrhea among University Students: a Randomized Clinical Trial." Journal of midwifery & reproductive health 11(1): 3592‐3601.
	
Fata, S. and M. A. Tokat (2021). "Does Hypnofertility-Based Nursing Care Affect Cortisol Levels, Fertility Preparedness, and Pregnancy Outcomes in Women Undergoing In Vitro Fertilization? A Randomized Controlled Trial." Biological Research for Nursing 23(3): 418-429.
	This study used Hypnofertility-based interventions to determine whether these interventions would lead to increased fertility preparedness and pregnancy outcomes and decreased cortisol levels in women undergoing In Vitro Fertilization (IVF) treatment. This randomized, controlled, prospective study was conducted from November 2017 through March 2019 in 61 Turkish women with unexplained infertility (intervention group: 30, control group: 31). Hypnofertility-based nursing care included affirmations, visualization, imagination, and relaxation from the first day of treatment until the day of the pregnancy test. The Fertility Preparedness Scale, a saliva sample for cortisol level, and the pregnancy test results were used for data collection. Hypnofertility-based nursing care decreased the cortisol levels of women in the intervention group compared to that in the control group (p = 0.00). Though fertility preparedness was higher in the intervention group, the difference was not statistically significant (p = 0.13). Although interventions relieved the women during the treatment process, there was no anticipated effect on pregnancy outcomes (p = 0.75). Hypnofertility-based nursing care significantly reduce the cortisol levels, suggesting that the intervention helped women relax.

Fatebenefratelli, I. C. S. G. d. D. (2022). Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies.
	[Non-randomized, open label; 4 locations; ] The study aims at identifying: specific biological and molecular alterations associated with development of depression in pregnancy or risk of it. specific biological and molecular alterations due to exposure to maternal depression in utero that are still present in the offspring, that could possibly mediate the development of negative outcomes, and which are the possible clinical moderators of the associated risk; whether antidepressant therapies prescribed by personal physician and the use of digital tools can have a preventive effect in the transmission of the risk from mothers to babies and in the development of depressive symptoms in high-risk pregnant women; In order to achieve these, 80 pregnant women with depression, 80 at high-risk and 80 controls will be recruited and clinically monitored over pregnancy and postpartum along with their babies, specifically at these timepoints: 25th and 32nd weeks of gestation, 1 week postpartum, 4 weeks postpartum, 8 weeks postpartum, 12 months postpartum. Women, based on their clinician choice, will receive antidepressants and will be provided with a smartphone app to monitor them, using a combination of personalised, daily self-reported assessments and sensors for passive data collection to cover mental and physical health. Blood and saliva samples from pregnant women will be collected at the 25th and 32nd week of gestation to perform biological analyses. Saliva samples from babies will be collected at 8 weeks and 12 months postpartum to perform biological analyses. Clinical and psychological data will be collected from women at all timepoints.

Fathy, A., et al. (2023). "The Effectiveness of using Letrozole prior Tomisoprostol Versus Misoprostol alone for Successful Induction of missed Abortion: a Randomized Controlled Trial." Research journal of pharmacy and technology 16(5): 2233‐2238.
	Objective: To evaluate the efficacy of medical abortion induction when Letrozole and misoprostol are combined vs when misoprostol is used alone. Methods: It was intended for 150 women to participate in a randomized controlled experiment. They were split into two groups at random, each with 75 people. While the control group (misoprostol alone group) only got misoprostol, the case group (letrozole group) received pretreatment letrozole 12.5mg for two days. According to American College of Obstetrics and Gynecology (ACOG) recommendations based on gestational Age, misoprostol was administered to both groups in the following dosages: 800mg sublingually in a single dose during the first trimester and 400mg sublingually every 3 hours for up to 5 doses during the second trimester. Results: 137 women in all, 69 of whom received Letrozole and 68 of whom received misoprostol alone. Complete abortions were recorded in 96 instances (70.07%), 51 of which were associated with Letrozole (73.9%) and 45(66.2%) with misoprostol alone (P=0.32). However, the case and control groups had corresponding mean expulsion start times of 7.51.8 hours and 8.31.5 hours. This suggests that the case group had an ejection that began much sooner (P=0.003). Conclusion: The current study found that a combination of misoprostol with Letrozole did not lead to a significantly higher rate of complete abortion if compared with misoprostol alone among women with missed abortion up to 20 weeks gestation. It only significantly shortened the interval to the initiation of expulsion.

Fathy, M., et al. (2021). "Literature review of the outcome of and methods used to improve transperineal repair of rectocele." World journal of gastrointestinal surgery 13(9): 1063-1078.
	BACKGROUND: Rectocele is commonly seen in parous women and sometimes associated with symptoms of obstructed defecation syndrome (ODS). AIM: To assess the current literature in regard to the outcome of the classical transperineal repair (TPR) of rectocele and its technical modifications. METHODS: An organized literature search for studies that assessed the outcome of TPR of rectocele was performed. PubMed/Medline and Google Scholar were queried in the period of January 1991 through December 2020. The main outcome measures were improvement in ODS symptoms, improvement in sexual functions and continence, changes in manometric parameters, and quality of life. RESULTS: After screening of 306 studies, 24 articles were found eligible for inclusion to the review. Nine studies (301 patients) assessed the classical TPR of rectocele. The median rate of postoperative improvement in ODS symptoms was 72.7% (range, 45.8%-83.3%) and reduction in rectocele size ranged from 41.4%-95.0%. Modifications of the classical repair entailed omission of levatorplasty, addition of implant, concomitant lateral internal sphincterotomy, changing the direction of plication of rectovaginal septum, and site-specific repair. CONCLUSION: The transperineal repair of rectocele is associated with satisfactory, yet variable, improvement in ODS symptoms with parallel increase in quality-of-life score. Several modifications of the classical TPR were described. These modifications include omission of levatorplasty, insertion of implants, performing lateral sphincterotomy, changing the direction of classical plication, and site-specific repair. The indications for these modifications are not yet fully clear and need further prospective studies to help tailor the technique to rectocele patients.

Fatih, Ö., et al. (2023). "Effectiveness of physical therapy on pain severity, disability and quality of life on lumbopelvic pain pain among postpartum: Systematic Review and Meta-analysis."
	
Fatima, R. and A. Hania (2022). "Predisposition of Early Maladaptive Schemas and Postpartum Depression during COVID-19 Crisis: Mediation of Mindfulness." Psychiatria Danubina 34(1): 148-156.
	BACKGROUND: Past studies provide crucial evidence that pregnancy and childbirth increase the risk of emotional vulnerability and instability. Current research intends to explore the role of early maladaptive schemas and mindfulness as determinants of postpartum depression for expecting mothers during COVID-19 pandemic. METHOD: The data was collected from 170 expecting mothers who conceived and gave birth during the COVID-19 pandemic. Edinburgh postnatal depression scale, the young schema questionnaire-SF 75 items, and the Kentucky inventory for mindfulness scale were administered. RESULTS: Results discovered that mindfulness partially mediated the relationship between three kinds of early maladaptive schemas and postpartum depression. CONCLUSION: Mindfulness-based control techniques can be considered to buffer the impact of the early maladaptive schemas on postpartum depression, for mothers who give birth during any challenging time.

Faucher, S., et al. (2024). "Investigating the role of the pelvic floor muscles in sexual function and sexual response: a systematic review and meta-analysis." Journal of Sexual Medicine 21(3): 217-239.
	Introduction: The pelvic floor muscles (PFMs) have been suggested to play a key role in sexual function and response in women. However, syntheses of the evidence thus far have been limited to interventional studies in women with pelvic pain or pelvic floor disorders, and these studies have failed to fully capture the involvement of the PFMs in a broader population. Aim(s): We sought to appraise the evidence regarding the role of the PFMs in sexual function/response in women without pelvic pain or pelvic floor disorders. More specifically, we examined the following: (1) effects of treatment modalities targeting the PFMs on sexual function/response, (2) associations between PFM function and sexual function/response, and (3) differences in PFM function between women with and those without sexual dysfunction. Method(s): We searched for all available studies in eight electronic databases. We included interventional studies evaluating the effects of PFM modalities on sexual outcomes, as well as observational studies investigating the association between PFM function and sexual outcomes or the differences in PFM function in women with and those without sexual dysfunction. The quality of each study was assessed using the Mixed Methods Appraisal Tool. Estimates were pooled using random-effects meta-analyses whenever possible, or a narrative synthesis of the results was provided. Main outcomes: The main outcomes were sexual function (based on a questionnaire)/sexual response (based on physiological test), and PFM function (assessment of the PFM parameters such as strength and tone based on various methods). Result(s): A total of 33 studies were selected, including 14 interventional and 19 observational studies, most of which (31/33) were deemed of moderate or high quality. Ten out of 14 interventional studies in women with and without sexual dysfunctions showed that PFM modalities had a significant effect on sexual function. Regarding the observational studies, a meta-analysis revealed a significant moderate association between PFM strength and sexual function (r = 0.41; 95% CI, 0.08-066). Of the 7 observational studies performed to assess sexual response, all showed that the PFMs were involved in arousal or orgasm. Conflicting results were found in the 3 studies that evaluated differences in PFM function in women with and those without sexual dysfunction. Clinical implications: Our results highlight the contribution of the PFMs in sexual function/response. Strengths and limitations: One strength of this review is the inclusion of a broad range of study designs and outcomes, allowing a thorough synthesis of evidence. However, interpretations of these data should consider risk of bias in the studies, small sample sizes, and the absence of control/comparison groups. Conclusion(s): The findings of this review support the involvement of the PFMs in sexual function/response in women without pelvic pain or pelvic dysfunction. Well-designed studies should be performed to further investigate PFM modalities as part of the management of sexual dysfunction.Copyright © The Author(s) 2024.

Faure-Conter, C., et al. (2023). "Extracranial germ cell tumours in children and adolescents: Results from the French TGM13 protocol." Pediatric blood & cancer 70(3): e30117.
	Background: Chemotherapy for non-seminomatous germ cell tumours (NSGCT) exposes to dose-dependent toxicities. The TGM13-NS protocol (EudraCT 2013-004039-60) aimed to decrease the chemotherapy burden compared to the previous TGM95 protocol while maintaining the 5-year event-free survival (EFS) at 80% or more.; Procedure: Patients less than 19 years of age with disseminated NSGCT were enrolled (May 2014 to May 2019) and stratified into four groups: two intermediate-risk (IR: localised tumour with low tumour markers [TM]) groups treated with VBP (vinblastine-bleomycin-cisplatin): three courses for IR1 (ovarian tumour any age/testis tumour less than or equal to 10 years) and four courses for IR2 (extragonadal tumour 10 years or less) groups, and two high-risk (HR: metastatic and/or high TM) groups treated with etoposide-cisplatin and either ifosfamide (VIP) or bleomycin (BEP): three courses for HR1 (ovarian tumour any age/testis tumour less than or equal to 10 years and low TM/testis tumour more than 10 years and very low TM) groups and four courses for HR2 (remainder) groups.; Results: One hundred fifteen patients were included: median age of 12.8 years (0.4-18.9); tumour sites: 44 ovaries, 37 testes and 34 extragonadal. The 5-year EFS and overall survival (OS) were 87% (95% CI: 80-92) and 95% (89-98), respectively (median follow-up: 3.5 years, range: 0.2-5.9), similar to those of the TGM95 protocol (5-year EFS 89% (84-93), 5-year OS 93% (89-95), p = .561). The 5-year EFS were 93% (95% CI: 80-98), 88% (71-95) and 79% (62-90) for ovarian, testicular and extragonadal tumours, respectively. The 5-year EFS varied (p = .02) according to the risk groups: 90% (66-97), 64% (30-85), 95% (72-99) and 87% (74-94) for IR1, IR2, HR1 and HR2, respectively. TM decline adjusted to tumour site, and alpha-fetoprotein (AFP) level revealed a prognostic impact of time to normalisation on EFS: HR = 1.03 (1.003-1.007).; Conclusion: Risk-adapted and globally decreased chemotherapy burden maintains excellent outcomes, exclusive of the IR2 group, which warrants more intensive chemotherapy. (© 2022 The Authors. Pediatric Blood & Cancer published by Wiley Periodicals LLC.)

Fauser, D., et al. (2023). "Work-Related Medical Rehabilitation for Cancer Patients Receiving Non-postacute Rehabilitation A Post-hoc Subgroup Analysis." Deutsches Arzteblatt international 120(49): 841-842.
	
Favilli, A., et al. (2023). "Impact of FIGO type 3 uterine fibroids on in vitro fertilization outcomes: A systematic review and meta-analysis." International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 163(2): 528-539.
	Background: The effect of FIGO (the International Federation of Gynecology & Obstetrics) type 3 myomas on in vitro fertilization (IVF) is uncertain.; Objectives: To evaluate whether FIGO type 3 myomas affect IVF outcomes, through a systematic review and meta-analysis (CRD42022379700).; Search Strategy: Electronic databases were searched until November 15, 2022.; Selection Criteria: Studies evaluating the effects of FIGO type 3 myomas on IVF outcome.; Data Collection and Analysis: Pooled results were expressed as odds ratios (OR) with 95% confidence intervals (CI). Heterogeneity was assessed using Higgins I 2 . Sources of heterogeneity were explored with sensitivity and subgroup analyses.; Main Results: In total, 1020 patients were included: 324 with FIGO type 3 myomas and 696 controls (without myomas). A pooled data analysis showed a significantly lower live birth rate (OR 2.16, 95% CI 1.55-3.01, I 2 = 0%, P < 0.00001), clinical pregnancy rate (OR 2.06, 95% CI 1.52-2.81, I 2 = 0%, P < 0.00001), and implantation rate (OR 1.77, 95% CI 1.35-2.32, I 2 = 0%, P < 0.00001) in women with untreated myomas compared with controls. The number and size of fibroids correlated with a worsening of IVF outcomes.; Conclusions: FIGO type 3 myomas are significantly associated with a lower implantation rate, cumulative pregnancy rate, and live birth rate. Furthermore, their deleterious effect on the outcome of IVF increases further with increasing size and number. Nevertheless, no firm conclusions could be drawn about the potential benefits of surgery for FIGO type 3 uterine fibroids on IVF outcomes. (© 2023 International Federation of Gynecology and Obstetrics.)

Favilli, A., et al. (2021). "Risk factors for non-adherent retained placenta after vaginal delivery: a systematic review." BMC Pregnancy and Childbirth 21(1): 268.
	Background: Retained placenta represents a cause of maternal morbidity and mortality affecting 0.5-3% of all vaginal deliveries. The unpredictability of this condition makes difficult to develop predictive and preventive strategies to apply in clinical practice. This analysis collected and analyzed all known risk factors related to this obstetric complication.; Methods: A systematic literature review for all original research articles published between 1990 and 2020 was performed. Observational studies about retained placenta risk factors published in English language were considered eligible. Conference abstracts, untraceable articles and studies focused on morbidly adherent placenta were excluded. The included articles were screened to identify study design, number of enrolled patients and retained placenta risk factors investigated. All stages of the revision followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement.; Results: Thirty-five studies met the inclusion criteria. The reported retained placenta prevalence ranged from 0.5 to 4.8%. Maternal age, previous cesarean sections, previous dilation and curettage, previous retained placenta, labor induction, resulted as the most recurrent, independent risk factors for retained placenta. Previous estro-progestins therapy, morphological placental features (weight, shape, insertion of umbilical cord, implantation site), endometriosis, Assisted Reproductive Technologies, Apgar score are fascinating new proposal risk factors.; Conclusions: Old and new data are not enough robust to draw firm conclusions. Prospective and well-designed studies, based on a well agreed internationally retained placenta definition, are needed in order to clarify this potential dramatic and life-threatening condition.

Favre, G., et al. (2021). "Sentinel lymph-node biopsy in early-stage cervical cancer: the 4-year follow-up results of the senticol 2 trial." International Journal of Gynecological Cancer 31(SUPPL 1): A60.
	Introduction/Background∗ Senticol 2 is a randomized multicenter trial in the treatment of early‐stage cervical cancer patients. The aim of the Senticol 2 study was to compare the effect of sentinel‐lymph‐node biopsy (SLNB) to that of SLNB + pelvic lymphadenectomy (PLND), and to determine the postoperative lymphati Methodology In the Senticol 2 trial, patients underwent a laparoscopy with a sentinel‐node‐detection procedure and were randomized into two groups, namely: Group A, in which participants received SLNB, and Group B, in which participants received SLNB + PLND. Patients with an intra‐operative macroscopically suspicious lymph node, were given a frozen‐section evaluation and were randomized only if the results were negative. All of the patients received follow up with a clinical examination at 1, 3, and 6 months after surgery, and then every 3‐4 months after that. The median follow up was 51 months (4 years and 3 months). Result(s)∗ Disease‐free survival after 4 years for the SLNB group and the SLNB + PLND group were 89.51% and 93.1% (p = 0.53), respectively. The only statistical factor associated with recurrence in the univariate analysis was the adjuvant radiotherapy. No other factors, including the age of the patients, histological type, tumor size, lymph vascular space invasion (LVSI), and positive nodal status, were significant in the univariate or multivariate analyses. The overall survival rates after 4 years in the SLNB and SLNB + PLND groups were 95.2% and 96% (p = 0.97), with five and four deaths, respectively. The univariate and multivariate analyses did not find any prognostic factors. Conclusion∗ This randomized study confirmed the results of the Senticol 1 study and supports the sentinel lymph node (SLN) technique as a safe technique for use in patients with early‐stage cervical cancer treated with SLNB only. Diseasefree survival after 4 years was similar in patients treated with SLN biopsy and patients who underwent a lymphadenectomy.

Fealy, S., et al. (2019). "The Support for New Mums Project: A protocol for a pilot randomized controlled trial designed to test a postnatal psychoeducation smartphone application." Journal of Advanced Nursing 75(6): 1347-1359.
	Aim: To report a pilot trial protocol for testing the effectiveness of the Support for New Mums smartphone application in a cohort of first-time mothers.; Design: A pilot/feasibility randomized controlled trial using a two-group pre-test and repeated post-test design.; Method: This protocol follows the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) guidelines. The Intervention group will receive access to the smartphone application for 6 weeks post birth. Both Intervention and control groups will receive standardized institutional postnatal care services. Trial funding was gained from respective grant sponsors in May and November 2016.; Discussion: The Support for New Mums smartphone application could be a novel method for addressing the gap in provision of postpartum care services providing psychoeducation and improving maternal parental self-efficacy for Australian childbearing women.; Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618001580268. (© 2019 John Wiley & Sons Ltd.)

Febrina, F., et al. (2022). "Efficacy of interventions to manage sexual dysfunction in women with cancer: A systematic review." Menopause 29(5): 609-626.
	Importance:Cancer and its treatment negatively affect female sexual health and function. The prevalence of female sexual dysfunction after cancer is between 33% and 43%. Numerous studies have addressed treatment options for sexual dysfunction in women with cancer, but it still remains a challenge to select the most efficacious option for patients. Objective(s):To compile and appraise recent evidence of any interventions for managing sexual dysfunction in female cancer survivors.Evidence Review:A literature search of the electronic databases MEDLINE, EMBASE, PsycINFO, and Cochrane Central Register of Controlled Trials (January 2011 to February 2021) was conducted using general search terms of "women", "cancer", "intervention", "sexual dysfunction". We included randomized controlled trials (RCTs) and uncontrolled before-after studies that evaluated the efficacy of intervention for female sexual dysfunction in women with history of cancer. Methodological quality of studies was assessed using Risk of Bias (RoB) 2.0 for RCTs and National Institutes of Health (NIH) assessment tools for uncontrolled before-after studies. Finding(s):Thirty-six studies were included for qualitative synthesis (14 RCTs (n = 1284), 17 uncontrolled trials (n = 589), and 5 cohort studies (n = 497). Only four studies were at low risk of bias. Topical interventions (vaginal gels or creams) were able to alleviate vaginal dryness and dyspareunia, with intravaginal dehydroepiandrosterone (DHEA) (6.5 mg) gel showing evidence of improved sexual function. Evidence for estriol-lactobacilli vaginal tablets was unreliable due to a small-scale study. Psychoeducational therapy (internet-based cognitive behavioral therapy [CBT]) studies typically were at high risk of bias, but all displayed significant improvements of sexual function. Both laser therapy (fractional CO2and erbium) and multimodal approach studies were at concerning risk of bias, although suggesting beneficial effects on sexual function. Conclusions and Relevance:The most reliable evidence for improvement was from a study of DHEA vaginal gel, but in general, gels or creams were useful in reducing dyspareunia. Pharmacological, psychoeducational, laser therapy, and multimodal approaches demonstrated potential in managing cancer-related sexual issues, but most were small in size (10-70 participants), with moderate to high risk of bias. Therefore, large-scale, double-blind, RCTs with long-period follow-up, and at low risk of bias are needed to show efficacy for these interventions.Copyright © 2022 Lippincott Williams and Wilkins. All rights reserved.

Feduniw, S., et al. (2020). "Epidemiology, prevention and management of early postpartum hemorrhage - a systematic review." Ginekologia polska 91(1): 38-44.
	Early Postpartum Hemorrhage (EPH) is one of the leading causes of postpartum mortality. It is defined as blood loss of at least 500 mL after vaginal or 1000 mL following cesarean delivery within 24 hours postpartum. The following paper includes literature review aimed to estimate the incidence and predictors of early postpartum hemorrhage (EPH). Available prevention and treatment methods were also assessed. The inclusion criteria for the study were met by 52 studies. The exact frequency of EPH in different populations varies from 1.2% to 12.5%. Maternal, pregnancy-associated, laborcorrelated and sociodemographic risk factors seem to be important predictors of EPH. In these cases appropriate prophylaxis should be considered. However, EPH may occur without previous risk factors. The main reason for EPH is uterine atony which contributes to up to 80% of cases of postpartum hemorrhage (PPH). Other common reasons for PPH include genital tract injuries, placenta accreta or coagulopathies. Interestingly, the majority of uterotonics seem to have a similar effect. However, carbetocin seems to be the most effective in certain situations. Appropriate diagnosis of EPH is the most important issue. The treatment should be causative. The first-line treatment should include uterotonics. Surgical interventions, if required, should be performed without delay, although preoperative uterine tamponade should be considered due to its high effectiveness. Medical staff training in medical simulation centers is an important factor that improves the outcomes of EPH treatment. It provides adaptation to hospital protocols, team work improvement, self-confidence building, more accurate blood loss evaluation and reduced perception of stress. The implementation of systematic trainings provides better outcomes in the future.

Feferkorn, I., et al. (2023). "Estimation of follicular growth-widely used, seldom studied." Human fertility (Cambridge, England) 26(5): 1173-1178.
	We assessed whether estimation of follicular growth, rather than actual measurement of follicular size on the day of hCG trigger, affected pregnancy rates in intrauterine insemination (IUI) cycles. Patient and cycle characteristics were extracted from an existing database. Comparisons were made between the pregnant (defined as a positive beta hCG) and non-pregnant groups for the following variables: patient's age, number of previous IUI cycles, type of ovarian stimulation, endometrial thickness, number of follicles measuring 14 mm and above, pre and post wash sperm parameters, cycle day when IUI was done and number of days between last ultrasound scan and ovulation trigger. A total of 7302 cycles were included in the final analysis. In 4055 cycles (55.5%) the hCG trigger was on the day of the last ultrasound, in 2285 cycles (31.3%) the hCG trigger was 1 day after the last ultrasound, in 850 (11.6%) it was 2 days after the last ultrasound and in 112 (1.5%) it was 3 or more days after the last ultrasound. Sperm parameters, younger maternal age, and the number of follicles above 14 mm were all associated with pregnancy. No association was found between positive pregnancy test rates and the time from last ultrasound to hCG trigger. Planning IUI based on the estimation of follicular growth 1-4 days before trigger, does not affect pregnancy rates.

Fehm, T., et al. (2022). "Diagnosis, Therapy and Follow-up of Cervical Cancer. Guideline of the DGGG, DKG and DKH (S3-Level, AWMF Registry No. 032/033OL, May 2021) - Part 2 with Recommendations on Psycho-oncology, Rehabilitation, Follow-up, Recurrence, Palliative Therapy and Healthcare Facilities." Geburtshilfe und Frauenheilkunde 82(2): 181-205.
	Aim This is an update of the interdisciplinary S3-guideline on the Diagnosis, Therapy and Follow-up of Cervical Cancer (AWMF Registry No. 032/033OL), published in March 2021. The work on the updated guideline was funded by German Cancer Aid (Deutsche Krebshilfe) as part of the German Guideline Program in Oncology. The guideline was coordinated by the German Society of Gynecology and Obstetrics ( Deutsche Gesellschaft für Gynäkologie und Geburtshilfe , DGGG) and the Working Group on Gynecological Oncology ( Arbeitsgemeinschaft Gynäkologische Onkologie , AGO) of the German Cancer Society ( Deutsche Krebsgesellschaft , DKG). Method The process used to update the 2014 S3-guideline was based on an appraisal of the available evidence using the criteria of evidence-based medicine, adaptations of existing evidence-based national and international guidelines or - if evidence was lacking - on the consensus of the specialists involved in compiling the update. After an initial review of the current literature was carried out according to a prescribed algorithm, several areas were identified which, in contrast to the predecessor version from September 2014, required new recommendations or statements which would take account of more recently published literature and the recent appraisal of new evidence. Recommendations The short version of this guideline consists of recommendations and statements on palliative therapy and follow-up of patients with cervical cancer. The most important aspects included in this updated guideline are the new FIGO classification published in 2018, the radical open surgery approach used to treat cervical cancer up to FIGO stage IB1, and the use of the sentinel lymph node technique for tumors ≤ 2 cm. Other changes include the use of PET-CT, new options in radiotherapy (e.g., intensity-modulated radiotherapy, image-guided adaptive brachytherapy), and drug therapies to treat recurrence or metastasis.; Competing Interests: Conflict of Interest/Interessenkonflikt The conflicts of interest of all the authors are listed in the long German-language version of the guideline report./Die Interessenkonflikte der Autoren sind im Leitlinienreport aufgelistet. (Thieme. All rights reserved.)

Fei, F., et al. (2021). "Effect of nalbuphine, dezocine or sufentanil combined with propofol in painless induced abortion." 中国计划生育学杂志 29(7): 1356‐1359.
	Objective: To compare the clinical effect of propofol combined with nalbuphine, dezocine and sufentanil for painless induced abortion. Methods: From January 2019 to June 2020, 156 early pregnant women who planned to undergo voluntary painless induced abortion in our hospital were selected and divided into 3 groups according to the random number table method, 52 cases in each group. Xin, propofol combined with nalbuphine in group B, and propofol combined with sufentanil in group C. The systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), blood oxygen saturation (SpO2), anesthesia and adverse reactions were compared between the groups at different times of surgery. Results: Before administration and when the eyelash reaction disappeared, the SBP, DBP and SpO2 of group B were higher than those of group A and group C (P<0.05). The dosage of propofol (113.7±10.3mg) and recovery time (3.35±0.4min) in group B were less than those in group A (132.2±21.5mg, 7.1±1.3min) and group C (129.4±15.7mg, 5.8±0.9min) (P<0.05), the total incidence of adverse reactions in group B (19.2%) was lower than that in group A (57.7%) and group C (53.9%) (P<0.05). Conclusion: The anesthetic efficacy and safety of propofol combined with nalbuphine are better than those of propofol combined with dezocine or sufentanil.

Feiyi, Z., et al. (2021). "Acupuncture as an independent or adjuvant management to standard care for perimenopausal depression: a systematic review and meta-analysis."
	
Fei-yi, Z., et al. (2021). "Acupuncture for perimenopause insomnia: An overview of systematic reviews and meta-analyses."
	
Felder, L., et al. (2022). "How does colpocleisis for pelvic organ prolapse in older women affect quality of life, body image, and sexuality? A critical review of the literature." Women's Health 18.
	Colpocleisis is a surgical treatment for pelvic organ prolapse that results in vaginal obliteration. This review aims to systematically evaluate the quality of life, changes in body image, regret, and impact on sexual activity in women after colpocleisis. A review was conducted using the PubMed and Scopus databases with search criteria specifying pelvic organ prolapse, colpocleisis, quality of life, body image, regret, sexuality, and their synonyms. For the selection of the eligible articles, we used the PRISMA reporting system. A total of 1285 articles were found. After removing duplicates and applying the inclusion and exclusion criteria, 30 articles were reviewed in full length. Quality of life after colpocleisis was evaluated in 22 articles, and 20 authors used validated questionnaires. All concluded that quality of life improved after surgical treatment. Twenty-one articles studied regret after obliterative treatment for pelvic organ prolapse. Most of the patients reported no regret. Regret was often due to bowel and bladder symptoms. A few patients reported regret because of loss of coital function. Body image was highlighted in six studies. Three articles assessed body image using the modified Body Image scale. The body image scores demonstrated a significant improvement after surgery. Women tended to remain sexually active and some also regained sexual activities after surgery. Colpocleisis remains a viable option for pelvic organ prolapse, without compromising quality of life, body image, or sexuality, but diligent patient selection is needed. Particular concern should be given to bladder and bowel symptoms since these are the main reason for dissatisfaction after colpocleisis.Copyright © The Author(s) 2022.

Felip, E., et al. (2023). "Impact of chemotherapy and/or immunotherapy on neutralizing antibody response to SARS-CoV-2 mRNA-1237 vaccine in patients with solid tumors." Molecular Oncology 17(4): 686-694.
	Patients with solid tumors have been a risk group since the beginning of the SARS-CoV-2 pandemic due to more significant complications, hospitalizations or deaths. The immunosuppressive state of cancer treatments or the tumor itself could influence the development of post-vaccination antibodies. This study prospectively analyzed 89 patients under chemotherapy and/or immunotherapy, who received two doses of the mRNA-1237 vaccine, and were compared with a group of 26 non-cancer individuals. Information on adverse events and neutralizing antibodies against the ancestral strain of SARS-CoV-2 (WH1) have been analyzed. Local reactions accounted for 65%, while systemic reactions accounted for 46% of oncologic individuals/cancer patients. Regarding the response to vaccination, 6.7% of cancer patients developed low neutralizing antibody levels. Lower levels of neutralizing antibodies between cancer and non-cancer groups were significant in individuals without previous SARS-CoV-2 infection, but not in previously infected individuals. We also observed that patients receiving chemotherapy or chemoimmunotherapy have significantly lower levels of neutralizing antibodies than non-cancer individuals. In conclusion, our study confirms the importance of prioritizing cancer patients receiving anticancer treatment in SARS-CoV-2 vaccination programs.Copyright © 2022 The Authors. Molecular Oncology published by John Wiley & Sons Ltd on behalf of Federation of European Biochemical Societies.

Feng, C., et al. (2021). "Application observation of mental health education combined with control of negative pressure suction pressure in high-risk early pregnancy patients with induced abortion." 当代护士·专科版 28(7): 108‐110.
	Objective: To study the clinical effect of combined control of negative pressure suction pressure with health education and psychological nursing in induced abortion in patients with high‐risk early pregnancy. Methods: A total of 148 patients with high‐risk early pregnancy who were treated in our hospital from June 2017 to January 2019 were selected as the research objects, and they were randomly divided into an observation group and a control group, 74 cases in each group. Both groups underwent painless artificial abortion. The surgical suction pressure was 100‐400 mmHg, and the suction time was less than or equal to 75 s. The control group received routine nursing; the observation group received routine nursing and health education and psychological nursing intervention. The intraoperative conditions, anxiety and postoperative complications of the two groups were observed and recorded. Results: After nursing intervention, the self‐rating anxiety scale (SAS) score of the observation group was significantly lower than that of the control group, and the difference was statistically significant (P<0.001). The intraoperative blood loss in the observation group was less than that in the control group, and the difference was statistically significant (P<0.001). The total incidence of postoperative complications in the observation group was lower than that in the control group, and the difference was statistically significant (P<0.05). Conclusion: Carrying out health education and psychological nursing for high‐risk early pregnancy patients in the process of induced abortion, while controlling the suction pressure and suction time of negative pressure can relieve the patient's negative psychological mood, improve the surgical effect, and reduce the occurrence of postoperative complications, which is worthy of promotion. application.

Feng, C. and L. Yingran (2023). "Moxifloxacin monotherapy for treatment of uncomplicated pelvic inflammatory disease: A meta-analysis of randomized controlled trials."
	
Feng, H., et al. (2022). "The effectiveness and safety of Chinese herbal medicine in infertile women with luteal phase deficiency: a systematic review and meta-analysis." Annals of Palliative Medicine 11(7): 2492-2502.
	BACKGROUND: Chinese herbal medicine (CHM) has been reported to treat infertile women with luteal phase deficiency (LPD) in some clinical studies, however, the efficacy and safety of CHM for LPD are still under controversy. Here, we aim to evaluate the efficacy and safety of CHM using meta-analysis, and further compare it with conventional Western therapies (CWT) to elucidate the improvement in progestin and clinical pregnancy rates. METHOD(S): Eight randomized controlled trials (RCTs) involving 465 women were included in our systematic review; these RCTs compared CHM with CWT in treating LPD in infertile women. The methodological quality of the included RCTs was assessed according to the Cochrane risk-of-bias assessment criteria. The data were analyzed by Review Manager 5.3 software. We estimated the risk ratio (RR) for dichotomous data and calculated the mean difference for continuous data. RESULT(S): In contrast to CWT, CHM was superior in improving clinical pregnancy rates (RR 0.19; 95% CI: 0.11-0.27; P<0.001), increasing progesterone levels in the luteal phase [mean difference (MD) 2.28; 95% CI: 1.91-2.64; P<0.001] and luteal phase estrogen (MD 9.88; 95% CI: 4.53-15.24; P=0.0003), reducing traditional Chinese medicine (TCM) syndrome scores (MD -3.06; 95% CI: -3.95 to -2.17; P<0.001), and the incidence of adverse reactions (RR 0.12; 95% CI: 0.02-0.70; P=0.02). CONCLUSION(S): Evidence from eight small studies suggested that CHM has a therapeutic effect on infertile women with luteal insufficiency. We indicated that CHM may improve the level of progesterone and estradiol in the luteal phase, and the clinical pregnancy rate, with few side effects based on the current studies. However, given the relatively small number of included studies, further studies about the higher quality of study designs, larger population and the underlying mechanism are required to elucidate the role of CHM in LPD treatment.

Feng, J., et al. (2021). "The Efficacy of Complementary and Alternative Medicine in the Treatment of Female Infertility." Evidence-based complementary and alternative medicine : eCAM 2021: 6634309.
	Female infertility is a state of fertility disorder caused by multiple reasons. The incidence of infertility for females has significantly increased due to various factors such as social pressure, late marriage, and late childbirth, and its harm includes heavy economic burden, psychological shadow, and even marriage failure. Conventional solutions, such as hormone therapy, in vitro fertilization (IVF), and embryo transfer, have the limitations of unsatisfied obstetric outcomes and serious adverse events. Currently, complementary and alternative medicine (CAM), as a new treatment for infertility, is gradually challenging the dominant position of traditional therapies in the treatment of infertility. CAM claims that it can adjust and harmonize the state of the female body from a holistic approach to achieve a better therapeutic effect and has been increasingly used by infertile women. Meanwhile, some controversial issues also appeared; that is, some randomized controlled trials (RCTs) confirmed that CAM had no obvious effect on infertility, and the mechanism of its effect could not reach a consensus. To clarify CAM effectiveness, safety, and mechanism, this paper systematically reviewed the literature about its treatment of female infertility collected from PubMed and CNKI databases and mainly introduced acupuncture, moxibustion, and oral Chinese herbal medicine. In addition, we also briefly summarized psychological intervention, biosimilar electrical stimulation, homeopathy, hyperbaric oxygen therapy, etc.

Feng, J., et al. (2020). "Efficacy of clomifene citrate combined Bushen Culuan Decoction for the treatment of infertility caused by polycystic ovary syndrome: A protocol of systematic review." Medicine 99(27): e20969.
	Background: The aim of this study is to assess the efficacy and safety of clomifene citrate combined Bushen Culuan Decoction (CCBCD) in treating infertility caused by polycystic ovary syndrome (PCOS).; Methods: We will carry out this study to identify eligible randomized controlled trials (RCTs) in Cochrane Library, PUBMED, EMBASE, Web of Science, CINAHL, and China National Knowledge Infrastructure from inception to the present. There are no limitations to the language and publication time. We will perform study selection, data extraction, and study quality assessment. If possible, a meta-analysis will be developed to judge the comparative efficacy and safety of CCBCD with other treatments.; Results: The results of this study will summarize current high quality RCTs to provide direct evidence of CCBCD in treating infertility in patients with PCOS.; Conclusion: This study may provide evidence to determine whether CCBCD is effective and safe or not for the treatment of infertility caused by PCOS.; Study Registration: INPLASY202050090.

Feng, J., et al. (2021). "Application of mobile APP in continuation intervention of women's post-abortion care program." Modern practical medicine / 现代实用医学 33(12): 1639‐1641.
	Objective: To explore the application effect of mobile APP in the continuation intervention of women's post‐abortion care (PAC) project. Methods: A total of 644 women who were required to undergo induced abortion were collected as the research objects, and they were divided into groups according to the admission numbers of the patients. The odd number was included in the observation group, and the double number was included in the control group. The control group was given conventional PAC, and the observation group was treated with mobile APP for PAC intervention. The application of this intervention in women with miscarriage. Results: The repeated abortion rates in the observation group within 1 year and within half a year were lower than those in the control group (all P<0.05); the negative emotion scores in the observation group after the intervention were lower than those in the control group (all P<0.05); the observation group was self‐management after the intervention The scores of behavior, self‐management environment and self‐management cognition were higher than those of the control group (all P<0.05); the non‐contraception rate, emergency contraceptives, rhythm contraception and other proportions in the observation group after intervention were lower than those in the control group, and the uterine The proportions of IUDs, oral contraceptives, and perfect condom use were higher than those in the control group (all P<0.05); postoperative bleeding time and menstrual bleeding volume in the observation group were lower than those in the control group, and menstrual recovery was better than that in the control group, but The recovery rate of sexual life was lower than that of the control group (all P<0.05). Conclusion: Mobile APP can improve patients' emotional state, improve self‐management ability, and promote the implementation of contraceptive measures in post‐abortion women's PAC project continuation intervention.

Feng, L. (2021). "bservation of curative effect of motherwort combined with progesterone + Premarin in regulating oligomenorrhea after induced abortion." Modern diagnosis and treatment / 现代诊断与治疗 32(21): 3376‐3378.
	Objective: To explore the therapeutic effect and safety of motherwort combined with progesterone + Premarin in patients with oligomenorrhea after induced abortion. Methods: A total of 168 patients with hypomenorrhea after induced abortion who were treated in our hospital from January 2018 to January 2020 were selected and randomly divided into the observation group and the control group with 84 cases in each group. The control group was treated with progesterone + Premarin, the observation group was treated with motherwort on the basis of the control group, the overall curative effect of the two groups of patients after treatment was compared, and the sex hormone indexes (including estradiol, progesterone), uterine Changes in endometrial thickness and incidence of adverse reactions during treatment. Results: After treatment, the overall treatment effective rate of the observation group was higher than that of the control group, and the difference was statistically significant (P<0.05). Conclusion: Motherwort combined with progesterone + Premarin in patients with oligomenorrhea after induced abortion can improve the overall treatment efficiency, promote sex hormone endocrine and endometrial repair, and has good safety.

Feng, L., et al. (2022). "The effect of flexible low-dose GnRH antagonist on pregnancy outcome in the fresh embryo transfer cycle of IVF-ET: a randomized controlled trial." Reproductive biology and endocrinology : RB&E 20(1): 55.
	Objective: To explore the practicality and effectiveness of a flexible low‐dose protocol in the fresh embryo transfer cycle: reducing the total amount of antagonist by increasing the interval between administrations of Cetrotide. Methods: A total of 211 patients with normal ovarian reserve who accepted GnRH‐ant protocol for IVF‐ET were selected, and they were randomized to the flexible low‐dose antagonist group (test group, n = 101) or the conventional dose antagonist group (control group, n = 110). The initial dose of Cetrotide in the test group was 0.25 mg every other day, and then the dose was adjusted to 0.25 mg every day based on the subsequent luteinizing hormone (LH) levels. The dosage of Cetrotide in the control group was 0.25 mg per day. The primary outcome was the clinical pregnancy rate. Secondary outcomes included the incidence of premature LH rise, total dosage of Cetrotide, number of oocytes retrieved, number of fertilized oocytes, number of high‐quality embryos, biochemical pregnancy rate and ongoing pregnancy rate. Results: There was no significant difference in the general condition of the two groups. There was no significant difference in the clinical pregnancy rate (51.49% vs. 48.18%, p = 0.632) or the incidence of premature LH rise (18.81% vs. 15.45%, p = 0.584) between the two groups. However, the amount of Cetrotide used in the test group was significantly lower than that in the conventional dose antagonist group (1.13 ± 0.41 vs. 1.61 ± 0.59 mg, p < 0.001). Conclusion: The flexible low‐dose antagonist protocol and the conventional dose antagonist protocol were equally effective in people with a normal ovarian reserve in the fresh embryo transfer cycle of IVF‐ET.

Feng, Q. (2021). "Clinical observation of estrogen-progestin combination in the treatment of incomplete induced abortion." 医药前沿 11(16): 42‐43.
	Objective: To observe the clinical effect of estrogen‐progestin combination in the treatment of incomplete induced abortion. Methods: Select 100 patients with incomplete induced abortion who were treated in our hospital from January 2019 to January 2020 as the research objects, after numbering, they were divided into the study group (odd number) and the control group (even number), each Group of 50 cases. The control group was treated with conventional antibiotics, while the study group was treated with estrogen‐progestin combination. After 2 weeks of treatment, the bleeding frequency and average recovery time during the treatment were counted. Results: The number of bleeding in the study group within 2 weeks was less than that in the control group, and the healing time was shorter than that in the control group, and the difference was statistically significant (P<0.05). Conclusion: Combined estrogen‐progestin therapy in the treatment of incomplete induced abortion can effectively relieve the related symptoms of patients and shorten the treatment time. It has a positive effect on the recovery of patients and is worthy of clinical application.

Feng, W., et al. (2021). "Effect of Oral versus Vaginal Administration of Estradiol and Dydrogesterone on the Proliferative and Secretory Transformation of Endometrium in Patients with Premature Ovarian Failure and Preparing for Assisted Reproductive Technology." Drug design, development and therapy 15: 1521-1529.
	PURPOSE: This study aimed to assess the efficacy of vaginally versus orally administered estradiol (E2) and dydrogesterone (DG) on the proliferative and secretory transformation of endometrium in patients with premature ovarian failure (POF) and preparing for assisted reproductive technology. METHODS: Twenty patients with POF who were awaiting oocyte donation were included in the study; they were randomly assigned to two groups to receive E2 and DG either orally or vaginally. Treatment efficacy was compared between the two groups regarding blood E2 concentrations, endometrial thickness, histology using hematoxylin and eosin staining, immunohistochemical analysis of ER expression, and PR and pinopodes morphology using scanning electron microscopy. RESULTS: E2 concentrations differed significantly between oral and vaginal E2 and DG administration for 14 days (82.3 vs 1015.6 pg/mL; P < 0.001) and 21 days (85.0 vs 809.8 pg/mL; P < 0.001). Endometrial thickening was more pronounced in the vaginal treatment group, and also ER staining was stronger on days 14 and 21 in the vaginal treatment group. PR staining in the endometrium appeared more intense in the oral treatment group, which was, however, not significant. The abundance of developing pinopodes was higher in the vaginal treatment group (P = 0.04). CONCLUSION: Vaginal administration of E2 and DG is more effective than oral administration regarding proliferative and secretory transformation of the endometrium in POF patients and preparing for assisted reproductive technology.

Feng, Y., et al. (2019). "Comparison of PARPis with Angiogenesis Inhibitors and Chemotherapy for Maintenance in Ovarian Cancer: A Network Meta-Analysis." Advances in Therapy 36(12): 3368-3380.
	Introduction: Seventy-five percent of ovarian cancer would relapse within 18-28 months after platinum-base chemotherapy. Evidence suggests that maintenance chemotherapy is effective in prolonging remission. Recent target therapies such as poly(ADP-ribose) polymerase inhibitors (PARPis) and angiogenesis inhibitors (AIs) are known to ease burden and recurrence of ovarian cancer. There is limited data for head-to-head comparison of PARPis, AIs, and chemotherapeutic agents (CTAs) as maintenance treatment. This network meta-analysis thus assessed the effectiveness and toxicity of these three maintenance therapies in patients with ovarian cancer.; Methods: We searched relevant sources (PubMed, EMBASE) to identify randomized controlled trials assessing efficacy and safety of maintenance therapy in patients with ovarian cancer. Primary outcome was progression-free survival (PFS) as assessed by blinded review; safety and tolerability were secondary outcomes. A network meta-analysis to compare three drug classes was performed using statistical software R.; Results: We included 24 trials (11,366 patients) assessing efficacy and safety of PARPis (n = 4), AIs (n = 12), and CTAs (n = 8). PARPis [hazard ratio (HR) 0.64; 95% credible intervals (CrI) 0.55-0.73] and AIs (HR 0.87; 95% CrI 0.81-0.93) showed significant improvement in PFS compared to placebo but not CTA (HR 1.00; 95% CrI 0.86-1.15). PARPis showed significant improvement in PFS compared to AIs (HR 0.73; 95% CrI 0.63-0.86) and CTA (HR 0.64; 95% CrI 0.52-0.78). Adverse events (AEs) leading to treatment discontinuation and dose reduction were lower in PARPis [incidence rate ratio (IRR) 0.60; CrI 0.31-1.18 and IRR 0.73, 95% CrI 0.50-1.06, respectively] compared to AIs, but the differences were not significant.; Conclusion: PARPi as maintenance treatment improved PFS in ovarian cancer and was relatively safer in terms of implications caused by AEs when compared to AIs. This network meta-analysis provides valuable evidence and significant insights into treatment of ovarian cancer.

Feng, Y., et al. (2019). "The security of radical trachelectomy in the treatment of IA-IIA cervical carcinoma requires further evaluation: updated meta-analysis and trial sequential analysis." Archives of Gynecology and Obstetrics 299(6): 1525-1536.
	Purpose: The aim of this study was to assess the security of radical trachelectomy (RT) in the treatment of IA-IIA cervical carcinoma and conducted a new survey based upon the results of previous researches.; Methods: The PMC, PubMed, Web of Science, Cochrane and EMBASE databases were retrieved to collect prospective clinical controlled trials (CCTs) published from 1984 to 2018. The oncologic outcomes were evaluated by meta-analysis, trial sequence analysis (TSA) and statistical analysis.; Results: Five prospective CCTs were collected in this study. The recurrence rate and mortality of RT was similar to that of radical hysterectomy (RH), which was consistent with the oncologic outcomes of meta-analysis and TSA. Patients with tumors 2-4 cm in diameter were more likely to receive RH, which may be a potential factor in the higher rate of adjuvant chemotherapy in the this group, and RH was significantly associated with the risk of intraoperative blood transfusion. It is notable that considerable negative margin was achieved by radical abdominal trachelectomy (RAT), and the clinical effect of RAT was slightly better than that of radical vaginal trachelectomy (RVT). However, the TSA results showed that the cumulative cases were not up to the required sample size to obtain the true negative or positive results.; Conclusions: It is safe and effective for early-stage patients with cervical cancer whose lesions are less than 2 cm to receive RVT. For those patients with lesions 2-4 cm who desire fertility preservation and without any evidence of infertility, RAT can be a feasible alternative to RH under fully informed consent. However, more CCTs with larger sample size are still required for further validation.

Feng, Y. Y., et al. (2021). "Psychological or educational eHealth interventions on depression, anxiety or stress following preterm birth: a systematic review." Journal of Reproductive and Infant Psychology 39(2): 140-152.
	Objective: To determine the efficacy and characteristics of psychological or educational eHealth interventions on reducing symptoms of mental illness in parents of preterm or low birthweight infants. Background(s): Many parents suffer psychological disorders after preterm birth. Computer or mobile application-based interventions are a promising alternative. Method(s): We searched seven electronic databases up to January 2020 and included randomised and quasi-randomised controlled trials assessing psychological or educational eHealth interventions in parents of infants born very preterm <32 weeks or with very low birthweight <1500g (primary question), or preterm <37 weeks or with low birthweight <2500g (secondary question). Primary outcomes were measures of depression, anxiety, acute stress disorder or post-traumatic stress disorder. Secondary outcomes included other indicators of mental health, quality of life and intervention characteristics. We had planned random-effects meta-analysis in our protocol (CRD42018105731). Result(s): Of 9768 records, no study reported our primary outcomes. Three studies showed potential benefits for parental self-efficacy, discharge preparedness, parental satisfaction and family satisfaction with the neonatal intensive care unit. Conclusion(s): We found scarce evidence on the efficacy of psychological or educational eHealth interventions on reducing mental illness in parents of preterm or low birthweight infants, highlighting the need for more research.Copyright © 2020 Society for Reproductive and Infant Psychology.

Fengping, S., et al. (2022). "Meta analysis efficacy of the combination metformin and progestin for women with early endometrial cancer or endometrial hyperplasia."
	
Fenocchi, L., et al. (2023). "Long-term effects and costs of pelvic floor muscle training for prolapse: trial follow-up record-linkage study." International Urogynecology Journal 34(1): 239-246.
	Introduction and Hypothesis: Pelvic organ prolapse affects around 40% of women aged over 50 years. A multicentre parallel group randomised trial (the Pelvic Organ Prolapse PhysiotherapY (POPPY) trial) demonstrated that pelvic floor muscle training (PFMT) was effective in reducing prolapse symptoms compared with no treatment. However, insight into the long-term impact of PFMT on health outcomes and health-service utilisation is scarce.; Methods: This study utilised linkage of Scottish administrative health records to follow-up POPPY trial participants resident in Scotland over 11 years. Mixed effects logistic regression determined the likelihood of receiving further prolapse treatment for those in the PFMT and control groups. Analyses were adjusted for age group, prolapse stage, baseline symptom severity and attitude towards surgery. A cost assessment estimated longitudinal costs to the UK National Health Service (in Scotland) of accessing further prolapse treatment for each trial group.; Results: Two hundred and ninety-three women, aged 25 to 79 years, were followed up. One hundred and forty-one women (48.1%) had received further prolapse treatment: 65 (of 149; 43.6%) in the PFMT group compared with 76 (of 144; 52.8%) in the control group. PFMT was associated with a reduction in the odds of any prolapse treatment during follow-up (AOR 0.61; 95% CI 0.37 to 0.99). Total cost of secondary care was £154,544 (GBP) in the PFMT group and £172,549 (GBP) in the control group.; Conclusions: Although PFMT did not lead to significant differences in total costs for further prolapse treatment over a post-intervention period of more than 10 years, it reduced the overall long-term risk of requiring hospital-based treatment for pelvic floor disorders. (© 2022. The Author(s).)

Fernanda Sayuri, F., et al. (2021). "Effect of pelvic floor muscle training on urinary incontinence symptoms in women who practice high-impact sports: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Fernandez, g., et al. (2023). "Comparison of progesterone levels according to the type of vaginal micronized progesterone used for luteal phase support in artificial-cycles for endometrial preparation in embryo transfer."  38: i451.
	Study question: Are there differences in the ongoing pregnancy rate (OPR) using Cyclogest® versus Progeffik® at a dose of 800 mg daily as luteal phase support? Summary answer: The administration of Cyclogest® as luteal phase support shows higher ongoing pregnancy rates (OPR) in a cycle of hormone replacement therapy (HRT) with own oocytes What is known already: The importance of serum progesterone levels around the time of embryo transfer in patients undergoing FET under artificial endometrial preparation has been well established; some studies have shown that optimizing serum progesterone levels on the day before, leads to an improvement in live birth rates (LBR). However, to date, no study has examined which vaginal preparation reports better serum progesterone levels and its impact on OPR. Study design, size, duration: This prospective randomized clinical trial was performed between September 2019 and June 2022 and enrolled 490 patients scheduled for cryopreserved ET after an artificial endometrial preparation cycle with estradiol valerate and micronized vaginal progesterone. They were divided into two groups, those who used Progeffik® and others with Cyclogest® total dose of 800mg. SPLs were measured the day before (P+4), the day of the transfer (P+5) and the day of BHCG (P+19) and compared the OPR. Participants/materials, setting, methods: Patients between 18‐40 years of age with BMI <30 and triple‐layer endometrium > 7,5mm underwent transfer of one blastocysts with own oocytes. The study was carried out in the assisted human reproduction unit of the Virgen de Valme University Hospital (Seville). Ethical approval was granted and formed consent was obtained. The primary endpoint is to assess which vaginal progesterone preparation gives better ongoing pregnancy rates. Main results and the role of chance: The 484 patients were randomized (1:1) into two groups. Progeffik was administered to 149 patient and Cuyclogest to 335 patient. The characteristics of the patients were comparable between groups with similar causes of fertility and type of IVF. Regarding the results of serum progesterone levels measured according to the type of micronized vaginal progesterone used to support the luteal phase, we obtained for day P+4 (13,69 for Progeffik® vs 15.89 for Cyclogest® ), while for day P+5 (11.95 vs 17.69) and on day P+19 (13.69 vs 15.41), the results obtained after the administration of Cyclogest® being significantly higher with a p‐value of 0,01. When assessing the ongoing pregnancy rate, they were also significantly higher with the administration of Cyclogest® versus Progeffik® (59.7% vs 48.3%) with a p value of 0,024. Limitations, reasons for caution: The newborm rate needs to be validated as it has not exceeded 9 months since the study. Wider implications of the findings: This study demonstrates the statistically significant superiority of Cyclogest‐type vaginal micronized progesterone administration over its competitor Progeffik used for luteal phase support, being a more convenient way of administration for women since it's simplicity.

Fernandez, H., et al. (2023). "Update on the management of endometriosis-associated pain in France." Journal of Gynecology Obstetrics and Human Reproduction 52(9): 102664.
	The French National College of Obstetricians and Gynecologists (CNGOF) published guidelines for managing endometriosis-associated pain in 2018. Given the development of new pharmacological therapies and a review that was published in 2021, most national and international guidelines now suggest a new therapeutic approach. In addition, a novel validated screening method based on patient questionnaires and analysis of 109-miRNA saliva signatures, which combines biomarkers and artificial intelligence, opens up new avenues for overcoming diagnostic challenges in patients with pelvic pain and for avoiding laparoscopic surgery when sonography and MRI are not conclusive. Dienogest (DNG) 2 mg has been a reimbursable healthcare expense in France since 2020, and, according to recent studies, it is at least as effective as combined hormonal contraception (CHC) and can be used as an alternative to CHC for first-line treatment of endometriosis-associated pain. Since 2018, the literature concerning the use of DNG has grown considerably, and the French guidelines should be modified accordingly. The levonorgestrel intrauterine system (LNG IUS) and other available progestins per os, including DNG, or the subcutaneous implant, can be offered as first-line therapy, gonadotropin-releasing hormone (GnRH) agonists with add-back therapy (ABT) as second-line therapy. Oral GnRH antagonists are promising new medical treatments for women with endometriosis-associated pain. They competitively bind to GnRH receptors in the anterior pituitary, preventing native GnRH from binding to GnRH receptors and from stimulating the secretion of luteinizing hormone and follicle-stimulating hormone. Consequently, estradiol and progesterone production is reduced. Oral GnRH antagonists will soon be on the market in France. Given their mode of action, their efficacy is comparable to that of GnRH agonists, with the advantage of oral administration and rapid action with no flare-up effect. Combination therapy with ABT is likely to allow long-term treatment with minimal impact on bone mass. GnRH antagonists with ABT may thus be offered as second-line treatment as an alternative to GnRH agonists with ABT. This article presents an update on the management of endometriosis-associated pain in women who do not have an immediate desire for pregnancy.; Competing Interests: Conflict of Interest H Fernandez: Gedeon Richter, Theramex A Agostini: Gedeon Richter, Theramex H Baffet: pas de liens d'intérêt N Chabbert Buffet: Bayer, Besins, Exeltis, Gedeon Richter, Organon, Theramex P Descamps: Gedeon Richter, Theramex JP Estrade: Gedeon Richter G Giraudet: Gedeon Richter, Theramex C. Hocké: Gedeon Richter, IBSA Pharma, Exeltis B Salle: pas de liens d'intérêt F Trémollieres: pas de liens d'intérêt C Chapron: Gedeon Richter, Theramex (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)

Fernandez, S., et al. (2023). "Impact of Enhanced Recovery After Surgery (ERAS) program in gynecologic oncology and patient satisfaction." Journal of Gynecology Obstetrics and Human Reproduction 52(2): 102528.
	Objective: The primary objective of this study was to compare lengths of stay since ERAS program implementation. We also evaluated ERAS protocol compliance, compared the outpatient rate, the complication rate and the readmission rate within 30 days after surgery and performed a satisfaction study.; Methods: This is a monocentric comparative study with a historical control group, performed in the gynecological surgery department of the University Hospital of Saint-Etienne. We compared a group of patients who underwent surgery in 2016, before the implementation of ERAS program, with a group of patients who underwent surgery from July 2021 to July 2022, for whom ERAS program was applied.; Results: 187 patients were included in this study, including 84 patients in the historical group before ERAS and 103 in the group with ERAS. Considering all approaches, the average length of stay decreased by 2 days (p<0.0001). Considering minimally invasive surgery, the outpatient rate increased from 5% to 50% (p<0.0001) and complication rate decreased from 23 to 11% (p = 0,04). The readmissions rate was similar. Satisfaction score for patients managed with ERAS program was 8.9/10.; Conclusion: The implementation of ERAS program in gynecological oncology surgery allowed a reduction in length of stay, with a high outpatient rate, decreasing complications in case of minimally invasive surgery, without increasing the readmission rate, and was associated with good patient satisfaction. (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)

Fernández-Cuadros, M. E., et al. (2020). "[Effectiveness of multimodal rehabilitation (biofeedback plus capacitive-resistive radiofrequency) on chronic pelvic pain and dyspareunia: prospective study and literature review]." Rehabilitacion.
	OBJECTIVE: To determine whether a multimodal rehabilitation protocol (Biofeedback [BFB] plus capacitive-resistive [INDIBA®] radiofrequency [RF]) reduces pain and increases muscular strength in patients with chronic pelvic pain (CPP) and dyspareunia. MATERIAL AND METHODS: We performed a prospective, quasi-experimental, before-after study in 37 patients with CPP and/or dyspareunia referred to the Rehabilitation Department of Hospital Universitario Santa Cristina (January 2016 to December 2018). The protocol consisted of 8 sessions of pelvic floor exercises assisted by manometric BFB (15min of tonic/phasic exercises each) supervised by a physiotherapist, followed by suprapubic and perineovaginal bipolar RF [capacitive(5 min)/resistive(10 min)]. The variables evaluated were pain (VAS 0-10) and strength (mmHg) of the pelvic floor musculature and the start/end of the treatment. RESULTS: The mean age was 41.5±12.65 years. The prevalence was higher among women aged 21-40 years (n=20, 54%) and those aged 41-60 years (n=12; 32.4%). Dyspareunia was present in 34 patients (91.8%), and non-specific CPP in 3 (8.2%). The protocol improved pain (from 7.27±1.34 to 3.75±2.21 points), maximal muscular strength (from 25.56±15.9mmHg to 35.35±20.4mmHg) and mean muscular strength (from 4.86±3.53mmHg to 7.18±4.46mmHg) respectively (p<0.0001). CONCLUSION: CPP and dyspareunia are a diagnostic challenge that requires multidisciplinary management. Treatment should be started early and should consist of distinct therapeutic modalities. The protocol of multimodal rehabilitation including BFB and capacitive-resistive RF reduces pain and improves strength in patients with CPP and dyspareunia.

Fernández-Férez, A., et al. (2021). "Nursing Interventions to Facilitate the Grieving Process after Perinatal Death: A Systematic Review." International Journal of Environmental Research and Public Health 18(11).
	Perinatal death is the death of a baby that occurs between the 22nd week of pregnancy (or when the baby weighs more than 500 g) and 7 days after birth. After perinatal death, parents experience the process of perinatal grief. Midwives and nurses can develop interventions to improve the perinatal grief process. The aim of this review was to determine the efficacy of nursing interventions to facilitate the process of grief as a result of perinatal death. A systematic review of the literature was carried out. Studies that met the selection criteria underwent a quality assessment using the Joanna Briggs Institute critical appraisal tool. Four articles were selected out of the 640 found. Two are quasi-experimental studies, and two are randomized controlled clinical studies. The interventions that were analyzed positively improve psychological self-concept and role functions, as well as mutual commitment, depression, post-traumatic stress and symptoms of grief. These interventions are effective if they are carried out both before perinatal loss and after it has occurred. The support of health professionals for affected parents, their participation in the loss, expressing feelings and emotions, using distraction methods, group sessions, social support, physical activity, and family education are some of the effective interventions.

Fernandez-Montoli, M.-E., et al. (2021). "Fertility-Sparing Treatment for Atypical Endometrial Hyperplasia and Endometrial Cancer: A Cochrane Systematic Review Protocol." Advances in Therapy 38(5): 2717-2731.
	Introduction: Endometrial cancer is the fifth most common cancer in women and atypical endometrial hyperplasia is a precancerous lesion. Obesity is an important risk factor for endometrioid endometrial adenocarcinoma and endometrial hyperplasia. Progesterone is recommended as first-line treatment in endometrial cancer or atypical endometrial hyperplasia in women who wish to preserve fertility, but optimal treatment schedules have not been defined. Metformin or bariatric surgery may also be useful in these women. The effectiveness and safety of fertility-preserving treatments being used for women with atypical endometrial hyperplasia and stage IA grade 1 endometrial cancer is unclear. Therefore, the systematic review aims to determine this point.; Methods: We will search the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, trial registers, conference proceedings, abstracts, cooperative trial groups and reference lists. We will include randomised controlled trials (RCTs) that compare fertility-preserving therapy including orally administered progesterone versus a levonorgestrel-releasing intrauterine system (IUS), metformin, other pharmacological interventions or bariatric surgery, and any of these interventions with womb-removing surgery. Quasi-randomised trials, non-randomised trials and cohort studies will be included. Two review authors will independently assess study eligibility and risk of bias and extract data. The primary outcomes are complete pathologic response and live birth rate. Secondary outcomes include overall survival, progression-free survival, pregnancy rate, need for hysterectomy, adverse events, psychological symptoms and quality of life.; Planned Outcomes: This review aims to clarify the effectiveness and risks of fertility-preserving treatments, including complete pathologic response rate, live birth rates, need for surgical treatment, adverse events, psychological symptoms and quality of life. The broad scope of the review includes the use of progesterone, metformin to reverse insulin resistance, and bariatric surgery or operative hysteroscopy.; Results: The results may help to determine the optimal fertility-sparing treatment in endometrial cancer and atypical endometrial hyperplasia.; Systematic Review Registration: Prospero 2019 number CRD42019145991.

Fernandez-Vaz, C. and J. D. Gonzalez-Sanz (2022). "Cortisol, Maternal Stress, and Breastfeeding Rate at Hospital Discharge: A Systematic Review." Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine.
	Introduction: Breastfeeding is considered the best way to provide essential and necessary nutrients to the newborn, intervening in its growth and development. However, early abandonment of this method is quite common, due to various factors such as stress. Objectives: To determine whether the level of postpartum cortisol can serve as an indicator of maternal stress and whether there is a relationship between the level of cortisol and the rate of exclusive breastfeeding (EBF) at hospital discharge. Methodology: Systematic review of the literature under the PRISMA guidelines. PubMed, Web of Science, CINAHL, and Scopus databases were used. Original articles published from 2017 to 2022 in English, French, Portuguese, and Spanish were included. All study designs were eligible. Of the 3,712 records initially identified, 15 studies were included in this review. Results: Elevated cortisol levels, due to immediate postpartum stressors, have direct effects on the performance of the essential hormones in breast milk production. The EBF rates are negatively influenced by perceived maternal stress. Conclusion: Cortisol levels may be a good indicator of the level of stress to which the mother is subjected during the immediate postpartum period.

Fernlund, A., et al. (2021). "Psychological impact of early miscarriage and client satisfaction with treatment: comparison between expectant management and misoprostol treatment in a randomized controlled trial." Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology 58(5): 757-765.
	OBJECTIVES: To compare the short- and long-term emotional distress (grief, anxiety and depressive symptoms) after early miscarriage and satisfaction with treatment between women randomized to expectant management vs vaginal misoprostol treatment. METHODS: This was a preplanned analysis of data collected during a randomized controlled trial comparing expectant management with misoprostol treatment in women with early anembryonic or embryonic miscarriage and vaginal bleeding. If the miscarriage was not complete on day 31 after inclusion, surgical evacuation was recommended. The main outcomes were levels of anxiety and grief, depressive symptoms and client satisfaction with the treatment, which were assessed using the following validated psychometric self-assessment instruments: Spielberger State-Trait Anxiety Inventory (STAI, Form Y), Perinatal Grief Scale (PGS), Montgomery-Åsberg Depression Rating Scale (MADRS-S; self-reported version) and Client Satisfaction Questionnaire (CSQ-8). All women were assessed at four timepoints: on the day of randomization, on the day when the miscarriage was judged to be complete, and at 3 months and 14 months after complete miscarriage. The psychometric and client satisfaction scores were compared between the misoprostol group and the expectant-management group at each assessment. Analysis was performed by the intention-to-treat principle. RESULTS: Ninety women were randomized to expectant management and 94 to misoprostol treatment. The psychometric and client satisfaction scores were similar in the two treatment groups at all assessment timepoints. At inclusion, 41% (35/86) of the women managed expectantly and 37% (34/92) of those treated with misoprostol had a STAI-state score of > 46 ('high level of anxiety'), and 9% (8/86) and 10% (9/91), respectively, had symptoms of moderate or severe depression (MADRS-S score ≥ 20). In both treatment groups, symptom scores for anxiety and depression were significantly higher at inclusion than after treatment and remained low until 14 months after complete miscarriage. Grief reactions were mild in both groups, with a median PGS score of 40.0 at 3 months and 37.0 at 14 months after complete miscarriage in both treatment groups. Four women treated with misoprostol and two women managed expectantly had a PGS score of > 90 (indicating deep grief) 3 months after complete miscarriage, while one woman managed expectantly had a PGS score of > 90 14 months after complete miscarriage. Women in both treatment groups were satisfied with their management, as indicated by a median CSQ-8 score of > 25 at each assessment. More than 85% of participants in each of the two groups reported that they would recommend the treatment they received to a friend. CONCLUSIONS: The psychological response to and recovery after early miscarriage did not differ between women treated with misoprostol and those managed expectantly. Satisfaction with treatment was high in both treatment groups. Our findings support patient involvement when deciding on the management of early miscarriage. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Ferradas-Galloso, M., et al. (2022). "Therapeutic Exercise Combined or not with Pelvic Floor Muscle Training for Urinary Incontinence." Archivos Espanoles de Urologia 75(6): 494-506.
	INTRODUCTION: The most used physiotherapy treatment is the pelvic floor muscle training. Other factors are involved in the control of urination, such as the management of abdominal pressure and the activity of the muscles and fascia of the lumbopelvic region and this could be trained through generalized therapeutic exercise, which is defined as an intervention aimed at restoring musculoskeletal, cardiopulmonary and neurological function. The objective of this review is to evaluate the effects of therapeutic exercise, combined or not with analytical training of the pelvic floor muscles, on urinary incontinence in women over 18 years of age, by reviewing the scientific literature. OBJECTIVE(S): To assess the effects of therapy exercise other than or combined with pelvic floor muscle training on urinary incontinence in women over 18 years. MATERIAL AND METHODS: An article research was done between 11th January and 7th February, 2021 on the following databases: Pubmed, Medline, Cinahl, Web Of Science, Sport Discus and PEDro using the search terms "Urinary Incontinence" and "Exercise Therapy". RESULT(S): An average of 245 results were obtained, of which 10 were selected after applying the eligibility criteria. The interventions of the analyzed articles are divided into two groups. First, a group where muscles of the abdominal-pelvic-perineal region are worked (hypopressives, yoga and strength of the abdominal muscles, resisted hip rotation...). Secondly, another group where muscles in general are worked (weight training, flexibility, balance and toning and cardiovascular training). CONCLUSION(S): Urinary incontinence treated with therapy exercise other than the pelvic floor muscles training, or combined with it, suggest improvements in symptoms.

Ferrando, C. A. and M. F. R. Paraiso (2021). "A prospective randomized trial comparing Restorelle® Y mesh and flat mesh for laparoscopic and robotic-assisted laparoscopic sacrocolpopexy: 24-month outcomes." International Urogynecology Journal 32(6): 1565-1570.
	OBJECTIVE: To compare prolapse recurrence and the incidence of mesh exposure between Restorelle® Y mesh and dual flat mesh. METHODS: A randomized trial of women undergoing laparoscopic (LSC) or robotic (RSC) sacrocolpopexy for post-hysterectomy vaginal prolapse. Subjects were randomized to either Y mesh or dual flat mesh. Subjects underwent a pelvic examination with POP-Q and evaluation of any mesh exposure, and the PFDI-20 was administered at 6, 12 and 24 months postoperatively. Subjective recurrence was defined by symptomatic vaginal bulge. All subjects underwent pelvic examination with POP-Q at 6, 12 and 24 months. Objective recurrence was defined by descent of the apex > 1/3 into the vaginal canal, anterior or posterior vaginal descent beyond the hymen, or retreatment for prolapse. RESULTS: Sixty-two patients were enrolled, and 59 patients were implanted with mesh: 30 Y mesh (17 LSC, 13 RSC) and 29 flat mesh (18 LSC, 11 RSC). There were no differences in patient characteristics between the groups. At 24 months, data were available for 44 (74.5%) patients. There were no mesh exposures for all subjects. PFDI-20 scores improved significantly for all subjects with no differences in mean improvement by mesh configuration. There were no differences in subjective and objective recurrence rates between the groups. Four patients (9.1%) complained of subjective vaginal bulge symptoms while nine (20.5%) patients had an objective recurrence (77.8% [7] examination only and 22.2% [2] reoperation). There were no apical recurrences. Of those patients who had a recurrence on examination only (n = 7), 85.7% (6) were asymptomatic. CONCLUSIONS: At 24 months, there were no differences in subjective outcomes and prolapse recurrence in patients who underwent sacrocolpopexy with the Restorelle® Y mesh versus dual flat mesh. One in five patients experienced an objective recurrence; however, there were no apical recurrences and the majority were asymptomatic.

Ferrante, K. L., et al. (2021). "Do Women Who Self-report More Exercise Have Increased Rates of Symptomatic Stress Urinary Incontinence After Midurethral Slings?" Female Pelvic Medicine & Reconstructive Surgery 27(1): e202-e207.
	OBJECTIVES: There is a paucity of data on postoperative exercise and how it relates to surgical failure, specifically after midurethral sling (MUS) surgery. We aimed to assess if women with higher self-reported activity levels as measured by strenuous exercise are more likely to experience stress urinary incontinence (SUI) symptoms after MUS than women with lower self-reported activity. METHODS: This is a secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss: the OPTIMAL Trial, a randomized trial comparing sacrospinous ligament suspension versus uterosacral ligament suspension, both with concomitant retropubic MUS. Participants completed a validated assessment of activity preoperatively and postoperatively. Women in the upper quartile for strenuous exercise (≥90 minutes per week) were compared with the remaining participants. Symptomatic SUI was defined as retreatment or reoperation for SUI and/or any positive response to Pelvic Floor Disorders Inventory stress incontinence questions 20 to 22. RESULTS: A total of 351 participants in the OPTIMAL study received MUS along with their prolapse repair and had postoperative exercise and Pelvic Floor Disorders Inventory data. At 2 years, 87 (29%) of 305 exercised strenuously for at least 90 minutes per week, and 63 (23%) of 277 experienced SUI. Women who were less active at 2 years were significantly more likely to experience SUI than women who were more active (26.6% vs 12.8%, P = 0.0138). CONCLUSIONS: In this study, symptomatic SUI occurred more frequently in women with lower self-reported exercise levels 2 years after MUS surgery.

Ferrari, F., et al. (2021). "Current Treatment Options for Cervical Leiomyomas: A Systematic Review of Literature." Medicina (Kaunas, Lithuania) 57(2).
	Background and objectives : Cervical leiomyomas are a rare benign disease. Although they are mainly treated surgically, currently, there is not a standardized treatment for cervical leiomyomas. This study aims to summarize current literature evidence about treatment options for cervical leiomyomas. Materials and methods : A systematic research of the literature was conducted in Scopus, PubMed/MEDLINE, ScienceDirect, and the Cochrane Library, including observational prospective and retrospective studies, case series and case reports. We collected data regarding studies related to treatment options for cervical leiomyomas, evaluating the following aspects: study design, population, treatment type, rate of surgical complications, and fertility outcome. Results : According to literature research, 38 articles were included. Among 214 patients, the weighted average age was 39.4 years-old; 23 patients were pregnant. Most of the leiomyomas (78%) were extracervical; in 22% of cases (29 patients) were intracervical; 188 patients (88%) received surgical treatment, 6 (3%) received exclusive conservative management and 21 (10%) underwent interventional radiology treatment. One hundred twenty-seven patients (67.5%) underwent myomectomy, while 54 (28.7%) and 7 (3.7%) hysterectomy and trachelectomy, respectively. Cervical myomectomy was performed by open surgery in 21 out of 127 cases (16.5%), while in 92 (72.4%) and 6 (4.7%) patients the surgical approach was performed by traditional and robot-assisted laparoscopy, respectively. The total rate of surgical complications was 5.6%. Conclusion : Surgery is the primary therapeutic option for cervical leiomyomas with a low rate of surgical complications. Interventional radiology techniques have reported promising but still limited results.

Ferraro, M. C., et al. (2023). "Ketamine and other NMDA receptor antagonists for chronic pain." Cochrane Database of Systematic Reviews(2).
	- Objectives This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the benefits and harms of ketamine and other NDMA receptor antagonists compared to placebo, usual care, or other medicines for adults with chronic non‐cancer pain.

Ferreira, A., et al. (2023). "Does microfluidic sperm selection improve clinical pregnancy and miscarriage outcomes in assisted reproductive treatments? A systematic review and meta-analysis." PloS One 18(11): e0292891.
	Background: The microfluidic sperm selection (MFSS) device has emerged as a promising adjunct in assisted reproduction treatments (ART). It employs mechanisms of biomimicry based on the microanatomy of the female reproductive tract through strategies like chemotaxis and rheotaxis. Numerous studies assert improvements in ART outcomes with the use of MFSS, often attributed to the theoretical reduction in sperm DNA damage compared to other techniques. However, these attributed benefits lack validation through large-scale clinical trials, and there is no significant evidence of enhanced assisted reproductive treatments (ART) outcomes.; Objective: To evaluate whether the utilization of MFSS enhances clinical pregnancy results and abortion outcomes in couples undergoing ART compared to standard sperm selection techniques for Intracytoplasmic Sperm Injection (ICSI). We also assessed laboratory outcomes as a supplementary analysis.; Search Methods: We conducted searches across databases including PubMed, NIH, LILACS, CENTRAL, Crossref, Scopus, and OpenAlex. A total of 1,255 records were identified. From these, 284 duplicate records were eliminated, and an additional 895 records were excluded due to their association with patent applications, diagnostic tests, forensic analyses, or irrelevance to the research focus. Among the initially eligible 76 studies, 63 were excluded, encompassing abstracts, studies lacking adequate control groups, and ongoing clinical trials. Ultimately, 13 studies were selected for inclusion in the ensuing meta-analysis.; Results: Regarding clinical pregnancy, we assessed a total of 868 instances of clinical pregnancies out of 1,646 embryo transfers. Regarding miscarriage, we examined 95 cases of pregnancy loss among the 598 confirmed clinical pregnancies in these studies.; Conclusion: The utilization of MFSS demonstrates marginal positive outcomes compared to standard sperm selection techniques, without statistical significance in any of the analyses.; Broader Implications: This study conducted the first meta-analysis to evaluate clinical pregnancy rates, miscarriage rates, and laboratory results associated with the use of MFSS compared to standard sperm selection techniques. We have also listed potentially eligible studies for future inclusion. It's important to emphasize the need for multicenter studies with standardized parameters to attain a more robust clarification of this issue.; Competing Interests: The authors have declared that no competing interests exist. (Copyright: © 2023 Ferreira Aderaldo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Ferreira, P. A. G., et al. (2024). "Sublingual human chorionic gonadotropin as an adjuvant to ovulation induction." JBRA Assisted Reproduction.
	OBJECTIVE: To evaluate the efficacy of sublingually administered human chorionic gonadotropin (HCG) in combination with clomiphene citrate (CC) or letrozole (LTZ) for ovulation induction. METHODS: In this prospective, double-blind, randomized study, the patients were divided into two placebo groups and two intervention groups using CC, LTZ, and HCG. RESULTS: There were no statistically significant differences in ovulation induction between the groups. We compared endometrial thickness at the beginning of the cycle and during the pre-ovulatory period, and detected a moderately positive correlation when CC was administered with HCG. CONCLUSIONS: Sublingual HCG with CC caused a moderately positive correlation with endometrial thickening when compared with that at the beginning of the cycle and during the pre-ovulatory period. There was no significant change in the number of pre-ovulatory follicles.

Ferrero, S., et al. (2019). "Ulipristal Acetate before Hysteroscopic and Laparoscopic Surgery for Uterine Myomas: Help or Hindrance?" Gynecologic and Obstetric Investigation 84(4): 313-325.
	Background/aims: Ulipristal acetate ([UPA], Esmya®) is an orally active selective progesterone-receptor modulator that has been approved as preoperative treatment for uterine myomas. This systematic review aims to summarize the available data on surgical outcomes of patients undergoing myomectomy by hysteroscopy or by laparoscopy after preoperative treatment with UPA.; Methods: this review was performed following PRISMA guidelines and was registered in PROSPERO (CRD42018092201). PubMed, EMBASE, and Medline databases were systematically searched electronically until March 2018 for keywords concerning this topic. There were included only peer-reviewed, English language journal articles.; Results: two prospective studies and 4 retrospective studies were included. The effect of UPA on the endometrium does not increase the technical difficulty during hysteroscopic myomectomy, but it increases the chance of complete primary resection in complex hysteroscopic myomectomies. Moreover, UPA does not increase the overall technical difficulty of laparoscopic myomectomy. Contradictory results have been reported on the impact of UPA on the separation of the myoma from the myometrium and on the consistency of the myomas.; Conclusion: current results support the use of UPA prior to both surgical procedures. Further studies should confirm these preliminary findings and to assess the long-term outcomes of myomectomies following UPA treatment. (© 2018 S. Karger AG, Basel.)

Fethney, J., et al. (2024). "Evaluating a shared care pathway intervention for people receiving chemotherapy to reduce post-treatment unplanned hospital presentations: a randomised controlled trial." Supportive Care in Cancer 32(1): 77.
	Purpose: The aim of this randomised controlled trial (RCT) was to explore whether a community nursing intervention for outpatients receiving systemic therapy reduced unplanned hospital presentations and improved physical and psychosocial health outcomes over the first three cycles of treatment compared to a control group receiving standard care. Method(s): The number of and reasons for unplanned presentations were obtained for 170 intervention and 176 control group adult patients with solid tumours starting outpatient chemotherapy. Poisson regression was used to compare the number of presentations between the intervention and control groups. Patients self-completed the Hospital Anxiety and Depression Scale, the Cancer Behavior Inventory and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) at the start of the first four cycles. Linear regression techniques were used to compare quality of life outcomes. Result(s): The reduction in unplanned presentations in the intervention group relative to the control group was 12% (95% CI, - 25%, 37%; P = 0.48). At the start of cycle 4, there was no difference in anxiety (difference = 0.47 (95% CI, - 0.28, 1.22; P = 0.22)), depression (difference = 0.57 (95% CI, - 0.18, 1.31; P = 0.13)) or EORTC QLQ-C30 summary score (difference = 0.16 (95% CI, - 2.67, 3.00; P = 0.91)). Scores for self-efficacy as measured by the Cancer Behavior Inventory were higher in the intervention group (difference = 4.3 (95% CI, 0.7, 7.9; P = 0.02)). Conclusion(s): This RCT did not demonstrate a benefit in reducing unplanned presentations to hospital. The trial identified improved cancer-based self-efficacy in patients receiving the intervention. Trial registration: Registered at Australian and New Zealand Clinical Trials Registry: ACTRN12614001113640, registered 21/10/2014.Copyright © 2024, The Author(s).

fhfdt, R. B. R. (2023). "Effectiveness of Ozone Therapy Treatment of Endometriosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Participants will be randomly allocated into 2 groups (n = 30) via a computer system maintaining confidentiality with opaque, sealed and numbered envelopes. Control Group (CG): volunteers will undergo conventional drug treatment. Ozone Group (OZ): volunteers will undergo conventional drug treatment associated with ozone therapy. The experimental design of this research will consist of the initial assessment (general data, anthropometric measurements, weight, height, BMI, history of endometriosis and medication in use, intestinal alterations, urinary incontinence and dysmenorrhea) and socio‐demographic questionnaire. In addition, at the beginning and end of the research (10 weeks) the pain questionnaire (VAS), sexual function, quality of life (EHP‐30), Beck anxiety and depression inventory and brief COPE will be applied. These assessments will be scheduled in advance and will be carried out by a biomedical and medical collaborator of the work. In addition, the participant will be asked to complete a daily pain and menstrual flow questionnaire and, in every treatment session, the pain questionnaire will be applied before and after therapy. Blind uni masking process CONDITION: C12.100.250 Endometriosis PRIMARY OUTCOME: Evaluate pain during the 10 weeks of treatment and for 60 days after the applications, verified by the Visual Analog Scale screening. This performance is expected to assess whether there has been a reduction in pain based on the verification of a variation of at least 2 points in pre‐ and post‐intervention follow‐ups SECONDARY OUTCOME: Evaluate sexual function and quality of life during the 10 weeks of treatment and for 60 days after the applications, verified by the Endometriosis Health Profile Questionnaire (EHP‐30). It is expected to evaluate the improvement or not of the patient&apos;s sexual function and quality of life from the verification of a variation of at least 2 points of pre‐ and post‐intervention measurements. Evaluate the anxiety and the level of depression during the 10 weeks of treatment and for 60 days after the applications, verified by the Beck Hopelessness Scale and sessions of dealing with”, “overcoming”, “coping”, “taking care of”, “ endure” (short COPE). It is expected to evaluate the level of anxiety and the level of depression from the verification of a variation of at least 2 points of exercises pre and post‐intervention. INCLUSION CRITERIA: Women with Endometriosis with laboratory diagnosis; age group between 20 and 50 years; ability to respond to questionnaires; ability to consent to participation in the study and sign informed consent

Figueredo, J. M., et al. (2020). "Well-Being at Work after Return to Work (RTW): A Systematic Review." International Journal of Environmental Research and Public Health 17(20).
	BACKGROUND: Employees' well-being at work after the return to work (RTW) is considered a key aspect of rehabilitation and maintenance of workability. This systematic review aimed at identifying the common psychosocial factors that predict the subjective and psychological well-being in RTW processes after having a long-standing health problem or disability. OBJECTIVE: To evaluate the subjective and psychological well-being at work of employees with chronic or long-standing health problems or those returning to work after any cause of disability. DATA SOURCE: Systematic review of articles published in English or Spanish using PsycINFO, PsycARTICLES, MEDLINE, Psychology, and Behavioral Sciences Collection, and Pubpsych. An additional study was identified by contacting expert academics in the field. The search equations used included terms such as Return to Work, Long-Standing Health Problems or Disability, Work Health Balance, and job satisfaction or subjective well-being. Eligibility criteria for the studies: Studies that included a measure of employees' well-being at work following return to work were selected for the review. Evaluation of the studies and synthesis methods: The studies were selected using predefined fields which included quality criteria. RESULTS: Of the 264 articles returned by the initial search, a total of 20 were finally selected. Results were organized around the three different theoretical approaches for understanding RTW and its antecedents and consequences: (a) RTW and autonomy at work have a positive effect on psychological well-being; (b) job demand is linked to less job satisfaction, whereas a higher level on the work-health balance is associated with job satisfaction and work engagement; (c) internal and external support is linked to job satisfaction in the case of a disease. LIMITATIONS: The evidence provided by the results is restricted by the limited availability of studies focusing on well-being at work following return to work. Moreover, the studies identified are of different kinds, thereby preventing comparisons. Conclusions and implications of the main findings: Employees' subjective well-being after return to work has received very little attention to date. Given its importance in the current configuration of the labor market, it should be the object of more research.

Figueroa, E. and M. K (2020). "Psychological treatments to improve sex life in gynecological cancer survivors: Systematic review." Psicooncologia 17(2): 293-309.
	Objective: explore what psychological treatments can help gynecological cancer survivors to improve their sexual lives and intimate relationhips. Method(s): I searched the databases PubMed, Scopus, PsycInfo and MedLine, research between 2005 and 2020, focused on women survivors of gynecological cancer and treatments led by a mental health professional on the improvement of sexuality and intimate relationships in this population. Result(s): 10 articles were obtained (mixed design, randomized controlled trials and case studie) that involved psychological interventions focused on the improvement of sexuality and intimate relationships with women survivors of gynecological cancer. Conclusion(s): the psychoeducational intervention proved to be the most controlled intervention for the improvement of sexual function and reduction of sexual distress in women survivors of gynecological cancer.Copyright © 2020, Universidad Complutense de Madrid. All rights reserved.

Filippini, M., et al. (2021). "Postpartum perineal pain: may the vaginal treatment with CO 2 laser play a key-role in this challenging issue?" The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians 34(8): 1190-1197.
	Purpose: Pregnancy and childbirth, despite being physiological events, represent a very delicate period in a woman's life, because they expose to important vulvo-perineal traumas. The pelvic pain that follows each delivery, whether spontaneous or surgical (caesarean section), does not end in the first days after birth but, depending on the studies, becomes persistent in a very variable percentage of cases. Therefore, in the present pilot study, we aimed, for the first time in literature, to assess the efficacy of CO 2 laser in women affected by perineal postpartum symptoms.; Materials and Methods: Between February 2013 and June 2018, all women with late postpartum pelvic pain referred to the Department of Obstetrics and Gynecology of San Marino Hospital, were recruited and treated using the CO 2 laser for three applications every 4-6 weeks.; Results: Between February 2013 and June 2018, according to the inclusion and exclusion criteria, 32 women with late postpartum pelvic pain were recruited in our protocol study. Mean age of patients was 34.1 years. At latest follow-up, our data demonstrated an improvement in symptoms (dyspareunia, pain at introitus, vaginal dryness, itching and vaginal burning) with a mean reduction of this symptom of 70% from baseline.; Conclusions: This study has shown the effectiveness of CO 2 laser treatment in postpartum perineal pain. Nevertheless, our results should be considered promising but preliminary. In fact, they need to be tested in larger cohort of patients to confirm its application in clinical practice and to evaluate the long-term duration of this treatment.

Filippini, M., et al. (2022). "CO2-Laser therapy and Genitourinary Syndrome of Menopause: A Systematic Review and Meta-Analysis." The Journal of Sexual Medicine 19(3): 452-470.
	Background: Genitourinary syndrome of menopause (GSM) is a widespread condition with a great impact on quality of life and self-image.; Aim: We aimed to systematically review the current literature on CO2-Laser therapy efficacy for the treatment of GSM.; Methods: MEDLINE and Embase databases were systematically queried in December 2020 Studies included women with a diagnosis of Vulvo-Vaginal Atrophy (VVA) or GSM without an history of gynaecological and/or breast cancer, pelvic organ prolapse staged higher than 2, pelvic radiotherapy or Sjogren's Syndrome. The quality of the evidence was assessed with the Cochrane risk of bias tool. This study is registered on PROSPERO, number CRD42021238121.; Outcomes: Effects of CO2-Laser therapy on GSM symptoms assessed through subjective or objective efficacy measurement methods.; Results: A total of 803 articles were identified. Of these, 25 studies were included in this review for a total of 1,152 patients. All studies showed a significant reduction in VVA and/or GSM symptoms (dryness, dyspareunia, itching, burning, dysuria). The pooled mean differences for the symptoms were: dryness -5.15 (95% CI:-5.72,-4.58; P < .001; I 2 :62%; n = 296), dyspareunia -5.27 (95% CI:-5.93,-4.62; P < .001; I 2 :68%; n = 296), itching -2.75 (95% CI:-4.0,-1.51; P < .001; I 2 :93%; n = 281), burning -2.66 (95% CI:-3.75, -1.57; P < .001; I 2 :86%; n = 296) and dysuria -2.14 (95% CI:-3.41,-0.87; P < .001; I 2 :95%; n = 281). FSFI, WHIS and VMV scores also improved significantly. The pooled mean differences for these scores were: FSFI 10.8 (95% CI:8.41,13.37; P < .001; I 2 :84%; n = 273), WHIS 8.29 (95% CI:6.16,10.42; P < .001; I 2 :95%; n = 262) and VMV 30.4 (95% CI:22.38,38.55; P < .001; I 2 :24%; n = 68). CO2-Laser application showed a beneficial safety profile and no major adverse events were reported.; Clinical Implications: Vaginal laser treatment resulted in both a statistically and clinically significant improvement in GSM symptoms. FSFI improved significantly in all 8 included studies but it reached a clinically relevant level only in 2 of them.; Strengths & Limitations: The strength of the current meta-analysis is the comprehensive literature search. We reported data from a high number of patients (1,152) and high number of laser applications (more than 3,800). The main limitations are related to the high heterogeneity of the included studies investigating laser effects. Moreover, most of them are single center and nonrandomized studies.; Conclusion: The data suggest that CO2-Laser is a safe energy-based therapeutic option for the management of VVA and/or GSM symptoms in postmenopausal women; however, the quality of the body of evidence is "very low" or "low". Filippini M, Porcari I, Ruffolo AF, et al., CO2-Laser therapy and Genitourinary Syndrome of Menopause: A Systematic Review and Meta-Analysis. J Sex Med 2022;19:452-470. (Copyright © 2021 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Filippo, A., et al. (2023). "Is TAP better than local anaesthetic wound infiltration for postoperative pain control in gynecological surgery: a systematic review and meta-analysis."
	
Fiol, G., et al. (2023). "Associations between Menopausal Hormone Therapy and Colorectal, Lung, or Melanoma Cancer Recurrence and Mortality: A Narrative Review." Journal of Clinical Medicine 12(16): 5263.
	Objective: to develop eligibility criteria for use in non-gynecological cancer patients. Method(s): We searched all the articles published in peer-reviewed journals up to March 2021. We utilized the PICOS standards and the following selection criteria: menopausal women with a history of non-gynecological and non-breast cancer who underwent hormone replacement therapy (HRT) using various preparations (oestrogens alone or in combination with a progestogen, tibolone, or tissue selective oestrogen complex) and different routes of administration (including oral, transdermal, vaginal, or intra-nasal). We focused on randomized controlled trials as well as relevant extension studies or follow-up reports, specifically examining recurrence and mortality outcomes. Result(s): Women colorectal cancer survivors who use MHT have a lower risk of death from any cause than those survivors who do not use MHT. Women who are skin melanoma survivors using MHT have a longer survival rate than non-MHT survivors. There is no evidence that women lung cancer survivors who use MHT have a different survival rate than those who do not use MHT. Conclusion(s): MHT is safe for women who have a history of colorectal, lung, or skin melanoma cancers.Copyright © 2023 by the authors.

Firdaoz, Y. (2023). "Effectiveness, safety and obedience of dienogest and leuprolide acetate in postlaparoscopic endometriosis patients." Journal of Obstetrics and Gynaecology Research 49: 47‐48.
	Objective: Comparing therapeutic effectiveness, safety profile, and adherence between Dienogest and postoperative Leuprolide Acetate in women with endometriosis who underwent laparoscopy. Methods: This study was a randomized clinical trial comparing the open label study to compare the effectiveness of therapy, safety profile, and obedience between postoperative dienogest and leuprolide acetate in women with endometriosis who underwent laparoscopy. Result: From the statistical test it was found that there was effectiveness of dienogest after 4 weeks of therapy (p = 0.004), after 8 weeks of therapy (p = 0.004) and after 12 weeks of therapy (p = 0.004). In the leuprolide acetate group it was also found that there was effectiveness of administration after 4 weeks of therapy (p = 0.004), after 8 weeks of therapy (p = 0.004) and after 12 weeks of therapy (p = 0.003). There was no difference in systolic blood pressure (p = 0.481), diastolic blood pressure (p = 1,000) and pulse frequency (p = 0.125) breath frequency (p = 1.000) and temperature (p = 0.236) between patients who received dienogest and leuprolide acetate. From the statistical analysis it was found that there were no differences in side effects in patients who received dienogest and leuprolide acetate (p = 0.238). Conclusion: There was no difference in therapeutic effectiveness, and the safety profile assessed by side effects as well as obedience of postoperative Dienogest and Leuprolide Acetate in endometriosis women undergoing Laparoscopy because in both groups there was a decrease in VAS scores from week to week.

Firmeza Mariana, A., et al. (2022). "The Effects of Hysterectomy on Urinary and Sexual Functions of Women with Cervical Cancer: A Systematic Review." Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia 44(8): 790-796.
	Objective: This systematic review aims at describing the prevalence of urinary and sexual symptoms among women who underwent a hysterectomy for cervical cancer.; Methods: A systematic search in six electronic databases was performed, in September 2019, by two researchers. The text search was limited to the investigation of prevalence or occurrence of lower urinary tract symptoms (LUTS) and sexual dysfunctions in women who underwent a hysterectomy for cervical cancer. For search strategies, specific combinations of terms were used.; Results: A total of 8 studies, published between 2010 and 2018, were included in the sample. The average age of the participants ranged from 40 to 56 years, and the dysfunctions predominantly investigated in the articles were urinary symptoms ( n = 8). The rates of urinary incontinence due to radical abdominal hysterectomy ranged from 7 to 31%. The same dysfunction related to laparoscopic radical hysterectomy varied from 25 to 35% and to laparoscopic nerve sparing radical hysterectomy varied from 25 to 47%. Nocturia ranged from 13%, before treatment, to 30%, after radical hysterectomy. The prevalence rates of dyspareunia related to laparoscopic radical hysterectomy and laparoscopic nerve sparing radical hysterectomy ranged from 5 to 16% and 7 to 19% respectively. The difficulty in having orgasm was related to laparoscopic radical hysterectomy (10 to 14%) and laparoscopic nerve sparing radical hysterectomy (9 to 19%).; Conclusion: Urinary and sexual dysfunctions after radical hysterectomy to treat cervical cancer are frequent events. The main reported disorders were urinary incontinence and dyspareunia.; Competing Interests: The authors have no conflict of interests to declare. (Federação Brasileira de Ginecologia e Obstetrícia. This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).)

Fischer, B., et al. (2021). "Assessment of the pelvic floor exercises with iPelvis® app. for treatment of women with urinary incontinence: a randomized controlled trial." Pelviperineology 40(3): 134‐144.
	Objective: To analyze the effectiveness of an application iPelvis® “app” for pelvic floor exercises, alone and associated with physiotherapy, in reducing urinary symptoms and improving the quality of life of incontinent women. Materials and Methods: This is a longitudinal randomized controlled clinical trial study. The Kings Health Questionnaire (KHQ) and the International Consultation on Incontinence Questionnaire‐Short Form (ICIQ‐SF) were used as outcome measurements. The participants were divided into four groups: application + physiotherapy (AP + PHYSIO); home exercise sheet + physiotherapy (P + PHYSIO); only application (AP); only home exercise sheet (P). Results: From the 138 women who were evaluated, 77 (who presented a mean age of 48.31 years) completed the proposed treatments. In the KHQ domains and overall scores, the only ones who presented significant difference between groups were: the General Health Perception (P + PHYSIO higher than P, p=0.008), Social Limitations (P + PHYSIO higher than AP, p=0.04; P higher than AP, p=0.05) and Part I Score (P + PHYSIO higher than P, p=0.04). The analysis of the ICIQ‐SF showed P + PHYSIO higher than P (p=0.01). Between the other groups there were no significant differences. The other nine variables analysed no significant differences in all groups. Conclusion: The use of the application alone and associated with physiotherapy, produces better resulted in reducing urinary symptoms and improving the quality of life of incontinent women, in most variables, but it is not significantly superior in related to the other groups.

Fitz Victoria, W. and S. Mahalingaiah (2022). "Optimization of assisted reproductive technology outcomes in patients with polycystic ovarian syndrome: updates and unanswered questions." Current opinion in endocrinology, diabetes, and obesity 29(6): 547-553.
	Purpose of Review: Narrative review of recent literature on optimization of assisted reproduction technology outcomes in patients with polycystic ovarian syndrome (PCOS).; Recent Findings: The key areas of focus include pre cycle treatment with the goal of cohort synchronization, methods of ovulation suppression and trigger medication. There is no definitive evidence that precycle treatment with combined oral contraceptives (COCs) or progestins improve or negatively impact in vitro fertilization outcomes in patients with PCOS. The reviewed evidence supports consideration of progestins as suppression of premature ovulation in patients with PCOS as an alternative to gonadotropin releasing hormone (GnRH) antagonist if a freeze all protocol is planned. There is limited prospective evidence in PCOS populations regarding use of a dual trigger using GnRH agonist and human chorionic gonadotropin (hCG).; Summary: This review has implications for clinical practice regarding ovarian stimulation protocols for patients with PCOS. We also identified areas of research need including the further exploration of the value of pre cycle COC or progestin use in a PCOS population, also the use of GnRH agonist in combination with hCG in a well defined PCOS population and using GnRH agonist trigger alone as a control. (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Five, L., et al. (2023). Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Von Willebrand Disease Patients.
	No Results Available Device: Volta System Blood loss during menses in von Willebrand Disease patients|Quality of Life of von Willebrand Disease patients|Duration and severity of dysmenorrhea in von Willebrand Disease patients|Duration of menstruation in von Willebrand Disease patients Female Not Applicable 10 Industry Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 5L-BLD-05 June 2024

fjx2jp, R. B. R. (2021). "Hormonal clinical treatment in deep endometriosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: The active intervention in this work consists of dividing an experimental group of 40 women into 2 subgroups. Experimental group 1: 20 women with deep and intestinal endometriosis who will be treated with oral medication (z30.8 dienogest ‐ progestogen to treat endometriosis). Experimental group 2: 20 women with deep and intestinal endometriosis who will be treated with an intrauterine levonorgestrel device (Z30.1). The choice of drug treatment was offered at random (drawing / envelope). These two groups will be followed for 6 months. We can consider the application of two quality of life questionnaires as another intervention. Being SF36 and EHP30. Both questionnaires will be applied before starting medical drug treatment and 6 months after using them. During this 6‐month interval, these patients will be followed up monthly at the clinic to assess how they are with the medication and its side effects. Everything will be filed in medical records. Z30.8 CONDITION: Deep endometriosis; endometriosis; pelvic peritoneum endometriosis PRIMARY OUTCOME: Clinically assess quality of life in two groups of patients with deep endometriosis over a six‐month period, using levonorgestrel iodine and progestin via the oral route, using the questionnaires: SF36 and EHP30 quality of life assessment. Being carried out before and after using the medication. SECONDARY OUTCOME: As a side effect, we could consider both the benefits and the side effects of the two medications: oral progestogen and levonogestrel implantation. The benefits would be the improvement in pain. And the side effects would be irregular bleeding and non‐tolerability to the medication INCLUSION CRITERIA: Women with clinical diagnosis of deep endometriosis; no hormone use for at least 3 months prior (wash out); who are patients of the Gynecology and Obstetrics Department of Santa Casa de Misericórdia de São Paulo, at the endometriosis clinic and who are on a waiting list for surgical treatment

Flandin-Cretinon, S., et al. (2019). "Assessment of pelvic floor muscle training programs and urinary incontinence in women: A literature Review." Gynecologie Obstetrique Fertilite et Senologie 47(7-8): 591-598.
	Objectives: Pelvic floor rehabilitation is efficient for the first line treatment of urinary incontinence in women. However, several questions remain as regards the best pelvic floor muscle training program to recommend. The objective was perform a literature review regarding the muscular strengthening program to recommend to treat stress or mixed urinary incontinence in women. Method(s): We performed a systematic review of studies on the topic using Medline's database covering the 10 last years. Among the 1130 articles that were identified, we retained 6 for our analysis. Result(s): Given the heterogeneity of the exercise programs, it was impossible to exhaustively and comparatively analyze their efficacies. However, a significant improvement is noted when the exercises are based on the muscular training principles of the American College of Sports Medicine. They combine long and short contractions with the practice of the knack in situations of pressure exertion and are part of a self-rehabilitation program based on the needs of the patient and the individual's progression. Conclusion(s): Current knowledge does not allow us to recommend an optimal muscle training program to treat female urinary incontinence. Research must be conducted to evaluate different muscular training regimens but also their integration into a program based on personal needs as well as factors of adherence to the treatment of patients.Copyright © 2019 Elsevier Masson SAS

Flatman, L. K., et al. (2024). "Tumour necrosis factor inhibitors and serious infections in reproductive-age women and their offspring: a narrative review." Scandinavian Journal of Rheumatology.
	Tumour necrosis factor inhibitors (TNFi) are commonly used to treat patients with chronic inflammatory diseases, and function by inhibiting the pro-inflammatory cytokine tumour necrosis factor-alpha (TNF-alpha). Although beneficial in reducing disease activity, they are associated with an increased risk of serious infections. Data on the risk of serious infections associated with TNFi use during the reproductive years, particularly in pregnancy, are limited. For pregnant women, there is an additional risk of immunosuppression in the offspring as TNFi can be actively transported across the placenta, which increases in the second and third trimesters. Several studies have explored the risk of serious infections with TNFi exposure in non-pregnant and pregnant patients and offspring exposed in utero, indicating an increased risk in non-pregnant patients and a potentially increased risk in pregnant patients. The studies on TNFi-exposed offspring showed conflicting results between in utero TNFi exposure and serious infections during the offspring's first year. Further research is needed to understand differential risks based on TNFi subtypes. Guidelines conditionally recommend the rotavirus vaccine before 6 months of age for offspring exposed to TNFi in utero, but more data are needed to support these recommendations because of limited evidence. This narrative review provides an overview of the risk in non-pregnant patients and summarizes evidence on how pregnancy can increase vulnerability to certain infections and how TNFi may influence this susceptibility. This review focuses on the evidence regarding the risk of serious infections in pregnant patients exposed to TNFi and the risk of infections in their offspring.Copyright © 2024 Scandinavian Journal of Rheumatology Foundation.

Flatow, V., et al. (2023). "Skeletal muscle relaxants for the treatment of myofascial pelvic pain and high tone pelvic floor disorders." Current opinion in obstetrics & gynecology 35(4): 311-315.
	Purpose of Review: Chronic pelvic main is a complex process that includes many causes. In gynecology, the treatment of myofascial pelvic pain and high tone pelvic floor disorders can be managed with skeletal muscle relaxants for select clinical indications. A review of skeletal muscle relaxants will be included for gynecologic indications.; Recent Findings: There are limited studies on vaginal skeletal muscle relaxants, but there can be oral forms used for chronic myofascial pelvic pain. They function as antispastic, antispasmodic, and combination of the two modes of action. Diazepam is the most studied for myofascial pelvic pain in both oral and vaginal formulations. Its use can be combined with multimodal management to optimize outcomes. Other medications have limitations due to dependency and limited studies that demonstrate improvement in pain scales.; Summary: Skeletal muscle relaxants have limited high quality studies for chronic myofascial pelvic pain. Their use can be combined with multimodal options to improve clinical outcomes. Additional studies are needed for vaginal preparations and evaluation of safety and clinical efficacy for patient reported outcomes measures in patients living with chronic myofascial pelvic pain. (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Fleischer, K. and G. Thiagamoorthy (2020). "Pelvic organ prolapse management." Post Reproductive Health 26(2): 79-85.
	Pelvic organ prolapse describes the loss of support and subsequent descent of pelvic organs into the vagina. It is common, affecting up to 50% of parous women, and can be accompanied by a number of burdening symptoms. Prolapse has been thrown into the spotlight secondary to mesh-related complications. There are a number of effective treatment options to consider when managing pelvic organ prolapse and most do not require mesh. Patients' choice, comorbidities and likelihood of treatment success should be considered when making decisions about their care. Vaginal mesh surgery is currently on hold in the UK and even prior to this there has been a reduction both in the number of all prolapse surgeries and the number of women seeking surgery to manage their symptoms. This article reviews the current evidence for the management of pelvic organ prolapse, providing an update on the current state of mesh in prolapse surgery and summarises the key evidence points derived from the literature.Copyright © The Author(s) 2020.

Fleury, E. A. B., et al. (2021). "Interactive Music Therapy on Stress Level Reduction in Women Submitted to IVF/ICSI. Prospective Randomized Study." JBRA Assisted Reproduction 25(2): 209-214.
	OBJECTIVE: To identify the effects of interactive music therapy on stress levels in women undergoing high complexity infertility treatments. METHODS: Prospective randomized study involving 113 women treated in the Reproduction Human Laboratory of the Clinics Hospital of the Federal University of Goiás State, submitted to in vitro fertilization/intracytoplasmic sperm injection. We used Depression, Anxiety and Stress Scale, and Lipp's Stress Symptoms Inventory for Adults. In the Intervention Group, we used small and easy to play percussive musical instruments, a guitar, voice, and a recorder. We used interactive music therapy approach individually, applied before baseline ultrasound scan, oocyte pick-up, and embryo transfer. We analyzed the data using the R. Paired Student t-test to compare the results. RESULTS: Comparison of the stress levels by Depression, Anxiety and Stress Scale between the groups in the final moment of data retrieval resulted in 23.13 (SD±10.51; n=32) in the Control Group and 16.12 (SD±7.87; n=33) in the Intervention Group, being statistically different (p=0.004). Also in Lipp's Stress Symptoms Inventory for Adults there was a significant stress reduction in 39% of the patients in the Intervention Group compared to a reduction of 14% in the patients of the Control Group (p=0.032). In this same measurement resulted that only 3% of the Intervention Group patients versus 23% of the Control Group patients (p=0.027) were in the exhaustion stage. CONCLUSION: Interactive music therapy was effective for stress reduction in women during assisted reproduction techniques.

Flint, R., et al. (2019). "Rationale and design for fractional microablative CO 2 laser versus photothermal non-ablative erbium:YAG laser for the management of genitourinary syndrome of menopause: a non-inferiority, single-blind randomized controlled trial." Climacteric : the journal of the International Menopause Society 22(3): 307-311.
	Genitourinary syndrome of menopause (GSM) is a common condition affecting up to 50% of postmenopausal women and up to 70% of postmenopausal breast cancer survivors. GSM is a chronic condition with a significant impact on sexual health and quality of life. The mainstay of treatment has been with symptomatic relief using topical emollients or lubricants. Second-line treatment is with topical vaginal estrogens to restore the physiology of the vaginal epithelium. For some, the latter is not suitable or acceptable. Newer treatments with ospemifene and vaginal lasers have now been introduced. The two main types of laser currently used for the treatment of GSM are the fractional microablative CO 2 laser and the non-ablative photothermal erbium:YAG laser. We present a study protocol for a multicenter, prospective, non-inferiority, single-blinded, randomized controlled trial comparing the fractional microablative CO 2 laser versus the photothermal non-ablative erbium:YAG laser for the management of GSM. We will recruit 88 postmenopausal women across two sites who will be randomized to one of the two laser groups. Participants will all have GSM symptoms and a Vaginal Health Index Score < 15. All participants will receive an active treatment. Each participant will receive three applications of vaginal laser 1 month apart and will be followed up at 1 month, 6 months, and 12 months. Our primary outcomes will look at all changes of GSM symptoms (dryness, dyspareunia, itching, burning, dysuria, frequency, urgency), urinary incontinence (if present), and overall sexual satisfaction. Both subjective and objective means will be used to assess participants. The findings of this trial have the potential to allow clinicians and women suffering from GSM to make an informed decision when opting for a specific laser type. The trial will add to the current growing body of evidence for the safe use of vaginal lasers in GSM as an alternative treatment. We hope this trial will provide robust and long-term data for the safe use of both lasers.

Flor-Alemany, M., et al. (2022). "Exercise, Mediterranean Diet Adherence or Both during Pregnancy to Prevent Postpartum Depression-GESTAFIT Trial Secondary Analyses." International Journal of Environmental Research and Public Health 19(21).
	Targeting lifestyle behaviors during pregnancy is crucial to prevent the highly prevalent postpartum depression and its consequences. In these secondary analyses of an intervention trial to investigate the effects of concurrent exercise training on postpartum depression, we aimed to investigate the potential role of Mediterranean diet (MD) adherence on the exercise effects. A total of 85 pregnant women met the per-protocol criteria (exercise n = 46, control n = 39). The exercise program was delivered in 60 min sessions, 3 days/week, from the 17th gestational week until birth. Women's dietary habits were assessed with a food frequency questionnaire. The Mediterranean Food Pattern (an MD index) was derived from it to assess MD adherence. We used the Edinburgh Postnatal Depression Scale to assess postpartum depression. The postpartum depression score was not statistically different between control and exercise groups ( p > 0.05). A higher consumption of fruits (β = -0.242, p = 0.022), lower intake of red meat and subproducts (β = 0.244, p = 0.020), and a greater MD adherence (β = -0.236, p = 0.027) were associated with lower levels of postpartum depression. Greater adherence to the MD during pregnancy was associated with fewer depressive symptoms and a lower risk of postpartum depression. Postnatal depression was not reduced by prenatal exercise. Promoting fruit consumption while controlling the intake of red meat during pregnancy might prevent postnatal depression.

Flores-Lovon, K., et al. (2023). "Effects of antituberculosis treatment on pregnancy outcomes in infertile women with genital tuberculosis: a systematic review." BMJ Open 13(9): e070456.
	Objectives: To evaluate the efficacy of antituberculosis therapy on pregnancy outcomes in infertile women with genital tuberculosis.; Design: Systematic review.; Data Sources: We searched in PubMed/MEDLINE, CENTRAL and EMBASE up to 15 January 2023. Additionally, we manually search the reference lists of included studies.; Eligibility Criteria: We included randomised controlled trials (RCT), non-RCTs (non-RCT) and cohort studies that evaluated the effects of antituberculosis treatment on pregnancy outcomes in infertile women with genital tuberculosis compared with not receiving antituberculosis treatment or receiving the treatment for a shorter period.; Data Extraction and Synthesis: Two independent reviewers extracted data. We used Cochrane Risk of Bias 1.0 and Risk Of Bias In Non-randomised Studies tools for risk of bias assessment and meta-analysis was not performed. We used Grading of Recommendations, Assessment, Development and Evaluations approach to assess the certainty of the evidence.; Results: Two RCTs and one non-RCT were included. The antituberculosis regimens were based on isoniazid, rifampicin, pyrazinamide and ethambutol for 6-12 months. In women without structural damage, very low certainty of evidence from one RCT showed that the antituberculosis treatment may have little to no effect on pregnancy, full-term pregnancy, abortion or intrauterine death and ectopic pregnancy, but the evidence is very uncertain. In women with structural damage, very low certainty of evidence from one non-RCT showed that the antituberculosis treatment may reduce the pregnancy rate (297 fewer per 1000, 95% CI -416 to -101), but the evidence is very uncertain. In addition, very low certainty of evidence from one RCT compared a 9-month vs 6-month antituberculosis treatment regimen showed similar effects between the schemes, but the evidence is very uncertain. Two RCTs reported that no adverse events of antituberculosis treatment were noted or were similar in both groups.; Conclusion: The effect of antituberculosis treatment on pregnancy outcomes in infertile women with genital tuberculosis is very uncertain.; Prospero Registration Number: CRD42022273145.; Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Florida University of, S. (2022). Vaginal Estradiol Use in Pessary Care.
	No Results Available Drug: Estradiol vaginal cream Pessary Discontinuation Rates|Phone calls/messages|Unscheduled office visits|Vaginal Bleeding|Pessary Discomfort|Vaginal Discharge|Urinary Tract Infection Rates|Vaginal Erosion Rates Female Early Phase 1 11 Other Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care STUDY004394 April 26, 2023

Floyd, R., et al. (2022). "The Effect of Time-Restricted Eating on Insulin Levels and Insulin Sensitivity in Patients with Polycystic Ovarian Syndrome: A Systematic Review." International Journal of Endocrinology 2022: 2830545.
	Results: 2662 papers were identified with 37 selected for full-text review and one paper meeting criteria for inclusion. Ramadan fasting was the only time-restricted eating regimen trialled in this population with no strong evidence of a significant effect on insulin levels.; Conclusion: As the systematic review retrieved only one study investigating time-restricted eating to reduce insulin in patients with PCOS, there is no evidence to suggest that this intervention is effective. From the narrative review, based on studies in other patient groups, time-restricted eating could improve insulin resistance in those with PCOS; however, well-designed studies are required before this intervention can be recommended.; Competing Interests: The authors declare that there are no conflicts of interest. (Copyright © 2022 R. Floyd et al.)

Flynn, A. N., et al. (2021). "Timing and efficacy of mifepristone pretreatment for medical management of early pregnancy loss." Contraception 103(6): 404-407.
	OBJECTIVES: To determine the time interval between mifepristone and misoprostol administration associated with the most efficacious early pregnancy loss (EPL) management. STUDY DESIGN: We performed a secondary analysis of a randomized trial. Participants with EPL were instructed to take 200 mg oral mifepristone followed by 800 mcg vaginal misoprostol 24 hours later. The primary outcome was gestational sac expulsion at the first follow-up visit (1-4 days after misoprostol use) after a single dose of misoprostol and no additional intervention within 30 days after treatment. Despite specification of drug timing, participants used the medication over a range of time. We graphed sliding average estimates of success and assessed the proportion of treatment successes over time to define timing interval cohorts for analysis. We used multivariable generalized linear regression to assess the association between time interval and success. RESULTS: Of 139 eligible participants, 70 (50.4%) self-administered misoprostol before 24 hours, and 69 (49.6%) at or after 24 hours. We defined the following time intervals: 0 to 6 hours (n = 22); 7 to 20 hours (n = 29); and 21 to 48 hours (n = 88). Success occurred in 96.6% of the 7- to 20-hour cohort compared to 54.6% and 87.5% of the cohorts self-administering misoprostol earlier or later, respectively. When adjusting for race, gestational age, diagnosis, bleeding at presentation, insurance status, and enrollment site, participants administering misoprostol between 0 and 6 hours (adjusted risk ratio 0.58, 95% CI 0.40-0.85) and 21 to 48 hours (adjusted risk ratio 0.91, 95% CI 0.72-0.99) had a lower risk of success when compared to participants administering 7 to 20 hours after mifepristone. CONCLUSIONS: These data suggest that medical management of EPL has the highest likelihood of success when misoprostol is self-administered 7 to 20 hours after mifepristone. IMPLICATIONS: These preliminary data suggest that patients have the highest likelihood of success when misoprostol is taken between 7 and 20 hours after mifepristone. In contrast with medical abortion, simultaneous medication administration may not be as effective as delayed. Future research is needed to confirm the optimal medication time interval.

Fogacci, F., et al. (2023). "Impact of anti-oestrogen therapy on lipoprotein(a) in postmenopausal women: a systematic review and meta-analysis of double-blind placebo-controlled clinical studies." Endocrine 80(2): 292-302.
	Purpose: The potential mechanisms of endocrine therapy for thrombosis remain currently unclear, and more studies are warranted for further investigation and elucidation. However, high plasma concentration of lipoprotein(a) (Lp(a)) is a recognized prothrombotic factor. The aim of our study was to systematically evaluate the effect of different anti-oestrogen therapy on plasma Lp(a) level in postmenopausal women.; Methods: A systematic literature search was conducted in multiple electronic databases to identify the randomized, double-blind, placebo-controlled clinical studies on this topic. Effect size for changes in Lp(a) was expressed as mean difference (MD) and 95% confidence intervals (CI).; Results: Data were pooled from 10 clinical trials comprising 24 treatment arms, which included 2049 women (1128 women in the active-treated arms and 921 women in the control arms). Meta-analysis of data suggested that anti-oestrogen therapy in women significantly reduced Lp(a) [MD = -5.92% (95%CI: -9.05%,-2.8%)].; Conclusions: This observation is of both clinical and pathophysiological relevance, also in view that the identification of molecular determinants and cellular pathways implicated in Lp(a) synthesis and metabolism is still of concern as a critical issue in lipidology and CV prevention. (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Foglietta, F., et al. (2023). "Ultrasound boosts doxorubicin efficacy against sensitive and resistant ovarian cancer cells." European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V 183: 119-131.
	Ovarian cancer (OC) is characterised by the highest mortality of all gynaecological malignancies, frequent relapses, and the development of resistance to drug therapy. Sonodynamic therapy (SDT) is an innovative anticancer approach that combines a chemical/drug (sonosensitizer) with low-intensity ultrasound (US), which are both harmless per sé, with the sonosensitizer being acoustically activated, thus yielding localized cytotoxicity often via reactive oxygen species (ROS) generation. Doxorubicin (Doxo) is a potent chemotherapeutic drug that has also been recommended as a first-line treatment against OC. This research work aims to investigate whether Doxo can be used at very low concentrations, in order to avoid its significant side effects, as a sonosensitiser under US exposure to promote cancer cell death in Doxo non-resistant (A2780/WT) and Doxo resistant (A2780/ADR) human OC cell lines. Moreover, since recurrence is an important issue in OC, we have also investigated whether the proposed SDT with Doxo induces immunogenic cell death (ICD) and thus hinders OC recurrence. Our results show that the sonodynamic anticancer approach with Doxo is effective in both A2780/WT and A2780/ADR cell lines, and that it proceeds via a ROS-dependent mechanism of action and immune sensitization that is based on the activation of the ICD pathway.; Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2023 Elsevier B.V. All rights reserved.)

Fondazione Irccs Ca' Granda, O. M. P., et al. (2021). IVF Versus Surgery for Endometriosis Related Infertility.
	No Results Available Procedure: Surgery|Procedure: IVF Live birth rate from pregnancies started within 12 months since randomization|Cost-effectiveness evaluation of the two different approaches in the treatment of endometriosis|Detachment of inflammatory mediators that might interfere with IVF through analysis of extracellular vescicles (EV). Female Not Applicable 206 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ENDO-2020-23670289 January 31, 2025

Font Fundación Santiago, D. and U. Dexeus Institut (2021). Dual Trigger for Elective Fertility Preservation.
	No Results Available Drug: Ovulation triggering with GnRH-a+rhCG|Drug: Ovulation triggering with GnRH-a Number of mature oocytes (MIIs) retrieved|Number of oocytes retrieved|Change in Progesterone values|Change in Estradiol values|Change in FSH values|Change in LH values|Ovarian hyperstimulation syndrome (OHSS) (percent) Female Phase 4 136 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment FSD-PSE-2021-09|2021-002467-22 April 25, 2023

Fontes Adriana, F. S., et al. (2023). "Influence of metformin on hyperandrogenism in women with polycystic ovary syndrome: a systematic review and meta-analysis of randomized clinical trials." European Journal of Clinical Pharmacology 79(4): 445-460.
	Purpose: To summarize the effects of metformin treatment on markers of hyperandrogenism in patients diagnosed with polycystic ovary syndrome (PCOS).; Methods: A systematic review, with meta-analysis, of randomized placebo-controlled clinical trials that evaluated the effects of metformin treatment in adult patients with PCOS on the levels of hyperandrogenism markers was conducted. The literature search, data extraction, risk of bias, and the assessment of certainty of evidence were performed independently by two reviewers using a structured form. The results were combined by applying the random effect, and the effect measure presented as a standardized mean difference (SMD). Significant values were considered as p < 0.05 with 95% CI. Furthermore, sensitivity analyses were performed in order to explore possible heterogeneity between studies.; Results: Were included 18 studies in the quantitative evaluation and 17 studies (23 reports) in the quantitative evaluation. A significant reduction in total testosterone levels was seen in the metformin-treated group when compared to the control group after combining the results by the sensitivity analysis [SMD: - 0.46 (95% CI: - 0.89 to - 0.02)]. Therefore, FAI values were also regulated by metformin treatment.; Conclusion: We showed that metformin proved to be effective in reducing total testosterone levels, and the same was observed for free androgen index (FAI) values-a measure influenced by testosterone levels. The protocol of this study was registered at Prospero (CRD42021235761). (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Fordham, T. M., et al. (2024). "Metabolic effects of an essential amino acid supplement in adolescents with PCOS and obesity." Obesity.
	Objective: Polycystic ovary syndrome (PCOS) is characterized by hyperandrogenism, insulin resistance, and hepatic steatosis (HS). Because dietary essential amino acid (EAA) supplementation has been shown to decrease HS in various populations, this study's objective was to determine whether supplementation would decrease HS in PCOS. Method(s): A randomized, double-blind, crossover, placebo-controlled trial was conducted in 21 adolescents with PCOS (BMI 37.3 +/- 6.5 kg/m2, age 15.6 +/- 1.3 years). Liver fat, very low-density lipoprotein (VLDL) lipogenesis, and triacylglycerol (TG) metabolism were measured following each 28-day phase of placebo or EAA. Result(s): Compared to placebo, EAA was associated with no difference in body weight (p = 0.673). Two markers of liver health improved: HS was lower (-0.8% absolute, -7.5% relative reduction, p = 0.013), as was plasma aspartate aminotransferase (AST) (-8%, p = 0.004). Plasma TG (-9%, p = 0.015) and VLDL-TG (-21%, p = 0.031) were reduced as well. VLDL-TG palmitate derived from lipogenesis was not different between the phases, nor was insulin sensitivity (p > 0.400 for both). Surprisingly, during the EAA phase, participants reported consuming fewer carbohydrates (p = 0.038) and total sugars (p = 0.046). Conclusion(s): Similar to studies in older adults, short-term EAA supplementation in adolescents resulted in significantly lower liver fat, AST, and plasma lipids and thus may prove to be an effective treatment in this population. Additional research is needed to elucidate the mechanisms for these effects.Copyright © 2024 The Authors. Obesity published by Wiley Periodicals LLC on behalf of The Obesity Society.

Foreste, V., et al. (2021). "Hysteroscopy and retained products of conception: An update." Gynecology and Minimally Invasive Therapy 10(4): 203-209.
	Retained products of conception (RPOC) can occur after early or mid-trimester pregnancy termination and also following vaginal or cesarean delivery. It is frequently associated with continuous vaginal bleeding, pelvic pain, and infection. Late complications include intrauterine adhesions formation and infertility. Conventionally, the management of RPOC has been with blind dilation and suction curettage (D and C); however, hysteroscopic resection of RPOC is a safe and efficient alternative. In this review, we analyze the current available evidence regarding the use of hysteroscopic surgery for the treatment of RPOC comparing outcomes and complications of both traditional curettage and hysteroscopic technique. Data search has been conducted using the following databases MEDLINE, EMBASE, Web of Sciences, Scopus, Clinical Trial. Gov., OVID, and Cochrane Library interrogate all articles related to hysteroscopy and the preserved product of conception, updated through September 2020.Copyright © 2021 Wolters Kluwer Medknow Publications. All rights reserved.

Forget-Renaud, A., et al. (2021). "An Interdisciplinary Program Promoting the Adoption of a Healthy Lifestyle Increases Insulin Sensitivity in Women With Obesity and Infertility." Canadian journal of diabetes 45(7): S17‐S18.
	Insulin resistance contributes to the pathogenesis of polycystic ovary syndrome and may play a role in obesity‐associated infertility. Since lifestyle modifications are recommended in women affected by these conditions, we hypothesize that such modifications may increase their insulin sensitivity. Methods: Women with obesity and infertility were randomly allocated to usual fertility care (control group, CG) or a lifestyle intervention (LSG) alone for 6 months and then combined with standard care. Insulin resistance was estimated during fasting (HOMA‐IR) and a 75g oral glucose tolerance test (Matsuda Insulin Sensitivity Index, ISI(M)) in women not taking medication affecting insulin sensitivity (except metformin). Data were collected at baseline, 6, 12 and 18 months, and as soon as possible when the participant knew she was pregnant. We estimated the integrated change in insulin sensitivity during follow up, using the incremental area‐under‐the‐curve divided by time (iAUC‐ISI(M)/time). Results: Among 130 randomized participants, 106 had available data (LSG=51, CG=55). As compared to CG, women in the LSG improved significantly their ISI(M) after 6 months (+0.23±1.05 vs ‐0.33±1.53, p=0.045, n=90), as well as their iAUC‐ISI(M)/time during follow up (+0.18±0.84 vs ‐0,21±0,93, p=0.035, n=104). This result remained statistically significant after correction for baseline BMI, age and use of folic acid. There was no impact on HOMA‐IR. Conclusion: An interdisciplinary program promoting the adoption of a healthy lifestyle significantly increases insulin sensitivity in women with infertility and obesity. It may be explained, in part, by the weight loss associated with the intervention and may have a role in improving fertility in this population.

Foroozanfard, F., et al. (2022). "Erratum: note of Concern: effects of Zinc Supplementation on Markers of Insulin Resistance and Lipid Profiles in Women with Polycystic Ovary Syndrome: a Randomized, Double-blind, Placebo-controlled Trial (Exp Clin Endocrinol Diabetes (2015) 123 DOI 10.1055/s-0035-1548790)." Experimental and clinical endocrinology & diabetes.
	Since publication of this article, serious concerns have been raised about the integrity of the reported methods, results and analysis. Responses by the leading author and ethics committees have been unsatisfactory and inconclusive; we advise readers to interpret the information presented in the article with due caution

Foroozanfard, F., et al. (2022). "Erratum: note of Concern: effect of Two Different Doses of Vitamin D Supplementation on Metabolic Profiles of Insulin-Resistant Patients with Polycystic Ovary Syndrome: a Randomized, Double-Blind, Placebo-Controlled Trial (Horm Metab Res (2017) 49 DOI: 10.1055/s-0043-112346)." Hormone and metabolic research.
	Since publication of this article, serious concerns have been raised about the integrity of the reported methods, results and analysis. Responses by the leading author and ethics committees have been unsatisfactory and inconclusive; we advise readers to interpret the information presented in the article with due caution

Foschi, C., et al. (2022). "Vaginal metabolites in postmenopausal women with or without vulvo-vaginal atrophy at baseline and after ospemifeme and systemic hormone treatment." Maturitas 159: 7-14.
	Objectives: Vulvo-vaginal atrophy (VVA) is a highly prevalent chronic condition affecting the lives of postmenopausal women. Ospemifene and systemic hormone therapy (HT) improve vaginal health. This study aims to characterize the vaginal metabolic profile of women with VVA at baseline and after ospemifene and systemic HT.; Study Design: Sixty postmenopausal women, 32 of whom were affected by VVA, were consecutively enrolled. The vaginal metabolic profile of women with and without VVA at baseline and after three months of ospemifene or HT treatment was assessed.; Main Outcome Measures: The following parameters were evaluated: (i) the Vaginal Health Index; (ii) the Vaginal Maturation Index; and (iii) vaginal metabolic profile, by means of 1 H NMR spectroscopy.; Results: The vaginal metabolome of postmenopausal women with VVA was different from that of postmenopausal women without VVA, including a more profound decrease in the levels of lactate and several amino acids, typically found in eubiosis, together with an enrichment of molecules derived from anaerobes and gut microbes. After 3 months, ospemifene and HT had modified the vaginal metabolome of the women with VVA, specifically by increasing the levels of beneficial molecules (e.g., lactate, leucine, glycine) and reducing those involved in dysbiosis (e.g., formate). HT improved the vaginal metabolome to a lesser extent.; Conclusions: The vaginal metabolic profile of postmenopausal women with VVA differs from that of postmenopausal women without VVA. Our preliminary data show that both ospemifene and HT treatment increase the levels of molecules beneficial for vaginal health and reduce the levels of those involved in dysbiosis. HT improves the vaginal metabolic profile to a lower extent than ospemifene over the course of three months.; Competing Interests: MCM had past financial relationships (lecturer, member of advisory boards and/or consultant) with Shionogi Limited, Italfarmaco, MDS Italia, Bayer.MB had past financial relationships (consultant) with Shionogi Limited.All other authors declare that they have no competing interests. (Copyright © 2021. Published by Elsevier B.V.)

Fouad, S., et al. (2021). "Menopause anxiety and depression; how food can help?" Open Access Macedonian Journal of Medical Sciences 9: 64-71.
	BACKGROUND: Anxiety and depression are reported as two major frequent and chief complaints among peri-menopausal women in several societies. AIM: The objective of the study was to study the effect of using two dietary supplements to beat depression and anxiety associated with menopause. SUBJECTS AND METHODS: Sixty-six volunteers' menopausal women participated on the study for 8 weeks, 35 subjects consumed daily cookies prepared mainly from soya flour and flaxseed, and 31 females consumed daily a blend composed mainly of raw unroasted peanut and raw sesame. Follow-up was performed with menopause rating scale, anxiety score, depression score, and biochemical parameters. RESULT(S): Soya cookies were rich in plant-based protein and total phenols while blend was a good source of unsaturated fatty acid. Blend consumers showed significant percentage reduction in beck anxiety score and beck depression score after intervention, more than cookies consumers group. The anthropometrics parameters were statistical significant changed on both groups, more on the group who consumed the soya cookies. Soya cookies demonstrated an anti-inflammatory effect, while blend had an antioxidant and anti-inflammatory effects as was shown on the serum assay of interleukin-6 and malondialdehyde as an inflammatory marker and an antioxidant marker, respectively. CONCLUSION(S): From the results, it can be concluded that the supplementation of products enriched with unsaturated fatty acid was more beneficial to slow down the psychological menopause symptoms than natural estrogen rich product consumption. of women' menopause could develop a condition of.Copyright © 2021 Suzanne Fouad, Salwa M. El Shebini, Maha Abdel-Moaty, Nihad Hassan Ahmed, Ahmed Mohamed Saied Hussein, Hend Abbas Essa, Salwa T. Tapozada.

Foundation, G. O. G. and I. Foundation (2022). A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer.
	No Results Available Device: da Vinci|Other: open surgery Survival Female Not Applicable 840 Other Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GOG-3043 August 2029

Foundation, G. O. G. and GlaxoSmithKline (2024). Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer.
	Main Outcome Measure: Progression-free survival Secondary Outcome Measure: Overall Survival, Frequency and severity of adverse events etc. Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC (Arm A) will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (Arm B) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per institutional standard (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 2-3 cycles) for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing until progression or 36 months (if no evidence of disease).

Fox, R. S., et al. (2022). "Optimizing a Behavioral Sleep Intervention for Gynecologic Cancer Survivors: Study Design and Protocol." Frontiers in Neuroscience 16: 818718.
	Sleep difficulties, particularly symptoms of insomnia and circadian disruption, are among the primary complaints of gynecologic cancer survivors before, during, and after treatment. Moreover, difficulty sleeping has been linked to poorer health-related quality of life and elevated symptom burden in this population. Although leading behavioral sleep interventions have demonstrated efficacy among cancer survivors, up to 50% of survivors are non-adherent to these treatments, likely because these interventions require labor-intensive behavior and lifestyle changes. Therefore, there is a need for more effective and acceptable approaches to diminish sleep disturbance among cancer survivors. This manuscript describes the methodology of a two-part study guided by the Multiphase Optimization Strategy (MOST) framework to identify a streamlined behavioral sleep intervention for gynecologic cancer survivors. Three candidate intervention components previously shown to decrease sleep disturbance will be evaluated, including sleep restriction, stimulus control, and systematic bright light exposure. Participants will be adult women with a history of non-metastatic gynecologic cancer who have completed primary treatment and who report current poor sleep quality. Fifteen participants will be recruited for Part 1 of the study, which will utilize qualitative methods to identify barriers to and facilitators of intervention adherence. Results will inform changes to the delivery of the candidate intervention components to promote adherence in Part 2, where 80 participants will be recruited and randomized to one of eight conditions reflecting every possible combination of the three candidate intervention components in a full factorial design. Participants will complete assessments at baseline, post-intervention, and 3-months post-intervention. Part 2 results will identify the combination of candidate intervention components that yields the most efficacious yet efficient 6-week intervention for diminishing sleep disturbance. This is the first known study to apply the MOST framework to optimize a behavioral sleep intervention and will yield a resource-efficient treatment to diminish sleep disturbance, improve health-related quality of life, and decrease symptom burden among gynecologic cancer survivors. ClinicalTrials.gov Identifier: NCT05044975.Copyright © 2022 Fox, Gaumond, Zee, Kaiser, Tanner, Ancoli-Israel, Siddique, Penedo, Wu, Reid, Parthasarathy, Badger, Rini and Ong.

Fraga Mirian, V., et al. (2022). "Effect of Surgical Treatment for Deep Infiltrating Endometriosis on Pelvic Floor Disorders: A Systematic Review with Meta-analysis." Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia 44(5): 503-510.
	Objectives: To evaluate the impact of surgical treatment of deep infiltrative endometriosis (DIE) on pelvic floor dysfunction (urinary incontinence [UI], pelvic organ prolapse [POP], fecal incontinence [FI)] or constipation, and sexual function [dyspareunia]).; Data Source: The present systematic review was performed in the PubMed database. For the selection of studies, articles should be published by January 5, 2021, without language restriction.; Study Selection: Six randomized controlled studies that evaluated surgical treatment for DIE and the comparison of different surgical techniques were included.; Data Collection: The studies were selected independently by title and abstract by two authors. Disagreements were resolved by a third author. All included studies were also evaluated according to the Cochrane risk of bias tool and the quality of the evidence was analyzed using the GRADE criteria. Subgroup analysis by different treatments and follow-up periods was also performed.; Results: Six studies were included in the quantitative analysis. The risk of bias between studies showed an uncertain risk of bias for most studies, with concealment of allocation being the least reported category. The quality of the evidence was considered low. High heterogeneity was found between the studies. No study has evaluated UI or POP comparatively before and after surgery.; Conclusion: Dyspareunia and FI have improved after the surgical procedure, but it was not possible to demonstrate which surgical technique was related to these outcomes as there was surgical heterogeneity. This diversity was found across data, with the recommendation of future prospective studies addressing pelvic floor disorders with DIE.; Competing Interests: The authors have no conflict of interests to declare. (Federação Brasileira de Ginecologia e Obstetrícia. This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).)

Fraison, E., et al. (2019). "Pregnancy following diagnosis of premature ovarian insufficiency: a systematic review." Reproductive Biomedicine Online 39(3): 467-476.
	The aim of this review is to report the occurrence of pregnancies in women with premature ovarian insufficiency (POI), naturally or with different treatments (hormonal replacement therapy, IVF, in-vitro maturation and stem cell therapy). This study involved an exhaustive search of the electronic databases MEDLINE, PubMed and Embase covering the period January 2000 to January 2018. A combination of Medical Subject Heading and text words was used to generate a subset of citations, including studies involving POI ('premature menopause' or 'premature ovarian failure' or 'POI' or 'hypergonadotrophic amenorrhoea'). This subset of citations was then combined with 'AND' to the Medical Subject Heading term 'pregnancy'. Fifteen studies were included in this review. Two randomized controlled trials, two observational studies, and 11 interventional studies reporting cases of pregnancy in women with POI were included. This review reports pregnancy rates across studies ranging from 2.2% to 14.2%. Mean age in patients who achieved a pregnancy was 30 years, highlighting that oocyte quality in these patients is likely unaffected. No treatment has thus far shown its superiority in improving fertility in women with POI. Recent advances in options such as in-vitro maturation and stem-cell therapy, however, are likely to be the future of treatment and may generate new hope for these patients.Copyright © 2019 Reproductive Healthcare Ltd.

Francés-Herrero, E., et al. (2022). "Bioengineering trends in female reproduction: a systematic review." Human Reproduction Update 28(6): 798-837.
	Background: To provide the optimal milieu for implantation and fetal development, the female reproductive system must orchestrate uterine dynamics with the appropriate hormones produced by the ovaries. Mature oocytes may be fertilized in the fallopian tubes, and the resulting zygote is transported toward the uterus, where it can implant and continue developing. The cervix acts as a physical barrier to protect the fetus throughout pregnancy, and the vagina acts as a birth canal (involving uterine and cervix mechanisms) and facilitates copulation. Fertility can be compromised by pathologies that affect any of these organs or processes, and therefore, being able to accurately model them or restore their function is of paramount importance in applied and translational research. However, innate differences in human and animal model reproductive tracts, and the static nature of 2D cell/tissue culture techniques, necessitate continued research and development of dynamic and more complex in vitro platforms, ex vivo approaches and in vivo therapies to study and support reproductive biology. To meet this need, bioengineering is propelling the research on female reproduction into a new dimension through a wide range of potential applications and preclinical models, and the burgeoning number and variety of studies makes for a rapidly changing state of the field.; Objective and Rationale: This review aims to summarize the mounting evidence on bioengineering strategies, platforms and therapies currently available and under development in the context of female reproductive medicine, in order to further understand female reproductive biology and provide new options for fertility restoration. Specifically, techniques used in, or for, the uterus (endometrium and myometrium), ovary, fallopian tubes, cervix and vagina will be discussed.; Search Methods: A systematic search of full-text articles available in PubMed and Embase databases was conducted to identify relevant studies published between January 2000 and September 2021. The search terms included: bioengineering, reproduction, artificial, biomaterial, microfluidic, bioprinting, organoid, hydrogel, scaffold, uterus, endometrium, ovary, fallopian tubes, oviduct, cervix, vagina, endometriosis, adenomyosis, uterine fibroids, chlamydia, Asherman's syndrome, intrauterine adhesions, uterine polyps, polycystic ovary syndrome and primary ovarian insufficiency. Additional studies were identified by manually searching the references of the selected articles and of complementary reviews. Eligibility criteria included original, rigorous and accessible peer-reviewed work, published in English, on female reproductive bioengineering techniques in preclinical (in vitro/in vivo/ex vivo) and/or clinical testing phases.; Outcomes: Out of the 10 390 records identified, 312 studies were included for systematic review. Owing to inconsistencies in the study measurements and designs, the findings were assessed qualitatively rather than by meta-analysis. Hydrogels and scaffolds were commonly applied in various bioengineering-related studies of the female reproductive tract. Emerging technologies, such as organoids and bioprinting, offered personalized diagnoses and alternative treatment options, respectively. Promising microfluidic systems combining various bioengineering approaches have also shown translational value.; Wider Implications: The complexity of the molecular, endocrine and tissue-level interactions regulating female reproduction present challenges for bioengineering approaches to replace female reproductive organs. However, interdisciplinary work is providing valuable insight into the physicochemical properties necessary for reproductive biological processes to occur. Defining the landscape of reproductive bioengineering technologies currently available and under development for women can provide alternative models for toxicology/drug testing, ex vivo fertility options, clinical therapies and a basis for future organ regeneration studies. (© The Author(s) 2022. Published by Oxford Universit Press on behalf of European Society of Human Reproduction and Embryology.)

Francis Julie, A., et al. (2019). "No. 370-Management of Squamous Cell Cancer of the Vulva." Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC 41(1): 89-101.
	Objective: This guideline reviews the clinical evaluation and management of squamous cell cancer (SCC) of the vulva with respect to diagnosis, primary surgical, radiation, or chemotherapy management and need for adjuvant treatment with chemotherapy and/or radiation therapy. Other vulvar cancer pathologic diagnoses are not included in the guideline.; Intended Users: The first part of this document which includes recommendations 1 through 3 is for general gynaecologists, obstetricians, family doctors, registered nurses, nurse practitioners, residents, and health care providers with a focus on the presentation, diagnosis, and updated information about surgical procedures performed by subspecialists. The surgical management and treatment of advanced vulvar cancer are intended for gynaecologic oncologists, radiation oncologists, and medical oncologists who treat these complex patients. This guideline is intended to provide information for interested parties who may follow these patients once treatment is complete.; Target Population: Adult women (18 years and older) with SCC of the vulva. Excluded from these guidelines are women with preinvasive disease.; Options: Women diagnosed with SCC of the vulva should be referred to a gynaecologic oncologist for initial evaluation, consideration for primary surgery and inguinal lymph node assessment, and potentially adjuvant radiation and/or chemotherapy. All cases of vulvar cancer should have access to discussion at a multidisciplinary cancer case conference. Women who would otherwise require radical surgery such as abdominal-perineal resection or exenterative procedures may be considered for primary treatment with radiation and/or chemotherapy.; Evidence: For this guideline, relevant studies were searched in PubMed, Medline, and the Cochrane Systematic Reviews using the following terms, either alone or in combination, with the search limited to English language materials: vulva, vulvar cancer, inguinofemoral lymph node dissection, sentinel nodes, systemic chemotherapy, radiotherapy, neoadjuvant, adjuvant, primary, exenteration, survival, follow up. The initial search was performed in September 2016 with a final literature search in May 2017. Relevant evidence was selected for inclusion in the following order: meta-analyses, systematic reviews, guidelines, randomized controlled trials, prospective cohort studies, observational studies, non-systematic reviews, case series, and reports. Additional significant articles were identified through cross-referencing the identified reviews. The total number of studies identified was 286, and 78 studies were included in this review.; Validation Methods: The content and recommendations were drafted and agreed upon by the principal authors. The Executive and Board of the Society of Gynecologic Oncology of Canada reviewed the content and submitted comments for consideration, and the Board of the Society of Obstetricians and Gynaecologists of Canada approved the final draft for publication. The quality of evidence was rated using the criteria described in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology framework (Table 1). The interpretation of strong and weak recommendations is described in Table 2. The Summary of Findings is available upon request.; Benefits, Harms, And/or Costs: These guidelines are to encourage physicians in the appropriate use of sentinel inguinal lymph node assessment for SCC of the vulva. The committee also promotes the centralization of treatment of vulvar cancer in specialized treatment centres.; Guideline Update: Evidence will be reviewed 5 years after publication to decide whether all or part of the guideline should be updated. However, if important new evidence is published prior to the 5-year cycle, the review process may be accelerated for a more rapid update of some recommendations.; Sponsors: This guideline was developed with resources funded by the Society of Gynecologic Oncology of Canada and the Society of Obstetricians and Gynaecologists of Canada.; Summary Statemen s: RECOMMENDATIONS. (Copyright © 2018 Society of Obstetricians and Gynaecologists of Canada. Published by Elsevier Inc. All rights reserved.)

Francis, K. E., et al. (2021). "Reporting the trajectories of adverse events over the entire treatment course in patients with recurrent platinum-sensitive ovarian cancer treated with platinum-based combination chemotherapy regimens: a graphical approach to trial adverse event reporting." European journal of cancer (Oxford, England : 1990) 148: 251‐259.
	BACKGROUND: Clinical trials report adverse events (AEs) in a dense table focusing on the frequency of 'worst grade' AEs experienced over the duration of treatment. There is usually no granular information provided on the timing and trajectory of AEs or whether they are likely to worsen, improve, or remain constant over time. PATIENTS AND METHODS: Non‐hematologic (NH) AE data was extracted from the CALYPSO trial comparing carboplatin with pegylated liposomal doxorubicin (CD) to carboplatin with paclitaxel (CP) in recurrent ovarian cancer (ROC). Generalised estimating equations (GEE) were used to assess the risk and trajectory of combined Grade 2 or higher (G2+) AE and of each specific AE. The risk of G2+AE was also compared between treatment arms. RESULTS: The study included 976 patients and AE were reported for the duration of treatment. Most patients experienced at least one G2+NHAE (CP:CD, 96.0%:80.6%). Risk of combined G2+AE increased with CP (4.1% per‐cycle) but decreased with CD (0.8%, P <0.01). When alopecia and sensory neuropathy were excluded, risk of G2+ AE decreased by 2.7% per‐cycle, with no significant difference between treatment arms. G2+ nausea improved (15.2% per‐cycle, P <0.01). G2+ sensory neuropathy worsened (29.3% per‐cycle, P <0.01). Fatigue was stable (17% per‐cycle, P =0.06) whilst G2+ pain decreased over time (13.4% per‐cycle, P <0.01), with no difference between treatment arms. CONCLUSION: Existing trial data can be used to provide AE trajectories as illustrated here for ROC. These trajectories have utility in guiding treatment choice and potentially optimising AE management with novel therapies and treatment combinations.

Francis, K. E., et al. (2022). "The impact of olaparib dose reduction and treatment interruption on treatment outcome in the SOLO2/ENGOT-ov21 platinum-sensitive recurrent ovarian cancer." Annals of oncology : official journal of the European Society for Medical Oncology 33(6): 593-601.
	Background: Maintenance treatment with poly (ADP-ribose) polymerase (PARP) inhibitor is now the standard of care in patients with BRCA-mutated platinum-sensitive recurrent ovarian cancer following response to chemotherapy. In the SOLO2 trial, adverse event (AE)-associated olaparib interruption, dose reduction, and discontinuation occurred in 50%, 28%, and 17% of patients, respectively. We used data from the SOLO2 trial to evaluate the impact of dose alterations on survival outcomes and identified baseline characteristics associated with dose alteration.; Patients and Methods: We computed relative dose intensity (RDI) defined as the received dose as a percentage of the standard dose (300 mg twice a day) during the first 12 weeks on treatment. Patients were categorized into RDI >98%, RDI 90%-98%, and RDI <90%. The association between RDI categories with progression-free survival (PFS) and overall survival (OS) were examined using a 12-week landmark Cox regression analysis. Logistic regression analysis was used to correlate baseline factors with RDI at 12 weeks.; Results: In patients on olaparib included in the landmark analysis (n = 185), the mean 12-week RDI was 91.4%. There was no significant difference across 12-week RDI >98% (n = 110), 90%-98% (n = 29), and <90% (n = 45) categories for PFS (median, 14.2 versus 19.3 versus 34.4 months; P = 0.37) and OS (median, 49.7 versus 49.5 versus 54.1 months; P = 0.84). Risk of RDI ≤90% increased with baseline performance status 1 [odds ratio (OR): 2.54; 95% confidence interval (CI): 1.11-5.82] any nausea (OR: 3.17; 95% CI: 0.9-11.23), and with body weight ≤70 kg (OR: 1.86; 95% CI: 0.92-3.76).; Conclusions: Dose reduction and interruption for the management of olaparib-associated AEs during the first 12 weeks did not impact on PFS and OS. When counselling patients requiring dose reductions or interruptions due to AEs, the results of this study will help assure patients that their outcomes will not be adversely affected.; Competing Interests: Disclosure KEF reports intuitional funding from AstraZeneca (AZ). MF reports institutional funding from AZ, Novartis, and Beigene; consulting fees from AZ, Novartis, GlaxoSimthKline (GSK), Merck Sharp & Dohme (MSD), Takeda, and Lilly; honoraria for lectures from AZ, GSK, and ACT-Genomics; travel support from AZ; and participation in a data advisory role with Australasian Gastro-Intestinal Cancer Trials Group and Independent Data and Safety Monitoring Board. IRC reports personal fees and travel support from AZ, GSK, and Clovis Oncology; and personal fees from Roche, Mersana, Deciphera, Eisai, Amgen, Bristol Myers Squibb, OncXerna, and Aravive. AC reports institutional research funding from AZ; payment from Clovis Oncology for lectures and travel support; and he participates in an advisory role to AZ. RP reports institutional funding from AZ. He participates in an advisory role to AbbVie, AZ, Care4ward (unpaid), Clovis Oncology, Curio Science, Eisai Inc., Genentech, Janssen Oncology (J&J), Merck & Co., Mersana Therapeutics, Inc., NewLink Genetics, Nexus Global Group, Pieris Pharma Inc., Roche, Inc., Sutro Biopharma, Syndax Pharmaceuticals, Tesaro Inc., Vascular Biogenics Ltd. NC reports grants, consulting fees, and personal fees from AZ; consulting fees and personal fees from GSK; and personal fees from Tesaro, Novartis, Clovis, MSD, GSK, EISAI. She participates in an advisory role with Roche, PharmaMar, AZ, Clovis Oncology, MSD, GSK, Tesaro, Pfizer, BIOCAD, ImmunoGen, Mersana, OncXerna, and Eisai. KF reports institutional research funding and honoraria for lectures from AZ. GS reports institutional research funding from AZ, MSD, Novartis, and Roche; and consulting fees paid to the institution from BioViva and Segen. IV reports receiving institutional fees from Oncoinvent AS and Genmab; grant funding from Amgen and Roche; consulting fees from Aksebio, Amgen, GmbH, AZ, Clovis Oncology, Carrick Therapeutics, Deciphera Pharmaceuticals, Eisai, Elevar Therapeutics, Roche, Genmab, GSK, Immunogen Inc., Jazz Pharma, Karyopharm, Mersana, Millennium Pharmaceuticals, MSD, Novocure, Novartis, Octimet Oncology NV, Oncoinvent AS, Sotio a.s., Verastem Oncology, Zentalis; and travel expenses from Amgen, MSD, Tesaro, AZ, Roche. EPL reports medical writing assistance for the primary SOLO2 publication from AZ; institutional grants from AZ and Merck; personal payments for lectures from AZ and GSK; and participation in an advisory role with Incyte, Roche, and Pfizer. He reports other interests including as an employee of ARCAGY GINECO research group. CKL reports institutional payments from Roche, AZ, and Merck KGA; and personal payments for lectures, presentations or travel support from AZ, Amgen, Takeda, Boehringer Ingelheim, Pfizer, Yuhan, Merck KGA, Roche, and MSD. All other authors have declared no conflicts of interest. (Copyright © 2022 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved.)

Francischini Cristiane Raquel, D., et al. (2022). "Antitumor effects of oleandrin in different types of cancers: Systematic review." Toxicon : official journal of the International Society on Toxinology 216: 15-27.
	Oleandrin, a cardiac glycoside isolated from the leaves of Nerium oleander, has known effects on the heart. Evidence from recent studies have highlighted its potential for anticancer properties. Therefore, we aimed to investigate the effects of oleandrin on cancer cell proliferation, viability and apoptosis in vitro and in vivo. We performed a systematic search in six electronic databases up to Jan 2022. We extracted information about the effects of oleandrin on cell proliferation, cell viability, apoptosis and/or cell cycle arrest in in vitro studies, and the effects on tumor size and volume in animal experimental models. We have retrieved 775 scientific studies. 14 studies met the inclusion criteria. They investigated the effects of oleandrin on breast, lung, pancreatic, colon, prostate, colorectal, oral, ovarian, glioma, melanoma, glioblastoma, osteosarcoma, and histiocytic lymphoma cancers. Overall, in vitro studies demonstrated that oleandrin was able to inhibit cell proliferation, decrease cell viability, and induce apoptosis and/or cell cycle arrest. In addition, oleandrin had an effect on reducing mean tumor size and volume in animal studies. Oleandrin, as a cytotoxic agent, demonstrated antitumor effects in different types of cancers, however important clinical limitations remain a concern. These results encourage future studies to verify the applicability of oleandrin in antineoplastic therapeutic protocols human and veterinary medicine, the investigation of antimetastatic properties, as well as the potential increase in patient survival and the decrease of tumor markers. (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Francisco, A.-C., et al. (2022). "A systematic review on the effectiveness of physical rehabilitation interventions to reduce symptom burden and improve quality of life in women with endometriosis and/or adenomyosis."
	
Francisco Javier, R., et al. (2021). "Uterine artery embolization of uterine arteriovenous malformation: a systematic review."
	
Francisco Phorenice, D., et al. (2022). "Efficacy of lymphocyte immunotherapy in the treatment of recurrent pregnancy loss from alloimmunity: A systematic review and meta-analysis." American journal of reproductive immunology (New York, N.Y. : 1989) 88(4): e13605.
	Problem: The efficacy of lymphocyte immunotherapy (LIT) in the treatment of recurrent pregnancy loss (RPL) from alloimmunity has been debated for years. There is conflicting evidence on the therapeutic role of LIT, since the etiology of most cases of RPL is previously classified as idiopathic.; Method of Study: A systematic search of PubMed and Cochrane databases was done for randomized controlled trials that assessed the efficacy of paternal lymphocyte or third donor LIT among patients with primary or secondary RPL. The primary outcome was live birth rate after LIT. Random-effect meta-analysis was conducted using the software RevMan 5.4. Pre-planned subgroup analyses of source of lymphocytes, timing and frequency of administration, and concentration per immunization dose were conducted.; Results: Data from eight trials showed a statistically significant benefit of LIT (RR = 1.45, 95% CI 1.05-2.01). The overall live birth rate is higher in the treatment group (65.6%) compared to placebo or no treatment (45.2%). Subgroup analysis based on source of lymphocytes revealed a trend towards benefit with paternal LIT but with wide confidence interval (RR = 1.34, 95% CI = .84-2.14). Multiple doses of immunotherapy before pregnancy and low dose (5×10 6 cells) LIT showed significant benefit. Sensitivity analysis involving studies with a low risk of bias demonstrated significant benefit of increased live birth rate among patients treated with LIT compared to those who received placebo or no treatment (RR = 1.97, 95% CI = 1.53-2.53).; Conclusion: LIT demonstrate benefit in improving pregnancy outcome of patients with RPL from alloimmunity. (© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Franciszek, D., et al. (2020). "Ovarian Cancer and Pregnancy-A Current Problem in Perinatal Medicine: A Comprehensive Review." Cancers 12(12): 1-18.
	The frequency of concomitant adnexal tumors in pregnancy is reported to be at 0.15-5.7%, while ovarian cancer complicates 1 in 15,000 to 1 in 32,000 pregnancies, being the second most common gynecologic cancer diagnosed during pregnancy. The aim of this review is to discuss the problem of ovarian cancer complicating pregnancy and the current recommendations for diagnostics and treatment, with an emphasis on the risk to the fetus. A detailed analysis of the literature found in the PubMed and MEDLINE databases using the keywords "ovarian cancer", "ovarian malignancy", "adnexal masses", "ovarian tumor" and "pregnancy" was performed. There were no studies on a large series of pregnant women treated for ovarian malignancies and the management has not been well established. The diagnostics and therapeutic procedures need to be individualized with respect to the histopathology of the tumor, its progression, the gestational age at the time of diagnosis and the mother's decisions regarding pregnancy preservation. The multidisciplinary cooperation of specialists in perinatal medicine, gynecological oncology, chemotherapy, neonatology and psychology seems crucial in order to obtain the best possible maternal and neonatal outcomes.

Franck, L. S., et al. (2023). "Maternal mental health after infant discharge: a quasi-experimental clinical trial of family integrated care versus family-centered care for preterm infants in U.S. NICUs." BMC pediatrics 23(1): 396.
	BACKGROUND: Involvement in caregiving and tailored support services may reduce the risk of mental health symptoms for mothers after their preterm infant's neonatal intensive care unit (NICU) discharge. We aimed to compare Family-Centered Care (FCC) with mobile-enhanced Family-Integrated Care (mFICare) on post-discharge maternal mental health symptoms. METHOD: This quasi-experimental study enrolled preterm infant (≤ 33 weeks)/parent dyads from three NICUs into sequential cohorts: FCC or mFICare. We analyzed post-discharge symptoms of perinatal post-traumatic stress disorder (PTSD) and depression using intention-to-treat and per protocol approaches. RESULTS: 178 mothers (89 FCC; 89 mFICare) completed measures. We found no main effect of group assignment. We found an interaction between group and stress, indicating fewer PTSD and depression symptoms among mothers who had higher NICU-related stress and received mFICare, compared with mothers who had high stress and received FCC (PTSD: interaction β=-1.18, 95% CI: -2.10, -0.26; depression: interaction β=-0.76, 95% CI: -1.53, 0.006). Per protocol analyses of mFICare components suggested fewer PTSD and depression symptoms among mothers who had higher NICU stress scores and participated in clinical team rounds and/or group classes, compared with mothers who had high stress and did not participate in rounds or classes. CONCLUSION: Overall, post-discharge maternal mental health symptoms did not differ between the mFICare and FCC groups. However, for mothers with high levels of stress during the NICU stay, mFICare was associated with fewer post-discharge PTSD and depression symptoms.

Franco, M. M., et al. (2021). "Pelvic Floor Muscle Training Effect in Sexual Function in Postmenopausal Women: A Randomized Controlled Trial." The Journal of Sexual Medicine 18(7): 1236-1244.
	BACKGROUND: The prevalence of sexual dysfunction is high in postmenopausal women and pelvic floor muscle training (PFMT) could improve sexual function during this period. AIM: To assess the effect of a PFMT protocol on sexual function in postmenopausal women and to investigate the effect of this protocol on pelvic floor muscle function. METHODS: This is an assessor blinded randomized controlled trial including 77 postmenopausal women. The study was registered in ReBEC Trial: RBR-3s3ff7. The intervention group (n = 40) received an intensive supervised PFMT protocol during 12 weeks and the control group (n = 37) received no intervention. OUTCOMES: The primary outcome of the study was assessed by the Female Sexual Function Index (FSFI) questionnaire and the secondary outcome was the evaluation of pelvic floor muscle function performed by digital palpation using the modified Oxford scale at baseline and after 12 weeks. RESULTS: No difference between groups was found in the FSFI domains and total score at baseline and in the second evaluation after 12 weeks. However, after 12 weeks, a higher percentage of women without sexual dysfunction was found in the intervention group (95% CI = 27.97-72.03) when compared to the control group (95% CI = 7.13-92.87). No difference was found between groups in relation to the pelvic floor muscle function at the baseline (P = .2) and after 12 weeks (P = .06). CLINICAL IMPLICATIONS: PFMT is a conservative intervention that can lead women to have less sexual dysfunction. STRENGTHS & LIMITATIONS: The protocol provided a reduced number of women with sexual dysfunction, the strength of this research is the study design and the limitation is to have used only one tool to assess sexual function although it is a validated questionnaire. CONCLUSION: PFMT decreases sexual dysfunction in postmenopausal women. MM Franco, CC Pena, LM de Freitas, et al. Pelvic Floor Muscle Training Effect in Sexual Function in Postmenopausal Women: A Randomized Controlled Trial. J Sex Med 2021;18:1236-1244.

François, R. and O. D (2021). "Effectiveness of Osteopathic Treatment in Patients With Primary Dysmenorrhea." ClinicalTrials.gov.
	It will be a prospective study, a double-blind randomized controlled clinical trial. The sample group will include 60 patients, between 18 and 30 years old divided into two experimental groups. The experimental group (n = 30) will be treated following an osteopathic treatment, through a bilateral global pelvic manupulation (GPM) and a specific internal technique for mobility of the cervix, and the control group (n = 30) will only carry out a bilateral GPM. A measurement will be made before the first treatment, another after each session, and the last one two weeks after the last intervention (anthropometric measurements, quality of life questionnaire, sexual health, osteopathic tests, pressure point with algometer, pain and medicines consumption). The established outcome measures are: pain intensity according to the visual analog scale (VAS), depression points measured with an algometer, a health-related quality of life questionnaire, questionnaire sexual health and sexual dysfunctions, and the measurement of drug consumption.

Franik, S., et al. (2020). "Aromatase inhibitors for ovarian stimulation in subfertile women with polycystic ovary syndrome: Summary of a Cochrane meta-analysis." Gynakologe 53(12): 841-846.
	Background: Polycystic ovary syndrome (PCOS) is the most common cause of infrequent periods (oligomenorrhoea) and absence of periods (amenorrhoea), often leading to subfertlity. The aim of this meta-analysis was to compare the effectiveness and safety of aromatase inhibitors with other medical therapies for ovulation induction in subfertile women with PCOS. Method(s): An extensive systematic literature search was done to identify relevant randomized controlled trials (RCTs). The primary outcomes were live birth and ovarian hyperstimulation syndrome (OHSS). Secondary endpoints were pregnancy rate, miscarriage rate, and multiple pregnancy rate. Result(s): A total of 42 RCTs (7935 women) in which the aromatase inhibitor letrozole was used were included. In 25 RCTs, comparisons were also made to clomiphene citrate. Live birth rates were higher with letrozole compared to clomiphene citrate (odds ratio [OR] 1.68, 95% CI 1.42-1.99; 2954 participants; 13 studies; I2= 0%; number needed to treat for an additional beneficial outcome [NNTB]= 10; moderate-quality evidence). There is high-quality evidence that OHSS rates are similar with letrozole and clomiphene citrate (0.5% in both arms: risk difference [RD] -0.00, 95% CI -0.01 to 0.00; 2536 participants; 12 studies; I2= 0%; high-quality evidence). There is evidence for a higher pregnancy rate in favor of letrozole (OR 1.56, 95% CI 1.37-1.78; 4629 participants; 25 studies; I2= 1%; NNTB= 10; moderate-quality evidence). There is little or no difference between treatment groups in the rate of miscarriage (OR 0.94, 95% CI 0.70-1.26; 1210 participants; 18 studies; I2= 0%; high-quality evidence) and multiple pregnancy rate (OR 0.69, 95% CI 0.41-1.16; 3579 participants; 17 studies; I2= 0%; high-quality evidence). Conclusion(s): Compared to clomiphene citrate, letrozole shows a significantly increased rate of live births and pregnancies. The quality of evidence of the analysis is high to moderate. The incidence of OHSS was the same in both groups-Copyright © 2020, Springer Medizin Verlag GmbH, ein Teil von Springer Nature.

Frankel, J., et al. (2022). "Interpretation of the Meaningfulness of Symptom Reduction with Vibegron in Patients with Overactive Bladder: Analyses from EMPOWUR." Advances in Therapy 39(2): 959-970.
	Introduction: Reductions in bothersome symptoms of overactive bladder (OAB) demonstrate improvement in clinical trials, but patient perception of meaningfulness of such improvement is lacking. In the 12-week phase 3 EMPOWUR trial, vibegron significantly reduced average daily number of micturitions, urgency episodes, and urge urinary incontinence (UUI) episodes vs placebo (P < 0.01 each). This analysis assessed meaningfulness of reductions in clinical endpoints observed in EMPOWUR using patient perception of improvement. Method(s): An anchor-based approach using Patient Global Impression of Change (PGI-C) applied to phase 2 data allowed predefining phase 3 responder definitions. To confirm in phase 3, median change from baseline at week 12 in average daily number of micturitions, urgency episodes, and UUI episodes was generated for each PGI-C category and pooled across treatments. Based on predefined meaningful responder definitions, percentages of patients achieving >= 15% reduction in micturitions (post hoc), >= 50% reduction in urgency episodes (predefined), and >= 75% (predefined) and >= 90% (post hoc) reduction in UUI episodes were determined for patients receiving vibegron or placebo. Result(s): Across treatments, for micturitions, urgency episodes, and UUI episodes, median change from baseline to week 12 increased with greater subjective improvement based on PGI-C scores, and median reductions pooled across treatment groups were higher than the responder definitions that patients perceived as improved. Significantly more patients receiving vibegron vs placebo achieved >= 15% reduction in micturitions (56.3% vs 44.6%, respectively), >= 50% reduction in urgency episodes (39.5% vs 32.8%), >= 75% reduction in UUI episodes (49.3% vs 32.8%), and >= 90% reduction in UUI episodes (35.2% vs 23.5%) at week 12 (P < 0.05 each). Conclusion(s): Significantly more patients treated with vibegron vs placebo in EMPOWUR achieved meaningful reductions in micturitions, urgency episodes, and UUI episodes that were associated with patient-perceived improvement. Results of these analyses support the meaningfulness of reductions in clinical endpoints observed in the 12-week EMPOWUR trial. Clinical Trials Registration: ClinicalTrials.gov identifier, NCT03492281.Copyright © 2021, The Author(s).

Frankel, J., et al. (2022). "LONG-TERM EFFICACY AND SAFETY OF VIBEGRON FOR OVERACTIVE BLADDER IN PATIENTS 65 YEARS OLD: ANALYSIS FROM THE EMPOWUR EXTENSION TRIAL." Journal of urology 207(SUPPL 5): e649-e650.
	INTRODUCTION AND OBJECTIVE: Overactive bladder (OAB) prevalence increases with age. Vibegron is a b3-adrenergic agonist approved for adults with OAB. In the phase 3 EMPOWUR extension trial, once-daily vibegron 75 mg showed long-term safety and efficacy in patients with OAB, consistent with results of the 12-week study. These post hoc analyses of the extension trial assessed safety and efficacy in patients >=65 years old. METHOD(S): Patients completing EMPOWUR could enter the 40-week extension (NCT03583372). Patients previously receiving vibegron or tolterodine 4 mg extended release continued treatment; patients receiving placebo were randomized 1:1 to vibegron or tolterodine. The primary outcome was safety, assessed by adverse events (AEs). Key efficacy endpoints were change from EMPOWUR baseline at week 52 in average daily micturitions, urge urinary incontinence (UUI) episodes, and urgency episodes. Outcomes were assessed in patients >=65 years old. RESULT(S): Of 505 patients receiving >=1 dose in the extension (n=273, vibegron; n=232, tolterodine), 235 were >=65 years old. Of patients >=65 years old, 71.1% were female; 75.7% had OAB wet (incontinence). After 40-52 weeks of treatment, treatment-related AE rate was similar between vibegron (33.3%) and tolterodine (25.5%) (Table 1). The most commonly occurring AEs (vibegron/tolterodine) were hypertension (10.9%/9.4%), urinary tract infection (7.8%/12.3%), and headache (7.0%/4.7%). Patients who received 52 weeks of active treatment showed improvement in least squares mean change from baseline at week 52 in micturitions (vibegron, -2.3; tolterodine, -1.7), UUI episodes (-1.8; -1.2), and urgency episodes (-3.3; -2.4) (Table 2). Safety and efficacy outcomes were generally similar in patients >=75 years old. CONCLUSION(S): In this subgroup analysis of the EMPOWUR extension trial, vibegron was associated with sustained reductions from baseline in micturitions, UUI episodes, and urgency episodes and was safe in older adults (>=65 y) with OAB, consistent with the overall population.

Frankel, J., et al. (2021). "Vibegron improves quality-of-life measures in patients with overactive bladder: patient-reported outcomes from the EMPOWUR study." International Journal of Clinical Practice 75(5): e13937.
	Background: Quality of life (QOL) can be significantly impacted by symptoms of overactive bladder (OAB). Vibegron is a highly selective β3‐adrenergic receptor agonist that showed efficacy in treatment of symptoms of OAB in the randomised, double‐blind, placebo‐ and active‐controlled phase 3 EMPOWUR trial. Here we report patient‐reported QOL outcomes from the EMPOWUR trial. Methods: Patients were randomly assigned 5:5:4 to receive vibegron 75 mg, placebo or tolterodine 4 mg extended release, respectively, for 12 weeks. Patients completed the OAB questionnaire (OAB‐q) at baseline and at week 12 and the patient global impression (PGI) scales for severity, control, frequency and leakage at baseline and at weeks 4, 8 and 12. Change from baseline at week 12 and responder rates (OAB‐q: patients achieving a ≥10‐point improvement; PGI: patients reporting best possible response) were assessed. Vibegron was compared with placebo, and no comparisons were made between vibegron and tolterodine. Results: Of the 1518 patients randomised, 1463 (placebo, n = 520; vibegron, n = 526; tolterodine, n = 417) had evaluable data for efficacy measures and were included in the analysis. Mean baseline OAB‐q and PGI scores were comparable among treatment groups. At week 12, patients receiving vibegron had greater improvements from baseline in OAB‐q subscores of coping, concern, sleep, health‐related QOL total and symptom bother (P <.01 each) compared with patients receiving placebo; a greater proportion of patients receiving vibegron vs placebo were responders in the OAB‐q coping (P <.05) and symptom bother scores (P <.0001). Compared with placebo, a greater proportion of patients who received vibegron achieved the best response on all PGI end‐points at week 12 (P <.05 each) and were classified as responders (P <.05 each). Conclusions: In the 12‐week EMPOWUR trial, treatment with vibegron was associated with significantly greater and clinically meaningful improvement in OAB‐q and PGI scores compared with placebo, consistent with improvements in OAB symptoms. Clinical trial registration: ClinicalTrials.gov identifier number NCT03492281.

Fransen, A. F., et al. (2020). "Multi-professional simulation-based team training in obstetric emergencies for improving patient outcomes and trainees' performance." The Cochrane Database of Systematic Reviews 12(12): CD011545.
	BACKGROUND: Simulation-based obstetric team training focuses on building a system that will anticipate errors, improve patient outcomes and the performance of clinical care teams. Simulation-based obstetric team training has been proposed as a tool to improve the overall outcome of obstetric health care. OBJECTIVES: To assess the effects of simulation-based obstetric team training on patient outcomes, performance of obstetric care teams in practice and educational settings, and trainees' experience. SEARCH METHODS: The Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) were searched (14 April 2020), together with references checking and hand searching the available proceedings of 2 international conferences. SELECTION CRITERIA: We included randomised controlled trials (RCTs) (including cluster-randomised trials) comparing simulation-based obstetric team training with no, or other type of training. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane, to identify articles, assess methodological quality and extract data. Data from three cluster-randomised trials could be used to perform generic inverse variance meta-analyses. The meta-analyses were based on risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs). We used the GRADE approach to rate the certainty of the evidence. We used Kirkpatrick's model of training evaluation to categorise the outcomes of interest; we chose Level 3 (behavioural change) and Level 4 (patient outcome) to categorise the primary outcomes. MAIN RESULTS: We included eight RCTs, six of which were cluster-randomised trials, involving more than 1000 training participants and more than 200,000 pregnancies/births. Four studies reported on outcome measures on Kirkpatrick level 4 (patient outcome), three studies on Kirkpatrick level 3 (performance in practice), two studies on Kitkpatrick level 2 (performance in educational settings), and none on Kirkpatrick level 1 (trainees' experience). The included studies were from Mexico, the Netherlands, the UK and the USA, all middle- and high-income countries. Kirkpatrick level 4 (patient outcome) Simulation-based obstetric team training may make little or no difference for composite outcomes of maternal and/or perinatal adverse events compared with no training (3 studies; n = 28,731, low-certainty evidence, data not pooled due to different composite outcome definitions). We are uncertain whether simulation-based obstetric team training affects maternal mortality compared with no training (2 studies; 79,246 women; very low-certainty evidence). However, it may reduce neonatal mortality (RR 0.70, 95% CI 0.48 to 1.01; 2 studies, 79,246 pregnancies/births, low-certainty evidence). Simulation-based obstetric team training may have little to no effect on low Apgar score compared with no training (RR 0.99, 95% 0.85 to 1.15; 2 studies; 115,171 infants; low-certainty evidence), but it probably reduces trauma after shoulder dystocia (RR 0.50, 95% CI 0.25 to 0.99; 1 study; moderate-certainty evidence) and probably slightly reduces the number of caesarean deliveries (RR 0.79, 95% CI 0.67 to 0.93; 1 study; n = 50,589; moderate-certainty evidence) Kirkpatrick level 3 (performance in practice) We found that simulation-based obstetric team training probably improves the performance of the obstetric teams in practice, compared with no training (3 studies; 2398 obstetric staff members, moderate-certainty evidence, data not pooled due to different outcome definitions). AUTHORS' CONCLUSIONS: Simulation-based obstetric team training may help to improve team performance of obstetric teams, and it might contribute to improvement of specific maternal and perinatal outcomes, compared with no training. However, high-certainty evidence is lacking due to serious risk of bias and imprecision, and the effect cannot be generalised for all outcomes. Future studies investigating simulation-based obstetric team training compared training courses with a different instructional design should carefully consider how and when to measure outcomes. Particular attention should be paid to effect measurement at the level of patient outcome, taking into consideration the low incidence of adverse maternal and perinatal events.

Frassanito, L., et al. (2023). "Hypotension Prediction Index guided Goal Directed therapy and the amount of Hypotension during Major Gynaecologic Oncologic Surgery: a Randomized Controlled clinical Trial." Journal of Clinical Monitoring and Computing 37(4): 1081-1093.
	Intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Hypotension Prediction Index (HPI) is a machine learning derived algorithm that predicts IOH shortly before it occurs. We tested the hypothesis that the application of the HPI in combination with a pre-defined Goal Directed Therapy (GDT) hemodynamic protocol reduces IOH during major gynaecologic oncologic surgery. We enrolled women scheduled for major gynaecologic oncologic surgery under general anesthesia with invasive arterial pressure monitoring. Patients were randomized to a GDT protocol aimed at optimizing stroke volume index (SVI) or hemodynamic management based on HPI guidance in addition to GDT. The primary outcome was the amount of IOH, defined as the timeweighted average (TWA) mean arterial pressure (MAP) < 65 mmHg. Secondary outcome was the TWA-MAP < 65 mmHg during the first 20 min after induction of GA. After exclusion of 10 patients the final analysis included 60 patients (30 in each group). The median (25-75th IQR) TWA-MAP < 65 mmHg was 0.14 (0.04-0.66) mmHg in HPI group versus 0.77 (0.36-1.30) mmHg in Control group, P < 0.001. During the first 20 min after induction of GA, the median TWA-MAP < 65 mmHg was 0.53 (0.06-1.8) mmHg in the HPI group and 2.15 (0.65-4.2) mmHg in the Control group, P = 0.001. Compared to a GDT protocol aimed to SVI optimization, a machine learning-derived algorithm for prediction of IOH combined with a GDT hemodynamic protocol, reduced IOH and hypotension after induction of general anesthesia in patients undergoing major gynaecologic oncologic surgery. Trial registration number: NCT04547491. Date of registration: 10/09/2020.Copyright © 2023, The Author(s).

Frassanito, L., et al. (2023). "Effect of a pre-emptive 2-hour session of high-flow nasal oxygen on postoperative oxygenation after major gynaecologic surgery: a randomised clinical trial." British Journal of Anaesthesia 131(4): 775-785.
	Background: We aimed at determining whether a 2-h session of high-flow nasal oxygen (HFNO) immediately after extubation improves oxygen exchange after major gynaecological surgery in the Trendelenburg position in adult female patients. Method(s): In this single-centre, open-label, randomised trial, patients who underwent major gynaecological surgery were randomised to HFNO or conventional oxygen treatment with a Venturi mask. The primary outcome was the Pao2/FiO2 ratio after 2 h of treatment. Secondary outcomes included lung ultrasound score, diaphragm thickening fraction, dyspnoea, ventilatory frequency, Paco2, the percentage of patients with impaired gas exchange (Pao2/FiO2 <=40 kPa) after 2 h of treatment, and postoperative pulmonary complications at 30 days. Result(s): A total of 83 patients were included (42 in the HFNO group and 41 in the conventional treatment group). After 2 h of treatment, median (inter-quartile range) Pao2/FiO2 was 52.9 (47.9-65.2) kPa in the HFNO group and 45.7 (36.4 -55.9) kPa in the conventional treatment group (mean difference 8.7 kPa [95% CI: 3.4 to 13.9], P=0.003). The lung ultrasound score was lower in the HFNO group than in the conventional treatment group (9 [6-10] vs 12 [10-14], P<0.001), mostly because of the difference of the score in dorsal areas (7 [6-8] vs 10 [9-10], P<0.001). The percentage of patients with impaired gas exchange was lower in the HFNO group than in the conventional treatment group (5% vs 37%, P<0.001). All other secondary outcomes were not different between groups. Conclusion(s): In patients who underwent major gynaecological surgery, a pre-emptive 2-h session of HFNO after extubation improved postoperative oxygen exchange and reduced atelectasis compared with a conventional oxygen treatment strategy. Clinical trial registration: NCT04566419.Copyright © 2023 British Journal of Anaesthesia

Frazer, K., et al. (2022). "Systematic Review of Smoking Cessation Interventions for Smokers Diagnosed with Cancer." International Journal of Environmental Research and Public Health 19(24).
	The detrimental impact of smoking on health and wellbeing are irrefutable. Additionally, smoking is associated with the development of cancer, a reduction treatment outcomes and poorer health outcomes. Nevertheless, a significant number of people continue to smoke following a cancer diagnosis. Little is understood of the smoking cessation services provided to smokers with cancer or their engagement with them. This systematic review aimed to identify existing smoking cessation interventions for this cohort diagnosed with breast, head and neck, lung and cervical cancers (linked to risk). Systematic searches of Pubmed, Embase, Psych Info and CINAHL from 1 January 2015 to 15 December 2020 were conducted. Included studies examined the characteristics of smoking cessation interventions and impact on referrals and quit attempts. The impact on healthcare professionals was included if reported. Included studies were restricted to adults with a cancer diagnosis and published in English. No restriction was placed on study designs, and narrative data synthesis was conducted due to heterogeneity. A review protocol was registered on PROSPERO CRD 42020214204, and reporting adheres to PRISMA reporting guidelines. Data were screened, extracted in duplicate and an assessment of the quality of evidence undertaken using Mixed Methods Assessment Tool. 23 studies met the inclusion criteria, representing USA, Canada, England, Lebanon, Australia and including randomized controlled trials (9), observational studies (10), quality improvement (3), and one qualitative study. Hospital and cancer clinics [including a dental clinic] were the settings for all studies. 43% (10/23) of studies reported interventions for smokers diagnosed with head and neck cancer, 13% (3/23) for smokers diagnosed with lung cancer, one study provides evidence for breast cancer, and the remaining nine studies (39%) report on multiple cancers including the ones specified in this review. Methodological quality was variable. There were limited data to identify one optimal intervention for this cohort. Key elements included the timing and frequency of quit conversations, use of electronic records, pharmacotherapy including extended use of varenicline, increased counselling sessions and a service embedded in oncology departments. More studies are required to ensure tailored smoking cessation pathways are co-developed for smokers with a diagnosis of cancer to support this population.

Frechtling, D., et al. (2024). "The Association Between Human Immunodeficiency Virus and Bacterial Vaginosis and Metronidazole Treatment Failure for Trichomonas vaginalis." Sexually Transmitted Diseases 51(1): 61-64.
	Background Trichomonas vaginalis (TV) is a common sexually transmitted infection. High rates of repeated infections have been observed, particularly among women living with human immunodeficiency virus (HIV). Trichomonas vaginalis frequently cooccurs with bacterial vaginosis (BV). The purpose of this study was to determine if coinfections with TV, BV, and HIV could lead to differential treatment failure outcomes. Methods Data were pooled from 2 prior randomized control trials comparing 2 g oral single-dose versus 500-mg twice daily oral 7-day dose metronidazole for the treatment of TV in HIV infected and HIV uninfected women. Trichomonas vaginalis rates 1-month postcompletion of treatment were compared by arm, HIV and BV status after removing those who had sexual reexposure, and/or did not complete their treatment. Results Data for 795 subjects were included in the study, of which 76 (9.6%) experienced treatment failure. In the final multivariable model, which included treatment dose, HIV status, and BV status, odds of treatment failure infection in the 7-day dose group were lower than the odds in the single dose group (odds ratio, 040; 95% confidence interval, 0.23-0.68). Treatment failure was lower in the multidose arm compared with single dose for both HIV-infected (4.0% vs 10.3%; P = 0.0568) and HIV-uninfected (7.3% vs 15.4%; P = 0.0037). Neither HIV nor BV was associated with higher treatment failure. Conclusions Human immunodeficiency virus infection and BV status did not significantly alter the rate of repeat infection for either single dose or 7-day dose metronidazole. Among all women, 7-day metronidazole lowered the odds of treatment failure.Copyright © Lippincott Williams & Wilkins.

Frederice Claudia, P., et al. (2022). "Effect of Vaginal Stretching and Photobiomodulation Therapy on Sexual Function in Women With Pelvic Floor Myofascial Pain - A Randomized Clinical Trial." The Journal of Sexual Medicine 19(1): 98-105.
	Background: Spasm or increased tonus of the pelvic floor muscles (PFM) can cause myofascial pain (MP), which may result in painful intercourse and sexual dysfunction.; Aim: The effect of vaginal stretching (VS) with photobiomodulation therapy (PBMT) is compared to VS with sham PBMT in overall sexual function, rate and severity of painful intercourse at baseline and after treatment in women with pelvic floor MP.; Methods: A double-blind randomized clinical trial of 103 women with MP: 1 group received 10 sessions of VS with PBMT (4 Joules of near-infrared light-808 nm at 3 points), and the other group received VS with sham PBMT.; Outcomes: Impact of treatment was measured by the number of women experiencing painful intercourse, Pain severity was measured by Visual Analog Scale and sexual function was assessed by the FSFI questionnaire. Variables were assessed at baseline and after ten sessions in the intervention groups.; Results: After treatment, the number of women experiencing painful intercourse was significantly lower in both the VS with PBMT group (90.2-55%, P = .001), and VS with sham PBMT group (86.6-46.2%, P < .001). There was a significant reduction in pain measure by Visual Analog Scale (P < .001, [VS with PBMT group: P = .002; VS with sham PBMT group: P < .001]). There was a significant decrease in the number of participants with sexual dysfunction (FSFI score ≤26.55) after the treatment in the VS with PBMT group (92.2-74.5%, P = .003) and in the VS with sham PBMT group (90.4-76.9%, P = .035). Both groups showed improvement in the FSFI pain domain after treatment (P < .001, [VS with PBMT group: P = .038; VS with sham PBMT group: P = .005]). Only the VS with sham PBMT group had a significant increase in FSFI desire and total score (P < .001) after treatment.; Clinical Implications: We found that VS associated or not with PBMT may be effective in reducing complaints of painful intercourse, alleviating pain severity, and reducing the number of women with pelvic floor MP suffering from sexual dysfunction.; Strengths & Limitations: Strengths of this study are the randomized design and use of validated questionnaires. Limitation of the study is the lack of a long follow-up period and the lack of a usual care comparison group hampers generalizability of the results.; Conclusion: VS only and VS with PBMT have short-term efficacy in reducing painful intercourse and reducing a number of women with sexual dysfunction. Frederice CP, de Mira TAA, Machado HC, et al. Effect of Vaginal Stretching and Photobiomodulation Therapy on Sexual Function in Women With Pelvic Floor Myofascial Pain - A Randomized Clinical Trial. J Sex Med 2022;19:98-105. (Copyright © 2021 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Frederick, R. U., et al. (2021). Comparison of Nodal Staging in Endometrial Cancer.
	No Results Available Procedure: Sentinel node procedure|Procedure: Selective staging Recurrence-free survival rate|Progression-free survival rate|Disease-specific survival rate|Overall patient survival rate|Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology|Patient morbidity|Patient mortality Female Phase 3 38 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment MCC-21-GYN-210 June 13, 2023

Free, L. L., et al. (2024). "Effects of aromatherapy on patient satisfaction with procedural abortion at less than 10 weeks' gestation: A randomized controlled trial." Contraception 130: 110311.
	Objectives: This study aimed to compare satisfaction with procedural abortion prior to 10 weeks' gestation in patients randomized to lavender essential oil aromatherapy vs placebo (jojoba oil). Study design: This randomized trial compared lavender aromatherapy vs placebo in patients undergoing procedural abortion <10 weeks' gestation. Participants self-administered and inhaled oil during their procedures. Our primary outcome was composite mean score on the Iowa Satisfaction with Anesthesia Scale. Participants completed the State-Trait Anxiety Inventory, a visual analog scale reporting maximum procedural pain, and reported postprocedure aromatherapy acceptability. Result(s): We analyzed 112 participants randomized to aromatherapy (n = 57) vs placebo (n = 55). Baseline characteristics were similar between groups. We found no difference in overall satisfaction (mean Iowa Satisfaction with Anesthesia Scale scores aromatherapy: 0.72 +/- 0.96 vs placebo: 0.46 +/- 0.98, p = 0.17) or maximum procedural pain (median visual analog scale score aromatherapy: 65 [range: 4-95] vs placebo: 63 [range: 7-97], p = 0.91). Independent predictors of satisfaction included the use of oral sedation (B: 0.36; 95% CI: 0.04-0.69), state anxiety (B: -0.45; 95% CI: -0.79 to -0.10), and maximum procedural pain (B: -0.17; 95% CI: -0.25 to -0.09). The aromatherapy participants were significantly more likely to have found inhaling scented oil helpful during their procedure (71.9% vs 45.5%; p = 0.005) and would recommend it to a friend who needed a procedural abortion (86.0% vs 56.4%; p = 0.0005) compared to those in the placebo group. Additionally, patients in the aromatherapy group were significantly more likely to agree with the statement, "If I need another procedural abortion, I would want to inhale scented oil during my procedure" (87.7% vs 70.9%; p = 0.03). Conclusion(s): The adjunctive use of lavender aromatherapy during first-trimester procedural abortion does not improve satisfaction with anesthesia but is highly valued by patients. Implications: Oral opioids as an adjunct to standard analgesics during procedural abortion (ibuprofen and paracervical block) do not decrease pain, and nonopioid options are lacking. Given current limited anesthesia options, aromatherapy could serve as an affordable and acceptable nonopioid adjunct to current standard of care during procedural abortion. ClinicalTrials.gov Identifier: NCT04969900.Copyright © 2023 Elsevier Inc.

Frenel, J. S., et al. (2022). "Efficacy of subsequent chemotherapy for patients with BRCA1/2-mutated recurrent epithelial ovarian cancer progressing on olaparib versus placebo maintenance: post-hoc analyses of the SOLO2/ENGOT Ov-21 trial." Annals of oncology : official journal of the European Society for Medical Oncology 33(10): 1021-1028.
	Background: In the SOLO2 trial (ENGOT Ov-21; NCT01874353), maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer (PSROC) and BRCA mutation significantly improved progression-free survival (PFS) and prolonged overall survival (OS). Following disease progression on olaparib, efficacy of subsequent chemotherapy remains unknown.; Patients and Methods: We conducted a post-hoc hypothesis-generating analysis of SOLO2 data to determine the efficacy of different chemotherapy regimens following RECIST disease progression in patients who received olaparib or placebo. We evaluated time to second progression (TTSP) calculated from the date of RECIST progression to the next progression/death.; Results: The study population comprised 147 patients who received chemotherapy as their first subsequent treatment after RECIST progression. Of these, 69 (47%) and 78 (53%) were originally randomized to placebo and olaparib arms, respectively. In the placebo-treated cohort, 27/69 and 42/69 received non-platinum and platinum-based chemotherapy, respectively, compared with 24/78 and 54/78, respectively, in the olaparib-treated cohort. Among patients treated with chemotherapy (N = 147), TTSP was significantly longer in the placebo than in the olaparib arm: 12.1 versus 6.9 months [hazard ratio (HR) 2.17, 95% confidence interval (CI) 1.47-3.19]. Similar result was obtained on multivariable analysis adjusting for prognostic factors at RECIST progression (HR 2.13, 95% CI 1.41-3.22). Among patients treated with platinum-based chemotherapy (n = 96), TTSP was significantly longer in the placebo arm: 14.3 versus 7.0 months (HR 2.89, 95% CI 1.73-4.82). Conversely, among patients treated with non-platinum-based chemotherapy (n = 51), the TTSP was comparable in the placebo and olaparib arms: 8.3 versus 6.0 months (HR 1.58, 95% CI 0.86-2.90).; Conclusions: Following progression from maintenance olaparib in the recurrent setting, the efficacy of platinum-based subsequent chemotherapy seems to be reduced in BRCA1/2-mutated patients with PSROC compared to patients not previously receiving poly (ADP-ribose) polymerase inhibitors (PARPi). The optimal strategy for patients who relapse after PARPi is an area of ongoing research.; Competing Interests: Disclosure JSF reports personal fees from Roche Genentech, personal fees and non-financial support from Seattle Genetics, Novartis, Pfizer, Lilly, Novartis, GSK, Clovis oncology, AstraZeneca, Daiichi Sankyo, Gilead, MSD, Pierre Fabre, and Amgen, outside the submitted work. PP reports non-financial support from GSK, AstraZeneca, Clovis Oncology outside the submitted work. JAL reports personal fees from Pfizer, AstraZeneca, GSK, MSD, Clovis Oncology, Eisai, Bristol Myers Squibb, Artios Pharma, VBL Therapeutics, Neopharm, outside the submitted work. RTP reports personal fees from AbbVie, AstraZeneca, Eisai, Genentech / Roche, GSK Inc., Merck & Co, Sutro Biopharma, Vascular Biogenics Ltd, outside the submitted work. SP reports personal fees from, AstraZeneca, MSD; ROCHE, Clovis, GSK, Pfizer, PharmaMar, outside the submitted work. NC reports personal fees from AstraZeneca, Esai, Genentech, GSK, Merck, Pfizer, Regeneron pharmaceutical, outside the submitted work. TWPS reports personal fee from AstraZeneca, Tesaro, GSK, outside the submitted work. GSS has received grant from Agendia, AstraZeneca, Merck, Novartis, Roche, Seagen, outside the submitted work. CKL reports personal fee from AstraZeneca, Amgen, Takeda, Boehringer Ingelheim, Pfizer, Yuhan, Merck KGA, Roche, MSD, outside the submitted work. EPL reports grants and personal fees from AstraZeneca, Merck, GSK, Roche, Incyte, ARCAGY Research, outside the submitted work. All other authors have declared no conflicts of interest. (Copyright © 2022. Published by Elsevier Ltd.)

Freuding, M., et al. (2019). "Mistletoe in oncological treatment: a systematic review : Part 2: quality of life and toxicity of cancer treatment." Journal of Cancer Research and Clinical Oncology 145(4): 927-939.
	Purpose: One important goal of any cancer therapy is to improve or maintain quality of life. In this context, mistletoe treatment is discussed to be highly controversial. The aim of this systematic review is to give an extensive overview about the current state of evidence concerning mistletoe therapy of oncologic patients regarding quality of life and side effects of cancer treatments.; Methods: In September and October 2017, Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, CINAHL and "Science Citation Index Expanded" (Web of Science) were systematically searched.; Results: The search strategy identified 3647 articles and 28 publications with 2639 patients were finally included in this review. Mistletoe was used in bladder cancer, breast cancer, other gynecological cancers (cervical cancer, corpus uteri cancer, and ovarian cancer), colorectal cancer, other gastrointestinal cancer (gastric cancer and pancreatic cancer), glioma, head and neck cancer, lung cancer, melanoma and osteosarcoma. In nearly all studies, mistletoe was added to a conventional therapy. Regarding quality of life, 17 publications reported results. Studies with better methodological quality show less or no effects on quality of life.; Conclusions: With respect to quality of life or reduction of treatment-associated side effects, a thorough review of the literature does not provide any indication to prescribe mistletoe to patients with cancer.

Freuding, M., et al. (2019). "Mistletoe in oncological treatment: a systematic review : Part 1: survival and safety." Journal of Cancer Research and Clinical Oncology 145(3): 695-707.
	Purpose: Mistletoe treatment of cancer patients is discussed highly controversial in the scientific literature. Aim of this systematic review is to give an extensive overview about current state of research concerning mistletoe therapy of oncologic patients regarding survival, quality of life and safety.; Methods: In September and October 2017 Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, CINAHL and "Science Citation Index Expanded" (Web of Science) were systematically searched.; Results: The search strategy identified 3647 hits and 28 publications with 2639 patients were finally included in this review. Mistletoe was used in bladder cancer, breast cancer, other gynecological cancers (cervical cancer, corpus uteri cancer, and ovarian cancer), colorectal cancer, other gastrointestinal cancer (gastric cancer and pancreatic cancer), glioma, head and neck cancer, lung cancer, melanoma and osteosarcoma. In nearly all studies, mistletoe was added to a conventional therapy. Patient relevant endpoints were overall survival (14 studies, n = 1054), progression- or disease-free survival or tumor response (10 studies, n = 1091). Most studies did not show any effect of mistletoe on survival. Especially high quality studies do not show any benefit.; Conclusions: With respect to survival, a thorough review of the literature does not provide any indication to prescribe mistletoe to patients with cancer.

Freuding, M., et al. (2019). "Mistletoe in oncological treatment: a systematic review : Part 1: survival and safety." Journal of Cancer Research and Clinical Oncology 145(3): 695-707.
	PURPOSE: Mistletoe treatment of cancer patients is discussed highly controversial in the scientific literature. Aim of this systematic review is to give an extensive overview about current state of research concerning mistletoe therapy of oncologic patients regarding survival, quality of life and safety. METHODS: In September and October 2017 Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, CINAHL and "Science Citation Index Expanded" (Web of Science) were systematically searched. RESULTS: The search strategy identified 3647 hits and 28 publications with 2639 patients were finally included in this review. Mistletoe was used in bladder cancer, breast cancer, other gynecological cancers (cervical cancer, corpus uteri cancer, and ovarian cancer), colorectal cancer, other gastrointestinal cancer (gastric cancer and pancreatic cancer), glioma, head and neck cancer, lung cancer, melanoma and osteosarcoma. In nearly all studies, mistletoe was added to a conventional therapy. Patient relevant endpoints were overall survival (14 studies, n = 1054), progression- or disease-free survival or tumor response (10 studies, n = 1091). Most studies did not show any effect of mistletoe on survival. Especially high quality studies do not show any benefit. CONCLUSIONS: With respect to survival, a thorough review of the literature does not provide any indication to prescribe mistletoe to patients with cancer.

Freyer, G., et al. (2023). "BEVACIZUMAB, OLAPARIB and DURVALUMAB in PATIENTS with RELAPSED OVARIAN CANCER (THE GINECO BOLD STUDY): PROGNOSTIC VALUE of KELIM-B and NANOSTRING TUMOR INFLAMMATION SIGNATURE." Anticancer Research 43(7): 3368-3369.
	Background/Aim: Strategies combining bevacizumab, olaparib, and durvalumab are anticipated to have synergistic activity. We evaluated this triple combination in platinumresistant and platinum-sensitive relapse of advanced ovarian cancer. Patients and Methods: This open-label, multicenter phase 2 study assessed activity and safety of 1120 mg durvalumab once every 3 weeks (q3w), 15 mg/kg bevacizumab q3w, and 300 mg tolaparib twice daily, in patients with relapsed, high-grade epithelial, advanced ovarian cancer. Previous bevacizumab or poly (ADP-ribose) polymerase inhibitor was permitted. The primary endpoint was the rate of non-progression at 3 months for patients with platinum-resistant relapse or 6 months for those with platinum-sensitive relapse. Secondary endpoints included the modeled cancer antigen 125 (CA-125) elimination rate constant (KELIM-B) for longitudinal CA-125 kinetics over 100 days, and the Nanostring tumor inflammation signature at baseline. Result(s): Between March 2019 and January 2020, 74 patients were included (41 with platinum-resistant and 33 with platinum-sensitive disease). With a median follow-up of 15.4 months, non-progression rates were 69.8% [90% confidence interval (CI)=55.9-80.0%] at 3 months for those with platinum-resistant relapse, and 43.8% (90% CI=29.0- 57.4%) at 6 months for those with platinum-sensitive relapse. Median PFS was 4.1 months (95% CI=3.5-5.9 months) for those with platinum-resistant relapse and 4.9 months (95% CI=2.9-7.0 months) for those with platinum-sensitive relapse. Median overall survival was 18.8 months (95% CI=9.6 months-not reached) and 18.5 months (95% CI=15.6 months-not reached), respectively. Higher (favorable) KELIM-B values were prognostic for improved PFS [median=6.2 months (95% CI=3.5-9.0 months) vs. 1.5 months (95% CI=0.7-6.2 months); p=0.03]. A higher tumor inflammation signature was associated with longer median PFS, notably for patients with platinum-sensitive relapse [6.9 months (95% CI=3.3-10.3) vs. 4.0 months (95% CI=1.4-5.7 months)]. No toxic deaths or major safety signals were observed. Conclusion(s): The chemotherapy-free triple combination of durvalumab, olaparib and bevacizumab was well tolerated, with encouraging efficacy in heavily pretreated patients with platinum-resistant relapse. Favorable KELIM-B and higher immune-related biomarkers are prognostic for survival. Further investigation of the triple combination is warranted.

Fricová, L. and J. Sláma (2022). "Current knowledge on fertility-sparing treatment of cervical cancer patients [Czech]." Ceska gynekologie 87(5): 362-370.
	Introduction: Cervical cancer directly affects the reproductive function of women of childbearing age. Up to one-third of the disease is dia-gnosed in women younger than 45 years of age, who may still have open reproductive plans. Therefore, in recent years, there has been increasing interest in performing fertility-sparing treatment (FST), which aims to preserve fertility while achieving the same oncologic safety as radical surgical treatment.; Objective: To summarize the current knowledge on FST in women with early stages of cervical cancer.; Methods: Review of published literature on the topic using medical databases.; Results: FST is reserved for patients with HPV-associated cervical cancer up to stage IB with negative nodes. Conservative procedures (conization and simple vaginal trachelectomy) and radical trachelectomy are available. Conservative procedures for tumors 2cm have comparable oncological outcomes as radical treatment with a significantly lower rate of perinatological complications. On average, 55% of patients become pregnant after treatment and of these, on average 70% give birth to a live newborn. Approximately 38% of deliveries are preterm, most often after radical trachelectomy. The most common postoperative complication with direct impact on fertility is cervical stenosis.; Conclusion: In a selected group of patients with tumors up to 2cm, FST is a safe procedure with good perinatological outcomes. However, it remains unclear whether it is safe to offer this treatment to patients with larger tumors. The use of neoadjuvant chemotherapy followed by conservative surgery is a promising approach but requires further validation in clinical trials.

Friedenreich, C. M., et al. (2020). "Physical Activity and Mortality in Cancer Survivors: A Systematic Review and Meta-Analysis." JNCI Cancer Spectrum 4(1): pkz080.
	BACKGROUND: Recommendations for improved survival after cancer through physical activity (PA) exist, although the evidence is still emerging. Our primary objective was to conduct a systematic review and meta-analysis of the association between prediagnosis and postdiagnosis PA and survival (cancer-specific, all-cause, and cardiovascular disease mortality) for all cancers and by tumor site. Secondary objectives were to examine the associations within population subgroups, by PA domain, and to determine the optimal dose of PA related to survival. METHODS: PubMed, EMBASE, and SportsDiscus databases were searched from inception to November 1, 2018. DerSimonian-Laird random-effects models were used to estimate the summary hazard ratios (HRs) and 95% confidence intervals (CI) for primary and secondary analyses and to conduct dose-response analyses. RESULTS: Evidence from 136 studies showed improved survival outcomes with highest vs lowest levels of prediagnosis or postdiagnosis total or recreational PA for all-cancers combined (cancer specific mortality: HR = 0.82, 95% CI = 0.79 to 0.86, and HR = 0.63, 95% CI = 0.53 to 0.75, respectively) as well as for 11 specific cancer sites. For breast and colorectal cancers, greater reductions were observed for postdiagnosis PA (HR = 0.58-0.63) compared with prediagnosis PA (HR = 0.80-0.86) for cancer-specific and all-cause mortality. Survival benefits through PA were observed in most subgroups (within sex, body mass index, menopausal status, colorectal subtypes, and PA domain) examined. Inverse dose-response relationships between PA and breast cancer-specific and all-cause mortality were observed, with steep reductions in hazards to 10-15 metabolic equivalent hours per week. CONCLUSION: Higher prediagnosis and postdiagnosis levels of PA were associated with improved survival outcomes for at least 11 cancer types, providing support for global promotion of PA guidelines following cancer.

Frieder, A., et al. (2019). "Pharmacotherapy of Postpartum Depression: Current Approaches and Novel Drug Development." CNS drugs 33(3): 265-282.
	Postpartum depression is one of the most common complications of childbirth. Untreated postpartum depression can have substantial adverse effects on the well-being of the mother and child, negatively impacting child cognitive, behavioral, and emotional development with lasting consequences. There are a number of therapeutic interventions for postpartum depression including pharmacotherapy, psychotherapy, neuromodulation, and hormonal therapy among others, most of which have been adapted from the treatment of major depressive disorder outside of the peripartum period. Current evidence of antidepressant treatment for postpartum depression is limited by the small number of randomized clinical trials, underpowered samples, and the lack of long-term follow-up. The peripartum period is characterized by rapid and significant physiological change in plasma levels of endocrine hormones, peptides, and neuroactive steroids. Evidence supporting the role of neuroactive steroids and gamma-aminobutyric acid (GABA) in the pathophysiology of postpartum depression led to the investigation of synthetic neuroactive steroids and their analogs as potential treatment for postpartum depression. Brexanolone, a soluble proprietary intravenous preparation of synthetic allopregnanolone, has been developed. A recent series of open-label and placebo-controlled randomized clinical trials of brexanolone in postpartum depression demonstrated a rapid reduction in depressive symptoms, and has led to the submission for regulatory approval to the US Food and Drug Administration (decision due in March 2019). SAGE-217, an allopregnanolone analog, with oral bioavailability, was recently tested in a randomized, double-blind, placebo-controlled phase III study in severe postpartum depression, with reportedly positive results. Finally, a 3beta-methylated synthetic analog of allopregnanolone, ganaxolone, is being tested in both intravenous and oral forms, in randomized, double-blind, placebo-controlled phase II studies in severe postpartum depression.Copyright © 2019, Springer Nature Switzerland AG.

Friedlander, M., et al. (2021). "Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial." The Lancet. Oncology 22(5): 632‐642.
	BACKGROUND: In the phase 3 SOLO1 trial, maintenance olaparib provided a significant progression‐free survival benefit versus placebo in patients with newly diagnosed, advanced ovarian cancer and a BRCA mutation in response after platinum‐based chemotherapy. We analysed health‐related quality of life (HRQOL) and patient‐centred outcomes in SOLO1, and the effect of radiological disease progression on health status. METHODS: SOLO1 is a randomised, double‐blind, international trial done in 118 centres and 15 countries. Eligible patients were aged 18 years or older; had an Eastern Cooperative Oncology Group performance status score of 0‐1; had newly diagnosed, advanced, high‐grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with a BRCA mutation; and were in clinical complete or partial response to platinum‐based chemotherapy. Patients were randomly assigned (2:1) to either 300 mg olaparib tablets or placebo twice per day using an interactive voice and web response system and were treated for up to 2 years. Treatment assignment was masked for patients and for clinicians giving the interventions, and those collecting and analysing the data. Randomisation was stratified by response to platinum‐based chemotherapy (clinical complete or partial response). HRQOL was a secondary endpoint and the prespecified primary HRQOL endpoint was the change from baseline in the Functional Assessment of Cancer Therapy‐Ovarian Cancer Trial Outcome Index (TOI) score for the first 24 months. TOI scores range from 0 to 100 (higher scores indicated better HRQOL), with a clinically meaningful difference defined as a difference of at least 10 points. Prespecified exploratory endpoints were quality‐adjusted progression‐free survival and time without significant symptoms of toxicity (TWiST). HRQOL endpoints were analysed in all randomly assigned patients. The trial is ongoing but closed to new participants. This trial is registered with ClinicalTrials.gov, NCT01844986. INTERPRETATION: The substantial progression‐free survival benefit provided by maintenance olaparib in the newly diagnosed setting was achieved with no detrimental effect on patients' HRQOL and was supported by clinically meaningful quality‐adjusted progression‐free survival and TWiST benefits with maintenance olaparib versus placebo. FUNDING: AstraZeneca and Merck Sharp & Dohme. FINDINGS: Between Sept 3, 2013, and March 6, 2015, 1084 patients were enrolled. 693 patients were ineligible, leaving 391 eligible patients who were randomly assigned to olaparib (n=260) or placebo (n=131; one placebo patient withdrew before receiving any study treatment), with a median duration of follow‐up of 40·7 months (IQR 34·9‐42·9) for olaparib and 41·2 months (32·2‐41·6) for placebo. There was no clinically meaningful change in TOI score at 24 months within or between the olaparib and placebo groups (adjusted mean change in score from baseline over 24 months was 0·30 points [95% CI ‐0·72 to 1·32] in the olaparib group vs 3·30 points [1·84 to 4·76] in the placebo group; between‐group difference of ‐3·00, 95% CI ‐4·78 to ‐1·22; p=0·0010). Mean quality‐adjusted progression‐free survival (olaparib 29·75 months [95% CI 28·20‐31·63] vs placebo 17·58 [15·05‐20·18]; difference 12·17 months [95% CI 9·07‐15·11], p<0·0001) and the mean duration of TWiST (olaparib 33·15 months [95% CI 30·82‐35·49] vs placebo 20·24 months [17·36‐23·11]; difference 12·92 months [95% CI 9·30‐16·54]; p<0·0001) were significantly longer with olaparib than with placebo.

Frigerio, M., et al. (2019). "Long-term effects of episiotomy on urinary incontinence and pelvic organ prolapse: a systematic review." Archives of Gynecology and Obstetrics 299(2): 317-325.
	Purpose: To focus attention on the long-term effects of episiotomy on urinary incontinence and pelvic organ prolapse.; Methods: A systematic review was conducted including only studies with mean follow-up ≥ 5 years. We searched using combinations of the following keywords and text words: "episiotomy", "perineal laceration", "perineal tear", "perineal damage" and "long term", "long term outcomes", "prolapse", "pelvic organ prolapse", "pelvic floor", "pelvic floor dysfunction", "urinary incontinence", "hysterocele", "cystocele" and "rectocele".; Results: The electronic database search provided a total of 6154 results. After exclusions, 24 studies were included yielding the following results: (1) episiotomy might be detrimental with respect to urinary incontinence symptoms; (2) the relationship between episiotomy and anti-incontinence surgery is not clear; (3) episiotomy does not seem to negatively influence genital prolapse development and might even be protective with respect to prolapse severity and prevalence; (4) episiotomy does not seem to affect genital prolapse surgery rate.; Conclusions: We did not find evidence for a long-term beneficial effect of episiotomy in the prevention of urinary incontinence symptoms and anti-incontinence surgery. Episiotomy does not seem to negatively influence genital prolapse development and might even be protective with respect to prolapse severity and prevalence without affecting surgery rates.

Frijstein, M. M., et al. (2023). "Effects of a pre-visit online information tool about genetic counselling for ovarian cancer patients, a randomized controlled trial." Patient Education and Counseling 113: 107786.
	Objective: In the Netherlands, patients with ovarian cancer are offered genetic testing. Pre-test preparation may help counseling patients. The aim of this study was to determine if use of a web-based intervention, leads to more effective genetic counseling of ovarian cancer patients.; Methods: Between 2016 and 2018, 127 ovarian cancer patients referred for genetic counseling in our hospital participated in this trial. 104 Patients were analyzed. All patients filled out questionnaires pre- and post-counseling. The intervention group also completed a questionnaire after visiting an online tool. Length of consultation, patients' satisfaction, knowledge, anxiety, depression and distress were compared before and after counselling.; Results: The intervention group had the same level of knowledge compared to the counseling group, but at an earlier point in time. They were satisfied with the intervention (86%) and better prepared for counseling (66%). The intervention did not lead to shorter consultations. No differences in levels of anxiety, depression, distress and satisfaction were observed.; Conclusion: Although consultation length was unaffected, the improvements in knowledge after online education and patients satisfaction indicates that this tool can be an effective addition to genetic counseling.; Practice Implications: Use of an educational tool may lead to a more effective, personalized way of genetic counselling and enables shared decision making.; Competing Interests: Declaration of Competing Interest None. (Copyright © 2023 Elsevier B.V. All rights reserved.)

Frohlich, G., et al. (2023). "Are active dwell positions always necessary in the ring/ovoids channel of the cervical applicator in the intracavitary-interstitial brachytherapy of cervical cancer?" Journal of Contemporary Brachytherapy 15(1): 48-56.
	Purpose: To compare dosimetric parameters of brachytherapy (BT) treatment plans made with or without active source positions of the ring/ovoid (R/O) applicator in locally advanced cervical cancer patients. Material(s) and Method(s): Sixty patients with cervical cancer without vaginal involvement were selected for the study, who received intra-cavitary/interstitial BT. For each patient, two plans with and without active source dwell positions in R/O were created, using the same dose-volume constraints. EQD2 total doses from external beam and BT of target volumes and organs at risk (OARs) between the competing plans were compared. Result(s): There was no significant difference in the dose of high-risk clinical target volume (HR-CTV) and gross tumor volume (GTV) between the plans with inactive vs. active R/O. The mean D98 of intermediate-risk clinical target volume (IR-CTV) was significantly lower with inactive R/O; however, the GEC-ESTRO (EMBRACE II study) and ABS criteria were fulfilled in 96% in both plans. There was no difference in dose homogeneity, but conformity of the plans with inactive R/O was higher. Doses to all OARs were significantly lower in plans without R/O activation. While all the plans without R/O activation fulfilled the recommended dose criteria for OARs, it was less achievable with R/O activation. Conclusion(s): Inactivation of R/O applicator results in similar dose coverage of the target volumes with lower doses to all OARs, as activation of R/O in cervix cancer patients when HR-CTV does not extend to R/O applicator. The use of active source positions in R/O shows worse performance regarding the fulfilment of the recommended criteria for OARs.Copyright © 2023 Termedia Publishing House Ltd.. All rights reserved.

frtzv, R. B. R. (2022). "Effects of the use of a mobile application in women with complaints of stress urinary incontinence." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: 62 participants will be randomly divided into 2 groups: one will perform a pelvic floor muscle training protocol guided by an application and the other, through a booklet. Before and after 6 and 12 weeks of intervention, the volunteers will be evaluated using the King's Health Questionnaire (KHQ) and the International Consultation on Incontinence Questionnaire ‐ Short Form (ICIQ‐SF). At the end of the research, a comparison of urinary complaints, quality of life and satisfaction with the intervention will be carried out between groups (app and booklet) and between phases (pre‐treatment, after 6 weeks, after 12 weeks). Initial assessments will be conducted before participants are randomized (1:1) to two groups (app, booklet), through a computer‐generated list of random numbers (by a single researcher, who will not have access to the data). evaluation or training of participants). Participants will be informed that they will receive one of two different forms of protocol application, but will not be aware of the study hypothesis. Statistical analysis will be performed by another person. L01.224.900.685 CONDITION: C12.050.351.968.934 Urinary incontinence PRIMARY OUTCOME: With this study, it is expected that the use of the application will improve the symptoms of urinary leakage in women, which will be evaluated through the Iciq‐sf (International Consultation on Incontinence Questionnaire ‐ Short Form) and Khq (King's Health Questionnaire). SECONDARY OUTCOME: With this study, it is expected that the use of the application will improve the impact of urinary incontinence on quality of life, which will be evaluated through the Iciq‐sf (International Consultation on Incontinence Questionnaire ‐ Short Form) and Khq (King's Health Questionnaire). INCLUSION CRITERIA: Women with symptoms of stress urinary incontinence and/or mixed; aged over 18; literate; with preserved cognitive ability; with access to the internet; who have a mobile device with Android system; with understanding of the functioning of the application developed by the team of researchers.

Frydman, J. L., et al. (2022). "Racial/ethnic disparities in serious illness communication for patients with cancer." Journal of Clinical Oncology 40(16).
	Background: Racial/ethnic disparities in serious illness communication exist between patients with cancer and their oncologists. Our prior work has shown that goals of care discussions are three minutes shorter with racial/ethnic minority patients. In this study, we sought to compare oncologist's use of serious illness communication skills, patient participatory behavior, and overall communication quality during encounters with patients with advanced cancer of different self‐reported races/ethnicities. Methods: We analyzed baseline recordings from a two‐arm multisite randomized controlled trial to test a coaching model of communication skills training for solid tumor oncologists and their newly diagnosed advanced cancer patients. We audio recorded post‐imaging patient‐oncologist encounters for patients receiving systemic cancer treatment and coded transcripts for oncologist's use of serious illness communication skills (coded as count/encounter): open‐ended questions, reflections, empathic responses to patient empathic opportunities, empathic statements, ���sorry” statements, and elicitation of questions. We also assessed global codes of oncologist communication (assessed on 5‐point Likert scales): flow, concerns addressed, attention, warmth, and respect. Finally, we coded patient participatory behavior (coded as count/encounter): asking questions and assertive responses. We compared the skills and behaviors by race/ethnicity of the patient using the non‐parametric Kruskal‐Wallis test. Results: We included the 56 (38%) recordings with oncologists who did not receive the intervention. The patients in these encounters were 25 (45%) female; 32 (57%) over the age of 65; 23 (41%) White Non‐Hispanic, 20 (36%) Black Non‐Hispanic, and 11 (20%) Hispanic. Overall, oncologists responded empathically to patients' emotions only 19% of the time. Oncologists used fewer reflective statements with Black Non‐Hispanic patients (mean 0.3 statements/encounter) as compared to White Non‐Hispanic patients (1.1) and Hispanic patients (1.1), p = 0.02. Furthermore, coders rated oncologists as being less likely to address concerns of Black Non‐Hispanic patients (mean Likert scale 3.1) as compared to White Non‐Hispanic (3.8) and Hispanic (3.4) patients, p = 0.04. Finally, coders rated oncologists as having less warmth with Black Non‐Hispanic patients (mean Likert scale 2.9) as compared to White Non‐Hispanic (3.8) and Hispanic (3.3) patients, p = 0.04. Conclusions: In this diverse sample of patients with advanced cancer, oncologists used fewer reflective statements, were less attentive to concerns, and expressed less warmth with Black Non‐Hispanic patients. Interventions are needed to overcome these striking racial/ethnic disparities in serious illness communication for patients with cancer.

Fu, H., et al. (2023). "Survival outcomes of robotic-assisted laparoscopy versus conventional laparoscopy and laparotomy for endometrial cancer: A systematic review and meta-analysis." Gynecologic Oncology 174: 55-67.
	Objective: Robotic-assisted laparoscopy (RALS) has gained widespread acceptance in the field of gynecological oncology. However, whether the prognosis of endometrial cancer after RALS is superior to conventional laparoscopy (CLS) and laparotomy (LT) remains inconclusive. Therefore, the aim of this meta-analysis was to compare the long-term survival outcomes of RALS with CLS and LT for endometrial cancer.; Methods: A systematic literature search was conducted on electronic databases (PubMed, Cochrane, EMBASE and Web of Science) until May 24, 2022, followed by a manual search. Based on inclusion and exclusion criteria, publications investigating long-term survival outcomes after RALS vs CLS or LT in endometrial cancer patients were collected. The primary outcomes included overall survival (OS), disease-specific survival (DSS), recurrence-free survival (RFS) and disease-free survival (DFS). Fixed effects models or random effects models were employed to calculate the pooled hazard ratios (HRs) and 95% confidence intervals (CIs) as appropriate. Heterogeneity and publication bias were also assessed.; Results: RALS and CLS had no difference in OS (HR = 0.962, 95% CI: 0.922-1.004), RFS (HR = 1.096, 95% CI: 0.947-1.296), and DSS (HR = 1.489, 95% CI: 0.713-3.107) for endometrial cancer; however, RALS was significantly associated with favorable OS (HR = 0.682, 95% CI: 0.576-0.807), RFS (HR = 0.793, 95% CI: 0.653-0.964), and DSS (HR = 0.441, 95% CI: 0.298-0.652) when compared with LT. In the subgroup analysis of effect measures and follow-up length, RALS showed comparable or superior RFS/OS to CLS and LT. In early-stage endometrial cancer patients, RALS had similar OS but worse RFS than CLS.; Conclusions: RALS is safe in the management of endometrial cancer, with long-term oncological outcomes equivalent to CLS and superior to LT.; Competing Interests: Declaration of Competing Interest The authors declare they have no conflicts of interest. (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Fu, K., et al. (2023). "Pregnancy Outcomes after Uterus-sparing Operative Treatment for Adenomyosis: A Systematic Review and Meta-analysis." Journal of Minimally Invasive Gynecology 30(12): 1006-1007.
	
Fu, M.-M. and X.-D. Meng (2020). "Assessment of clinical efficacy of traditional Chinese medicine for the management of primary dysmenorrhea in the UK: A protocol of systematic review." Medicine 99(47): e23246.
	Background: This study aims to appraise the clinical efficacy of traditional Chinese medicine (TCM) for the management of patients with primary dysmenorrhea (PD) in the UK.; Methods: We will comprehensively search electronic databases (Cochrane Library, PUBMED/MEDLINE, EMBASE, PsycINFO, AMED, Web of Science, and CNKI) and additional resources for original articles on randomized controlled trials published in English, Chinese, German, Spanish, Korean and Japanese. Outcomes will be the pain intensity, pain duration, menstrual cramps, amount of bleeding, and severity of dysmenorrhea symptoms, quality of life, and adverse events. Two authors will independently check all citations, extract data, and assess study quality. All potential conflicts will be solved through discussion by consulting another experienced author. A narrative synthesis will summarize the characteristics and findings of eligible trials. If it is possible, we will also pool the data and carry out meta-analysis.; Results: The available evidence of the clinical efficacy of TCM for the treatment of PD in UK will be assessed through outcome measurements.; Conclusion: The findings of this study will determine whether or not TCM is effective and safe for the treatment of PD in UK. OSF REGISTRATION NUMBER:: osf.io/jyc95.

Fu, S., et al. (2023). "Multicenter Phase II Trial of the WEE1 Inhibitor Adavosertib in Refractory Solid Tumors Harboring CCNE1 Amplification." Journal of clinical oncology : official journal of the American Society of Clinical Oncology 41(9): 1725-1734.
	Purpose: Preclinical cancer models harboring CCNE1 amplification were more sensitive to adavosertib treatment, a WEE1 kinase inhibitor, than models without amplification. Thus, we conducted this phase II study to assess the antitumor activity of adavosertib in patients with CCNE1 -amplified, advanced refractory solid tumors.; Patients and Methods: Patients aged ≥ 18 years with measurable disease and refractory solid tumors harboring CCNE1 amplification, an Eastern Cooperative Oncology Group performance status of 0-1, and adequate organ function were studied. Patients received 300 mg of adavosertib once daily on days 1 through 5 and 8 through 12 of a 21-day cycle. The trial followed Bayesian optimal phase II design. The primary end point was objective response rate (ORR).; Results: Thirty patients were enrolled. The median follow-up duration was 9.9 months. Eight patients had partial responses (PRs), and three had stable disease (SD) ≥ 6 months, with an ORR of 27% (95% CI, 12 to 46), a SD ≥ 6 months/PR rate of 37% (95% CI, 20 to 56), a median progression-free survival duration of 4.1 months (95% CI, 1.8 to 6.4), and a median overall survival duration of 9.9 months (95% CI, 4.8 to 15). Fourteen patients with epithelial ovarian cancer showed an ORR of 36% (95% CI, 13 to 65) and SD ≥ 6 months/PR of 57% (95% CI, 29 to 82), a median progression-free survival duration of 6.3 months (95% CI, 2.4 to 10.2), and a median overall survival duration of 14.9 months (95% CI, 8.9 to 20.9). Common treatment-related toxicities were GI, hematologic toxicities, and fatigue.; Conclusion: Adavosertib monotherapy demonstrates a manageable toxicity profile and promising clinical activity in refractory solid tumors harboring CCNE1 amplification, especially in epithelial ovarian cancer. Further study of adavosertib, alone or in combination with other therapeutic agents, in CCNE1 -amplified epithelial ovarian cancer is warranted.

Fu, W., et al. (2020). "Effect of diverting stoma for rectovaginal fistula: A protocol of systematic review and meta-analysis." Medicine 99(49): e23202.
	BACKGROUND: Rectovaginal fistula (RVF) is a pathologic channel between the anterior wall of the rectum and the posterior wall of the vagina, is rare, and the majority is of traumatic origin. The most common causes are obstetric trauma, local infection, rectal surgery or caused by chronic inflammatory bowel disease. Once the disease will seriously affect the patient's quality of life, and generally not self-healing, most require surgical intervention. At present, diverting stoma is mainly used in patients with severe RVF or complicated RVF or patients with Crohn disease. Due to the lack of large sample, linical studies, its clinical effectiveness is still controversial. The purpose of this systematic review is to evaluate the efficacy of diverting stoma in the treatment of diverting stoma. METHODS: EMBASE, PubMed, the Cochrane Library, Chinese National Knowledge Infrastructure (CNKI), Wanfang Database, Chinese Biomedical Literature Database (CBM), and Chinese VIP Information will be searched systematically by 2 reviewers from the inception until October 2020. The original study that randomized controlled trials (RCTs), clinical controlled trials (CCTs), nonrandomized control trials (NCTs), and retrospective trials (RTs) of diverting stoma for RVF will be selected. In addition, similar searches will be conducted for the reference lists, researches in progress, and the citation lists of identified publications. Study selection, data extraction, and assessment of the quality will be performed independently by 2 reviewers who have been trained prior to data extraction. A meta-analysis will be conduct if the quantity and quality of the original studies included are satisfactory; otherwise, a descriptive analysis will be conducted. Review Manager 5.4 software (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark) will be using for data synthesis and assessment the risk of bias according by Cochrane Handbook. RESULT: This study will provide a comprehensive review of current evidence for the treatment of diverting stoma on RVF. CONCLUSION: The conclusion of this study will provide a judging basis that whether the treatment of RVF with diverting stoma is effective. INPLASY REGISTRATION NUMBER: INPLASY2020090070.

Fu, Y., et al. (2020). "Efficacy and safety of traditional Chinese herbal formula combined with western medicine for uterine fibroid: A protocol for systematic review and meta-analysis." Medicine 99(36): e22039.
	Background: Clinical studies found that the combination of traditional Chinese herbal formula, and western medicine therapy are better in shrinking fibroids and improve other symptoms. This study aims to systematically evaluate the efficacy and safety traditional Chinese herbal formula combined with western medicine in the treatment of uterine fibroids.; Methods: Randomized controlled trials of traditional Chinese herbal formula combined with western medicine for uterine fibroids patients will be searched in PubMed, Medline, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biological and Medical database (CMB), and Wanfang database from inception to August 2020. Two researchers will perform data extraction and risk of bias assessment independently. Statistical analysis will be conducted in RevMan 5.3.; Results: This study will summarize the present evidence by exploring the efficacy and safety of traditional Chinese herbal formula combined with western medicine in the treatment of uterine fibroids CONCLUSIONS:: The findings of the study will help to determine potential benefits of traditional Chinese herbal formula combined with western medicine in the treatment of uterine fibroids.; Ethics and Dissemination: The private information from individuals will not be published. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences.; Osf Registration Number: DOI 10.17605/OSF.IO/XUA8V.

Fu, Y., et al. (2020). "Prophylactic antibiotics for miscarriage surgery: A protocol for systematic review and meta-analysis." Medicine 99(27): e20959.
	Background: Infection is a serious potential consequence of surgery to complete a spontaneous abortion. Antibiotic prophylaxis before some operations has been shown to reduce the risk of postoperative infections. However, for miscarriage surgery, evidence is lacking to show effectiveness.; Methods: In this systematic review, the electronic databases of Cochrane Central Register of Controlled Trials, EMBASE, and PUBMED will be searched from inception to May 1, 2020. Randomized controlled trials that assessed the effectiveness and safety of antibiotic prophylaxis for preventing infection for patients undergoing miscarriage surgery will be included. All process of the study selection, data extraction, and methodology evaluation will be carried out by two authors independently. RevMan 5.3 software will be utilized for statistical analysis.; Results: This study will provide a detailed summary of latest evidence related to the effectiveness and safety of antibiotic prophylaxis for preventing infection for patients undergoing miscarriage surgery.; Conclusion: The findings of this study may provide possible guidance for the use of antibiotic prophylaxis for preventing infection for patients undergoing miscarriage surgery.; Dissemination and Ethics: Ethical approval is not required in this study, because it will not collect the original data from individual patient. The results are expected to publish through a peer-reviewed journal.; Systematic Review Registration: PROSPERO CRD CRD42020155643.

Fu, Y., et al. (2019). "Multifaceted self-management interventions for older women with urinary incontinence: A systematic review and narrative synthesis [see correction in link]." BMJ Open 9(8): e028626.
	Objective To synthesise the evidence for the multifaceted self-management interventions for older women with urinary incontinence (UI) and to understand the outcomes associated with these interventions. Design A systematic review and narrative synthesis to identify randomised controlled trials that investigated the effect of multifaceted self-management interventions for older women with UI. Methods MEDLINE, PsycINFO, EMBASE, The Cochrane Library, CINAHL and Applied Social Sciences Index and Abstracts databases were searched (January 1990 to May 2019) using a systematic search strategy, complemented by manually screening the reference lists and citation indexes. Study selection, data extraction and risk of bias assessment were undertaken independently. A narrative synthesis was undertaken in which studies, interventions and outcomes were examined based on the intervention components. The effect size and 95% CI were estimated from each study. Results A total of 13 147 citations were identified and 16 studies were included. There was no study rated as of high quality. Three types of multifaceted interventions were found: those that had an element of pelvic floor muscle exercises (PFME), those with bladder retraining and some with combination behavioural interventions. Outcome measures varied across studies. A statistically significant improvement in incontinence symptoms was reported in the intervention group compared with the control in 15 studies. Conclusion Multifaceted interventions that included PFME, bladder retraining or combination behavioural techniques appear to be useful in some settings for UI management in older women, but the quality of the evidence was poor and unclear. There was insufficient evidence to determine whether any of the combination of components is superior to others in improving UI symptoms. There is a need for high-quality studies to confirm the effectiveness of these interventions and to identify comparative effectiveness.Copyright © 2019 BMJ Publishing Group. All rights reserved.

Fuentes-Márquez, P., et al. (2019). "Physiotherapy interventions for patients with chronic pelvic pain: A systematic review of the literature." Physiotherapy Theory and Practice 35(12): 1131-1138.
	Objective : To summarize the available scientific evidence on physiotherapy interventions in the management of chronic pelvic pain (CPP). Data Sources : A systematic review of randomized controlled trials was performed. An electronic search of MEDLINE, CINAHL, and Web of Science databases was performed to identify relevant randomized trials from 2010-2016. Study Selection : Manuscripts were included if at least one of the comparison groups received a physiotherapy intervention. Studies were assessed in duplicate for data extraction and risk of bias using the Physiotherapy Evidence Database scale PEDro. Data Extraction and Synthesis : Eight of the studies screened met the inclusion criteria. Four manuscripts studied the effects of electrotherapy including intravaginal electrical stimulation, short wave diathermy, respiratory-gated auricular vagal afferent nerve stimulation, percutaneous tibial nerve stimulation, and sono-electro-magnetic therapy with positive results. Three studies focused on manual assessing the efficacy of myofascial versus massage therapy in two of them and ischemic compression for trigger points. Conclusions : Although physiotherapy interventions show some beneficial effects, evidence cannot support the results. Heterogeneity in terms of population phenotype, methodological quality, interpretation of results, and operational definition result in little overall evidence to guide treatment.

Fuh, K., et al. (2022). "A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO/PACLITAXEL-CONTROLLED STUDY OF BATIRAXCEPT IN COMBINATION WITH WEEKLY PACLITAXEL IN PATIENTS WITH PLATINUMRESISTANT RECURRENT OVARIAN CANCER (GOG- 3059/ENGOT OV-66)." International Journal of Gynecological Cancer 32(Supplement 3): A234-A235.
	Objectives Introduction: The AXL receptor and its sole activating ligand, GAS6, are important drivers of metastasis and therapeutic resistance in human cancers. This signaling axis represents an attractive target for therapeutic intervention. The strong picomolar binding affinity between endogenous GAS6 and AXL and the promiscuity of small molecule AXL inhibitors have presented a barrier to specific and potent inhibition of AXL. Batiraxcept (AVB-S6-500) is a recombinant fusion protein with ~200-fold higher affinity for GAS6 than wildtype (WT) AXL. Batiraxcept binds GAS6, inhibiting its interaction with AXL thereby dramatically reducing AXL signaled invasion and migration of highly metastatic cells in vitro and inhibiting metastatic disease in nonclinical models of aggressive human cancers. The Phase 1b study showed no DLTs and established a RP2D of 15 mg/kg IV every 2 weeks with PAC/ PLD. Longer PFS and OS times were observed in patients who had not been previously treated with bevacizumab (bevnaive). Methods High-grade serous PROC, who received 1-4 prior lines randomized (1:1) batiraxcept/PAC or placebo/PAC; stratified by last platinum regimen, prior lines, and prior bevacizumab. The primary endpoint is PFS by RECIST v1.1 assessed by the investigator with OS a secondary endpoint. The primary PFS analysis will be triggered when 130 PFS events occur in the bev-naive; with an interim analysis of OS. Recruitment began April 2021; 252 of ~350 patients have been randomized globally (132 sites) (NCT04729608). Results Trial in progress: there are no available results at the time of submission Conclusions Trial in progress: there are no available conclusions at the time of submission.

Fuhr, L., et al. (2023). "RF1 Brachytherapy dose fractionation preliminary enrollment in a Preference Option Randomized Design Study: Providing the patient voice in a prospective clinical trial." Gynecologic Oncology 173(Supplement 1): S4-S5.
	Objectives: To describe patient preferences regarding adjuvant radiation (RT) treatment options for patients with early stage endometrial cancer following hysterectomy in a preference-option randomized design (PORD) vaginal brachytherapy (VBT) dose fractionation study. Method(s): This prospective multi-center randomized clinical trial (NCT03785288) evaluates patient-reported sexual dysfunction (PRSD) and vaginal shortening following VBT with two commonly used dose fractionation schedules of 7 Gray (Gy) x 3 Fractions (Fx) prescribed to 5 mm depth (Group A) or 4 Gy x 6 Fx prescribed to cylinder surface (Group B). Our hypothesis is that a longer course of 6 Fx results in less toxicity including lower PRSD and vaginal shortening. The protocol was amended to incorporate the PORD in response to direct conversation with patients, as some were hesitant to enroll in a traditional randomized clinical trial given strong treatment preferences. The PORD allows participants the option to switch treatment arms after randomization if they express a strong preference for the alternate arm. This design provides vital patient-centered evidence regarding both the primary quality of life endpoint and treatment preferences. Preliminary data regarding preferences and baseline characteristics was obtained on patients enrolled in the VBT trial to date. Result(s): 70 individuals have enrolled to date across three sites. Recruitment substantially improved following adoption of the PORD, with 64 participants enrolling after this protocol change. 26 participants opted to switch treatment arms (Group AB switching from 3 to 6 Fx and Group BA switching from 6 to 3 Fx). A summary of participants is provided in Fig. 1. The reason for change was documented for each participant, with primary rationales being potential for reduced toxicity (Group AB) and convenience due to travel/time (Group BA). The mean ages were 62 and 66 years for Groups AB and BA, respectively. The mean travel distance to treatment was nearly 50% further for those who opted for the shorter course in Group BA (59.8 vs 83.8 miles). The rate of opt out was similar among the three clinical sites (range 29-50%). Conclusion(s): To our knowledge, this is the first use of PORD in a prospective gynecologic oncology study. Patient preferences for adjuvant VBT following hysterectomy exist. In this ongoing trial, 40% of patients thus far have requested to switch treatment arms, with similar opt-out rates between arms. Patients' priorities regarding their adjuvant RT treatment options differed between convenience and toxicity. Results from this trial will ultimately provide patient-centered evidence to guide shared decision making and inform national guidelines. In the interim, patient preferences regarding VBT should be considered, as these are unique to the individual and may include perceived decreased toxicity, reduced travel burden, and efficiency of treatment. [Formula presented]Copyright © 2023

Fuiano, M., et al. (2019). "Current concepts about treatment options of plantar fibromatosis: A systematic review of the literature." Foot and Ankle Surgery 25(5): 559-564.
	Background: Plantar fibromatosis, or Ledderhose disease, is a benign and hyperproliferative disease of the plantar aponeurosis. There have been described different therapeutic options regarding plantar fibromatosis, both conservative and surgical. The aim of this review is to systematically analyze conservative and operative treatments of plantar fibromatosis described in literature, evaluating which procedure shows the highest success rate and best functional outcome. Method(s): A systematic review of PubMed, Google Scholar and Cochrane reviews computerized database was performed focusing on the different types of treatments for plantar fibromatosis. Research was performed using the keywords "plantar", "fibromatosis", "Ledderhose", "Dupuytren", "foot" in order to identify all papers regarding the treatment of plantar fibromatosis. In addition, the research was extended to the reference list of the relevant articles. A total of 25 citations were obtained from the research and included. Result(s): Considering all the studies, 233 patients were included in this systematic review. 5 studies reported conservative treatment of plantar fibromatosis, with a total of 35 patients included. Operative outcomes are reported for 178 patients (92 male, 86 female), with 196 feet treated. Conclusion(s): Valid conservative methods are presented in literature, with debated results. Some operative options show high recurrence rate; wide excision is recommended in selected cases. Further clinical trials with well-defined and standardized outcome measurements should be necessary in future to better evaluate success rate and complications of the various procedures.Copyright © 2018 European Foot and Ankle Society

Fujita, M., et al. (2023). "Acceptability of self-sampling human papillomavirus test for cervical cancer screening in Japan: A questionnaire survey in the ACCESS trial." PloS One 18(6): e0286909.
	Purpose: In terms of medical policy for cervical cancer prevention, Japan lags far behind other industrialized countries. We initiated a randomized controlled trial to evaluate the self-sampling human papillomavirus (HPV) test as a tool to raise screening uptake and detection of pre-cancer. This study was conducted to explore the acceptability and preference of self-sampling using a subset of the data from this trial.; Methods: A pre-invitation letter was sent to eligible women, aged 30-59 years who had not undergone cervical cancer screening for three or more years. After excluding those who declined to participate in this trial, the remaining women were assigned to the self-sampling and control groups. A second invitation letter was sent to the former group, and those wanting to undergo the self-sampling test ordered the kit. A self-sampling HPV kit, consent form, and a self-administered questionnaire were sent to participants who ordered the test.; Results: Of the 7,340 participants in the self-sampling group, 1,196 (16.3%) administered the test, and 1,192 (99.7%) answered the questionnaire. Acceptability of the test was favorable; 75.3-81.3% of participants agreed with positive impressions (easy, convenient, and clarity of instruction), and 65.1-77.8% disagreed with negative impressions (painful, uncomfortable, and embarrassing). However, only 21.2% were confident in their sampling procedure. Willingness to undergo screening with a self-collected sample was significantly higher than that with a doctor-collected sample (89.3% vs. 49.1%; p<0.001). Willingness to undergo screening with a doctor-collected sample was inversely associated with age and duration without screening (both p<0.001), but that with a self-collected sample was not associated.; Conclusions: Among women who used the self-sampling HPV test, high acceptability was confirmed, while concerns about self-sampling procedures remained. Screening with a self-collected sample was preferred over a doctor-collected sample and the former might alleviate disparities in screening rates.; Competing Interests: The authors have declared that no competing interests exist. (Copyright: © 2023 Fujita et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Fujiwara, K., et al. (2021). "Olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer: Japan subset from the PAOLA-1/ENGOT-ov25 trial." Journal of Gynecologic Oncology 32(5): e82.
	OBJECTIVE: The addition of maintenance olaparib to bevacizumab demonstrated a significant progression-free survival (PFS) benefit in patients with newly diagnosed, advanced ovarian cancer in the PAOLA-1/ENGOT-ov25 trial (NCT02477644). We evaluated maintenance olaparib plus bevacizumab in the Japan subset of PAOLA-1. METHODS: PAOLA-1 was a randomized, double-blind, phase III trial. Patients received maintenance olaparib tablets 300 mg twice daily or placebo twice daily for up to 24 months, plus bevacizumab 15 mg/kg every 3 weeks for up to 15 months in total. This prespecified subgroup analysis evaluated investigator-assessed PFS (primary endpoint). RESULTS: Of 24 randomized Japanese patients, 15 were assigned to olaparib and 9 to placebo. After a median follow-up for PFS of 27.7 months for olaparib plus bevacizumab and 24.0 months for placebo plus bevacizumab, median PFS was 27.4 versus 19.4 months, respectively (hazard ratio [HR]=0.34; 95% confidence interval [CI]=0.11-1.00). In patients with tumors positive for homologous recombination deficiency, the HR for PFS was 0.57 (95% CI=0.16-2.09). Adverse events in the Japan subset were generally consistent with those of the PAOLA-1 overall population and with the established safety and tolerability profiles of olaparib and bevacizumab. CONCLUSION: Results in the Japan subset of PAOLA-1 support the overall conclusion of the PAOLA-1 trial demonstrating that the addition of maintenance olaparib to bevacizumab provides a PFS benefit in patients with newly diagnosed, advanced ovarian cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02477644.

Fujiwara, K., et al. (2022). "A randomized phase 3 trial of intraperitoneal versus intravenous carboplatin with dose-dense weekly paclitaxel in patients with ovarian, fallopian tube, or primary peritoneal carcinoma (a GOTIC-001/JGOG-3019/GCIG, iPocc Trial) (LBA 3)." Gynecologic Oncology 166(Supplement 1): S49-S50.
	Objectives: Traditionally, the target of intraperitoneal (IP) chemotherapy for ovarian cancer was patients with minimal residual disease after debulking surgery. However, our pharmacological study suggested that IP carboplatin therapy should also be feasible for patients with larger size residual disease, and our previous phase 2 study demonstrated a satisfactory response rate of IP carboplatin plus dose-dense paclitaxel (ddTCip) regimen in patients with macroscopic residual disease after initial surgery for ovarian (OV), fallopian tube (FT), and primary peritoneal (PP) carcinoma. The purpose of this study is to assess whether IP administration of carboplatin is superior to intravenous (IV) administration of carboplatin (ddTCiv regimen) in OV, FT, and PP carcinoma patients with either minimal or macroscopic residual disease. Method(s): Eligible patients were those with newly diagnosed stages II-IV disease. All patients were to undergo an initial laparotomy or laparoscopy with primary debulking surgery if possible. Before abdomen was closed, patients were randomized to either IV or IP arm. An IP port and catheter was placed if the patient was assigned to IP arm. Chemotherapy regimen was either IV paclitaxel plus IV carboplatin (IV arm) or IV paclitaxel plus IP carboplatin (IP arm). Dose of paclitaxel was 80 mg/m2 Q1W and dose of carboplatin was at an area under the curve (AUC) of 6 Q3W. Each patient was to receive 6 to 8 cycles of chemotherapy. Patients with bulky residual disease were allowed to undergo interval debulking surgery followed by assigned arm regimen up to 8 cycles total. Primary endpoint was PFS, and secondary endpoints included OS, safety, QOL, and cost/benefit. Result(s): Total of 655 patients were randomized between 2010 and 2016 from Japan, Singapore, Korea, New Zealand, USA, and Hong Kong. Stage distribution was II (n= 88), III (n=448), and IV (n=119). Size of residual disease at randomization was either 0 cm (n=163), < 1 cm (n=97), 1-2 cm (n=33), or >2 cm (n=362). Histological types were serous (n=420), endometrioid (n=61), clear cell (n=74), and others (n=100). Median follow-up was 55.7 months. IP chemotherapy significantly improved PFS in the ITT population (HR=0.83, 95%CI:0.69-0.99, p=.041) and in the 602 eligible patients (HR=0.78, 95%CI:0.65-0.94, p=.009). Median PFS for ITT population was 20.7 (95%CI: 18.1-22.8) months in the IV arm and 23.5 (95%CI: 20.5-26.9) months in the IP arm. Median PFS for eligible patients was 20.0 (95%CI: 18.0-22.2) months in the IV arm and 22.9 (95%CI:19.6-26.9) months in the IP arm. Subset analysis showed that the survival benefit was greater in patients with larger size residual disease. Toxicity profile was essentially equivalent in both arms except for catheter-related toxicities (11.8%). Conclusion(s): ddTCip chemotherapy improved the PFS over ddTCiv regimen in patients with OV, FT, and PP carcinoma regardless of the residual tumor size after initial surgery.Copyright © 2022 Elsevier Inc.

Fujiwara, K., et al. (2022). "LBA31 Randomized phase III trial of maintenance chemotherapy with tegafur-uracil versus observation following concurrent chemoradiotherapy for locally advanced cervical cancer, GOTIC-002 LUFT trial." Annals of Oncology 33(Supplement 7): S1398.
	Background: Maintenance chemotherapy with oral tegafur-uracil (UFT) after surgery was shown to prolong survival in lung, breast, gastric and colon cancer. Aim of this trial is to elucidate the efficacy of maintenance chemotherapy using UFT following concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer. Method(s): Eligible patients (pts) are those with FIGO (2008) stage Ib2 -IVa cervical cancer, who have squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma. Pts must have completed curative treatment of CCRT with a response of CR or PR. Pts were randomized to observation only (Arm O) or UFT maintenance cohort (Arm UFT) with 1:1 ratio. Dose of oral UFT was 400 mg /day for pts with body surface area (BSA)>= 1.25 m2 and 300 mg/day for pts with BSA < 1.25 m2. Pts received UFT for 2 years without interruption unless disease progression or unacceptable toxicities happened. Primary endpoint was PFS and secondary endpoints included OS, safety and QOL. Significant level was 0.05 (one-side). Result(s): Enrollment started in 2010 and completed in 2018. A total of 351 pts from 55 institutions in Japan were randomized either to Arm O (178 pts) or Arm UFT (173 pts). Safety data was analyzed in 176 pts in Arm O and 168 pts in Arm UFT. Pts characteristics were well balanced between two arms. Most of pts were stage IIb or IIIb, and received CCRT using weekly cisplatin. Median PFS did not reach for both arms. Five-year PFS rates were 61.3% (90%CI: 54.8-67.1) for Arm O and 62.0% (90%CI: 55.4-67.8) for Arm UFT (p=0.634). Hazard ratio (HR) of PFS for Arm UFT vs. Arm O was 0.92 (90%CI: 0.69-1.22). Five-year OS rates were 77.6% (90%CI: 71.8-82.4) for Arm O and 76.1% (90%CI: 70.1-81.1) for Arm UFT (p=0.869). HR of OS for Arm UFT vs. Arm O was 1.04 (90%CI: 0.73-1.47). All grade adverse events (AEs) occurred significantly more in Arm UFT (93.5%) than Arm O (73.9%) (Odds ratio = 5.05, 95%CI: 2.51, 10.15) but most of them were grade 1 or 2. Incidence of AEs >= grade 3 were 15.9% in Arm O and 22.6% in Arm UFT. Conclusion(s): Maintenance chemotherapy using UFT for 2 years after definitive chemoradiation therapy for locally advanced cervical cancer was well tolerated. However, it did not improve either PFS or OS. Clinical trial identification: jRCTs031180174. Legal entity responsible for the study: Gynecologic Oncology Trial and Investigation Consortium (GOTIC). Funding(s): Taiho Pharmaceutical CO., Ltd. Disclosure: K. Fujiwara: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Takeda, Regenerone, Zeria; Financial Interests, Personal, Advisory Board: MSD, Eisai, Genmab, Nano Carrier, Daiichi Sankyo; Financial Interests, Institutional, Funding: Regenerone; Financial Interests, Institutional, Research Grant: MSD, Ono, Zeria, Genmab; Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca; Non-Financial Interests, Leadership Role: GOTIC. K. Hasegawa: Financial Interests, Personal, Invited Speaker: MSD, AstraZeneca, Takeda, Chugai, Genmab, Kaken, Eisai; Financial Interests, Institutional, Funding, contracted research: MSD, Ono, Daiichi Sankyo, Eisai. All other authors have declared no conflicts of interest.Copyright © 2022 European Society for Medical Oncology

Fujiwara, Y., et al. (2022). "Incidence of hepatotoxicity associated with addition of immune checkpoint blockade to systemic solid tumor therapy: a meta-analysis of phase 3 randomized controlled trials." Cancer Immunology, Immunotherapy 71(12): 2837-2848.
	Hepatotoxicity is a major immune-related adverse event that may become life-threatening. The impact of adding immune checkpoint blockade (ICB) to systemic therapy on the incidence of hepatotoxicity remains unknown. We performed a systematic review and meta-analysis to compare the incidence of hepatotoxicity among patients with cancer who received therapy with and without addition of ICB. PubMed, Embase, Web of Science, and Cochrane Library were searched to select phase 3 randomized controlled trials (RCTs) evaluating the effect of adding ICB to systemic therapy, placebo, or supportive care. The odds ratio (OR) of any grade and grade 3-5 hepatitis, elevations in aspartate aminotransferase (AST), and alanine aminotransferase (ALT) was pooled for meta-analysis. 43 RCTs with 28,905 participants were analyzed. Addition of ICB increased the incidence of hepatitis (any grade: OR, 2.13, 95% confidence interval [CI] 1.52-2.97, grade 3-5: OR, 2.66, 95% CI 1.72-4.11), elevated AST (any grade: OR, 2.16, 95% CI 1.73-2.70, grade 3-5: OR, 2.72, 95% CI 1.86-3.99), and elevated ALT (any grade: OR, 2.01, 95% CI 1.59-2.54, grade 3-5: OR, 2.40, 95% CI 1.62-3.55). Subgroup analysis based on the ICB mechanism revealed no significant heterogeneity among each mechanism for hepatitis (any Grade: I2 = 11.1%, p for heterogeneity = 0.32, grade 3-5: I2 = 0%, p = 0.48). Adding ICB to systemic therapy increases the incidence of hepatotoxicity regardless of the mechanism of ICB. Hepatotoxicity is common and vigilant monitoring of liver function is required during ICB therapy for patients with cancer.Copyright © 2022, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Fukuda, F. S., et al. (2023). "Pelvic floor muscles training in women practicing high impact sports: a systematic review." International journal of sports medicine 44(6): 397-405.
	Urinary incontinence (UI) in female sports women can impair their quality-of-life (QoL) and reduce their participation in sport. This review aims to evaluate the effect of pelvic floor muscle training (PFMT) in treating UI in women participating in high-impact sports. Furthermore, to assess the influence of PFMT on pelvic floor muscles (PFM) function and the UI impact on their QoL. For this purpose, a systematic review of randomized controlled trials (RCTs) and non-RCTs was performed. Electronic search was conducted on PubMed, EMBASE, SciELO and Scopus. The quality of evidence was assessed using the PEDro and ROBINS-I scales. The Consensus on Exercise Reporting Template (CERT) was used to assess the quality of PFMT protocols. All studies were available at full-text including incontinent female participants who are practitioners of high-impact sports, investigating PFMT vs control groups(inactive) or undergoing other treatments. Three RCTs and two non-RCTs (104 participants) were analyzed. PFMT provided a significant improvement in UI symptoms with reduction in the frequency (n=3) and the amount of UI (n=5). PFM function was assessed in three studies, and two found improvement in maximal contraction and one in vaginal resting pressure in favor of PFMT. None of the two studies that assessed QoL found a difference after PFMT intervention.

Fukui, M., et al. (2022). "Olaparib-induced cutaneous vasculitis in a patient with recurrent ovarian cancer." European journal of dermatology : EJD 32(5): 655-656.
	
Fukumoto, S., et al. (2023). "Incidence of Hypophosphatemia After Intravenous Administration of Iron: A Matching-Adjusted Indirect Comparison of Data from Japanese Randomized Controlled Trials." Advances in Therapy 40(11): 4877-4888.
	Introduction: Intravenous (IV) administration of iron is considered a safe and efficacious treatment for iron deficiency anemia (IDA), recommended in patients requiring rapid replenishment of iron, or intolerant or unresponsive to oral administration of iron. Recent randomized controlled trials (RCTs) have shown high incidence of hypophosphatemia after administration of two IV iron preparations: saccharated ferric oxide (SFO) and ferric carboxymaltose (FCM). The present study aimed to conduct matching-adjusted indirect comparison (MAIC) of hypophosphatemia incidence with these iron formulations and ferric derisomaltose (FDI) based on data from head-to-head RCTs conducted in Japan.; Methods: A MAIC of hypophosphatemia incidence was conducted on the basis of data from two head-to-head RCTs. The relative odds of hypophosphatemia with FDI versus SFO were obtained from patient-level data from a recent RCT and adjusted for cumulative iron dose, while parametric models of serum phosphate levels from a separate RCT were used to estimate the relative odds of hypophosphatemia with FCM with SFO. An anchored MAIC was then conducted comparing FDI with FCM.; Results: The adjusted odds of experiencing hypophosphatemia were significantly lower with FDI than SFO [odds ratio (OR) of 0.02; 95% confidence interval (CI) 0.01-0.05]. The parametric models of serum phosphate from the RCT comparing FCM with SFO provided an estimated OR of 1.17 for the incidence of hypophosphatemia with FCM versus SFO. Combining the two estimates in the MAIC showed that the odds of experiencing hypophosphatemia would be 52.5 (95% CI 27.7-99.4) times higher with FCM than FDI in patients with IDA associated with heavy menstrual bleeding in Japan.; Conclusions: Direct comparison of patient-level data and a MAIC from two RCTs in Japanese patients with heavy menstrual bleeding indicated that hypophosphatemia is less frequent in patients treated with FDI than those with FCM or SFO. Results are in agreement with RCTs comparing FDI and FCM in patients with various etiologies conducted in the USA and Europe. (© 2023. The Author(s).)

Fundación, I. V. I., et al. (2021). 4-step ASCOT in POI Women to Promote Follicular Rescue.
	No Results Available Drug: G-CSF treatment for Bone marrow derived stem cell Mobilization|Procedure: Platelet Rich Plasma ovarian injection AFC|FSH, AMH and E2 levels|Number of COS and IVF cycle parameters for each patient, initiated before and after treatment.|Menses recovery (YES/NO)|Ovarian function (YES/NO) Female Phase 3 42 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 1912-FIVI-113-SH October 2024

Fung, J. Y. T., et al. (2022). "Effectiveness of eHealth mindfulness-based interventions on cancer-related symptoms among cancer patients and survivors: A systematic review and meta-analysis." Journal of Telemedicine and Telecare: 1357633X221078490.
	OBJECTIVES: This review aimed to synthesize the best available evidence concerning the effectiveness of electronic health, mindfulness-based interventions (eHealth-MBIs) on anxiety, depression, mindfulness and quality of life (QoL) among cancer patients/survivors. METHODS: Published and unpublished studies were retrieved from 10 electronic databases. Two independent authors screened and selected articles, extracted data using a standardized form and appraised the studies with the Cochrane risk of bias assessment tool. Meta-analyses were performed using a random-effect model with Review Manager (REVMAN). Standardized mean differences (SMDs) were used to determine intervention effects. Narrative syntheses were conducted for studies not suitable for meta-analyses. Heterogeneity was identified through I2 and chi-square statistics. Subgroup analyses were performed based on types of controls, age groups and gender. The Grading of Recommendations Assessment, Development and Evaluation approach was used to assess overall quality. RESULTS: In total, 18 studies were included. The eHealth-MBIs improved primary outcomes of anxiety (SMD = -0.28) and depression (SMD = -0.24), among cancer patients/survivors with small effect sizes. Effects for the secondary outcomes of QoL (SMD = 0.25) and mindfulness (SMD = 0.29) were observed at short-term follow-up assessments but not at post-intervention. Overall quality was rated as low for the primary and very low for the secondary outcomes. CONCLUSION: The eHealth-MBIs can be offered as a cost-effective and accessible alternative for cancer patients and survivors in healthcare settings. Future research may further explore the effectiveness of eHealth-MBIs based on different types of MBIs, cancer types, modes of delivery and other outcomes such as stress and post-traumatic growth.

Fuoco, V., et al. (2024). "Sentinel node biopsy in gynaecological cancers: state of art and future perspectives." Clinical and Translational Imaging.
	Purpose: This review aims to provide an overview of current knowledge and future perspectives on sentinel node biopsy in gynaecological cancers. Method(s): Literature research in the PubMed/MEDLINE database was carried out to identify relevant studies on sentinel node biopsy in gynaecological cancers. We selected only original studies, published in the English language and including a minimum of nine patients. Result(s): The most relevant results on sentinel node biopsy in gynaecological cancers were summed up, focusing on clinical indications, technical aspects, preoperative and intraoperative procedures and the latest technological advances. Conclusion(s): Sentinel node biopsy has been widely validated in well-selected patients with early-stage vulvar, cervical and endometrial cancers. It is essential to standardise the acquisition protocol, including SPECT/CT imaging, for an improved surgical planning and a personalised approach. Recent technological advances, such as hybrid tracers and intraoperative tools, may efficiently guide gynaecological cancer surgery.Copyright © The Author(s) 2024.

Fusca, L., et al. (2019). "The Effectiveness of Tranexamic Acid at Reducing Blood Loss and Transfusion Requirement for Women Undergoing Myomectomy: A Systematic Review and Meta-analysis." Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC 41(8): 1185.
	Background: The surgical removal of fibroids can be associated with excessive blood loss requiring transfusion.; Objective: This review sought to determine the effectiveness of tranexamic acid (TA) in reducing perioperative blood loss in women undergoing myomectomy.; Methods: Electronic bibliographic databases were searched from inception until June 3, 2017. The review included RCTs of women of reproductive age with uterine fibroids who were undergoing myomectomy and who received TA or a comparator. Two independent reviewers extracted relevant data, and meta-analysis was performed.; Results: Three studies included women undergoing abdominal myomectomy. TA significantly reduced intraoperative blood loss by a mean difference of 213.1 mL (95% CI -242.4 to -183.7) and postoperative blood loss by a mean difference of 56.3 mL (95% CI -67.8 to -44.8) compared with control arms. However, no significant differences were seen in blood transfusion requirement (relative risk 0.58; 95% CI 0.33-1.00). In one study for women undergoing hysteroscopic myomectomy, TA was not associated with improved outcomes in transfusion requirement and resulted in reduced postoperative hemoglobin levels compared with oxytocin.; Conclusion: Among women undergoing abdominal myomectomy, TA is effective at reducing perioperative blood loss compared with no treatment or placebo. For women undergoing hysteroscopic myomectomy, TA compared with oxytocin is not associated with improved outcomes in transfusion requirement and resulted in reduced postoperative hemoglobin levels. (Copyright © 2019 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.)

Fuschi, A., et al. (2022). "Sexual and functional outcomes after prolapse surgery: a randomized prospective comparison of trocarless transvaginal mesh and pelvic organ prolapse suspension." Langenbeck's archives of surgery 407(4): 1693-1700.
	Purpose: Stress urinary incontinence (SUI) related to pelvic organ prolapse represents a common condition that negatively impacts female sexual activity. Laparoscopic pelvic organ prolapse surgery (POPs) and the anterior repair with a trocar-less trans-vaginal mesh (TTMs) represent two different surgical techniques to treat SUI secondary to POP. This study aimed to report the results of these techniques comparing the sexual and functional outcome improvement.; Materials and Methods: Fifty-nine sexually active female patients, complaining of urodynamic stress incontinence, were enrolled in this prospective study, and simply randomized in two groups: 29 POPs and 30 TTMs. All patients were studied at baseline and 6 months after surgery. Preoperative evaluation included medical history, urodynamic test, Female Sexual Function Index (FSFI), and pelvic magnetic resonance defecography. Six months after surgery, all patients completed the FSFI and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and were investigated with a uroflowmetry test with post-void residual volume (PVR).; Results: At 6 months after surgery, 87% of POPs patients and 79% of TTMs subjects resulted dry. No statistically significant results were obtained in terms of urinary outcomes between the two surgical groups. Regarding sexual function, POPs group exhibited a significant greater improvement of global FSFI (mean: 27.4; SD: 4.31) compared to TTMs group (mean FSFI: 23.56; SD: 2.28; p-value ≤ 0.0001).; Conclusions: Our results indicated that POPs and TTMs lead to satisfactory and safe functional outcomes with a good recovery of urinary continence. Furthermore, POPs, when compared to TTMs, led to a greater improvement of sexual function. (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

fxm4g, R. B. R. (2021). "Menorrhagia Control with Two Hormonal IUDs." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: 7596 Hormonal IUDs: levonorgestrel intrauterine systems (52 mg versus 19.5 mg) Group Mirena (52 mg): 73 women with menorrhagia will use Mirena and will be accompanied by 1 year. Group Kyleena (19,5 mg): 73 women with menorrhagia will use Kyleena and will be accompanied by 1 year. Neither the woman nor the principal investigator will know the IUD in use. CONDITION: 8768 Menorrhagia PRIMARY OUTCOME: Considering the margin of 20%, it is thought that the levonorgestrel intrauterine system of 19.5 mg would be similar to the system of 52 mg on the heavy menstrual bleeding control. SECONDARY OUTCOME: Comparison of baseline and 12‐month ferritin levels between Mirena and Kyleena users. Comparison of baseline and 12‐month hematocrit levels between Mirena and Kyleena users. Comparison of baseline and 12‐month hemoglobin levels between Mirena and Kyleena users. Comparison of baseline and 12‐month serum iron levels between Mirena and Kyleena users. Comparison of bleeding pattern between Mirena and Kyleena users by PBAC each 3‐month period, after the insertion of IUD. Comparison of endometrial lining between Mirena and Kyleena users by US scan at baseline and each 3‐month period, after the insertion of IUD. INCLUSION CRITERIA: Women with age between 18 years (complete) ‐ 48 years (incomplete); heavy menstrual bleeding (menorrhagia).

g8mjzk, R. B. R. (2023). "Use of transvaginal non-ablative Radiofrequency in the Treatment of Urinary Incontinence and Vaginal Atrophy." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: This is a randomized, controlled clinical trial, blinded to study participants. The Randomization was defined by using the method of randomly permuted blocks at randomization.com. The sample size is 62 women, 31 for intevention and 31 for control group. Study participants will undergo three treatment sessions with transvaginal non‐ablative Radiofrequency (RFNATV), with an interval of 3 weeks between sessions. They will be reassessed at each treatment session and one month after the end of the third and final session. Application of the ICIQ‐SF, KHQ, FSFI questionnaire and assessment of pelvic floor muscles strength will be performed. The device used for the application of RFNATV, will be the Spectra Medic, it is developed by the Brazilian company Tonederm (510, Rua Angelo Michelin ‐ Caxias do Sul, RS), released by the National Health Surveillance Agency (ANVISA), through registration number 104.115 .200.22. The transducer to be used will be from the same company. The participant will be in a conventional lithotomy position (gynecological position) when the transducer is introduced. The duration of the application in the groups will be four minutes in each quadrant of the vagina (anterior, posterior, right‐side and left‐side), associated with this, the participant must perform a series of exercises for the pelvic floor muscles, under supervision of the researchers. In the control group, the procedure will be simulated in the same way but the device will be turned off, only using the same sound effects. The time of use will be similar to the time of use in the group and the exercises for the pelvic floor muscles will also be guided under the supervision of the researchers. CONDITION: C12.050.351.500 Genitourinary Syndrome of Menopause. Urinary incontinence PRIMARY OUTCOME: We expect to find an improvement in the symptoms of the menopausal genitourinary syndrome using transvaginal non‐ablative radiofrequency in the treatment of the menopausal genitourinary syndrome, through the application of specific and validated questionnaires for quality of life and sexual satisfaction, as well as the evaluation of vaginal pH, estimating a 5‐point improvement between the pre and post‐treatment evaluations; ; Translated with www.DeepL.com/Translator (free version) SECONDARY OUTCOME: Describe safety and possible side effects induced by Radiofrequency non ablative transvaginal INCLUSION CRITERIA: Postmenopausal women, diagnosed with genitourinary syndrome of menopause, urinary incontinence (stress or mixed with predominance of stress)

Gaba, F., et al. (2023). "Prognosis Following Surgery for Recurrent Ovarian Cancer and Diagnostic Criteria Predictive of Cytoreduction Success: A Systematic Review and Meta-Analysis." Diagnostics (Basel, Switzerland) 13(22).
	For women achieving clinical remission after the completion of initial treatment for epithelial ovarian cancer, 80% with advanced-stage disease will develop recurrence. However, the standard treatment of women with recurrent platinum-sensitive diseases remains poorly defined. Secondary (SCS), tertiary (TCS) or quaternary (QCS) cytoreduction surgery for recurrence has been suggested to be associated with increased overall survival (OS). We searched five databases for studies reporting death rate, OS, cytoreduction rates, post-operative morbidity/mortality and diagnostic models predicting complete cytoreduction in a platinum-sensitive disease recurrence setting. Death rates calculated from raw data were pooled based on a random-effects model. Meta-regression/linear regression was performed to explore the role of complete or optimal cytoreduction as a moderator. Pooled death rates were 45%, 51%, 66% for SCS, TCS and QCS, respectively. Median OS for optimal cytoreduction ranged from 16-91, 24-99 and 39-135 months for SCS, TCS and QCS, respectively. Every 10% increase in complete cytoreduction rates at SCS corresponds to a 7% increase in median OS. Complete cytoreduction rates ranged from 9-100%, 35-90% and 33-100% for SCS, TCS and QCS, respectively. Major post-operative thirty-day morbidity was reported to range from 0-47%, 13-33% and 15-29% for SCS, TCS and QCS, respectively. Thirty-day post-operative mortality was 0-6%, 0-3% and 0-2% for SCS, TCS and QCS, respectively. There were two externally validated diagnostic models predicting complete cytoreduction at SCS, but none for TCS and QCS. In conclusion, our data confirm that maximal effort higher order cytoreductive surgery resulting in complete cytoreduction can improve survival.

Gadducci, A. and D. Aletti Giovanni (2020). "Locally advanced squamous cell carcinoma of the vulva: A challenging question for gynecologic oncologists." Gynecologic Oncology 158(1): 208-217.
	Squamous cell carcinoma of the vulva is a rare female malignancy, with an incidence increasing with age. Unfortunately, one third of the patients are diagnosed with locally advanced disease, which constitutes a clinical challenge for the clinicians who treat these patients. The main challenges are represented by: 1. The primary site of the disease, which can be proximal to anatomical structures like the anal canal posteriorly, or the urethra and the bladder anteriorly, that in some circumstances cannot be spared without a bowel and/or urinary stoma; 2. The locoregional nodes that can be involved by the tumor, and they can be bulky, fixed or ulcerated; 3. The clinical condition of the patient, who may carry several comorbidities. Treatment modalities include radiation with or without chemotherapy, and surgery. In order to preserve the bowel and the urinary function without a permanent stoma, a personalized management with a multimodality approach is warranted. In this systematic review, we first clarify the different definitions of "locally advanced vulvar carcinoma". Secondly, we evaluated the different treatment modalities described in the literature, and the impact of the different treatment strategies on prognosis and on preservation of bowel/urinary function. Finally, we offer a possible algorithm that may help the clinicians in treating patients with these uncommon and challenging situations with a multidisciplinary approach.; Competing Interests: Declaration of competing interest The authors declare no conflict of interest. (Copyright © 2020 Elsevier Inc. All rights reserved.)

Gadducci, A., et al. (2019). "Placental site trophoblastic tumor and epithelioid trophoblastic tumor: Clinical and pathological features, prognostic variables and treatment strategy." Gynecologic Oncology 153(3): 684-693.
	Placental site trophoblastic tumor [PSTT] and epithelioid trophoblastic tumor [ETT] are the rarest gestational trophoblastic neoplasias, developing from intermediate trophoblast of the implantation site and chorion leave, respectively. PSTT and ETT share some clinical-pathological features, such as slow growth rates, early stage at presentation, relatively low βhCG levels and poor response to chemotherapy. The mortality rate ranges from 6.5% to 27% for PSTT and from 10% to 24.2% for ETT. Advanced stage, long interval between antecedent pregnancy and diagnosis, and presence of clear cells are the independent prognostic variables for PSTT, and they may be similar for ETT. Hysterectomy can represent the only therapy for early disease, whereas adjuvant chemotherapy should be reserved to patients with poor risk factors, such as an interval from the antecedent pregnancy >4 years, deep myometrial invasion or serosal involvement. Few cases of fertility-sparing treatment in young women have been reported. An individualized multidisciplinary approach, including chemotherapy and debulking surgery with abdominal and/or extra-abdominal procedures, is warranted for advanced disease. EP/EMA and TP/TE are the preferred regimens in this setting. Immunohistochemistry has sometimes shown expression of EGFR, VEGF, MAPK, PDGF-R and PD-L1, and therefore investigational studies on biological agents targeting these molecules are strongly warranted for chemotherapy resistant-disease. (Copyright © 2019 Elsevier Inc. All rights reserved.)

Gadducci, A. and S. Cosio (2022). "Trabectedin and lurbinectedin: Mechanisms of action, clinical impact, and future perspectives in uterine and soft tissue sarcoma, ovarian carcinoma, and endometrial carcinoma." Frontiers in Oncology 12: 914342.
	The ecteinascidins trabectedin and lurbinectedin are very interesting antineoplastic agents, with a favorable toxicity profile and peculiar mechanisms of action. These drugs form adducts in the minor groove of DNA, which produce single-strand breaks (SSBs) and double-strand breaks (DSBs) and trigger a series of events resulting in cell cycle arrest and apoptosis. Moreover, the ecteinascidins interact with the tumor microenvironment, reduce the number of tumor-associated macrophages, and inhibit the secretion of cytokines and chemokines. Trabectedin has been approved by the Federal Drug Administration (FDA) for patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-based regimen. Moreover, trabectedin in combination with pegylated liposomal doxorubicin (PLD) has been approved in the European Union for the treatment of platinum-sensitive recurrent ovarian cancer. Lurbinectedin has been approved by the FDA for patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy. The review assesses in vitro and in vivo experimental studies on the antineoplastic effects of both ecteinascidins as well as the clinical trials on the activity of trabectedin in uterine sarcoma and ovarian carcinoma and of lurbinectedin in ovarian carcinoma and endometrial carcinoma.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Gadducci and Cosio.)

Gadducci, A., et al. (2022). "Hyperthermic Intraperitoneal Chemotherapy in the Management of Primary Epithelial Ovarian Cancer: A Debated Issue for Gynecologic Oncologists." Anticancer Research 42(10): 4659-4665.
	Hyperthermic intraperitoneal chemotherapy (HIPEC) has been widely investigated in patients with peritoneal carcinomatosis, including those with epithelial ovarian cancer (EOC), with conflicting results. The hyperthermia enhances drug tissue penetration, synergizes with several cytotoxic drugs including cisplatin, degrades BRCA2, suppresses homologous recombination, and elicits an anticancer immune response. A meta-analysis of retrospective studies including both patients with primary advanced EOC and those with recurrent platinum-sensitive EOC failed to detect a benefit in terms of progression-free survival (PFS) or overall survival (OS) from the addition of HIPEC after surgery. The aim of the present review was to analyze the recent randomized clinical trials designed to assess the value of HIPEC in the management of patients with primary advanced EOC. Although not free from criticism and bias, the available data from two phase III trials seem to suggest that the addition of HIPEC to interval debulking surgery after neoadjuvant chemotherapy significantly improves PFS and OS. Conversely, HIPEC does not appear to offer any advantage after primary debulking surgery. Several phase III trials are currently ongoing on these issues and the use of HIPEC is still a matter of debate in the scientific community. Additional translational research is strongly warranted to detect biological variables able to identify a subset of patients who may have a major benefit from this therapeutic approach. In particular, the clinical outcome of patients who undergo HIPEC should be correlated with BRCA status and homologous recombination repair status. (Copyright © 2022 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Gagnon, S., et al. (2022). "Evaluation of Hysteroscopic Endometrectomy: A Reappraisal." Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC 44(11): 1190-1192.
	Endometrial ablation can be performed using a variety of techniques, including resectoscopic or non-resectoscopic approaches. In this study, we compared 2 resectoscopic endometrial ablation techniques. The first technique was rollerball coagulation followed by endometrectomy (type A; n = 103), and the second was the reverse (type B; n = 107). Besides excessive bleeding in 4 cases, the procedures were uneventful in both groups of patients. We did not encounter uterine perforation or cervical laceration. Satisfaction rates were 97% and 99% with an overall hysterectomy rate of 2.9%. These results compared favorably with those in the literature. The results of our study show that hysteroscopic endometrectomy is effective with few associated complications. (Copyright © 2022 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.)

Gagyor, D., et al. (2022). "Relationship between urethrovesical junction mobility changes and postoperative progression of stress urinary incontinence following sacrospinous ligament fixation - a multicentre prospective study." International Urogynecology Journal 33(Supplement 1): S158-S159.
	Introduction: De novo stress urinary incontinence (SUI) develops following surgery for pelvic organ prolapse in preoperatively asymptomatic patients, affecting 8-10% of women undergoing the surgery. Many patients, particularly those with severe prolapse, may have SUI symptoms masked by urethral obstruction. Posterior deviation of the vaginal axis following sacrospinous ligament fixation (SSF) predisposes to development of anterior compartment defects in approximately 10-20%. Objective(s): The study aimed to assess the relationship between urethrovesical junction (UVJ) descent and development of de novo SUI and postoperative progression of preexisting SUI following surgery for pelvic organ floor prolapse using the SSF method. This was a secondary analysis of the SAME prospective randomized multicentre study (reg. no. NCT03053479) comparing three approaches to surgery for apical defects - sacropexy, SSF and transvaginal mesh. Since May 2016, five tertiary urogynaecology centres have prospectively recorded history, clinical and anatomical (POP-Q), ultrasound (3D/4D transperineal ultrasound) and subjective (VAS, standardized tools - ICIQ-UI, PSIQ-12, POP SS, PFDI-44) data preoperatively, intraoperatively and postoperatively at 3- month, 12-month, 24-month and 60-month follow-up. Method(s): The subanalysis included 81 patients with apical defects managed by SSF, either right-sided (n=14; 17.3%) or bilateral (n=67; 82.7%). Postoperative follow-up was assessed at 3 months (n=59), 12 months (n=47) and 24 months (n=30). Preoperative demographic data were analyzed. Preoperative and postoperative clinical and anatomical findings were assessed using the Pelvic Organ Prolapse Quantification System (POP-Q). UVJ mobility at rest and with the maximum effort Valsalva manoeuvre was determined using a standardized 3D/4D transperineal ultrasound protocol proposed by Dietz et al. UVJ descent values were calculated as differences in mobility at rest and during Valsalva manoeuvre. De novo SUI and postoperative progression of preexisting SUI were ascertained from history. Patients who had undergone SIU surgery were excluded. Statistical analyses were performed using IBM SPSS Statistics 22 (Armonk, NY: IBM Corp.). The level of statistical significance was set at p<0.05. Result(s): Preoperative demographic data (n=81) were as follows: BMI 27.3 (16.8-44.5), age 67.0 years (31-85), parity 2 (1-6). Concomitant anterior repair was performed in 65.4%. Preoperatively, median measures for POP-Q were Aa 1.0, Ba 4.0 and C 3.0. Postoperative median measures were Aa -1, Ba -1.5, C -7 at 3 months, Aa -1, Ba -1, C -6 at 12 months, and Aa -1, Ba 0, C -5.5 at 24 months. Postoperative progression of SUI was 45.8% at 3 months, 21.3% at 12 months, and 23.3% at 24 months. There were significant differences between preoperative and postoperative UVJ descent values at 3, 12 and 24 months (p< 0.0001). Correlations between UVJ descent at 3, 12 and 24 months postoperatively and de novo SUI or progression of preexisting SUI at 3, 12 and 24 months postoperatively were not statistically significant (p= 0.051-0.883). Correlations between differences (preoperative UVJ descent minus UVJ descent at 3, 12 and 24 months postoperatively) and de novo SUI or progression of preexisting SUI at 3, 12 and 24 months postoperatively were not statistically significant (p= 0.691-0.779). Conclusion(s): The study showed significant changes in UVJ descent values preoperatively and at 3, 12 and 24 months after SSF. There were no significant correlations between UVJ descent and de novo SUI and postoperative progression of preexisting SUI following surgery for pelvic organ floor prolapse at 3-, 12- and 24-month follow-up.

Gágyor, I., et al. (2021). "Herbal treatment with uva ursi extract versus fosfomycin in women with uncomplicated urinary tract infection in primary care: a randomized controlled trial." Clinical microbiology and infection 27(10): 1441‐1447.
	Objective: We explored whether initial treatment with the herbal drug uva ursi (UU) reduces antibiotic use in women with uncomplicated urinary tract infection (UTI) without increasing symptom burden and complication frequency compared with antibiotic treatment. Methods: A double‐blind randomized controlled trial was conducted in 42 family practices in Germany. The participants were adult women with suspected uncomplicated UTIs receiving either UU 105 mg 3 × 2 tablets for 5 days (intervention) or fosfomycin a 3‐g single dose (control), and their respective placebos. Participants and investigators were blinded. The primary outcome included (1) antibiotic courses day 0–28 as superiority, and (2) symptom burden (sum of daily symptom scores) day 0–7, as non‐inferiority outcome (margin 125%). Clinicaltrials.gov: NCT03151603. Results: Overall, 398 patients were randomly allocated to groups receiving UU (n = 207) and fosfomycin (n = 191). The number of antibiotic courses was 63.6% lower (95% CI 53.6%–71.4%; p < 0.0001) in the UU group than in the fosfomycin group. The ratio of total symptom burden in the UU group compared with control was 136.5% (95% CI 122.7–151.9; p 0.95), failing non‐inferiority. Eight women developed pyelonephritis in the UU group compared with two in the fosfomycin group (mean difference 2.8; 95% CI 0.2–5.9; p 0.067). Adverse events were similar between the groups. Discussion: In women with uncomplicated UTIs, initial treatment with UU reduced antibiotic use but led to a higher symptom burden and more safety concerns than fosfomycin.

Gala, A., et al. (2022). "Does artificial shrinkage prior to fresh blastocyst transfer improve ongoing pregnancy rate? A prospective double blind randomized controlled trial." Human reproduction (Oxford, England) 37: i294‐i295.
	Study question: Does artificial shrinkage (AS) of blastocoelic cavity (BC) prior to fresh elective single blastocyst transfer (SBET) increase ongoing pregnancy rate? Summary answer: Ongoing pregnancy rates were similar with or without AS of blastocoelic cavity. AS does not seem to provide benefit before fresh blastocyst transfer. What is known already: AS of the vitrified blastocysts enhances success rate in frozen embryo transfer cycles. In vitro cultured embryos suffer changes in temperature, pH and osmotic pressure. Moreover, manipulations such as pipetting, fertilization, microscopic observations and changes of dishes can induce oxidative stress and apoptosis. The presence of cell free DNA (cfDNA) in blastocyst fluids could be the consequence of its release from dead cells. The quantity of cfDNA in blastocyst fluids could possibly be related to the rate of cell death. It is thus interesting to estimate whether AS of BC could improve the implantation rate in cycles with fresh blastocyst transfer. Study design, size, duration: Prospective, randomized, double blind controlled study. From May 20th 2018 to June 30th 2021, 150 couples elected for fresh SBET were included in the study and were randomly selected as AS + group (n=100), where AS of blastocoel was performed by laser pulse before fresh blastocyst transfer, and AS‐ group (n=50), where fresh blastocysts were transferred without any additional intervention. Participants/materials, setting, methods: On day 5 after fertilization, one blastocyst with a grade of expansion B3, B4, B5 or B6 and type A or B quality trophectoderm (Gardner and Schoolcraft classification, 1999) was selected for transfer. After replacement, the droplet that contained the embryo from day 3 was collected for cfDNA level quantification. Ongoing pregnancy rate was determined by the visualization of a gestational sac with a foetal heartbeat 6 weeks later and cfDNA was assessed by ALU‐qPCR. Main results and the role of chance: The two groups were similar for age, BMI, infertility duration and cause, stimulation characteristics and embryological parameters. The global ongoing pregnancy rate per transfer after SBET was 49.7 %. The pregnancy rate in the AS + group was slightly higher than in the control group but not significantly (respectively 50.00 % and 48,9 %, p=0,91). cfDNA median value in the AS+ group was comparable to the control group (0.493 (0.219; 0.915) mg/ml and 0.595 (0.271; 1.129) mg/ml respectively (p=0.45)). No link was found between cfDNA rate and clinical pregnancy rate. Limitations, reasons for caution: Patients included in the study are still followed to evaluate the impact of AS on live birth rate, wastage rate, obstetrical and neonatal complications. cfDNA rate was evaluated in spent culture media and not by blastocentesis, which could provide a more accurate quantification. Wider implications of the findings: To our knowledge, this is the first prospective randomized controlled study assessing the benefit of AS of BC before fresh blastocyst transfer. The inclusion of live birth rate is crucial to ascertain the interest of this technique and more studies are needed to improve the use of cfDNA in routine.

Galati, G., et al. (2022). "Folliculogenesis in random start protocols for oocytes cryopreservation: quantitative and qualitative aspects." Reproductive Sciences 29(11): 3260-3265.
	Random start protocols are commonly used for oocytes cryopreservation in women with cancer. However, evidence to support their effectiveness is yet modest. This study aims to compare the quality of ovarian response between the ovary carrying the dominant follicle or the corpus luteum (active ovary) and the contralateral ovary (resting ovary). Women with a diagnosis of malignancy who underwent oocytes cryopreservation were reviewed. The main inclusion criterion was the presence of a unilateral dominant follicle or a unilateral corpus luteum on the first day of ovarian hyperstimulation. The primary outcome was the number of mature oocytes retrieved. Intra-patient comparisons between the two ovaries were made using the nonparametric Wilcoxon test for paired data. Forty-three women were included. The number of mature oocytes retrieved from the active and the resting ovaries did not differ, the median [interquartile range-IQR] being 4 [2-7] and 5 [2-8], respectively (p = 0.09). The rate [IQR] of mature oocytes per developed follicle was 58% [40-80%] and 65% [33-87%], respectively (p = 0.42). In addition, no significant difference emerged when repeating the analyses separately for women carrying dominant follicles and for those carrying corpora lutea. This study failed to detect any detrimental effect of the presence of a dominant follicle or a corpus luteus on the ovarian response to hyperstimulation, thus supporting the validity of random start protocols.Copyright © 2022, The Author(s).

Galazis, N., et al. (2020). "Intraoperative Ultrasound during Fertility-Sparing Surgery: A Systematic Review and Practical Applications." Gynecologic and Obstetric Investigation: 1-22.
	Fertility-sparing surgery (FSS) is an established concept within operative gynaecology. Intraoperative ultrasound (IOUS) has the potential of assessing lesion margins, allowing complete resection with minimal damage to the surrounding healthy tissue and could potentially play a major role in FSS for benign or malignant gynaecological pathologies. In this paper, we review the current literature on the use of IOUS in gynaecological FSS. We also propose technical guidance on the IOUS during FSS. The findings of this review demonstrate that IOUS can assist in the safe resection of disease with high rates of completion, low rates of recurrence and without damage to the nearby healthy reproductive organs. Improved training in transvaginal ultrasonography and minimal access surgery are likely to facilitate the application of IOUS in FSS.

Galliera Ente Ospedaliero, O., et al. (2022). Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial).
	No Results Available Drug: Letrozole tablets|Drug: carboplatin AUC 5 and paclitaxel 175 mg/m2 Progression-free survival (PFS)|Objective Response Rate (ORR)|Predictive effect of ER and PgR (% expression) on response to letrozole in terms of PFS and ORR|Clinical Benefit (CB)|Overall survival (OS)|Safety (Adverse Events) Female Phase 3 132 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 10UCS2018|2020-003066-39 September 22, 2029

Gamba, T., et al. (2023). "Poly (ADP-Ribose) Polymerase Inhibitors in Patients With Urothelial Cancer." Clinical genitourinary cancer 21(5): 509-516.
	Poly ADP-ribose polymerase inhibitors (PARPis) have clinical activity in several cancers. The rationale of their therapeutic use in urothelial cancer (UC) resides in the high homologous-recombination repair (HRR) deficiency (HRD) prevalence and potential cross-sensitivity with platinum-based chemotherapy (PBCT). This review aims to summarize and analyze trials exploring the activity of PARPis in UC, focusing on patients who may benefit from those agents, the best clinical setting for the treatment and the benefit of the association with immune-checkpoint inhibitors (ICIs). We included all the available trials analyzing the activity of PARPis in UC in neoadjuvant, adjuvant, first or subsequent lines, and maintenance setting. We included PARPis in monotherapy and in association with other agents. The results in the maintenance setting are intriguing: ATLANTIS trial showed signals of improved progression-free survival in patients with known HRR aberrations, although the Meet-URO12 trial, with its negative results, suggested the failure of clinical selection based on platinum sensitivity only. Single-agent PARPis in pretreated patients showed discouraging results in an unselected population of chemo-refractory patients. Concerning the association of PARPis with ICIs, several trials are exploring their role in platinum-naïve setting; the results in the advanced setting were globally negative. Prior selection of HRD status is essential to identify patients who might benefit from PARPis. The ideal clinical settings seem to be the maintenance treatment and the combination with ICIs in platinum-naïve patients. Definitive results of ongoing and further trials will delineate the position for PARPis, if any, in UC therapy.; Competing Interests: Disclosure All authors declare no support from any organization for the submitted work; MDM reports honoraria from AstraZeneca, Boehringer Ingelheim, Janssen, Merck Sharp & Dohme (MSD), Novartis, Pfizer, Roche, GlaxoSmithKline, Amgen, Merck, Takeda for consultancy or participation to advisory boards and direct research funding from Tesaro/GlaxoSmithKline, institutional funding for work in clinical trials/contracted research from Beigene, Exelixis, MSD, Pfizer and Roche; other authors declare no conflicts of interest that could appear to have influenced the submitted work. (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Gambacciani, M. (2023). "Treating where it hurts: tailoring the genitourinary syndrome of menopause treatments." Menopause (New York, N.Y.) 30(5): 463-464.
	Competing Interests: Financial disclosures/conflicts of interest: None reported.

Gamé, X. and V. Phé (2020). "[First-line treatment for non-neurogenic overactive bladder]." Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie 30(14): 904-919.
	INTRODUCTION: The aim was to synthesize current knowledge on overactive bladder (OAB) first-line treatments. METHOD: A systematic literature review based on PubMed, Embase and Google Scholar was conducted in June 2020. RESULTS: Behavioral treatments are based on bladder training and timed voiding using a bladder diary. Lifestyle modifications should be suggested. They include reduction of fluid intake, consumption of caffeine, sodas, weight loss, avoidance of acidic fruit juices and of spicy and acidic salty diet, alkalization of urine by diet and possibly, vitamin D supplementation. Pelvic floor muscle training is mainly based on manual techniques, electrostimulation and/or biofeedback. It has been shown to be effective in treating OAB. In menopausal women, local hormone therapy improves all OAB symptoms. Oral drugs include anticholinergics and beta-3-agonists. Their efficacy is quite similar and superior to placebo. In case of failure of monotherapy, they may be combined. CONCLUSION: Apart from some lifestyle modifications, the efficacy of first-line treatments for OAB has been demonstrated by prospective controlled studies. They may be prescribed individually or in combination.

Gamé, X. and V. Phé (2020). "[Non-neurological overactive bladder and pelvic-perineal pathology in women]." Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie 30(14): 887-894.
	Introduction: The aim was to synthesize current knowledge on overactive bladder (OAB) and female pelvic-perineal diseases.; Method: A systematic literature review based on PubMed, Embase and Google Scholar was conducted in April 2020.; Results: Women with pelvic organ prolapse very often have OAB. Prolapse surgery should be considered if the prolapse is symptomatic and never be indicated in case of overactive bladder symptoms solely. In case of symptomatic prolapse and OAB, pessary and surgical treatments are effective on both pathologies up to 71 % of the cases. OAB may occur in parallel or as part of a menopausal genitourinary syndrome. In the latter case, only local estrogen therapy is effective. OAB may occur alongside stress urinary incontinence (SUI) or be integrated into mixed urinary incontinence. The initial treatment should be based on the most troublesome symptoms. In case of SUI, the outcome of surgical treatment on OAB remains uncertain. De novo, OAB follows prolapse or SUI surgery. It requires investigations to exclude urinary tract infection, bladder outlet obstruction or erosion. The treatment is the same as OAB.; Conclusion: The clinician's challenge is to draw a balance between the OAB and a pelvic-perineal pathology in order to adapt the treatment. (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Gan, L., et al. (2022). "Effect of preoperative group cognitive behavior counseling on anesthesia and postoperative psychology of patients undergoing painless abortion." Modern medicine / 现代医药卫生 38(10): 1650‐1653.
	Objective: To explore the clinical application value of preoperative group cognitive behavioral intervention (GCBC) in pre‐anesthesia evaluation of painless induced abortion. Methods: A total of 240 patients with painless abortion who were admitted to our hospital from January to November 2019 were selected and divided into a control group (CON group) and an intervention group (GCBC group) by random number table method, with 120 cases in each group. The evaluation included 231 cases (115 cases in CON group and 116 cases in GCBC group). The CON group underwent routine diagnosis and treatment procedures and did not participate in GCBC. In the GCBC group, GCBC was performed by a psychologist before surgery, and professional psychological guidance and emotional relaxation therapy were given. The preoperative general data, the incidence of intraoperative respiratory depression, the dosage of propofol per unit time, the incidence of abortion syndrome, postoperative visual analog pain scale (VAS) scores, as well as nausea, the incidence of vomiting, Self‐rating Anxiety Scale (SAS) and Hamilton Depression Scale (HAMD) scores and satisfaction before and after surgery. Results: There was no significant difference in the incidence of bradykinesia and vomiting in the operation center between the two groups (P>0.05); the incidence of respiratory depression, nausea, and abortion syndrome, the dosage of propofol per unit time, and the operation rate of GCBC group The VAS score was significantly lower than that of the CON group, and the difference was statistically significant (P<0.05). The SAS and HAMD scores of the GCBC group decreased more significantly after operation, and the difference was statistically significant compared with the CON group (P<0.05). The satisfaction degree of GCBC group was significantly higher than that of CON group, and the difference was statistically significant (P<0.05). Conclusion: GCBC during preoperative anesthesia assessment can improve postoperative anxiety and depression in patients with abortion surgery, reduce the incidence of intraoperative complications, and improve patients' satisfaction with surgical anesthesia.

Gan, Z. S. and A. L. Smith (2023). "Urinary Incontinence in Elite Female Athletes." Current Urology Reports 24(2): 51-58.
	Purpose of Review: To summarize the current understanding on the epidemiology, pathophysiology, and management strategies of urinary incontinence (UI) in female athletes, highlighting findings specific to nulliparous elite athletes. Recent Findings: UI occurs in about 20-50% of female athletes of all ages and parity status, around 40% for younger nulliparous athletes, and is more prevalent in high-impact sports. Possible contributing factors to UI in female elite athletes include pelvic floor laxity and bladder neck descent, pelvic floor muscle fatigue, low energy availability, and hypermobility syndrome. In female elite athletes, urinary symptoms negatively affect quality of life, although the effects of symptoms on exercise participation are not well understood. Current management strategies are primarily conservative and centered on behavioral modifications and pelvic floor muscle physiotherapy. Summary: UI in female elite athletes appears to be multifactorial. Clarifying how individual factors influence UI in this population will inform athlete counseling, prevention, and treatment strategies.Copyright © 2022, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Gangadharan, S. and L. Venkatesan (2021). "Effect of Yoga on Somato-Vegetative Symptoms of Menopausal Women and its Association with Demographic Variables among Yoga and Non-Yoga Groups." Nursing journal of India 112(5): 225‐232.
	Abstract: Background: As longevity increases, the population of menopausal age group women is ever rising even in India. According to the Indian Menopausal Society, the number of menopausal women comes in around 43 million. Fortunately, menopause is now better understood and more openly discussed than ever before. The discipline of Yoga and its methodologies has now been reoriented to suit modern sociological needs and lifestyles. The Objectives of the study are to assess and compare the effectiveness of Yoga on somato-vegetative menopausal symptoms before and after administration of Yoga between Yoga and Non –Yoga groups of menopausal women and to associate the post-test somato-vegetative menopausal symptoms with the selected demographic variables in Yoga and Non-Yoga groups of menopausal women. Methods: A true experimental design involving random assignment to treatment group and control group. The study focuses on Yoga as intervention for menopausal symptoms in somato-vegetative domain. The study was conducted between June 2015 and July 2016. The study was conducted among menopausal women coming under selected Sub Centres in two Primary Health Centres. The sample size was 120 in Yoga group and 120 in Non – Yoga group There were 12 drop outs in the Yoga group. The study adopted cluster sampling technique with randomisation. Results: Majority (61.1%) of them experienced mild Somato-vegetative symptoms and significant (34.3%) of them experienced moderate level of Somato-vegetative symptoms after post-test in the Yoga group. Conclusion: The findings of this study show that there is a reduction in menopausal somato-vegetative symptoms in Yoga group of menopausal women thus proving Yoga intervention to be effective. Women in menopause showed a positive attitude towards performing Yoga as they found it safe in their home settings Key words: Menopause, Somato-vegetative symptoms, Yoga.

Ganho-Ávila, A., et al. (2019). "Efficacy of rTMS in decreasing postnatal depression symptoms: A systematic review." Psychiatry Research 279: 315-322.
	Background: Repetitive Transcranial Magnetic Stimulation (rTMS) has been suggested as an alternative treatment to postnatal depression (PPD).; Objectives: This systematic review aims to examine and summarise evidence on rTMS efficacy in treating depression during the postnatal period.; Methods: We included randomized and non-randomized, single arm, and case report studies, with active rTMS and theta-burst stimulation, sham rTMS, pharmacotherapy or no treatment as comparators. Participants included women with PPD, who were administered rTMS after delivery and up to 12 months postpartum. The observed outcomes were response rate and acceptability.; Results: rTMS shows promising results, with clinically significant decreases in Edinburgh Postnatal Depression Scale (EPDS) scores at week 4 and an overall low risk of dropout.; Limitations: The reduced number of reports, the lack of complete datasets and the serious/high risk of bias of the studies warrant cautious interpretations.; Conclusions and Implications: Despite the promising results, existing evidence on rTMS efficacy is limited, and questions remain on what the most beneficial stimulation parameters should be. Future multicentre randomized clinical trials are needed to better ascertain the clinical efficacy of rTMS in the treatment of depression in the postpartum period. (Copyright © 2019 Elsevier B.V. All rights reserved.)

Gao, C., et al. (2022). "Observation on the application effect of esketamine intravenous injection in artificial abortion." 山东医药 62(11): 56‐58.
	Objective: To observe the anesthesia effect of esketamine in painless induced abortion (abbreviated as painless abortion) and its effect on postoperative depression and recovery of patients. Methods: A total of 160 female patients who were going to undergo painless abortion were selected and randomly divided into esketamine group and control group, 80 cases in each group. In the esketamine group, after intravenous injection of esketamine 0.25 mg/kg, propofol 2 mg/kg was slowly intravenously injected, and propofol 6 mg/(kg·h) was injected intravenously during the operation to maintain anesthesia. The control group was anesthetized with the same dose of propofol as the esketamine group after intravenous injection of sufentanil 0.1 μg/kg. Intraoperative propofol consumption, anesthesia recovery time, observation room stay time, pain visual analog scale (VAS) were recorded in the two groups; the two groups were evaluated by self‐rating depression scale (SDS) 1 day before operation and 3 days after operation, respectively The emotional state of the patients (defined as depression by SDS score ≥53); the quality of recovery (QoR‐40 scale) was used to evaluate the overall quality of recovery in the two groups 3 days after surgery, including physical comfort, emotional state, self‐care ability, Psychological support, pain. The incidence of adverse reactions between the two groups was compared. RESULTS: There was no significant difference in the amount of propofol used, anesthesia recovery time, observation room stay time and VAS between the two groups (all P>0.05). Compared with 1 day before operation, the SDS score and the incidence of depression in the two groups at 3 days after operation were decreased, and the reduction was more obvious in the esketamine group (P<0.05). There was no respiratory depression or skin itching in the two groups. Nausea and vomiting occurred in 3 cases (3.8%), dizziness in 9 cases (11.3%), drowsiness in 6 cases (7.5%) in the esketamine group, and 5 cases (6.3%) in the control group, respectively. ), 5 cases (6.3%), 7 cases (8.9%), and there was no statistical difference between the two groups (all P>0.05). Conclusion: The application of esketamine in painless abortion has better anesthesia effect, and it is helpful to relieve the depression of patients in the short term after operation and improve the quality of postoperative recovery of patients.

Gao, F., et al. (2023). "Current status and progress of endocrine therapy for endometrial carcinoma." Chinese Journal of Cancer Prevention and Treatment 30(11): 693-698.
	Objective To summarize the research progress in endocrine therapy for endometrioid adenocarcinoma (EEC), and systematically review the treatment indications, drug selection, efficacy, and adverse reactions in order to provide useful reference for clinical practice. Methods Using "endocrine therapy, fertility sparing, recurrence and metastasis tumors, endometrial carcinoma" as keywords, searched PubMed, Web of Science, CNKI, and Wanfang Database from January 1, 1961 to December 30, 2022-11-30. A total of 368 English and 96 Chinese literatures were retrieved. Inclusion criteria: (1) current status of endocrine therapy for EEC; (2) early EEC fertility preservation therapy; (3) endocrine therapy for metastatic and recurrent EEC. Exclusion criteria: (1) literatures with small sample size or incomplete data; (2) low quality literature. Finally, 48 related articles were included. Results EEC is a hormone dependent tumor, and estrogen and progesterone play an important role in tumor genesis, progression, and prognosis. The endocrine therapy of EEC can be traced back to the 1960s. Through long-term clinical exploration and practice, currently, the endocrine therapy of EEC is mainly applicable to patients who intend to retain reproductive function in the early stage and some patients with recurrent and metastatic diseases, with good disease control and tolerable adverse reactions. Conclusion The efficacy of endocrine therapy is related to factors such as histological type, expression of estrogen and progesterone receptor in endometrioid adenocarcinoma, and it is necessary to strictly and carefully grasp the indications.Copyright © 2023 Chinese Journal of Cancer Prevention and Treatment, Editorial board. All rights reserved.

Gao, J. (2024). "Effect of Clotrimazole Suppositories on Distribution of Pathogens in Vaginal Secretions and Oxidative Stress in Patients with Vaginitis." Alternative Therapies in Health and Medicine.
	Objective: To evaluate the impact of clotrimazole suppositories on the distribution of vaginal pathogens and oxidative stress in patients with vaginitis. Method(s): A total of 120 patients with vaginitis were recruited from our hospital between January 2021 and December 2022 and were divided into an observation group and a control group using a random envelope method. The control group received treatment with miconazole tablets alone, while the observation group received combined treatment with miconazole tablets and clotrimazole suppositories. Vaginal secretions were collected from the subjects for pathogenic microbial testing. The clinical efficacy of the patients was evaluated, and indicators related to vaginal microecology and microbial imbalance were examined. Serum levels of IL-8, CRP, TNF-alpha, IL-6, PCT, P, LH, FSH, SOD, MDA, NO, and ET-1 were measured in the subjects. Result(s): Among patients with vaginitis, bacteria, fungi, and gram-negative cocci accounted for a relatively high proportion, with bacterial infections accounting for more than 30% and fungal and gram-negative cocci infections both exceeding 10%. Pathogenic infections such as Chlamydia and Trichomonas were less than 10%. The observation group showed significantly higher clinical efficacy compared to the control group, with a statistically significant difference (P < .05). Following treatment, the observation group exhibited significantly lower scores for itching, vaginal discharge, and burning sensation compared to the control group, with a statistically significant difference (P < .05). After treatment, the observation group had significantly lower bacterial density and Nugent score, higher cleanliness, positive lactobacilli rate, and pH value compared to the control group, and the difference was statistically significant (P < .05). After treatment, the observation group demonstrated significantly lower blood levels of IL-8, CRP, TNF-alpha, IL-6, and PCT compared to the control group, with a statistical significance of P < .05. Similarly, the levels of P, LH, and FSH hormones in the observation group were significantly lower than those in the control group, also with a statistical significance of P < .05. In contrast, the levels of SOD and NO in the observation group were significantly higher, while the levels of MDA and ET-1 were significantly lower compared to the control group, with a statistical significance of P < .05. Conclusion(s): Clotrimazole suppositories have been shown to significantly enhance therapeutic outcomes for patients with vaginitis by alleviating inflammation, rebalancing vaginal microecology, regulating hormone secretion, and mitigating oxidative stress.

Gao, J., et al. (2019). "Effects of psychological care in patients with endometriosis: A systematic review protocol." Medicine 98(10): e14772.
	Background: This systematic review will be proposed for investigating the effects of psychological care (PC) in patients with endometriosis.; Methods: We will search the following 7 electronic databases from inception to the present: MEDLINE, EMBASE, SinoMed, Web of Science, Cochrane Library, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. We will include randomized controlled trials for evaluating the effects of PC in patients with endometriosis. Cochrane risk of bias tool will be used to evaluate the methodological quality for each included study. Two authors will independently carry out the study selection, data extraction, and methodological quality evaluation. Any disagreements will be solved by a third author through discussion.; Results: This proposed systematic review will use high-quality evidence-based medicine to evaluate the efficacy and safety of PC for endometriosis. The primary outcomes include depression and anxiety. The secondary outcomes consist of pain intensity, health-related quality of life, and adverse events.; Conclusion: The findings of this study will provide convincing evidence to determine whether PC therapy is an effective and safe intervention for patients with endometriosis.; Prospero Registration Number: PROSPERO CRD42019123292.

Gao, J., et al. (2023). "Effect of esmketamine for labor analgesia on development of postpartum depression." Chinese journal of anesthesiology 43(11): 1351‐1354.
	Objective To evaluate the effect of esmketamine for labor analgesia on the occurrence of postpartum depression (PPD). Methods Two hundred and forty‐two cases of nulliparous parturients who selected natural labor and agreed to receive labor analgesia were selected and divided into conventional labor analgesia group (C‐LA group, n= 119) and esmketamine‐based labor analgesia group (E‐LA group, n= 123). The epidural labor analgesia solution contained ropivacaine 100 mg and sufentanil 30 μg in 100 ml of normal saline in C‐LA group. The epidural labor analgesia solution contained ropivacaine 100 mg, sufentanil 30 μg and esketamine 50 mg in 100 ml of normal saline in E‐LA group. The Edinburgh Postnatal Depression Scale (EPDS) was used to screen parturients for depression on admission to the predelivery room and at 2 h and 1, 7 and 42 days after delivery, and EPDS scores were recorded. The patients were diagnosed as having PPD when EPDS score ≥ 9 at 7‐42 days after delivery. Peripheral venous blood samples were collected on admission to the predelivery room and at 1 day after delivery to determine the concentrations of serum estrogen, progesterone, 5‐hydroxytryptamine and cortisol by enzyme linked inmunosorbent assay. Results Compared with group C‐LA, the EPDS scores were significantly decreased on the 1 and 42 days after delivery (P<0.01), no significant change was found in the incidence of PPD (1.7%∕0.8%, P> 0.05), no significant change was found in the concentrations of serum estrogen, progesterone, 5‐hydroxytryptamine and cortisol on admission to the delivery room (P>0.05), and the concentrations of serum progesterone and cortisol were significantly increased on 1 day after delivery in group E‐LA (P<0.05). Conclusions Combination of esketamine is helpful in reducing the risk of postpartum depression when used for epidural labor analgesia, and the mechanism is related to slowing the declines in blood levels of sex hormones and stress hormones after delivery.

Gao, K., et al. (2022). "Intrauterine adhesions combined with Robert's uterus: a case report and literature review." Archives of Gynecology and Obstetrics 306(4): 1069-1075.
	Purpose: To summarize the clinical characteristics and surgical option of Robert's uterus.; Methods: We reported a rare case of Robert's uterus with severe uterine adhesion with successive laparoscopic and hysteroscopic surgery. To our knowledge, such a case has not been reported previously. We also performed a systematic literature review from the PubMed, Embase, and Cochrane databases.; Results: Our patient with Robert's uterus with severe uterine adhesions was successfully treated with hysteroscopic septal resection and hysteroscopic adhesiolysis, and the intractable dysmenorrhea disappeared after the hysteroscopic septal resection. In our study, we analyzed the selected 22 reported cases, 10/22 cases (45.5%) were diagnosed before age 20; 20/22 cases (90.91%) experienced dysmenorrhea, 19/22 cases (86.36%) were with hematometra. 5/22 cases (22.73%) underwent re-operation or a third surgery before diagnosis and management.; Conclusion: Robert's uterus, a rare congenital abnormality of Mullerian duct development, consists of an oblique septum and non-communicating asymmetrical uterine hemi-cavity. The main symptoms are the presence of hematometra and severe dysmenorrhea. Septal resection is the main surgical procedure; however, the rarity and difficulty obtaining a pre-operative diagnosis lead to a high rate of misdiagnosis and second surgery. (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Gao, L., et al. (2021). "Study on the effect of combination oral contraception and artificial cycle on endometrium regeneration after induced abortion." 中外女性健康研究(21): 1‐2,7.
	Objective: To investigate the effect of estradiol + dydrogesterone artificial cycle therapy and compound oral contraceptive ethinyl estradiol cyproterone on endometrial repair after induced abortion. Methods: 240 cases of induced abortion women were randomly divided into artificial cycle group, COC group and control group. The postoperative vaginal bleeding time, menstrual rehydration time, menstrual volume, endometrial thickness, endometrial blood flow and the incidence of intrauterine adhesions were compared. Results: The vaginal bleeding time in the artificial cycle group and the COC group was shorter than that in the control group, and the menstrual rehydration time was shorter than that in the control group; the menstrual flow in the artificial cycle group was more than that in the control group, while the menstrual flow in the COC group was less than that in the control group; the artificial cycle group The endometrial thickness of the 14 d after operation was greater than that of the control group, and the endometrial thickness of the COC group was smaller than that of the control group; 14 d after operation, the endometrial blood flow in the artificial cycle group and the COC group was better than that in the control group, and there was no significant difference between the artificial cycle group and the COC group. The incidence of intrauterine adhesions in the artificial cycle group and COC group after operation was lower than that in the control group. Conclusion: Both estrogen and progesterone artificial cycles and compound oral contraceptives can effectively reduce postoperative vaginal bleeding time, promote menstrual cramps, and prevent intrauterine adhesions. Artificial cycle treatment can increase endometrial thickness, increase endometrial blood flow, and effectively repair Endometrial, combined short‐acting oral contraceptives can also promote endometrial repair.

Gao, L., et al. (2019). "A comparison of the efficacy of Chinese herbal medicines in the treatment of primary dysmenorrhea: A network meta-analysis protocol." Medicine 98(14): e15100.
	Introduction: Chinese herbal medicines (CHM) have been commonly used in the treatment of primary dysmenorrhea in East Asia. Several systematic reviews have been conducted to assess the clinical efficacy of CHM in the treatment of primary dysmenorrhea. However, their comparative efficacy is still unclear. Therefore, the purpose of this study is to conduct a network meta-analysis (NMA) to systematically compare the advantages of different CHM in the treatment of primary dysmenorrhea.; Methods and Analysis: The following electronic databases will be searched in this study: Web of Science, PubMed, Cochrane Library, Chinese Biomedical Literature Database, Chinese National Knowledge Infrastructure, Chinese Scientific Journal Database, and Wan-fang Database. Search terms include (Chinese herbal medicine or Chinese patent medicine or medicinal plants or phytotherapy or traditional medicine or Chinese herbal drugs or plant extracts or herbal medicine or herbal extract or herb or traditional Chinese medicine) and (primary dysmenorrhea or dysmenorrhea or painful menstruation) and (randomized controlled trial). The language will be limited to Chinese and English, and the search date will be up to May 2019. The included studies must be randomized controlled trials (RCTs) with patients diagnosed with primary dysmenorrhea. CHM must be used as interventions in the experimental group. While in the control group, studies that used a different herbal medicine, nonsteroidal anti-inflammatory drugs (NSAIDs), or placebo will be included. The primary outcomes include clinical efficacy and visual analog scale (VAS), and the secondary outcomes include adverse events and quality of life. Four reviewers will independently extract the data and assess the qualities of the studies. Statistical analysis will be conducted with R package for each outcome.; Ethics and Dissemination: Ethical approval is not required as this NMA is based on published studies. The completed NMA will be published in a peer-reviewed scientific journal.; Trial Registration Number: PROSPERO CRD42018095254.

Gao, M., et al. (2020). "Traditional Chinese medicine on treating premenstrual syndrome and premenstrual dysphoric disorder: A protocol for systematic review and meta-analysis." Medicine 99(42): e22694.
	Background: Premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) are common disorders that manifest themselves in the late luteal phase, and significantly interfere with an individual's daily activities. Clinical evidence suggests that traditional Chinese medicine (TCM) may ease PMS/PMDD symptoms. Here, we review a protocol for exploring the effectiveness and safety of TCM in PMS/PMDD management.; Methods: We will conduct a literature search for randomized controlled trials (RCT) for TCM use in PMS/PMDD on PubMed, web of science, EMBASE, the Cochrane central register of controlled trials (Cochrane Library), Chinese national knowledge infrastructure, Chinese VIP Information, Wanfang, as well as Chinese biomedical literature database. The search included all relevant reports for up to June 1, 2020. The search results were independently analyzed by 2 reviewers who extracted the data. RCT quality will be assessed using the risk-of-bias tool. The evidence will be inspected using the grading of recommendations assessment development and evaluation (GRADE). We will utilize Stata and Revman for systematic review and meta-analysis and analysis of direct and indirect evidence.; Results: Based on current evidence, this study will elucidate the rationale for the utilization of TCM in PMS/PMDD treatment.; Conclusion: Conclusions from this study will inform about the effectiveness and safety of TCM in PMS/PMDD management.; Trial Registration Number: CRD42020192822.; Ethics and Dissemination: Since all data utilized in this systematic review and meta-analysis are published, ethical approval is not needed. Additionally, in the trial of the review process, all data will be evaluated anonymously.

Gao, M., et al. (2021). "Influence of humanistic care based on Carolina care model for ovarian cancer patients on postoperative recovery and quality of life." American journal of translational research 13(4): 3390-3399.
	OBJECTIVE: Our aim was to explore the influence of humanistic care based on Carolina care model on postoperative recovery and quality of life in patients with ovarian cancer (OC). METHODS: In this prospective study, we selected 85 OC patients and randomly divided them into the Carolina group (n = 43) given humanistic care based on Carolina care model and the control group (n = 42) given routine nursing intervention. The postoperative recovery and Functional Assessment of Cancer Therapy-Ovary Cancer (FACT-O) scores were compared between the two groups. RESULTS: After intervention, the time of first flatus and defecation after surgery, the time of first ambulation and the length of average postoperative hospital stay were much shorter, and the pain score, total complication rate, self-rating anxiety scale and self-rating depression scale scores as well as Cortisol, C-reactive protein and fasting blood glucose levels at 48 hours postoperatively were significantly lower in the Carolina group than in the control group. The nursing satisfaction in the Carolina group was markedly higher than that in the control group (97.67% vs. 78.57%, P<0.01). After 3 months of follow-up, the Carolina group showed higher dimension scores of FACT-O than the control group (all P<0.001). CONCLUSION: Humanistic nursing care based on Carolina care model can significantly ameliorate the recovery of OC patients, reduce the physical and psychologic stress response, and effectively enhance the nursing satisfaction and quality of life.

Gao, Q., et al. (2022). "Salvia miltiorrhiza -Containing Chinese Herbal Medicine Combined With GnRH Agonist for Postoperative Treatment of Endometriosis: A Systematic Review and meta-Analysis." Frontiers in Pharmacology 13: 831850.
	Background: Endometriosis is an estrogen-dependent gynecological inflammatory condition that may lead to infertility and recurrent pelvic pain. The purpose of this research was to determine the efficacy and safety of Salvia miltiorrhiza -containing Chinese herbal medicine (CHM) combined with gonadotropin-releasing hormone agonist (GnRH-a) for postoperative endometriosis management. Methods: Eight databases were systematically searched before October 2021, including PubMed, Embase, Cochrane Library, Scopus, Web of Sceince, CNKI, VIP, and Wanfang. Finally, all randomized controlled studies comparing Salvia miltiorrhiza -containing CHM paired with GnRH-a to GnRH-a alone for postoperative endometriosis management were included. Results: A total of 10 trials involving 836 patients were reported and analyzed. Compared with the control group, the Salvia miltiorrhiza -containing CHM combined with GnRH-a group showed significant superiority in decreasing endometriosis recurrence (risk ratio [RR] = 0.26; 95% confidence intervals [CI]: 0.16-0.41) and increasing the pregnancy rate ([RR] = 1.96; 95% CI: 1.58-2.44). Similarly, the effect of the Salvia miltiorrhiza -containing CHM combined with GnRH-a on CA-125 serum levels was positive (standardized mean difference [SMD] = -0.79; 95% CI: -1.11 to -0.47). Furthermore, this group showed a significant reduction in adverse effects. Conclusion: The results indicate that Salvia miltiorrhiza -containing CHM may be a viable choice for postoperative endometriosis therapy, with the potential to enhance pregnancy while decreasing recurrence and adverse effects.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Gao, Shen, Jiang, Luan, Lin, Meng, Wang and Cong.)

Gao, Q., et al. (2023). "Efficacy and safety of sintilimab (anti-PD-1 mAb) for advanced cervical cancer: Results from a Phase II trial." Cancer Research 83(8 Supplement).
	Background: Patients (pts) with advanced cervical cancer who progressed on first-line treatment have no standard therapy and derive limited benefit from currently available treatment. More effective therapeutic strategies are required. This phase II trial was conducted to evaluate the efficacy and safety of IBI310 (anti-CTLA-4 mAb) plus sintilimab (sint) versus sint in pts with recurrent/metastatic cervical cancer. Here we present the efficacy and safety results for pts in sint plus placebo group. Method(s): Pts aged 18-75 years, with histologically or cytologically confirmed cervical cancer who had progressed on or been intolerant to first-line or above platinum-based chemotherapy were enrolled. Pts in sint plus placebo group received sint (200mg) plus placebo IV Q3W for 4 cycles followed by sint monotherapy till disease progression, intolerable toxicity, withdrawal of informed consent, death, or for up to 24 months. The primary endpoint was objective response rate (ORR) assessed by IRRC per RECIST V1.1. The data cutoff date was April 20, 2022. Result(s): Overall, 101 pts were enrolled and received at least one dose of assigned treatment (median age of 53.0 years, 71.3% pts with PD-L1 CPS >=1, 91.0% pts with squamous-cell carcinoma, and 36.6% pts with >=2 lines of prior systemic therapy). The median treatment exposure was 18.0 weeks. The IRRC-assessed confirmed objective response rate (ORR) was 24.5% (95%CI: 16.4%-34.2%), disease control rate was 56.1% (95%CI: 45.7%-66.1%), and median duration of response was not reached. Pts with PD-L1 CPS >=1 showed numerically higher ORR versus those with CPS <1 (32.9% vs 17.2%). With a median follow-up of 8.3 months, median PFS was 2.7 months (95%CI: 1.5-4.3). Median overall survival (OS) was not reached; OS rate was 89.6% (95%CI: 80.9%-94.5%) at 6 months and 65.5% (95%CI: 50.9%-76.7%) at 12 months. Treatmentrelated adverse events (TRAEs) occurred in 75.2% pts, with the most common being anaemia (13.9%), hypothyroidism (12.9%), white blood cell count decreased (12.9%), and hyperthyroidism (10.9%). 18.8% pts experienced CTCAE Grade 3 or higher TRAEs (no TRAE leading to death occurred). TRAEs leading to drug discontinuation occurred in 1 pt (myocarditis, grade 2). Conclusion(s): This study demonstrated favorable antitumor activity and acceptable safety with sintilimab alone over available therapies in >=2 line advanced cervical cancer.

Gao, R., et al. (2020). "Acupuncture and clomiphene citrate for anovulatory infertility: a systematic review and meta-analysis." Acupuncture in medicine : journal of the British Medical Acupuncture Society 38(1): 25-36.
	Objective: To evaluate the comparative effectiveness of acupuncture or acupuncture combined with clomiphene citrate (CC) versus CC alone on the outcomes of anovulatory infertility.; Methods: A literature search in eight databases yielded nine randomised controlled trials (RCTs) that evaluated the comparative effectiveness of acupuncture and CC in anovulatory infertility. Subsequently, data were extracted and the studies were assessed for the quality of their methodological designs and risk of bias. Meta-analyses of the RCT data were conducted.; Results: Nine trials including 1441 women were included in the meta-analysis. There were no significant differences in the rates of pregnancy (odds ratio (OR) 1.18, 95% CI 0.83 to 1.69), ovulation (OR 2.57, 95% CI 0.59 to 11.29) or pregnancy loss (OR 0.98, 95% CI 0.59 to 1.63) when acupuncture was used as an adjuvant therapy alongside CC. Although acupuncture alone did not increase the ovulation rate (OR 0.41, 95% CI 0.11 to 1.49), our review demonstrated superior effects in patients who received acupuncture as a separate treatment modality with respect to both the pregnancy rate (OR 2.34, 95% CI 1.76 to 3.10) and the maximum follicular diameter (mean difference 0.50 mm, 95% CI 0.44 to 0.56 mm) when compared with CC alone. Statistical analysis also showed a reduction in the rate of pregnancy loss when acupuncture was used as a separate treatment compared with CC alone (OR 0.19, 95% CI 0.08 to 0.45).; Conclusions: Based on the above pooled results of the studies, the use of acupuncture as a monotherapy significantly improved the rate of pregnancy among the study participants compared with the use of CC alone. However, any results drawn from these studies should be interpreted with caution when considering the context of clinical practice.

Gao, X., et al. (2022). "Application Effect Analysis on Remifentanil and Propofol Anesthesia in Patients Undergoing Painless Artificial Abortion." 中国社区医师 38(4): 40‐42.
	Objective: To analyze the application effect of remifentanil and propofol anesthesia in patients undergoing painless induced abortion. Methods: A total of 120 patients who underwent painless induced abortion from June 2020 to April 2021 were selected and divided into two groups according to different anesthesia methods, with 60 cases in each group. The control group was anesthetized with propofol; the experimental group was anesthetized with remifentanil and propofol. The levels of surgery‐related indexes, analgesic effects, hemodynamic indexes and the incidence of adverse reactions were compared between the two groups. Results: The dosage of propofol, intraoperative blood loss, postoperative recovery time and incidence of adverse reactions in the experimental group were lower than those in the control group, and the differences were statistically significant (P<0.05). Conclusion: Remifentanil and propofol combined anesthesia in painless induced abortion can not only reduce the dosage of anesthetics, shorten the recovery time, but also improve the analgesic effect, and it will not affect the body's hemodynamics. academic indicators have a greater impact.

Gao, Y., et al. (2021). "Small Extracellular Vesicles: A Novel Avenue for Cancer Management." Frontiers in Oncology 11: 638357.
	Extracellular vesicles are small membrane particles derived from various cell types. EVs are broadly classified as ectosomes or small extracellular vesicles, depending on their biogenesis and cargoes. Numerous studies have shown that EVs regulate multiple physiological and pathophysiological processes. The roles of small extracellular vesicles in cancer growth and metastasis remain to be fully elucidated. As endogenous products, small extracellular vesicles are an ideal drug delivery platform for anticancer agents. However, several aspects of small extracellular vesicle biology remain unclear, hindering the clinical implementation of small extracellular vesicles as biomarkers or anticancer agents. In this review, we summarize the utility of cancer-related small extracellular vesicles as biomarkers to detect early-stage cancers and predict treatment outcomes. We also review findings from preclinical and clinical studies of small extracellular vesicle-based cancer therapies and summarize interventional clinical trials registered in the United States Food and Drug Administration and the Chinese Clinical Trials Registry. Finally, we discuss the main challenges limiting the clinical implementation of small extracellular vesicles and recommend possible approaches to address these challenges.© Copyright © 2021 Gao, Qin, Wan, Sun, Meng, Huang, Hu, Jin and Yang.

Gao, Y., et al. (2021). "Efficacy and safety of niraparib maintenance treatment in platinumsensitive recurrent ovarian cancer after shorter or longer chemotherapy: a post hoc subgroup analysis." International Journal of Gynecological Cancer 31(SUPPL 4): A10‐A11.
	Objectives Traditionally ≥6 cycles of platinum‐containing chemotherapy (Pt‐chemo) are recommended for platinum‐sensitive recurrent ovarian cancer (PSROC). PARP inhibitor maintenance treatment (MT) can be initiated upon clinical complete/ partial response (CR/PR) after ≥4 cycles of chemotherapy. Shorter chemotherapy may improve patient experience without compromising efficacy. This study aims to compare the efficacy and safety of niraparib to placebo as MT administered after ≤4 or >4 cycles of Pt��chemo. Methods This is a post hoc analysis of the published NORA phase III study (NCT03705156). Adults with PSROC and CR/ PR to most recent Pt‐chemo were randomized 2:1 to niraparib or placebo. Primary endpoint was PFS by BICR. Subgroups comprised patients with ≤4 or >4 cycles of most recent Pt‐chemo. Results Table 1 summarizes key baseline characteristics which were overall balanced between groups. Median (95% CI) PFS was 18.37 months (8.54‐not estimable [NE], ≤4‐cycle/niraparib) versus 3.88 months (3.68‐7.43, ≤4‐cycle/placebo; HR=0.36 [p=0.0016]), and was 18.33 months (10.28‐NE, >4‐cycle/niraparib) versus 5.49 months (3.71‐5.75, >4‐cycle/ placebo; HR=0.33 [p<0.0001]) (figure 1). Overall safety profiles were comparable between ≤4‐cycle/niraparib and >4‐ cycle/niraparib, with similar percentages of patients experiencing neutrophil count decrease (60.4%; 58.1%), anemia (50.0%; 55.0%), and platelet count decrease (45.8%; 58.1%). Composition of grade ≥3 TEAEs was consistent with the overall NORA results. Conclusions Similar niraparib‐versus‐placebo PFS benefits were observed after ≤4‐cycle or >4‐cycle Pt‐chemo in CR/PR patients. The efficacy and safety of niraparib MT after shorter Pt‐chemo remain to be verified in larger samples.

Gao, Y., et al. (2020). "Metformin and acupuncture for polycystic ovary syndrome: A protocol for a systematic review and meta-analysis." Medicine 99(14): e19683.
	Backgrounds: Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women and can lead to serious social burdens associated with various reproductive and metabolic abnormalities. Studies have demonstrated that metformin can reduce liver glucose in PCOS, lower testosterone levels and increase peripheral insulin sensitivity. There has been also evidence suggesting acupuncture may influence ovulation (release of the egg) by affecting levels of various hormones. We will conduct a systematic review and meta-analysis is to compare the efficacy and safety of metformin with or without acupuncture in PCOS.; Methods and Analysis: We will search publications from Web of Science, PubMed, Science Direct, Wan Fang Data Knowledge Service Platform, Chinese Biomedical Literature Database (CBM), Chinese Scientific Journal Database (VIP database), China National Knowledge Infrastructure (CNKI) and EMBASE, which should be published from inception to February 2020. Two researchers will independently perform the selection of the studies, data extraction, and synthesis. The Cochrane Risk of Bias Tool will be used to evaluate the risk of bias of the randomized controlled trials. Statistical analysis will be performed by using the Cochrane Review Manager (RevMan 5.3) software. The I test will be used to identify the extent of heterogeneity. We will use the Egger funnel chart to evaluate possible publication biases, in addition, when possible we will perform a subgroup/meta-regression analysis. The strength of the evidence will be assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE).; Results and Conclusion: This study will systematically evaluate the efficacy and safety of Metformin combined with acupuncture in the treatment of PCOS, thus providing evidence to the clinical application of this combination therapy. The results will be published in a peer-reviewed journal.

Gao, Z., et al. (2020). "Impact of Bariatric Surgery on Female Sexual Function in Obese Patients: a Meta-Analysis." Obesity surgery 30(1): 352-364.
	We aimed to make a meta-analysis regarding the effect of bariatric surgery on female sexual function. PubMed, EMBASE, and CENTRAL were searched from database inception through August 2019. Articles were eligible for inclusion if they examined the effect of bariatric surgery on obese women's sexual function assessed by the Female Sexual Functioning Index (FSFI) or/and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Twenty articles were included into meta-analysis. Bariatric surgery was associated with significant increase in the total FSFI score. When parameters included in the FSFI scoring system were separately evaluated, significant improvements were observed in sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction, and sexual pain. However, the PISQ-12 and FSFI scores in women with pelvic floor disorders (PFDs) were not significantly changed postoperatively. Bariatric surgery improves female sexual function in obese patients, but not in women with PFD.

Gao, Z., et al. (2022). "Acupuncture combined with SSRIs in the treatment of perimenopausal depressive disorder: A protocol for systematic review and meta-analysis." Medicine 101(3): e28558.
	Background: Perimenopausal depressive disorder (PDD) is an affective disorder involving endocrine, neurological, immune, which seriously endangers the physical and mental health of human. Selective serotonin reuptake inhibitors (SSRIs) are the current first-line clinical treatment, have limited efficacy and serious side effects. Acupuncture combined with SSRIs therapy has been widely used clinically because it increases efficacy and reduces side effects. There is a lack of high-quality evidence to assess its efficacy and safety. This study evaluated the effectiveness and safety of acupuncture combined with SSRIs in the treatment of PDD by meta-analysis.; Methods: All randomized controlled trials articles about acupuncture combined with SSRIs treatment of PDD will be searched in databases, such as PubMed, Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wan Fang, Wei Pu from the construction of the library to December 16, 2021. According to Cochrane 5.1 Handbook criteria, two researchers independently screened the literature, extracted data, and evaluated the quality of included studies. Meta-analysis was performed by using RevMan 5.4 and STATA 16.0 software.; Results: This study will summarize the current evidence to evaluate the effectiveness and safety of acupuncture combined with SSRIs for the treatment of PDD.; Conclusion: The results of this study will provide clinicians with new treatment ideas and bring benefits to most patients.; Registration Number: INPLASY2021120080 (DOI number: 10.37766/inplasy2021.12.0080).; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Garcia, P., et al. (2021). "Fertility preservation in endometrial cancer: Perinatal and oncologic outcomes." International Journal of Gynecological Cancer 31(SUPPL 1): A370-A371.
	Introduction/Background* The aim of our study is to evaluate the oncological and perinatal outcomes in young women diagnosed with atypical endometrial hyperplasia (AH) or endometrial cancer (EC) treated with hormone therapy. Methodology A single institutional ambispective study was performed including all patients diagnosed with AH or EC grade 1 without myometrial invasion who received hormone therapy between January 2011 and July 2021. We analyzed the complete response rate and recurrence rate of disease and pregnancy rate in these patients as well as perinatal results (live births rate, type of delivery and perinatal morbidity). In addition, we evaluated complete response rate according to type of hormone therapy, dosage received and treatment length. A review of literature was performed to identify studies involving patients with AH or EC who received fertility sparing management. All statistical analysis were performed using the software SPSS Statistics v.24.0 (IBM Corp., Armonk, NY, USA). Result(s)* There were 6 patients with AH/EC (4 and 2 patients respectively) who received hormone therapy with a mean treatment time of 8.6+/-1.96 months. Hormone therapy with megestrol acetate was carried out in 4 patients (66.6%). Complete remission was achieved in 5 patients (83.3%) and 2 of them (33.3%) attempted pregnancy. Finally, no complications during pregnancy were reported in this 2 patients and both had normal delivery. The rate of live birth was 33.3%. During the follow-up no recurrences were detected and overall survival was 100% Conclusion* Conservative management with progestins of young patients with AH or EC grade 1 limited to the endometrium is an acceptable possibility given the high remission rate and live birth rates achieved. However, definitive surgical treatment cannot be avoided given the high recurrence rate described in the literature.

Garcia-Beltran, C., et al. (2023). "Raised Thyroid-Stimulating Hormone in Girls with Polycystic Ovary Syndrome: Effects of Randomized Interventions." Hormone Research in Paediatrics 96(5): 458-464.
	Introduction: Polycystic ovary syndrome (PCOS) in women associates with raised levels of circulating thyroid-stimulating hormone (TSH) and with high rates of gestational complications. A low range of preconception TSH is followed by low rates of gestational complications. It is unknown whether TSH levels are elevated in adolescents with PCOS and, if so, whether traditional or exploratory treatments can lower them into safe preconception range. We investigated TSH in nonobese adolescents with PCOS, including the effects of randomized interventions.; Methods: Morning TSH was a safety marker in randomized pilot studies comparing the effects of an oral contraceptive (OC) versus those of a low-dose combination of spironolactone-pioglitazone-metformin (SPIOMET) in nonobese adolescents with PCOS. A post hoc analysis compared TSH levels in PCOS (N = 62) versus controls, TSH changes on treatment (for 1 year), and TSH levels posttreatment (for 1 year).; Results: Mean TSH levels were higher in PCOS patients than in control girls (p &lt; 0.01). On-treatment TSH levels diverged (p &lt; 0.001), remaining elevated on OC, and descending swiftly on SPIOMET, well into safe preconception range. Posttreatment TSH levels were stable in both subgroups. On-treatment changes of circulating TSH associated to those of liver fat (R = 0.307, p = 0.017).; Conclusion: The endocrine signature of early PCOS is herewith extended to include modestly raised levels of circulating TSH; the normalizing effects of SPIOMET intervention in nonobese adolescents with PCOS are herewith extended to include on- and posttreatment TSH. (© 2023 The Author(s). Published by S. Karger AG, Basel.)

Garcia-Bienes, H. M. and C. C. Sanchez-Mateo (2022). "Cimicifuga racemosa (L.) Nutt. in the treatment of vasomotor symptoms of menopause: a review." Ars Pharmaceutica 63(2): 178-188.
	Introduction: Several studies have shown that preparations based on the rhizomes and roots of black cohosh (Cimicifuga racemosa (L.) Nutt.) can be useful in alleviating the menopausal symptoms. The aim of this study is to perform an update bibliographic review of the efficacy and safety of black cohosh in the treatment of the vasomotor symptoms of menopause. Method(s): A review of published articles from January 2005 to March 2021 in the resource search engine of the University of La Laguna, el punto Q". Randomized and controlled clinical trials, which had the key words in the abstract, text or title, in both English and Spanish, were selected. Result(s): We found 13 trials which met the selection criteria. The studies reviewed showed that the black cohosh preparations (mainly commercial extracts standardized in their content of active ingredients) produced in most of the studies a significant reduction compared to placebo in the vegetative (hot flashes and night sweats) and psychological symptoms of menopause, as well as an improvement in the quality of life. No serious adverse effects were reported at the dose administered. Conclusion(s): Cimicifuga racemosa extracts can be effective and safe for the treatment of vegetative and psychological symptoms of menopause, being well tolerated. However, more clinical trials with a larger number of patients, more extensive, the use of standardized preparations, as well as similar criteria for inclusion and assessment of symptoms, are necessary to obtain more conclusive data.Copyright © 2022 Editorial Universida de Granada. All rights reserved.

Garcia-Donas, J., et al. (2023). "Open-label phase II clinical trial of ketoconazole as CYP17 inhibitor in metastatic or advanced non-resectable granulosa cell ovarian tumors: the GREKO (GRanulosa Et KetOconazole) trial, GETHI 2011-03." Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico 25(7): 2090-2098.
	Background: Granulosa cell ovarian tumor (GCT) is characterized by a pathognomonic mutation in the FOXL2 gene (402 C > G) that leads to an overactivation of steroidogenesis. CYP17 is a key enzyme in such process and can be inhibited by ketoconazole.; Methods: We designed a phase II clinical trial to assess the efficacy of ketoconazole in advanced GCT and conducted several in vitro studies to support the clinical findings.; Results: From October 1st 2012 to January 31st 2014, six evaluable patients were recruited in ten hospitals of the Spanish Group for Transversal Oncology and Research in Orphan and Infrequent Tumors" (GETTHI). FOXL2 (402C > G) mutation was confirmed in three; two cases were wild type and it could not be assessed in one. No objective response by RECIST was observed, but five cases achieved stable disease longer than 12 months. Median progression-free survival was 14.06 months (CI 95% 5.43-22.69) for the whole study population (3.38 and 13.47 months for wild-type cases and 14.06, 20.67 and 26.51 for those with confirmed FOXL2 mutation). Median overall survival was 22·99 months (CI 95% 8.99-36.99). In vitro assays confirmed the activity of ketoconazole in this tumor and suggested potential synergisms with other hormone therapies.; Conclusion: Ketoconazole has shown activity in advanced GCT in clinical and in vitro studies. Based on these data, an orphan designation was granted by the European Medicines Agency for ketoconazole in GCT (EU/3/17/1857).; Gov Identifier: NCT01584297. (© 2023. The Author(s), under exclusive licence to Federación de Sociedades Españolas de Oncología (FESEO).)

García-García, I., et al. (2022). "Recurrence Rate and Morbidity after Ultrasound-guided Transvaginal Aspiration of Ultrasound Benign-appearing Adnexal Cystic Masses with and without Sclerotherapy: A Systematic Review and Meta-analysis." Journal of Minimally Invasive Gynecology 29(2): 204-212.
	Objective: To determine the pooled recurrence rate of benign adnexal masses/cysts (namely simple cyst, endometrioma, hydrosalpinx, peritoneal cyst) after transvaginal ultrasound-guided aspiration, with or without sclerotherapy.; Data Sources: Search of studies published in PubMed and Web of Science databases between January 1990 and December 2020.; Methods of Study Selection: A systematic search strategy was done using Medical Subject Heading terms. Only randomized trials and prospective studies published in English language were included.; Tabulation, Integration, and Results: A total of 395 articles were screened. After applying inclusion and exclusion criteria, 20 studies were included in this review comprising data from 1386 patients with a mean follow-up of 11.4 months (range 0.5-26.5 months). The overall pooled rate of recurrence of adnexal masses was 27%, (95% confidence interval [CI], 18%-39%). Recurrence rate was significantly higher after only aspiration than after sclerotherapy (53%; 95% CI, 46%-60% vs 14%; 95% CI, 8%-22%; p <.001). However, a high heterogeneity across the studies was found. A total of 10 major complications were recorded in the different publications.; Conclusion: In a selected population, aspiration with sclerotherapy had a lower recurrence rate than aspiration without sclerotherapy. However, these results should be interpreted with caution given the heterogeneity of the studies and the paucity of randomized controlled trials. Regarding the adoption of this procedure in routine clinical practice, we believe that aspiration should be considered an experimental procedure as there are few studies addressing long-term recurrence rate, and data comparing this technique with surgical cystectomy are lacking. (Copyright © 2021 AAGL. Published by Elsevier Inc. All rights reserved.)

García-Gómez, E., et al. (2023). "The Effect of Metformin and Carbohydrate-Controlled Diet on DNA Methylation and Gene Expression in the Endometrium of Women with Polycystic Ovary Syndrome." International Journal of Molecular Sciences 24(7).
	Polycystic ovary syndrome (PCOS) is an endocrine disease associated with infertility and metabolic disorders in reproductive-aged women. In this study, we evaluated the expression of eight genes related to endometrial function and their DNA methylation levels in the endometrium of PCOS patients and women without the disease (control group). In addition, eight of the PCOS patients underwent intervention with metformin (1500 mg/day) and a carbohydrate-controlled diet (type and quantity) for three months. Clinical and metabolic parameters were determined, and RT-qPCR and MeDIP-qPCR were used to evaluate gene expression and DNA methylation levels, respectively. Decreased expression levels of HOXA10 , GAB1 , and SLC2A4 genes and increased DNA methylation levels of the HOXA10 promoter were found in the endometrium of PCOS patients compared to controls. After metformin and nutritional intervention, some metabolic and clinical variables improved in PCOS patients. This intervention was associated with increased expression of HOXA10 , ESR1, GAB1 , and SLC2A4 genes and reduced DNA methylation levels of the HOXA10 promoter in the endometrium of PCOS women. Our preliminary findings suggest that metformin and a carbohydrate-controlled diet improve endometrial function in PCOS patients, partly by modulating DNA methylation of the HOXA10 gene promoter and the expression of genes implicated in endometrial receptivity and insulin signaling.

Garcia-Hernandez Samantha, C., et al. (2021). "Metformin does not improve insulin sensitivity over hypocaloric diets in women with polycystic ovary syndrome: a systematic review of 12 studies." Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology 37(11): 968-976.
	Objective: To improve insulin action, most clinicians prescribe Metformin in patients with insulin resistance (IR). Women with polycystic ovary syndrome (PCOS), in which IR is an important physiopathological mechanism, treatment with Metformin and specialized diets have been suggested to reduce the patient's IR. However, numerous studies have demonstrated conflicting results with respect to supplementing a diet with Metformin. Therefore, we conducted a meta-analysis to determine if Metformin provides a benefit in conjunction with hypocaloric diets to improve insulin sensitivity in PCOS women.; Methods: PubMed, SCOPUS, LILACS, and EBSCO databases and retrieved studies' bibliographies were searched for prospective studies that investigated the effect between Metformin and hypocaloric diets in PCOS women until April 2020. Pre- and post-intervention values for fasting plasma glucose (FPG), fasting plasma insulin (FPI), and IR indices (HOMA1-IR, ISI, and QUICKI) were extracted. Using Comprehensive Meta-Analysis software, the pooled standard difference in the means (SDM) and 95%CIs were calculated.; Results: 11 publications (12 studies) were selected. There was not a benefit of adding Metformin to a hypocaloric diet with respect to FPG (SDM= -0.17; 95%CI: -0.48-0.14, p = .28) and FPI (SDM = 0.16; 95%CI: -0.24-0.55, p = .45). None of the IR indices also demonstrated any benefit of using Metformin when a diet intervention was implemented (HOMA1-IR: SDM = 0.28; 95%CI: -0.27-0.84, p = .315; ISI: SDM = 0.344; 95%CI: -0.17-0.85, p = .186; QUICKI: SDM= -0.01; 95%CI: -0.42-0.41, p = .968).; Conclusion: Here, we determined that adding Metformin to hypocaloric diets did not improve serum glucose or insulin concentrations as well as IR in PCOS women.

Garcia-Illescas, D., et al. (2024). "The evolving landscape of antibody-drug conjugates in ovarian cancer: new drugs for a new era." Current opinion in obstetrics & gynecology.
	PURPOSE OF REVIEW: This review addresses the emerging role of antibody-drug conjugates (ADCs) in the treatment of ovarian cancer, a field marked by a high need for more effective and targeted therapies. Given the recent advancements in ADC technology and the ongoing challenges in treating ovarian cancer, particularly in late-stage and recurrent cases, this review is both timely and relevant. It synthesizes current research findings and clinical trial data, highlighting the potential of ADCs to revolutionize ovarian cancer treatment. RECENT FINDINGS: The review covers key themes including the mechanism of action of ADCs, their specificity in targeting ovarian cancer cells, recent clinical trial outcomes, advancements in ADC design for improved efficacy and reduced toxicity, and strategies to overcome drug resistance in ovarian cancer. It also addresses the heterogeneity of ovarian cancer and the implications for personalized ADC therapies. SUMMARY: The review underscores the potential of ADCs to significantly impact clinical practice, offering a more effective and personalized treatment approach for ovarian cancer patients. The review suggests a paradigm shift in the treatment of this malignancy, emphasizing the need for further research and development in this area.Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.

García-López, F.-J., et al. (2023). "Virtual reality to improve low-back pain and pelvic pain during pregnancy: a pilot RCT for a multicenter randomized controlled trial." Frontiers in Medicine 10: 1206799.
	A significant proportion of women experience low back and pelvic pain during and after pregnancy, which can negatively impact their daily lives. Various factors are attributed to these complaints, and many affected women do not receive adequate healthcare. However, there is evidence to support the use of different physiotherapeutic interventions to alleviate these conditions. Virtual reality is a promising complementary treatment to physiotherapy, particularly in improving pain perception and avoidance. The primary objective of this study is to evaluate the efficacy of a four-week program combining VR and physiotherapy compared to standard physiotherapy in pregnant women with low back and pelvic pain, in terms of improving pain avoidance, intensity, disability, and functional level. The study also aims to investigate patient satisfaction with the VR intervention. This research will be conducted through a multi-center randomized controlled clinical trial involving pregnant patients residing in the provinces of Seville and Malaga with a diagnosis of low back and pelvic pain during pregnancy. The alternative hypothesis is that the implementation of a Virtual Reality program in combination with standard physiotherapy will result in better clinical outcomes compared to the current standard intervention, which could lead to the development of new policies and interventions for these pathologies and their consequences. Clinical trial registration : clinicaltrials.gov, identifier NCT05571358.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2023 García-López, Pastora-Bernal, Moreno-Morales, Estebanez-Pérez, Liñán-González and Martín-Valero.)

Garcia-Ruiz, N. S., et al. (2022). "Preoperative Tamsulosin to Prevent Postoperative Urinary Retention after Pelvic Floor Repair Surgery." Journal of Minimally Invasive Gynecology 29(11 Supplement): S17-S18.
	Study Objective: The purpose of the study is to evaluate the effect of preoperative Tamsulosin on postoperative urinary retention (POUR) in patients undergoing surgery for pelvic organ prolapse. Design(s): A prospective randomized control trial. Setting(s): Patients enrolled in the outpatient clinic setting. Medication given in the preoperative area, the day of surgery. Voiding trial was performed in the post-anesthesia recovery unit (PACU). Patients or Participants: 100 patients were enrolled with 50 in each arm, randomly assigned. Patients diagnosed with pelvic organ prolapse undergoing vaginal or laparoscopic reconstructive pelvic surgery with or without mid-urethral sling. Intervention(s): Oral Tamsulosin 0.4mg given 30-90 minutes before the procedure. Active voiding trial was performed within 4 hours of patients arriving to the PACU. Measurements and Main Results: 48 patients enrolled in the control group and 47 patients in the study group. When comparing demographics, there were no statistically significant differences between the groups except for preoperative uterine prolapse (p<0.05). For the primary outcome, there was no statistically significant difference in incidence of POUR between the 2 groups (p=0.73). A total of 36 patients had POUR; 17 (36.2%) in the study group and 19 (39.6%) in the placebo group. A multivariate cox regression analysis determined that the study group had a hazard risk of 1.1 [95% CI 0.47-2.59] but was not statistically significant (p=0.81). Preoperative uterine prolapse also had an increase hazard risk of 1.25 [95% CI 0.52-3.04] but also failed to meet statistical significance (p=0.62). Postoperative narcotic use (p=1.0) and increased length of surgery (p=0.51) had no increase in POUR. Conclusion(s): In this study, the incidence of POUR was not significantly decreased after a single preoperative dose of Tamsulosin. Receiving Tamsulosin with preoperative uterine prolapse had an increased hazard risk for POUR but was not statistically significant. At this time, we do not recommend a single dose of tamsulosin to decrease POUR after prolapse surgery.Copyright © 2022

Garcia-Sanchez, J., et al. (2021). "Cognitive functions under anti-her2 targeted therapy in cancer patients: A scoping review." Endocrine, Metabolic and Immune Disorders - Drug Targets 21(7): 1163-1170.
	Pharmacological therapy targeting the HER2 protein is one of the major breakthroughs in the treatment of cancer patients overexpressing HER2 who have increased survival rates. Despite im-proved survival, it is important to determine the less frequent adverse effects in order to tailor treatments more personalized to the patients' features. The possible impact of cancer treatments on cognitive functions is huge, and the effects of anti-HER 2 therapies on this issue have not been reviewed and are the objective of this study. Analysis of PubMed, Scopus, Cochrane library and Web of Science databases revealed six studies performed in breast and serous uterine cancer patients analyzing cognitive function under chemotherapy regimens including anti-HER2 drugs. Four of these studies reported small to significant worsening of cognitive function following chemotherapy regimens containing tras-tuzumab (the most widely used anti-HER2 drug). In neoadjuvant settings, and in breast cancer patients, treatment with the new anti-HER-2 drug trastuzumab emtansine seems to induce less cognitive impairment than therapeutic regimens containing chemotherapy and trastuzumab. Acute administration of trastuzumab induced cognitive impairment in gastric cancer mice models, confirming its ability to alter cognitive function in patients. More studies analyzing the impact of anti-HER2 therapy on cognitive function are necessary at preclinical and clinical levels in order to personalize pharmacological treatment and offer cancer patients a better quality of life.Copyright © 2021 Bentham Science Publishers.

Garcia-Sayre, J., et al. (2023). "Two staged phase II clinical trial of Eribulin monotherapy in advanced or recurrent cervical cancer." Gynecologic Oncology 173: 49-57.
	Background: Eribulin a microtubule targeting agent and analog of Halichondrin B, a natural product isolated from marine sponge H. okadai, has proven clinical efficacy in metastatic pretreated breast cancer and liposarcoma. We conducted a 2-stage Phase II study of eribulin in patients with advanced/recurrent cervical cancer to examine its clinical activity and evaluate biomarkers for predictors of response.; Methods: Women with advanced/recurrent cervical cancer after ≤1 prior chemotherapy regimen, measurable disease and ECOG performance status ≤2 were treated with eribulin (1.4 mg/m 2 IV day 1 and 8, every 21 days) with tumor assessments every 2 cycles. Primary endpoint was 6-month progression-free survival (PFS6); secondary were best overall response (RECISTv1.1), toxicity (CTCAEv4.03) and overall survival (OS). Exploratory endpoints were associations of biomarkers with clinical activity. Immunohistochemistry was performed on archival tumor samples. Overexpression was defined when both intensity and distribution scores were ≥ 2.; Results: 32 patients enrolled from 11/2012-5/2017. 29/32 patients had prior chemotherapy with cisplatin/paclitaxel/bevacizumab (n = 12) or cisplatin/gemcitabine (n = 12) as the most common regimens. 14 patients received prior paclitaxel. 1 (3%) had a complete response, 5 (16%) had a partial response and 13 (41%) had stable disease for ORR of 19% (95% CI 8, 37). Those who are paclitaxel naïve experienced the greatest benefit with a 29% ORR (95% CI 12, 54). Patients who received prior paclitaxel responded less favorably than those who did not (p = .002) and had a shorter PFS and OS. Grade 3/4 adverse events occurring in >10% of patients were anemia (n = 12, 38%), neutropenia (n = 7, 22%) and leukopenia (n = 6, 19%). Analysis of correlative predictors of response revealed that patients who did not overexpress βII and BAX were significantly more likely to respond to e`ribulin. PFS was significantly shorter in patients with βII and BAX overexpression, OS was significantly shorter in those with βIII and BAX overexpression. These associations remained after multivariate analysis.; Conclusions: Eribulin shows modest activity in patients with recurrent/advanced cervical cancer with a favorable toxicity profile. Prior paclitaxel exposure is associated with decreased eribulin response. βII, βIII tubulin subtypes and BAX are predictors of response and survival. Eribulin may be an option for women with paclitaxel-naïve recurrent/advanced cervical cancer.; Competing Interests: Declaration of Competing Interest Dr. Lin reports having financial interests in Genentech-Roche. Dr. Louie reports having received grants and research funding from the National Cancer Institute and the United States Department of Defense. Dr. A. Garcia reports participation in the Advisory Board for Biotheranostics Inc. Dr. Roman reports consulting for Cardiff Oncology, Nutcracker Therapeutics and AXDEV as well as participation in the Steering Committee for the Global Coalition of Adaptive Research. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Garcia-Soto, A. E., et al. (2021). "Phase 1 trial of nelfinavir added to standard cisplatin chemotherapy with concurrent pelvic radiation for locally advanced cervical cancer." Cancer 127(13): 2279-2293.
	BACKGROUND: Nelfinavir (NFV), an HIV-1 protease inhibitor, has been shown to sensitize cancer cells to chemoradiation (CRT). The objectives of this phase 1 trial were to evaluate safety and identify the recommended phase 2 dose of NFV added to concurrent CRT for locally advanced cervical cancer. METHODS: Two dose levels of NFV were evaluated: 875 mg orally twice daily (dose level 1 [DL1]) and 1250 mg twice daily (DL2). NFV was initiated 7 days before CRT and continued through CRT completion. Toxicity, radiographic responses, and pathologic responses were evaluated. Serial tumor biopsies (baseline, after NFV monotherapy, on NFV + CRT, and posttreatment) were evaluated by immunohistochemistry, NanoString, and reverse-phase-protein-array analyses. RESULTS: NFV sensitized cervical cancer cells to radiation, increasing apoptosis and tumor suppression in vivo. Patients (n = 13) with International Federation of Gynecology and Obstetrics stage IIA through IVA squamous cell cervical carcinoma were enrolled, including 7 patients at DL1 and 6 patients at DL2. At DL1, expansion to 6 patients was required after a patient developed a dose-limiting toxicity, whereas no dose-limiting toxicities occurred at DL2. Therefore, DL2 was established as the recommended phase 2 dose. All patients at DL2 completed CRT, and 1 of 6 experienced grade 3 or 4 anemia, nausea, and diarrhea. One recurrence was noted at DL2, with disease outside the radiation field. Ten of 11 evaluable patients remained without evidence of disease at a median follow-up of 50 months. NFV significantly decreased phosphorylated Akt levels in tumors. Cell cycle and cancer pathways also were reduced by NFV and CRT. CONCLUSIONS: NFV with CRT is well tolerated. The response rate is promising compared with historic controls in this patient population and warrants further investigation.

Garcia-Yu, I. A., et al. (2021). "Cocoa-rich chocolate and body composition in postmenopausal women: a randomised clinical trial." British journal of nutrition 125(5): 548‐556.
	During menopause, women undergo a series of physiological changes that include a redistribution of fat tissue. This study was designed to investigate the effect of adding 10 g of cocoa‐rich chocolate to the habitual diet of postmenopausal women daily on body composition. We conducted a 6‐month, two‐arm randomised, controlled trial. Postmenopausal women (57·2 (sd 3·6) years, n 132) were recruited in primary care clinics. Participants in the control group (CG) did not receive any intervention. Those of the intervention group (IG) received 10 g daily of 99 % cocoa chocolate in addition to their habitual diet for 6 months. This quantity comprises 247 kJ (59 kcal) and 65·4 mg of polyphenols. The primary outcomes were the between‐group differences in body composition variables, measured by impendancemetry at the end of the study. The main effect of the intervention showed a favourable reduction in the IG with respect to the CG in body fat mass (‐0·63 kg (95 % CI ‐1·15, ‐0·11), P = 0·019; Cohen's d = ‐0·450) and body fat percentage (‐0·79 % (95 % CI ‐1·31, ‐0·26), P = 0·004; Cohen's d = ‐0·539). A non‐significant decrease was also observed in BMI (‐0·20 kg/m2 (95 % CI ‐0·44, 0·03), P = 0·092; Cohen's d = ‐0·345). Both the body fat mass and the body fat percentage showed a decrease in the IG for the three body segments analysed (trunk, arms and legs). Daily addition of 10 g of cocoa‐rich chocolate to the habitual diet of postmenopausal women reduces their body fat mass and body fat percentage without modifying their weight.

Garcia-Yu Irene, A., et al. (2022). "Effects of cocoa-rich chocolate on cognitive performance in postmenopausal women. A randomised clinical trial [see note]." Nutritional neuroscience 25(6): 1147-1158.
	Objectives: The aim of this research was to evaluate the effects of adding 10 g of cocoa-rich chocolate (99%) to the habitual diet on cognitive performance in postmenopausal women.; Methods: Following a randomised controlled parallel clinical trial, a total of 140 postmenopausal women aged 50-64 were recruited. The intervention group ( n = 73) consumed daily 10 g of chocolate (99% cocoa) in addition to their usual food intake for 6 months, whereas the control group ( n = 67) did not receive any intervention. Attention and executive functions, verbal memory, working memory, phonological fluency, category fluency and clinical variables were assessed at baseline and 6 months.; Results: Trail Making Test B execution time showed a decreased of -12.08 s (95% CI: -23.99, -0.18; p = 0.047) in the intervention group compared to the control group, after adjusting for age, educational level, time elapsed from the beginning of menopause and daily energy consumption (Cohen's d = -0.343). Attention, immediate or delayed verbal memory, phonological or category fluency, and working memory remained unchanged.; Conclusions: The consumption of cocoa-rich (99%) chocolate in addition to the habitual diet could be related to a slight improvement in cognitive performance regarding cognitive flexibility and processing speed in postmenopausal women, with no changes in the rest of the cognitive performance variables evaluated. Trial registration: This clinical trial has been registered at clinicaltrials.gov as NCT03492983.

Gardella, B., et al. (2023). "Aromatase inhibitors in the pharmacotherapy of endometriosis." Expert Opinion on Pharmacotherapy 24(9): 1067-1073.
	Introduction: Endometriosis is a benign chronic inflammatory disease responsible for debilitating pain and decreased quality of life. The traditional treatment is based on estroprogestins, progestins, GnRH analogs, and surgery. Recently, aromatase inhibitors (AIs) demonstrated good efficacy in controlling symptoms and size of endometriotic implants, mostly because they suppress extraovarian estrogen synthesis, which can enhance the hypoestrogenic state ameliorating symptoms of endometriosis.; Areas Covered: Phase I, II, III and IV trials, on the use of AIs used for the treatment of endometriosis, have been retrieved. The pharmacokinetics and pharmacodynamics of third-generation non-steroidal AIs have also been investigated. A MEDLINE search has been performed using the following MeSH keywords: 'endometriosis,' aromatase inhibitors,' 'therapy,' and 'treatment'. The timeframe was from 2010 up to November 2022 including reviews, systematic reviews, reports, case series, and retrospective or prospective trials.; Expert Opinion: AIs have shown good clinical efficacy in combination with hormonal therapy in disease control, and they represent a promising second-line therapy in selected patients, yet more research is needed on alternative drug delivery systems and better control of adverse effects. In postmenopausal women in which surgery is contraindicated, AIs represent an excellent treatment option. Their application in routine clinical practice remains limited by adverse effects.

Garg, A., et al. (2022). "Treatments targeting neuroendocrine dysfunction in polycystic ovary syndrome (PCOS)." Clinical Endocrinology 97(2): 156-164.
	Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and is the leading cause of anovulatory subfertility. Increased gonadotrophin releasing hormone (GnRH) pulsatility in the hypothalamus results in preferential luteinizing hormone (LH) secretion from the pituitary gland, leading to ovarian hyperandrogenism and oligo/anovulation. The resultant hyperandrogenism reduces negative feedback from sex steroids such as oestradiol and progesterone to the hypothalamus, and thus perpetuates the increase in GnRH pulsatility. GnRH neurons do not have receptors for oestrogen, progesterone, or androgens, and thus the disrupted feedback is hypothesized to occur via upstream neurons. Likely candidates for these upstream regulators of GnRH neuronal pulsatility are Kisspeptin, Neurokinin B (NKB), and Dynorphin neurons (termed KNDy neurons). Growing insight into the neuroendocrine dysfunction underpinning the heightened GnRH pulsatility seen in PCOS has led to research on the use of pharmaceutical agents that specifically target the activity of these KNDy neurons to attenuate symptoms of PCOS. This review aims to highlight the neuroendocrine abnormalities that lead to increased GnRH pulsatility in PCOS, and outline data on recent therapeutic advancements that could potentially be used to treat PCOS. Emerging evidence has investigated the use of neurokinin 3 receptor (NK3R) antagonists as a method of reducing GnRH pulsatility and alleviating features of PCOS such as hyperandrogenism. We also consider other potential mechanisms by which increased GnRH pulsatility is controlled, which could form the basis of future avenues of research. (© 2022 John Wiley & Sons Ltd.)

Garg, K. and S. Zilate (2022). "Umbilical Cord-Derived Mesenchymal Stem Cells for the Treatment of Infertility Due to Premature Ovarian Failure." Cureus 14(10): e30529.
	Females belonging to the reproductive age group may face challenges regarding infertility or miscarriage due to conditions such as premature ovarian failure (POF). It is the condition that happens when a female's ovaries stop working before she is 40. The majority of the causes of POF cases are idiopathic. Other reasons include genetic disorders (Turner's syndrome, bone morphogenetic protein 15 ( BMP15 ) mutation, galactosemia, mutation of forkhead box protein L2 ( FOXL2 ), growth differentiation factor-9 ( GDF9 ), mutation of luteinizing hormone (LH) and follicle-stimulating hormone receptors ( FSHR ), etc.), enzymatic mutation such as aromatase, autoimmune disorders (Addison's disease, vitiligo, systemic lupus erythematosus, myasthenia gravis, autoimmune thyroiditis, autoimmune polyglandular syndrome, etc.), vaccination, and environmental factors (cigarette smoking, toxins, and infections). Many attempts have been made to treat POF by various methods. Some of the methods of treatment include hormone replacement therapy (HRT), melatonin therapy, dehydroepiandrosterone (DHEA) therapy, and stem cell therapy. Stem cell therapy has proven to be the most efficient form for treating POF as compared to all other options. Umbilical cord-derived mesenchymal stem cells (UC-MSCs) are the best among the other sources of mesenchymal stem cells (MSCs) for the treatment of POF as they have a painless extraction procedure. They have a tremendous capacity for self-repair and regeneration, which helps them in restoring degenerated ovaries. This review includes information on the causes of POF, its efficacious therapeutic approaches, and the impact of transplantation of human umbilical cord mesenchymal stem cells (hUCMSCs) as an option for the therapy of POF. Numerous studies conducted on stem cell therapy prove that it is an effective approach for the treatment of sterility.; Competing Interests: The authors have declared that no competing interests exist. (Copyright © 2022, Garg et al.)

Garg, S., et al. (2022). "A randomized controlled trial to compare antibiotic prophylaxis in elective gynecological surgeries: Single dose of cefazolin versus single dose of cefazolin and tinidazole." Tzu Chi Medical Journal 34(2): 207-213.
	Objectives: To evaluate if addition of an anti-Anaerobic agent to standard drug-cefazolin for antimicrobial prophylaxis would further decrease postoperative infectious morbidity or not. This is relevant as most of the infections in gynecological surgeries are anaerobic but cefazolin does not protect against anaerobes. Material(s) and Method(s): The study design was a parallel randomized controlled trial. Two hundred patients undergoing benign gynecological surgeries were divided into two groups of 100 each. Group A received 2 g cefazolin 30-60 min before incision and Group B received 2 g cefazolin 30-60 min and 1.6 g tinidazole 60-120 min before incision. The patients were followed for any infectious morbidity for 1 month postoperatively. The analysis was done separately for abdominal, laparoscopic, and vaginal surgeries. The analysis was also done for surgeries according to the wound category, i.e. clean and clean-contaminated. Result(s): The two groups were comparable for age and body mass index (BMI). The two groups were comparable for the factors affecting infectious morbidity such as duration of surgery, blood loss, blood transfusions, duration of hospital stay, and need for additional antibiotics. The postoperative infectious morbidity was analyzed in terms of fever, surgical site infection (SSI), and urinary tract infection (UTI). No patient in vaginal and laparoscopic groups suffered from infectious morbidity. In abdominal surgeries group, postoperative fever occurred in 6/74 (8.1%) and 11/74 patients (14.8%) in Groups A and B, respectively (P = 0.38). SSI occurred in 1/74 (1.3%) and 2/74 (2.7%) patients in Groups A and B, respectively (P = 1.0). UTI occurred in 5/74 patients (6.7%) and 2/74 patients (2.7%) in Groups A and B, respectively (P = 0.44). The data were also analyzed for infectious morbidity for clean and clean-contaminated wound categories, and the results were nonsignificant between both groups for each type of wound category (P > 0.05). Conclusion(s): Cefazolin alone is a sufficient antibiotic prophylaxis for benign gynecological procedures.Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.

Garhofer, G., et al. (2021). "Effect of topical oestradiol eye drops on signs and symptoms of dry eye disease in post-menopausal women." Investigative ophthalmology & visual science 62(8).
	Purpose : Previous evidence indicates that topical oestradiol may be beneficial for patients with dry eye disease (DED), especially in post‐menopausal women. The current phase II study was performed to investigate the effect of a recently developed formulation of oestradiol eye drops on signs and symptoms of DED. Methods : In this randomized, controlled, parallel‐group study, 104 post‐menopausal women with moderate to severe dry eye were included. 17‐β‐oestradiol‐3‐phosphate eye drops (RP101) were administered in three different dosage groups (group 1: 0.5% twice daily, group 2: 0.1% morning and vehicle in the evening, group 3: 0.1% twice daily) and compared to control (group 4: vehicle IntelliGel, twice daily). Treatment was administered for a total period of three months. Schirmer's test II, corneal staining and SANDE symptom score were assessed at baseline and at day 14, 30, 60 and 90 after treatment start. Safety was determined via frequency of adverse events. Results : Schirmer's test II wetting distance significantly increased in all 4 groups from baseline to day 90 without significant difference between groups (group 1: +5.6±6.7; group 2: +3.7±4.2; group 3: +4.8±4.5, group 4: +4.0±5.3 mm/5min). Statistical significance versus baseline occurred earlier in the treatment groups versus the control group. Corneal staining score was significantly reduced after the three‐month treatment period with no significant difference between treatment groups (p<0.001 vs baseline in all groups). Staining of the inferior cornea, however, showed a significantly more pronounced decrease in the highest dose group compared to vehicle (p=0.0463). Symptoms as assessed with the SANDE test decreased at the end of the treatment period in all 4 groups (between ‐18.7±23.5 and ‐26.3±28.0 mm for frequency of symptoms and between ‐13.1±26.8 and ‐24.1±40.2 mm for severity of symptoms). Topical RP101 eye drops were well tolerated on the ocular surface and showed a favorable safety profile. Conclusions : The results of the study indicate that topical RP101 eye drops improve signs and symptoms of DED in post‐menopausal women. The results of the study showed a good safety profile of the topical ophthalmic formulation. Further adequately powered phase III studies are required to assess therapeutic efficacy of topical oestradiol in the treatment of DED.

Gari, R., et al. (2022). "Use of Botulinum Toxin (Botox) in Cases of Refractory Pelvic Floor Muscle Dysfunction." Sexual Medicine Reviews 10(1): 155-161.
	Introduction: Pelvic floor muscle (PFM) dysfunction is a sexual pain disorder characterized by involuntary spasm of pelvic floor muscles (PFMs) around the vagina that interferes with intercourse or any kind of vaginal penetration, making it impossible or extremely painful. Recently, researchers have shown increased interest in botulinum toxin (BoNTA) as an alternative option for refractory cases of PFM dysfunction, especially those that fail first-line treatments. Questions have been raised about the efficacy of BoNTA for the treatment of PFM dysfunction. Objective(s): To provide an updated and comprehensive review on the role of BoNTA in the management of refractory PFM dysfunction. Method(s): We reviewed the literature using a systematic search strategy via PubMed and Google Scholar databases, to identify articles investigating the use of BoNTA in PFM dysfunction. We included studies that explored its indications, mechanism of action, injection dosing and technique, success rate, side effects, and contraindications. Result(s): We identified 20 relevant articles. Of these, 12 were original studies: 7 clinical trials, 1 retrospective cohort study and 4 case reports or case series. Doses of BoNTA that were used in these studies ranged between 20 and 500 units. The most commonly injected sites were levator ani muscles. Success rates varied between 62 and 100 %. Most studies showed no recurrence within 1 year after treatment. The majority of these studies used BoNTA after conventional first-line treatments have failed. Conclusion(s): PFM dysfunction is a debilitating condition that adversely affects quality of life. There is promising evidence to support the use of BoNTA in cases of refractory PFM dysfunction. Further randomized controlled trials are warranted to standardize the use of BoNTA as a treatment option for these cases. Gari R, Alyafi M, Gadi RU, et al. Use of Botulinum Toxin (Botox) in Cases of Refractory Pelvic Floor Muscle Dysfunction. Sex Med Rev 2022;10:155-161.Copyright © 2021 The Authors

Garimella, S., et al. (2021). "A prospective study of oral estrogen versus transdermal estrogen (gel) for hormone replacement frozen embryo transfer cycles." Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology 37(6): 515-518.
	AIM: This study was done to compare the efficacy of transdermal estrogen (gel) to oral estradiol in hormone replacement frozen embryo transfer cycles (HR- FET). MATERIALS AND METHODS: This was a prospective study conducted between March 2019 and December 2019. We included 294 HR FET cycles: 156 cycles using oral estrogen tablets (oral group) and 138 cycles using transdermal gel (17 beta estradiol 0.06% w/w) (gel group). Primary objective of this study was to compare endometrial thickness (ET) on the day of progesterone start between the two groups. Our secondary objective was to compare implantation rates (IR), clinical pregnancy rates (CPR), miscarriage rates (MR), duration of estrogen administration, estradiol (E2) levels before the start of progesterone, cycle cancellation rates, patient satisfaction score and undesirable side effects between both the groups. RESULTS: There was no significant difference in the ET, IR, CPR, MR and duration of E2 administration and cycle cancellation rates between both the groups. Patient satisfaction score was significantly higher (8.02 ± 1.07 vs 6.96 ± 0.99 p < .01) and side effects were significantly lower (18.1% vs 55.1%, p≤.01), in the gel group compared to the oral group. CONCLUSION: This study concluded that transdermal estrogen (gel) is equally efficacious as oral estrogen in HR FET cycles with transdermal gel having an added benefit of better patient comfort with less side effects and better safety profile.

Garthwaite, H., et al. (2022). "Multiple pregnancy rate in patients undergoing treatment with clomifene citrate for WHO group II ovulatory disorders: a systematic review." Human fertility (Cambridge, England) 25(4): 618-624.
	Clomifene citrate has long been associated with a multiple pregnancy rate of up to 8-10%. Studies from which these figures originated have largely included patients who received clomifene outside of current national and international treatment guidelines. In January 2020, a systematic review of MEDLINE and relevant reference lists was conducted. Studies were included that reported multiple pregnancy rate in a cohort of patients undergoing treatment with single agent clomifene citrate for WHO group II dysovulatory subfertility. Twelve studies were included in the analysis, with a total sample size of 1,387 patients. The overall multiple pregnancy rate was 3.8% (3.6% twins/0.2% triplets); this dropped to 2.4% (all twins) when studies with a mean BMI ≥35kg/m 2 were excluded. This review suggests that contemporary single agent clomifene use following current guidelines in terms of indication, results in a lower than expected multiple pregnancy rate. Further evidence from clinical practice is required to ensure that patients are adequately informed.

Garutti, M., et al. (2021). "Checkpoint inhibitors, fertility, pregnancy, and sexual life: a systematic review." ESMO Open 6(5): 100276.
	Immune checkpoint inhibitors (i.e. anti-PD1, anti-PDL1, and anti-CTLA4) have revolutionized the therapeutic approach of several cancer types. In a subset of metastatic patients, the duration of the response is so long that a cure might be hypothesized, and a treatment discontinuation strategy could be proposed. Considering that long-term efficacy, some patients could also plan to have a child. Moreover, immunotherapy is moving to the early setting in several diseases including melanoma and breast cancer that are common cancers in young patients. However, there is a paucity of data about their potential detrimental effect on fertility, pregnancy, or sexuality. Herein, we conducted a systematic review with the aim to comprehensively collect the available evidence about fertility, pregnancy, and sexual adverse effects of checkpoint inhibitors in order to help clinicians in daily practice and trialists to develop future studies.

Garzon, S., et al. (2020). "Aromatase inhibitors for the treatment of endometriosis: a systematic review about efficacy, safety and early clinical development." Expert opinion on investigational drugs 29(12): 1377-1388.
	Introduction: Pharmacotherapy has a key role in endometriosis treatment and management, however, a significant proportion of patients have only intermittent or limited benefits with current treatment options. Therefore, novel therapeutic approaches are necessary.; Areas Covered: This systematic review provides an overview of the efficacy and safety of aromatase inhibitors (AIs) as monotherapies and combination therapies for endometriosis. A systematic literature search was performed from January 1990 to April 2020 in the electronic database MEDLINE, EMBASE, The Cochrane Library, and Web of Science.; Expert Opinion: Based on the critical role of estrogens and the rate-limiting step in the production of the estrogens represented by the aromatase enzyme, AIs are a potential therapeutic option for women affected by endometriosis. Nevertheless, further research is needed to clarify the efficacy of AIs in this setting. Adverse effects need to be investigated to clarify the preventive role of add-back therapy. On that basis, AIs should be adopted only as second-line therapy in patients who are refractory to standard treatments in the setting of scientific research. Further studies should define best dosages, appropriate add-back therapies, administration routes, treatment length, and which patients may benefit more from AIs.

Garzon, S., et al. (2020). "Hysteroscopic Metroplasty for T-Shaped Uterus: A Systematic Review and Meta-analysis of Reproductive Outcomes." Obstetrical & gynecological survey 75(7): 431-444.
	Importance: To date, a comprehensive review on the safety and effectiveness of hysteroscopic metroplasty for T-shaped uterus is still missing.; Objective: To provide a robust synthesis of the available studies investigating reproductive outcomes after hysteroscopic metroplasty for T-shaped uterus.; Evidence Acquisition: We performed a systematic review and meta-analysis (CRD42019143291), using the proportion method with 95% confidence interval (CI). Statistical heterogeneity was assessed by Higgins test ( I 2 ).; Results: We included 11 cohort studies embedding 937 women who underwent hysteroscopic metroplasty. After surgery, the pooled percentage of live birth was 44.54% (95% CI, 36.12%-53.12%; I 2 = 46.22%) and 56.88% (95% CI, 46.48%-66.98%; I 2 = 36.38%) in women with primary infertility and recurrent miscarriage, respectively. In women with recurrent miscarriage, the pooled proportion of miscarriage was 21.46% (95% CI, 15.09%-28.61%; I 2 = 30.18%). The pooled clinical pregnancy proportion in women with primary infertility was 57.19% (95% CI, 43.83%-70.03%; I 2 = 77.81%). The pooled rate of surgical complications was 0.65% (95% CI, 0.20%-1.33%; I 2 = 11.44%).; Conclusions: The hysteroscopic correction of T-shaped uteri was associated with high live birth rate and low miscarriage rate, both in case of primary infertility and recurrent miscarriage.; Relevance: Hysteroscopic metroplasty can be considered a safe and effective strategy to improve reproductive outcomes in case of T-shaped uterus.

Garzon, S., et al. (2021). "Fertility-sparing management for endometrial cancer: Review of the literature." Minerva Medica 112(1): 55-69.
	INTRODUCTION: Primary surgery is effective in low-risk endometrial cancer (EC). However, in young women, this approach compromises fertility. Therefore, fertility-sparing management in the case of atypical endometrial hyperplasia, or grade 1 EC limited to the endometrium can be considered. EVIDENCE ACQUISITION: We performed a literature review to identify studies involving women with EC or atypical hyperplasia who underwent fertility-sparing management. We conducted multiple bibliographic databases research from their inception to May 2020. EVIDENCE SYNTHESIS: Oral therapy with medroxyprogesterone acetate and megestrol acetate is recommended based on extensive experience, although without consensus on dosages and treatment length. The pooled complete response rate, recurrence rate, and pregnancy rate of EC were 76.3%, 30.7% and 52.1%, respectively. Endometrial hyperplasia was associated with better outcomes. LNG-IUSs appears an alternative treatment, particularly in patients who do not tolerate oral therapy. In a randomized controlled trial, megestrol acetate plus metformin guaranteed an earlier complete response rate than megestrol acetate alone for endometrial hyperplasia. Hysteroscopic resection followed by progestogens is associated with a higher complete response rate, live birth rate, and lower recurrence rate than oral progestogens alone. Pooled complete response, recurrence, and live birth rates were 98.1%, 4.8% and 52.6%. CONCLUSION(S): Fertility preservation appears feasible in young patients with grade 1 EC limited to the endometrium or atypical endometrial hyperplasia. Progestins are the mainstay of such management. The addition of Metformin and hysteroscopic resection seems to provide some improvements. However, fertility preservation is not the standard approach for staging and treatment, potentially worsening oncologic outcomes.Copyright © 2021 Edizioni Minerva Medica. All rights reserved.

Gaspard, U., et al. (2023). "A multicenter, randomized, placebo-controlled study to select the minimum effective dose of estetrol in postmenopausal participants (E4Relief): part 2-vaginal cytology, genitourinary syndrome of menopause, and health-related quality of life." Menopause (New York, N.Y.) 30(5): 480-489.
	Objective: A phase 2 study showed that 15 mg estetrol (E4) alleviates vasomotor symptoms (VMS). Here, we present the effects of E4 15 mg on vaginal cytology, genitourinary syndrome of menopause, and health-related quality of life.; Methods: In a double-blind, placebo-controlled study, postmenopausal participants (n = 257, 40-65 y) were randomized to receive E4 2.5, 5, 10, or 15 mg or placebo once daily for 12 weeks. Outcomes were the vaginal maturation index and maturation value, genitourinary syndrome of menopause score, and the Menopause Rating Scale to assess health-related quality of life. We focused on E4 15 mg, the dose studied in ongoing phase 3 trials, and tested its effect versus placebo at 12 weeks using analysis of covariance.; Results: Least square (LS) mean percentages of parabasal and intermediate cells decreased, whereas superficial cells increased across E4 doses; for E4 15 mg, the respective changes were -10.81% ( P = 0.0017), -20.96% ( P = 0.0037), and +34.17% ( P < 0.0001). E4 15 mg decreased LS mean intensity score for vaginal dryness and dyspareunia (-0.40, P = 0.03, and -0.47, P = 0.0006, respectively); symptom reporting decreased by 41% and 50%, respectively, and shifted to milder intensity categories. The overall Menopause Rating Scale score decreased with E4 15 mg (LS mean, -3.1; P = 0.069) and across doses was associated with a decreasing frequency and severity of VMS ( r = 0.34 and r = 0.31, P < 0.001).; Conclusions: E4 demonstrated estrogenic effects in the vagina and decreased signs of atrophy. E4 15 mg is a promising treatment option also for important menopausal symptoms other than VMS.; Competing Interests: Financial disclosure/conflicts of interest: M.T. and M.J. are employees, U.G. and J.-M.F. are consultants, and W.H.U. and R.A.L. are members of the Scientific Advisory Board of Mithra Pharmaceuticals. W.H.U. received funding from Pharmavite, Los Angeles. H.J.T.C.B. is president and CEO of Pantarhei Bioscience. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The North American Menopause Society.)

Gaspard, U., et al. (2021). "Effects of estetrol on vaginal cytology, genitourinary syndrome of menopause and health-related wuality of life: results from the E4Relief Phase 2b Study." Maturitas 152: 71.
	Introduction: Estetrol (E4), a native estrogen with selective action in tissues, is in development for the treatment of menopausal symptoms. A dose of E4 15 mg was considered to be the minimal effective dose for alleviating vasomotor symptoms (VMS)*. Here we present the data for vaginal cytology, genitourinary syndrome of menopause (GSM) and health‐related quality of life (HR‐QoL). Design and methods: E4Relief was a multicenter, randomized, dose‐finding, double‐blind, placebo‐controlled study. Postmenopausal women (n=257) aged 40‒65y, received E4 2.5; 5; 10; or 15 mg, or placebo (1:1:1:1:1) once‐daily for 12 weeks (W12). At baseline and W12, we calculated the Vaginal Maturation Value (VMV; a weighted proportion score of vaginal epithelial cell types) and GSM (vaginal dryness, vaginal pain and bleeding associated with sexual activity, vaginal and/or vulvar irritation/itching, and dysuria). HR‐QoL was assessed at baseline, Week 4 (W4), and W12, using the Menopause Rating Scale (MRS). Results were analyzed descriptively and pairwise comparisons versus placebo were performed. Significance level was set at p≤0.05. Results: Participants mean age was 54.2±4.4 yrs and mean BMI was 26.0±3.9 kg/m2. Baseline characteristics of treatment groups were similar. The parabasal cell count decreased significantly vs placebo already at E4 2.5 mg, and conversely, superficial cell count increased vs placebo at W12. Accordingly, the VMV significantly increased for all E4 treatments vs placebo; the largest increase was observed with E4 15 mg (42.5 to 73.1). GSM symptoms improved versus baseline in all E4 groups. GSM scores decreased significantly (improved) by 45% vs baseline for vaginal dryness with E4 15 mg, and particularly for vaginal pain associated with sexual activity by 40‐50% vs baseline with E4 5 mg to 15 mg. HR‐QoL total and domain scores improved in all groups, the highest reduction in total score was reached by E4 15 mg already at W4 (‐47.0% vs baseline). In the 15 mg E4 group, total and all domain scores were significantly improved vs baseline. A highly significant correlation was observed between all MRS domains and VMS frequency and severity, except for the urogenital symptom score. Conclusion: This phase 2 study showed that E4 15 mg is effective for the treatment of the full spectrum of menopausal symptoms. E4 15 mg is not only the minimal effective dose for the treatment of VMS but also effective for the treatment of GSM and improves HR‐QoL and vaginal cytology.

Gates, M., et al. (2023). "Does hormone replacement therapy prevent cognitive decline in postmenopausal women?" The Journal of family practice 72(4): E10-E11.
	NO. Hormone replacement therapy (HRT) does not prevent cognitive decline in postmenopausal women-and in fact, it may slightly increase risk (strength of recommendation, A; systematic review, meta-analysis of randomized controlled trials [RCTs], and individual RCT).

Gatta, G., et al. (2022). "MRI in Pregnancy and Precision Medicine: A Review from Literature." Journal of Personalized Medicine 12(1): 9.
	Magnetic resonance imaging (MRI) offers excellent spatial and contrast resolution for evaluating a wide variety of pathologies, without exposing patients to ionizing radiations. Additionally, MRI offers reproducible diagnostic imaging results that are not operator-dependent, a major advantage over ultrasound. MRI is commonly used in pregnant women to evaluate, most frequently, acute abdominal and pelvic pain or placental abnormalities, as well as neurological or fetal abnormalities, infections, or neoplasms. However, to date, our knowledge about MRI safety during pregnancy, especially about the administration of gadolinium-based contrast agents, which are able to cross the placental barrier, is still limited, raising concerns about possible negative effects on both the mother and the health of the fetus. Contrast agents that are unable to cross the placenta in a way that is safe for the fetus are desirable. In recent years, some preclinical studies, carried out in rodent models, have evaluated the role of long circulating liposomal nanoparticle-based blood-pool gadolinium contrast agents that do not penetrate the placental barrier due to their size and therefore do not expose the fetus to the contrast agent during pregnancy, preserving it from any hypothetical risks. Hence, we performed a literature review focusing on contrast and non-contrast MRI use during pregnancy.Copyright © 2021 by the authors. Licensee MDPI, Basel, Switzerland.

Gauroy, E., et al. (2020). "Borderline Ovarian Tumours: CNGOF Guidelines for Clinical Practice - Diagnosis and Management of Recurrent Borderline Ovarian Tumours." Gynecologie Obstetrique Fertilite et Senologie 48(3): 314-321.
	Objective: To provide recommendations for the diagnosis and management of the recurrence of Borderline Ovarian Tumour (BOT). Method(s): Literature review by consulting Pubmed, Medline and Cochrane databases. Result(s): In the case of BOT, most of recurrences are a new BOT without invasive contingent (LE2). In the case of bilateral BOT, bilateral cystectomy is associated with a shorter recurrence time compared to unilateral oophorectomy and contralateral cystectomy (LE2). In recurrent serous BOT, cysts are usually fluid thin-walled with vegetation, corresponding in the IOTA classification to a solid unilocular cyst (LE2). A size of the cyst less than 20 mm is not a sufficient to eliminate the diagnosis of recurrent serous BOT (LE2). Recurrence of mucinous BOT predominantly appears as multilocular or as solid multilocular cysts (LE4). In the case of ovarian preservation, recurrences are most often observed on the preserved ovary(s) (LE2). Non-invasive peritoneal recurrence after initial radical treatment including bilateral hysterectomy and adnexectomy is possible, mainly in patients initially diagnosed with stage II or III BOT with non-invasive peritoneal implant (LE3). Most BOT recurrences are asymptomatic, but clinical examination may allow diagnosis of recurrence (LE2). The normality of the CA 125 dosage does not rule out the diagnosis of recurrent BOT (LE2). A second conservative treatment in the event of recurrence of BOT entails the risk of new recurrence (LE2) with no impact on survival (LE4). Totalization of the adnexectomy in case of recurrence of BOT reduces the risk of new recurrence (LE2). Conservative treatment does not increase the risk of recurrence with non-invasive peritoneal implants (LE4). Conservative treatment may be offered after a first non-invasive recurrence in young women who wish to preserve their fertility (grade C). In the absence of infiltrating tumor, chemotherapy is not indicated. The only cases for which chemotherapy can be considered are those for which there is an infiltrative component in addition to TFO.Copyright © 2020 Elsevier Masson SAS

Gawron, I., et al. (2023). "Nonsteroidal anti-inflammatory drug with a local anesthetic compared to nonsteroidal anti-inflammatory drug alone significantly reduce the pain associated with vaginoscopic office hysteroscopy." European Journal of Obstetrics and Gynecology and Reproductive Biology 288: 61-66.
	Introduction and objectives: Pain is the most common cause of office hysteroscopy (OH) failure. There is no consensus on alleviation of pain during OH. The aim was to compare the effectiveness of pain-relieving methods during OH. Study design: A prospective randomized open-label trial included women subjected to OH. All women received 100 mg of ketoprofen intravenously pre-procedure. Women were randomly assigned to 3 arms: A) no local anesthesia, B) infiltration anesthesia with 20 ml of 1% lidocaine solution, C) paracervical block with 20 ml of 1% lidocaine solution. Karl Storz Bettocchi rigid hysteroscope with a 5 mm operative sheath was used. Intensity of pain in numeric rating scale (NRS), intensity of cervical bleeding, frequency of vasovagal episodes, and failure rate were compared. Result(s): The study involved 201 women, 67 in each arm. NRS value during OH was higher in arm A than in B and C (6.3 vs. 5.1 vs. 5.0; p = 0.01). NRS value after OH did not differ and in all arms pain was imperceptible (p = 0.007). Cervical bleeding was more frequent in arm B than in A and C (76.1% vs. 33.4% vs. 35.9%; p < 0.0001), but its intensity did not differ from the other arms (p = 0.3). Vasovagal episode was most common in arm B (p = 0.048). There was no difference in the failure rate between the arms (p = 0.08). Conclusion(s): The paracervical block, albeit technically the most laborious, has proven to be the most beneficial for the patient in terms of overall comfort and for the surgeon regarding feasibility.Copyright © 2023

Gayathri, D., et al. (2021). "A systematic review to evaluate current Digital Pain Medicine tools (ELEMI Project)."
	
Gayathri, R., et al. (2021). "Safety and tolerability of solifenacin in children and adolescents with overactive bladder."
	
gbffqc, R. B. R. (2023). "Does nurse counseling reduce anxiety in women starting assisted reproductive treatments?" International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: This is a randomized controlled trial with two arms, single‐blind. After enrolment, the 100 participants will be randomly allocated into two groups using a computer program. Experimental group: 50 women with infertility will have a nurse consultation in person, lasting 40 to 60 minutes. Control group: 50 women with infertility will watch a 20 min video recorded by the same nurse with the same information provided in the consultation. The consultations and the video sessions will be carried out in the university hospital. CONDITION: F41.1 Female infertility, unspecified PRIMARY OUTCOME: We expect to find a decrease in the anxiety levels of the participants, as assessed by the State‐Trait Anxiety Inventory (STAI), with a variation of at least 6 points between pre‐ and post‐intervention tests. SECONDARY OUTCOME: No secondary outcomes will be assessed. INCLUSION CRITERIA: Infertility; IVF/ICSI

Ge, J. and X. Han (2021). "Effect of sufentanil or remifentanil combined with propofol during painless induced abortion." 中国计划生育学杂志 29(12): 2668‐2670.
	Objective: To compare the effect of sufentanil and remifentanil combined with propofol in painless induced abortion. Methods: A total of 126 patients who underwent painless induced abortion in the obstetrics department of our hospital from August 2017 to December 2018 were selected. They were divided into sufentanil combined with propofol group or remifentanil combined with propofol group by random number table method, 63 cases in each group. The anesthesia effect, vital signs before and after anesthesia, and adverse reactions were compared between the two groups. Results: The qualified rate of anesthesia effect was 61 cases (96.8%) in sufentanil combined with propofol group and 62 cases (98.4%) in remifentanil combined with propofol group, there was no difference between the two groups (P>0.05). After anesthesia, there was no difference in heart rate and blood oxygen saturation between the two groups, but the mean arterial pressure in the sufentanil plus propofol group was higher than that in the remifentanil plus propofol group (P<0.05). Postoperatively, 4 cases of dizziness, 2 cases of nausea and vomiting, 2 cases of bradycardia occurred in the sufentanil combined with propofol group, with a total adverse event rate of 12.7%; 3 cases of dizziness occurred in the remifentanil combined with propofol group, There were 5 cases of nausea and vomiting and 1 case of bradycardia. The total incidence of adverse events was 14.3%, and there was no difference between the two groups (P<0.05). Conclusion: The compound intravenous anesthesia scheme (sufentanil combined with propofol or remifentanil combined with propofol) can achieve satisfactory anesthesia effect in painless artificial abortion operation. The anesthesia effect and incidence of adverse reactions in the two groups No significant difference.

Gecgil, E. and G. Baysoy (2023). "DIET FOR THE SOUL: MEDITERENNEAN DIET IS BENEFICIAL FOR POSTPARTUM DEPRESSION." Journal of Pediatric Gastroenterology and Nutrition 76(Supplement 1): 1227.
	Objectives and Study: Breastfeeding mothers experience postpartum depression (PPD) frequently. Postpartum depression neagitvely affects well-being of infant and decreases diet quality of mother. In this study, we aimed to investigate the effect of Mediterranean diet (MD) on postpartum depression scores of depressive mothers and the growth of the baby. Method(s): Mothers of children under 1 year of age who were admitted for vaccination or well-child visit were screened for PPD with Edinburgh postpartum depression scale (EDPS). 430 mothers were screened and 100 of them had scores >=12 included in the study and randomized into 2 groups. After dropouts, 31 mothers were remained in MD and 29 mothers in the control group finished. Demographic data, EPDS, Multidimensional Scale of Perceived Social Support, physical activity record, 3 days food diary, healthy eating index-2010 and Mediterranean Diet Adherence Scale were used at 1st and 3rd months. Ethical approval was obtained from Istanbul Medipol University Ethics Committee on Non- Interventional Studies. Result(s): Smoking and family history of depression were more common in control group. Other demographic data, social support and physical activity didn't change between groups throughout the study period. In intention-to-treat analysis depression score were significantly lower in the study group in 1st month. At the 3rd month this difference was not apparent. Length-for-age was significantly higher in study group at 3rd month. In per-protocol analysis, depression scores were significantly lower, diet quality was higher in mothers with high adherence to MD group in 1st and 3rd months. Conclusion(s): Adherence to MD decreases PPD scores and increases diet quality in breastfeeding mothers. Mothers should be screened for postpartum depression in pediatrics clinics and multidisciplinary support including dietitian, psychologist/psychiatric for mothers with depression should be provided.

Geetha, K. and R. Elangovan (2022). "EFFECT OF YOGIC PRACTICES ON SELECTED RISK FACTORS AMONG ADOLESCENT GIRLS SUFFERING WITH DYSMENORRHEA." Asian Journal of Microbiology, Biotechnology and Environmental Sciences 24(2): 402-408.
	To achieve the purpose of the random group experimental study, 120 girls suffering with dysmenorrhea were identified, 90 girls among them would be screened and finally, 40 were selected randomly by using a random group sampling method between 18 and 22 years of age. The subjects might be divided into experimental group and control group of 20 subjects each. The Experimental Group was treated with Yogic practices for 12 weeks, Six days a week during the morning. The control group was on active rest. The pre-test and post-test were conducted before and after the training for the experimental and control group and the scores on Body Weight and General Mental Alertness were measured. Analysis of covariance (ANCOVA) was used to find out the significant differences among the groups. The result of the study showed that Body Weight reduced significantly and General Mental Alertness improved as a result of Yogic practices in the Experimental Group. Hence the hypothesis was accepted at a 0.05 level of confidence. The conclusion was that the Yogic practices helped to reduced Body Weight and improve General Mental Alertness among adolescent girls suffering from dysmenorrhea.Copyright © Global Science Publications.

Geldof Nadine, I., et al. (2022). "Hyperbaric oxygen treatment for late radiation-induced tissue toxicity in treated gynaecological cancer patients: a systematic review." Radiation oncology (London, England) 17(1): 164.
	Purpose: The aim of this study was to investigate the result of hyperbaric oxygen therapy (HBOT) in women with treated gynaecological malignancies who suffer from late radiation-induced tissue toxicity (LRITT). Moreover, which symptoms of LRITT benefit most from HBOT was evaluated as well.; Material and Methods: An online literature search was conducted using PubMed; Embase and the Cochrane Library. Studies were included if the study examined gynaecological cancer patients who had been treated with radiotherapy, who suffered from LRITT and who subsequently received HBOT. In addition, the outcome measures were based on examining the effects of HBOT.; Results: Twenty-one articles were included. The study investigating proctitis reported an improvement and three out of four studies investigating cystitis reported decreased complaints in women treated for gynaecological malignancies. In addition, all studies reported improvement in patients with wound complications and fifty percent of the studies reported better Patient Reported Outcome Measurements (PROMS) in women with gynaecological malignancies. Finally, all studies, except one related to pelvic malignancies reported reduced prevalence of symptoms for cystitis and proctitis and all studies reported better PROMS. However, only eleven studies reported p-values, nine of which were significant.; Conclusion: This study demonstrated that HBOT has a positive effect in women with gynaecological LRITT. Within the included patient group, gynaecological cancer patients with wound complications seem to benefit most from this treatment compared to other late side effects of LRITT. (© 2022. The Author(s).)

Gemma, L., et al. (2021). "The effectivity and safety of luteal phase support with progesterone following ovarian stimulation and intra uterine insemination: A systematic review and meta-analysis."
	
GeneMedicine, C. and Ltd (2024). GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors.
	No Results Available Drug: GM103 (Part A)|Drug: GM103 (Part B)|Drug: GM103 and Pembrolizumab (Part C) Percentage of patients with DLTs by cohorts|Percentage of patients with DLTs|Incidence of AEs, AESIs, SAEs, AEs leading to discontinuation, and AEs resulting in death|ORR|DCR defined as the proportion of patients whose BOR was CR, PR and SD|Median PFS defined as the time from the date of the first administration of study drug to the date of disease progression or death|Incidence of GM103 detection|Changes in the level of anti-adenovirus antibodies(ADA) in blood compared to baseline (ADA in genome copies/mL using qPCR) All Phase 1|Phase 2 125 Industry Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GM103-CT-101 October 30, 2028

Genentech, I. (2022). A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors.
	No Results Available Drug: RO7502175|Drug: Atezolizumab Phase Ia: Number of Participants with Dose Limiting Toxicities (DLTs)|Phase Ib: Number of Participants with DLTs|Phase Ia: Number of Participants with Treatment Emergent Adverse Events|Phase Ib: Number of Participants with Treatment Emergent Adverse Events|Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of RO7502175|Phase Ia and Phase Ib: Objective Response Rate (ORR)|Phase Ia and Phase Ib: Duration of Response (DOR)|Phase Ia and Phase Ib: Progression Free Survival (PFS)|Phase Ia and Phase Ib: Percentage of Participants With Anti-Drug Antibody (ADA) to RO7502175 All Phase 1 365 Industry Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GO43860|2021-006708-34 October 31, 2025

Geng, A. (2022). "Observation on the effect of biomimetic electrical stimulation combined with fenmotone on promoting endometrial repair after repeated artificial abortion." Medical Theory and Practice / 医学理论与实践 35(6): 1010‐1012.
	Objective: To investigate the efficacy and safety of biomimetic electrical stimulation therapy combined with sequential oral administration of fenmoxone for repeated induced abortion. Methods: A total of 120 patients who underwent repeated abortion in our hospital from January 2019 to March 2021 were randomly divided into two groups, the control group was given sequential oral administration of fenmeton, and the observation group was additionally treated with biomimetic electrical stimulation; The postoperative rehabilitation indexes and physiological related indexes at 21 days after operation were observed, and the complication rate and adverse reactions were followed up for 6 months. RESULTS: The postoperative abdominal pain duration, vaginal bleeding time, vaginal bleeding volume, menstrual rehydration time and other rehabilitation indicators in the observation group were significantly lower than those in the control group (P<0.05). CONCLUSION: Biomimetic electrical stimulation therapy combined with sequential oral administration of fenmoxone can promote endometrial repair in repeated abortion recipients, speed up the postoperative recovery process, and reduce intrauterine adhesions.

Geng, X., et al. (2022). "Effect of overall nursing combined with acupressure in preventing postpartum urinary retention." American journal of translational research 14(2): 1347-1353.
	OBJECTIVES: This study investigated the effects of overall nursing care combined with acupressure in preventing postpartum urinary retention. METHODS: A total of 200 parturients with vaginal delivery in our hospital from March to October 2019 were enrolled and randomized to a control group and an observation group with 100 cases each. The control group received conventional nursing, while the observation group was also given "overall" nursing combined with acupressure. The two groups were compared in the incidence of urinary retention, time to the first urination, first urine volume, residual urine volume, pelvic floor muscle fiber contraction time, satisfaction, and treatment efficiency. RESULTS: The two groups presented no significant difference in general information (P>0.05). Compared to the control group, the observation group showed a lower incidence of urinary retention and experienced an earlier time to first urination (both P<0.001). A significantly smaller residual urine volume was observed in the observation group as compared to controls at 4 h and 12 h after delivery (P<0.05). The observation group outperformed the control group in terms of pelvic floor muscle fiber contraction duration (P<0.001). Moreover, the observation group showed a treatment efficiency and nursing satisfaction superior to the control group (P<0.05). CONCLUSIONS: Overall nursing care combined with acupressure can exert strong positive effects on the incidence of postpartum urinary retention, time to the first urination, and residual urine volume in parturients with vaginal delivery and improve their satisfaction.

Geng, Z. Y., et al. (2023). "Addition of preoperative transversus abdominis plane block to multimodal analgesia in open gynecological surgery: a randomized controlled trial." BMC anesthesiology 23(1): 21.
	BACKGROUND: Transversus abdominis plane (TAP) block can provide effective analgesia for abdominal surgery. However, it was questionable whether TAP had additional effect in the context of multimodal analgesia (MMA). Therefore, this study aimed to assess the additional analgesic effect of preoperative TAP block when added to MMA protocol in open gynecological surgery. METHODS: In this prospective, randomized‐controlled trial, 64 patients scheduled for open gynecological surgery were randomized to receive preoperative TAP block (Study group, n = 32) or placebo (Control group, n = 32) in addition to MMA protocol comprising dexamethasone, acetaminophen, flurbiprofen and celecoxib, and rescued morphine analgesia. The primary outcome was rescued morphine within 24 h after surgery. Secondary outcomes included pain scores, adverse effects, quality of recovery measured by 40‐item quality of recovery questionnaire score (QoR‐40) at 24 h, and quality of life measured with short‐form health survey (SF ‐ 36) on postoperative day (POD) 30. RESULTS: The Study group had less rescued morphine than the control group within 24 h [5 (2‐9) vs. 8.5 (5‐12.8) mg, P = 0.013]. The Study group had lower pain scores at 1 h [3 (2‐4) vs. 4 (3‐5), P = 0.007], 2 h [3 (2‐4) vs. 3.5 (3‐5), P = 0.010] and 6 h [3 (2‐3) vs. 3 (2.3‐4), P = 0.028], lower incidence of nausea at 48 h (25.8% vs. 50%, P = 0.039), and higher satisfaction score [10 (10‐10) vs. 10 (8‐10), P = 0.041]. The SF‐36 bodily pain score on POD 30 was higher in the Study group (59 ± 13 vs. 49 ± 16, P = 0.023). CONCLUSIONS: Preoperative TAP block had additional analgesic effect for open gynecological surgery when used as part of multimodal analgesia. Rescued morphine within 24 h was significantly reduced and the SF‐36 bodily pain dimension at 30 days after surgery was significantly improved. TRIAL REGISTRATION: www.chictr.org.cn (ChiCTR2000040343, on Nov 28 2020).

Genmab and S. E. BioNTech (2024). GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer.
	No Results Available Biological: Pembrolizumab|Biological: Acasunlimab Objective Response Rate (ORR)|Duration of Response (DOR)|Time to Response (TTR)|Disease Control Rate (DCR)|Number of Participants with Treatment Emergent Adverse Events (TEAEs) and as Per Severity Female Phase 2 80 Industry Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GCT1046-05|2022-502453-33-00 June 1, 2028

Genovese, F., et al. (2023). "Impact of Hysterotomy Closure Technique on Subsequent Cesarean Scar Defects Formation: A Systematic Review [see note]." Gynecologic and Obstetric Investigation 88(2): 81-90.
	Introduction: The uterine caesarean scar defect, also known as uterine niche or isthmocele, is an irregularity in the anterior uterine wall at the site of a previous cesarean section scar. It is associated with obstetrical complications such as caesarean scar, ectopic pregnancy, uterine rupture, and the placenta accreta spectrum. Women with cesarean scar defects are frequently asymptomatic but may also experience abnormal vaginal bleeding, chronic pelvic pain, and infertility.; Methods: This systematic review aims to determine the best hysterotomy closure technique to prevent subsequent development of uterine scar defects. An electronic search in Medline, Embase, Cochrane Database of Systematic Reviews, ClinicalTrials.gov was performed from January 2001 until December 2020 for studies evaluating hysterotomy closure techniques.; Results: Our systematic search strategy identified 1,781 titles. Six studies fulfilled inclusion criteria and were included in the final analysis. The results supported the superiority of the double-layer closure over the single-layer closure.; Conclusions: Hysterotomy closure with continuous running sutures in two layers represents a suitable option to prevent cesarean scar defect formation. Particularly, the first layer should include the decidua and the second layer should overlap the first. (© 2023 S. Karger AG, Basel.)

Genovese, F., et al. (2023). "Techniques and endocrine-reproductive outcomes of ovarian transposition prior to pelvic radiotherapy in both gynecologic and non-gynecologic cancers: A systematic review and meta-analysis." International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics.
	Background: Premature ovarian failure may be a consequence of radiotherapy administered for the treatment of various female oncologic diseases. Before radiotherapy, fertility may be preserved through ovarian transposition (OT), which consists of moving the ovaries away from the radiation field.; Objective: To ascertain all types of surgical techniques employed for OT, outline the endocrine and reproductive outcomes of each one, and discover if one works better than the others.; Search Strategy: The authors performed a systematic search of the English literature looking for all studies related to OT before radiotherapy published up to June 2023. Nine studies were included.; Selection Criteria: The eligible studies were assessed based on the presence of a description of the surgical technique employed for OT before pelvic radiotherapy and a report of the endocrine and reproductive outcomes.; Data Collection and Analysis: Odds ratios (OR) with 95% confidence intervals were used to compare endocrine and reproductive outcomes The χ 2 test was employed for the statistical analysis and a P value less than 0.05 was considered significant.; Main Results: A total of 323 female patients aged between 7 and 51 years-198 (61.3%) with non-gynecologic cancer and 125 (38.7%) with gynecologic cancer-underwent OT, either bilateral (221, 68.4%) or unilateral (102, 31.6%), before radiotherapy. Essentially, two types of OT were employed: lateral and medial. A total of 71 (22%) patients underwent medial OT and 252 (78%) patients (127 with non-gynecologic tumors and 125 with gynecologic tumors) had a lateral OT. The latter was used in a similar percentage of cases for gynecologic (50.4%) and non-gynecologic (49.6%) tumors, whereas the medial approach was performed only for non-gynecologic cancers (Hodgkin's lymphoma). The difference between medial OT and lateral OT was not significant regarding the preservation of endocrine function (OR 0.65, P = 0.120). However, midline OT worked better in terms of reproductive outcomes. In fact, the percentage of patients with pregnancy (49.2%) and live births (45%) associated with medial OT was significantly higher than that associated with lateral OT, 6.5% and 13.4%, respectively, and the difference between such data was statistically significant (OR 7.04, P = 0.001 and OR 5.29, P = 0.003, respectively).; Conclusions: Ovarian transposition is an important method to preserve fertility before radiotherapy, considering the worldwide ongoing use of this treatment for various cancers arising in young women. The surgical method depends on the type of disease, but OT-especially medial OT when feasible-is effective in terms of ovarian function preservation and reproductive outcomes. (© 2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Geoffrion, R. and M. Larouche (2021). "Directive clinique no 413: Traitement chirurgical du prolapsus genital apical chez les femmes." Journal of Obstetrics and Gynaecology Canada 43(4): 524-538.e521.
	Objectif: Comparer les taux de reussite et de complications des interventions de suspension apicale pour le traitement du prolapsus symptomatique de l'uterus ou du dome vaginal. Population cible: Les femmes presentant un prolapsus symptomatique de l'uterus ou du dome vaginal qui souhaitent obtenir un traitement chirurgical. Options: Les interventions abordees sont les methodes reconstructives apicales par voie abdominale (colposacropexie, hysterosacropexie ou hysteropexie avec suspension aux ligaments utero-sacres) par chirurgie ouverte, laparoscopique ou robotisee; les methodes reconstructives apicales par voie vaginale (suspension du dome vaginal ou hysteropexie, sacrospinofixation, suspension aux ligaments utero-sacres, suspension au muscle ilio-coccygien, culdoplastie de McCall ou amputation du col [technique de Manchester]); et les interventions vaginales obliterantes (avec ou sans uterus in situ). Les interventions individuelles ou les grandes categories d'interventions ont ete comparees: (1) reconstruction par voie vaginale versus abdominale, (2) interventions reconstructives par voie abdominale, (3) interventions reconstructives par voie vaginale, (4) reconstruction par hysterectomie avec suspension par comparaison a la reconstruction par hysteropexie et (5) options reconstructives versus obliterantes. Resultats: Le comite d'urogynecologie a selectionne les resultats cliniques suivants: echec objectif (obtenu par des systemes valides de quantification du prolapsus genital et defini comme un echec global objectif et un taux d'echec par compartiment); echec subjectif (reapparition de la sensation de protuberance determinee subjectivement, avec ou sans l'utilisation d'un questionnaire valide); reoperation pour un prolapsus genital recidive; complications postoperatoires de troubles mictionnels (incontinence urinaire d'effort de novo ou postoperatoire; reoperation d'une incontinence urinaire d'effort de novo, persistante ou recidivee; incontinence urinaire par urgenturie; et dysfonction mictionnelle); lesion des voies urinaires detectee en perioperatoire (vessie ou uretere); autres complications (exposition prothetique, definie comme un treillis visible et expose dans le vagin et une douleur pelvienne non sexuelle); et fonction sexuelle (dyspareunie de novo et score de la fonction sexuelle d'apres un questionnaire valide). Benefices, risques et couts: Cette directive clinique sera benefique pour les patientes qui souhaitent obtenir une correction chirurgicale du prolapsus genital apical en ameliorant les conseils sur les options de traitement chirurgical et les resultats cliniques possibles. La directive sera egalement utile pour les fournisseurs de soins chirurgicaux en ameliorant leurs connaissances sur diverses methodes chirurgicales. Les donnees presentees pourraient servir a elaborer des cadres et des outils pour la prise de decision partagee. Donnees probantes: Nous avons effectue des recherches dans les bases de donnees Medline, Cochrane Central Register of Controlled Trials (CENTRAL) et Embase pour des articles publies entre 2002 et 2019. Les termes de recherche etaient nombreux et portaient sur les interventions de correction du prolapsus genital apical, les voies d'abord et les complications. Nous avons exclu les reconstructions par treillis transvaginal et les etudes comparant les interventions sans suspension apicale. Nous avons inclus des essais cliniques randomises et des etudes comparatives prospectives ou retrospectives. Nous avons limite nos recherches aux articles publies en anglais ou en francais dont le texte integral etait accessible. Une revue systematique des articles avec meta-analyse a ensuite ete effectuee. Methodes de validation: Les auteures ont evalue la qualite des donnees probantes et la force des recommandations en utilisant lecadre methodologique d'evaluation, de developpement et d'evaluation (GRADE). Voir l'annexe A en ligne (tableau A1 pour les definitions et tableau A2 pour l'interpretation des recommandations fortes et faibles). Professionnels cibles: Gynecologues, urologues urogynecologues et autres fournisseurs de soins de sante qui evaluent, conseillent et soignent des femmes ayant un prolapsus genital. DECLARATIONS SOMMAIRES: Toutes les declarations font reference a la correction du prolapsus genital apical a court et a moyen terme (jusqu'a 5 ans), sauf indication contraire. 1 La suspension vaginale par suture a divers ligaments pelviens etait inferieure a la colposacropexie par voie abdominale (toutes voies d'abord confondues) avec treillis synthetique pour ce qui est des resultats cliniques suivants: * echec global objectif (moyenne); * echec apical objectif (moyenne). 2 La suspension vaginale par suture a divers ligaments pelviens etait comparable a la colposacropexie par voie abdominale (toutes voies d'abord confondues) avec treillis synthetique pour ce qui est des resultats cliniques suivants: * echec anterieur objectif (moyenne); * echec posterieur objectif (moyenne); * sensation subjective d'un prolapsus genital recidive (moyenne); * reoperation pour un prolapsus genital recidive (moyenne); * lesions vesicales et ureterales peroperatoires (faible); * troubles mictionnels postoperatoires (faible). 3 La suspension vaginale par suture a divers ligaments pelviens n'etait pas associee au risque d'exposition du treillis comparativement a la colposacropexie abdominale (toutes voies d'abord confondues) avec treillis synthetique, qui est associee a un risque d'exposition du treillis de 2,7 % a 3,4 % (moyenne). 4 La colposacropexie par voie abdominale ouverte etait inferieure a la colposacropexie minimalement invasive (laparoscopique ou robotisee) pour ce qui est des resultats cliniques suivants: * echec global objectif (faible); * echec posterieur objectif (faible). 5 La colposacropexie par voie abdominale ouverte etait comparable a la colposacropexie minimalement invasive (laparoscopique ou robotisee) pour ce qui est des resultats cliniques suivants: * echec objectif anterieur (faible); * sensation subjective d'un prolapsus genital recidive (moyenne); * reoperation pour un prolapsus genital recidive (moyenne); * lesions vesicales peroperatoires (moyenne); * reoperation pour incontinence urinaire d'effort (faible); * exposition du treillis (moyenne). 6 Les diverses voies d'abord minimalement invasives de la colposacropexie (laparoscopique ou robotisee) se sont revelees comparables pour ce qui est des risques suivants: * sensation subjective d'un prolapsus genital recidive (tres faible); * lesions vesicales peroperatoires (moyenne); * incontinence urinaire d'effort postoperatoire (tres faible); * exposition du treillis (moyenne). 7 Il n'y a pas suffisamment de donnees comparant l'incontinence urinaire par urgenturie et le risque de dysfonction mictionnelle apres une colposacropexie par voie abdominale ouverte et minimalement invasive ni entre les differentes methodes de colposacropexie minimalement invasive (tres faible). 8 La suspension aux ligaments utero-sacres et la sacrospinofixation se sont revelees comparables pour ce qui est des risques suivants: * taux d'echec objectif (global et par compartiment) (moyenne); * sensation subjective d'un prolapsus genital recidive (moyenne); * reoperation pour un prolapsus genital recidive (moyenne); * lesions vesicales peroperatoires (moyenne); * reoperation pour incontinence urinaire d'effort (faible). 9 La suspension aux ligaments utero-sacres s'est revelee avoir un risque plus eleve comparativement a la sacrospinofixation pour ce qui est du risque suivant: * lesions ureterales peroperatoires (moyenne). 10 L'hysterectomie avec suspension etait comparable a l'hysteropexie (toutes voies d'abord confondues) pour ce qui est des resultats cliniques suivants: * echec global objectif (faible); * echec anterieur objectif (faible); * echec apical objectif (faible); * sensation subjective d'un prolapsus genital recidive (faible); * reoperation pour un prolapsus genital recidive (faible); * troubles mictionnels (faible); * lesions vesicales et ureterales peroperatoires (faible). 11 L'hysterectomie avec suspension s'est revelee inferieure a l'hysteropexie (t tes voies d'abord confondues) pour ce qui est du resultat clinique suivant: * echec posterieur objectif (faible). 12 L'hysterectomie avec colposacropexie s'est revelee avoir un risque superieur comparativement a l'hysterosacropexie (par voie abdominale, laparoscopique ou robotisee) pour ce qui est du risque suivant: * exposition du treillis (faible). 13 L'hysterectomie vaginale avec suspension et l'hysteropexie par voie vaginale se sont montrees comparables pour ce qui est des risques suivants: * echec objectif (global et par compartiment) (faible); * reoperation pour un prolapsus genital recidive (tres faible); * lesions ureterales peroperatoires (tres faible). 14 A court terme (1 an), la correction du prolapsus apical de stade avance (stade 3 ou 4) au moyen de la suspension vaginale par suture a divers ligaments pelviens est comparable au colpocleisis pour ce qui est des resultats cliniques d'echec global objectif, de lesions peroperatoires des voies urinaires et d'amelioration specifique de la qualite de vie (tres faible). 15 La suspension aux ligaments utero-sacres s'est revelee avoir un risque plus faible comparativement a la sacrospinofixation pour ce qui est du risque suivant: * douleur aux fesses transitoire ou a court terme (faible). 16 Les donnees actuelles ne sont pas concluantes pour ce qui est des resultats cliniques relatifs a la douleur pelvienne persistante ou a la fonction sexuelle postoperatoire, notamment la dyspareunie de novo, lorsque l'on compare la suspension apicale par voie vaginale par rapport a la voie abdominale, la suspension apicale minimalement invasive a la voie ouverte, les differentes methodes de suspension apicale du dome vaginal entre elles et l'hysterectomie avec suspension par rapport a l'hysteropexie (tres faible). RECOMMANDATIONS: 1 Il y a lieu d'informer les femmes souhaitant obtenir une correction chirurgicale pour un prolapsus apical que la suspension vaginale par suture, par comparaison a la colposacropexie par voie abdominale (toutes voies d'abord confondues), presente un risque accru d'echec objectif, mais un taux comparable pour ce qui est (1) de l'echec subjectif, (2) de la reoperation pour un prolapsus genital recidive et (3) des complications. Il importe donc de prendre ces risques en compte au regard du risque permanent d'exposition du treillis apres une colposacropexie, complication qui peut exiger une reoperation (conditionnelle, moyenne). 2 Il est recommande pour les chirurgiens dument formes de privilegier la colposacropexie minimalement invasive par voie laparoscopique ou robotisee (si l'equipement chirurgical est disponible), plutot que la colposacropexie par chirurgie ouverte, etant donne l'amelioration objective globale des resultats cliniques et l'equivalence des resultats cliniques subjectifs a court et a moyen terme (conditionnelle, faible). 3 Il est possible d'offrir la suspension vaginale aux ligaments utero-sacres et la sacrospinofixation aux femmes ayant un prolapsus genital apical en fonction des preferences du chirurgien et de la patiente. Les deux methodes semblent avoir des resultats cliniques objectifs et subjectifs comparables jusqu'a 5 ans post-intervention, a l'exception d'une augmentation du risque de lesion ureterale peroperatoire dans le cas de la suspension aux ligaments utero-sacres et du risque de douleur aux fesses transitoire ou a court terme apres une sacrospinofixation (forte, moderee). 4 Il est possible d'offrir differentes voies d'abord et techniques d'hysteropexie comme solution de rechange a l'hysterectomie et a la suspension pour les femmes atteintes d'un prolapsus genital apical qui souhaitent preserver leur uterus; ces techniques et voies d'abord sont associees a des resultats cliniques objectifs et subjectifs comparables pour les 5 premieres annees post-intervention (conditionnelle, faible). 5 En depit du manque de donnees probantes comparatives, il y a lieu d'aborder le colpocleisis comme option therapeutique avec les femmes qui ne souhaitent plus etre sexuellement actives; il semble s'agir d'une intervention reussie pour laquel on signale peu de complications (fortes, faibles). 6 Il y a lieu d'informer les femmes qui se soumettent au traitement chirurgical du prolapsus apical symptomatique qu'il existe peu de donnees comparatives sur la douleur pelvienne et la fonction sexuelle postoperatoires pour diverses interventions. Dans l'ensemble, le risque de douleur pelvienne postoperatoire semble faible, et la fonction sexuelle semble s'ameliorer chez les femmes sexuellement actives qui se soumettent au traitement chirurgical reconstructif du prolapsus genital apical (conditionnelle, tres faible).Copyright © 2021

Geoffrion, R. and M. Larouche (2021). "Guideline No. 413: Surgical Management of Apical Pelvic Organ Prolapse in Women." Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC 43(4): 511.
	Objective: To compare success and complication rates of apical suspension procedures for the surgical management of symptomatic uterine or vaginal vault prolapse.; Target Population: Women with symptomatic uterine or vaginal vault prolapse seeking surgical correction.; Options: Interventions included abdominal apical reconstructive repairs (sacrocolpopexy, sacrohysteropexy, or uterosacral hysteropexy) via open, laparoscopic, or robotic approaches; vaginal apical reconstructive repairs (vault suspensions or hysteropexy, sacrospinous, uterosacral, iliococcygeus, McCall's, or Manchester types); and vaginal obliterative procedures (with or without uterus in situ). Individual procedures or broad categories of procedures were compared: (1) vaginal versus abdominal routes for reconstruction, (2) abdominal procedures for reconstruction, (3) vaginal procedures for reconstruction, (4) hysterectomy and suspension versus hysteropexy for reconstruction, and (5) reconstructive versus obliterative options.; Outcomes: The Urogynaecology Committee selected outcomes of interest: objective failure (obtained via validated pelvic organ prolapse [POP] quantification systems and defined as overall objective failure as well as failure rate by compartment); subjective failure (recurrence of bulge symptoms determined subjectively, with or without use of a validated questionnaire); reoperation for POP recurrence; complications of postoperative lower urinary tract symptoms (de novo or postoperative stress urinary incontinence; reoperation for persistent, recurrent, or de novo stress urinary incontinence; urge urinary incontinence; and voiding dysfunction); perioperatively recognized urinary tract injury (bladder or ureter); other complications (mesh exposure, defined as mesh being visible and exposed in the vagina, and non-sexual pelvic pain); and sexual function (de novo dyspareunia and sexual function score according to a validated questionnaire).; Benefits, Harms, and Costs: This guideline will benefit patients seeking surgical correction of apical POP by improving counselling on surgical treatment options and possible outcomes. It will also benefit surgical providers by improving their knowledge of various surgical approaches. Data presented could be used to develop frameworks and tools for shared decision-making.; Evidence: We searched Medline, the Cochrane Central Register of Controlled Trials (CENTRAL), and Embase from 2002 to 2019. The search included multiple terms for apical POP surgical procedures, approaches, and complications. We excluded POP repairs using transvaginal mesh and studies that compared procedures without apical suspension. We included randomized controlled trials and prospective or retrospective comparative studies. We limited language of publication to English and French and accessibility to full text. A systematic review and meta-analysis was performed.; Validation Methods: The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and weak recommendations).; Intended Users: Gynaecologists, urologists, urogynaecologists, and other health care providers who assess, counsel, and care for women with POP.; Summary Statements: All statements refer to correction of apical vaginal prolapse in the short and medium term (up to 5 years), except when otherwise specified. (Copyright © 2021. Published by Elsevier Inc.)

Gerbasi, M. E., et al. (2021). "Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making." Journal of women's health (2002) 30(3): 385-392.
	Background: Brexanolone (BRX) injection was approved by the United States Food and Drug Administration in 2019 for the treatment of adults with postpartum depression (PPD) based on two Phase 3 clinical trials. Materials and Methods: Data from the three trials were combined. PPD-specific 17-item Hamilton Rating Scale for Depression (HAMD-17) group-level minimal important difference (MID) and patient-level meaningful change (meaningful change threshold [MCT]) were estimated and applied to differences in BRX versus placebo (PBO) at hour 60 (primary endpoint) and day 30 (end of trial follow-up). Likelihood of HAMD-17 response and remission and Clinical Global Impression of Improvement (CGI-I) response for BRX versus PBO were assessed at hour 60 and as sustained through day 30 using relative risk. Associated number needed to treat (NNT) and number needed to harm (NNH) values were also estimated. Results: Two-hundred nine patients were included. The average HAMD-17 MID estimate was -2.1; the least-squared mean difference between BRX and PBO exceeded this at hour 60 and day 30. Minimal, moderate, and large MCTs were estimated to be -9, -15, and -20 points, respectively. Significantly more BRX-treated than PBO-treated patients achieved minimal, moderate, and large change (all ps < 0.05) at hour 60 and large meaningful response at day 30 (p < 0.05). BRX-treated patients were more likely to sustain HAMD-17 remission and CGI-I response through day 30 versus PBO. NNTs ranged from 4 to 8, with NNH of 97. Conclusions: BRX provided meaningful changes relative to PBO, rapid (hour 60), and sustained improvements (day 30) in PPD symptoms, low NNT, and large NNH. These results may help inform treatment decision-making. Clinicaltrials.gov registration numbers: NCT02614547, NCT02942004, and NCT02942017.

Gerber, E., et al. (2022). "Predicting chemoresponsiveness in epithelial ovarian cancer patients using circulating small extracellular vesicle-derived plasma gelsolin." MedRxiv.
	Background: Resistance to chemotherapy continues to be a challenge when treating epithelial ovarian cancer (EOC), contributing to low patient survival rates. While CA125, the conventional EOC biomarker, has been useful in monitoring patients' response to therapy, there are no biomarkers used to predict treatment response prior to chemotherapy. Previous work in vitro showed that plasma gelsolin (pGSN) is highly expressed in chemoresistant EOC cell lines, where it is secreted in small extracellular vesicles (sEVs). Whether sEVs from tumour cells are secreted into the circulation of EOC patients and could be used to predict patient chemoresponsiveness is yet to be determined. This study aims to determine if sEV-pGSN in the circulation could be a predictive biomarker for chemoresistance in EOC. Method(s): Sandwich ELISA was used to measure pGSN concentrations from plasma samples of 96 EOC patients (primarily high grade serous EOC). sEVs were isolated using ExoQuick ULTRA and characterized using western blot, nanoparticle tracking analysis, and electron microscopy after which pGSN was measured from the sEVs. Patients were stratified as platinum sensitive or resistant groups based on first progression free interval (PFI) of 6 or 12 months. Result(s): Total circulating pGSN was significantly decreased and sEV-pGSN increased in patients with a PFI <= 12 months (chemoresistant) compared to those with a PFI > 12 months (chemosensitive). The ratio of total pGSN to sEV-pGSN further differentiated these groups and was a strong predictive marker for chemoresistance (sensitivity: 73.91%, specificity: 72.46%). Predetermined CA125 was not different between chemosensitive and chemoresistant groups and was not predictive of chemoresponsiveness prior to treatment. When CA125 was combined with the ratio of total pGSN/sEV-pGSN, it was a significant predictor of chemoresponsiveness, but the test performance was not as robust as the total pGSN/sEV-pGSN alone. Conclusion(s): Total pGSN/sEV-pGSN was the best predictor of chemoresponsiveness prior to treatment, outperforming the individual biomarkers (CA125, total pGSN, and sEV-pGSN). This multianalyte predictor of chemoresponsiveness could help to inform physicians' treatment and follow up plan at the time of EOC diagnosis, thus improving patients' outcomes.Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license.

Gerkowicz, A., et al. (2021). "Photodynamic Therapy in the Treatment of Vulvar Lichen Sclerosus: A Systematic Review of the Literature." Journal of Clinical Medicine 10(23).
	Vulvar lichen sclerosus (VLS) is a chronic inflammatory disease involving the genital skin and mucous membrane. Patients exhibit focal atrophy and destructive scarring, with an increased risk of malignant transformation. Due to objective symptoms as well as subjective complaints, patients with VLS experience emotional distress, lowered mood, and sexual dysfunction, which is reflected in impaired health-related quality of life. Thus, the necessity of implementing appropriate therapy at the earliest possible stage of the disease in order to avoid serious complications is highlighted. We presented the systematic review of available literature, performed with MEDLINE, Cinahl, Central, Scopus, and Web of Science databases. We identified a total of twenty relevant studies which indicate that photodynamic therapy (PDT) is a valuable therapeutic modality in the treatment of VLS.

Gerontakos, S., et al. (2023). "Feasibility and efficacy of implementing group visits for women's health conditions: a systematic review." BMC Health Services Research 23(1): 549.
	Background: Shared medical appointments, also known as group visits, are a feasible and well-accepted approach for women receiving antenatal care, yet the feasibility and efficacy of this approach for female-specific reproductive conditions is uncertain.; Objective: The aim of this systematic review was to (a) determine the feasibility of group visits in adults with any female-specific reproductive condition, and (b) identify whether delivering group care for these conditions impacts clinical outcomes.; Method: Six databases and two clinical trials registries were searched from inception through to 26 January 2022 for original research examining group medical visits or group consultation interventions for adults with female reproductive conditions or pathologic conditions specific to the female reproductive system.; Results: The search yielded 2584 studies, of which four met the inclusion criteria. Included studies sampled women with breast cancer, chronic pelvic pain, polycystic ovary syndrome and gynaecological cancers. Studies reported high levels of patient satisfaction, with participants indicating their expectations had been met or exceeded. The impact of group visits on clinical outcomes was inconclusive however.; Discussion/conclusions: The studies in this review indicate delivery of female-specific healthcare via a group model maybe feasible and well-accepted. The review provides a solid basis for proposing larger and longer studies on group visits for female reproductive conditions.; Trial Registration: The review protocol was registered with PROSPERO (CRD42020196995). (© 2023. The Author(s).)

Gerosa, D., et al. (2022). "Application of Honey to Reduce Perineal Laceration Pain during the Postpartum Period: A Randomized Controlled Trial." Healthcare (Basel, Switzerland) 10(8).
	Perineal lacerations affect between 35 and 85% of women during childbirth and may be responsible for postpartum pain. Honey has been demonstrated to have interesting properties that can promote wound healing. The aim was to evaluate the effectiveness of the application of honey to the perineum to reduce perineal pain during the early postpartum period. A randomized controlled trial including 68 women was conducted. In the intervention group, honey was applied to perineal lacerations for four days, in addition to standard care. The control group received only standard care. The primary outcome was pain intensity using the Visual Analog Scale and pain perception using the McGill Pain Questionnaire (QDSA). The secondary outcomes were a burning sensation, the use of a pain killer, and the women's satisfaction with the honey application. The intensity of pain was not significantly different between the groups on Day 1 (VAS 3.38 in the control group versus 3.34 in the intervention group, p = 0.65) or on Day 4 (VAS 2.28 versus 1.41, respectively, p = 0.09). There was no significant difference regarding the perception of pain with the QDSA. Despite this, most of the women in the intervention group (93%) were satisfied or very satisfied with the use of honey on their perineum.

Gershenson David, M., et al. (2022). "Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial." Lancet (London, England) 399(10324): 541-553.
	Background: Low-grade serous carcinoma of the ovary or peritoneum is characterised by MAPK pathway aberrations and its reduced sensitivity to chemotherapy relative to high-grade serous carcinoma. We compared the MEK inhibitor trametinib to physician's choice standard of care in patients with recurrent low-grade serous carcinoma.; Methods: This international, randomised, open-label, multicentre, phase 2/3 trial was done at 84 hospitals in the USA and UK. Eligible patients were aged 18 years or older with recurrent low-grade serous carcinoma and measurable disease, as defined by Response Evaluation Criteria In Solid Tumors version 1.1, had received at least one platinum-based regimen, but not all five standard-of-care drugs, and had received an unlimited number of previous regimens. Patients with serous borderline tumours or tumours containing low-grade serous and high-grade serous carcinoma were excluded. Eligible patients were randomly assigned (1:1) to receive either oral trametinib 2 mg once daily (trametinib group) or one of five standard-of-care treatment options (standard-of-care group): intravenous paclitaxel 80 mg/m 2 by body surface area on days 1, 8, and 15 of every 28-day cycle; intravenous pegylated liposomal doxorubicin 40-50 mg/m 2 by body surface area once every 4 weeks; intravenous topotecan 4 mg/m 2 by body surface area on days 1, 8, and 15 of every 28-day cycle; oral letrozole 2·5 mg once daily; or oral tamoxifen 20 mg twice daily. Randomisation was stratified by geographical region (USA or UK), number of previous regimens (1, 2, or ≥3), performance status (0 or 1), and planned standard-of-care regimen. The primary endpoint was investigator-assessed progression-free survival while receiving randomised therapy, as assessed by imaging at baseline, once every 8 weeks for 15 months, and then once every 3 months thereafter, in the intention-to-treat population. Safety was assessed in patients who received at least one dose of study therapy. This trial is registered with ClinicalTrials.gov, NCT02101788, and is active but not recruiting.; Findings: Between Feb 27, 2014, and April 10, 2018, 260 patients were enrolled and randomly assigned to the trametinib group (n=130) or the standard-of-care group (n=130). At the primary analysis, there were 217 progression-free survival events (101 [78%] in the trametinib group and 116 [89%] in the standard-of-care group). Median progression-free survival in the trametinib group was 13·0 months (95% CI 9·9-15·0) compared with 7·2 months (5·6-9·9) in the standard-of-care group (hazard ratio 0·48 [95% CI 0·36-0·64]; p<0·0001). The most frequent grade 3 or 4 adverse events in the trametinib group were skin rash (17 [13%] of 128), anaemia (16 [13%]), hypertension (15 [12%]), diarrhoea (13 [10%]), nausea (12 [9%]), and fatigue (ten [8%]). The most frequent grade 3 or 4 adverse events in the standard-of-care group were abdominal pain (22 [17%]), nausea (14 [11%]), anaemia (12 [10%]), and vomiting (ten [8%]). There were no treatment-related deaths.; Interpretation: Trametinib represents a new standard-of-care option for patients with recurrent low-grade serous carcinoma.; Funding: NRG Oncology, Cancer Research UK, Target Ovarian Cancer, and Novartis.; Competing Interests: Declaration of interests DMG reports payments made to his institution from the National Cancer Institute (NRG Oncology), Novartis, and the GOG Foundation for this study; royalties or licenses from Elsevier and UpToDate outside the submitted work; consulting fees from Genentech outside the submitted work; personal fees for service as a member of the Committee of the National Cancer Institute outside the submitted work; and stock or stock options from Johnson & Johnson, Bristol Myers Squibb, and Biogen outside the submitted work. AM reports service as a masked study statistician for VBL Therapeutics; provision of statistical institutional support for Advaxis; service as a data safety monitoring board reporting statistician for Regeneron; and service on a study steering committee for Genentech and A traZeneca, all outside the submitted work. RLC reports consulting fees from AstraZeneca, Merck–GlaxoSmithKline, and Clovis; grants from Genmab, Genentech–Roche, Janssen, Agenus, Regeneron, and OncoQuest; payments or honoraria for lectures, presentations, speaker's bureaus, manuscript writing, or educational events from AstraZeneca, Merck–GlaxoSmithKline, and Clovis; and service on a data safety monitoring board or an advisory board for Janssen, VBL Therapeutics, and AstraZeneca, all outside the submitted work. KNM reports service on advisory boards for Alkemeres, AstraZeneca, Aravive, Blueprint Medicines, Eisai, Elevar, GlaxoSmithKline–Tesaro, Genentech–Roche, Hengrui, Immunogen, IMab, Merck, Mereo, Mersana, Myriad, OncXerna, Onconova, Novartis, Sorrento, Tarveda, and VBL Therapeutics, all outside the submitted work; grant funding from PTC Therapeutics, Lilly, Merck, and Genentech–Roche outside the submitted work; funding paid to her institution from Cyteir, Immunocore, Bolt Bio, Amgen, Artios, GlaxoSmithKline–Tesaro, Mereo, Regeneron, Aravive, Verastem, and AstraZeneca, for all of which she also serves as a local principal investigator; serving as national principal investigator for the IMaGYN050 trial of ovarian cancer (Genentech–Roche), the MIRASOL trial of ovarian cancer (Immunogen), the Relevare study of ovarian cancer (OncXerna), the FIRST study of ovarian cancer (GlaxoSmithKline–Tesaro), and the ETCTN 10422 study of ovarian cancer (National Cancer Institute); being the associate director for GOG Partners, on the GOG Foundation board of directors, and the NRG Oncology chair of the ovarian cancer committee; and receiving speaking reimbursement from PER, Research to Practice, Medscape, Great Debates and Updates, and Gyn Mal, all of which are outside the scope of this work but were active during the conduct of this study. SB reports grants paid to their institution from AstraZeneca, Tesaro, and GlaxoSmithKline; personal fees for participation in advisory boards from Amgen, AstraZeneca, Genmab, GlaxoSmithKline, Immunogen, Merck Sharp & Dohme, Merck Serono, Mersana, Oncxerna, Seagen, Shattuck Lab, and Epsilogen; and personal fees for lectures from Amgen, AstraZeneca, Clovis, GlaxoSmithKline, Immunogen, Merck Sharp & Dohme, Mersana, Pfizer, Roche, and Takeda, all outside the submitted work. AAS reports a National Cancer Trial Network grant; grants paid to her institution from AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Clovis, Eisai, Immutep, Merck, OncoQuest, PharmaMar, Genentech–Roche, Seagen, Tesaro–GlaxoSmithKline, and VBL Therapeutics; consulting fees from Aravive, AstraZeneca, Clovis, Cordgenics, Eisai, Merck, Mersana, Myriad, Oncoquest, Genentech–Roche, and Tesaro–GlaxoSmithKline; presentations for educational events on cervical cancer sponsored by Research to Practice; service on advisory boards (uncompensated) for AbbVie and Regeneron; service on clinical trial steering committees (all uncompensated) for the AtTEnd trial (Hoffman-LaRoche), the Oval Trial (VBL Therapeutics), and the FLORA-5 trial (Oncoquest); and service on the GOG Foundation Board of Directors, the Society of Gynecologic Oncology Board of Directors, and the American Association of Obstetricians and Gynecologists Foundation Board of Trustees, all outside the submitted work. DMO reports National Cancer Institute support for this clinical trial; research funding paid to their institution from AstraZeneca, Tesaro–GlaxoSmithKline, Immunogen, Janssen–Johnson & Johnson, AbbVie Regeneron, Amgen, Novocure, Genentech–Roche, VentiRx Array Biopharma EMD Serono, Ergomed, Ajinomoto, Ludwig Cancer Research Stemcentrx, Cerulean Pharma, the GOG Foundation, the National Cancer Institute, Bristol Myers Squibb, C Serono, TRACON Pharmaceuticals, Yale University, New Mexico Cancer Care Alliance, inVentiv Health Clinical, Iovance Biotherapeutics, PRA Intl, Eisai, Agenus, Merck, GenMab, SeaGen, Mersana, and Clovis; personal fees for consulting or advisory board membership, or both, from AstraZeneca, Tesaro–GlaxoSmithKline, Immuno en, Ambry, Janssen–Johnson & Johnson, BBI, Agenus, AbbVie, Regeneron, Amgen, Novocure, Genentech–Roche, GOG Foundation, Iovance Biotherapeutics, Myriad Genetics, Eisai, Agenus, Tarveda, Merck, SeaGen, Novartis, Mersana, Clovis, Rubius, and Elevar, all outside the submitted work. OD reports grants or contracts from AstraZeneca, Clovis, Genentech, AbbVie, IMV, Millenium, and Pharmamar; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Tesaro–GlaxoSmithKline and AstraZeneca; payment for expert testimony in one legal case unrelated to the current study; and participation on a data safety monitoring board or advisory board for Merck, Clovis, PACT, and Genentech, all outside the submitted work. SG reports financial support paid to her institution for the present study from the National Clinical Trials Network; grants or contracts from AstraZeneca, AbbVie, Pfizer, Rigel, Iovance, Tesaro, Genentech–Roche, PharmaMar, and GlaxoSmithKline; patents licensed to Sermonix (US patent numbers 10,905,659 and 10,258,604); participation on a data safety monitoring board or advisory board for Sermonix, Elevar Therapeutics, and GlaxoSmithKline; and service as an NRG Oncology phase 1 subcommittee co-chair, all outside the submitted work. BS reports personal fees for service on advisory boards for Abbvie, AstraZeneca, Bostongene, Clovis, Eisai, Genentech, GlaxoSmithKline, Jazz Pharmaceticals, Lilly, Merck, Myriad, Novartis, Nuvation, Onconova, and Seagen; and consulting for the GOG Foundation, all outside the submitted work. AE reports grants or contracts from UKRI for a post-doctoral fellowship outside the submitted work. CG reports grants from GlaxoSmithKline and Novartis for this study (trametinib, the test drug, was sold by GlaxoSmithKline to Novartis during the course of the study). WEB, JP, KCa, WR, DM, KCo, HG, PH, JF, MC, RLH, CSH, HQH, and LW declare no competing interests. (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Gerstl, B., et al. (2019). "Reproductive outcomes following a stem cell transplant for a haematological malignancy in female cancer survivors: a systematic review and meta-analysis." Supportive Care in Cancer 27(12): 4451-4460.
	Purpose: The use of high-dose chemotherapy and radiotherapy combined with haematopoietic stem cell transplantation (HSCT) may negatively affect a woman's reproductive potential. Reproductive outcomes such as infertility are a major concern for women who undergo treatment for a haematological cancer diagnosis. Objective(s): This systematic review and meta-analysis explores reproductive outcomes following a haematological cancer requiring HSCT. Method(s): Electronic databases were searched to identify studies that reported on reproductive outcomes after treatment for a haematological cancer diagnosis. Studies were included that reported on pregnancy and reproductive outcomes following HSCT for a haematological malignancy. Result(s): The meta-analysis included 14 studies, collectively involving 744 female patients. The subgroup analysis showed an overall pooled estimated pregnancy rate, for autologous or allogeneic HSCT recipients, of 22.7% (n = 438). There were 25% (n = 240) of women who became pregnant after autologous HSCT compared with 22% (n = 198) who subsequently became pregnant following allogeneic HSCT. Conclusion(s): This meta-analysis reflects low pregnancy rates for cancer survivors desiring a family. However, live births are improving over time with new technology and novel therapies. Hence, female cancer patients should be offered timely discussions, counselling and education around fertility preservation options prior to starting treatment with gonadotoxic therapy.Copyright © 2019, Springer-Verlag GmbH Germany, part of Springer Nature.

Getaneh, F., et al. (2023). "ONABOTULINUM TOXIN A VERSUS SACRAL NEUROMODULATION FOR TREATMENT OF NOCTURIA IN WOMEN WITH REFRACTORY URGE URINARY INCONTINENCE." Neurourology and Urodynamics 42(Supplement 1): S201-S202.
	Introduction: To compare the effect of onabotulinum toxin A versus sacral neuromodulation on nocturia episodes in women with refractory urge urinary incontinence. Method(s): This is a secondary analysis of data prospectively collected in the ROSETTA trial, a multicenter randomized controlled trial comparing the effectiveness of onabotulinum toxin A (BTX) versus sacral neuromodulation (SNM) for women with refractory urge urinary incontinence (UUI). Data was obtained from the National Institute of Health Data and Specimen Hub (DASH) database. Only subjects who reported >= 2 nocturia episodes on average over 3-day diary at baseline were included and divided into two cohorts by treatment: BTX versus SNM. The primary outcome (nocturia episodes per night based on a 3-day bladder diary) was compared between cohorts at baseline, 3 months, 6 months and 9 months post-treatment. A sub- analysis was performed on only treatment Responders (defined as subjects with >= 50% improvement in mean number of UUI episodes/day on 3-day diary). Baseline demographic and clinical characteristics were compared between treatment groups with unpaired t-tests for continuous and contingency table analysis for categorical variables. Change in episodes/day from baseline to 9 months was assessed by mixed effects models for repeated measures data. Comparison of BOTOX and SNM groups at each time point was analyzed by unpaired t-tests with no adjustment for multiple testing. No adjustment of p values was made for multiple testing. Result(s): A total of 119 subjects were included with 64 (54%) undergoing BTX and 55 (46%) undergoing SNM. 116 (97%) subjects were 'Responders' with 62 (53%) BTX and 54 (47%) SNM. There were no significant differences in demographics between groups (p >= 0.05 for all). For the 'Responders', there was a significant decrease in mean nocturia episodes per night after treatment for up to 9 months posttreatment (36.7% decrease in BTX, 33% decrease in SNM, p <= 0.001) with no significant treatment difference between BTX vs SNM. There was a total of 32 patients who had resolution of nocturia (defined as <= 1 mean nocturia episode on 3-day diary) with 18 (56%) undergoing BTX and 14 (44%) undergoing SNM. Conclusion(s): For women with refractory UUI and >= 2 nocturia episodes per night at baseline, treatment with BTX or SNM are associated with a decrease in nocturia episodes over a 9-month follow-up period. Women with UUI and bothersome nocturia can be reassured that BTX and SNM are reasonable options for treatment..

Gezer, Ş., et al. (2021). "Application of thrombin gel matrix for the prevention of lymphocele in patients with endometrial cancer: A prospective randomized trial." Journal of Gynecology Obstetrics and Human Reproduction 50(7): 101994.
	OBJECTIVE: To evaluate a thrombin gel matrix (TGM), Floseal, for the prevention of lymphocele in patients with endometrial cancer who underwent pelvic lymphadenectomy. METHODS: A total of 79 consecutive patients with endometrial cancer were randomly allocated to one of two groups: the TGM group and control group. After completion of the lymphadenectomy, 5 mL of Floseal was applied to the bilateral pelvic sidewalls, especially the femoral canal, obturator, and common iliac vessels areas. Computed tomography scans were obtained for lymphocele evaluation 2 months after the surgery. RESULTS: Three patients from the TGM group, and four patients from the control group were lost during follow-up, and data from 36 participants from each group were analyzed. As the primary outcome, lymphocele developed in 12 patients in both groups (33 %). There was no significant difference between the groups in terms of lymphocele and symptomatic lymphocele development. Lymphocele localization was also not different between the two groups, but the diameter of the lymphoceles detected in the TGM group was significantly greater (p = 0.021). The mean drainage days was significantly shorter in the TGM group (p = 0.015). The amount of drainage was also less in the TGM group, but the difference was not statistically significant. CONCLUSION: Thrombin gel matrix applied to the pelvic sidewalls does not reduce the incidence of symptomatic or asymptomatic lymphoceles after pelvic lymphadenectomy in endometrial cancer. However, it can reduce the amount of drainage and the number of drainage days so it can help to shorten hospitalization.

Gezici, S. and N. Sekeroglu (2019). "Current perspectives in the application of medicinal plants against cancer: Novel therapeutic agents." Anti-Cancer Agents in Medicinal Chemistry 19(1): 101-111.
	Background: Cancer is a disease characterized by uncontrolled cell growth and proliferation. It has become a major health problem in the past decades and is now the second leading cause of death globally. Although, there are different types of treatment such as chemotherapy, immune therapy, radiation, hormone therapy and targeted therapy used against cancer, they have possible side effects and significant deficiencies. Method(s): This review aims to outline the benefits of medicinal plants and plant-derived products and highlight why they should be used as novel anti-cancer therapeutics. Electronic databases, including PubMed, Scopus, ScienceDirect, Cochrane library, and MedlinePlus were searched to summarize in vitro, in vivo and clinical studies on anticancer effects of medicinal plants and their bioactive compounds up-to-date. Result(s): In recent years, a number of medicinal plants have been administered to cancer patients in order to prevent and treat cancer as an alternative therapy. These plants were used because of their rich anticarcinogenic and chemoprotective potentials. In addition to these remarkable properties, these plants have less toxic anticancer, anti-tumor and anti-proliferation agents than traditional therapeutics. Nevertheless, only a small number of natural anti-tumor products including vinblastine, vincristine, podophyllotoxin, paclitaxel (Taxol) and camptothecin have been tested clinically, while vinflunine ditartrate, anhydrovinblastine, NK-611, tafluposide, paclitaxel poliglumex, combretastatins, salvicine, curcumin, indirubin, triptolide, homoharringtonine are still on trial. Conclusion(s): Consequently, more effective anticancer compounds are identified during the clinical trials; these natural products could be a key source of antitumor agents in modern anticancer therapy. It is expected that novel anticancer phytopharmaceuticals produced from medicinal plants could be effectively used in prevention and therapy for the cancers.Copyright © 2019 Bentham Science Publishers.

gGmb, H. E. K. K. W. and o. Cologne University (2024). Biological Mesh Versus Synthetic Mesh in Interdisciplinary RRP With SCP.
	No Results Available Device: interdisciplinary mesh sacro colpopexy with resection rectopexy safety of the experimental internvention as measured by surgical outcome|Altomare Score for Obstruct4ed defecation syndrome (ODS)|Pelvic organ prolapse Quantification (POP Q)|Rectal Toxicity Score for bowel dysfunction|Wexner Incontinence Score for fecal incontinence Female Not Applicable 28 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Treatment EVKKoeln_BioSynIRS May 31, 2026

Ghafarzadeh, M., et al. (2021). "The role of anti-proliferative effects of atorvastatin on uterine fibroids: findings from a clinical study." Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology 37(8): 721-724.
	AIM: Uterine myomas/fibroids are one of the most common benign tumors of the reproductive system in women. Given pleiotropic effects of statins, the aim of this study is to evaluate the therapeutic effects of atorvastatin on uterine fibroids in women of reproductive age. MATERIALS AND METHODS: This randomized clinical study included 90 women aged 35-45 years with uterine fibroids. The patients were randomly allocated into the intervention group (received one tablet, 20 mg of atorvastatin every day for three months) and placebo. Ultrasound was performed every month, and the change in the size of fibroids was recorded for each patient. At the end of the study, the data obtained were analyzed using SPSSv22 and a p value < .05 was considered statistically significant. RESULTS: The mean age in the placebo and intervention group was 39.63 ± 36.3 and 40.35 ± 3.32 years, respectively. The number and location of the tumor was comparable for the two groups. We observed a statically significant reduction in fibroid size from the treatment initiation until completion of three months, (41.06 ± 6.68 mm3 vs 35.16 ± 6.67 mm3) p = .0001. However, the decrease in fibroid size from 1st month to the 3rd month was not statistically significant, p = .189 (36.71 ± 5.54 mm3 vs 35.16 ± 6.67 mm3). CONCLUSION: This study shows that treatment with atorvastatin might positively reduce the size of fibroids. The decrease was only statistically significant during the first month. Further studies with a detailed analysis of the intervention's clinical impact are required to consider statins as a therapeutic tool.

Ghaffari, F. and A. Arabipoor (2020). "Role of surgery in treatment of infertile women with endometriosis: A review study." Iranian Journal of Obstetrics, Gynecology and Infertility 23(8): 75-86.
	Introduction: Endometriosis is a chronic inflammatory disease which affects fertility. This study was performed with aim to evaluate the clinical role of surgical intervention and assisted reproductive technology (ART) in infertile women with endometriosis on the basis of recent clinical guidelines. Method(s): In this review study, the published articles in the databases of PubMed, Science direct, Scopus, Google scholar were searched using the keywords of "endometriosis" and / or "endometrioma" and / or "assisted reproductive technology" and / or "infertility" and / or "laparoscopy" and / or "cystectomy" and / or "surgery" and/ or "guideline" from January of 2000 to November 2019. All guidelines published in English in the field of laparoscopy and surgery in endometriosis and infertility were reviewed. Result(s): Until now, 6 international guidelines have been published in this field and we reviewed these articles in the present study. According to the recent evidences, laparoscopy is not routinely performed prior to ART and its clinical application is to diagnose mild from moderate endometriosis; however surgical resection is considered if mild endometriosis is present, as it may improve the spontaneous pregnancy rate. In the case of more severe types of disease (endometrioma and deep penetrating endometriosis), the benefits of pre-ART surgery are still unclear and its risks and benefits should be assessed. Conclusion(s): Based on the available guidelines, it is suggested that decision for surgery in infertile women with endometriosis should be made individually and on the basis of the patient' selection, age and ovarian reserve, association with annoying symptoms, other causes of infertility, location of lesion and possible risk of repeated surgery.Copyright © 2020, Mashhad University of Medical Sciences. All rights reserved.

Ghahremani, T., et al. (2022). "Women's Mental Health Services and Pregnancy: A Review." Obstetrical and Gynecological Survey 77(2): 122-129.
	Importance The importance of women's mental health services is becoming more evident as we learn more about the impact of mental health on maternal and perinatal outcomes. Objective The purpose of this review is to identify the importance of mental health issues arising during pregnancy including prevention, timely diagnosis and treatment, and referral to specialized services. Evidence Acquisition A literature search was undertaken using the search engines PubMed, CINAHL, and PsycINFO. The search terms were as follows: "mental health services"or "behavioral health"or "mental health counseling"or "psychological"and "delivery of health care"and "pregnancy"or "pregnant."The years searched were January 2000 to November 2020. The search was limited to English language. Results Of the 255 abstracts identified and reviewed, 35 full-text articles were the basis of this review. Literature summarizing the availability and models of care for mental health services for pregnant women is limited. After reviewing the literature, the themes of depression and anxiety in the antepartum and postpartum periods that emerged as mental health issues, especially during adolescent pregnancies, the coronavirus pandemic, intimate partner violence, and pregnancy loss, are of primary importance to obstetrical providers. All of these issues can have a significant impact on maternal and neonatal outcomes and should be addressed during routine practice. Conclusions and Relevance Maternal mental health is garnering deserved attention and has enormous implications on maternal and infant outcomes. Obstetrical providers should be comfortable with screening, identification, and basic treatment algorithms including when to refer to specialized services. Relevance Statement Mental health issues during pregnancy and the postpartum period can be profound with severe maternal and perinatal consequences. Target Audience Obstetricians and gynecologists, family physicians, psychiatrists. Learning Objectives After completing this activity, the learner should be better able to identify the mental health services that are available for pregnant women; outline the common mental illnesses that are present during adolescent pregnancies; explain the risk factors that have been linked with perinatal depression; and describe the management and potential complications of pregnant patients presenting with mental illness.Copyright © Wolters Kluwer Health, Inc. All rights reserved.

Ghajari, G., et al. (2023). "Mesenchymal Stem Cell-based Therapy and Female Infertility: Limitations and Advances." Current Stem Cell Research and Therapy 18(3): 322-338.
	Infertility in women can be caused by various female reproductive diseases such as premature ovarian failure (POF), polycystic ovary syndrome (PCOS), endometriosis and Asherman syndrome that affect couples' quality of life and lead to mental, emotional, and physical problems. In recent years, clinical researchers have sought infertility treatments using new methods that are more effective and noninvasive than the old methods. Today, stem cell-based therapy has been introduced as a promising method and an alternative to the old strategy of infertility treatment. Understanding the main features and functional perspective of mesenchymal stem cells (MSCs) in the future of infertility by physicians is crucial. Mesenchymal stem cells (MSCs) are multipotent stem cells with a high proliferation range, abundant source and multidirectional differentiation potential. They have a high potential for the treatment of injured tissues in regenerative medicine through cell homing, secretion of active factors, and participation in immune regulation. At present, due to fewer ethical restrictions on the use of mesenchymal stem cells compared to embryonic stem cells, more attention has been paid to these cells as a new treatment for gynecological disorders. In this paper, we first review the various type of female reproductive disorders along with their common treatment methods, then we evaluate the recent advances in the application of MSCs in the diseases related to infertility and improve the reproductive health of women worldwide.Copyright © 2023, Bentham Science Publishers. All rights reserved.

Ghanaatgar-Kasbi, S., et al. (2022). "Targeting the Transforming Growth Factor-beta Signaling Pathway in the Treatment of Gynecologic Cancer." Current cancer drug targets 23(1): 15-24.
	The transforming growth factor-beta (TGF-β) signaling pathway has been reported to be dysregulated in the pathogenesis of several malignancies, including gynecologic cancers. This provides proof of concept of its potential value as a therapeutic target and prognostic biomarker in cervical cancer. Here we provide an overview of the biological role and clinical impact of TGF-β inhibitors either as a single agent or as a combinatorial therapy in gynecological cancers, concentrating on phase I to phase II/III clinical trials. Aberrant TGF-β signaling may lead to carcinogenesis. Inhibition of TGF-β represents an interesting area of focus for the treatment of gynecological cancer. Several TGF-β inhibitors are potential anticancer agents and are undergoing clinical trials in cancer, including galunisertib, dalantercept, and vigil. There is a growing body of data showing the potential therapeutic impact of targeting the TGF-β pathway in different cancer types, although further studies are still warranted to explore the value of this strategy and finding the most appropriate patients who could most benefit from therapy. (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Ghanbari, A., et al. (2021). "Tribulus terrestris and female reproductive system health: A comprehensive review." Phytomedicine : international journal of phytotherapy and phytopharmacology 84: 153462.
	BACKGROUND: Tribulus terrestris L. (T. terrestris) positive performance on the male sexual system has been confirmed, but little is known about its effects on the female reproductive system. PURPOSE: This review discussed in detail the beneficial impact of T. terrestris and its secondary metabolites on the female reproductive system. STUDY DESIGN AND METHODS: In this review, the scientific Databases of Science direct, Pubmed, Web of Science, Google, Google Scholar, Researchgate, EMBASE, Scientific Information (SID), and Elsevier were searched profoundly. Studies about the pharmacological activities of T. terrestris on the female reproductive system in each aspect of investigations: human, in vivo, and in vitro studies, in the period from 1998 to 2020 were admitted. Our study was not limited by the language of publications. RESULTS: 23 articles about the effects of T. terrestris on the female reproductive system were found. These studies approved the T. terrestris efficacy on improvements in histological features of the ovary and uterus of polycystic ovary syndrome patients as well as the well-working of normal ovaries, enhancements in the sexual desire of postmenopausal syndrome, improve ovarian and breast cancers. CONCLUSION: These studies showed that the positive effect of T. terrestris on the female reproductive system was due to the presence of a secondary metabolite called protodioscin; a steroidal saponin compound, as the dominant active component of this plant.

Ghanbari-Movahed, M., et al. (2021). "A Systematic Review of the Preventive and Therapeutic Effects of Naringin Against Human Malignancies." Frontiers in Pharmacology 12: 639840.
	Background: Natural product-based cancer preventive and therapeutic entities, such as flavonoids and their derivatives, are shown to have a noticeable capability to suppress tumor formation and cancer cell growth. Naringin, a natural flavanone glycoside present in various plant species, has been indicated to modulate different signaling pathways and interact with numerous cell signaling molecules, which allows for an extensive variety of pharmacological actions, such as amelioration of inflammation, oxidative stress, metabolic syndromes, bone disorders, and cancer. The purpose of this systematic review is to present a critical and comprehensive assessment of the antitumor ability of naringin and associated molecular targets in various cancers. Method(s): Studies were identified through systematic searches of Science Direct, PubMed, and Scopus as well as eligibility checks according to predefined selection criteria. Result(s): Eighty-seven studies were included in this systematic review. There was strong evidence for the association between treatment with naringin alone, or combined with other drugs and antitumor activity. Additionally, studies showed that naringin-metal complexes have greater anticancer effects compared to free naringin. It has been demonstrated that naringin employs multitargeted mechanisms to hamper cancer initiation, promotion, and progression through modulation of several dysregulated signaling cascades implicated in cell proliferation, autophagy, apoptosis, inflammation, angiogenesis, metastasis, and invasion. Conclusion(s): The results of our work show that naringin is a promising candidate for cancer prevention and treatment, and might offer substantial support for the clinical application of this phytocompound in the future. Nevertheless, further preclinical and clinical studies as well as drug delivery approaches are needed for designing novel formulations of naringin to realize the full potential of this flavonoid in cancer prevention and intervention.© Copyright © 2021 Ghanbari-Movahed, Jackson, Farzaei and Bishayee.

Gharaei, H. and N. Gholampoor (2023). "The Role of Interventional Pain Management Strategies for Neuropathic Pelvic Pain in Endometriosis." Pain Physician 26(5): E487-E495.
	Background: Endometriosis is a chronic common condition affecting 10% of reproductive-aged women globally. It is caused by the growth of endometrial-like tissue outside the uterine cavity and leads to chronic pelvic pain, affecting various aspects of a woman's physical, mental, emotional, and social well-being. This highlights the importance of an understanding of the potential involvement of the nervous system and involved nerves as well as an effective multidisciplinary pain management. Objective(s): Our aim was to assess the current understanding of pain mechanisms in endometriosis and the effectiveness of different interventional pain management strategies. Study Design: Literature review. Method(s): A search was conducted using multiple databases, including Google Scholar, MEDLINE (Ovid), PubMed, and Embase. We used keywords such as "endometriosis," "pain," pelvic pain, "management," and "anaesthesia" along with Boolean operators and MeSH terms. The search was limited to English language articles published in the last 15 years. Result(s): Nerve involvement is a well-established mechanism for pain generation in patients with endometriosis, through direct invasion, irritation, neuroangiogenesis, peripheral and central sensitization, and scar tissue formation. Endometriosis may also affect nerve fibers in the pelvic region, causing chronic pelvic pain, including sciatic neuropathy and compression of other pelvic nerves. Endometriosis can cause sciatica, often misdiagnosed due to atypical symptoms. Interventional pain management techniques such as superior hypogastric plexus block, impar ganglion block, S3 pulsed radiofrequency, myofascial pain trigger point release, peripheral nerve hydrodissection, and neuromodulation have been used to manage persistent and intractable pain with positive patient outcomes and improved quality of life. Limitation(s): The complex and diverse clinical presentations of endometriosis make it challenging to compare the effectiveness of different pain management techniques. Conclusion(s): Endometriosis is a complex condition causing various forms of pain including nerve involvement, scar tissue formation, and bowel/bladder symptoms. Interventional pain management techniques are effective for managing endometriosis-related pain.Copyright © 2023, American Society of Interventional Pain Physicians. All rights reserved.

Ghasemi, T., et al. (2022). "Ethanol Sclerotherapy versus Laparoscopic Surgery in Management of Ovarian Endometrioma; a Randomized Clinical Trial." Archives of academic emergency medicine 10(1): e55.
	Introduction: A variety of therapeutic modalities are available in management of ovarian endometrioma. This study aimed to compare the effects of ethanol sclerotherapy and laparoscopic surgery on disease recurrence and ovarian factors of these patients.; Methods: 70 women with ovarian endometrioma and chronic pelvic pain were randomly divided into two groups. The first group underwent sclerotherapy with a puncture needle (cook) and the second group underwent laparoscopic surgery. Both groups were followed up every three months to investigate the recurrence rate. In this regard, ultrasonography was performed 3 months and 12 months after treatment, and serum anti-Müllerian hormone (AMH) levels were also reassessed 12 weeks after the intervention.; Results: 70 women with the mean age of 31.46 ± 4.71 years, and the mean body mass index (BMI) of 23.12 ± 1.01 were studied. The two groups were similar regarding age (p = 0.770), BMI (p = 0.371), history of gastrointestinal signs (p = 0.794), history of urinary diseases (p = 0.324), dysmenorrhea (p = 0.403), pelvic pain (p = 0.454), dyspareunia (p = 0.448), location of cyst (p = 0.448), and diameter of cyst (p = 0.250). In the laparoscopic group, a significant decrease in anti-Müllerian hormone (AMH) levels was observed after 12 weeks (p < 0.0001), while in the sclerotherapy group, no significant changes were found between pre-and post-operative AMH levels (p = 0.120). Cyst size decreased significantly in both groups three months (p < 0.001) and twelve months (p < 0.0001) after treatment. In the third month, 8 patients in the sclerotherapy group and 13 patients in the laparoscopic group had recurrences, and in the twelfth month, 17 patients in the sclerotherapy group and 15 patients in the laparoscopic group had recurrence of symptoms (p > 0.05).; Conclusions: Although AMH level and mean cyst diameter were significantly lower one year after laparoscopy, recurrence rate of ovarian endometrioma was similar between ethanol sclerotherapy and laparoscopy methods.; Competing Interests: The authors declare that there is no conflict of interest.

Ghijselings, L., et al. (2021). "Clinical efficacy of transcutaneous tibial nerve stimulation (TTNS) versus sham therapy (part I) and TTNS versus percutaneous tibial nerve stimulation (PTNS) (part II) on the short term in children with the idiopathic overactive bladder syndrome: protocol for part I of the twofold double-blinded randomized controlled TaPaS trial." Trials 22(1): 247.
	Background: Transcutaneous tibial nerve stimulation (TTNS) and percutaneous tibial nerve stimulation (PTNS) are effective and safe therapies for overactive bladder (OAB) syndrome in adults. However, few randomized sham‐controlled trials have been conducted in a pediatric population. To our knowledge, both therapies never have been compared in children. Aim: The aim of the complete study is twofold: (1) to assess the efficacy of TTNS therapy on bladder symptoms after 12 weeks of treatment in a pediatric population with idiopathic overactive bladder syndrome (iOAB) and/or nocturnal enuresis (part I) and (2) to assess the effect of TTNS compared to PTNS (part II). In this article, we aim to present the protocol of the first part of the TaPaS trial (TTNS, PTNS, sham therapy). Methods: Part I of the TaPaS trial is set up as a single‐center randomized‐controlled trial. Children, aged from 5 to 12 years with iOAB and/or nocturnal enuresis, are assigned to two groups by computer‐generated randomization: TTNS therapy (intervention) and sham therapy (control). The primary outcome is the percentage difference in average voided volume (AVV) between baseline and after 12 weeks of treatment. Secondary endpoints are the percentage difference in supervoid volumes, number of urinary incontinence episodes/24 h and in voiding frequency, the difference in parent reported outcomes between baseline and after 12 weeks of treatment, and the duration of clinical response. Discussion: We hypothesize that TTNS is a non‐inferior treatment for iOAB in children compared to PTNS therapy. Since literature is inconclusive about the efficacy of TTNS in a pediatric population, a sham‐controlled RCT on TTNS will be conducted (part I). A protocol for a prospective randomized sham‐controlled trial has been developed. Enrolment has started in November 2018. Study completion of part I is expected by August 2021. Trial registration: ClinicalTrials.gov NCT 04256876. Retrospectively registered on February 5, 2020.

Ghirardi, V., et al. (2023). "Diagnostic and Therapeutic Pathway of Advanced Ovarian Cancer with Peritoneal Metastases." Cancers 15(2): 407.
	Over two thirds of ovarian cancer patients present with advanced stage disease at the time of diagnosis. In this scenario, standard treatment includes a combination of cytoreductive surgery and carboplatinum-paclitaxel-based chemotherapy. Despite the survival advantage of patients treated with upfront cytoreductive surgery compared to women undergoing neo-adjuvant chemotherapy (NACT) and interval debulking surgery (IDS) due to high tumor load or poor performance status has been demonstrated by multiple studies, this topic is still a matter of debate. As a consequence, selecting the adequate treatment through an appropriate diagnostic pathway represents a crucial step. Aiming to assess the likelihood of leaving no residual disease at the end of surgery, the role of the CT scan as a predictor of cytoreductive outcomes has shown controversial results. Similarly, CA 125 level as an expression of tumor load demonstrated limited applicability. On the contrary, laparoscopic assessment of disease distribution through a validated scoring system was able to identify, with the highest specificity, patients undergoing suboptimal cytoreduction and therefore best suitable for NACT-IDS. Against this background, with this article, we aim to provide a comprehensive review of available evidence on the diagnostic and treatment pathways of advanced ovarian cancer.Copyright © 2023 by the authors.

Ghirardi, V., et al. (2023). "Current and future trials about HIPEC in ovarian cancer." Bulletin du cancer.
	Due to the typical peritoneal spread of the disease, together with cytoreductive surgery and adjuvant platinum-based chemotherapy, the role of hyperthermic intraperitoneal chemotherapy (HIPEC) is gainig more interest in advanced ovarian cancer (AOC) treatment. Indeed, the addition of hyperthemia seems to enhance the cytotoxic effect of chemotherapy directly delivered on peritoneal surface. So far, data on HIPEC administration during the primary debulking surgery (PDS) have been controversial. Indeed, despite flaws and biases, a survival advantage in a subgroup analysis of a prospective randomized trial of PDS+HIPEC treated patients was not demonstrated, whilst positive results are coming from a large retrospective cohort of patients treated with HIPEC after upfront surgery. In this setting, larger prospective data from an ongoing trial are expected by 2026. Contrariously, the addition of HIPEC with cisplatin 100mg/m 2 at the time of interval debulking surgery (IDS) has shown to prolong both progression-free and overall survival by prospective randomized data, despite few controversies on the methodology and the results of this trial arose among the experts. So far, available high quality data on HIPEC treatment after surgery for disease recurrence failed to demonstrate a survival benefit in this group of patients, however few trials are ongoing and results are awaited. With this article, we aim to discuss the main findings of available evidence and the objectives of ongoing trials on the addition of HIPEC to various timing of cytoreductive surgery in AOC, also in view of the development of precision medicine and targeted therapies in AOC treatment. (Copyright © 2023 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

Ghogare, A. S., et al. (2023). "Beyond the Antidepressant Action, Paroxetine in Managing the Hot Flashes in Women with Menopause: A Systematic Review." Global Journal of Medical Pharmaceutical and Biomedical Update 18(31): 18.
	Background: Women in the menopausal phase of their lives often experience the vasomotor symptoms of menopause, namely, hot flushes or flashes and disturbances of sleep. About 75-85% of menopausal women tend to experience one or more vasomotor symptoms of menopause. Menopausal hormone therapy (MHT) is considered to be the mainstay treatment in treating vasomotor symptoms of menopause. However, MHT tends to be accompanied by adverse outcomes and there exist contraindications to it. Hence, an alternative treatment strategy is required in view of contraindications, intolerance, or side effects of MHT. Recently, paroxetine is the first and only selective serotonin reuptake inhibitor antidepressant which is United States Food and Drug Administration approved as a non-hormonal management method of vasomotor/climacteric symptoms in menopausal women. Objective(s): In the present study, we systematically reviewed paroxetine's role in the management of hot flashes in menopausal women. Material(s) and Method(s): For the review purpose, we included the previously published relevant original, review, meta-analysis, and randomized controlled trial articles that were published in the English language using a 4-phase process of the preferred reporting items for systematic reviews and meta-analyses statement. Result(s): The severity and frequency of hot flashes were significantly reduced among menopausal women who received paroxetine compared to placebo. Five studies also showed improvement in the night-time sleep duration among menopausal women who received paroxetine in low doses. Conclusion(s): Thus, this study shows that low-dose paroxetine can be a beneficial and effective non-hormonal management option in managing hot flashes among menopausal women.Copyright © The Author(s) 2023.

Gholamalizadeh, M., et al. (2023). "The effects of dietary supplements in patients with cervical cancer: a comprehensive systematic review." European Journal of Obstetrics & Gynecology and Reproductive Biology: X 19: 100217.
	Background: Recent studies reported that complementary therapy including dietary supplements may has a beneficial role in cervical cancer. However, the results are inconsistent. This study aimed to investigate the association between cervical cancer and dietary supplements.; Methods: A systematic literature review was conducted to summarize and quantify the most recent findings on dietary supplement and cervical cancer. Several databases were checked for relevant publications published in English up to March 2023. Of the 32 articles identified, only 20 met the inclusion criteria and were included.; Results: Women with cervical intraepithelial neoplasia may benefit from folate supplementation against oxidative stress and inflammation. Vitamin D may reduce oxidative stress and may have a therapeutic effect. Zinc promotes the clearance of the human papilloma virus and reduces the chance of viral infection. The use of probiotic supplements may improve the complications associated with chemotherapy in patients with cervical cancer, such as diarrhea and abdominal pain. Radiotherapy and chemotherapy complications may also be reduced by omega-3 fatty acids.; Conclusion: Some dietary supplements including folate, vitamin D, zinc, probiotics, and omega-3 fatty acids may have beneficial effects in patients with cervical cancer. Further studies are warranted to confirm these results.; Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article. (© 2023 The Authors.)

Gholami, A., et al. (2022). "The efficacy of soy isoflavones combined with soy protein on serum concentration of interleukin-6 and tumour necrosis factor-α among post-menopausal women? A systematic review and meta-analysis of randomized controlled trials." Clinical and Experimental Pharmacology & Physiology 49(1): 10-24.
	The post-menopausal stage in women's life is associated with the enhancement of inflammation that may be reduced using soy isoflavones or soy protein. The present study aimed to summarize the effect of soy isoflavones plus soy protein on circulating interleukin-6 (IL-6) and tumour necrosis factor-α (TNF-α) in post-menopausal women. The English-language articles were identified from the databases such as Cochrane Library, clinicaltrials.gov, Web of Science, PubMed, and Scopus until December 2020. The mean change from baseline and its standard deviation (SD) for intervention and comparison groups were used to calculate the effect size. The statistical heterogeneity of the intervention effects was computing by Cochran's Q test and I 2 statistic. Nine and seven studies were selected for systematic review and meta-analysis, respectively. The results of our meta-analysis indicated a non-significant effect on the serum concentrations of IL-6 and TNF-α (weighted mean differences [WMD] = 0.07 pg/mL; 95% confidence interval [CI] = -0.03, 0.17 pg/mL; P = 0.190; WMD =0.05 pg/mL; 95% CI = -0.01, 0.12 pg/mL; P = 0.092; respectively). In subgroup analysis, soy isoflavones plus soy protein could increase the serum concentration of IL-6 in studies with soy isoflavones dose ≤87 mg/days, cross-over design, weak quality, and studies on participants who had health risk factors or diseases. The serum concentration of TNF-α increased in studies with cross-over design, intervention duration ≤56 days, and body mass index (BMI) >27, and in studies that were conducted on at-risk or sick participants. In conclusion, our meta-analysis did not confirm any significant effect on serum concentration of IL-6 and TNF-α among post-menopausal women. (© 2021 John Wiley & Sons Australia, Ltd.)

Ghorayeb Joe, H., et al. (2023). "Dorsal root ganglion stimulation for the treatment of chronic pelvic pain: A systematic review." Pain practice : the official journal of World Institute of Pain 23(7): 838-846.
	Background: Chronic pelvic pain (CPP) is a difficult condition to treat. Due to complex pelvic innervation, dorsal column spinal cord stimulation (SCS) has not been shown to produce the same effect as dorsal root ganglion stimulation (DRGS) given emerging evidence suggesting that applying DRGS may result in favorable outcomes for individuals with CPP. The aim of this systematic review is to investigate the clinical use and effectiveness of DRGS for patients with CPP.; Materials and Methods: A systematic review of clinical studies demonstrating the use of DRGS for CPP. Searches were conducted using four electronic databases (PubMed, EMBASE, CINAHL, and Web of Science) across August and September 2022.; Results: A total of nine studies comprising 65 total patients with variable pelvic pain etiologies met the inclusion criteria. The majority of subjects implanted with DRGS reported >50% mean pain reduction at variable times of follow-up. Secondary outcomes reported throughout studies including quality of life (QOL) and pain medication consumption were reported to be significantly improved.; Conclusions: Dorsal root ganglion stimulation for CPP continues to lack supportive evidence from well-designed, high-quality studies and recommendations from consensus committee experts. However, we present consistent evidence from level IV studies showing success with the use of DRGS for CPP in reducing pain symptoms along with reports of improved QOL through periods as short as 2 months to as long as 3 years. Because the available studies at this time are of low quality with a high risk of bias, we strongly recommend the facilitation of high-quality studies with larger sample sizes in order to better ascertain the utility of DRGS for this specific patient population. At the same time, from a clinical perspective, it may be reasonable and appropriate to evaluate patients for DRGS candidacy on a case-by-case basis, especially those patients who report CPP symptoms that are refractory to noninterventional measures and who may not be ideal candidates for other forms of neuromodulation. (© 2023 World Institute of Pain.)

Ghorbani, Z., et al. (2021). "The Effect of Panax ginseng on Genitourinary Syndrome in Postmenopausal Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial." Complementary Medicine Research 28(5): 419-426.
	BACKGROUND: Menopause and estrogen deprivation cause a rise in the number of urogenital tract complaints. OBJECTIVE: This study was conducted to assess the effectiveness of ginseng on genitourinary syndrome. METHODS: This randomized trial was conducted on 60 postmenopausal women with genitourinary syndrome. The participants were randomly allocated to ginseng and placebo groups twice daily for 4 weeks. Vaginal maturation index and vaginal pH were evaluated before and 4 weeks after intervention as the primary outcomes. Also, the atrophic vaginitis and incontinence questionnaires were completed before and after intervention as the secondary outcomes. The safety of intervention was assessed by the side effects checklist. RESULTS: No significant differences were observed between the 2 groups in objective symptoms after the intervention, but the difference was statistically significant (p < 0.001) in terms of subjective symptoms of atrophic vaginitis. One case of insomnia and palpitation and 2 cases of hot flashes were reported in the intervention group, and 1 case of gastric discomfort and change in urine appearance was reported in the placebo group. CONCLUSION: Ginseng only improved the patient-assessed symptoms and had no significant effect on the clinician-assessed outcomes. Further studies are required to determine the precise pharmacological mechanisms of ginseng on genitourinary syndrome.

Giampaolino, P., et al. (2019). "Role of Ovarian Suspension in Preventing Postsurgical Ovarian Adhesions in Patients with Stage III-IV Pelvic Endometriosis: A Systematic Review." Journal of Minimally Invasive Gynecology 26(1): 53-62.
	Endometriosis is a benign complex gynecologic condition with high morbidity that affects women of reproductive age. Pelvic adhesion formation represents a serious clinical challenge in the management of patients with endometriosis. Several interventions aimed at reducing postoperative ovarian adhesion formation have been proposed in recent years. Here we summarize the published evidence on the efficacy of ovarian suspension in preventing postoperative ovarian adhesion formation in women undergoing laparoscopic surgery for stage III-IV endometriosis. The research was conducted using electronic databases. A review of the abstracts of all references retrieved from the search was conducted. Selection criteria for the systematic review included all randomized controlled trials (RCTs) and nonrandomized studies (NRSs) of premenopausal women diagnosed with stage III-IV pelvic endometriosis who underwent ovarian suspension or no ovarian suspension (control group). The RCTs were eligible for meta-analysis. Eight studies, 2 RCTs and 6 NRSs, were included in the systematic review. In all 8 studies, ovarian suspension was performed during surgery for stage III-IV endometriosis. The site of the suspension was the anterior abdominal wall in 76.8% of the cases. Five studies reported the use of polypropylene as suture for the suspension. Removal of the suspension suture in the postoperative period was reported in 6 studies. Pooled data from a meta-analysis of the RCTs show that women who underwent ovarian suspension had a significantly lower incidence of postoperative adhesion formation, particularly of moderate to severe adhesions. Ovarian suspension may reduce the rate and severity of postoperative adhesions formation in women undergoing laparoscopy for the treatment of stage III-IV endometriosis; however, RCTs with larger sample sizes are needed. (Copyright © 2018 AAGL. Published by Elsevier Inc. All rights reserved.)

Giannini, A., et al. (2022). "The giant steps in surgical downsizing toward a personalized treatment of vulvar cancer." The Journal of Obstetrics and Gynaecology Research 48(3): 533-540.
	The present article aims to highlight the importance of changes of personalized surgical treatment for vulvar cancer. Current international literature regarding surgical treatment of vulvar cancer was evaluated. This included several studies and systematic reviews. Radical surgery approach, such as en bloc resection, was the first therapeutic option and the standard care for many years, even if burdened with a high complication rate and frequently disfiguring. Taussing and Way introduced radical vulvectomy approach with en bloc bilateral inguinal-femoral lymphadenectomy; modified radical vulvectomy was developed, with a wide radical excision of the primary tumor. The role of inguinofemoral lymphadenectomy (mono or bilateral) changed in the years too, particularly with the advent of SLN biopsy as minimally invasive surgical approach for lymph node staging, in patients with unifocal cancer <4 cm, without suspicious groin nodes. More personalized and conservative surgical approach, consisting of wide local or wide radical excisions, is necessary to reduce complications as lymphedema or sexual disfunction. The optimal surgical management of vulvar cancer needs to consider dimensions, staging, depth of invasion, presence of carcinoma at the surgical margins of resection and grading, with the goal of making the treatment as individualized as possible. (© 2021 The Authors. Journal of Obstetrics and Gynaecology Research published by John Wiley & Sons Australia, Ltd on behalf of Japan Society of Obstetrics and Gynecology.)

Giannini, A., et al. (2022). "Impact on ovarian reserve and fertility using carbon dioxide laser for endometriosis treatment: a systematic review." Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology 38(8): 617-622.
	Background The application of carbon dioxide (CO 2 ) laser for laparoscopic gynecologic surgery was introduced in 1979 and spread after improving instrumentation, due to the versatility of the CO 2 laser technology and the parallel increase of laparoscopic use. In a gynecologic setting, laser laparoscopy has been demonstrated to be effective in treating infertility and pain associated with mild to severe endometriosis.Aim and methods: This document aims at conducting a systematic review to provide a comprehensive literature overview regarding the rationale, indications, safety, and efficacy of CO 2 laser treatment of endometriosis and related outcomes on ovarian reserve and fertility. Results CO 2 laser seems to lead to lower heat damage in the ovarian tissue than bipolar energy during endometriomas treatment. Moreover, several reports have pointed out that laser vaporization allows to selectively destroy the endometrioma wall's internal surface, preserving the pericystic fibrotic capsule or the adjacent healthy ovarian cortex. Despite this, robust data we have so far indicates that the most effective laparoscopic approach for managing endometriomas is the traditional excisional technique providing better postoperative outcomes than drainage and electrocoagulation, and laser treatment. Data about fertility after treatment of deep infiltrating endometriosis (DIE) using dioxide laser are emerging but very poor. Conclusions Current scientific evidence in this field is inconclusive, and the debate about the safety and efficacy of the CO 2 laser on fertility outcomes is still ongoing. Further randomized case-control studies are mandatory to attain more consistent evidence.

Gien Lilian, T., et al. (2023). "Phase II activity trial of high-dose radiation and chemosensitization in patients with macrometastatic lymph node spread after sentinel node biopsy in vulvar cancer: GROningen INternational Study on Sentinel nodes in Vulvar cancer III (GROINSS-V III/NRG-GY024)." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 33(4): 619-622.
	Background: Standard treatment of early-stage vulvar cancer is a radical, wide, local excision of the primary tumor and a sentinel lymph node (SLN) procedure for the groins. An inguinofemoral lymphadenectomy is no longer necessary for patients who have a negative SLN or micrometastasis ( ≤ 2 mm). When there is macrometastasis (>2 mm) in the SLN, an inguinofemoral lymphadenectomy is indicated; however, this procedure is associated with major morbidity, such as wound healing, lymphoceles, and lymphedema.; Primary Objective: To investigate the safety of replacing inguinofemoral lymphadenectomy by chemoradiation in patients with early-stage vulvar cancer with a macrometastasis (>2 mm) and/or extracapsular extension in the sentinel node.; Study Hypothesis: Combination of 56 Gy of radiation to the inguinal site and concurrent cisplatin chemotherapy without completion inguinofemoral lymphadenectomy will be feasible and safe, with low groin recurrence rates.; Trial Design: This is a single-arm, prospective phase II treatment trial with stopping rules for unacceptable groin recurrences. Eligible patients will receive 56 Gy of radiation to the involved inguinal site and chemotherapy with concurrent cisplatin.; Major Inclusion/exclusion Criteria: Eligible patients undergoing sentinel node procedure will have stage I, unifocal, invasive (>1 mm depth of invasion) squamous cell carcinoma of the vulva with tumor size <4 cm, and no suspicious nodes on imaging. Those eligible for the trial are those with a metastasis >2 mm in the sentinel node and/or extracapsular extension, or more than one sentinel node with micrometastasis ≤2 mm.; Primary Endpoint: Groin recurrence rate in the first 2 years after primary treatment.; Sample Size: 157 patients with macrometastases in their SLN.; Estimated Dates for Completing Accrual and Presenting Results: January 1, 2029.; Trial Registration Number: NCT05076942.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Giese, N. and K. Heirs Morag (2023). "Development of Provisional Acupuncture Guidelines for Pelvic Pain in Endometriosis Using an e-Delphi Consensus Process." Journal of Integrative and Complementary Medicine 29(3): 169-180.
	Introduction: Growing evidence suggests that acupuncture can improve pelvic pain in women with endometriosis. The treatments used in research vary considerably. It remains unclear which treatment could be recommended for clinical practice. This research project aimed at clarifying how acupuncture could be used when treating this condition. Methods: This research comprised two phases: a systematized literature review to extract acupuncture treatment details from published research, and an e-Delphi study to gain knowledge about details as used by expert acupuncturists. Review: Four databases were searched using predefined eligibility criteria. Data were extracted based on the STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) criteria. e-Delphi: Purposeful sampling from colleagues and international experts. An open first round gathered qualitative data, analyzed with the Framework method. In rounds 2 and 3, experts rated statements to build group consensus, defined as a rating of ≥5 on a 7-point Likert scale by ≥70% of the experts. The strength of agreement was graded using the median score and interquartile range. Results from the literature review and the e-Delphi were compared using the STRICTA items. Results: The literature review ( n = 29 unique studies) found a wide range of treatment details with little agreement. The e-Delphi of international experts ( n = 20) resulted in agreement on 94 statements (such as key factors for effectiveness); disagreement on a further 29 (such as acupressure); and absence of consensus on 55 statements (such as the number of needle insertions). A comparison of the review and e-Delphi results found little agreement. Conclusions: Details of acupuncture treatment for endometriosis-related pelvic pain were presented. In the absence of acupuncture guidelines for this condition, the researchers of this e-Delphi recommend using the treatment details on which experts agreed as guidance for good practice. The effectiveness of these guidelines should be evaluated in future research. Study registration: Deutsches Register Klinischer Studien, DRKS00022215, June 30, 2020, retrospectively registered.

Gil, G., et al. (2022). "Role of hysteroscopy during conservative management of atypical endometrial hyperplasia and early-stage endometrial cancer in patients who desire pregnancy." Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology 42(8): 3435-3440.
	Twenty-five percent of cases of endometrial cancer appear in women with unfulfilled reproductive desires . An adequate selection of patients and a close hysteroscopic follow-up to monitor the endometrial response to the levonorgestrel-releasing intrauterine system (LNG-IUS) may be a valid and safe option for these patients . This is a case series and review of the literature study. We included eight patients diagnosed of complex endometrial hyperplasia with atypia (CEHA) or stage 1AG1 well-differentiated endometrial cancer without myometrial invasion who desired to get pregnant and opted for a conservative treatment. Follow-up was performed with hysteroscopy and directed biopsy at 3, 6 and 12 months. Of the 854 cases of complex endometrial hyperplasia with atypia (CEHA)/endometrial cancer were diagnosed, 2.3% were candidates for conservative management. We obtained a favourable regression of 71.2% at 6 months and 57% at one year with hormonal treatment. Conservative treatment in complex endometrial hyperplasia with atypia (CEHA)/low-grade endometrial cancer in reproductive age patients with a strong desire for pregnancy is feasible.

Gilandoust, A., et al. (2023). "The effect of cognitive behavioral therapy on symptoms on premenstrual syndrome and premenstrual dysphoric disorder." Advances in Cognitive Science 25(3): 64-76.
	Introduction: Menstruation is an essential event and the beginning of reproduction in a woman's life. However, some women suffer from menstrual disorders. This study aimed to determine the effect of cognitive behavioral therapy on the symptoms of premenstrual syndrome and premenstrual dysphoric disorders. Methods: This quasi-experimental study with pre-test, post-test and follow-up phases was con- ducted with a control group. The statistical population was all women who were referred to the gynecological and maternity clinics of Hamedan, Iran, in 2022. Forty people were selected by purposeful sampling method and randomly divided into four groups of ten people (two experimen- tal and two control groups). The experimental groups participated in cognitive behavioral therapy during eight weekly sessions of 60 minutes, but the control groups did not receive any intervention. A month and a half later, the follow-up phase was done. Data analysis was done by using SPSS-24 statistical software using univariate covariance analysis. Results: The results showed that cognitive behavioral therapy was effective in reducing pre- menstrual syndrome symptoms in the post-test phase (F=8.33, P<0.01) and the follow-up phase (F=28.05, P<0.000). Furthermore, this treatment was effective in reducing the symptoms of premenstrual dysphoric disorder in the post-test phase (F=9.36, P<0.007) and follow-up phase (F=21.97, P<0.000). Conclusion: Cognitive behavioral therapy was effective in reducing the symptoms of menstrual disorders, and its effects lasted for one and a half months after the intervention. Therefore, cognitive behavioral therapy should be used as a tool to improve society's overall health. Recommendedly, treatment programs should be established, comprehensive women's health education should be offered, and initiatives to enhance the mental health of women experiencing menstrual disorders must be prioritized. (PsycInfo Database Record (c) 2024 APA, all rights reserved)

Gilchrist Robert, B., et al. (2024). "A fresh start for IVM: capacitating the oocyte for development using pre-IVM." Human Reproduction Update 30(1): 3-25.
	Background: While oocyte IVM is practiced sporadically it has not achieved widespread clinical practice globally. However, recently there have been some seminal advances in our understanding of basic aspects of oocyte biology and ovulation from animal studies that have led to novel approaches to IVM. A significant recent advance in IVM technology is the use of biphasic IVM approaches. These involve the collection of immature oocytes from small antral follicles from minimally stimulated patients/animals (without hCG-priming) and an ∼24 h pre-culture of oocytes in an advanced culture system ('pre-IVM') prior to IVM, followed by routine IVF procedures. If safe and efficacious, this novel procedure may stand to make a significant impact on human ART practices.; Objective and Rationale: The objectives of this review are to examine the major scientific advances in ovarian biology with a unique focus on the development of pre-IVM methodologies, to provide an insight into biphasic IVM procedures, and to report on outcomes from animal and clinical human data, including safety data. The potential future impact of biphasic IVM on ART practice is discussed.; Search Methods: Peer review original and review articles were selected from PubMed and Web of Science searches for this narrative review. Searches were performed using the following keywords: oocyte IVM, pre-IVM, biphasic IVM, CAPA-IVM, hCG-triggered/primed IVM, natural cycle IVF/M, ex-vivo IVM, OTO-IVM, oocyte maturation, meiotic competence, oocyte developmental competence, oocyte capacitation, follicle size, cumulus cell (CC), granulosa cell, COC, gap-junction communication, trans-zonal process, cAMP and IVM, cGMP and IVM, CNP and IVM, EGF-like peptide and IVM, minimal stimulation ART, PCOS.; Outcomes: Minimizing gonadotrophin use means IVM oocytes will be collected from small antral (pre-dominant) follicles containing oocytes that are still developing. Standard IVM yields suboptimal clinical outcomes using such oocytes, whereas pre-IVM aims to continue the oocyte's development ex vivo, prior to IVM. Pre-IVM achieves this by eliciting profound cellular changes in the oocyte's CCs, which continue to meet the oocyte's developmental needs during the pre-IVM phase. The literature contains 25 years of animal research on various pre-IVM and biphasic IVM procedures, which serves as a large knowledge base for new approaches to human IVM. A pre-IVM procedure based on c-type natriuretic peptide (named 'capacitation-IVM' (CAPA-IVM)) has undergone pre-clinical human safety and efficacy trials and its adoption into clinical practice resulted in healthy live birth rates not different from conventional IVF.; Wider Implications: Over many decades, improvements in clinical IVM have been gradual and incremental but there has likely been a turning of the tide in the past few years, with landmark discoveries in animal oocyte biology finally making their way into clinical practice leading to improved outcomes for patients. Demonstration of favorable clinical results with CAPA-IVM, as the first clinically tested biphasic IVM system, has led to renewed interest in IVM as an alternative, low-intervention, low-cost, safe, patient-friendly ART approach, and especially for patients with PCOS. The same new approach is being used as part of fertility preservation in patients with cancer and holds promise for social oocyte freezing. (© The Author(s) 2023. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Gil-Ibanez, B., et al. (2023). "Side effects screening and early intervention to impact in quality of life of patients with gynecological cancers (HALIS study)." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 33(10): 1645-1648.
	Background: Advances in the treatment of gynecological cancers have led to increased survival in patients with gynecological cancers. Nevertheless, patients may still experience prevalent long term consequences, including lower limb lymphedema, depression, anxiety, sexual dysfunction, malnutrition, and sarcopenia, that negatively impact their quality of life.; Primary Objective: To assess the impact on self-perceived quality of life of systematic screening and early treatment of lower limb lymphedema, anxiety and depression, sexual dysfunction, and sarcopenia and malnutrition compared with standard practice.; Study Hypothesis: Systematic screening with validated questionnaires leading to early diagnosis and treatment of side effects will have a positive impact on quality of life.; Trial Design: This prospective clinical trial will randomize candidates for surgery to either standard of care or systematic screening every 2 months for 2 years. Quality of life data will be collected every 4 months. After randomization, patients in the control group will follow standard usual care. Their screening scales will not be considered. In the experimental group, positive screenings will generate an alert to the physician, and patients will be referred to the corresponding specific area (rehabilitation unit, psycho-oncology unit, sexual health unit, or nutrition unit).; Major Inclusion and Xclusion Criteria: Patients aged ≥18 years with ovarian, cervical, or endometrial cancer who are candidates for surgery will be included.; Primary Endpoint: Self-reported quality of life questionnaire score.; Sample Size: 168 patients will be randomized to detect a difference of 6 points in the questionnaires.; Estimated Dates for Completing Accrual and Presenting Results: Study completion is estimated for January 2026 and the results will be presented in May 2026.; Trial Registration Number: NCT05918770.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Gill, B., et al. (2023). "Safety, feasibility, and tolerability of estrogen and/or probiotics for improving vaginal health: A phase 1 clinical trial." American Journal of Reproductive Immunology 89(Supplement 1): 78.
	Problem: The vaginal microenvironment is central in mediating susceptibility to infection within the female genital tract (FGT). Studies suggest a polymicrobial environment coupled with reduced Lactobacillus colonization is associated with bacterial vaginosis (BV), vaginal inflammation, and an increased risk of HIV infection. Given the prevalence of BV among African/Caribbean/Black (ACB) women a prospective, randomized, open-label phase 1 clinical trial was conducted to determine the safety, tolerability, and feasibility of intravaginal estrogen and/or probiotic interventions for improving vaginal health in high-risk populations. Method of Study: Pre-menopausal ACB women aged 18-49 from the Toronto area were enrolled in a 30-day intervention with samples collected at baseline, with subsequent randomization to four treatment groups including: low dose intravaginal estradiol (Estring; 7.5 mg/day), a twice daily vaginal probiotic (RepHresh Pro-B; 1 x 107 cfu total of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 per capsule), and a combination of both an oral or vaginal probiotic with the Estring. A 1-week follow-up was conducted after 30 days, for a final assessment among participants who completed the study. Feasibility was evaluated through enrolment, retention, and intervention protocol (IP) adherence rates. In addition, safety and tolerability were assessed according to adverse events (AEs) recorded during the intervention, in addition to comprehensive blood panels comprised of blood glucose, complete blood count, as well as metabolic and lipid profiles. Result(s): Over the duration of 2 years (November 2019-December 2021), 63 ACB women were screened, with 51 participants enrolled, and 41 completing the intervention. Accordingly, enrollment and retention rates were 81% and 83%, exceeding the set targets of 70% and 80%, respectively. Overall, a total of six (12%) participants withdrew consent, four (8%) withdrew due to IP non-compliance, and one (2%) was lost to follow up. Of those that completed the study, an acceptable IP adherence of 94% (IQR 93%-100%) and 91% (IQR 87%-100%) was established for both overall Estring and probiotic groups, respectively. In addition, no significant difference in IP adherence was observed between the four treatment arms (p > .05). Safety and tolerability results indicated a total of 92 AEs reported by 29 (57%) participants, of which 66 (72%) were mild in intensity and 86 (93%) resolved by the end of the study. Specifically, vaginal irritation/burning/itching, cramps/abdominal pain, and headache were among the most frequently reported AEs, with vaginal irritation/ burning/itching being the only AE reported more than once by multiple participants (5, 11%). Three (7%) participants reported cramps/abdominal pain, headache, light headedness, and/or nausea of severe intensity 1-2 times over the course of the 30 days, all of which resolved by study completion. Moreover, comprehensive blood panels exhibited no significant change (p > .05) between baseline and study completion, with concentrations and counts found within a healthy clinical range for all participants. Conclusion(s): Our results demonstrate acceptable enrollment, retention, and adherence, with no severe AEs reported. Overall, this study indicates that the administration of intravaginal estrogen and probiotics, either in combination or alone are safe, tolerable as well as feasible interventions for pre-menopausal ACB women.

Gillis Brenna, D. and L. Parish Abby (2019). "Group-based interventions for postpartum depression: An integrative review and conceptual model." Archives of Psychiatric Nursing 33(3): 290-298.
	This integrative review explores how and to what extent group-based therapy and social support interventions affect women's recovery from postpartum depression (PPD). Thirteen articles from three databases met inclusion criteria. The studies revealed that a group environment of acceptance and understanding set a foundation for women to share their experiences with PPD. As women shared challenges, wisdom, and guidance within the group, they attained positive outcomes: validation, empowerment, and improvements in depressive symptoms. An integrated conceptual model was created to depict the identified characteristics and outcomes of PPD groups; clinicians can use the model to optimize group-based PPD interventions. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

Gimovsky Alexis, C., et al. (2022). "Prolonged second stage effect on pelvic floor dysfunction: a follow up survey to a randomized controlled trial." The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians 35(25): 5520-5525.
	Background: Pelvic floor dysfunction is a group of disorders that can significantly impact quality of life due to persistent urinary and anal incontinence. Data evaluating the effect of prolonged second stage of labor and postpartum pelvic floor dysfunction is heterogenous and limited.; Objective: To evaluate whether extending the length of labor in nulliparous women with prolonged second stage affects the presence of self-reported pelvic floor dysfunction after a randomized controlled trial of prolonged second stage.; Study Design: We conducted a planned follow up survey to our randomized controlled trial of prolonged second stage of labor using the Pelvic Floor Distress Inventory-20 (PFDI-20). The primary outcome was the PFDI-20 summary score. Secondary outcomes included urinary and fecal incontinence, prolapse, and patient satisfaction. Women surveyed were nulliparous patients with epidural anesthesia, previously enrolled in a randomized controlled trial that assigned them to extended labor , at least 1 additional hour in the second stage if they were undelivered after three hours, or to usual labor , defined as expedited delivery after three hours in the second stage. Women were surveyed at 12 - 36 months postpartum.; Results: Thirty-four of the seventy-eight women responded to the survey (43.6%). 17 women (50.0%) were from the extended labor group and 17 from the usual labor group (50.0%). Maternal demographic data were not significantly different between groups. The PFDI-20 summary score was 13.8 ± 23.3 in the extended labor group and 13.1 ± 20.9 in the usual labor group ( p = 0.9). The Pelvic Organ Prolapse Distress Inventory-6 was 1.2 ± 2.9 in the extended labor group and 2.7 ± 6.4 in the usual labor group ( p = 0.4). The Colorectal-Anal Distress Inventory-8 was 0.8 ± 2.8 in the extended labor group and 2.1 ± 4.0 in the usual labor group ( p = 0.6). The Urinary Distress Inventory-6 was 11.8 ± 21.1 in the extended labor group and 8.3 ± 14.5 in the usual labor group ( p = 0.6). Maternal and neonatal outcomes, as well as patient satisfaction, were not statistically significantly different between groups.; Conclusion: Extending the length of labor in nulliparas with singleton gestations, epidural anesthesia, and prolonged second stage did not have an impact on PFDI-20 scores at 12-36 months postpartum. However, our study was underpowered to detect small, but potentially clinically important, differences.; Clinical Trial Number: NCT02101515 (Study Registration Date March 28, 2014) https://clinicaltrials.gov/ct2/show/NCT02101515.

Gingold Julian, A., et al. (2019). "Perioperative Interventions to Minimize Blood Loss at the Time of Hysterectomy for Uterine Leiomyomas: A Systematic Review and Meta-analysis." Journal of Minimally Invasive Gynecology 26(7): 1234.
	Study Objective: Hysterectomy for uterine leiomyoma(s) is associated with significant morbidity including blood loss. A systematic review and meta-analysis was conducted to identify nonhormonal interventions, perioperative surgical interventions, and devices to minimize blood loss at the time of hysterectomy for leiomyoma.; Data Sources: Librarian-led search of Embase, MEDLINE, Web of Science, Scopus, Cumulative Index to Nursing and Allied Health Literature, and Cochrane databases from 1946 to 2018 with hand-guided updates.; Methods of Study Selection: Included studies reported on keywords of hysterectomy, leiomyoma, and operative blood loss/postoperative hemorrhage/uterine bleeding/metrorrhagia/hematoma. The review excluded a comparison of route of hysterectomy, morcellation, vaginal cuff closure, hormonal medications, vessel sealing devices for vaginal hysterectomy, and case series with <10 patients.; Tabulation, Integration, and Results: Surgical blood loss, postoperative hemoglobin (Hb) drop, hemorrhage, transfusion, and major and minor complications were analyzed and aggregated in meta-analyses for comparable studies in each category. A total of 2016 unique studies were identified, 33 of which met the inclusion criteria, and 22 were used for quantitative synthesis. The perioperative use of misoprostol in abdominal hysterectomy (AH) was associated with a lower postoperative Hb drop (0.59 g/dL; 95% confidence interval [CI], 0.39-0.79; p < .01) and blood loss (-96.43 mL; 95% CI, -153.52 to -39.34; p < .01) compared with placebo. Securing the uterine vessels at their origin in laparoscopic hysterectomy (LH) was associated with decreased intraoperative blood loss (-69.07 mL; 95% CI, -135.20 to -2.95; p = .04) but no significant change in postoperative Hb (0.24 g/dL; 95% CI, -0.31 to 0.78; p = .39) compared with securing them by the uterine isthmus. Uterine artery ligation in LH before dissecting the ovarian/utero-ovarian vessels was associated with lower surgical blood loss compared with standard ligation (-27.72 mL; 95% CI, -35.07 to -20.38; p < .01). The postoperative Hb drop was not significantly different with a bipolar electrosurgical device versus suturing in AH (0.26 g/dL; 95% CI, -0.19 to 0.71; p = .26). There was no significant difference between an electrosurgical bipolar vessel sealer (EBVS) and conventional bipolar electrosurgical devices in the Hb drop (0.02 g/dL; 95% CI, -0.15 to 0.20; p = .79) or blood loss (-50.88 mL; 95% CI, -106.44 to 4.68; p = .07) in LH. Blood loss in LH was not decreased with the LigaSure (Medtronic, Minneapolis, MN) impedance monitoring EBVS compared with competing EBVS systems monitoring impedance or temperature (2.00 mL; 95% CI, -8.09 to 12.09; p = .70). No significant differences in hemorrhage, transfusion, or major complications were noted for all interventions.; Conclusion: Perioperative misoprostol in AH led to a reduction in surgical blood loss and postoperative Hb drop (moderate level of evidence by Grading of Recommendations, Assessment, Development and Evaluation guidelines) although the clinical benefit is likely limited. Remaining interventions, although promising, had at best low-quality evidence to support their use at this time. Larger and rigorously designed randomized trials are needed to establish the optimal set of perioperative interventions for use in hysterectomy for leiomyomas. (Copyright © 2019 AAGL. Published by Elsevier Inc. All rights reserved.)

giorgia, D. and M. Andrea (2021). "Minimally invasive versus open surgery in women with high-risk endometrial cancer: a systematic review and meta-analysis, and a cohort study."
	
Giovannopoulou, E., et al. (2021). "The Emerging Role of Robotic Single-site Approach for Myomectomy: A Systematic Review of the Literature." Surgical innovation 28(3): 352-359.
	Objective. To review the existing studies on single-site robotic myomectomy and test the safety and feasibility of this innovative minimally invasive technique. Data Sources. PubMed, Scopus, Google Scholar (from their inception to October 2019), as well as Clinicaltrials.gov databases up to April 2020. Methods of Study Selection. Clinical trials (prospective or retrospective) that reported the outcomes of single-site robotic myomectomy, with a sample of at least 20 patients were considered eligible for the review. Results. The present review was performed in accordance with the guidelines for Systematic Reviews and Meta-Analyses (PRISMA). Four (4) studies met the inclusion criteria, and a total of 267 patients were included with a mean age from 37.1 to 39.1 years and BMI from 21.6 to 29.4 kg/m2. The mean operative time ranged from 131.4 to 154.2 min, the mean docking time from 5.1 to 5.45 min, and the mean blood loss from 57.9 to 182.62 ml. No intraoperative complications were observed, and a conversion rate of 3.8% was reported by a sole study. The overall postoperative complication rate was estimated at 2.2%, and the mean hospital stay ranged from 0.57 to 4.7 days. No significant differences were detected when single-site robotic myomectomy was compared to the multiport technique concerning operative time, blood loss, and total complication rate. Conclusion. Our findings support the safety of single-site robotic myomectomy and its equivalency with the multiport technique on the most studied outcomes. Further studies are needed to conclude on the optimal minimally invasive technique for myomectomy.

Girda, E., et al. (2022). "Phase I trial of daily subcutaneous SPL-108 injections in combination with paclitaxel in patients with platinum resistant CD44+ advanced ovarian epithelial cancer." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society.
	Objective: Preclinical evidence and early clinical trials have demonstrated the activity of SPL-108, a targeted agent that inhibits CD44 mediated induction of multidrug resistance specifically to paclitaxel and platinum agents. We conducted a phase I, open label, dose escalation study of the safety and tolerability of the combination of SPL-108 with weekly paclitaxel in patients with platinum resistant CD44+ ovarian, primary peritoneal, or fallopian tube cancer.; Methods: Patients with platinum resistant histologically proven epithelial ovarian, primary peritoneal, or fallopian tube cancers and measurable disease according to RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1 were selected. Tumors were tested for CD44 expression for eligibility, defined as strong (+++) or moderate (++) staining in ≥20% of the tumor tissue or diffuse + staining. Patients were treated with daily and then twice daily SPL-108 subcutaneous injections and weekly intravenous paclitaxel on days 1, 8, and 15 of a 28 day cycle. Endpoints included safety, determination of maximum tolerated dose, and efficacy. Tumors underwent comprehensive genomic profiling, and cell lines and western blotting were used to study markers of response.; Results: We screened 16 patients, and 14 were enrolled based on CD44+ expression. A total of 86% of patients had high grade serous tumors and all had received multiple prior therapies. There were no grade 4-5 toxicities. One patient had grade 3 peripheral sensory neuropathy attributed to paclitaxel and one patient developed presumed colonic perforation attributed to the study drug. No dose reductions or treatment discontinuations were required. All patients tolerated the maximum planned dose; no maximum tolerated dose was reached. Overall response rate was 36%; 5 (36%) patients had partial response and 5 (36%) patients had stable disease.; Conclusions: The combination of SPL-108 with weekly paclitaxel was safe and well tolerated. Encouraging antitumor activity was observed, with 72% of patients deriving a clinical benefit.; Trial Registration: NCT03078400.; Competing Interests: Competing interests: DN and MF have ownership options in Splash Pharmaceuticals. (© IGCS and ESGO 2022. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)

Giroux, M., et al. (2021). "A randomized comparison of training programs using a pelvic model designed to enhance pelvic floor examination in patients presenting with chronic pelvic pain." International Urogynecology Journal 32(2): 423-431.
	INTRODUCTION: Pelvic floor myalgia is a common cause and contributor to chronic pelvic pain [Neurourol Urodyn 4:984-1008 (2017)]. The purpose of this study was to compare in-person versus video-based teaching methods of a comprehensive assessment of the pelvic floor musculature on a pelvic model. METHODS: A randomized controlled trial of 46 participants was conducted. The participants were randomized into two groups. Both groups were taught by the same pelvic floor physiotherapist using two different teaching methods on a pelvic model. Group 1 watched an instructional video, whereas group 2 had in-person training. Both groups underwent pre- and post-training assessments consisting of a written examination and an Objective Structured Clinical Examination (OSCE). Primary outcome measure was the change in participants' pre- and post-training assessment scores. Secondary outcome measures were perceived changes in both participants' comfort level in performing pelvic floor examination and applicability of the training program to clinical practice. RESULTS: There was no statistically significant difference between the teaching methods in the degree of improvement of the participants' mean written assessment scores (p = 0.58), OSCE scores (p = 0.15), and perceived comfort level (p = 0.19). Participants' mean pre- and post-assessment scores improved significantly (p < 0.001). Participants reported the training program to be applicable towards their clinical practice. CONCLUSIONS: This study demonstrates that learners' assessment of pelvic floor musculature can be enhanced using varied teaching methods on a pelvic model.

Girtner, F., et al. (2021). "Randomized Crossover-Controlled Evaluation of Simultaneous Bilateral Transcutaneous Electrostimulation of the Posterior Tibial Nerve During Urodynamic Studies in Patients With Lower Urinary Tract Symptoms." International neurourology journal 25(4): 337‐346.
	Purpose: Transcutaneous tibial nerve stimulation (TTNS) has proven to be a valuable treatment option for various lower urinary tract conditions, such as overactive bladder syndrome and neurogenic detrusor overactivity. The aim of this study was to investigate acute changes in urodynamic parameters due to bilateral TTNS. Methods: Fifty‐one patients (18–87 years; 61% female) with various lower urinary tract symptoms were enrolled in this study. They were single‐blinded and randomly assigned to receive simultaneous bilateral TTNS either during their first urodynamic examination, followed by a second round using a placebo stimulation technique, or vice versa. Results: For subjects without signs of anatomical pathologies, the filling volume at the first desire to void (FDV) increased significantly by 54 mL (interquartile range [IQR], 26–81 mL; P < 0.01) under the influence of TTNS compared to placebo. The maximum cystometric capacity increased by 41 mL (IQR, 10–65 mL; P = 0.02). The median micturition volume of patients with pathological postvoid residual volumes (> 100 mL) increased by 76 mL compared to patients without urinary retention (IQR, 6–166 mL; P = 0.03). Conclusions: Compared to placebo, simultaneous bilateral TTNS showed significant improvements in bladder functioning, such as delayed FDV, increased maximum cystometric capacity, and reduced urinary retention. Patients with signs of anatomical pathologies did not seem to benefit from TTNS. Further studies need to be conducted to compare the effectiveness of bilateral versus unilateral TTNS.

Gish, B., et al. (2023). "Neuromodulation for the management of chronic pelvic pain syndromes: A systematic review." Pain practice : the official journal of World Institute of Pain.
	BACKGROUND: Chronic pelvic pain is a burdensome condition that involves multiple medical sub-specialties and is often difficult to treat. Sacral stimulation for functional bladder disease has been well established, but little large-scale evidence exists regarding utilization of other neuromodulation techniques to treat chronic pelvic pain. Emerging evidence does suggest that neuromodulation is a promising treatment, and we aim to characterize the use and efficacy of such techniques for treating chronic pelvic pain syndromes. MATERIALS AND METHODS: A systematic review of the literature demonstrating the treatment of chronic pelvic pain syndromes with neuromodulation. Abstracts were reviewed and selected for inclusion, including case series, prospective studies, and randomized controlled trials (RCTs). Case studies and publications in abstract only were not included. The reporting for this systematic review follows Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). The literature search was performed using MEDLINE, Embase, Cochrane Library, PubMed, CINAHL, and Scopus. RESULTS: A total of 50 studies were included in this review, three of which were randomized controlled trials, and the remaining were prospective and retrospective case series. The range of pelvic pain conditions treated included interstitial cystitis, peripheral neuralgia, pudendal neuralgia, gastrointestinal pain, urogenital pain, sacroiliac joint pain, and visceral chronic pelvic pain. We reported on outcomes involving pain, functionality, psychosocial improvement, and medication reduction. CONCLUSIONS: Neuromodulation is a growing treatment for various chronic pain syndromes. Peripheral nerve stimulation was the least studied form of stimulation. Posterior tibial nerve stimulation appears to offer short-term benefit, but long-term results are challenging. Sacral nerve stimulation is established for use in functional bladder syndromes and appears to offer pain improvement in these patients as well. Dorsal root ganglion stimulation and spinal cord stimulation have been used for a variety of conditions with promising results. Further studies of homogeneous patient populations are necessary before strong recommendations can be made at this time, although pooled analysis may also be impactful.

Gislinge Julie Isabelle, P., et al. (2023). "Hormone replacement in premature ovarian insufficiency [Danish]." Ugeskrift for laeger 185(28).
	Premature ovarian insufficiency (POI) is defined as loss of ovarian function in women less-than 40 years. This review summarises the causes and the possible treatment options. POI can be idiopathic, caused by genetic, autoimmune, or metabolic disease, or be induced by cancer therapy or surgery. POI causes infertility, increased morbidity and mortality, and decreased quality of life. Hormonal replacement therapy (HRT) can alleviate symptoms of POI and should be initiated at diagnosis. The benefit of HRT outweighs the minor side effects in most cases and should be continued until age of natural menopause.

Gitas, G., et al. (2021). "Surgical outcomes of conventional laparoscopic and robotic-assisted hysterectomy." The international journal of medical robotics + computer assisted surgery : MRCAS 17(3): e2225.
	INTRODUCTION: The aim of the present study was to compare surgical outcomes of total laparoscopic hysterectomy with those of the robotic approach using the da Vinci Xi system. METHODS: Patients who underwent hysterectomy with da Vinci Xi for early endometrial cancer or benign indications from 2018 to 2019 were selected. The control group consisted of patients who underwent conventional laparoscopy. RESULTS: A total of 300 patients were included in the study. The mean duration of surgery differed significantly (p = 0.025) between those who underwent laparoscopy (125.01 ± 76.168) and robotic-assisted surgery (142.96 ± 82.657 min). Blood loss, median hospital stay, intraoperative and postoperative complications were similar in both groups. No statistical difference was observed in the subgroups with a body mass index of more than 30 kg/m2 or more than 40 kg/m2 concerning the duration of surgery or the surgical outcome. CONCLUSION: The da Vinci Xi did not improve surgical outcomes in patients who underwent hysterectomy by trained laparoscopists and takes more time than conventional laparoscopy when performed in patients of normal weight.

Gitas, G., et al. (2022). "Robotic surgery in gynecology: is the future already here?" Minimally invasive therapy & allied technologies : MITAT : official journal of the Society for Minimally Invasive Therapy 31(6): 815-824.
	Robotic-assisted surgery has gained widespread acceptance in the surgical community and appears to be the most rapidly developing sector of minimally invasive surgery. However, robotic surgery has been viewed as a development of, or alternative to, laparoscopic surgery and not necessarily as a superior technology. The advantages of MIS over open surgery apply to robotic-assisted surgery as well. Nevertheless, conflicting data have been published about the advantages and disadvantages of robotic-assisted and laparoscopic surgery. In the last few years, robotic-assisted surgery has been used for various gynecological procedures such as hysterectomy, lymphadenectomy, myomectomy, sacrocolpopexy or endometriosis operations. In the present review, we analyze the current use of robotic-assisted surgery and its efficiency in gynecology. Patient-based outcomes, such as quality of life and outcomes in morbidly obese patients are also addressed. The potential benefits of single-port robotic-assisted surgery are discussed. Most of the studies published so far state that robotic-assisted surgery does not essentially improve the surgical outcome compared to conventional laparoscopic surgery. However, randomized studies are scarce. Ongoing technological progress over the next few years may improve robotic-assisted techniques and thus optimize the patient's treatment.

Gitas, G., et al. (2023). "Role of laparoscopic hysterectomy in cervical and endometrial cancer: a narrative review." Minimally invasive therapy & allied technologies : MITAT : official journal of the Society for Minimally Invasive Therapy 32(1): 1-11.
	Endometrial cancer is the most common carcinoma of the female genital organs and cervical cancer is the leading cause of cancer death in women worldwide. The aim of this review is to evaluate the role of laparoscopic hysterectomy in patients with endometrial and cervical cancer in this period, and analyze the outcome of hysterectomy in terms of survival. Moreover, we present the historical background, new techniques, the anatomical features, and surgical steps of radical hysterectomy. According to new evidence, minimally invasive surgery in patients with cervical cancer is associated with higher rates of recurrence and mortality compared to the open approach. Despite the numerous explanations offered for this phenomenon, the reasons for these results are unclear. Additional large trials have been launched to reevaluate the above-mentioned data. On contrary, the laparoscopic approach provides surgical outcomes and similar survival rates as open surgery in patients with early endometrial carcinoma. Furthermore, the radicality of hysterectomy does not influence local recurrence rates or overall survival in cases with complete surgical removal of the tumor. A laparoscopic radical hysterectomy is no longer an option in patients with cervical cancer. When minimally invasive surgery is offered, the patients must be counseled in detail about the current debate.

Giudice, E., et al. (2021). "Tisotumab vedotin in cervical cancer: Current status and future perspectives." US Oncology and Hematology Review 17(2): 1-5.
	Despite the introduction of screening programmes and vaccination campaigns, cervical cancer (CC) still represents one of the leading causes of cancer-related mortality in women worldwide and the fourth most common female malignancy. The prognosis of CC remains poor, especially for late-stage and relapsed disease. While platinum-based chemotherapy with or without bevacizumab has been the established standard of care in the first-line setting, no standard second-line treatments have been identified, and new active agents are needed. Antibody-drug conjugates (ADCs) represent a novel class of agents approved by the US Food and Drug Administration to treat haematological malignancies and metastatic breast cancer. According to available data, ADCs could also represent a valid option for metastatic and recurrent CC. This review describes the role of tisotumab vedotin, an ADC targeting tissue factor, in the metastatic and recurrent CC setting. An overview of published data and ongoing clinical trials is also provided.Copyright © Touch Medical Media 2021.

Giudice, E., et al. (2023). "Recent progress in the use of pharmacotherapy for endometrial cancer." Expert Opinion on Pharmacotherapy 24(1): 83-94.
	Introduction: Endometrial cancer (EC) is the most common gynecological cancer in developed countries. The ESGO/ESTRO/ESP updated evidence-based guidelines in 2020, introducing molecular classification to guide EC treatment. The genomic-based approach has identified four prognostic subgroups of EC. Each of these may benefit from a tailored treatment depending on the molecular profile, the histotype, and stage of disease for the adjuvant and the metastatic/recurrent setting. Several clinical trials are now ongoing to identify the best treatment according to the molecular profile of EC.; Areas Covered: This review analyzes tailored treatment for EC according to the molecular profile, both in the adjuvant and in the metastatic/recurrent setting. The authors review the results of clinical studies and highlight ongoing trials.; Expert Opinion: Several new agents are under evaluation in order to personalize EC treatment according to specific molecular profiles in the adjuvant, advanced, and recurrent settings. Clinical trials investigating the impact of molecular classification have yielded encouraging results. EC can no longer be considered a single tumor entity susceptible to a single treatment modality but rather be split into four distinct types, requiring tailored treatments.

Giugale, L., et al. (2022). "Long-term Urinary Outcomes After Transvaginal Uterovaginal Prolapse Repair With and Without Concomitant Midurethral Slings." Female Pelvic Medicine & Reconstructive Surgery 28(3): 142-148.
	Importance: Many health care providers place concomitant midurethral slings during pelvic organ prolapse repair, yet growing evidence supports staged midurethral sling placement.; Objectives: The aim of this study was to compare urinary function after transvaginal uterovaginal prolapse repair with and without midurethral sling.; Study Design: Secondary analysis of the Study of Uterine Prolapse Procedures Randomized Trial (hysterectomy with uterosacral ligament suspension vs mesh hysteropexy). Our primary outcome was Urinary Distress Inventory score (UDI-6) through 5 years compared between women with and without a concomitant sling within prolapse repair arms. Sling effect was adjusted for select clinical variables and interaction terms (α = .05).; Results: The sling group included 90 women (43 hysteropexy, 47 hysterectomy), and the no-sling group included 93 women (48 hysteropexy, 45 hysterectomy). At baseline, the sling group reported more bothersome stress (66% vs 36%, P < 0.001) and urgency incontinence (69% vs 48%, P = 0.007). For hysteropexy, there were no significant long-term differences in UDI-6 scores or bothersome urine leakage between sling groups. For hysterectomy, women with sling had better UDI-6 scores across time points (adjusted mean difference, -5.1; 95% confidence interval [CI], -9.9 to -0.2); bothersome stress and urgency leakage were less common in the sling group (stress adjusted odds ratio, 0.1 [95% CI, 0.0-0.4]; urge adjusted odds ratio, 0.5 [95% CI, 0.2-1.0]). Treatment for stress incontinence over 5 years was similar in the sling (7.9%) versus no-sling (7.6%) groups.; Conclusions: Five-year urinary outcomes of concomitant midurethral sling may vary by type of transvaginal prolapse surgery, with possible benefit of midurethral sling at the time of vaginal hysterectomy with apical suspension but not after mesh hysteropexy. (Copyright © 2022 American Urogynecologic Society. All rights reserved.)

Giugale, L. E., et al. (2021). "Preoperative Pelvic Floor Injections With Bupivacaine and Dexamethasone for Pain Control After Vaginal Prolapse Repair: A Randomized Controlled Trial." Obstetrics and Gynecology 137(1): 21-31.
	OBJECTIVE: To test the hypothesis that preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone would decrease postoperative pain after vaginal native tissue prolapse repairs, compared with saline and bupivacaine. METHODS: We conducted a three-arm, double-blind, randomized trial of bilateral transobturator levator ani muscle injections and transvaginal pudendal nerve blocks before vaginal reconstructive and obliterative prolapse procedures (uterosacral ligament suspension, sacrospinous ligament fixation, levator myorrhaphy, or colpocleisis). Women were randomized to one of three study medication groups: 0.9% saline, 0.25% bupivacaine, or combination 0.25% bupivacaine with 4 mg dexamethasone. Our primary outcome was a numeric rating scale pain score on postoperative day 1. Using an analysis of variance evaluated at the two-sided 0.05 significance level, an assumed variance of the means of 0.67, and SD of 1.75, we calculated 21 women per arm to detect a 2-point change on the numeric rating scale (90% power), which we increased to 25 per arm to account for 20% attrition and the use of nonparametric statistical methods. RESULTS: From June 2017 through April 2019, 281 women were screened and 75 (26.7%) were randomized with no differences in baseline demographics among study arms. There was no significant difference in median pain scores on postoperative day 1 among study groups (median [interquartile range] pain score 4.0 [2.0-7.0] for placebo vs 4.0 [2.0-5.5] for bupivacaine vs 4.0 [1.5-5.0] for bupivacaine with dexamethasone, P=.92). CONCLUSION: Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone did not improve postoperative pain after vaginal native tissue prolapse procedures. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03040011.

Giugale, L. E., et al. (2022). "Total Vaginal Hysterectomy with Uterosacral Ligament Suspension Compared with Supracervical Hysterectomy with Sacrocervicopexy for Uterovaginal Prolapse." Obstetrical and Gynecological Survey 77(3): 151-152.
	
Giulia, B., et al. (2022). "Impact of uterine manipulator on endometrial cancer."
	
Giuseppe, C., et al. (2022). "Systematic lymphadenectomy during interval debulking surgery for advanced epithelial ovarian cancer: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
gkbbq, R. B. R. (2022). "Manual therapy in menopausal women suffering from insomnia." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: D035061 The first stage, selection by telephone, will be brief and will serve to verify the menopausal status, interest in joining the study and ask questions for exclusion and inclusion criteria. The questionnaires will also be sent via the telephone application, through a google forms link, so that the first evaluation and session can then be scheduled. The first session will last an average of 2 hours (heart rate variability, assessment and intervention) and the 2nd session, with an interval of two weeks, 1 hour and 30 minutes on average (slightly faster, as there will be no randomization) . In the second stage, face‐to‐face, the participants, who will not know which group they will be allocated to, will provide demographic data and undergo an assessment with heart rate variability, carried out by a properly trained professional. Soon after, they will be randomized into an Experimental Group (osteopathic treatment) or Control Group (sham treatment, with positioning and soft touch) and referred for treatment, which includes assessment and manual therapy techniques, performed by osteopathy students in the 5th year of training. of osteopathy by the Madrid School of Osteopathy and trained by an experienced osteopath. Being the sham treatment for those included in the control group and osteopathic treatment. Each group will be composed of 51 participants, all of whom must be menopausal and have symptoms of insomnia, in addition to residing in Itaúna. In the third stage, the evaluation and intervention will take place in two sessions, and the heart rate variability in decubitus, supine and orthostatism will be evaluated before and after the osteopathic intervention. And in the fourth stage, which is one month after the last service, we will contact the participants by phone and vi CONDITION: D008593 Sleep initiation and maintenance disorders (insomnia) PRIMARY OUTCOME: It is expected to identify osteopathic physiotherapeutic treatment as an effective tool in improving autonomic nervous system function and sleep quality in menopausal women. SECONDARY OUTCOME: To establish a correlation between the worsening of dysautonomia in patients with insomnia and the perceived stress. INCLUSION CRITERIA: The following will be included in the studies: Women with amenorrhea for more than 11 (eleven) months; PSQI (Pittsburgh Sleep Quality Index) score > 5 (greater than five); Participants who voluntarily agree to participate in the study and sign the Free and Informed Consent Form (FICT) for a randomized clinical trial.

Gkegkes Ioannis, D., et al. (2023). "Pancreatic endometriosis: a systematic review." Annals of gastroenterology 36(1): 61-67.
	Background: Extrapelvic manifestations of endometriosis can be identified in nearly every part of the female body, and the true prevalence of extrapelvic locations is unknown. Pancreatic endometriosis may manifest in several ways, ranging from emergency presentations to asymptomatic cysts.; Method: A systematic PubMed and Scopus search was conducted.; Results: Eighteen patients from 17 case reports were included. The patients' mean age was 39.3 (range: 21-72) years. An emergency presentation was noted in 8 of the 18 (44.4%) patients. Menstrual irregularity was present in 3 (16.7%) patients, while in 3 (16.7%) cases there was simultaneous presence of endometriosis elsewhere. The most frequent symptoms at presentation of pancreatic endometrial cysts were epigastric pain, acute left upper quadrant pain, back pain, nausea/vomiting/diarrhea, which occurred in 12 (66.7%), 11 (61.1%), 4 (22.2%), and 6 (33.3%) patients, respectively. Only one case presented as an asymptomatic pancreatic cyst. The maximum diameter of the endometrial cysts ranged from 1-16 cm. In the majority of cases, surgical treatment was offered (16/18, 88.9%). Recurrence of pancreatic endometrial cyst occurred in one case only, following needle aspiration of the endometrial cyst. No fatality was reported.; Conclusions: Review of the available published literature suggests that pancreatic endometriosis is a rare condition that should be included in the differential diagnosis of pancreatic masses. Further clinical and experimental studies are necessary to investigate the pathogenesis of extrapelvic and pancreatic endometriosis.; Competing Interests: Conflict of Interest: None (Copyright: © Hellenic Society of Gastroenterology.)

Gkrozou, F., et al. (2022). "Endometrial Cancer Following Endometrial Ablation: An Overview of Published Literature." Indian Journal of Gynecologic Oncology 20(2): 26.
	Purpose: This study is an evaluation of the long-term risk of endometrial cancer in patients undergoing EA with first- and second-generation ablative techniques. A variety of different endometrial ablation devices developed, with complication rate lower than the hysteroscopic resection. The incidence of endometrial cancer has risen by 57% in the last 20 years worldwide. More than 90% of patients will present with postmenopausal bleeding as the most common red flag symptom for endometrial cancer. A reasonable assumption is that through destruction of the endometrium, the incidence of endometrial cancer after EA should be reduced. However, there are concerns raised regarding intrauterine scarring and distortion of the uterine cavity after EA, which may delay the diagnosis of endometrial cancer. Method(s): For this narrative review, four major search engines were explored (MEDLINE, Google Scholar, PubMed and EMBASE) up to December 2021, to retrieve articles that provide information about on incidence of endometrial cancer after endometrial ablation. Result(s): Thirty-two cases have been identified and studied. This study has confirmed that 76.5% of endometrial cancer cases after EA were diagnosed at stage I, which is consistent with the evidence from the literature. It has also showed that endometrial ablation does not delay the diagnosis of endometrial cancer. Conclusion(s): All clinicians need to maintain high degree of suspicion and thus offer in-depth counselling to their patients. Patient selection is important, and thus, ablation should be offered only to women preferable without risk factors, along with a recent normal endometrial biopsy.Copyright © 2022, The Author(s) under exclusive licence to Association of Gynecologic Oncologists of India.

Gkrozou, F., et al. (2021). "Tubo-ovarian abscess: Exploring optimal treatment options based on current evidence." Journal of Endometriosis and Pelvic Pain Disorders 13(1): 10-19.
	Purpose: Tubo-ovarian abscess (TOA) and pelvic abscess are characterized by an inflammatory pelvic mass. In the majority of cases, this condition involves the ovaries, the fallopian tubes and/or any other adjacent tissue. TOA is considered a severe complication of PID and can cause severe sepsis. The main risk factors for women's health are the size of the abscess, the initial amount of white blood cells (WBC), patients' age as well as, any co-existing comorbidities. Method(s): This study provides a review of the current literature regarding the management of TOA and the different criteria used in order to establish the optimal therapeutic approach or to predict outcome by individualizing cases. Four major search engines, MEDLINE, Google Scholar, PubMed and EMBASE, up to February 2020 were explored, focusing in epidemiology and risk factors, pathogenesis, diagnosis and treatment. Result(s): Our review suggests that there are no clear guidelines for best practice, in case of TOA, but it appears that intravenous antibiotics combined with interventional radiology have good results for TOA <5 cm. When TOA is >5 cm, laparoscopic approach is indicated. Further studies are needed in order to evaluate the best treatment for women with TOA. Conclusion(s): More prospective studies on large-series of patients are in need, in order to determine a clear pathway and to suggest specific criteria, which can guide clinicians to choose optimal approach in a timely manner.Copyright © The Author(s) 2020.

Glanville Elizabeth, J., et al. (2022). "A randomized trial of endometrial scratching in women with PCOS undergoing ovulation induction cycles." Reproductive Biomedicine Online 44(2): 316-323.
	Research Question: Does endometrial scratching improve the chance of a live birth in women with polycystic ovary syndrome (PCOS) undergoing ovulation induction and trying to conceive?; Design: An international, multicentre, randomized, sham-controlled trial across six fertility clinics in three countries (New Zealand, UK and Brazil). Women with a diagnosis of PCOS who were planning to commence ovulation induction cycles (at least three cycles) in order to conceive were randomly assigned to receive the pipelle (scratch) procedure or a sham (placebo) procedure in the first cycle of ovulation induction. Women kept a diary of ovulation induction and sexual intercourse timing over three consecutive cycles and pregnancies were followed up to live birth. Primary outcome was live birth and secondary outcomes were clinical pregnancy, ongoing pregnancy, multiple pregnancy, adverse pregnancy outcomes, neonatal outcomes, bleeding following procedure and pain score following procedure.; Results: A total of 117 women were randomized; 58 to the scratch group and 59 to the sham group. Live birth occurred in 11 (19%) women in the scratch group and 14 (24%) in the sham group (odds ratio 0.76, 95% confidence interval [CI] 0.30-1.92). Secondary outcomes were similar in each group. Significantly higher pain scores were reported in the scratch group (adjusted mean difference 3.2, 95% CI 2.5-3.9) when measured on a visual analogue scale.; Conclusion: No difference was detected in live birth rate for women with PCOS who received an endometrial scratch when trying to conceive using ovulation induction; however, uncertainty remains due to the small sample size in this study. (Copyright © 2021 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Gleason, C. E., et al. (2024). "Long-term cognitive effects of menopausal hormone therapy: Preliminary data from the KEEPS Continuation Study." Journal of Neurosurgical Anesthesiology 36(1): 1258.
	Objective: Findings from the Kronos Early Estrogen Prevention Study (KEEPS)- Cog trial suggested no cognitive benefit or harm after 48 mos of early postmenopause hormone therapy (HT) taken in early menopause. Long-term effects of early menopausal HT are understudied. The KEEPS-Continuation reevaluated cognition, mood, and neuroimaging effects in KEEPS women, ~10 yrs after randomization (~6 yrs after trial completion). Preliminary cognitive findings are presented here. Design(s): Women enrolled in KEEPS were randomized to placebo or HT [oral conjugated equine estrogens (oCEE+progesterone) or transdermal 17-beta-estradiol (tE2+progesterone)] for 48mos. After ~10 yrs (M(SD)=9.57(1.08) yrs), KEEPS-Continuation assessed long-term HT effects. Cognitive tests from KEEPS and KEEPS-Continuation were analyzed as 4 factor scores. Because KEEPS-Continuation visits occurred 8-14 yrs post-randomization, Linear latent growth models (LGM) with distal outcomes, tested whether baseline cognitive performance and change-in-cognition across KEEPS visits predicted "distal" KEEPS-Cognition cognition, and whether HT randomization modified this relationship. Covariates included education, age, and APOEe4 carrier status. LGMs summary fit measures were assessed along with residuals for mean and covariance. Result(s): Of KEEPS enrollees, N=299 (41%) participated in KEEPS-Continuation. Similar health characteristics were observed at randomization for participants (agemean=65.8; range: 56-71) and non-participants (i.e. women not enrolled in KEEPS-Continuation). For women in the KEEPS-Continuation, cognitive performance was not influenced by either HT formulation. Instead, models showed strong associations between baseline and changein- cognition during KEEPS and the same measures in KEEPS-Continuation (Table 1); i.e., strongest predictor of cognitive performance in KEEPS-Continuation was cognitive performance in KEEPS. KEEPS-Continuation cross-sectional comparisons confirmed that both HT-groups performed similarly to placebo on cognitive measures. Conclusion(s): Preliminary KEEPS-Continuation analyses detected no long-term cognitive effects of shortterm (48mos) menopausal HT vs placebo. Subsequent analyses will examine the influence of HT vs. placebo on mood and amyloid PET, and non-randomized use of HT post KEEPS on all outcomes. These data provide important information for recently menopausal women with good cardiovascular health considering HT for menopausal symptoms. (Table Presented).

Gluck, O., et al. (2023). "The Effect of Preemptive Local Infiltration on Postoperative Pain After Vaginal Hysterectomy: A Retrospective Study." Journal of Minimally Invasive Gynecology 30(4): 308-311.
	Study Objective: To investigate the effect of preemptive infiltration on postoperative pain and the use of analgesics after vaginal hysterectomy (VH). Design(s): A retrospective study. Setting(s): An urogynecology unit in a tertiary medical center. Patient(s): A total of 120 patients who had undergone VH. Intervention(s): The study group contained 60 patients who participated in a former randomized control study, in which preemptive local infiltration of bupivacaine (n = 30) or sodium chloride 0.9% (n = 30) was performed. The control group included 60 consecutive patients who underwent a VH, for whom no local infiltration was performed. Measurements and Main Results: Postoperative pain at rest was assessed using the 10 cm visual analog scale at 3, 8, and 24 hours after surgery. The levels of pain, as well as the use of analgesics, postoperatively, were compared between the groups. The mean surgery length in the infiltration group was shorter (86.4+/-29 vs 118.6+/-30, p <.001) and the rate of posterior colporrhaphy was lower (73.1% vs 91.3%, p = .010) than the control group. There were no differences in levels of pain at all points of time. However, the infiltration group required a lower morphine dose in the recovery unit (3.7 +/- 2.3 mg vs 5.3 +/- 2.4 mg, p <.001) and less use of analgesia (all kinds) 24 hours after surgery (54.2% vs 79.6%, p <.001) compared with the control group. On multivariant analysis, preemptive infiltration was found to be independently inversely associated with the dose of morphine used in recovery, as well as analgesics used 24 hours after surgery. Conclusion(s): Preemptive local infiltration of either bupivacaine or sodium chloride 0.9% reduced the use of morphine in the recovery unit, as well as the use of analgesics 24 hours after VH, compared with no infiltration at all.Copyright © 2022 AAGL

Gluck, O., et al. (2021). "The effect of preemptive local anesthesia on postoperative pain following vaginal hysterectomy: a randomized controlled trial." European Journal of Obstetrics, Gynecology, and Reproductive Biology 267: 269‐273.
	OBJECTIVE: We aimed to study the effect of preemptive local anesthetic without adrenaline on postoperative pain following vaginal hysterectomy and concomitant trans obturator tape (TOT). STUDY DESIGN: This was a double‐blinded, randomized, controlled trial. Women who undergone elective vaginal hysterectomy were included. Solutions of either Bupivacaine‐Hydrochloride 0.5%, or Sodium‐Chloride 0.9% as a placebo, were prepared prior to surgery, according to randomization. The chosen solution was injected before incision, in a circumferential manner, to the cervix. The amount of fluid administered was 10 ml. When colporrhaphy was also performed, an additional 5 ml of solution were injected in the midline of the vaginal wall prior to each incision line. We conformed to the CONSORT recommendations. By utilizing the 10 cm Visual‐analogue‐scale (VAS) we assessed post‐operative pain at rest at 3, 8, and 24 h, and during ambulation at 8 and 24 h. We estimated that the intervention would cause a 25% reduction in the primary outcome. The required total sample size was calculated to be 30 patients women for each group. We used ANOVA for continuous variables and the Chi‐square or Fisher exact tests for categorical variables. RESULTS: A total of 30 women were included in each group. The level of postoperative pain, as assessed by VAS, was not significantly different between the groups, in all points of time. In addition, there was no difference between the groups in opioid based analgesics during recovery, nor in postoperative analgesic use. CONCLUSION: Preemptive local anesthesia was not shown to be efficient in reducing postoperative pain after vaginal hysterectomy and TOT.

Gmb, H. A. G. O. R. and GlaxoSmithKline (2023). Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi.
	No Results Available Drug: Niraparib|Drug: Dostarlimab Objective Response Rate (ORR)|Response Rate|Median Progression Free Survival (PFS)|6 months Progression Free Survival (PFS) rate|Disease Control Rate (DCR)|Overall Survival (OS)|Time from registration to start of first subsequent therapy (TFST) Female Phase 2 100 Industry Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment AGO-OVAR 2.35|2021-003572-14 November 1, 2026

Gmb, H. E. H. (2024). Pilotstudie Zur Untersuchung Des Effektes Einer Dysmenorrhoe-App.
	No Results Available Device: Pia-App Dysmenorrhea Symptom Interference Scale (DSI)|Moos Menstrual Distress Questionnaire, Form C (MDQ)|Visuelle Analogskala Schmerz (VAS)|Depression Anxiety Stress Scale mit 21 Items (DASS-21)|Fragebogen zur Erfassung der schmerzspezifischen Selbstwirksamkeit (FESS)|Fatigue Severity Scale (FSS)|Pain Disability Index (PDI) Female Not Applicable 100 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Investigator, Outcomes Assessor)|Primary Purpose: Supportive Care RCT004_PilotPia July 2024

Gmb, H. p. (2021). CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib.
	No Results Available Drug: Rucaparib Safety follow-up All Phase 3 34 Industry Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CO-338-111|2020-001538-37 March 8, 2023

Gnanachandran, C., et al. (2023). "Myomectomy Benefits, Risks, Long-Term Outcomes, and Effects on Fertility and Pregnancy Outcomes: A Literature Review." Journal of Gynecologic Surgery 39(4): 151-157.
	Objective: Abdominal myomectomy is the mainstay for women with intramural fibroids who want to conceive. Informed choice, discussion on alternatives, and consent for surgery are essential prior to the procedure. Women with fibroids need to understand the potential long-term complications and future implications, including the effects of fibroids or myomectomy on fertility and pregnancy outcomes. This article offers evidence-based information for informing women about the consequences and benefits of myomectomy and other treatments. Method(s): Using thesaurus terms, articles in English since 2012, on PubMed, Embase (OVID), and MEDLINE (ProQuest) databases were retrieved via the National Institute for Health and Care Excellence Healthcare Databases Advanced Search interface. Myomectomy outcomes, risks, complications, fertility, and rare complications later in pregnancy were reviewed. Result(s): Ninety-two articles were chosen. They covered topics relevant to this review. Duplicate articles, those not related to this review, or with low numbers of cases in retrospective studies were excluded. When fibroids affect reproductive age women, myomectomy's surgical and reproductive outcomes have significant benefits, compared to relatively severe but uncommon complications. Myomectomy-related long-term reintervention is higher than for hysterectomy, but short-term outcomes for pain and bleeding are comparable to hysterectomy. Conclusion(s): Myomectomy (laparoscopic or open) is safe. Benefits are greatest for reproductive-age women with fibroids. Surgical and reproductive outcomes of myomectomy have benefits, compared to relatively few severe but uncommon complications. This review article of all the potential benefits, risks, and complications can help surgeons inform patients appropriately and reduce potential litigation. (J GYNECOL SURG 39:151)Copyright © Mary Ann Liebert, Inc.

Godiwala, P., et al. (2024). "The impact of microfluidics sperm processing on blastocyst euploidy rates compared with density gradient centrifugation: a sibling oocyte double-blinded prospective randomized clinical trial." Fertility and Sterility 122(1): 85-94.
	OBJECTIVE: To compare the euploidy rates among blastocysts created from sibling oocytes injected with sperm and processed using microfluidics or density gradient centrifugation. DESIGN: Sibling oocyte randomized controlled trial. SETTING: Single university-affiliated infertility practice. PATIENTS: A total of 106 patients aged 18-42 years undergoing fresh in vitro fertilization treatment cycles with preimplantation genetic testing between January 2021 and April 2022 contributed 1,442 mature oocytes, which were injected with sperm and processed using microfluidics or density gradient centrifugation. INTERVENTION(S): The sperm sample is divided and processed using a microfluidics device and density gradient centrifugation for injection into sibling oocytes. MAIN OUTCOME MEASURE(S): The primary outcome was the embryo euploidy rate. Secondary outcomes included fertilization, high-quality blastulation, and ongoing pregnancy rates. RESULT(S): The blastocyst euploidy rate per mature oocyte was not significantly different in the study group compared with the control group (22.9% vs. 20.5%). The blastocyst euploidy rate per biopsied embryo was also similar between the 2 groups (53.0% vs. 45.7%). However, the fertilization rate per mature oocyte injected was found to be significantly higher in the study group compared with the control group (76.0% vs. 69.9%). The high-quality blastulation rate per mature oocyte injected was similar between the 2 groups, as was the total number of embryos frozen. There were no differences in the number of participants with no blastocysts for biopsy or the number of participants with no euploid embryos between the 2 groups. Among the male factor infertility and recurrent pregnancy loss subgroups, there were no differences in euploidy rates, fertilization rates, blastulation rates, or total numbers of blastocysts frozen, although the study was underpowered to detect these differences. Seventy-seven patients underwent frozen embryo transfer; there were no significant differences in pregnancy outcomes between the 2 groups. CONCLUSION(S): Microfluidics processing did not improve embryo euploidy rates compared with density gradient centrifugation in this sibling oocyte study, although fertilization rates were significantly higher. CLINICAL TRIAL REGISTRATION NUMBER: NCT04744025.

Goel, V., et al. (2023). "The Comparative Analysis of the Effectiveness of Inj. Methotrexate and Tab Mifepristone vs Inj. Methotrexate alone in the Medical Management of Ectopic Pregnancy." Journal of Cardiovascular Disease Research 14(8): 2201-2208.
	Background: Recent trends in ectopic pregnancy morbidity and the percentage of young, childless patients make it critical to identify EP early to save patients' lives and preserve their fertility to the fullest extent possible. The most commonly used conservative therapies are methotrexate and mifepristone, but it is impossible to determine which treatment is superior. Aim and Objective: The Comparative Analysis of the Effectiveness of Inj. Methotrexate and Tab Mifepristone vs Inj. Methotrexate alone in the Medical Management of Ectopic Pregnancy. Material(s) and Method(s): This was a randomized control trial. Patients with a progressing ectopic pregnancy meeting criteria for medical management were included in the study. Patients were assigned to two groups based on random selection. Group 1 was given a combination of 200 mg of Tab mifepristone and inj. Methotrexate IM (50 mg/m2). Group 2 received only injections of methotrexate. The dose of methotrexate was repeated depending on the individual patient's response. Results and Conclusion(s): In terms of success rate and the requirement for a second dosage of methotrexate, there was no statistically significant difference between the two groups. However, employing a combination therapy instead of just methotrexate for medical care resulted in a quicker resolution of the ectopic pregnancy and a shorter hospital stay. p=0.002275.Copyright © 2023 EManuscript Technologies. All rights reserved.

Goenka, L., et al. (2022). "Use of "Repurposed" Drugs in the Treatment of Epithelial Ovarian Cancer: A Systematic Review." American Journal of Clinical Oncology 45(4): 168-174.
	Epithelial ovarian cancer has poor outcomes with standard therapy and limited options for treatment of recurrent disease. This systematic review summarizes the data on the clinical use of repurposed drugs. We searched for clinical studies using "repurposed" agents for the treatment of ovarian cancer in the following databases: PubMed, clinicaltrials.gov, Clinical Trial Registry of India, European Clinical Trials Registry, and Chinese Clinical Trial Registry. We excluded reviews, preclinical studies, and non-English language studies. We assessed the quality of included studies. The following agents/class of agents were included: statins, hydroxychloroquine, metformin, itraconazole, nonsteroidal anti-inflammatory drugs, vitamin D, proton pump inhibitors, beta-blockers, and sodium valproate. Only one randomized controlled trial investigated metformin, which found no benefit of metformin. However, this had a high risk of bias (no details of randomization). Among the observational studies, 70% were of high quality (Newcastle-Ottawa scale ≥7). Clinical benefit was seen for itraconazole, beta-blockers, metformin, statins, and proton pump inhibitors. Though multiple studies aim to repurpose agents in epithelial ovarian cancer, the most published literature is observational, and none are practice-changing. Given the solid preclinical data regarding the anticancer efficacy of these agents, well-designed clinical trials are urgently required.; Competing Interests: The authors declare no conflicts of interest. (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Goitia, M. and J. Estadella (2023). "[Emerging therapies in the medical treatment of uterine fibroids]." Medicina clinica 161 Suppl 1: S32-S37.
	
Goje, O., et al. (2021). "Outcomes of Minimally Invasive Management of Tubo-ovarian Abscess: A Systematic Review." Journal of Minimally Invasive Gynecology 28(3): 556-564.
	Objective: To compare the success rate, complications, and hospital length-of-stay of 3 modalities of minimally invasive management of tubo-ovarian abscesses (TOAs): laparoscopy, ultrasound-guided drainage, and computed tomography-guided drainage.; Data Sources: Electronic-based search in PubMed, EMBASE, Ovid MEDLINE, Google Scholar, and Cochrane Central Register of Controlled Trials, using the following Medical Subject Heading terms: "minimally invasive surgical procedures," "drainage," "abscess," "tubo-ovarian," "ovarian diseases," and "fallopian tube diseases."; Methods of Study Selection: Of the 831 articles in the initial results, 10 studies were eligible for inclusion in our systematic review.; Tabulation, Integration, and Results: A total of 975 patients were included in our study; 107 (11%) had laparoscopic drainage procedures, and 406 (42%) had image-guided (ultrasound or computed tomography) drainage of TOAs. Image-guided TOA drainage had higher success rates (90%-100%) than laparoscopic drainage (89%-96%) and the use of antibiotic treatment alone (65%-83%). Patients treated with image-guided drainage had no complications (for up to 6 months of follow-up) and shorter lengths of hospital stay (0-3 days on average) compared with laparoscopic drainage (5-12 days) or conservative management with antibiotics alone (7-9 days).; Conclusion: Although conservative management of TOAs with antibiotics alone remains first-line, our review indicates that better outcomes in the management of TOA were achieved by minimally invasive approach compared with conservative treatment with antibiotics only. Of the minimally invasive techniques, image-guided drainage of TOAs provided the highest success rates, the fewest complications, and the shortest hospital stays compared with laparoscopy. The low magnitude of evidence in the included studies calls for further randomized trials. This systematic review was registered in the International Prospective Register of Systematic Review (register, http://www.crd.york.ac.uk/PROSPERO;CRD 42020170345). (Copyright © 2020 AAGL. Published by Elsevier Inc. All rights reserved.)

Goje, O., et al. (2023). "Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306." Journal of women's health (2002) 32(2): 178-186.
	Background: Ibrexafungerp is a novel antifungal treatment for acute vulvovaginal candidiasis (VVC). Using pooled data from two phase three studies (VANISH 303 and 306) in the treatment of acute VVC, this analysis sought to determine the effectiveness of ibrexafungerp in various patient subgroups that may impact outcomes. Materials and Methods: Data from VANISH 303 (NCT03734991) and VANISH 306 (NCT03987620) evaluating ibrexafungerp 300 mg twice daily (BID) for 1 day versus placebo, were pooled and analyzed to determine clinical cure rate, clinical improvement, and mycological cure at the test-of-cure visit (day 11 ± 3) and symptom resolution at the follow-up visit (day 25 ± 4) in the overall population. Patient subgroups analyzed included race, body mass index (BMI), baseline vulvovaginal signs and symptoms (VSS) score, and Candida species. Results: At the test-of-cure visit, patients receiving ibrexafungerp, compared with those who received placebo, had significantly higher rates of clinical cure (56.9% [214/376 patients] vs. 35.7% [65/182 patients]), clinical improvement (68.4% [257/376 patients] vs. 45.1% [82/182 patients]), and mycological cure (54.0% [203/376 patients] vs. 24.2% [44/182 patients]; all p < 0.0001). At the follow-up visit, patients receiving ibrexafungerp had sustained responses with higher symptom resolution rates (66.8% [251/376 patients]) versus placebo (48.4% [88/182 patients]; p < 0.0001). Race, BMI, baseline VSS score (including VSS severity score 13-18), and Candida species infection did not adversely affect clinical cure rates. Safety analysis results were consistent with the individual studies. Conclusions: Ibrexafungerp provides a safe and well-tolerated first-in-class fungicidal, 1-day oral treatment for patients with acute VVC, the first new therapy in >20 years. Clinical Trial Registration Number: NCT03734991.

Goje, T., et al. (2022). "Outcomes in Subpopulations from Pooled Phase 3 Clinical Studies of Oral Ibrexafungerp Versus Placebo in Patients with Vulvovaginal Candidiasis (VANISH 303 and 306)." American Journal of Obstetrics and Gynecology 226(2): 290.
	Objectives: In the United States (US), there are approximately 10 million office visits annually for vaginal symptoms, of which approximately 20-25% are vulvovaginal candidiasis (VVC). The current approved therapies for treatment of VVC are all azoles which are fungistatic. Here, we introduce oral ibrexafungerp (IBX), a novel triterpenoid antifungal, with fungicidal activity against a broad range of Candida species for treatment of VVC. The purpose of this research is to examine efficacy and safety; and subpopulation outcomes from two phase 3 clinical trials of oral IBX versus Placebo (PLC) in patients with vulvovaginal candidiasis (VVC) in a pooled analysis Methods: Two randomized, double-blind, placebo-controlled clinical trials of IBX were conducted in patients with VVC, (VANISH 303 and 306). VANISH 303 enrolled patients in the United States (US) and VANISH 306 in the US and Bulgaria. Inclusion criteria were: females with vaginal sign and symptoms (VSS) >=4 at baseline, age >=12 years, potassium hydroxide (KOH)-positive microscopy. Patients were randomized 2:1 to receive IBX 300 mg BID for one day for a total treatment dosage of 600 mg or matching PLC. The primary endpoint was the percentage of patients with clinical cure (complete resolution of VSS=0) at the test-of-cure (TOC) (day 11+/-3) visit. Data from both studies were pooled, and key subgroups of interest analyzed. Result(s): 376 patients receiving IBX and 182 patients receiving placebo were included in the pooled modified intent-to-treat (mITT) analysis. Overall, IBX demonstrated superiority over PLC in the primary endpoint of clinical cure at TOC, 56.9% vs. 35.7% respectively (p<0.001), Clinical cure at TOC in sub-populations for IBX were as follows: in patients aged <65, 57.0% (n=374), in Black patients, 52.3% (n=107), in Hispanic or Latino patients, 54.7% (n=75), in patients with BMI >35, 46.2% (n=65). IBX was generally well-tolerated, with Treatment-Emergent Adverse Events (TEAEs) reported in >=5% of IBX-treated patients including diarrhea (16.7%), nausea (11.9%), and abdominal pain (8.3%), the majority were mild to moderate in nature, lasting 1 day. Conclusion(s): This analysis shows the efficacy and safety of IBX, a fungicidal anti-fungal in the treatment of VVC, and in relevant sub-populations. If approved, oral IBX will provide the first new non-azole option for clinicians to prescribe to their patients suffering from VVC.Copyright © 2021

Gök, S. and E. Alataş (2022). "Effects of Levonorgestrel-Releasing Intrauterine Device Therapy on Ovarian Reserve in Menorrhagia." Cureus 14(11): e31721.
	Objective This study aimed to investigate the effects of levonorgestrel-releasing intrauterine device (LNG-IUD) treatment on ovarian reserve in women of reproductive age diagnosed with menorrhagia. Methods This was a prospective controlled trial involving 50 women with menorrhagia and a control group comprising age-matched 50 healthy women. Women who satisfied the LNG group criteria underwent an endometrial pipelle biopsy and LNG-IUD insertion. Ovarian reserve tests were performed prior to and six months after LNG-IUD insertion in the LNG group cases. Results Follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), anti-Müllerian hormone (AMH), endometrial thickness (ET), total antral follicle count (AFC), and mean ovarian volume values before LNG-IUD insertion did not differ between the LNG and control groups. When the final measurements were compared, FSH, AMH, total AFC, and average ovarian volume increased (p=0.05, 0.046, 0.022, and 0.022, respectively), E2 and ET decreased (p=0.034 and 0.001, respectively) in the LNG group, while LH did not differ significantly between the groups (p=0.71). Conclusion We observed that LNG-IUD use effectively improves fertility capacity. In this study, LNG-IUD use in reproductive-age women diagnosed with menorrhagia decreased E2 levels, did not change LH levels, and increased FSH, AFC, and AMH levels.; Competing Interests: The authors have declared that no competing interests exist. (Copyright © 2022, Gök et al.)

Gökbulut, N., et al. (2022). "The impact of foot massage given to postmenopausal women on anxiety, fatigue, and sleep: a randomized-controlled trial." Menopause (New York, N.Y.) 29(11): 1254-1262.
	Objective: This study aims to determine the impact of foot massage given to postmenopausal women on anxiety, fatigue, and sleep.; Methods: This randomized-controlled study was conducted with 70 women (35 experimental, 35 control) who resided in a village located in Northern Turkey. In the study, the women in the experimental group were given foot massage once every day for 7 days. No intervention was applied to the women in the control group. The data were collected using a Personal Information Form, the Fatigue Severity Scale (FSS), and the Beck Anxiety Inventory (BAI) Descriptive statistics (frequency, percentage distribution, median, and Q1-Q3), χ 2 test, Mann-Whitney U test, and Wilcoxon test were used in the analysis of the data.; Results: It was found that the women in the control group had lower pretest BAI scores than those in the experimental group ( P < 0.05), whereas before the foot massage intervention, the women in the experimental and control groups had similar FSS scores and sleep hours ( P > 0.05). After the foot massage, the FSS scores were 2.3 (1.6-3.4) in the experimental group and 5.5 (4.6-6.2) in the control group, the BAI scores were 26.0 (23.0-29.0) in the experimental group and 36.0 (31.0-43.0) in the control group, the daily sleep hours were 8.0 (8.0-10.0) in the experimental group and 7.0 (6.0-8.0) in the control group, and the differences between the groups were statistically significant ( P < 0.001).; Conclusions: It was determined that foot massage applied during menopause increases the average daily sleep duration (hours) and reduces women's fatigue and anxiety levels.; Competing Interests: Financial disclosures/conflicts of interest: None reported. (Copyright © 2022 by The North American Menopause Society.)

Gold, M. H., et al. (2023). "Improvements in Skin Quality Parameters in Postmenopausal Participants After Use of Topical Growth Factor Serum." Journal of cosmetic dermatology 22(1): 236‐244.
	BACKGROUND: Photodamage can induce skin aging processes that can be particularly concerning for postmenopausal women. Growth factors from hypoxic human fibroblast‐conditioned media have demonstrated improvements in skin quality parameters. AIMS: The aim of the study was to assess efficacy and tolerability of topical combination‐treatment hypoxic growth factor serum (TNS A+) in postmenopausal women with moderate to severe facial photodamage. PATIENTS/METHODS: In this 12‐week, open‐label, single‐center study, participants used TNS A+ serum twice daily. Postmenopausal women (40‐65 years of age) with Fitzpatrick skin types I‐VI and modified Griffiths scale scores 4‐9 were eligible. Clinical and participant‐reported assessments were evaluated at Weeks 6 and 12. Statistical significance was defined as p ≤ 0.05. RESULTS: There were 17 enrolled participants. TNS A+ treatment demonstrated significant improvements from baseline in fine lines and wrinkles in periocular, forehead, and cheek areas at Week 12 and the perioral area at Weeks 6 and 12. Significant improvements from baseline in coarse lines and wrinkles were observed for the perioral area at Week 12 and periocular and cheek areas at Weeks 6 and 12. Improvements in overall photodamage, skin tone evenness, and tactile roughness were significantly greater at Weeks 6 and 12 versus baseline. Most participants reported TNS A+ made their skin look and feel smooth, soft, and rejuvenated; improved skin radiance; made lines and wrinkles less apparent; and improved skin texture. No treatment‐related adverse events were reported. CONCLUSIONS: The TNS A+ regimen was well tolerated and provided significant improvements in skin quality in postmenopausal women with moderate to severe facial photodamage.

Goldberg Rebecca, M., et al. (2022). "Secondary cytoreductive surgery for recurrent low-grade serous ovarian carcinoma: A systematic review and meta-analysis." Gynecologic Oncology 164(1): 212-220.
	Objectives: Low-grade serous ovarian cancer (LGSC) is a relatively chemo-resistant disease with limited effective treatment options for patients with recurrence. Secondary cytoreductive surgery (SCS) is commonly offered at recurrence, although any benefit this has on survival is not fully determined. This review evaluates the impact of SCS, including residual disease, on progression-free survival (PFS) and overall survival (OS) in recurrent LGSC.; Methods: A comprehensive search of Medline ALL, Embase Classic + Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Web of Science was conducted to obtain studies evaluating optimal or complete SCS versus suboptimal SCS and the amount of residual disease in recurrent LGSC. Meta-analysis was performed and PFS and OS outcomes were calculated.; Results: 1Of 5296 studies screened, 350 progressed to full-text review, with 9 ultimately selected for inclusion in the systematic review. Two studies met criteria for meta-analysis of PFS and of OS. The presence of visible residual disease at the conclusion of SCS negatively impacted PFS (HR = 3.51, 95% CI = 1.72-7.14), whereas SCS with no residual disease significantly improved OS (HR = 0.4, 95% CI = 0.23-0.7) in patients with recurrent LGSC. Diffuse and extensive disease distribution was inversely linked to survival. In addition, SCS as an initial treatment for recurrent LGSC was associated with superior survival in comparison to chemotherapy. A short platinum-free interval was not associated with worse survival in this cohort.; Conclusions: Complete SCS, and to a lesser extent optimal SCS, are associated with improved PFS and OS in patients with recurrent LGSC. SCS may be a better initial treatment strategy than systemic chemotherapy for recurrent disease. Patients with recurrent LGSC should be evaluated for the role of SCS based on disease distribution and functional status, irrespective of the platinum-free interval. Prospective studies are needed to further study the role of SCS in patients with recurrent LGSC.; Competing Interests: Declaration of Competing Interest The authors have no conflict of interests to declare. (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Goldman, A. R., et al. (2021). "Transcutaneous Electrical Nerve Stimulation to Reduce Pain With Medication Abortion: a Randomized Controlled Trial." Obstetrics and Gynecology 137(1): 100‐107.
	OBJECTIVE: To evaluate whether high‐frequency transcutaneous electrical nerve stimulation (hfTENS) reduces pain during medication abortion. METHODS: We conducted a randomized, placebo‐controlled trial. Participants who were undergoing medication abortion with mifepristone and misoprostol through 70 days of gestation either received active 80 Hz hfTENS or sham to use for a minimum of 60 minutes within 8 hours of misoprostol. Maximum pain on an 11‐point numerical rating scale at 8 hours after misoprostol was the primary outcome. We estimated 20 per group for 80% power to detect a 2‐point difference and up to 10% attrition. Secondary outcomes included a maximum pain score at 24 hours, additional analgesia use, the difference in score before and after treatment, the experience of side effects, abortion outcomes, and acceptability. We collected data at baseline, time of misoprostol (0‐hour), 8‐hour and 24 hours using real‐time electronic surveys, and at follow‐up. RESULTS: Between June 2019 and March 2020, we screened 251 patients and randomized 40‐20 each to hfTENS or sham‐with one postrandomization exclusion and two patients lost to follow‐up. Baseline characteristics were similar. Median maximum pain scores at 8 hours were 7.0 (interquartile range 3.0) and 10.0 (interquartile range 3.0) for hfTENS and sham, respectively. The distribution of these scores was lower among hfTENS users compared with sham (mean rank 15.17 vs 22.63, P=.036). High‐frequency TENS users also experienced a significant reduction in posttreatment pain score (‐2.0 [interquartile range 2.5] vs 0 [interquartile range 1.5], P=.008). We found no statistically significant differences in use of additional analgesia, distribution of maximum pain scores at 24 hours, side effects, or measures of acceptability. CONCLUSION: High‐frequency TENS reduced maximum pain scores within 8 hours of misoprostol and reduced pain scores immediately after treatment compared with placebo. High‐frequency TENS offers an effective nonpharmacologic option for pain management during medication abortion. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03925129.

Goldštajn Marina, Š., et al. (2023). "Effects of transdermal versus oral hormone replacement therapy in postmenopause: a systematic review." Archives of Gynecology and Obstetrics 307(6): 1727-1745.
	Purpose: To summarize available evidence comparing the transdermal and the oral administration routes of hormone replacement therapy (HRT) in postmenopausal women.; Methods: We performed a systematic review of the literature on multiple databases between January 1990 and December 2021. We included randomized controlled trials and observational studies comparing the transdermal and oral administration routes of estrogens for HRT in postmenopausal women regarding at least one of the outcomes of interest: cardiovascular risk, venous thromboembolism (VTE), lipid metabolism, carbohydrate metabolism, bone mineral density (BMD), and risk of pre-malignant and malignant endometrial lesions, or breast cancer.; Results: The systematic literature search identified a total of 1369 manuscripts, of which 51 were included. Most studies were observational and of good quality, whereas the majority of randomized controlled trials presented a high or medium risk of bias. Oral and transdermal administration routes are similar regarding BMD, glucose metabolism, and lipid profile improvements, as well as do not appear different regarding breast cancer, endometrial disease, and cardiovascular risk. Identified literature provides clear evidence only for the VTE risk, which is higher with the oral administration route.; Conclusions: Available evidence comparing the transdermal and oral administration routes for HRT is limited and of low quality, recommending further investigations. VTE risk can be considered the clearest and strongest clinical difference between the two administration routes, supporting the transdermal HRT as safer than the oral administration route. (© 2022. The Author(s).)

Goldstein, A., et al. (2023). "Phase II Study of AbobotulinumtoxinA in Patients with Provoked Vestibulodynia: Outcomes From Dose-finding Stage." Journal of Sexual Medicine 20(Supplement 2).
	Introduction Vulvodynia is associated with significant burden and impaired quality of life and affects up to 28% of women of reproductive age. The most common subtype is provoked vestibulodynia (PVD), in which pain is localized and triggered by vestibular contact. Treatment options are limited; no therapy is approved for PVD. Hypertonicity of the pelvic floor muscles is a common factor associated with PVD; therefore, patients may benefit from treatments that relax the pelvic floor. BotulinumtoxinA is used for prolonged muscle relaxation across multiple conditions. Current clinical data in patients with PVD are inconclusive, but off-label anecdotal use suggests benefit. Objective To assess the safety, efficacy, and optimal dosing of abobotulinumtoxinA (aboBoNT-A) for the treatment of PVD and explore the utility of a novel endpoint for pain assessment in PVD. Methods This phase II, randomized, placebo-controlled study (NCT03598777) comprised two steps: dose escalation (stage 1) and dose expansion (stage 2). Stage 1 included up to four treatment cycles; cycle 1 was double-blind, while cycles 2-4 were open-label. Patients were assessed for retreatment every 6 weeks. Enrolled premenopausal, adult women with PVD associated with pelvic-floor hypertonia were randomized 4:1 to receive aboBoNT-A (100 units [U] [n=8], 300 U [n=8], 400 U [n=14], and 500 U [n=17]) or placebo (n=13). A new efficacy endpoint was introduced, combining the use of eight vaginal dilators of increasing diameter and patient-reported pain in response to dilator insertion on an 11-point numeric rating scale (NRS) to derive a composite pain score. Based on the subjective pain threshold, the largest-sized dilator that the patient accepted was defined as the dilator maximum tested size (DMTS). Results Patients (aged 19-45 years; mean, 29.4 years) received aboBoNT-A or placebo. Baseline demographics and disease characteristics were well-balanced across treatment groups. All treatment-emergent adverse events (TEAEs) were mild or moderate. Among aboBoNT-A-treated patients, urinary incontinence occurred in one patient in cycle 1, one patient in cycle 2, and two patients in cycle 3. During cycle 1, treatment-related TEAEs occurred in patients receiving aboBoNT-A 500 U or placebo (3/17 patients and 1/13 patients, respectively), with none reported for doses <500 U. In terms of composite score for dilator test, there was a numerical trend for benefit with aboBoNT-A 300 U and a trend for increasing benefit with increasing number of injections. All women who received at least three active treatment cycles with aboBoNT-A had a decrease in dilator-induced pain from baseline of >=30% and >=2 points at week 6, as reported on the 11-point NRS. Efficacy and validity of the DMTS were not statistically analyzed owing to the sponsor's decision to discontinue the trial (for reasons unrelated to efficacy or safety). Conclusions AboBoNT-A showed an acceptable safety profile in patients with PVD. Patients treated with multiple sequential cycles showed continued reductions in dilator-induced pain and NRS scores with repeated injections, suggesting a potential benefit of repeated aboBoNT-A treatment; trials assessing efficacy and validating DMTS are warranted to explore these findings.

Goldstein, S. W., et al. (2023). "Safety and efficacy of fractional CO2 laser treatment to the vestibule: a randomized, double-blind, sham-controlled, prospective 3-site clinical study in women with vestibular pain." The Journal of Sexual Medicine 20(6): 800-812.
	BACKGROUND: Data are limited regarding fractional CO2 laser as a nonhormonal treatment for vestibular pain. AIM: We sought to perform what is, to our knowledge, the first multisite prospective randomized, double-blind, sham-controlled clinical trial to assess the safety and efficacy of fractional CO2 laser treatment to the vestibule in women with vestibular pain. METHOD(S): Subjects (n=70) meeting inclusion/exclusion criteria at each of 3 sites were randomized 2:1 to active or sham (zero energy) fractional CO2 laser treatment using the vestibular probe (SmartXide2 V2LR - MonaLisa Touch, DEKA, Florence, Italy). Subjects in each treatment arm received 3 treatments 4 weeks apart. At the initial follow-up (week 12), subjects were unblinded and those initially assigned to sham started active treatment. OUTCOME(S): Outcome measures included changes from baseline in sexual activity diaries and scores for the Vulvoscopic Genital Tissue Appearance Scale (VGTA), vestibular cotton-tipped swab testing, McGill Pain Questionnaire, Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), and the O'Leary-Sant voiding and pain indices, the Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI). RESULT(S): After active treatment, VGTA scores significantly improved in 5 parameters. Pain associated with cotton-tipped swab testing was significantly reduced at weeks 4 through 16 (mean change from baseline -0.64 [95% CI, -0.79 to -0.50] and-1.31 [95% CI, -1.46 to -1.16], respectively). FSFI pain domain scores improved significantly at weeks 12 and 16 (mean change from baseline 0.925 [95% CI, 0.10-1.75] and 1.22 [95% CI, 0.40-2.05], respectively). FSFI total scores increased significantly at weeks 12 and 16 (mean change from baseline 6.24 [95% CI, 2.64-9.85] and 4.96 [95% CI, 1.36-8.57], respectively). FSDS-R scores decreased significantly at weeks 12 and 16 (mean change from baseline -5.84 [95% CI, -8.80 to -2.87] and-9.15 [95% CI, -12.11 to -6.18], respectively). ICSI scores decreased significantly at weeks 12 and 16 (mean change from baseline -0.91 [95% CI, -1.65 to -0.18] and-0.754 [95% CI, -1.49 to -0.02], respectively). ICPI scores decreased significantly at week 16 (mean change from baseline -0.99 [95% CI, -1.63 to -0.34]). In contrast, there were no significant changes in outcomes in the sham arm. No serious adverse events occurred. CLINICAL IMPLICATIONS: Fractional CO2 laser treatment in women with vestibular pain resulted in improvement from baseline in multiple key outcome measures of vestibular health. STRENGTHS AND LIMITATIONS: Strengths of the study were that it was a multisite prospective randomized double-blind, sham-controlled clinical trial that included multiple measures related to vestibular pain and sexual function. Limitations were the nonvalidated primary outcome measure and limited study cohort. CONCLUSION(S): Fractional CO2 laser therapy is a safe and effective nonhormonal treatment for vestibular pain.Copyright © The Author(s) 2023. Published by Oxford University Press on behalf of The International Society of Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Golfier, F., et al. (2022). "Spontaneous hemoperitoneum in pregnancy: A life-threatening maternal and fetal complication of endometriosis." Journal of Gynecology Obstetrics and Human Reproduction 51(7): 102415.
	Background: Spontaneous hemoperitoneum in pregnancy (SHiP) is a complication of endometriosis. We describe the clinical characteristics and outcomes of mother and fetus in 11 new cases of SHiP with endometriosis and 43 cases reported in the literature since 1995.; Material and Methods: The 60 maternity hospitals in the Auvergne-Rhône-Alpes region in France were contacted to identify cases of SHiP associated with endometriosis. In parallel, a systematic review of the literature used the PRISMA chart to report published cases.; Results: Fifty-four cases of SHIP associated with endometriosis are presented. Twenty-four patients (44%) conceived with assisted reproductive techniques. Hemoperitoneum occurred before delivery in 47/54 cases (87%).The average gestational age of occurrence was 27 weeks (13 weeks to 40+6 weeks). An hypovolemic shock was present in 24/51 (47%) of patients. Forty-six women (85%) were treated by laparotomy, 5 (9%) by laparoscopy, 2 (2%) by interventional radiology. The hemorrhage site was in the mediolateral compartment of the pelvis in 29 cases (54%), corresponding to bleeding from vessels in the broad ligament in 24/29 (83%) of these cases. The mean estimated blood loss was 1957 mL (150-7500 mL). Emergency peripartum hysterectomy was required in 3/54 cases (6%). There were no maternal deaths. The average gestational age at birth was 30 weeks (13+2 weeks to 42 weeks). The fetus died in 19/64 cases (30%).; Conclusion: SHiP is an underestimated potentially fatal complication of endometriosis. Maternal salvage by emergency laparotomy is usually required to identify and treat the bleeding site. Fetal prognosis remains poor.; Competing Interests: Declarations of Competing Interest none. (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

Gómez de Quero Córdoba, M., et al. (2021). "[Systematic review of the treatment with pessaries in the pelvic organ prolapse (POP).]." Archivos Espanoles de Urologia 74(3): 306-316.
	Pelvic organ prolapse (POP) has a general incidence of > 10% in the female population of the Western world. The pessary is a silicone device, inserted into the vagina to provide support to the pelvic organs. It is used as a conservative treatment to improve prolapse symptoms.OBJECTIVES: To evaluate the effectiveness of pessary treatment in pelvic organ prolapse through a systematic review of the current literature.MATERIAL AND METHODS: A Scoping Review was carried out based on the PRISMA guidelines for the development of systematic reviews. The PICO research question was asked, the sources of information were selected, and the eligibility criteria were established. Subsequently, the descriptors in health sciences and keywords, combined with Boolean operators, were appliedin each of the search engines. RESULTS: A total of 19 references were included in the analysis of this work. To delimit the data extraction, the information was divided into four dimensions: improvements in symptoms related to POP and quality of life, sexual function; discontinuation, justification for discontinuation and complications. CONCLUSIONS: The pessary produces positive effects on the quality of life of women with POP, with good satisfaction rates. The main reasons for the interruption include: inability to retain the pessary, discomfort, and the desire for surgery.

Gómez de Vicente, J. M. and G. Trelles (2020). "[Laser technology applications in functional urology and urogynecology.]." Archivos Espanoles de Urologia 73(8): 709-723.
	OBJECTIVE: LASER (Light Amplification by Stimulated Emission of Radiation) technology consists of the emission of a high-energy light beam. In medicine, it is used to cut, coagulate, fragment and evaporate biological or synthetic tissues. In the field of Functional Urology and Urogynecology its use has been widely explored. This article tries to give an overview of its applications in this subspecialty. MATERIAL AND METHOD: A non-systematic free search was performed in Pubmed, Embase and Google Scholar,combining the terms "laser", "laser technology", "interstitial cystitis", "trigonitis", "urinary tract infections","mesh", "mesh complications", "microbiome", "menopause genitourinary syndrome", "vulvovaginal atrophy", "urinary incontinence", "pelvic organ prolapse", "lichensclerosus", "complications" and "vaginal laxity". All relevant studies were retrieved in full text, in order to prepare a summary of each of the pathologies in which laser therapy has been used in Functional Urology and Urogynecology over time. RESULTS: There are different types of lasers and different application modalities to treat a wide variety of functional pathologies, including interstitial cystitis, trigonitis, mesh complications, urinary incontinence or pelvic organ prolapse. In some of them its use has been abandoned, despite the fact that, theoretically, they offer advantages over other therapies, such as in the case of interstitial cystitis. In others there is still not enough evidence in terms of safety and efficacy to be an alternativeto other conventional treatments. CONCLUSIONS: Although laser therapy offers certain advantages over other treatments, its use has not been generalized in the subspecialty of Functional Urology and Urogynecology. More evidence is needed to demonstrate its efficacy and safety.

Gómez-Hidalgo Natalia, R., et al. (2022). "Adjuvant therapy in early-stage cervical cancer after radical hysterectomy: are we overtreating our patients? A meta-analysis." Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico 24(8): 1605-1614.
	Objective: There is a gap in knowledge regarding the ideal management of patients with early-stage cervical cancer and intermediate-risk features. Here, we present a meta-analysis of the published literature on oncological outcomes in these patients and determine trends in postoperative management.; Methods: MEDLINE and PubMed were used for literature searches. The inclusion criteria were: English language articles including ≥ 10 patients, patients who underwent radical hysterectomy, nodes negative, studies reporting oncological outcomes and complications treatment-related and compare a surgery-only cohort with a radiotherapy cohort. The PRISMA guidelines were followed. Combined relative risk was calculated using DerSimonian-Laird random-effects model and a forest plot was drawn.; Results: We collected 183 manuscripts on early-stage cervical cancer treated with radical hysterectomy alone or with adjuvant radiotherapy after surgery. A total of eight studies met the inclusion criteria. Regarding oncological outcomes, survival was reported in five studies. The relative risk of recurrence and the relative risk of mortality was similar in both groups independently whether receive or not adjuvant therapy. Most of the studies did not report significant differences regarding morbidity treatment related between the groups, except for a higher rate of lymphedema after radiotherapy.; Conclusion: We found that the relative risk of recurrence and mortality was similar in both groups not depending on adjuvant therapy. Therefore, whether radiotherapy adjuvant treatment is indicated remains a topic of debate. (© 2022. The Author(s), under exclusive licence to Federación de Sociedades Españolas de Oncología (FESEO).)

Gonçalves Caroline, R., et al. (2022). "Hormone therapy in women with premature ovarian insufficiency: a systematic review and meta-analysis." Reproductive Biomedicine Online 44(6): 1143-1157.
	The aim of this systematic review and meta-analysis was to evaluate the effectiveness of different hormone therapies, including hormonal contraceptives, in women with premature ovarian insufficiency (POI). Thirty reports of 28 studies were included, with a total of 4004 participants with POI from diverse aetiologies, of whom 3785 received hormone therapies and 219 received calcium supplementation, vitamin D, placebo or no treatment. Hormone therapy was superior to non-treatment, placebo, calcitriol or calcium in preserving bone mineral density (BMD) in women with POI. Hormone therapy was associated with up to 80% reduction in the prevalence of hot flushes and with stability or improvement in the quality of life scores. Hormone therapy induced significant increases in uterine volume and endometrial thickness in women with POI. The studies yielded convergent results and were of good quality, although some lacked blinding or had incomplete outcome data. Moderate to high quality evidence was found that hormone therapy with oestrogen and progesterone or progestin (including contraceptives) is beneficial to women with POI, not only to mitigate hypoestrogenic symptoms but also to preserve BMD and avoid uterine atrophy. More studies are needed to confirm the long-term safety of this therapy and to assess its possible impact on the risk of hard outcomes such as bone fractures and cardiovascular events. (Copyright © 2022 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Gonçalves-Henriques, M., et al. (2022). "Ulipristal Acetate in Adenomyosis." Gynecology and Minimally Invasive Therapy 11(4): 198-202.
	Adenomyosis is defined as the invasion of the basal endometrium (stroma and glands) into the underlying myometrium. It may lead to abnormal uterine bleeding (AUB), pelvic pain, and infertility. The definitive treatment is hysterectomy. Some conservative measures have been used in patients willing to procreate. Ulipristal acetate is a selective progesterone receptor modulator used to treat AUB caused by leiomyomas. This is a systematic review on the use of ulipristal to treat adenomyosis. Eight eligible articles were retrieved from PubMed, SCOPUS, and Cochrane Library. Only one randomized clinical trial was published until date concerning this matter. It seems that ulipristal acetate induces partial or complete remission of AUB caused by adenomyosis, but the evidence concerning its effect on pelvic pain and the radiologic findings of the disease is conflicting. Nevertheless, given the paucity of data, it is still preliminary to draw any conclusion about the subject.; Competing Interests: There are no conflicts of interest. (Copyright: © 2022 Gynecology and Minimally Invasive Therapy.)

Gong, H., et al. (2020). "Poly (ADP-ribose) polymerase (PARP) inhibitor regimens for ovarian cancer in phase III randomized controlled trials: a network meta-analysis." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 30(10): 1576-1582.
	Introduction: We aimed to evaluate poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi) regimens in BRCA-mutated ovarian cancer for patients responsive to front-line platinum (bevacizumab and olaparib, veliparib and chemotherapy, olaparib) or platinum-sensitive relapsed (olaparib, rucaprib, niraparib) patients in phase III randomized controlled trials.; Methods: A network meta-analysis was utilized to generate the direct and indirect comparisons. The primary outcomes for network meta-analysis were efficacy (hazard ratios for progression-free survival in BRCA mutation cohort) and toxicity (odds ratios for all grade 3-4 adverse events). The American Society of Clinical Oncology (ASCO) value framework was used to assess the cost-effectiveness of the PARPi regimens.; Results: Network meta-analysis indicated no statistically significant differences in efficacy and toxicity among the assessed upfront or relapsed PARPi regimens (95% CI included 1). The ASCO value framework indicated that current PARPi regimens were similar in clinical benefits, toxicity, and net health benefit in the upfront (bevacizumab and olaparib, veliparib and chemotherapy, olaparib) and relapsed setting (olaparib, rucaprib, niraparib). The addition of bevacizumab to olaparib ($353.72) increased the cost per unit net health benefit for patients compared with olaparib monotherapy ($260.57). The upfront PARPi regimens had lower toxic scores than the regimens used at relapse.; Conclusions: The choice of PARPi regimens both in the upfront and relapsed setting should consider not only efficacy and toxicity but also costs in BRCA mutation patients. Current combining PARPi regimens are not recommended for such patients in the upfront setting from the cost-effective perspective. Upfront PARPi regimens are less toxic than those used at relapse.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Gong, W., et al. (2023). "Dose-dense regimen versus conventional three-weekly paclitaxel combination with carboplatin chemotherapy in first-line ovarian cancer treatment: a systematic review and meta-analysis." Journal of Ovarian Research 16(1): 136.
	Background: Paclitaxel dose-dense regimen has been controversial in clinical trials in recent years. This systematic review and meta-analysis tried to evaluate the efficacy and safety of paclitaxel dose-dense chemotherapy in primary epithelial ovarian cancer.; Methods: An electronic search following PRISMA guidelines was conducted (Prospero registration number: CRD42020187622), and then a systematic review and meta-analysis of included literature were initiated to determine which regimen was better.; Results: Four randomized controlled trials were included in the qualitative evaluation, and 3699 ovarian cancer patients were included in the meta-analysis. The meta-analysis revealed that the dose-dense regimen could prolong PFS (HR0.88, 95%CI 0.81-0.96; p = 0.002) and OS (HR0.90, 95%CI 0.81-1.02; p = 0.09), but it also increased the overall toxicity (OR = 1.102, 95%CI 0.864-1.405; p = 0.433), especially toxicity of anemia (OR = 1.924, 95%CI 1.548-2.391; p < 0.001), neutropenia (OR = 2.372, 95%CI 1.674-3.361; p < 0.001). Subgroup analysis indicated that the dose-dense regimen could significantly prolong not only PFS (HR0.76, 95%CI 0.63-0.92; p = 0.005 VS HR0.91, 95%CI 0.83-1.00; p = 0.046) but also OS (HR0.75, 95%CI 0.557-0.98; p = 0.037 VS HR0.94, 95%CI 0.83-1.07; p = 0.371) in Asian, and overall toxicity was significantly increased in Asians (OR = 1.28, 95%CI: 0.877-1.858, p = 0.202) compared to non-Asians (OR = 1.02, 95%CI 0.737-1.396, p = 0.929).; Conclusion: Paclitaxel dose-dense regimen could prolong PFS and OS, but it also increased the overall toxicity. Therapeutic benefits and toxicity of dose-dense are more obvious in Asians compared to non-Asians, which need to be further confirmed in clinical trials. (© 2023. The Author(s).)

Gong, Y., et al. (2023). "Effects of carnitine on glucose and lipid metabolic profiles and fertility outcomes in women with polycystic ovary syndrome: A systematic review and meta-analysis." Clinical Endocrinology 98(5): 682-691.
	Objectives: To quantify the effect of carnitine on glucose and lipid metabolic profiles and fertility outcomes in women with Polycystic ovary syndrome (PCOS).; Design: A systematic review and meta-analysis were conducted.; Patients: Women with PCOS diagnosed by Rotterdam or Androgen Excess Society (AES) criteria and taking carnitine supplement were assessment.; Measurements: Fertility outcomes (ovulation, clinical pregnancy, live birth, and miscarriage), lipid parameters (BMI, triglyceride, total cholesterol, high-density lipoprotein, low-density lipoprotein), fasting glucose and insulin, and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).; Results: In total, 839 participants were included in this analysis. The dosage of carnitine and treatment duration reported by studies varied from 250 mg to 3000 mg daily and 84 to 90 days, respectively. The publication bias was absent. Compared with placebo, carnitine significantly improved ovulation rates (RR 3.42, 95% CI 2.39 to 4.89, I2 = 0%) and pregnancy rates (RR 11.05, 95% CI 1.21 to 100.58, I2 = 79%). None of included studies reported live birth. After treatment, carnitine resulted in significant reductions relative to baseline in body mass index (BMI, MD -0.93 kg/m2, 95% CI -1.15 to -0.70, I2 = 55.0%), insulin levels (MD -2.47 mIU/L, 95% CI -4.49 to -0.45, I2 = 0%) and the Homeostasis Model Assessment index (MD -0.67, 95% CI -1.20 to -0.14, I2 = 0%) than placebo, but not for lipid profiles including triglyceride, total cholesterol, and low-density lipoprotein.; Conclusion: With the available literature, carnitine seems to improve ovulation and clinical pregnancy and insulin resistance, BMI in women with PCOS. These effects are warranted to be further validated, due to insufficient statistical power. (© 2023 The Authors. Clinical Endocrinology published by John Wiley & Sons Ltd.)

Gonzales, A. L., et al. (2021). "Prevalence and Treatment of Postpartum Stress Urinary Incontinence: A Systematic Review." Female Pelvic Medicine & Reconstructive Surgery 27(1): e139-e145.
	OBJECTIVES: Many women present for treatment of stress urinary incontinence (SUI) after childbirth. This systematic review describes the efficacy of treatment options for SUI initiated during the 12 months after delivery. METHOD(S): We conducted a systematic review to identify studies comparing treatment options for SUI initiated in the 12 months after parturition. We searched MEDLINE from inception to February 2019, using Medical Subject Heading terms related to pregnancy and urinary incontinence. Preintervention and postintervention populations were compared using analysis of variance with Fisher least significant difference method used to determine efficacy between groups. Grades for Recommendation, Assessment, Development and Evaluation system was used to categorize quality of evidence as high, moderate, low, or very low. RESULT(S): We double screened 4548 abstracts, identifying 98 articles for full-text review. Seven studies met the eligibility criteria and were included. Compared with a control group, the 4 interventions identified outperformed the control group (P < 0.001) using Fisher (with effect sizes noted): (1) supervised pelvic floor physical therapy (0.76), (2) electrical stimulation (0.77), (3) home physical therapy (PT) (0.44), and (4) surgery (not applicable). Based on Grades for Recommendation, Assessment, Development and Evaluation assessment, there was moderate evidence to support PT and electrical stimulation, with insufficient evidence for surgery. There were no significant differences in parity, age, or body mass index via analysis of variance. The overall strength of evidence is poor for the treatment of postpartum SUI; more data are needed to fully evaluate other treatment options. CONCLUSION(S): All identified interventions demonstrated greater improvement for postpartum SUI over no treatment. Supervised PT +/- electrostimulation was the most effective nonsurgical intervention.Copyright © 2020 American Urogynecologic Society. All rights reserved.

Gonzalez, C. D., et al. (2019). "Metformin and pregnancy outcomes: Evidence gaps and unanswered questions." Current Clinical Pharmacology 14(1): 54-60.
	Background: Metformin is sometimes used as an alternative to insulin in gestational diabetes mellitus (GDM). It is also used to achieve ovulation in polycystic ovary syndrome (PCOS). Pre-natal exposure to metformin results from its continuation after a successful ovulation in women with PCOS, its maintenance in women with pre-gestational diabetes or the installation of metformin in GDM. Little is known about the potential consequences of metformin exposure on pregnancy outcomes and offspring development. The aim of this review is to summarize the metformin effects on pregnancy outcomes and offspring development. Gaps in the available evidence and unanswered questions are also discussed. Method(s): A comprehensive literature search was carried out to identify eligible studies from MEDLINE/PubMed, EMBASE and SCIELO databases through 1995 first semester. Result(s): Several factors limit the effect of metformin on embryos. In contrast, placental transport of metformin is effective allowing for a higher fetal exposure; the impact of this finding remains unclear. It seems that the interruption of metformin after a pregnancy diagnosis in women with PCOS is not associated with a higher miscarriage risk and it continuation does not seem to impair the maternal metabolic prognosis or prevent emerging GDM. Conclusion(s): It seems to have no sense to prolong the use of metformin after a pregnancy diagnosis in women with PCOS. Patients with GDM may be treated with metformin under on judicious basis, and a careful attachment to clinical guidelines and regulations is recommended. The long-term effects of pre-natal exposure to metformin on the offspring remain uncertain © 2019 Bentham Science Publishers.

Gonzalez, R. R., et al. (2023). "Three-year patient-reported outcomes of single-incision versus transobturator slings for female stress urinary incontinence are equivalent." International Urogynecology Journal 34(9): 2265-2274.
	Introduction and hypothesis: Patient-reported outcome measures (PROMs) are important for understanding the success of surgery for stress urinary incontinence, as patient perception of success does not always correlate with physician perception of success. We report PROMS after single-incision slings (SIS) and transobturator mid-urethral slings (TMUS). Method(s): This was a planned outcome analysis of secondary endpoints in a study in which the primary aim was to compare efficiency and safety using a non-inferiority design (results reported previously). In this analysis of quality of life (QOL), validated PROMs were collected at baseline, 6, 12, 18, 24, and 36 months to quantify incontinence severity (Incontinence Severity Index), symptom bother (Urogenital Distress Inventory), disease-specific QOL impact (Urinary Impact Questionnaire), and generic QOL impact (PGI-I; not applicable at baseline). PROMs were analyzed within treatment groups as well as between groups. Propensity score methods were used to adjust for baseline differences between groups. Result(s): A total of 281 subjects underwent the study procedure (141 SIS, 140 TMUS). Baseline characteristics were balanced after propensity score stratification. Participants had significant improvement in incontinence severity, disease-specific symptom bother, and QOL impact. Improvements persisted through the study and PROMs were similar between treatment groups in all assessment at 36 months Conclusion(s): Following SIS and TMUS, patients with stress urinary incontinence had significant improvement in PROMs including Urogenital Distress Inventory, Incontinence Severity Index, and Urinary Impact Questionnaire at 36 months, indicating disease-specific QOL improvement. Patients have a more positive impression of change in stress urinary incontinence symptoms at each follow-up visit, indicating generic QOL improvement.Copyright © 2023, The International Urogynecological Association.

Gonzalez-Mena, A., et al. (2024). "Treatment of Women with Primary Dysmenorrhea with Manual Therapy and Electrotherapy Techniques: A Systematic Review and Meta-Analysis." Physical Therapy.
	OBJECTIVE: The objective of this study was to evaluate the efficacy of electrotherapy and manual therapy for the treatment of women with primary dysmenorrhea. METHOD(S): Systematic searches were conducted in Scopus, Web of Science, PubMed, CINAHL, and MEDLINE. The articles must have been published in the last 10 years, had a sample exclusively of women with primary dysmenorrhea, had a randomized controlled trial design, and used interventions that included some form of manual therapy and/or electrotherapy techniques. Two reviewers independently screened articles for eligibility and extracted data. Difference in mean differences and their 95% CIs were calculated as the between-group difference in means divided by the pooled standard deviation. The I2 statistic was used to determine the degree of heterogeneity. RESULT(S): Twelve selected studies evaluated interventions, with 5 evaluating electrotherapy techniques and 7 evaluating manual therapy techniques. All studies analyzed identified improvements in pain intensity and meta-analysis confirmed their strong effect. CONCLUSION(S): Manual therapy and electrotherapy are effective for the treatment of women with primary dysmenorrhea. Transcutaneous electrical nerve stimulation combined with thermotherapy and effleurage massage stands out for its effects on the intensity and duration of pain with the application of a few sessions and their long-term effects. IMPACT: Manual therapy techniques and electrotherapy methods reduce the pain intensity of women with primary dysmenorrhea. Quality of life and degree of anxiety improved significantly with manual therapy interventions. Transcutaneous electrical nerve stimulation combined with thermotherapy and effleurage massage are the interventions with which positive effects were achieved with fewer sessions.Copyright © The Author(s) 2024. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Gonzalo-Encabo, P., et al. (2021). "Dose-response effects of aerobic exercise on adiposity markers in postmenopausal women: pooled analyses from two randomized controlled trials." International journal of obesity (2005) 45(6): 1298‐1309.
	Background/objective: Exercise may reduce the risk of breast cancer through adiposity changes, but the dose‐response effects of exercise volume on adiposity markers are unknown in postmenopausal women. We aimed to compare the dose‐response effects of prescribed aerobic exercise volume on adiposity outcomes. Participants/methods: Data from the Alberta Physical Activity and Breast Cancer Prevention (ALPHA) and Breast Cancer and Exercise Trial in Alberta (BETA) were pooled for this analysis (N = 720). These were 12‐month randomized controlled trials, where participants were randomized to 225 min/week (mid‐volume) of aerobic exercise versus usual inactive lifestyle (ALPHA), or 150 min/week (low‐volume) versus 300 min/week (high‐volume) (BETA). Fat mass and fat‐free mass were measured using DXA and intra‐abdominal and subcutaneous fat area were assessed with computed tomography. Results: After 12 months of aerobic exercise, increasing exercise volumes from no exercise/control to 300 min/week resulted in statistically significant reductions in BMI, weight, fat mass, fat percentage, intra‐abdominal and subcutaneous fat area (P < 0.001). Compared with controls, fat mass loss was −1.13, −1.98 and −2.09 kg in the low‐, mid‐ and high‐volume groups, respectively. Similarly, weight loss was −1.47, −1.83, −2.21 kg in the low‐, mid‐ and high‐volume groups, respectively, compared to controls, and intra‐abdominal fat area loss was −7.44, −15.56 and −8.76 cm2 in the low‐, mid‐ and high‐volume groups, respectively, compared to controls. No evidence for a dose‐response effect on fat‐free mass was noted. Conclusion: A dose‐response effect of exercise volume on adiposity markers was noted, however, the differences in adiposity markers were smaller when comparing 225 min/week to 300 min/week of exercise. Given the strong positive associations between obesity and postmenopausal breast cancer risk, this study provides evidence on the importance of exercise volume as part of the exercise prescription to reduce adiposity and, ultimately, postmenopausal breast cancer risk.

Gonzalo-Encabo, P., et al. (2021). "Weight Regain and Breast Cancer-Related Biomarkers Following an Exercise Intervention in Postmenopausal Women." Cancer epidemiology, biomarkers & prevention 30(6): 1260‐1269.
	BACKGROUND: Epidemiologic studies have reported associations between weight fluctuations and postmenopausal breast cancer risk; however, the biological markers involved in this association are unknown. This study aimed to explore the associations between breast cancer‐related biomarkers and weight regain following exercise‐induced weight loss. METHODS: From the 400 participants included in the Breast Cancer and Exercise Trial in Alberta, a total of 214 lost weight during the intervention and had follow‐up blood samples, body composition, and covariate measurements. Outcomes were measured at baseline, 12 months (end of the study), and 24 months (follow‐up). RESULTS: During follow‐up, weight regain was 1.80 kg [95% confidence interval (CI): ‐0.40‐3.90], and was significantly associated with increases in estradiol [treatment effect ratio (TER) = 1.03; 95% CI, 1.01‐1.04], estrone (TER = 1.02; 95% CI, 1.01‐1.03), free estradiol (TER = 1.04; 95% CI, 1.02‐1.05), the homeostatic model assessment for insulin resistance (TER = 1.03; 95% CI, 1.02‐1.05), and insulin (TER = 1.03; 95% CI, 1.01‐1.04), and decreases in sex hormone‐binding globulin (SHBG; TER = 0.98; 95% CI, 0.97‐0.99) levels. Nonstatistically significant associations were found for glucose and C‐reactive protein. Furthermore, a statistically significant linear trend of increasing levels for all biomarkers, and decreasing SHBG, across weight regain categories was found. CONCLUSIONS: These results suggest that weight regain following exercise‐induced weight loss is associated with breast cancer‐related biomarker changes in postmenopausal women. IMPACT: These findings provide evidence to support the importance of developing effective strategies to prevent weight regain and, consequently, decrease postmenopausal breast cancer risk via changes in adiposity‐related biomarkers.

Gopal, S., et al. (2021). "Effect of an ashwagandha (Withania Somnifera) root extract on climacteric symptoms in women during perimenopause: A randomized, double-blind, placebo-controlled study." The Journal of Obstetrics and Gynaecology Research 47(12): 4414-4425.
	BACKGROUND: Perimenopause is the period during which many physiological changes mark the transition into the final menstrual period of a woman and these changes are associated with climacteric symptoms. OBJECTIVES: This study aimed to assess the efficacy and tolerability of an Ashwagandha root extract on the climacteric symptoms, quality of life (QoL), and hormonal parameters in perimenopausal women. MATERIALS AND METHODS: In this 8-week, randomized, double-blind, placebo-controlled study, 100 women with climacteric symptoms were randomly allocated to take either a placebo or 300 mg of an Ashwagandha root extract twice daily. Outcomes were measured using the menopause rating scale (MRS), menopause-specific QoL (MENQoL), hot flash score, and hormonal changes in estradiol, follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone. RESULTS: Among 100 participants enrolled, 91 participants completed the study. In comparison with the placebo, ashwagandha supplementation was associated with a statistically significant reduction in total MRS score (p < 0.0001), reflected by significant reductions in the psychological (p = 0.0003), somato-vegetative (p = 0.0152), and urogenital (p < 0.0001) domains. Ashwagandha intake demonstrated a statistically significant reduction in total MENQoL scores (p < 0.0001) and was also associated with a statistically significant increase in serum estradiol (p < 0.0001) and a significant reduction in serum FSH (p < 0.0001) and serum LH (p < 0.05) compared with the placebo. There was no significant between the group differences in the serum testosterone level. CONCLUSION: These findings suggest that ashwagandha root extract can be a safe and effective option to relieve mild to moderate climacteric symptoms during perimenopause in women.

Gora, K. B. and S. Wozniak (2023). "Evaluation of effectiveness of pharmacological treatment in pelvic congestion syndrome." Ginekologia polska.
	Pelvic congestion syndrome (PCS) is a pain syndrome characterized by positional pelvic pain and is associated with pelvic and vulvar varicosities as well as symptoms of dyspareunia and postcoital pain. Since the etiology of PCS is complex, the treatment should be individualized. Despite both pharmacological and interventional methods being used, there is significant predominance of minimally invasive therapies e.g. embolization. The study considers the answer to the question of whether pharmacological therapy is altogether effective. Using a combination of keywords, a PubMed search was performed for the years 1987-2022. The relevant articles were appointed and included in this narrative review. Despite the multitude of alternatives for pharmacological treatment, the systemic side effects of the medications used, as well as the interactions between drugs, affect patients' compliance and persistence. Furthermore, the quality of the currently existing evidence, considering the efficacy of the given substances, is low. Because of the adverse effects and thus the limited drug administration period, there is currently insufficient research on long-term effectiveness of the PCS pharmacological treatment. Therefore, prospective, comparative studies with larger patient population sizes are necessary to provide the possibility of efficient pharmacological therapy.

Gorelova, I. V., et al. (2020). "[Vitamin D and reproductive health]." Problemy endokrinologii 66(5): 96-101.
	Vitamin D insufficiency and deficiency in women with infertility is more common than in the population. However, we still do not know the exact mechanisms for the participation of vitamin D in the regulation of reproductive function. The purpose of this study is to analyze actual literature data on the role of vitamin D in the regulation of reproductive system and its influence on using of assisted reproductive technologies for the treatment of infertility. A search was carried out for literary sources published in the NSBI database PubMed, Medline, and others with a search depth of up to 20 years. 135 sources on this topic were studied, of which 54 were included in the analysis. The review presents data obtained in animal studies, in vitro and in clinical studies. Thus, the absence of vitamin D resulted in a dramatical decrease in fertility in both female and male rats and mice, due to the development of hypocalcemia. In vitro studies describe its involvement in the receptive transformation of the endometrium and in the regulation of the immune response during embryo implantation. However, clinical studies often show conflicting results. There is no unequivocal data on the effect of vitamin D levels on spermogram parameters, but a decrease in the pregnancy rate was shown when ovulation was induced in pairs, where a vitamin D deficiency was revealed in men. A meta-analysis published in 2017 showed a decrease in the pregnancy and live birth rate in women with low levels of vitamin D after the use of assisted reproductive technologies (ART). It was not possible to establish whether this decrease depends on oocyte quality or endometrium. There is an opportunity that the effect of vitamin D deficiency on fertility will not come with all forms of infertility. For example, in women with anovulation due to polycystic ovary syndrome, vitamin D deficiency is demonstrated to decrease pregnancy rate in ovulation induction cycles and in ART. Such relationship was not found in women with unexplained infertility.Thus, the role of vitamin D in the pathogenesis of infertility requires further study, as well as the possibilities of therapy in order to increase the effectiveness of infertility treatment methods and assisted reproductive technology programs.

Gori, S., et al. (2024). "Exploring conservative management for cervical intraepithelial neoplasia grade 2 in organised cervical cancer screening programmes: a multicentre study in Italy." Family medicine and community health 12(Suppl 2).
	Cervical intraepithelial neoplasia grade 2 (CIN2) lesions may regress spontaneously, offering an alternative to immediate treatment, especially for women of childbearing age (15-45 years).We conducted a prospective multicentre study on conservative CIN2 management, with semiannual follow-up visits over 24 months, biomarkers' investigation and treatment for progression to CIN3+ or CIN2 persistence for more than 12 months. Here, we assess women's willingness to participate and adherence to the study protocol.The study was set in population-based organised cervical cancer screening.From April 2019 to October 2021, 640 CIN2 cases were diagnosed in women aged 25-64 participating in the screening programmes.According to our predefined inclusion and exclusion criteria, 228 (35.6%) women were not eligible; 93 (22.6%) of the 412 eligible refused, and 319 (77.4%) were enrolled. Refusal for personal reasons (ie, desire to become pregnant, anxiety, difficulty in complying with the study protocol) and external barriers (ie, residence elsewhere and language problems) accounted for 71% and 17%, respectively. Only 9% expressed a preference for treatment. The primary ineligibility factor was the upper age limit of 45 years. After enrolment, 12 (4%) women without evidence of progression requested treatment, 125 (39%) were lost to follow-up (mostly after 6-12 months) and 182 (57%) remained compliant. Remarkably, 40% of enrolees did not fully adhere to the protocol, whereas only 5% (20/412) of the eligible women desired treatment.Our study demonstrates a good acceptance of conservative management for CIN2 lesions by the women, supporting its implementation within cervical screening programmes.; Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Gorman, J. R., et al. (2022). "Opening the Conversation: study protocol for a Phase III trial to evaluate a couple-based intervention to reduce reproductive and sexual distress among young adult breast and gynecologic cancer survivor couples." Trials 23(1): 730.
	Background: Reproductive and sexual health (RSH) concerns are common and distressing for young adults diagnosed with breast and gynecologic cancer and their partners. This study evaluates the efficacy of a virtual couple-based intervention called Opening the Conversation (OC). The OC intervention is grounded in theory and evidence-based practice and was adapted to improve coping and communication specifically in relation to RSH concerns after cancer. Method(s): This Phase III trial is conducted in a fully remote setting and enrolls young adult couples (current age 18-44 years) with a history of breast or gynecologic cancer (stage 1-4, diagnosed under age 40) within the past 6 months to 5 years. Eligible dyads are recruited from across the USA. The target sample size is 100 couples. Dyads are randomly assigned to receive either the 5-session OC intervention or a 4-session active control intervention (Side by Side). The primary outcomes are change in reproductive distress and sexual distress. Secondary outcomes include communication about reproductive concerns, communication about sexual concerns, depressive symptoms, sexual function, relationship quality, relationship intimacy, sexual satisfaction, self-efficacy to communicate about sex and intimacy, and quality of life. An exploratory aim examines whether dyadic coping and communication quality mediate intervention effects on survivors' and partners' reproductive distress or sexual distress. Self-report outcome measures are assessed for both groups at baseline (T1), 2 weeks post-treatment (T2), and 3 months post-treatment (T3). Discussion(s): Despite the importance of RSH for quality of life for young adult cancer survivors and their partners, evidence-based interventions that help couples navigate RSH concerns are lacking. This randomized controlled trial will determine the efficacy of a novel couple-based intervention to reduce distress related to RSH concerns for younger couples after breast or gynecologic cancer, in comparison to an active control intervention. Trial registration: ClinicalTrials.gov NCT04806724. Registered on Mar 19, 2021.Copyright © 2022, The Author(s).

Gouda Mohamed, A. and Z. Thein Kyaw (2023). "Selinexor: Changing the paradigm in patients with TP53 wild-type endometrial cancer?" Med (New York, N.Y.) 4(11): 752-754.
	Recurrent endometrial cancer (EC) remains a therapeutic challenge despite advancements in personalized medicine. SIENDO trial showed the potential clinical benefit of selinexor in patients with TP53 wild-type advanced/recurrent EC. The quest for novel therapeutic avenues and approaches continues as researchers seek a glimmer of hope in an area of uncertainty.; Competing Interests: Declaration of interests K.Z.T. served on the advisory board of Exelixis. M.G. declares no competing interests. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Goudelocke, C., et al. (2024). "A Multicenter Study Evaluating the FREquency of Use and Efficacy of a Novel Closed-Loop Wearable Tibial Neuromodulation System for Overactive Bladder and Urgency Urinary Incontinence (FREEOAB)." Urology 183: 63-69.
	Objective: To evaluate the effectiveness and safety of a novel wearable neuromodulation system incorporating embedded electromyographic evaluation, representing the first closed-loop wearable therapy for bladder control. Method(s): This 12-week, multicenter, open-label, single-arm study of subjects with overactive bladder assessed response of bladder diary parameters and quality of life (QOL) metrics. Subjects used the transcutaneous tibial neuromodulation system, either once or three times weekly, with evaluations at weeks 1, 4, 8, and 12. Enrolled subjects (N = 96) were assessed for changes in urinary frequency, urgency, and urgency urinary incontinence episodes, and QOL changes using various questionnaires. Result(s): In the intent-to-treat population (N = 96, mean age 60.8 +/- 13.0 years, 88.5% female), significant reductions in 3-day diary parameters were observed for daily voids, incontinence, and urgency episodes at 12 weeks. QOL improvements exceeded the minimal clinically important difference for all QOL questionnaires. Long-term results remained robust at 12 months. Device-related adverse events were mild and there were no device-related serious adverse events. Mean therapy compliance at 12 weeks was 88.5%. High satisfaction rates were reported for the device overall. Conclusion(s): The Avation device demonstrates promising efficacy in treating adults with overactive bladder and urge urinary incontinence. At 12 weeks, both diary parameters and QOL indicators showed significant improvement and remained robust at 12 months. The device had a favorable safety profile with high compliance and patient satisfaction. This novel, closed-loop wearable tibial neuromodulation system represents a significant advancement in bladder control therapy, offering a noninvasive, patient-centered alternative with improved accessibility and ease of use.Copyright © 2023 Elsevier Inc.

Gough, K., et al. (2022). "Differential adherence to peer and nurse components of a supportive care package-The appeal of peer support may be related to women's health and psychological status." Patient Education and Counseling 105(3): 762-768.
	Objective: Knowledge of factors associated with intervention non-adherence may provide insights into the clinical utility of non-pharmacologic interventions. Method(s): This study compared complete and incomplete adherers to two separate components of a novel intervention package for women undergoing curative intent radiotherapy for gynaecological cancer on socio-demographic, clinical and pre-radiotherapy patient-reported outcomes data. Result(s): Adherence to the tailored specialist nurse consultations was satisfactory (71% participated in all available sessions, 19% participated in all but one). Adherence to the telephone peer support sessions was less satisfactory (47% participated in all available sessions, 24% participated in all but one session). Complete adherers to the peer sessions reported significantly lower levels of psychological distress and significantly higher levels of physical, emotional and functional wellbeing before radiotherapy. No other statistically significant differences were observed between complete and incomplete adherers to the nurse- or peer-led sessions. Conclusion(s): Women's ability or motivation to engage with peer support may be influenced by their health and psychological status. Further, the extent of intervention non-adherence to the peer-led component may have compromised the assessment of its efficacy. Practice implications: Peer support may be less acceptable or appropriate for women with more complex care needs. Such women may prefer specialised care from trained professionals.Copyright © 2021

Gould, J. F., et al. (2022). "A Systematic Review of Vitamin D during Pregnancy and Postnatally and Symptoms of Depression in the Antenatal and Postpartum Period from Randomized Controlled Trials and Observational Studies." Nutrients 14(11): 2300.
	Depression is a common mood disorder associated with childbirth and is hypothesized to be affected by low vitamin D. This systematic review identified two randomized controlled trials (RCT) of vitamin D supplementation for the treatment or prevention of depressive symptoms in the perinatal period, as well as 18 observational studies of vitamin D exposure and depression in the antenatal and postnatal periods. Both RCTs claimed an improvement in depressive symptoms in the vitamin D group, although the sample sizes were too small to draw firm conclusions. The case-control and cohort studies had mixed findings and were limited by study quality. There were inconsistent results within the few studies with a more robust methodology or within samples restricted to women likely to have depression. The current evidence is inconclusive due to the poor quality and heterogeneity of studies, likely contributing to the contradictory findings. Given there are already numerous RCTs of prenatal vitamin D supplementation, we recommend adding an appropriate measure of depression in the perinatal period to assist in resolving the uncertainty.Copyright © 2022 by the authors. Licensee MDPI, Basel, Switzerland.

Goulding Elizabeth, A., et al. (2020). "Low-grade serous ovarian carcinoma: A comprehensive literature review." The Australian & New Zealand Journal of Obstetrics & Gynaecology 60(1): 27-33.
	Background: Low-grade serous ovarian carcinoma (LGSOC) is a unique entity with clinical and molecular characteristics distinct from high-grade serous ovarian carcinoma (HGSOC). To date the majority of research has focused on the more common HGSOC, with treatment recommendations often extrapolated to LGSOC. Women with LGSOC are typically diagnosed younger and have indolent and relatively chemoresistant disease. Recently there have been major research advances in LGSOC.; Aims: This systematic review describes the epidemiological, clinical and molecular characteristics of LGSOC, with advances in research and novel treatment options also discussed.; Materials and Methods: A 10-year comprehensive systematic review of peer-reviewed literature was conducted, with a total of 132 abstracts read, 89 articles reviewed and 49 included in this review.; Results: This review highlights the clinical and molecular features of LGSOC, current and traditional treatment options and areas of current research into targeted agents.; Conclusions: Our growing knowledge about LGSOC as a distinct clinical and molecular entity from HGSOC has led to the investigation of more targeted and tailored therapies as their clinical course, optimal management and therapeutic targets differ. There is a need for ongoing collaborative research to provide better treatment options for these patients. (© 2019 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Govahi, A., et al. (2023). "Antitumor Effects of Curcumin on Cervical Cancer with the Focus on Molecular Mechanisms: An Exegesis." Current Pharmaceutical Design 29(42): 3385-3399.
	Cervical cancer is one of the most prevalent malignancies among females and is correlated with a significant fatality rate. Chemotherapy is the most common treatment for cervical cancer; however, it has a low success rate due to significant side effects and the incidence of chemo-resistance. Curcumin, a polyphenolic natural compound derived from turmeric, acts as an antioxidant by diffusing across cell membranes into the endoplasmic reticulum, mitochondria, and nucleus, where it performs its effects. As a result, it's been promoted as a chemo-preventive, anti-metastatic, and anti-angiogenic agent. As a consequence, the main goal of the present review was to gather research information that looked at the link between curcumin and its derivatives against cervical cancer. (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Govindarajah, N., et al. (2019). "Sphingolipids and acid ceramidase as therapeutic targets in cancer therapy." Critical Reviews in Oncology/Hematology 138: 104-111.
	Background: Sphingolipids have been shown to play a key part in cancer cell growth and death and have increasingly become the subject of novel anti-cancer therapies. Acid ceramidase, a sphingolipid enzyme, has an important role in the regulation of apoptosis. In this review we aim to assess the current evidence supporting the role of sphingolipids in cancer and the potential role that acid ceramidase may play in cancer treatment. Method(s): A literature search was performed for published full text articles using the PubMed, Cochrane and Scopus databases using the search criteria string "acid ceramidase", "sphingolipid", "cancer". Additional papers were detected by scanning the references of relevant papers. A summary of the evidence for each cancer subgroup was then formed. Given the nature of the data extracted, no meta-analysis was performed. Result(s): Over expression of acid ceramidase has been demonstrated in a number of human cancers. In vitro data demonstrate that manipulation of acid ceramidase may present a useful therapeutic target. In the clinical setting, a number of drugs have been investigated with the ability to target acid ceramidase, with the most promising of those being small molecular inhibitors, such as LCL521. Conclusion(s): The role of the sphingolipid pathway in cancer is becoming very clearly established by promoting ceramide accumulation in response to cancer or cellular stress. Acid ceramidase is over expressed in a variety of cancers and has a role as a potential target for inhibition by novel specific inhibitors or off-target effects of traditional anti-cancer agents. Further work is required to develop acid ceramidase inhibitors safe for progression to clinical trials.Copyright © 2019

Goyal, M., et al. (2021). "Cesarean myomectomy in the last ten years; A true shift from contraindication to indication: A systematic review and meta-analysis." European Journal of Obstetrics, Gynecology, and Reproductive Biology 256: 145-157.
	Background: A lot of debate is present about Cesarean myomectomy (CM) in women with uterine myoma whether to consider it a feasible and safe procedure or an absolute contraindication.; Objective: To assess the safety and feasibility of myomectomy during cesarean section in women with uterine myoma.; Search Strategy: Electronic search was made on MEDLINE, EMBASE, Cochrane Library, ISI web of knowledge and Scopus from January 1, 2008 to December 31, 2019 using terms "Caesarean section", "Myomectomy", "Fibroid", "Caesarean myomectomy".; Selection Criteria: All full length studies either prospective or retrospective that address caesarean myomectomy were included.; Data Collection and Analysis: The outcomes studied were haemorrhage, mean change in haemoglobin, operative time, need for blood transfusion, febrile morbidity and duration of hospital stay.; Results: Total 249 studies were assessed for eligibility and 17 studies included in analysis with 6545 women. There were 4702 (71.85 %) women in caesarean myomectomy (CM) group and 1843 (28.15 %) women in cesarean section (CS) group. There was statistically significant but clinically insignificant decrease in hemoglobin [MD = 0.27, 95 %CI = 0.08-0.45, p = 0.005; very low quality], significant higher need for blood transfusion [RR = 1.45, 95 %CI = 1.05-1.99, p = 0.02; high quality] in CM group versus CS alone. The mean operative time (minutes) [MD = 14.77, 95 %CI = 6.91-22.64, p = 0.0002; moderate quality] and mean hospital stay (days) [MD = 0.36, 95 %CI = 0.19-0.53, p < 0.00001; high quality] was significantly less in CM group, though of not any clinical significance. No difference in incidence of haemorrhage [RR = 1.16, 95 %CI = 0.86-1.56, p = 0.32; moderate quality evidence] and fever [RR = 1.17, 95 %CI = 0.83-1.65), p = 0.36; moderate quality] in two groups.; Conclusions: The meta-analysis suggests CM is associated with clinical insignificant increase in operative time, blood loss and hospital stay, especially with multiple and large size myomas. CM should be preferred over CS alone especially by experienced surgeons with appropriate haemostatic techniques and tertiary care centres.; Competing Interests: Declaration of Competing Interest The authors report no declarations of interest. (Copyright © 2020 Elsevier B.V. All rights reserved.)

Gozlersuzer, O., et al. (2023). "Investigation of the effectiveness of magnetic field therapy in women with urinary incontinence: Literature review." Urologia Journal 90(1): 51-57.
	Objective: Magnetic stimulation (MS) provides a novel strategy for the treatment of urinary incontinence (UI), although its efficacy remains uncertain. This systematic review both evaluated the effects of MS treatment on UI and investigated its impacts on female patients' life quality. Method(s): A review of the literature that was conducted in EMBASE, PubMed, Google Scholar, and the Cochrane Library (2016-2021) with the search terms; Incontinence of stress OR urge of urination OR Urinary incontinence mixed type. The search was carried out for all randomised controlled trials (RCTs) in English. A manual search has also been conducted for the reference lists of the studies found. Seven studies, with a total of 523 patients (475 patients with SUI), 12 urge urinary incontinence. The study included patients with (UUI) and 36 patients with mixed urinary incontinence (MUI). A total of 10 male patients were excluded from the study. In the included studies, The International Incontinence Questionnaire-Short Form was used to investigate the effects of MS therapy on UI symptoms (ICIQ-SF). Result(s): According to the literature review, MS is an effective therapy option for female patients with UI. Still, to establish the efficacy of MS in this area, more large-scale, high-quality RCTs with extended follow-up periods that use consistent stimulation modalities and evaluate comparable outcomes are needed. Conclusion(s): MS treatment leads to an improvement in the symptoms of UI, in addition to an associated Improved quality of life for patients, without any reported side effects, while the longer-term treatment outcomes must be determined by long-term trials.Copyright © The Author(s) 2022.

Grabowski, J. P., et al. (2022). "PERCEPTION: Phase II investigational study of pembrolizumab combination with chemotherapy in platinum-sensitive recurrent low-grade serous ovarian cancer- A NOGGO trial." Journal of Clinical Oncology 40(16 Supplement 1).
	Background: Low-grade serous ovarian cancer (LGSOC) represents a minority within the group of invasive epithelial ovarian malignancies. Recent analyses showed a very limited responsiveness to chemotherapy in LGSOC. Since bevacizumab many years ago, none other agents have been approved in LGSOC. There is a high demand of new therapy combinations with modern substances to improve the response rate and prognosis in this group of patients. Immune check-point inhibitors provide a new possibility which showed to be effective in different malignant diseases as well as in selected ovarian cancer patients. In this study, the standard chemotherapy is going to be combined with pembrolizumab in recurrent LGSOC cases with therapy free interval (TFI) over 6 months after last platinum-based chemotherapy. To the authors knowledge no comparable studies have been performed or planned. If our trial should show pembrolizumab effectivity in LGSOC, it would be a signal and impulse for future clinical studies in this rare disease. Method(s): PERCEPTION/NOGGO-ov44 (NCT04575961) clinical trial is a multi-center, single-arm phase 2 study to evaluate pembrolizumab therapy concomitant to platinum-based chemotherapy (carboplatin plus pegylated liposomal doxorubicin, carboplatin plus gemcitabine or carboplatin monotherapy) and as maintenance in recurrent low-grade serous ovarian cancer cases. LGSOC patients with progression or recurrence at least six months after most previous platinum-containing therapy and in good general performance (ECOG 0 or 1) are eligible to participate in this clinical trial. The primary objective is the 12 months progression free survival (PFS) rate. Secondary end-points include overall survival, response rate (RR), PFS and RR according to Ki67 expression levels, time to first subsequent therapy (TFST) and its response, safety and quality of life. The trial is planned according to Simon's two-stage design with total sample size up to 33 patients. The null hypothesis is PFS-rate after 12 months of 20%. In the first phase 18 patients will be enrolled and if at least 5 patients show PFS after 12 months the study is going to be continued with an additional 15 patients. The trial is claimed successful, if at least 11 patients show PFS after 12 months. Assuming a true PFS-rate of 40%, this trial has 5% type I error rate and 80% power.

Grace, L., et al. (2022). "Fezolinetant for Moderate to Severe Vasomotor Symptoms Associated with Menopause: Effectiveness and Value."
	
Grace, L., et al. (2023). Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery.
	No Results Available Drug: Ketamine (Ketalar) Dose Level 1|Drug: Ketamine (Ketalar) Dose Level 2|Drug: Ketamine (Ketalar) Dose Level 3|Drug: Ketamine (Ketalar) Dose Level 4 Maximum Tolerated Dose of ketamine|Patient reported acceptability of any reported side effects Female Phase 1 12 Other|NIH Allocation: N/A|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Other STUDY22100018|1R01MH134538-01 July 2026

Gracia, M. and Q. Isern (2023). "Controversy in the treatment of uterine fibroids." Clinica e Investigacion en Ginecologia y Obstetricia 50(3): 100854.
	Uterine fibroids are the most common tumours in women of reproductive age, but only 25% of women will require treatment due to the presence of symptoms. There are few randomised studies that have compared the different treatment options for uterine myoma; for the moment, surgery remains the option that offers the best rates of symptomatic resolution, improved quality of life, and a lower recurrence rate. Despite the widespread use of myoma surgery, it seems reasonable to believe that by reducing surgical treatments, either with less invasive therapies or with new medical treatments, both associated morbidity and costs would be reduced. In this sense, ablative techniques for myoma treatment, UAE, HIFU, and radiofrequency, have demonstrated results in terms of symptomatic control and quality of life comparable to surgery, with a low rate of major complications. Recurrence rates and the impact on patients' future fertility would be the main concern. Future long-term comparative studies of ablative techniques and surgical approaches are needed.Copyright © 2023

Graham, R. and C. Kotsopoulos Ioannis (2023). "A comparison of end-to-end and end-to-side anastomosis following rectosigmoid resection in ovarian cancer cytoreductive surgery." European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology 49(2): 468-474.
	Introduction: A rectosigmoid resection with anastomosis is a common component of cytoreductive surgery for ovarian cancer. Evidence from colorectal studies suggests that end-to-side anastomoses may be associated with fewer complications than end-to-end approaches, but these have not previously been compared in an ovarian cancer patient cohort.; Materials and Methods: Over a 51-month period, 239 patients underwent cytoreductive surgery for FIGO stage III/IV ovarian cancer. A rectosigmoid resection was performed in 79 (33.1%) with anastomosis in 59 (74.7%). Pre-operative and intra-operative factors associated with anastomotic leak, and post-operative complications were compared by anastomotic technique.; Results: Anastomoses were end-to-end in 33 (55.9%) and end-to-side in 26 (44.1%) patients. There was a greater proportion of patients with a higher American Society of Anaesthesiologists score in the end-to-side group, but no other statistically significant differences in pre-or intra-operative factors between the groups. There were three (9.1%) cases of anastomotic leak in the end-to-end group, and no leaks in the end-to-side group, but the difference did not reach statistical significance. Both leaks were small, and successfully conservatively managed. There was no significant difference in rate of Clavien Dindo grade III/IV complications, although there was a higher rate of grade II complications following an end-to-side anastomosis (p = 0.036). There was no difference in length of stay, time to restarting chemotherapy, re-operation or 90-day mortality rate.; Conclusion: There was no significant difference in major morbidity following end-to-end or end-to-side anastomosis. Prospective randomised trials specifically focussed in ovarian cancer are needed.; Competing Interests: Declaration of competing interest None. (Copyright © 2022 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Graham, S., et al. (2022). "Review of menopausal hormone therapy with estradiol and progesterone versus other estrogens and progestins." Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology 38(11): 891-910.
	Objective: The objective of the present document was to review/summarize reported outcomes compared between menopausal hormone therapy (MHT) containing estradiol (E2) versus other estrogens and MHT with progesterone (P4) versus progestins (defined as synthetic progestogens). Methods: PubMed and EMBASE were systematically searched through February 2021 for studies comparing oral E2 versus oral conjugated equine estrogens (CEE) or P4 versus progestins for endometrial outcomes, venous thromboembolism (VTE), cardiovascular outcomes, breast outcomes, cognition, and bone outcomes in postmenopausal women. Results: A total of 74 comparative publications were identified/summarized. Randomized studies suggested that P4 and progestins are likely equally effective in preventing endometrial hyperplasia/cancer when used at adequate doses. E2- versus CEE-based MHT had a similar or possibly better risk profile for VTE and cardiovascular outcomes, and P4- versus progestin-based MHT had a similar or possibly better profile for breast cancer and cardiovascular outcomes. E2 may potentially protect better against age-related cognitive decline and bone fractures versus CEE; P4 was similar or possibly better versus progestins for these outcomes. Limitations are that many studies were observational and some were not adequately powered for the reported outcomes. Conclusions: Evidence suggests a differential effect of MHT containing E2 or P4 and those containing CEE or progestins, with some evidence trending to a potentially better safety profile with E2 and/or P4.

Grammatis Alexandros, L., et al. (2021). "Pentoxifylline for the treatment of endometriosis-associated pain and infertility." The Cochrane Database of Systematic Reviews 8: CD007677.
	Background: Endometriosis is a chronic inflammatory condition that occurs during the reproductive years. It is characterised by endometrium-like tissue developing outside the uterine cavity. This endometriotic tissue development is dependent on oestrogen produced primarily by the ovaries and partially by the endometriotic tissue itself, therefore traditional management has focused on ovarian suppression. In this review we considered the role of modulation of the immune system as an alternative approach. This is an update of a Cochrane Review previously published in 2012.; Objectives: To determine the effectiveness and safety of pentoxifylline in the management of endometriosis. SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility (CGF) Group Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO, and AMED on 16 December 2020, together with reference checking and contact with study authors and experts in the field to identify additional studies.; Selection Criteria: We included randomised controlled trials (RCTs) comparing pentoxifylline with placebo or no treatment, other medical treatment, or surgery in women with endometriosis. The primary outcomes were live birth rate and overall pain (as measured by a visual analogue scale (VAS) of pain, other validated scales, or dichotomous outcomes) per woman randomised. Secondary outcomes included clinical pregnancy rate, miscarriage rate, rate of recurrence, and adverse events resulting from the pentoxifylline intervention.; Data Collection and Analysis: Two review authors independently assessed studies against the inclusion criteria, extracted data, and assessed risk of bias, consulting a third review author where required. We contacted study authors as needed. We analysed dichotomous outcomes using Mantel-Haenszel risk ratios (RRs), 95% confidence intervals (CIs), and a fixed-effect model. For small numbers of events, we used a Peto odds ratio (OR) with 95% CI instead. We analysed continuous outcomes using the mean difference (MD) between groups presented with 95% CIs. We used the I 2 statistic to evaluate heterogeneity amongst studies. We employed the GRADE approach to assess the quality of the evidence.; Main Results: We included five parallel-design RCTs involving a total of 415 women. We included one additional RCT in this update. Three studies did not specify details relating to allocation concealment, and two studies were not blinded. There were also considerable loss to follow-up, with four studies not conducting intention-to-treat analysis. We judged the quality of the evidence as very low. Pentoxifylline versus placebo No trials reported on our primary outcomes of live birth rate and overall pain. We are uncertain as to whether pentoxifylline treatment affects clinical pregnancy rate when compared to placebo (RR 1.38, 95% CI 0.91 to 2.10; 3 RCTs, n = 285; I 2 = 0%; very low-quality evidence). The evidence suggests that if the clinical pregnancy rate with placebo is estimated to be 20%, then the rate with pentoxifylline is estimated as between 18% and 43%. We are also uncertain as to whether pentoxifylline affects the recurrence rate of endometriosis (RR 0.84, 95% CI 0.30 to 2.36; 1 RCT, n = 121; very low-quality evidence) or miscarriage rate (Peto OR 1.99, 95% CI 0.20 to 19.37; 2 RCTs, n = 164; I 2 = 0%; very low-quality evidence). No trials reported on the effect of pentoxifylline on improvement of endometriosis-related symptoms other than pain or adverse events. Pentoxifylline versus no treatment No trials reported on live birth rate. We are uncertain as to whether pentoxifylline treatment affects overall pain when compared to no treatment at one month (MD -0.36, 95% CI -2.12 to 1.40; 1 RCT, n = 34; very low-quality evidence), two months (MD -1.25, 95% CI -2.67 to 0.17; 1 RCT, n = 34; very low-quality evidence), or three months (MD -1.60, 95% CI -3.32 to 0.12; 1 RCT, n = 34; very low-quality evidence). No trials reported on adverse events caused by pentoxifylline or any of our other secondary outcomes. Pentoxifylline versus other medical hera ies One study (n = 83) compared pentoxifylline to the combined oral contraceptive pill after laparoscopic surgery to treat endometriosis, but could not be included in the meta-analysis as it was unclear if the data were presented as +/- standard deviation and what the duration of treatment was. No trials reported on adverse events caused by pentoxifylline or any of our other secondary outcomes. Pentoxifylline versus conservative surgical treatment No study reported on this comparison.; Authors' Conclusions: No studies reported on our primary outcome of live birth rate. Due to the very limited evidence, we are uncertain of the effects of pentoxifylline on clinical pregnancy rate, miscarriage rate, or overall pain. There is currently insufficient evidence to support the use of pentoxifylline in the management of women with endometriosis with respect to subfertility and pain relief outcomes. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Grandi, G., et al. (2019). "Hormonal contraception in women with endometriosis: a systematic review." The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception 24(1): 61-70.
	Objective: A systematic review was carried out of studies of women with endometriosis, to examine the evidence for efficacy of the use of hormonal contraception to improve disease-related pain and decrease postoperative risk of disease recurrence.; Methods: A search of the Medline/PubMed and Embase databases was performed to identify all published English language studies on hormonal contraceptive therapies (combined hormonal contraceptives [CHCs], combined oral contraceptives [COCs], progestin-only pills [POPs] and progestin-only contraceptives [POCs]) in women with a validated endometriosis diagnosis, in comparison with placebo, comparator therapies or other hormonal therapies. Main outcome measures were endometriosis-related pain (dysmenorrhoea, pelvic pain and dyspareunia), quality of life (QoL) and postoperative rate of disease recurrence during treatment.; Results: CHC and POC treatments were associated with clinically significant reductions in dysmenorrhoea, often accompanied by reductions in non-cyclical pelvic pain and dyspareunia and an improvement in QoL. Only two COC preparations (ethinylestradiol [EE]/norethisterone acetate [NETA] and a flexible EE/drospirenone regimen) demonstrated significantly increased efficacy compared with placebo. Only three studies found that the postoperative use of COCs (EE/NETA, EE/desogestrel and EE/gestodene) reduced the risk of disease recurrence. There was no evidence that POCs reduced the risk of disease recurrence.; Conclusions: CHCs and POCs are effective for the relief of endometriosis-related dysmenorrhoea, pelvic pain and dyspareunia, and improve QoL. Some COCs decreased the risk of disease recurrence after conservative surgery, but POCs did not. There is insufficient evidence, however, to reach definitive conclusions about the overall superiority of any particular hormonal contraceptive.

Grandone, E., et al. (2024). "Concerns about the ALIFE2 trial." The Lancet 403(10423): 246.
	
Granell José, C., et al. (2023). The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary Incontinence.
	The present study is a double-blind randomized clinical trial. Two groups are located, case group and placebo group. The total number of sessions will be 18 sessions per patient, divided into three sessions per week for a total of six weeks. These sessions last one hour, with a net treatment time of 40 minutes in the supine position. The vaginal probe is inserted into the cavity using a lubricant suitable for intracavitary use and RF, the device is turned on, while the RF is applied, pelvic floor contractions are performed guided by the physiotherapist 2 (Marta Martínez Colmenar) . The evaluations before and after the study will be carried out by the physiotherapist 1 (Yasmin Er Rabiai Boudallaa) who is blinded to group allocation. All participants will be assessed before, after six weeks and 6 months after the start of the study.

Grant Christopher, R., et al. (2023). "Endometrial Adenocarcinoma with Discordant Microsatellite Stability Status Treated with First-Line Pembrolizumab: A Case Report and Narrative Review." The American journal of case reports 24: e939448.
	BACKGROUND Microsatellite instability (MSI) is a hallmark of specific cancers and can be diagnosed using both tissue- and liquid-based approaches. When these tissue- and liquid-based approaches give differing results, they are known as discordant or being at variance. MSI-H tumors are well-researched candidates for treatment with programmed cell death protein 1 (PD-1) inhibitor-based immunotherapy, but the efficacy of immunotherapy in MSI-H discordant endometrial cancer, especially as first-line therapy, is not yet well documented in the literature. CASE REPORT A 67-year-old woman presented with a retroperitoneal mass positive for recurrent adenocarcinoma of endometrial origin. Her stage I endometrial adenocarcinoma 7 years ago demonstrated microsatellite stable (MSS) by immunohistochemical (IHC) stain and indeterminant due to insufficient tissue by Caris Next-Generation Sequencing (NGS). She then presented with a retroperitoneal mass that was MSI-H on IHC stain and Caris NGS, as well as MSI high on liquid biopsy @Guardant360 (@G360). The patient proceeded with pembrolizumab treatment 1 year ago and has sustained a complete clinical response at the time of writing. CONCLUSIONS Our case provides further evidence for the need to retest the microsatellite stability of metastatic sites, especially after a long disease-free survival. Here, we providing a literature review of case reports and a review of studies outlining discordance of testing modalities. Our case also highlights the importance of considering the use of immunotherapy as a first-line agent in patients who may have a poor ECOG performance status, as it can significantly improve their quality of life and reduce the number of adverse effects compared to chemotherapy.

Grant, W. B. (2019). "Vitamin D and health in the Mediterranean countries." Hormones 18(1): 23-35.
	Vitamin D, traditionally well known for its role in maintaining optimal health through its contribution to calcium metabolism and skeletal health, has received increased attention over the past two decades, with considerable focus being placed on its nonskeletal benefits. This paper is a narrative review of the nonskeletal health benefits of vitamin D, of particular interest to inhabitants of Mediterranean countries, namely, autism, cancer, cardiovascular disease, chronic obstructive pulmonary disease, dental caries, diabetes mellitus, erectile dysfunction, hypertension, metabolic syndrome, respiratory tract infections, all-cause mortality, and pregnancy and birth outcomes, because of the relatively high incidence and/or prevalence of these disorders in this region. Currently, the best evidence is coming out of observational studies related to serum 25-hydroxyvitamin D [25(OH)D] concentrations. Vitamin D clinical trials have generally been poorly designed and conducted, usually being based on vitamin D dose rather than 25(OH)D concentration. The optimal 25(OH)D concentration is above 75 nmol/l (30 ng/ml), with even better health outcomes in the range of 100-150 nmol/l. Achieving these concentrations with vitamin D3 supplements will require 1000-4000 IU/day of vitamin D3. Sensible sun exposure should also be encouraged. Countries should also consider fortifying grain and dairy products with vitamin D3.Copyright © 2018, Hellenic Endocrine Society.

Grau, J.-F., et al. (2023). "Advances in immunotherapy in cervical cancer." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 33(3): 403-413.
	Cervical cancer represents a major public health problem, being the fourth most common cancer in incidence and mortality in women worldwide. Patients with recurrent, persistent, or metastatic disease unsuitable for curative therapeutic approaches have a dismal prognosis. Until recently, these patients were only candidates for cisplatin-based chemotherapy plus bevacizumab. However, the introduction of immune checkpoint inhibitors has revolutionized the treatment of this disease, achieving historical overall survival improvements in both the post-platinum and front-line settings. Interestingly, the clinical development of immunotherapy in cervical cancer is currently advancing to the locally advanced setting, although preliminary efficacy outcomes in this setting have been disappointing so far. Moreover, promising data are emerging from early-phase trials on novel immunotherapy approaches, such as human papillomavirus therapeutic vaccines and adoptive cell therapy. This review summarizes the main clinical trials carried out in the field of immunotherapy in the last several years.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Gray, L., et al. (2023). "Does resistance training ameliorate cancer-related fatigue in cancer survivors? A systematic review with meta-analysis." Disability and Rehabilitation: 1-10.
	Purpose: Cancer-related fatigue (CRF) is unrelenting. As neither rest nor sleep ameliorates cognitive, emotional, and physical symptoms, quality of life is diminished. This study examines resistance training (RT) effectiveness on CRF in cancer survivors. The secondary aims were to identify the dose-response relationship of RT frequency, intensity, and volume on CRF in different cancer survivor populations.; Materials and Methods: Systematic searches via numerous databases for RCTs were performed in June 2022. Patient-reported outcome measures (PROM), were analysed, pre-to-post intervention, using a random-effects model. The Physiotherapy Evidence Database (PEDro) scale informed methodological quality assessment.; Results: Eight studies were included (cancer survivors: breast (BCS) = 5; endometrial (ECS) = 1; prostate (PCS) = 2). Overall, RT interventions ≥ 6 weeks elicited large significant reductions in CRF for FACIT-F (SMD = 0.932, p = <0.001) and moderate significant reductions in CRF for PFS-R (SMD = -0.622, p = 0.004).; Conclusion: Main findings indicate that RT ameliorates CRF, especially in BCS; however, individualised approaches should be advocated. Supervised training elicited the greatest positive outcomes, thus should be a pivotal part of the cancer rehabilitation pathway. Future studies should be adequately powered, undertake discrete analyses of different cancer types, and investigate chronic RT effects.

Graz Medical University, o. (2022). Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain.
	No Results Available Procedure: Acupuncture Change of Subjective Pain Perception|Change of Health-related quality of life - DSF|Change of Health-related quality of life - PHQ-D|Change of Health-related quality of life - PSQ|Change of Health-related quality of life - EHP-30|Change of Subjective improvement|Patient treatment satisfaction Female Not Applicable 68 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Amalia V2.4. July 2025

Green Daniel, S., et al. (2023). "Intraperitoneal Monocytes plus IFNs as a Novel Cellular Immunotherapy for Ovarian Cancer: Mechanistic Characterization and Results from a Phase I Clinical Trial." Clinical cancer research : an official journal of the American Association for Cancer Research 29(2): 349-363.
	Purpose: Ovarian cancer is the most lethal gynecologic cancer and intrinsically resistant to checkpoint immunotherapies. We sought to augment innate immunity, building on previous work with IFNs and monocytes.; Patients and Methods: Preclinical experiments were designed to define the mechanisms of cancer cell death mediated by the combination of IFNs α and γ with monocytes. We translated these preclinical findings into a phase I trial of autologous IFN-activated monocytes administered intraperitoneally to platinum-resistant or -refractory ovarian cancer patients.; Results: IFN-treated monocytes induced caspase 8-dependent apoptosis by the proapoptotic TRAIL and mediated by the death receptors 4 and 5 (DR4 and DR5, respectively) on cancer cells. Therapy was well tolerated with evidence of clinical activity, as 2 of 9 evaluable patients had a partial response by RECIST criteria, and 1 additional patient had a CA-125 response. Upregulation of monocyte-produced TRAIL and cytokines was confirmed in peripheral blood. Long-term responders had alterations in innate and adaptive immune compartments.; Conclusions: Given the mechanism of cancer cell death, and the acceptable tolerability of the clinical regimen, this platform presents a possibility for future combination therapies to augment anticancer immunity. See related commentary by Chow and Dorigo, p. 299. (©2022 American Association for Cancer Research.)

Green, S. M., et al. (2024). "Cognitive Behavioural Therapy for Sexual Concerns During Peri- and Post-Menopause: Preliminary Outcomes." Journal of Neurosurgical Anesthesiology 36(1): 1265.
	Objective: Sexual concerns are reported by 68% to 86.5% of peri- and post-menopausal women, which negatively impact physical and emotional well-being. Despite this, little attention has been paid to this area in the literature and no well-established, nonpharmacological treatments exist. The primary objective of this study is to evaluate the efficacy of a four-session individual Cognitive Behavioural Therapy protocol in improving sexual satisfaction and reducing distress during peri- and post-menopause (CBT-SC-Meno). Secondary objectives include sexual functioning, relationship satisfaction, body image, menopausal symptoms, depression, and anxiety. Design(s): Participants (n=20) recruited during peri- or post-menopause experiencing primary sexual concerns were assessed for study eligibility during an initial assessment. Eligible participants (n=15) were assigned to a waitlist control condition for four weeks, after which they completed four individual CBT sessions focusing on sexual concerns. Participants completed measures assessing sexual satisfaction, distress, and desire [Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), Female Sexual Desire Questionnaire (FSDQ)], as well as menopause symptoms [Greene Climacteric Scale (GCS)], body image [Dresden Body Image Questionnaire (DBIQ)], relationship satisfaction [Couples Satisfaction Index (CSI)], depression [Beck Depression Inventory-II (BDI-II)], and anxiety [Hamilton Anxiety Rating Scale (HAM-A)] at baseline, post-waitlist, and post-treatment. Participants also completed the Client Satisfaction Questionnaire at post-treatment. Result(s): No significant changes were observed during the waitlist period across all measures, apart from the FSDQ concern subscale. Participants experienced a significant decrease in symptoms of sexual distress, concern, and resistance, menopausal symptoms, and symptoms of depression. Significant increases in sexual dyadic desire, sexual functioning, body-image satisfaction, and relationship satisfaction were also observed. No significant changes were observed in anxiety symptoms, although post-waitlist scores were indicative of mild anxiety. Further, 100% of participants indicated that they were very satisfied with the treatment and that it helped them cope with their symptoms more effectively. Qualitative treatment satisfaction outcomes were captured and will be reported at the time of presentation. Conclusion(s): To our knowledge, this study is the first to examine the efficacy of a CBT protocol aimed at improving sexual concerns experienced during peri- and post-menopause. Preliminary results suggest CBT-SC-Meno leads to significant improvements across sexual concern domains, as well as commonly co-occurring symptoms including bodyimage, relationship satisfaction, menopausal and depression symptoms. As consumer demand increases for non-pharmacological treatments for peri- and post-menopause symptoms, this form of treatment may not only be preferred by some, but necessary for others as medications, including long-term hormonal-based treatments, have known associated adverse risks. (Figure Presented).

Greer, A., et al. (2021). "Impact of residual disease at interval debulking surgery on platinum resistance and patterns of recurrence for advanced-stage ovarian cancer." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 31(10): 1341-1347.
	OBJECTIVE: To evaluate the impact of size and distribution of residual disease after interval debulking surgery on the timing and patterns of recurrence for patients with advanced-stage epithelial ovarian cancer. METHODS: Patient demographics and data on disease treatment/recurrence were collected from medical records of patients with stage IIIC/IV epithelial ovarian cancer who were managed with neoadjuvant chemotherapy/interval debulking surgery between January 2010 and December 2014. Among patients without complete surgical resection but with ≤1 cm of residual disease, the number of anatomic sites (<1 cm single anatomic location vs <1 cm multiple anatomic locations) was used to describe the size and distribution of residual disease. RESULTS: A total of 224 patients were included. Of these, 70.5% (n=158) had a complete surgical resection, 12.5% (n=28) had <1 cm single anatomic location, and 17.0% (n=38) had <1 cm multiple anatomic locations. Two-year progression-free survival for complete surgical resection, <1 cm single anatomic location, and <1 cm multiple anatomic locations was 22.2%, 17.9% and 7%, respectively (p=0.007). Size and distribution of residual disease after interval debulking surgery did not affect location of recurrence and most patients had recurrence at multiple sites (complete surgical resection: 64.7%, <1 cm single anatomic location: 55.6%, and <1 cm multiple anatomic locations: 71.4%). Controlling for additional factors that may influence platinum resistance and surgical complexity, the rate of platinum-resistant recurrence was similar for patients with complete surgical resection and <1 cm single anatomic location (OR=1.07, 95% CI 0.40 to 2.86; p=0.888), but women with <1 cm multiple anatomic locations had an increased risk of platinum resistance (OR=3.09, 95% CI 1.41 to 6.78 p=0.005). CONCLUSIONS: Despite current classification as 'optimal,' <1 cm multiple anatomic location at the time of interval debulking surgery is associated with a shorter progression-free survival and increased risk of platinum resistance.

Greff, D., et al. (2023). "Inositol is an effective and safe treatment in polycystic ovary syndrome: a systematic review and meta-analysis of randomized controlled trials." Reproductive biology and endocrinology : RB&E 21(1): 10.
	Background: Metformin is the gold standard insulin sensitizer, which is widely used to treat insulin resistance in polycystic ovary syndrome (PCOS). However, metformin may induce gastrointestinal side effects.; Objective: Inositols have long been debated as a potential alternative for metformin in treating PCOS. Therefore, the present systematic review aimed to evaluate the efficacy and safety of inositols in treating PCOS.; Methods: The present systematic search was performed in CENTRAL, MEDLINE, and Embase from the inception until October 20th, 2021. Eligible randomized controlled trials (RCTs) included women diagnosed with PCOS and compared any inositols with metformin or placebo. Our primary outcome was cycle normalization, whereas secondary outcomes were body mass index (BMI), parameters of carbohydrate metabolism and clinical and laboratory hyperandrogenism. Results are reported as risk ratios or mean differences (MDs) with 95% confidence intervals (CIs).; Results: Twenty-six RCTs were identified, including data of 1691 patients (806 inositol, 311 with placebo, and 509 metformin groups). In patients treated with inositols, the risk (CI: 1.13; 2.85) of having a regular menstrual cycle was found by 1.79 higher than in the case of placebo. Moreover, the inositols showed non-inferiority compared to metformin in this outcome. In the case of BMI (MD = -0.45; CI: -0.89; -0.02), free testosterone (MD = -0,41, CI: -0.69; -0.13), total testosterone (MD = -20.39, CI: -40.12; -0.66), androstenedione (MD = -0.69, CI: -1,16; -0.22), glucose (MD = -3.14; CI: -5.75; -0.54) levels and AUC insulin (MD = -2081.05, CI: -2745.32; -1416.78) inositol treatment induced greater decrease compared to placebo. Inositol increased sex-hormone-binding globulin significantly compared to placebo (MD = 32.06, CI:1.27; 62.85).; Conclusion: Inositol is an effective and safe treatment in PCOS. Moreover, inositols showed non-inferiority in most outcomes compared to the gold standard treatment; metformin.; Trial Registration: PROSPERO registration number: CRD42021283275. (© 2023. The Author(s).)

Greg, M., et al. (2021). "Effect of Single and Double Layer Cesarean Section Closure on Residual Myometrial Thickness and Isthmocele - a Systematic Review and Meta Analysis."
	
Greg, M., et al. (2021). "Systematic Review and Meta Analysis of the Effect of Gabapentin on Female Chronic Pelvic Pain in Placebo Controlled Randomized Controlled Trials." PROSPERO International prospective register of systematic reviews.
	
Greg, M., et al. (2021). "Effect of 20% Intravenous Fat Emulsion Therapy on Pregnancy Outcomes in Women with RPL or RIF undergoing IVF/ICSI: A Systematic Review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Gregory Stephanie, N., et al. (2023). "Oregovomab Plus Chemo in Newly Diagnosed Patients with Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery (FLORA-5/GOG-3035)." Annals of Surgical Oncology 30(3): 1299-1301.
	
Greig, J., et al. (2023). "Sacral neuromodulation in the management of chronic pelvic pain: A systematic review and meta-analysis." Neurourology and Urodynamics 42(4): 822-836.
	Introduction: Sacral neuromodulation (SNM) is a treatment approved for use in several conditions including refractory overactive bladder (OAB) and voiding dysfunction. Chronic pelvic pain (CPP) is a debilitating condition for which treatment is often challenging. SNM shows promising effect in patients with refractory CPP. However, there is a lack of clear evidence, especially in long-term outcomes. This systematic review will assess outcomes of SNM for treating CPP. Method(s): A systematic search of MEDLINE, Embase, Cochrane Central and clinical trial databases was completed from database inception until January 14, 2022. Studies using original data investigating SNM in an adult population with CPP which recorded pre and posttreatment pain scores were selected. Primary outcome was numerical change in pain score. Secondary outcomes were quality of life assessment and change in medication use and all-time complications of SNM. Risk of bias was assessed using the Newcastle Ottawa Tool for cohort studies. Result(s): Twenty-six of 1026 identified articles were selected evaluating 853 patients with CPP. The implantation rate after test-phase success was 64.3%. Significant improvement of pain scores was reported in 13 studies; three studies reported no significant change. WMD in pain scores on a 10-point scale was -4.64 (95% confidence interval [CI] = -5.32 to -3.95, p < 0.00001) across 20 studies which were quantitatively synthesized: effects were maintained at long-term follow-up. Mean follow-up was 42.5 months (0-59). Quality of life was measured by RAND SF-36 and EQ-5D questionnaires and all studies reported improvement in quality of life. One hundred and eighty-nine complications were reported in 1555 patients (Clavien-Dindo Grade I-IIIb). Risk of bias ranged from low to high risk. Studies were case series and bias stemmed from selection bias and loss to follow-up. Conclusion(s): Sacral Neuromodulation is a reasonably effective treatment of Chronic Pelvic Pain and significantly reduces pain and increases patients' quality of life with immediate to long-term effects.Copyright © 2023 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.

Greiman, A. K., et al. (2019). "Urethral diverticulum: A systematic review." Arab Journal of Urology 17(1): 49-57.
	Objective: To present a review of the current literature regarding the presentation, diagnosis, and treatment of female urethral diverticula (UD). Method(s): A systematic search of the PubMed database was performed to identify studies evaluating female UD. Article titles, abstracts and full-text manuscripts were screened to identify relevant studies, which then underwent data extraction and analysis. Result(s): In all, 50 studies evaluating the presentation, diagnosis and treatment of female UD were deemed relevant for inclusion. Almost all studies were retrospective single-arm case series. Female UD are outpouchings of the urethral lumen into the surrounding connective tissue. The presentation of female UD is diverse and can range from incidental findings to lower urinary tract symptoms, frequent urinary tract infections, dyspareunia, urinary incontinence (UI), or malignancy. Repair of UD begins with an accurate assessment and diagnosis, which should include adequate radiographic imaging, usually including magnetic resonance imaging. Once the diagnosis is confirmed, the usual treatment is surgical excision and reconstruction, most often through a transvaginal approach. The principles of transvaginal urethral diverticulectomy include: removal of the entire urethral diverticulum wall, watertight closure of the urethra, multi-layered and non-overlapping closure of surrounding tissue with absorbable suture, and preservation or creation of continence. Results of surgical repair are usually excellent, although long-term recurrence of these lesions may occur. Complications of urethral diverticulectomy include urethrovaginal fistula, UI, and rarely urethral stricture. Conclusion(s): Whilst urethral diverticulectomy excision and reconstruction is a challenging procedure, it is ultimately satisfying for the patient and the surgeon when relief of bothersome symptoms is achieved. Adherence to principles of reconstructive surgery is important to ensure a satisfactory result. Abbreviations: PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses; UD: urethral diverticulum/diverticula; UI: urinary incontinence; US: ultrasonography; VCUG: voiding cystourethrogram.Copyright © 2019, © 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Griesinger, G., et al. (2020). "Dydrogesterone as an oral alternative to vaginal progesterone for IVF luteal phase support: A systematic review and individual participant data meta-analysis." PloS One 15(11 November): e0241044.
	The aim of this systematic review and meta-analysis was to conduct a comprehensive assessment of the evidence on the efficacy and safety of oral dydrogesterone versus micronized vaginal progesterone (MVP) for luteal phase support. Embase and MEDLINE were searched for studies that evaluated the effect of luteal phase support with daily administration of oral dydrogesterone (20 to 40 mg) versus MVP capsules (600 to 800 mg) or gel (90 mg) on pregnancy or live birth rates in women undergoing fresh-cycle IVF (protocol registered at PROSPERO [CRD42018105949]). Individual participant data (IPD) were extracted for the primary analysis where available and aggregate data were extracted for the secondary analysis. Nine studies were eligible for inclusion; two studies had suitable IPD (full analysis sample: n = 1957). In the meta-analysis of IPD, oral dydrogesterone was associated with a significantly higher chance of ongoing pregnancy at 12 weeks of gestation (odds ratio [OR], 1.32; 95% confidence interval [CI], 1.08 to 1.61; P = 0.0075) and live birth (OR, 1.28; 95% CI, 1.04 to 1.57; P = 0.0214) compared to MVP. A meta-analysis combining IPD and aggregate data for all nine studies also demonstrated a statistically significant difference between oral dydrogesterone and MVP (pregnancy: OR, 1.16; 95% CI, 1.01 to 1.34; P = 0.04; live birth: OR, 1.19; 95% CI, 1.03 to 1.38; P = 0.02). Safety parameters were similar between the two groups. Collectively, this study indicates that a higher pregnancy rate and live birth rate may be obtained in women receiving oral dydrogesterone versus MVP for luteal phase support.Copyright © 2020 Griesinger et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Griesinger, G., et al. (2021). "Effect of the oxytocin receptor antagonist nolasiban on pregnancy rates in women undergoing embryo transfer following IVF: analysis of three randomised clinical trials." Human reproduction (Oxford, England) 36(4): 1007-1020.
	Study Question: Does a single oral dose of nolasiban 900 mg administered 4 h before embryo transfer (ET) increase pregnancy rates in women undergoing IVF?; Summary Answer: In an individual patient data (IPD) meta-analysis of three clinical trials, a single oral dose of nolasiban 900 mg was associated with an increased ongoing pregnancy rate of an absolute 5% (relative 15%).; What Is Known Already: Several clinical studies have shown that blocking activation of oxytocin receptors by an oxytocin receptor (OTR) antagonist has the potential to decrease uterine contractions, increase endometrial perfusion and enhance endometrial decidualisation and other parameters of endometrial receptivity. It has been hypothesised that antagonism of oxytocin receptors could improve the likelihood of successful embryo implantation and thus increase pregnancy and live birth rates following ET.; Study Design, Size, Duration: This is an analysis of three randomised, double-blind, placebo-controlled trials, which randomised 1836 subjects between 2015 and 2019. We describe the results of a meta-analysis of individual participant data (IPD) from all three trials and the pre-specified analyses of each individual trial.; Participant/material, Setting, Methods: Participants were patients undergoing ET following IVF/ICSI in 60 fertility centres in 11 European countries. Study subjects were below 38 years old and had no more than one previously failed cycle. They were randomised to a single oral dose of nolasiban 900 mg (n = 846) or placebo (n = 864). In IMPLANT 1, additional participants were also randomised to nolasiban 100 mg (n = 62) or 300 mg (n = 60). Fresh ET of one good quality embryo (except in IMPLANT 1 where transfer of two embryos was allowed) was performed on Day 3 or Day 5 after oocyte retrieval, approximately 4 h after receiving the study treatment. Serum hCG levels were collected at 14 days post oocyte retrieval (Week 2) and for women with a positive hCG result, ultrasound was performed at Week 6 post-ET (clinical pregnancy) and at Week 10 post-ET (ongoing pregnancy). Pregnant patients were followed for maternal (adverse events), obstetric (live birth, gestational age at delivery, type of delivery, incidence of twins) and neonatal (sex, weight, height, head circumference, Apgar scores, congenital anomalies, breast feeding, admission to intensive care and specific morbidities e.g. jaundice, respiratory distress syndrome) outcomes.; Main Results and the Role of Chance: In an IPD meta-analysis of the clinical trials, a single oral dose of nolasiban 900 mg was associated with an absolute increase of 5.0% (95% CI 0.5, 9.6) in ongoing pregnancy rate and a corresponding increase of 4.4% (95% CI -0.10, 8.93) in live birth rate compared to placebo. Similar magnitude increases were observed for D3 or D5 transfers but were not significantly different from the placebo. Population pharmacokinetics (PK) demonstrated a correlation between higher exposures and pregnancy.; Limitations, Reason for Caution: The meta-analysis was not a pre-specified analysis. While the individual trials did not show a consistent significant effect, they were not powered based on an absolute increase of 5% in ongoing pregnancy rate. Only a single dose of up to 900 mg nolasiban was administered in the clinical trials; higher doses or extended regimens have not been tested. Only fresh ET has been assessed in the clinical trials to date.; Wider Implications of the Findings: The finding support the hypothesis that oxytocin receptor antagonism at the time of ET can increase pregnancy rates following IVF. The overall clinical and population PK data support future evaluation of higher doses and/or alternate regimens of nolasiban in women undergoing ET following IVF.; Study Funding/competing Interests: The trials were designed, conducted and funded by ObsEva SA. A.H., O.P., E.G., E.L. are employees and stockholders of ObsEva SA. E.L. is a board member of ObsEva SA. G.G. reports honoraria and/or non-financial support from ObsEva, Merck, M D, Ferring, Abbott, Gedeon-Richter, Theramex, Guerbet, Finox, Biosilu, Preglem and ReprodWissen GmbH. C.B. reports grants and honoraria from ObsEva, Ferring, Abbott, Gedeon Richter and MSD. P.P. reports consulting fees from ObsEva. H.T. reports grants and or fees from ObsEva, Research Fund of Flanders, Cook, MSD, Roche, Gedeon Richter, Abbott, Theramex and Ferring. H.V. reports grants from ObsEva and non-financial support from Ferring. P.T. is an employee of Cytel Inc., who provides statistical services to ObsEva. J.D. reports consulting fees and other payments from ObsEva and, Scientific Advisory Board membership of ObsEva.; Trial Registration Numbers: ClinicalTrials.gov: NCT02310802, NCT03081208, NCT03758885.; Trial Registration Dates: December 2014 (NCT02310802), March 2017 (NCT03081208), November 2018 (NCT03758885).; First Patient’s Enrolment: January 2015 (NCT02310802), March 2017 (NCT03081208), November 2018 (NCT03758885). (© The Author(s) 2021. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Griffith, T., et al. (2022). "The role for vaginal cuff brachytherapy boost after external beam radiation therapy in endometrial cancer." Brachytherapy 21(2): 177-185.
	Purpose: To evaluate the role and technique of a vaginal cuff brachytherapy (VB) boost to adjuvant external beam (EB) radiation for endometrial cancer through a systematic review.; Methods and Materials: Relevant trials were identified through a systematic search of the literature.; Results: A total of 21 prospective and retrospective studies which had a patient cohort undergoing EB + VB was identified to evaluate for rates of vaginal and pelvic recurrences, overall survival, and toxicity. Additional database studies were utilized to demonstrate differences in local control and overall survival between EB and EB + VB.; Conclusions: While there is limited prospective evidence to guide the use of a VB boost after EB, the evidence suggests that patients with a higher risk of a vaginal recurrence such as those with cervical stromal involvement in select Stage III patients may derive local control and survival benefits from a VB boost. Additional individual risk factors such as grade, histology, extent of invasion, margin status, age, and the use of lower doses of EB should be considered when deciding when to add a VB boost. (Published by Elsevier Inc.)

Grigolon Ruth, B., et al. (2023). "Effects of nutritional interventions on the severity of depressive and anxiety symptoms of women in the menopausal transition and menopause: a systematic review, meta-analysis, and meta-regression." Menopause (New York, N.Y.) 30(1): 95-107.
	Importance: Depression and anxiety may significantly affect women during the menopausal transition. In addition to traditional treatment strategies such as hormone therapy, antidepressants, and psychotherapy, nutritional interventions have been increasingly studied, but there is no consensus about their role in this patient population.; Objective: This systematic review and meta-analysis aimed to evaluate the effect of nutritional interventions on the severity of depressive (DS) and anxiety (AS) symptoms in women during the menopausal transition or menopausal years.; Evidence Review: Electronic search using databases PubMed, Cochrane, and Embase to identify articles indexed until January 31, 2021, focusing on randomized placebo-controlled trials documenting the effect of diet, food supplements, and nutraceuticals on DS and AS.; Findings: Thirty-two studies were included (DS, n = 15; AS, n = 1; DS and AS combined, n = 16). We found two studies that demonstrated data combined with other interventions: one with lifestyle interventions (vitamin D plus lifestyle-based weight-loss program) and another with exercise (omega 3 plus exercise). The pooled effect size favored the intervention group over placebo for both DS and AS (DS: standardized mean difference, -0.35 [95% confidence interval, -0.68 to -0.03; P = 0.0351]; AS: standardized mean difference, -0.74 [95% CI, -1.37 to -0.11; P = 0.0229]). There was significant heterogeneity in the pooled results, which can be attributed to differences in assessment tools for depression and anxiety as well as the variety of nutritional interventions studied. The subgroup analysis showed a statistically significant effect of menopausal status (perimenopausal or menopausal) but not the type or duration of nutritional intervention. Older age was the only significant predictor of the effect size of nutritional interventions in the meta-regression.; Conclusions and Relevance: Nutritional interventions are promising tools for the management of mood/anxiety symptoms in women during the menopausal transition and in postmenopausal years. Because of significant heterogeneity and risk of bias among studies, the actual effect of different approaches is still unclear.; Competing Interests: Financial disclosure/conflicts of interest: C.N.S. has received research funds from Otsuka, Eisai, Ontario Research Fund, and Ontario Brain Institute and acted as a consultant for Otsuka, Eisai, Pfizer, and Bayer. E.B. receives funding from PSI Foundation, Queen's University Faculty of Health Science, and Queen's University Department of Psychiatry. The other authors have nothing to disclose. (Copyright © 2022 by The North American Menopause Society.)

Grigore, M., et al. (2021). "Large ovarian tumors in adolescents, a systematic review of reported cases, diagnostic findings and surgical management." Taiwanese Journal of Obstetrics & Gynecology 60(4): 602-608.
	The purpose of this study was to analyze the published cases regarding large ovarian masses in adolescents, in order to find useful clinical implications for the diagnosis and management of the condition. The methodology employed a systematic review of reported cases of large/giant ovarian tumor in adolescence. The main objective was to assess the imagery findings, histology of the tumor, and the type of surgery performed. Our study included 58 patients with the tumor diameters ranged between 11 and 42 cm, with a median value of 22.75 cm and a mean diameter of 24.66 ± 8.50 cm. The lesions were benign in 47 cases (81%), borderline in 2 cases (3.4%), and malign in 9 cases (15.6%). We found no statistically significant difference (p > 0.05) between the size of the tumors and the ovarian markers levels. At the same time, a statistically significant difference was identified (p=<0,001) between elevated levels of the serum markers and the malignant tumor type (OR = 12.45; CI 95 = 2.55-94.77). The main types of surgery performed were cystectomy (35 cases), oophorectomy (4 cases), salpingo-oophorectomy (18 cases). Open laparotomy was performed in 46 cases on tumors with a median diameter of 25 ± 8.8 cm, while laparoscopy was done in 12 cases on tumors with a median diameter of 23.7 ± 7.6 cm. For optimal surgical management, it is advisable to assess first the imagery findings and tumor markers. Then, the laparoscopic approach should be considered as a feasible option, especially in cases where there are no predictive factors for a malign disease.; Competing Interests: Declaration of competing interest The authors declare no conflicts of interest. (Copyright © 2021. Published by Elsevier B.V.)

Grigoryan, B., et al. (2023). "Adjustable slings versus other surgical methods in female stress urinary incontinence: a systematic review and meta-analysis." International Urogynecology Journal 34(7): 1351-1367.
	Introduction and hypothesis: The objective of this study was to evaluate the efficacy and safety of different adjustable slings compared to other surgical methods for the treatment of stress urinary incontinence (SUI) among women. Method(s): The inclusion criteria were as follows: randomized controlled trials (RCTs) and non-RCTs assessing adult women with SUI. The exclusion criteria were as follows: other types of urinary incontinence, studies that combined conservative interventions and pharmacological treatment, pregnant and lactating patients. Databases were searched up to November 2022 to identify articles evaluating the effectiveness and safety of different adjustable slings compared to other surgical methods for the treatment of SUI among women. The systematic review was conducted in accordance with the PRISMA 2020 checklist and registered in PROSPERO. Risk-of-bias assessment tools recommended by the Cochrane Society were used to evaluate the risk of bias in the included studies. Result(s): Eighteen clinical trials were included in this systematic review, and 11 studies were included in the meta-analysis. Fourteen studies were RCTs, and four were retrospective studies. Only RCTs were included in the meta-analyses. There was no statistically significant difference in the objective cure rate, subjective cure rate, or long-term postoperative complication rate between Ajust single-incision mini-slings (SIMS) and standard mid-urethral slings (SMUS) or MiniArc SIMS. However, the operation time in the adjustable SIMS group was significantly shorter (RR = -4.20, 95% CI: [-7.51, -0.89], p = 0.01). Conclusion(s): This systematic review and meta-analysis revealed that adjustable SIMS is equally effective when compared with SMUS for the treatment of SUI among women. Moreover, the operation time for the adjustable SIMS was shorter. However, additional well-designed studies with standard outcome measures and complete follow-up periods will help to increase confidence in the choice of different options for treating SUI among women.Copyright © 2023, The International Urogynecological Association.

Grilli, D., et al. (2023). "Combined treatment with vaginal native tissue repair plus mid-urethral sling or pelvic floor muscle training in patients with anterior defect and occult stress urinary incontinence: quality of life and sexual function analysis." Minerva Obstetrics and Gynecology.
	BACKGROUND: The aim of this study was to compare the efficacy of vaginal native tissue repair (VNTR) combined with tension-free transobturator tape (TVT-O) or pelvic floor muscle training (PFMT) in terms of quality of life (QoL) and sexual function (SF) in women affected by anterior defect and occult stress urinary incontinence (OSUI). METHOD(S): One hundred forty-seven patients with symptomatic anterior defect with OSUI underwent VNTR. In 71 patients TVT-O was inserted and 76 underwent PFMT after surgery. Clinical exam, 3-day voiding diary and urodynamic testing were evaluated in preoperative and postoperative times. Specific questionnaires were also administered, in order to indagate disease perception and the impact on QoL and SF. RESULT(S): Nine patients had postoperative pain in the TVT-O group vs. 0 patients in the PMFT group (P=0.001) and 7 patients reported de novo urgency vs. 3 in the two groups, respectively. At 12 weeks follow-up (FU), the first voiding desire was at 88.12+19.70 mL in VNTR+TOT vs. 102.29+19.13 (P=0.03); the mean number of voids (24 hours) was 9.95+/-2.66 vs. 6.14+/-1.77 (P=0.04), respectively. No significant differences in terms of QoL and SF were shown. CONCLUSION(S): This retrospective study suggests that VNTR+TVT-O and VNTR+PMFT have the same efficacy in terms of QoL and SF, with several post-operative complications, even if minor, in patients treated with combined surgery.

Grimes Cara, L., et al. (2019). "Surgical interventions for posterior compartment prolapse and obstructed defecation symptoms: a systematic review with clinical practice recommendations." International Urogynecology Journal 30(9): 1433-1454.
	Introduction and Hypothesis: Several posterior compartment surgical approaches are used to address posterior vaginal wall prolapse and obstructed defecation. We aimed to compare outcomes for both conditions among different surgical approaches.; Methods: A systematic review was performed comparing the impact of surgical interventions in the posterior compartment on prolapse and defecatory symptoms. MEDLINE, Embase, and ClinicalTrials.gov were searched from inception to 4 April 2018. Randomized controlled trials, prospective and retrospective comparative and single-group studies of women undergoing posterior vaginal compartment surgery for vaginal bulge or bowel symptoms were included. Studies had to include both anatomical and symptom outcomes both pre- and post-surgery.; Results: Forty-six eligible studies reported on six surgery types. Prolapse and defecatory symptoms improved with native-tissue transvaginal rectocele repair, transanal rectocele repair, and stapled transanal rectocele repair (STARR) surgeries. Although prolapse was improved with sacrocolpoperineopexy, defecatory symptoms worsened. STARR caused high rates of fecal urgency postoperatively, but this symptom typically resolved with time. Site-specific posterior repairs improved prolapse stage and symptoms of obstructed defecation. Compared with the transanal route, native-tissue transvaginal repair resulted in greater improvement in anatomical outcomes, improved obstructed defecation symptoms, and lower chances of rectal injury, but higher rates of dyspareunia.; Conclusions: Surgery in the posterior vaginal compartment typically has a high rate of success for anatomical outcomes, obstructed defecation, and bulge symptoms, although these may not persist over time. Based on this evidence, to improve anatomical and symptomatic outcomes, a native-tissue transvaginal rectocele repair should be preferentially performed.

Grinstein, E., et al. (2022). "Long term outcomes of laparoscopic sacro/colpo-hysteropexy with and without rectopexy for the treatment of prolapse." International Urogynecology Journal 33(2): 343-350.
	Introduction and Hypothesis: Laparoscopic sacrohysteropexy (LSH), sacrocolpopexy (LSC) and ventral rectopexy (LVR) with mesh are advocated for surgical treatment of pelvic and rectal prolapse. Our study aims at showing the feasibility of concomitant laparoscopic prolapse repair by comparing perioperative and long-term outcomes of LSH or LSC with and without LVR.; Methods: This is a retrospective study carried out on 348 women operated on between July 2009 and July 2019. Patients were divided into four groups: (1) LSH only, (2) LSC only, (3) LSH + LVR and (4) LSC + LVR. POP-Q scores and satisfaction questionnaires were recorded at baseline and then annually. Outcomes were defined as subjective failure (vaginal/rectal prolapse symptoms), objective failure (prolapse to/beyond the hymen, full thickness rectal prolapse) or retreatment for prolapse. Complications were collected and graded according to the Clavien-Dindo classification.; Results: Three hundred forty-eight women underwent laparoscopic repair for pelvic and rectal prolapse (219, 44, 66 and 19 in group 1, 2, 3 and 4, respectively). Median follow-up was 24 (4-174) months. Success rate for both rectal and pelvic prolapse was 90.2%. Recurrence rates were not significantly different between the groups (12.3%, 6.8%, 9.1% and 10.5% for groups 1, 2, 3 and 4, respectively). Significant improvement was noticed in satisfaction questionnaires in all groups. There was no difference in perioperative and late complications.; Conclusion: The combined laparoscopic procedure appears to be safe and efficient in treating pelvic and rectal prolapse. Appropriate patient selection and available surgical expertise should determine whether to perform these procedures combined or separately. (© 2021. The International Urogynecological Association.)

Grisham Rachel, N. and M. H. Chui (2022). "Advancements in Low-Grade Serous Carcinoma of the Ovary and Peritoneum." Current oncology reports 24(11): 1549-1555.
	Purpose of Review: Low-grade serous ovarian cancer (LGSOC) is a rare form of epithelial ovarian cancer that generally exhibits a protracted course and is less sensitive to chemotherapy than high-grade serous ovarian cancer. Over the past decade, it has become clear that patients with LGSOC have a clinically distinct course and are molecularly and histologically unique from patients with high-grade serous ovarian cancer.; Recent Findings: Endocrine therapy is frequently used for the treatment of patients with recurrent LGSOC and is now also part of the standard upfront treatment of this disease, with an ongoing phase III clinical trial seeking to determine if chemotherapy can be eliminated altogether from the initial treatment of LGSOC. Tumors are frequently found to exhibit alterations affecting the mitogen-activated protein kinase (MAPK) pathway, recently leading to developments in the use of targeted treatments for those patients with recurrent disease. LGSOC is a clinically, histologically, and molecularly unique form of epithelial ovarian cancer. Recent advances in the understanding of endocrine and molecular drivers of this disease have led to changes in both the treatment of newly diagnosed and recurrent disease, with ongoing studies focused on refining upfront therapy and seeking novel targeted combinations for those patients with recurrent disease. (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Grisham Rachel, N., et al. (2023). "The highs and lows of serous ovarian cancer." Cancer 129(17): 2613-2620.
	Low-grade serous ovarian cancer was initially described as a distinct type of rare epithelial ovarian cancer 20 years ago; however, only recently have physicians begun to leverage the understanding of the clinical behavior and molecular profile of this disease for treatment. The use of routine next-generation sequencing has allowed a deeper understanding of the molecular drivers of this disease and shown how molecular alterations in mitogen-activated protein kinase pathway genes such as KRAS and BRAF can affect overall prognosis and disease behavior. The use of targeted therapies, including MEK inhibitors, BRAF kinase inhibitors, and other investigational targeted therapies are changing the way this disease is viewed and treated. In addition, endocrine therapy can provide prolonged disease stability with generally mild toxicity, as well as promising response rates in recent studies examining combination therapy with CDK 4/6 inhibitors in the upfront and recurrent setting. Once seen merely as a chemo-resistant form of ovarian cancer, recent studies have worked to harness the unique features of low-grade serous ovarian cancer to provide individualized treatment options for patients with this disease. (© 2023 American Cancer Society.)

Group, A. and Gineco (2022). Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer.
	No Results Available Drug: Chemotherapy|Drug: Bevacizumab-Awwb|Drug: Niraparib Progression-Free survival (PFS) rate up to 24 months|PFS2|Number of Participants with abnormal physical examinations, abnormal vital signs and abnormal findings according to CTC-AE v5|Time to First Subsequent Treatment|Time to Second Subsequent Treatment|Long-term Overall Survival in both arms|Confirmation of the predictive value (overall chemo-sensitivity) of the KELIM. Female Phase 2 390 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GINECO-OV129b February 2030

Group, A., et al. (2022). Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line.
	No Results Available Drug: Carboplatin-Paclitaxel|Drug: Dostarlimab Progression Free Survival (PFS)|Overall Survival (OS) (key secondary endpoint)|Progression Free Survival 2 (PFS2)|Quality Of Life evaluation based on Quality of Life Questionnaire EQ5D5L (The 5-level EQ-5D version)|To assess the effects of Dostarlimab on Health related quality of Life (QoL) based on EORTC QLQ C30 (Quality of Life questionnaire-core 30)|To assess the quantity of peripheral neuropathy event induced by chemotherapy based on EORTC QLQ-CIPN 20 (Quality of Life questionnaire-Chemotherapy induced peripheral neuropathy 20)|To assess the effects of treatment on health-related quality of life (HRQoL) as measure by determining time to deterioration in Quality of life, based EORTC QLQ-EN24 (Quality of Life Questionnaire - Endometrial Cancer Module)|To assess the status of health for patients with endometrial cancer based on EUROQOL EQ-5D (Descriptive system)|Best Objective Response Rate (ORR)|Disease Control Rate (DCR)|Duration of Response Rate (DoR)|Safety and number of adverse events|Tolerability to the treatment|Time to first and second Subsequent Treatment|To determine the immunogenicity of dostarlimab Female Phase 3 260 Other|Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GINECO-EN105b October 2029

Group, A., et al. (2021). OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC.
	No Results Available Drug: OSE2101|Drug: Pembrolizumab 25 MG/ML [Keytruda] Progression free survival (PFS)|Objective response rate (ORR)|Incidence of treatment emergent adverse events|Time to subsequent first treatments (TTST-1)|Time to subsequent second treatments (TTST-2)|Overall Survival (OS) Female Phase 2 180 Other|Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GINECO-OV244b|2020-004364-25|ENGOT-ov58 December 2025

Group, A. G. O. S. and T. Groups European Network of Gynaecological Oncological (2022). Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer.
	No Results Available Drug: Carboplatin|Drug: Paclitaxel|Drug: Bevacizumab|Drug: Niraparib Progression Free Survival (PFS)|PFS according to tumor BRCA status|Overall Survival (OS)|Time to First Subsequent Therapy (TFST)|Second Progression (PFS 2)|Time to Second Subsequent Therapy (TSST)|Number of participants with treatment-related adverse events (AE) and/or serious adverse events (SAEs) and/or AEs that led to premature withdrawal of trial treatment and/or interruptions/dose modifications|Effects on Quality of Life (QoL) Female Phase 3 970 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment AGO-OVAR 28|2021-001271-16|ENGOT-ov57 September 2030

Group Australia New Zealand Gynaecological, O., et al. (2023). EPOCH: Eribulin and Pembrolizumab in Ovarian/Uterine Carcinosarcoma.
	No Results Available Drug: Eribulin Mesylate|Drug: Pembrolizumab Clinical Benefit Rate (CBR) by RECIST v1.1 in combination therapy arm|Clinical Benefit Rate (CBR) by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in single agent therapy arm|Objective Response Rate (ORR) in both the single agent eribulin and combination eribulin/pembrolizumab arms|Clinical Benefit Rate (CBR) by iRECIST (modified RECIST guidelines for use in cancer immunotherapy trials)|Time to progression in the combination therapy arm|Progression free survival (PFS)|Overall Survival (OS)|Adverse events|Health related Quality of Life using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for cancer patients (QLQ C30)|Health related Quality of Life using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire module for Ovarian Cancer patients (OV28) All Phase 2 30 Other|Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ANZGOG 1828/2021 December 2026

Group Canadian Cancer, T., et al. (2022). Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer.
	No Results Available Drug: Durvalumab|Drug: BA3011|Drug: BA3021|Drug: To be determined To efficiently identify based on objective response rate (ORR), by investigator assessment using RECIST 1.1, promising immunotherapy combinations for the treatment of high grade serous ovarian cancer for later validation in randomized trials|Evaluate ORR by investigator assessment using RECIST 1.1|Determine progression-free survival of immunotherapy regimens (RECIST 1.1 and iRECIST)|Determine overall-survival of immunotherapy regimens (RECIST 1.1 and iRECIST)|Number and severity of adverse events Female Phase 2 60 Other|Industry Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment I240 June 2025

Group, S. B. C. R. and Novartis (2021). Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors.
	No Results Available Drug: Spartalizumab|Drug: Tislelizumab Overall Response rate (ORR) (Cohort 3)|Clinical Benefit Rate (CBR) in patients with high mRNA PD1 expressing tumors (Cohort 3)|Progression free survival (PFS) in patients with high mRNA PD1 expressing tumors (Cohort 3)|Duration of response (DoR) in patients with high mRNA PD1 expressing tumors (Cohort 3)|Time to response (TtR) in patients with high mRNA PD1 expressing tumors (Cohort 3)|Overall survival (OS) in patients with high mRNA PD1 expressing tumors (Cohort 3)|PFS compared to PFS on prior line of therapy (pre-PFS) in patients with high mRNA PD1 expressing tumors (Cohort 3)|ORR in patients with low mRNA PD1-expressing tumors (Cohorts 1 and 2)|CBR in patients with low mRNA PD1 expressing tumors (Cohorts 1 and 2)|PFS in patients with low mRNA PD1 expressing tumors (Cohorts 1and 2)|DoR in patients with low mRNA PD1 expressing tumors (Cohorts 1and 2)|TtR in patients with low mRNA PD1 expressing tumors (Cohorts 1 and 2)|OS in patients with low mRNA PD1 expressing tumors (Cohorts 1 and 2)|PFS compared to PFS on prior line of therapy (pre-PFS) in patients with low mRNA PD1 expressing tumors (Cohorts 1 and 2)|Incidence, seriousness, treatment-related and intensity of Treatment Emergent Adverse Events All Phase 2 184 Other|Industry Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ACROPOLI (SOLTI-1904) March 31, 2027

Grushina, T. I. and I. I. Orlov (2022). "[Shock wave therapy in oncology: in vitro, in vivo, rehabilitation]." Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury 99(3): 58-65.
	Extracorporeal shock wave therapy (ESWT) is a relatively new branch of physiotherapy.; Purpose of the Study: Conduct an analytical review of the available literature data on the use of ESWT in oncology.; Material and Methods: A review was conducted, including data from electronic databases: Scopus, Web of Science, MedLine, World Health Organization, The Cochrane Central Register of Controlled Trials, ScienceDirect, US National Library of Medicine National Institutes of Health, PubMed, Google Scholar, elibrary, CyberLeninka, disserCat.; Results and Conclusion: The study of ESWT in oncology is carried out in two directions: 1) impact on the tumor with the aim of its disintegration, inhibition of growth, enhancement of the action of radiation and/or chemotherapy; 2) rehabilitation of cancer patients. Shock waves in vitro and in vivo significantly reduce the viability and activate apoptosis of cell lines of osteosarcoma, cancer of the stomach, colon, rectum, bladder, breast, urothelial cancer of the upper urinary tract, adenocarcinoma of the cervix, Burkitt's lymphoma, sarcoma, anaplastic thyroid cancer glands, glioblastoma multiforme. Shock waves also sensitize tumor cells for adjuvant chemotherapy and increase its antitumor activity. The lack of a stimulating effect on a number of malignant tumors in this physical factor makes it possible to conduct ESWT studies in the rehabilitation of cancer patients. The data obtained by a number of authors indicate the clinical efficacy of ESWT in the rehabilitation of patients with erectile dysfunction after radical prostatectomy, with postmastectomy lymphedema of the upper limb, with myofascial pain syndrome after cervical lymph node dissection due to malignant neoplasms of the head and neck, with peripheral polyneuropathy induced by cytostatics. However, in order to develop indications and contraindications for the appointment of ESWT in the rehabilitation of cancer patients, it is not enough just to evaluate its clinical effectiveness; currently absent scientific studies with long-term follow-up of patients who received this method of physiotherapy are needed.

Grzyb, K., et al. (2022). "Effect of Equal Volume, High-Repetition Resistance Training to Volitional Fatigue, With Different Workout Frequencies, on Muscle Mass and Neuromuscular Performance in Postmenopausal Women." Journal of strength and conditioning research 36(1): 31-36.
	Abstract: Grzyb, K, Candow, DG, Schoenfeld, BJ, Bernat, P, Butchart, S, and Neary, JP. Effect of equal volume, high-repetition resistance training to volitional fatigue, with different workout frequencies, on muscle mass and neuromuscular performance in postmenopausal women. J Strength Cond Res 36(1): 31-36, 2022-This study examined the effects of equal volume, high-repetition resistance training (HRRT) performed to volitional fatigue, with different workout frequencies, on muscle mass and neuromuscular performance (strength, endurance) in untrained postmenopausal women. Subjects were randomized to perform HRRT 2 d·wk-1 (HRRT-2; 3 sets of 20-30 repetitions/set for elbow and knee flexion and extension) or 3 d·wk-1 (HRRT-3; 2 sets of 20-30 repetitions/set per exercise) for 8 weeks. Baseline and post-training assessments were made for muscle thickness, strength (1 repetition maximum [1RM]) and endurance (number of repetitions performed at 50% baseline 1RM) for elbow and knee flexor and extensor muscle groups. Significance was set at p < 0.05. There was a significant increase over time for all measures of muscle thickness, strength, and endurance (p < 0.005), with no differences between groups. Untrained postmenopausal women can expect to achieve similar improvements in muscle size, strength, and endurance when training 2 or 3 days per week, provided total weekly training volume is equal. (Copyright © 2020 National Strength and Conditioning Association.)

Grzybowska, M. E., et al. (2022). "Colpocleisis as an obliterative surgery for pelvic organ prolapse: is it still a viable option in the twenty-first century? Narrative review." International Urogynecology Journal 33(1): 31-46.
	Introduction and hypothesis: The aims were to review the literature from the last two decades and analyze treatment efficacy and findings of the studies on colpocleisis. Method(s): A systematic search was conducted within the MEDLINE/PubMed and ClinicalTrials.gov databases, using the following keywords: pelvic organ prolapse (POP), colpocleisis, obliterative, and LeFort. All English full-text prospective and retrospective observational and interventional studies were included. Anatomical and subjective success, surgical techniques, concomitant procedures, complication rates, anesthesia methods, and decision regret were analyzed. Result(s): A total of 237 papers were identified and 49 met the inclusion criteria. Mean patient age was 69.0 +/- 8.0 to 84 +/- 3.1. Over 90.2% of patients undergoing colpocleisis were diagnosed with POP stage >= 3. The follow-up ranged from 30 days to a median of 5 years. Anatomical success, defined as POP-Q stage <= 1 and no prolapse beyond the hymen, was achieved in 62.5 to 100% and 87.5 to 100% of all patients respectively. Subjective success ranged from 88% to 100%. Regret over the loss of coital ability ranged from 0% in many studies to 12.9%, general decision regret from 0% to 13.8%. After concomitant midurethral sling surgery, 86.8% to 94% of all patients were continent, with a 0-14% sling revision rate due to urinary retention. Urinary tract infection was the most common postoperative complication (4.3 to 9% confirmed with urine culture, 34.7% based on symptom definition). Bowel (0 to 2.7%) and urinary tract (0 to 9.1%) injuries were the consequences of concomitant procedures. The mortality rates were up to 1.3%. Conclusion(s): Colpocleisis is a heterogeneous procedure, characterized by high subjective and objective success, low coital ability regret, and a low risk of complications.Copyright © 2021, The Author(s).

Gu, M., et al. (2022). "Effect on the cardiovascular independent risk factor lipoprotein(a) in overweight or obese PCOS patients with ethinyl-estradiol/drospirenone alone or plus orlistat." Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology 38(7): 598-602.
	Objective: This study aimed to assess the effect on the cardiovascular independent risk factor Lipoprotein(a) [Lp(a)] in overweight or obese polycystic ovary syndrome (PCOS) patients with ethinyl-estradiol/drospirenone (EE/DRSP) alone or plus orlistat.; Methods: In this randomized controlled prospective study, 66 PCOS patients with overweight or obesity were matched according to age and BMI. All participants were randomly divided into two groups to receive EE/DRSP plus Orlistat ( n = 33) or EE/DRSP alone ( n = 33) for 3 months. Changes in cardiovascular risk factors including Lp(a), CRP, LDL-C, anthropometric assessments, variations in sex hormones related parameters, and in glucolipid metabolic index were evaluated after the intervention.; Results: Lp(a) and CRP were significantly decreased at 3 months only in the EE/DRSP plus Orlistat group. There were significant reductions in LDL-C, weight, BMI, waist circumference (WC), body fat percentage (BFP), FT in both groups compared to baseline. However, these reductions were significantly greater in EE/DRSP plus Orlistat group. The levels of HDL-C, TG, and SHBG significantly increased, while TT and LH significantly decreased in both groups over time. TC, FINS, FPG were not significantly changed in both groups after the intervention.; Conclusions: This is the first study found that EE/DRSP plus Orlistat could significantly decrease Lp(a) in overweight or obese PCOS patients. This result can be assessed as particularly important, because Lp(a) is well-known as an independent risk factor predicting an increased risk of cardiovascular diseases (CVDs).

Gu, Y., et al. (2021). "Operative and Oncological Outcomes Comparing Sentinel Node Mapping and Systematic Lymphadenectomy in Endometrial Cancer Staging: Meta-Analysis With Trial Sequential Analysis." Frontiers in Oncology 10: 580128.
	Objective: To evaluate the utility of sentinel lymph node mapping (SLN) in endometrial cancer (EC) patients in comparison with lymphadenectomy (LND).; Methods: Comprehensive search was performed in MEDLINE, EMBASE, CENTRAL, OVID, Web of science databases, and three clinical trials registration websites, from the database inception to September 2020. The primary outcomes covered operative outcomes, nodal assessment, and oncological outcomes. Software Revman 5.3 was used. Trial sequential analysis (TSA) and Grading of Recommendations Assessment, Development, and Evaluation (GRADE) were performed.; Results: Overall, 5,820 EC patients from 15 studies were pooled in the meta-analysis: SLN group (N = 2,152, 37.0%), LND group (N = 3,668, 63.0%). In meta-analysis of blood loss, SLN offered advantage over LND in reducing operation bleeding (I 2 = 74%, P<0.01). Z-curve of blood loss crossed trial sequential monitoring boundaries though did not reach TSA sample size. There was no difference between SLN and LND in intra-operative complications (I 2 = 7%, P = 0.12). SLN was superior to LND in detecting positive pelvic nodes (P-LN) (I 2 = 36%, P<0.001), even in high risk patients (I 2 = 36%, P = 0.001). While no difference was observed in detection of positive para-aortic nodes (PA-LN) (I 2 = 47%, P = 0.76), even in high risk patients (I 2 = 62%, P = 0.34). Analysis showed no difference between two groups in the number of resected pelvic nodes (I 2 = 99%, P = 0.26). SLN was not associated with a statistically significant overall survival (I 2 = 79%, P = 0.94). There was no difference in progression-free survival between SLN and LND (I 2 = 52%, P = 0.31). No difference was observed in recurrence. Based on the GRADE assessment, we considered the quality of current evidence to be moderate for P-LN biopsy, low for items like blood loss, PA-LN positive.; Conclusion: The present meta-analysis underlines that SLN is capable of reducing blood loss during operation in regardless of surgical approach with firm evidence from TSA. SLN mapping is more targeted for less node dissection and more detection of positive lymph nodes even in high risk patients with conclusive evidence from TSA. Utility of SLN yields no survival detriment in EC patients.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2021 Gu, Cheng, Zong, Kong and Xiang.)

Gu, Y., et al. (2024). "The benefits and risks of menopause hormone therapy for the cardiovascular system in postmenopausal women: a systematic review and meta-analysis." BMC Women's Health 24(1): 60.
	Background: Menopause hormone therapy (MHT), as an effective method to alleviate the menopause-related symptoms of women, its benefits, risks, and potential influencing factors for the cardiovascular system of postmenopausal women are not very clear. Objective(s): To evaluate cardiovascular benefits and risks of MHT in postmenopausal women, and analyze the underlying factors that affect both. Search strategy: The EMBASE, MEDLINE, and CENTRAL databases were searched from 1975 to July 2022. Selection Criteria: Randomized Clinical Trials (RCTs) that met pre-specified inclusion criteria were included. Data Collection and Analysis: Two reviewers extracted data independently. A meta-analysis of random effects was used to analyze data. Main Result(s): This systematic review identified 33 RCTs using MHT involving 44,639 postmenopausal women with a mean age of 60.3 (range 48 to 72 years). There was no significant difference between MHT and placebo (or no treatment) in all-cause death (RR = 0.96, 95%CI 0.85 to 1.09, I2 = 14%) and cardiovascular events (RR = 0.97, 95%CI 0.82 to 1.14, I2 = 38%) in the overall population of postmenopausal women. However, MHT would increase the risk of stroke (RR = 1.23, 95%CI 1.08 to 1.41,I2 = 0%) and venous thromboembolism (RR = 1.86, 95%CI 1.39 to 2.50, I2 = 24%). Compared with placebo, MHT could improve flow-mediated arterial dilation (FMD) (SMD = 1.46, 95%CI 0.86 to 2.07, I2 = 90%), but it did not improve nitroglycerin-mediated arterial dilation (NMD) (SMD = 0.27, 95%CI - 0.08 to 0.62, I2 = 76%). Compared with women started MHT more than 10 years after menopause, women started MHT within 10 years after menopause had lower frequency of all-cause death (P = 0.02) and cardiovascular events (P = 0.002), and more significant improvement in FMD (P = 0.0003). Compared to mono-estrogen therapy, the combination therapy of estrogen and progesterone would not alter the outcomes of endpoint event. (all-cause death P = 0.52, cardiovascular events P = 0.90, stroke P = 0.85, venous thromboembolism P = 0.33, FMD P = 0.46, NMD P = 0.27). Conclusion(s): MHT improves flow-mediated arterial dilation (FMD) but fails to lower the risk of all-cause death and cardiovascular events, and increases the risk of stroke and venous thrombosis in postmenopausal women. Early acceptance of MHT not only reduces the risk of all-cause death and cardiovascular events but also further improves FMD, although the risk of stroke and venous thrombosis is not reduced. There is no difference in the outcome of cardiovascular system endpoints between mono-estrogen therapy and combination therapy of estrogen and progesterone.Copyright © 2024, The Author(s).

Gu, Y. and G. Liang (2021). "Application value of remifentanil combined with propofol anesthesia in painless artificial abortion." 医学临床研究 38(7): 1079‐1081.
	Objective: To observe the effect of remifentanil anesthesia in painless induced abortion and the effect of interleukin‐6 (IL‐6), γ‐interferon (IFN‐γ) and nuclear factor κB (NF‐κB) levels in patients. influences. Methods: A total of 146 patients with painless abortion who were admitted to our hospital were divided into observation group (remifentanil plus propofol scheme) and control group (propofol scheme) according to the corresponding anesthesia scheme, with 73 cases in each group. The intraoperative anesthesia effect and Ramsay sedation score at 6 hours after operation were compared between the two groups, and the changes of IL‐6, IFN‐γ, and NF‐κB levels before and after anesthesia were compared. Results: The excellent and good rate of anesthesia in the observation group was 93.15% (68/73), which was significantly higher than 89.04% (63/73) in the control group, and there was a significant difference between the two groups (P<0.05). The level of IFN‐γ was lower than that before anesthesia, while the levels of IL‐6 and NF‐kB were increased (P<0.05), and the improvement in the observation group was more obvious than that in the control group (P<0.05). Conclusion: The addition of remifentanil to patients with painless abortion can achieve better anesthesia effect, and the serum levels of IFN‐γ, IL‐6 and NF‐κB can also be effectively improved. postoperative pain level.

Guan, J. and X.-J. Chen (2022). "The present status of metformin in fertility-preserving treatment in atypical endometrial hyperplasia and endometrioid endometrial cancer." Frontiers in Endocrinology 13: 1041535.
	Progestin therapy is the main fertility-sparing treatment for women with endometrial cancer (EC) and atypical endometrial hyperplasia (AEH). However, still 15-25% of these women failed to achieve complete response (CR) and then lost their fertility after definitive surgery. Metformin has been demonstrated to play an anti-cancer role in multiple cancers including EC. Several studies also suggested metformin had potential benefit in improving the therapeutic outcome of fertility-preserving treatment alongside with progestin. This review has discussed existed evidence regarding the effect of metformin combined with progestin for women with AEH and EC who desire childbearing. Nevertheless, the therapeutic effect of metformin varied in different studies due to the high heterogeneity in the patient's characteristics, the inconsistency in dose and treatment duration of metformin, the combined use of hysteroscopy, the insufficient sample size and underpowered study-design. Therefore, care should be taken when interpreting the current results on this issue. Till now, there is still no strong evidence supporting the use of metformin in fertility-preserving treatment in AEH and EEC patients. Further research is needed to provide high-quality data to validate the role of metformin as adjunctive therapy alongside with progestin to preserve fertility for AEH and EEC patients.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Guan and Chen.)

Guan, Y. and J. Han (2024). "Quality-of-life improvements in patients after various surgical treatments for pelvic organ prolapse." Archives of Gynecology and Obstetrics 309(3): 813-820.
	Objective: To compare the improvements in quality of life of patients with pelvic organ prolapse (POP) treated using various surgical methods. Material(s) and Method(s): The PUBMED, MEDLINE and Cochrane Library online databases were searched using the keywords "pelvic organ prolapse", "surgery", "PFDI-20" and "PFIQ-7" for articles published from January 2010 to December 2022 that included quality-of-life scores before and after surgery. Result(s): Forty-nine articles were include. The mean postoperative PFDI-20 and PFIQ-7 scores decreased by 67.50% and 76.98%, respectively, compared with those before surgery. In 76.9% of patients, this change did not decrease with increased postoperative time. The improvement rate in PFDI-20 scores after colpocleisis did not differ statistically from that after sacrocolpopexy and was significantly higher than that after other procedures. The improvement rate in PFIQ-7 scores after colpocleisis did not statistically differ from that after high uterosacral ligament suspension and was significantly higher than that after other procedures. The improvement rate in PFDI-20 scores after transvaginal mesh-based repair (TVM) did not significantly differ from that after sacrospinous ligament fixation and was significantly lower than that after other procedures except traditional vaginal wall repair. The improvement rate in PFIQ-7 scores after TVM did not significantly differ from that after new procedures and was significantly lower than that after other procedures. Conclusion(s): Surgical treatment can significantly improve the quality of life of patients with POP. Colpocleisis may offer more advantages than those of other surgical procedures, and improvement was lower after TVM than after other procedures.Copyright © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2023.

Guarano, A., et al. (2023). "Alpha Lipoic Acid Efficacy in PCOS Treatment: What Is the Truth?" Nutrients 15(14).
	Polycystic ovary syndrome (PCOS) is among the most common female endocrinopathies, affecting about 4-25% of women of reproductive age. Women affected by PCOS have an increased risk of developing metabolic syndrome, type 2 diabetes mellitus, cardiovascular diseases, and endometrial cancer. Given the pivotal role of insulin resistance (IR) in the pathogenesis of PCOS, in the last years, many insulin-sensitizing factors have been proposed for PCOS treatment. The first insulin sensitizer recommended by evidence-based guidelines for the assessment and treatment of PCOS was metformin, but the burden of side effects is responsible for treatment discontinuation in many patients. Inositols have insulin-mimetic properties and contribute to decreasing postprandial blood glucose, acting by different pathways. ALA is a natural amphipathic compound with a very strong anti-inflammatory and antioxidant effect and a very noteworthy role in the improvement of insulin metabolic pathway. Given the multiple effects of ALA, a therapeutic strategy based on the synergy between inositols and ALA has been recently proposed by many groups with the aim of improving insulin resistance, reducing androgen levels, and ameliorating reproductive outcomes in PCOS patients. The purpose of this study is to review the existing literature and to evaluate the existing data showing the efficacy and the limitation of a treatment strategy based on this promising molecule. ALA is a valid therapeutic strategy applicable in the treatment of PCOS patients: Its multiple actions, including antinflammatory, antioxidant, and insulin-sensitizing, may be of utmost importance in the treatment of a very complex syndrome. Specifically, the combination of MYO plus ALA creates a synergistic effect that improves insulin resistance in PCOS patients, especially in obese/overweight patients with T2DM familiarity. Moreover, ALA treatment also exerts beneficial effects on endocrine patterns, especially if combined with MYO, improving menstrual regularity and ovulation rhythm. The purpose of our study is to review the existing literature and to evaluate the data showing the efficacy and the limitations of a treatment strategy based on this promising molecule.

Guberti, M., et al. (2021). "Bovine colostrum applications in sick and healthy people: A systematic review." Nutrients 13(7): 2194.
	Colostrum is the first secretion of mammalian glands during the early period after birth giving. Its components are biologically active and have beneficial effects on new-born growth and well-being. Bovine colostrum has the highest concentration of these substances and its supplementation or application may provide health benefits. This systematic review was conducted to update current knowledge on bovine colostrum effects including all administration routes on healthy and sick subjects. Full texts or abstracts of twenty-eight papers as reports of systematic reviews, randomized controlled trials, observational studies and case series were included after searches in Medline, Embase, Cochrane Library and Cinahl databases. The full texts of selected studies were assessed for quality using validated tools and their results were summarized in different categories. Studies were highly heterogeneous as regards to population, intervention, outcome and risk of bias. Bovine colostrum topical application was shown effective on vaginal dryness related symptoms limitation. Its use as food supplement showed interesting effects preventing upper respiratory illness in sportsmen, modulating immune system response and reducing intestinal permeability in healthy and sick subjects. Conflicting results were provided in pediatric population and little evidence is available on its use with older adults. Further studies are mandatory to better understand all factors influencing its activity.Copyright © 2021 by the authors. Licensee MDPI, Basel, Switzerland.

Guducu, N. and N. K. Ozcan (2023). "The effect of emotional freedom techniques (EFT) on postpartum depression: A randomized controlled trial." Explore 19(6): 842-850.
	This study examines the effect of EFT on postpartum depression, investigating EFT as a therapeutic method that is easy to apply and carries no cost as a preventive treatment for depression in pregnancy and postpartum depression. Based on prior research, we hypothesized that depressive symptoms would reduced by using EFT during pregnancy and the postpartum period. Secondly, we hypothesized that EFT could be used to reduce anxiety during pregnancy and the postpartum period. Thirdly, we hypothesized that using EFT to cope with stress during pregnancy and the postpartum period increases the use of active tools (seeking social support, being positive, and being self-confident), and finally, we hypothesized that the effect of EFT when applied during pregnancy to reduce depressive symptoms persists for a long time. Section snippets Study design The Consolidated Standards of Reporting Trials (CONSORT) 2018 instructions were followed in this randomized controlled, intervention study.44,45,46 The present study was conducted between April 15, 2018 and July 15, 2019 in a university hospital's pregnancy outpatient clinic. The trial protocol was registered (NCT04355091). Participants The current study's sample size was calculated using the G*Power application (Version 3.1.9.3). The sample size was calculated using a Cohen's standard effect size value of Results The current study concluded with 136 pregnant women, 69 in the intervention group and 67 in the control group. The consort flowchart of the study is shown in Fig. 2. Discussion The present study, which is the first randomized controlled study to evaluate the effectiveness of EFT on PPD, examined pregnant women's risk of depression and approaches to coping with anxiety and stress. However, because there are no studies in the literature on the effects of EFT on postpartum depression, this study's findings were discussed in reference to studies that evaluated the effectiveness of other psychotherapies on postpartum depression. In the current study, both the intervention Conclusion and recommendations The present study is the first to test the effectiveness of EFT applied during pregnancy on postpartum depression and shows that EFT reduce anxiety and depression, with long-term positive effects. The study findings reveal that EFT effectively reduce depression and anxiety and increases active (positive) coping styles. The study fndings confirm all the hypotheses generated at the beginning of the study. In the presence of mild depression, the study's findings support activating the therapeutic First page preview

Gueli, A., et al. (2019). "Laparoscopy vs. laparotomy for advanced ovarian cancer: a systematic review of the literature." Minerva Medica 110(4): 341-357.
	Introduction: In the last decade, laparoscopy has been progressively introduced in the management of advanced-stage ovarian cancer (AOC) to evaluate tumor resectability, avoiding an explorative laparotomy, to identify non-responders to submit to second-line chemotherapy and to perform primary or interval minimally invasive debulking surgery in selected patients. This review aims to deeply focus on the differences between laparoscopy and laparotomy in the management of advanced ovarian cancer.; Evidence Acquisition: The electronic database search provided a total of 80 results. Out of these, 63 results were excluded because considered not relevant to the review, for linguistic reasons or case reports. A total of 17 articles were considered eligible for the review.; Evidence Synthesis: Many studies have assessed the value of laparoscopy in predicting the optimal resectability of AOC patients avoiding exploratory laparotomies. More recently, its role in primary and interval cytoreduction has been investigated for selected patients in terms of safety, feasibility and oncological outcomes. Published data are comparable to the standard laparotomic management in terms of oncological outcomes but with improved perioperative and psychological results. The selection of patients is crucial to perform a successful surgery.; Conclusions: To date, laparoscopy has replaced the primary laparotomic approach in the evaluation of optimal resectability. As far as primary and interval minimally invasive debulking surgery are concerned, instead, most of the works report an overlap of oncological outcomes compared to traditional surgery. The selection of patients is a crucial point to reach a successful minimally invasive surgical treatment, taking into account surgical complexity and surgical adequacy.

Guerette, N., et al. (2022). "HIGH INTENSITY FOCUSED ELECTROMAGNETIC THERAPY VS. PELVIC FLOOR THERAPY WITH BIOFEEDBACK FOR TREATMENT OF FEMALE URINARY INCONTINENCE. A MULTI-CENTER RANDOMIZED-CONTROLLED TRIAL: 12-MONTH ANALYSIS." Female Pelvic Medicine & Reconstructive Surgery 28(6): S74.
	Introduction: The pelvic floor musculature (PFM) is essential for support and function of the pelvic organs. A common consequence of loss of PFM function is urinary incontinence (UI). Pelvic floor therapy (PFT), in particular biofeedback therapy, is a cornerstone of conservative management of urinary incontinence. However, studies of long‐term outcomes have had limited success and long‐term adherence has been challenging. This study investigated the efficacy of novel method of pelvic floor therapy, High Intensity Focused Electromagnetic Therapy (HIFEM), compared to conventional PFT with biofeedback for improvement of UI in women. Objective: The objective of the study was to compare HIFEM pelvic floor therapy to PFT with biofeedback for the treatment of UI as well as urinary urgency and frequency symptoms. Methods: Forty‐seven women (27‐66 years) at 3 centers diagnosed with UI were randomized to 2 groups: PFT (N = 22) and HIFEM (N = 25). All subjects underwent 6 treatment sessions scheduled twice a week for three weeks with either standard HIFEM therapy or a standardized pelvic floor biofeedback and electrical stimulation protocol adopted from Harvard Deaconess Department of Physical Therapy. Follow‐up visits performed at 1, 3, 6, 9 and 12 months after final treatment session. Outcome measures include qol questionnaires (ICIQBD, ICIQ‐LUTS), pad use, subjective leakage, therapy adherence, and therapy comfort. Adverse events and side effects were recorded. Results: Analysis at 6‐months post‐treatment showed significant improvement in UI symptoms measured by ICIQ‐LUTS in the HIFEM group (‐15.2 points, 35%, P < 0.001) but not in the PFT group (‐5.1 points, 13%, P = 0.24). Significant improvement over baseline was maintained at 12‐months in HIFEM (24%, P = 0.02) but not in the PFT group (3%, P = 0.85). ICIQ‐BD demonstrated greater improvement in urgency symptoms in the HIFEM vs. PFMT group (34% vs. 5%) at 12‐months. 87% of HIFEM subjects reported less leakage at 12‐months compared to 71% of PFMT subjects. Pad use decreased by ‐2.0/day in the HIFEM group vs. ‐0.4/day in the PFMT group. Average therapy comfort was rated 3.9/5 for HIFEM vs. 2.4/5 for PFMT at 12‐months. Subjects were 3.5 times more likely to complete the entire series of treatments in the HIFEM group. No adverse events or negative side effects were reported in either group. Conclusions: HIFEM technology appears safe and effective for the treatment of UI in women. HIFEM was more effective and better tolerated for the treatment of UI than conventional PFTwith biofeedback at 12‐months in this study. Larger studies are needed.

Guerin, J., et al. (2021). "Use of Hormonal Contraceptives in Perimenopause: A Systematic Review." Pharmacotherapy.
	INTRODUCTION: Hormonal contraceptives have been used in perimenopausal women to manage a variety of symptoms and prevent unintended pregnancy. However, it is unclear what contraceptive regimen is best for these women. OBJECTIVE: To evaluate hormonal contraceptive methods in women experiencing perimenopause using two prespecified outcomes: perimenopausal symptom management and long-term effects. METHODS: A literature search of PubMed and EMBASE databases was performed (January 1990 to October 2021) using search terms "perimenopause" and "contraception." Relevant full-text articles in English were included. RESULTS: Fifteen clinical articles were reviewed. Fourteen were internationally-based and one study was conducted in the United States. Nine articles evaluated symptom resolution, and six of these nine reported statistically significant changes in favor of treating perimenopausal women with hormonal contraceptives compared with no treatment. Seven studies evaluated long-term outcomes including bone loss and metabolic parameters, and six of these seven showed statistically significant improvements with hormonal contraceptives. Based on limited data and a lack of comparative studies, the use of a levonorgestrel intrauterine device with supplemental low-dose menopausal estrogen has positive results for the management of disruptive perimenopausal symptoms and long-term outcomes. CONCLUSION: Hormonal contraception in perimenopausal women improves symptom management and long-term outcomes if patients do not have contraindications. When selecting a contraceptive for women in perimenopause, clinicians and pharmacists need to address specific patient risk factors, symptom profiles, long-term risks and benefits, and patient preferences.

Guerra-Martin, M. D. and I. Guillen-Gallego (2020). "Effectiveness of the use of mindfulness in pregnancy, delivery and postpartum." Matronas Profesion 21(3-4): 59-66.
	Objective: To analyze the effectiveness of the mindfulness use in pregnancy, delivery and postpartum, and describe the different mindfulness methods. Methodology: A bibliographic review was carried out according to the objective of studies published between 2014-2019, in the databases: PubMed, CINAHL, WOS and Scopus, in the period March-April 2019. Result(s): A total of 124 studies were located and 22 were finally selected. Of these, 54.5% used mindfulness based on cognitive therapies (MBCT). 50% of the studies show effectiveness of the use of mindfulness, in terms of decreased anxiety and depression; however, in 13.6% they report that these aspects do not improve. Conclusion(s): There is scientific evidence of the use of mindfulness, with MBCT being the most widely used therapy. The use of mindfulness improves, among others, anxiety, depression, fear of childbirth, stress, nausea and vomiting.Copyright © 2021 Ediciones Mayo, S.A. All rights reserved.

Guerzoni, S., et al. (2023). "Monoclonal anti-CGRP antibodies in post-menopausal women: a real-life study." Acta neurologica Belgica 123(3): 1039-1047.
	Introduction: Migraine usually ameliorates after menopause. However, 10-29% of women still experience migraine attacks after menopause, especially if menopause is surgical. The use of monoclonal antibodies against the calcitonin gene-related peptide (CGRP) is changing the landscape of migraine treatment. This study aims to explore the effectiveness and safety of anti-CGRP monoclonal antibodies in women in menopause.; Methods: Women affected by either migraine or chronic migraine and treated with an anti-CGRP monoclonal antibody for up to 1 year. Visits were scheduled every 3 months.; Results: Women in menopause displayed a similar response compared to women of childbearing age. Among women in menopause, the women experiencing surgical menopause seemed to exhibit a similar response compared to the ones experiencing physiological menopause. Erenumab and galcanezumab displayed similar effectiveness in women in menopause. No serious adverse events were registered.; Discussion: The effectiveness of anti-CGRP monoclonal antibodies is almost the same between women in menopause and women of childbearing age, without appreciable differences between the different antibodies. (© 2023. The Author(s) under exclusive licence to Belgian Neurological Society.)

Guha, P., et al. (2023). "Estrogen receptors as potential therapeutic target in endometrial cancer." Journal of receptor and signal transduction research 43(1): 19-26.
	Endometrial cancer (EC) is one of the most common gynecological carcinomas in both developed and developing countries. Majority of the gynecological malignancies are hormonally driven where estrogen signaling acts as an oncogenic signal. Estrogen's effects are mediated via classical nuclear estrogen receptors; estrogen receptor alpha and beta (ERα and ERβ) and a trans-membrane G protein-coupled estrogen receptor (GPR30 and GPER). ERs and GPER through ligand binding triggers multiple downstream signaling pathways causing cell cycle regulation, cell differentiation, migration, and apoptosis in various tissues including endometrium. Although the molecular aspect of estrogen function in ER-mediated signaling is now partly understood, the same is not true for GPER-mediated signaling in endometrial malignancies. Understanding the physiological roles of ERα and GPER in EC biology therefore leads to the identification of some novel therapeutic targets. Here we review the effect of estrogen signaling through ERα-and GPER in EC, major types, and some affordable treatment approaches for endometrial tumor patients which has interesting implications in understanding uterine cancer progression.

Gui, J., et al. (2019). "Impact of local endometrial injury on in vitro fertilization/intracytoplasmic sperm injection outcomes: A systematic review and meta-analysis." The Journal of Obstetrics and Gynaecology Research 45(1): 57-68.
	Aim: Recent studies have revealed positive effects of endometrial injury on clinical pregnancy rates, but with inconsistent results. The aim of this meta-analysis was to assess the efficacy of endometrial injury (biopsy and/or hysteroscopy) as a potential treatment measure for implantation failure in the in vitro fertilization population.; Methods: We searched in PubMed for studies comparing the efficacy of endometrial injury versus no intervention in women with at least one implantation failure. A random-effects model was used to evaluate the clinical pregnancy rate (CPR) and the live birth rate (LBR).; Results: Seventeen studies (11 randomized and 6 non-randomized studies) were included in this meta-analysis, including 1864 women in the intervention group and 2193 women in the control group. Overall, the CPR and LBR were significantly higher in the intervention group than in the control group (for CPR, n = 3997, 16 studies, P < 0.00001, risk ratio (RR) = 1.47, 95% confidence interval [CI] [1.24, 1.74]; for LBR, n = 2361, 11 studies, P = 0.003, RR = 1.41, 95% CI [1.12, 1.78]). However, after excluding the non-randomized studies, there was no significant difference in CPR (P = 0.29 for endometrial biopsy, P = 0.05 for hysteroscopy) and LBR (P = 0.23 for endometrial biopsy, P = 0.39 for hysteroscopy) between the intervention group and the control group.; Conclusion: There is still insufficient evidence to support the use of endometrial injury in women with implantation failure. Robust randomized controlled studies should be designed and performed before clinical implementation of endometrial injury. (© 2018 Japan Society of Obstetrics and Gynecology.)

Guida, F., et al. (2022). "Role of tertiary cytoreductive surgery in recurrent epithelial ovarian cancer: Systematic review and meta-analysis." Gynecologic Oncology 166(1): 181-187.
	Objective: To evaluate the clinical utility of tertiary cytoreductive surgery (TCS) in recurrent ovarian cancer.; Methods: MEDLINE via PubMed, Embase (Elsevier), ClinicalTrials.gov, Scopus (Elsevier) and Web of Science for studies from inception to 4/09/2021. Studies reporting disease specific survival (DSS) and overall survival (OS) among women who underwent optimal cytoreductive surgery as compared to those who had a suboptimal cytoreductive surgery at time of TCS were abstracted. Study quality was assessed with the Quality In Prognosis Studies (QUIPS) tool. The data were extracted independently by multiple observers. Random-effects models were used to pool associations and to analyze the association between survival and surgical outcomes.; Results: 10 studies met all the criteria for inclusion in the systematic review. Patients with optimal tertiary cytoreductive surgery had better DSS (HR = 0.35; 95% CI, 0.19-0.64, P < 0.001), with low heterogeneity (I 2 = 0%, P = 0.41) when compared to those with suboptimal tertiary cytoreductive surgery. Pooled results from these studies also demonstrated a better OS (HR = 0.34; 95% CI, 0.15-0.74, P < 0.007) with moderate heterogeneity (I 2 = 59%, P = 0.09) when compared to patients with a suboptimal tertiary cytoreductive surgery. This remained significant in a series of sensitivity analyses. Due to the limited number of studies, we were unable to do further subgroup analyses looking at outcomes comparing tertiary cytoreductive surgery to chemotherapy.; Conclusion: In this systematic review and meta-analysis of observational studies examining tertiary cytoreductive surgery for recurrent ovarian cancer, optimal tertiary cytoreductive surgery was associated with improved OS and DSS survival compared to suboptimal tertiary cytoreductive surgery. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Guidi, S., et al. (2021). "Adult Granulosa Cell Tumor in Pregnancy: A New Case and a Review of the Literature." Healthcare (Basel, Switzerland) 9(11).
	Granulosa cell tumors are rare ovarian tumors that can arise during pregnancy. We present a new case of recurrent adult granulosa cell tumor (AGCT) in pregnancy and a systematic review of the literature. The new case described is a 41-year-old woman G5P1122 with a prior history of AGCT that was referred to our center at 29 weeks because of a symptomatic abdominal mass, compatible with a possible recurrence of AGCT. At 36 + 3 weeks, she underwent a cesarean delivery for preterm labor and a total hysterectomy with a radical surgical staging. A healthy female infant was delivered. The patient received a platinum-based chemotherapy, with a 26-month follow-up negative for recurrence. Analyzing our case with the four identified by the literature review, three were recurrent and two were primary AGCT. Only one required surgery for AGCT at 15 weeks, while another underwent chemotherapy in pregnancy. In the other three cases, surgery for AGCT was done at the time of cesarean delivery. There were three cases of preterm delivery. All five pregnancies resulted in the birth of live babies with weight adequate for gestational age. In conclusion, AGCT diagnosed in pregnancy is rare, reported in only five cases. All gave birth to live babies in the third trimester, and maternal outcome at up to 18 months showed no recurrence.

Guild, D. J., et al. (2021). "Attachment and Affect between Mothers with Depression and their Children: longitudinal Outcomes of Child Parent Psychotherapy." Research on child and adolescent psychopathology 49(5): 563‐577.
	The present investigation examined the longitudinal effects of Child‐Parent Psychotherapy (CPP) for toddlers and their mothers with depression on: a) maternal affective expression, b) child affective expression, and c) mother‐child cohesion. Mothers with depression (Mage = 31.7 years; 92.8% White, 3.5% Black, 2.1% Hispanic, 2.3% other) and their toddlers were randomized to receive CPP (DI; n = 66) or to a control group (DC; n = 64). Mothers without depression and their toddlers (NC; n = 68) were recruited as an additional comparison group. Dyads were assessed at baseline (T1; 20 months old), post‐intervention (T2; 36 months old), and follow‐up (T3; 9 years old). Data from a mother‐child conflict task was coded as a measure of observed outcome variables. Change in post‐intervention attachment security assessed via the Strange Situation was evaluated as a mediator between intervention condition and maternal and child affective expression and dyadic cohesion at T3. Change to secure attachment post‐intervention significantly mediated the association between intervention condition and T3 maternal warmth and child anger/problem behavior. Toddlers of mothers with depression who received CPP showed higher rates of change to secure attachment compared to those in both the DC and NC groups. Dyads who changed to secure attachment at T2 displayed higher levels of maternal warmth at T3 and lower levels of child anger and problem behavior at T3. Implications for the use of CPP as a preventive intervention and the importance of attachment as a mediator of long‐term outcomes are discussed.

Guillon, S., et al. (2019). "A systematic review and meta-analysis of prognostic factors for remission in fertility-sparing management of endometrial atypical hyperplasia and adenocarcinoma." International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 146(3): 277-288.
	Background: Endometrial cancer and atypical hyperplasia are rare in young women but create a dilemma between desire for pregnancy and oncologic outcomes.; Objective: To identify remission rates and associated prognostic factors in patients undergoing fertility-sparing management for endometrial cancer and atypical hyperplasia.; Search Strategy: MEDLINE was searched for studies published between January 1, 1950 and July 31, 2017 using various search terms.; Selection Criteria: Studies evaluating fertility-sparing management in patients aged between 19 and 44 years with atypical hyperplasia or stage I endometrial cancer.; Data Collection and Analysis: Use of PRISMA guidelines to conduct a meta-analysis of the proportion of patients in remission and meta-regression analysis to test the effect of possible prognostic factors for remission.; Main Results: A total of 3673 studies were screened; 65 studies including 1604 patients met the inclusion criteria. The remission rate was 0.75 (95% CI, 0.73-0.77). Operative hysteroscopy for endometrial sampling was associated with higher remission rates (OR 2.31; 95% CI, 1.10-4.84; P=0.03). Studies with higher ratios of infertile women were associated with higher remission rates (OR 4.21; 95% CI, 1.44-12.33; P<0.01).; Conclusion: Operative hysteroscopy is the preferred endometrial sampling method for patients with atypical hyperplasia or endometrial cancer undergoing fertility-sparing management. (© 2019 International Federation of Gynecology and Obstetrics.)

Guirguis, H., et al. (2023). "The impact of postinjection urinary tract infection on efficacy of intravesical onabotulinumtoxinA-A secondary analysis." Neurourology and Urodynamics 42(6): 1238-1244.
	Objectives: To compare treatment response in women who did and did not develop a urinary tract infection (UTI) within 14 days after intravesical onabotulinumtoxinA injections for treatment of refractory urgency urinary incontinence (UUI). Method(s): This is a secondary analysis of women who received Onabotulinumtoxin A in the Refractory Overactive Bladder: Sacral Neuromodulation vs Botulinum Toxin Assessment (ROSETTA) Trial. Participants were grouped by presence or absence of UTI within 14 days of injection. UTI was defined as symptomatic with positive urine culture per the primary ROSETTA protocol. Our primary outcome was change from baseline in mean number of UUI episodes based on monthly 3-day bladder diaries averaged over 6 months. We performed t tests and chi-square/Fisher's exact for continuous and categorical variables. A p value of <0.05 was considered statistically significant. Result(s): Of 187 participants in the onabotulinumtoxinA arm, 10 (5.3%) experienced UTI within 14 days of injection, and 177 (94.7%) did not. At baseline, groups did not differ in demographics, mean UUI episodes per day (no UTI [5.37 +/- 2.65] vs. UTI [6.40 +/- 3.02], p = 0.24), or other diary parameters. For our primary outcome, groups did not differ in the change in mean daily UUI episodes at 1 month (no UTI [-4.29 +/- 2.75] vs. UTI [-3.74 +/- 2.01]; mean difference [95% confidence interval, CI] -0.55 [-2.39 to 1.28], p: 0.55) or 6 months (no UTI [-3.63 +/- 2.89] vs. UTI [-2.15 +/- 3.18]; mean difference [95% CI] -1.48 [-3.44 to 0.48], p: 0.14). Conclusion(s): UTI within 14 days after intravesical injection of onabotulinumtoxinA for refractory UUI was not significantly associated with inferior treatment response at 1 or 6 months.Copyright © 2023 Wiley Periodicals LLC.

Guittard, C., et al. (2024). "Effect of tactile and/or kinesthetic stimulation therapy of preterm infants on their parents' anxiety and depressive symptoms: A systematic review." BMC Psychology 12(1): 3.
	Background: In the case of preterm birth, the idealized postnatal period is replaced by an anxious and even traumatic experience for parents. Higher prevalence of parental anxiety, postnatal depression, and posttraumatic stress disorder has been observed in mothers of preterm infants up to 18 months after childbirth. There is increasing evidence that proprioceptive stimulation has a beneficial effect on preterms' short-term outcomes. Could this care also have an impact on parental anxiety and depressive symptoms? We reviewed recent publications on the impact on parents' anxiety and depressive symptoms of delivering tactile and/or kinesthetic stimulation to their premature newborn.; Methods: We conducted a systematic review by searching the PubMed, PsycInfo, Scopus, ScienceDirect and Google Scholar databases for English-language publications from the past 10 years. We focused on the mothers or fathers of infants born preterm (before 37 weeks of gestation) who provided tactile and/or kinesthetic stimulation to their premature newborn in the neonatal intensive care unit. Relevant outcomes were the parents' anxiety, stress, depressive symptoms, and symptoms of posttraumatic stress disorder, assessed with reliable standardized inventories.; Results: Eleven articles were included in the systematic review. Results suggested a beneficial effect of parents' early tactile and kinesthetic stimulation of their preterm infants.; Conclusions: These interventions may act as protective factors against the occurrence of anxiety and depressive symptoms in parents and deserve to be studied further in this population. (© 2024. The Author(s).)

Gulati, G. and T. S. Bhagat (2022). "EFFECT OF CERVICAL MUCUS ASPIRATION ON PREGNANCY RATE IN INTRAUTERINE INSEMINATION." Journal of Pharmaceutical Negative Results 13: 802-805.
	Infertility1is a disease or disability that is both a health problem as well as a social problem. The problem of infertility has risen to enormous extent over the last few decades2which is attributable mainly to lifestyle changes, late age at marriage with growing women empowerment and increased incidence of pelvic infections. The prevalence of infertility varies widely, being less in developed countries and more in developing countries where limited resources for investigation and treatment are available3. It affects 60-80 million couples worldwide every year4. The prevalence of infertility in India ranges from 5-15%5. Infertility is classified as primary when the couple has not conceived even once or secondary when the couple has conceived at least once but is unable to conceive again. Secondary infertility occurs more commonly than primary infertility. The main causative factors for infertility are classified as female factors, male factors, combined male and female factors & unexplained infertility6. The cause of infertility is unexplained in 10-15 % of the cases5. The first step in treating infertility is to treat the underlying cause of infertility. The treatment modalities for infertility are broadly classified into three major categories medical treatment, surgical treatment and artificial insemination and different assisted reproductive technologies (ART) 7. The methods of insemination can be intravaginal, intracervical, intrauterine or intrafallopian. Intrauterine insemination (IUI) is a much cheaper, simpler & less invasive than more sophisticated assisted reproductive techniques. Intra Uterine Insemination is the most widely used medically assisted conception (MAC)technique.IUI is mainly indicated in patients with mild male factor, cervical mucus hostility, and idiopathic infertility. The pregnancy rate per IUI cycle varies between 6-22%8. The outcome of IUI may be affected by numerous factors such as timing9, number of inseminations (single or double)10, catheter type11, volume of prepared semen12and to some extent on the modality of ovulation induction. The rationale for the use of intrauterine insemination instead of intravaginal or intracervical insemination is to deposit the prepared semen as close as possible to the oocytes at the time of ovulation and also to bypass the effect of vaginal acidity and cervical mucus hostility. Intrauterine insemination is a better insemination technique as compared to other insemination methods because it bypasses the hostile cervical mucus. Therefore one way to increase pregnancy rate following IUI and perhaps during IVF13is to aspirate the cervical mucus before insemination. This study was conducted with the aim to evaluate the effect of cervical mucus aspiration on the pregnancy rate in intrauterine insemination.Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.

Güler, B. and S. Mete (2023). "Effects of Relaxation-Focused Nursing Program in Women with Ovarian Cancer: A Randomized Controlled Trial." Pain management nursing : official journal of the American Society of Pain Management Nurses 24(4): e35-e45.
	Background: Surgical treatment is a major cause of hospitalization in ovarian cancer. In this process, physical problems, such as pain and changes in respiratory functions, and psychological problems, such as anxiety and stress, may develop.; Aim: This study aims to investigate the effects of the Relaxation-Focused Nursing Program on pain, anxiety, lung volume, level of knowledge, and nursing care satisfaction in ovarian cancer surgery.; Method: A randomized controlled trial in which participants were randomly assigned to either the experimental (preoperative relaxation exercises and education; n = 24) or control (usual nursing care; n =22) groups. The intervention consisted of practicing four sessions of relaxation exercises and education in the hospital for two days before surgery. Data were collected using the Trait and State Anxiety Inventory, Surgical Information Form, and Perioperative Assessment Form. The results were analyzed using the Friedman and Wilcoxon tests.; Results: The findings showed significant reductions in pain (p = .045) and anxiety scores (p < .001). The level of knowledge means scores were higher in the experimental group, but there was no significant difference between mean scores of spirometer volume and care satisfaction.; Conclusions: The program was more effective than usual nursing care in preoperative anxiety, pain, and level of knowledge. Although there was no difference between the care satisfaction scores of the patients, the reasons for care satisfaction were different in the program. Developing and implementing care that combines stress reduction interventions and preoperative education can improve the preoperative outcomes of patients.; Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2023 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.)

Gulia, S., et al. (2023). "Secondary cytoreduction in platinum sensitive relapsed ovarian cancer: an individual patient level meta-analysis." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 33(9): 1440-1447.
	Objective: To synthesize the role of secondary cytoreduction in recurrent ovarian cancer from the results of randomized studies.; Methods: We conducted a meta-analysis of randomized controlled trials which compared secondary cytoreductive surgery versus no surgery in patients with platinum sensitive relapsed ovarian cancer. Individual patient data for overall survival and progression free survival were manually extracted from published survival curves, for whole study populations and subgroups based on completeness of surgical resection and bevacizumab use, using WebPlotDigitizer software. Overall survival and progression free survival curves for each study and the combined population were reconstructed from extracted data.; Results: Three studies with 1249 patients were included, of whom complete resection was achieved in 427 (34.2%) patients. In individual patient data analysis of the whole study population with 562 deaths, there was no significant difference in overall survival between the surgery and no surgery groups (median 52.8 vs 52.1 months, respectively, hazard ratio (HR) 0.94, 95% confidence interval (CI) 0.80 to 1.11; p=0.5) but the surgery group had significantly longer progression free survival compared with the no surgery group (median 18.3 vs 14.4 months, respectively, HR 0.70, 95% CI 0.62 to 0.80; p<0.001). In subgroup analyses, overall survival was significantly longer in the complete cytoreduction subgroup compared with the no surgery group (median 62.0 vs 52.1 months, respectively, HR 0.70, 95% CI 0.57 to 0.92; p<0.001) while overall survival was significantly worse in the incomplete cytoreduction subgroup compared with the no surgery group (median 34.2 vs 52.1 months, respectively, HR 1.72, 95% CI 1.38 to 2.14; p<0.001). In the no bevacizumab subgroup, there was no significant overall survival difference between the surgery and no surgery groups (median 49.3 vs 47.0 months, HR 0.86, 95% CI 0.67 to 1.10; p=0.25).; Conclusions: Secondary cytoreductive surgery among women with platinum-sensitive relapsed ovarian cancer did not lead to significant benefit in overall survival although it increased progression free survival. However, overall survival was significantly longer among patients in whom complete cytoreduction was possible compared with no surgery.; Competing Interests: Competing interests: SGul: institutional financial interest for conducted research from Eli Lilly, Pfizer, Celltrion, Kendle India, and Zydus; non-remunerated activities include advisory board of Novartis and Eisai. SR: institutional financial interest for conducted research from AstraZeneca and JSS Clinical Research. SGup: institutional financial interest for conducted research from Roche, Sanofi, Johnson & Johnson, Amgen, Celltrion, Oncosten, Novartis, Intas, Eisai, Biocon, and AstraZeneca; non-remunerated activities include advisory board of Sanofi, Dr Reddy’s Laboratories, Biocon, Pfizer, Oncosten, Core Diagnostics, and AstraZeneca; general secretary of non-profit organization, Women Cancer Initiative and president-elect of the Indian Society of Medical and Pediatric Oncology. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Gulino Ferdinando, A., et al. (2022). "Anti-Mullerian Hormone (AMH) and adenomyosis: Mini-review of literature of the last 5 years." Frontiers in Endocrinology 13: 1014519.
	Introduction: Adenomyosis is a form of endometriosis characterized by the presence of endometrial tissue in the myometrium. The correlation between anti-Mullerian hormone (AMH) expression and adenomyosis is unclear. Few studies investigated this possible correlation with promising results. The aim of this mini-review is to illustrate the potential prognostic and therapeutic role of AMH in adenomyosis.; Materials and Methods: A study protocol was completed conforming to the Preferred Reporting Items for Reviews and Meta-Analyses (PRISMA) guidelines for systematic reviews. We performed an electronic databases search from each database's inception from August 2017 to August 2022 for full-text articles and published abstracts. For database searches, the following main keywords were the following text words: "adenomyosis" or "uterine endometriosis" [Mesh] AND "AMH" or "anti-mullerian hormone".; Results: From the literature search, 8 abstracts of studies were retrieved and independently screened for inclusion by three authors. It was found that the most common therapeutic strategies (such as adenomyomectomy and high-intensity focused ultrasound (HIFU) do not alter AMH levels. Moreover, a higher expression of the AMH receptor II was observed in adenomyotic tissue, hence a possible therapeutic use of AMH was hypothesized.; Conclusion: The available evidence shows an unclear relationship between adenomyosis and AMH. Probably, women with adenomyosis have lower levels of AMH and the surgical treatment (adenomyomectomy, HIFU) does not alter this characteristic, therefore in all of them, ovarian function is not influenced.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Gulino, Dilisi, Capriglione, Cannone, Catania, Martire, Tuscano, Gulisano, D’Urso, Di Stefano, Cimino, Filippini, Latella, Sammarini, Musmeci and Palumbo.)

Gullo, G., et al. (2022). "Ovarian tissue cryopreservation and transplantation in menopause: new perspective of therapy in postmenopausal women and the importance of ethical and legal frameworks." European Review for Medical and Pharmacological Sciences 26(24): 9107-9116.
	Menopausal transition entails a progressive decrease in hormone production by the ovaries that lead to important physical and psychological changes that could significantly affect quality of life. Hormone replacement therapy (HRT) administered from the onset of menopausal symptoms usually improves quality of life and life expectancy. Nevertheless, it is not risk-free. Ovarian tissue cryopreservation (OTC) has been investigated as a potential new strategy for delaying menopause and/or to avoid HRT. This review analyzes the critical points of HRT to assess whether OTC and subsequent reimplantation can affect postmenopausal management. We assessed available randomized clinical trials in PubMed, Cochrane Library, ISI web of science, and Scopus from August 2021 to November 2022, including studies and trials evaluating the efficacy of OTC in both cancer and menopausal patients, the efficacy of freezing techniques and the possible clinical scenarios that OTC can open, even from the standpoint of legal and ethical issues arising as such innovative techniques become mainstream. Lower duration of the graft and efficacy on estrogen secretions at a physiological and safer concentration of estrogen than conventional HRT based on hormonal supplements. OTC can reportedly trigger estrogen secretions at a lower and safer physiological concentration than conventional HRT. OTC and subsequent reimplantation remain a valid fertility-sparing approach in patients undergoing gonadotoxic treatments. Further studies are needed to better evaluate its safety and efficacy within postmenopausal therapy management and in order to lay out widely shared and evidence-based guidelines and best practices and perform such novel and innovative techniques in a legally and ethically safe fashion, in the best interest of patients and healthcare professionals.

gunagpeng, w. and l. xueyan (2021). "Telemedicine treatment of postpartum depression: a systematic review."
	
Gundogdu, E. C. and T. G. Yilmaz (2023). "The role of intraoperative superior hypogastric plexus blocks in pain management for total abdominal hysterectomy: a comparative study." European Research Journal 9(5): 1201-1206.
	Objectives: This study aimed to investigate the efficacy of intraoperative Superior Hypogastric Plexus Blocks (SHPBs) in managing postoperative pain following total abdominal hysterectomy, comparing pain scores and analgesic requirements between patients who received SHPBs and those who did not. Method(s): A prospective, randomized, controlled trial was conducted on 70 female patients undergoing elective total abdominal hysterectomy. Patients were randomly assigned to either the SHPB group or the non-SHPB group. In the SHPB group, intraoperative SHPBs were administered after uterine removal. Postoperative pain scores were assessed using the Visual Analogue Scale (VAS) at various time points. Analgesic consumption and adverse effects were also recorded. Result(s): Patients in the SHPB group consistently exhibited lower pain scores compared to the non-SHPB group at various postoperative time intervals (p < 0.05). Initial analgesic requirements were significantly higher in the non-SHPB group, as was total analgesic consumption during the hospital stay (p < 0.05). No significant complications related to SHPB administration were observed. Conclusion(s): Intraoperative Superior Hypogastric Plexus Blocks demonstrated a potential benefit in reducing postoperative pain scores and analgesic consumption in patients undergoing total abdominal hysterectomy. These findings highlight the potential of SHPBs as an effective approach to enhance pain management in this surgical population, warranting further investigation and refinement of administration protocols.Copyright © 2023 by Prusa Medical Publishing.

Gunduz-Bruce, H., et al. (2022). "Development of neuroactive steroids for the treatment of postpartum depression." Journal of neuroendocrinology 34(2): e13019.
	Postpartum depression (PPD) is a common major depressive episode surrounding childbirth, with estimated rates ranging from 5.5% to 23.5% of all live births across Europe and the USA based on the presence of key symptoms. PPD has been associated with significant impairments in both maternal functioning and mother-infant attachment, and these impairments can have lasting effects on the emotional and cognitive development of children. Although the precise pathophysiology of PPD is unknown, preclinical findings suggest that large fluctuations in neurosteroid hormone levels can induce physiological plasticity in the expression of functional GABA A receptors during pregnancy and the postpartum period, and that deficits in this plasticity may underpin a biological mechanism that contributes to the manifestation of depressive symptoms. Here, we review the controlled clinical trials to date that have assessed the efficacy of pharmacological treatments for PPD, including oestradiol, selective serotonin reuptake inhibitors, brexanolone (an iv formulation of allopregnanolone) and an investigational neuroactive steroid and GABA A positive allosteric modulator, zuranolone. Coupled with the GABAergic deficits implicated in major depressive disorder, these findings highlight not only the potential role of GABA A receptor plasticity in the pathophysiology of PPD, but also the novel therapeutic approach of using positive allosteric modulators targeting GABAergic transmission to treat women affected by PPD. (© 2021 Sage Therapeutics Inc. Journal of Neuroendocrinology published by John Wiley & Sons Ltd on behalf of British Society for Neuroendocrinology.)

Gungorduk, K., et al. (2021). "Robotic platforms for endometrial cancer treatment: Review of the literature." Minerva Medica 112(1): 47-54.
	INTRODUCTION: The cornerstone in the management of endometrial cancer (EC) is surgical staging. Over the last few decades, minimally invasive surgery has been widely accepted as a mainstay in the treatment of endometrial cancer. The first robotic-assisted gynecological surgery was performed in 1998. EVIDENCE ACQUISITION: The literature search was conducted using MEDLINE, EMBASE and PUBMED databases from January 1998 to September 2020. EVIDENCE SYNTHESIS: Several studies have reported the advantages of robotic-assisted surgery over laparoscopy in the management of EC. These are most pronounced in obese patients. Robotic-assisted surgery is also associated with a shorter learning curve, particularly for lymphadenectomy, which enables more surgeons to perform minimally invasive surgery for EC. CONCLUSION(S): The effectiveness and oncological results of robotic surgery for EC appear to be similar to those of other surgical methods, but fewer intraoperative complications occur than with other methods.Copyright © 2021 Edizioni Minerva Medica. All rights reserved.

Gungorduk, K. and A. Ozdemir Isa (2021). "Non-pharmacological interventions for the prevention of postoperative ileus after gynecologic cancer surgery." Taiwanese Journal of Obstetrics & Gynecology 60(1): 9-12.
	Postoperative ileus (POI) is characterized by impaired gastrointestinal motility after surgery. POI is a major concern for surgeons because it increases hospital stay, the cost of care, and postoperative morbidity in patients who have undergone extensive gynecological oncological surgery. Although several interventions have been proposed and investigated, no effective treatment for the prevention and management of POI has been established. The present review summarizes the current evidence on non-pharmacological interventions, including coffee consumption and chewing gum, used to prevent and treat POI. We obtained studies from MEDLINE, Cochrane Database of Systematic Reviews, ISI Web of Science, and SCOPUS databases.; Competing Interests: Declaration of competing interest The author has no conflicts of interest to disclose. (Copyright © 2021. Published by Elsevier B.V.)

Gungorduk, K., et al. (2024). "Effect of abdominal hot pack application on gastrointestinal motility recovery after comprehensive gynecologic staging surgery." International Journal of Gynecology and Obstetrics 164(3): 1108-1116.
	Objective: To evaluate whether abdominal hot water pack application improves gastrointestinal motility following gynecological oncology surgery. Method(s): The study was registered at ClinicalTrials.gov (NCT04833699). (https://clinicaltrials.gov/ct2/show/NCT04833699?cond=NCT04833699&draw=2&rank=1). In this randomized controlled trial, participants were randomly assigned (1:1) to the hot water pack group (standardized enhanced recovery protocols plus rubber water bag with a fluffy cover filled with boiled tap water [80degreeC] and placed on the abdomen at 3, 6, 9, and 12 h postoperatively for 30 min each time) or the control group (standardized enhanced recovery protocols). A subumbilical or supraumbilical vertical midline incision was made to perform staging surgery procedures, including hysterectomy, salpingo-oophorectomy with retroperitoneal lymphadenectomy. The primary outcome was the time to first passage of flatus from the end of the staging procedure. Result(s): In total, 121 women were randomized to the control (n = 62) or hot water pack (n = 59) group. The use of an abdominal hot water pack significantly reduced the mean time to passing first flatus (25.2 +/- 3.6 vs. 30.6 +/- 3.9 h; hazard ratio [HR] = 4.4; 95% confidence interval [CI]: 2.8-7.1; P < 0.0001), mean time to first bowel movements (28.4 +/- 4.0 vs. 34.4 +/- 4.5 h; HR = 4.9; 95% CI: 3.0-7.9; P < 0.0001), mean time to first defecation (33.4 +/- 4.9 vs. 41.0 +/- 7.6 h; HR = 4.3; 95% CI: 2.1-6.8; P < 0.0001), and mean time to tolerating solid diet (2.1 +/- 0.6 vs. 2.8 +/- 1.0 days; HR = 4.4; 95% CI: 2.2-8.7; P < 0.0001) compared to the control group. The postoperative ileus incidence was significantly lower in the hot water pack group (3.4%) than the control group (16.1%) (P = 0.01). Conclusion(s): Abdominal hot water pack application improved gastrointestinal function recovery in women following surgical staging procedures for gynecological malignancy.Copyright © 2023 International Federation of Gynecology and Obstetrics.

Gunter, J. (2024). "Fractional CO2 laser for genitourinary syndrome of menopause: evaluating the evidence." Menopause (New York, N.Y.) 31(3): 231-233.
	The fractionated CO2 laser has been marketed to women for a variety of gynecologic symptoms and conditions, including the genitourinary syndrome of menopause (GSM). The evidence has been limited, precluding conclusions regarding the efficacy and safety of the therapy. However, data from randomized, controlled trials evaluating this technology for GSM are now available. This Practice Pearl addresses the latest data concerning the use of the fractionated CO2 laser for the treatment of GSM. (Copyright © 2024 by The Menopause Society.)

Guo Emma, J., et al. (2019). "Reproductive outcomes after surgical treatment of asherman syndrome: A systematic review." Best practice & research. Clinical obstetrics & gynaecology 59: 98-114.
	In this systematic review, we analysed the reproductive outcomes of hysteroscopic adhesiolysis in women with Asherman syndrome (AS). We searched PubMed, Web of Science and Cochrane Library (from database inception to April 2018) and selected studies that quantitatively described the reproductive outcomes. We assessed study quality and pooled rate data for each outcome. There were 54 studies (4640 women) of varying quality. The pooled rate of pregnancy was 50.7% (95% CI [confidence interval]: 49.1 to 52.3) in 53 studies, early pregnancy loss was 17.7% (95% CI: 15.9 to 19.6) in 31 studies, ectopic pregnancy (EP) was 4.2% (95% CI: 2.8 to 6.3) in 9 studies, mid-trimester loss (MTL) was 11.5% (95% CI: 7.6 to 17.8) in 7 studies, cervical incompetence was 12.5% (95% CI: 3.3 to 33.5) in 2 studies and placenta accreta syndrome was 10.1% (95% CI: 8.6 to 11.8) in 23 studies. The pregnancy rate in women with severe adhesion was significantly lower than that in women with mild adhesion (P = 0.021). These results can be used to counsel women with AS before surgical treatment and for planning antenatal care after conception. (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Guo, F. and H. Wang (2022). "Potential of histone deacetylase inhibitors for the therapy of ovarian cancer." Frontiers in Oncology 12: 1057186.
	Malignant ovarian tumors bear the highest mortality rate among all gynecological cancers. Both late tumor diagnosis and tolerance to available chemotherapy increase patient mortality. Accumulating evidence demonstrates that histone modifications play a key role in cancerization and progression. Histone deacetylases is associated with chromatin condensed structure and transcriptional repression and play a role in chromatin remodeling and epigenetics. Histone deacetylases are promising targets for therapeutic interventions intended to reverse aberrant epigenetic associated with cancer. Therefore, histone deacetylases inhibitors could be used as anti-cancer drugs. Preclinical studies have shown promising outcomes of histone deacetylases inhibitors in ovarian cancer while clinical trials have had mixed results and limited success as monotherapy. Therefore, combination therapy with different anticancer drugs for synergistic effects and newly selective histone deacetylases inhibitors development for lower toxicity are hot issues now. In this review, we summarize the latest studies on the classification and mechanisms of action of histone deacetylase and the clinical application of their inhibitors as monotherapy or combination therapy in ovarian cancer.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Guo and Wang.)

Guo, H. and Q. Lu (2021). "Efficacy of dydrogesterone on treating recurrent miscarriage and its influence on immune factors: a systematic review and meta-analysis." Annals of Palliative Medicine 10(10): 10971-10985.
	Background: This study aimed to explore the clinical efficacy of dydrogesterone in treating recurrent spontaneous abortion (RSA), analyze the influence of dydrogesterone on cellular immune factors, and provide evidence for clinical medication.; Methods: We used the China National Knowledge Infrastructure (CNKI) platform, Wanfang Data resource, PubMed, Web of Science, and Embase database to conduct a literature search to screen clinical studies published between 2005 and 2021 concerning dydrogesterone treatment for RSA. Stata 16.0 was used for meta-analysis and sensitivity analysis, and Begg's funnel chart was used to test publication bias.; Results: Only 13 studies, which included a total of 2,454 RSA patients, met the study inclusion criteria. The experimental group was treated with dydrogesterone, and the control group was treated with progesterone, human chorionic gonadotropin (hCG), placebo, or active immunization. Meta-analysis showed that the pregnancy success rate of the experimental group was higher than the control group, and the adverse reaction rate was lower than the control group. In addition, subgroup analysis also revealed that the experimental group had a higher pregnancy success rate than the control group and a lower adverse reaction rate. Levels of progesterone and hCG in the experimental group were dramatically higher than the control group after treatment. The experimental group also had higher levels of interleukin 4 (IL-4) and interleukin 10 (IL-10) than the control group, while levels of interferon-gamma (IFN-γ) were lower.; Discussion: Dydrogesterone, a safe and effective synthetic progesterone drug, had a significant clinical effect on RSA and effectively improved hormone levels and related cellular immune factors in RSA patients.

Guo, J., et al. (2021). "Outcomes of Trachelectomy vs. Hysterectomy for Early-Stage Cervical Cancer: A Systematic Review and Meta-Analysis." Frontiers in surgery 8: 735944.
	Objective: To provide updated evidence on comparative efficacy for clinical outcomes of radical trachelectomy and radical hysterectomy in patients with early-stage cervical cancer. Methods: A systematic search was conducted in the PubMed, Scopus, Cochrane Database of Systematic Reviews, and Google scholar databases. Studies were done in patients with early-stage cervical cancer that compared the outcomes between radical trachelectomy (RT) and hysterectomy (RH) were considered for inclusion in the review. The outcomes of interest were operative time, the volume of blood loss, need for blood transfusion, any complications, length of hospital stay, risk of recurrence, and survival. The strength of association was presented in the form of pooled relative risk (RR), hazards risk (HR), and weighted mean difference (WMD). Statistical analysis was done using STATA version 16.0. Results: A total of 12 articles were included in the meta-analysis. The majority were retrospective cohort-based studies. Compared to RH, the operative time (in min) was comparatively higher in RT (WMD 23.43, 95% CI: 5.63, 41.24). Patients undergoing RT had blood loss (in ml) similar to those undergoing RT (WMD -81.34, 95% CI: -170.36, 7.68). There were no significant differences in the risk of intra-operative (RR 1.61, 95% CI: 0.49, 5.28) and post-operative complications (RR 1.13, 95% CI: 0.54, 2.40) between the two groups. Patients in the RT group had lesser duration of post-operative hospital stay (in days) (WMD -1.65, 95% CI: -3.22, -0.09). There was no statistically significant difference in the risk of recurrence (HR 1.21, 95% CI: 0.68, 2.18), 5-year overall survival (HR 1.00, 95% CI: 0.99, 1.02), and recurrence-free survival (HR 0.99, 95% CI: 0.96, 1.01) between the two groups. Conclusion: Among the patients with early-stage cervical cancer, RT is similar to RH in safety and clinical outcomes. Future studies with a randomized design and larger sample sizes are needed to further substantiate these findings.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2021 Guo, Hu, Deng and Jin.)

Guo, J., et al. (2023). "Comparison of the probability of four anticonvulsant mood stabilizers to facilitate polycystic ovary syndrome in women with epilepsies or bipolar disorder-A systematic review and meta-analysis." Frontiers in Psychiatry 14: 1128011.
	Background: Patients treated with anticonvulsant mood stabilizers have a higher incidence of polycystic ovary syndrome (PCOS). However, there is no comparison between different anticonvulsant mood stabilizers. The purpose of this study was to systematically evaluate the prevalence of PCOS in women taking anticonvulsant mood stabilizers and compare the probability of PCOS caused by different anticonvulsant mood stabilizers.; Methods: Five databases, namely PubMed, Embase, Web of Science, Cochrane Library, and Clinical Trials, were searched for literature on anticonvulsant mood stabilizers and PCOS published up to October 28, 2022. This meta-analysis was performed using Revman 5.4, Stata 14.0, and R4.1.0, and effect size pooling was performed in fixed- or random-effects models based on the results of I 2 and Q-test, and the surface under the cumulative ranking curve (SUCRA) was used for analysis to assess the cumulative probability of drug-induced PCOS. Publication bias was assessed by funnel plot Egger's test and meta regression.; Results: Twenty studies with a total of 1,524 patients were included in a single-arm analysis, which showed a combined effect size (95% CI) of 0.21 (0.15-0.28) for PCOS in patients taking anticonvulsant mood stabilizers. Nine controlled studies, including 500 patients taking medication and 457 healthy controls, were included in a meta-analysis, which showed OR = 3.23 and 95% CI = 2.19-4.76 for PCOS in women taking anticonvulsant mood stabilizers. Sixteen studies with a total of 1416 patients were included in a network meta-analysis involving four drugs, valproate (VPA), carbamazepine (CBZ), oxcarbazepine (OXC), and lamotrigine (LTG), and the results of the network meta-analysis showed that VPA (OR = 6.86, 95% CI = 2.92-24.07), CBZ (OR = 3.28, 95% CI = 0.99-12.64), OXC (OR = 4.30, 95% CI = 0.40-49.49), and LTG (OR = 1.99, 95% CI = 0.16-10.30), with cumulative probabilities ranked as VPA (90.1%), OXC (63.9%), CBZ (50.1%), and LTG (44.0%).; Conclusion: The incidence of PCOS was higher in female patients treated with anticonvulsant mood stabilizers than in the healthy population, with VPA having the highest likelihood of causing PCOS. The most recommended medication when considering PCOS factors is LTG.; Systematic Review Registration: identifier: CRD42022380927.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2023 Guo, Liu, Kong, Sun, Lu, Lu, Qu and Yue.)

Guo Julia, Z., et al. (2020). "Vaginal laser treatment of genitourinary syndrome of menopause: does the evidence support the FDA safety communication?" Menopause (New York, N.Y.) 27(10): 1177-1184.
	Importance: Genitourinary syndrome of menopause (GSM) is a chronic, progressive condition frequently manifesting as vaginal dryness and pain with intercourse. Survey data indicate this is a highly prevalent, likely underreported, condition that profoundly affects quality of life for millions of women. Vaginal lasers demonstrate promise as an effective, nonhormone therapeutic alternative for GSM; however, the risks associated with them may have been overstated.; Objective: Despite reports of improved sexual and vaginal comfort without serious safety concerns, the Food and Drug Administration (FDA) issued a 2018 safety communication warning against it. We conducted a systematic literature review and surveyed both the FDA Manufacturer and User Facility Device Experience (MAUDE) and Bloomberg Law Databases to evaluate risks associated with laser treatment for GSM.; Evidence Review: A systematic literature review identified articles published before September 2019. The MAUDE database was searched by name from 2009 to 2019 for safety claims for 24 vaginal laser devices. The Bloomberg Law database was searched for product liability claims against any vaginal laser device manufacturer before July 2019.; Findings: Literature review revealed 3 publications detailing 29 presumptive laser-associated complications, only 5 of which (17.2%) reported worsening symptoms after treatment. The MAUDE database contained 120 complaints; only 30 (25%) detailed potential adverse patient events, most frequently pain (n = 12) and burning (n = 10). The Bloomberg law database contained no claims asserting harm from device use.; Conclusions and Relevance: Lacking strong evidence indicating significant patient risk for vaginal laser treatment of GSM, the FDA safety communication appears unsubstantiated and implies gender bias. Identified complications suggest most reported "adverse events" represent lack of treatment effect. The well-documented benefits and low risk of adverse event suggest laser therapy for GSM is reasonable with appropriate pretreatment counseling. Additional randomized, well-controlled clinical trials are needed to further elucidate both the safety and efficacy of this nonhormone therapy.

Guo, M., et al. (2022). "Metformin Use and Mortality in Women with Ovarian Cancer: An Updated Meta-Analysis." International Journal of Clinical Practice 2022: 9592969.
	Background: Previous observational studies and meta-analysis suggested a possible association between metformin use and reduced mortality in women with ovarian cancer (OC). However, clinical factors that may influence the relationship remain poorly evaluated. We performed an updated meta-analysis to systematically evaluate the above association and to observe the potential influences of study characteristics on the association.; Methods: Relevant studies reporting the association between metformin use and mortality in women with OC in the multivariate adjusted model were identified by search of electronic databases that included PubMed, Embase, and Web of Science. The random-effects model was adopted to combine the results.; Results: Nine studies including 10030 women with OC were included. Overall, metformin use was independently associated with reduced overall mortality (hazard ratio (HR): 0.72, 95% confidence interval (CI): 0.55-0.93, P =0.01; I 2 = 62%). Consistent results were observed for studies comparing metformin users with nondiabetic women and studies comparing metformin users with diabetic women who did not use metformin ( P for subgroup analysis = 0.70). Further subgroup analyses showed consistent results in studies with metformin use before or after the diagnosis of OC, with or without adjustment of body mass index (BMI) and with or without adjustment of concurrent medications ( P for subgroup analyses all >0.10).; Conclusion: Metformin use is associated with reduced mortality in women with OC, which may be independent of the diabetic status of the controls, timing of metformin use, or adjustment of BMI and concurrent medications. Clinical trials are needed to validate the potential benefits of metformin on survival of OC.; Competing Interests: The authors declare that they have no conflicts of interest. (Copyright © 2022 Mingchuan Guo et al.)

Guo, Q., et al. (2022). "Comparison of adjuvant chemoradiotherapy versus radiotherapy in early-stage cervical cancer patients with intermediate-risk factors: A systematic review and meta-analysis." Taiwanese Journal of Obstetrics & Gynecology 61(1): 15-23.
	The presence of intermediate risk factors reduces the predictability of radical hysterectomy, demanding the use of adjuvant therapy for treatment of Early stage cervical cancer (ESCC) patients. Adjuvant radiotherapy (RT) and chemoradiotherapy (CRT) has been widely used with varied efficacy and safety issues. Therefore, the aim of this systematic review and meta-analysis was to update the available evidence and assess the effect of post-surgical adjuvant RT versus adjuvant CRT on survival rate and complications/toxicities in management of ESCC patients with intermediate risk factors. PubMed, EMBASE and Web of Science (WOS) and CENTRAL were searched using a combination of relevant keywords. All studies comparing outcomes of adjuvant RT versus CRT in ESCC patients with intermediate-risk factors in terms of recurrence free survival (RFS), overall survival (OS) and toxicities/complications were included. Both qualitative and quantitative analysis was carried out. The risk of bias assessment was done using Newcastle-Ottawa scale (NOS) for retrospective cohort studies and Cochrane risk of bias assessment tool was used for randomized clinical trials. Eleven retrospective cohort studies and two randomized clinical trials were included in this review. Adjuvant CRT was found to have better RFS with ESCC patients with multiple intermediate risk factors with OR 3.11 95% CI [1.04, 4.99], p < 0.0001; i2 = 6%. However, similar benefit was observed between both regimens in presence of a single intermediate risk factor OR 1.80 95% CI [0.96, 3.36], p = 0.07; i2 = 0%. Grade 3 or 4 haematological toxicity among patients receiving post-surgical adjuvant RT versus adjuvant CRT showed increased association of toxicity with adjuvant CRT with OR 7.73 95%CI [3.40, 17.59], p < 0.0001; i2 = 62%. Adjuvant CRT shows favourable RFS and OS in ESCC patients with multiple intermediate risk factors. CRT also showed greater incidence of grade 3 or 4 haematological and non-haematiological toxicity, however, the same could be well tolerated when used within the recommended dosage. (Copyright © 2021. Published by Elsevier B.V.)

Guo, T., et al. (2019). "Identifying the superior surgical procedure for endometrial polypectomy: A network meta-analysis." International Journal of Surgery 62: 28-33.
	Objective: To identify the superior surgical procedure for endometrial polypectomy based on network meta-analysis.; Method: Literature retrieval was conducted in globally recognized databases, namely, MEDLINE, EMBASE and Cochrane Central, to address relative randomized controlled trials (RCTs) investigating the clinical effects of respective surgical procedure for endometrial polypectomy. Surgical parametric data, including operative time, success rates and complications, were quantitatively pooled and estimated based on the Bayesian theorem. The values of surface under the cumulative ranking (SUCRA) probabilities regarding each parameter were calculated and ranked by various procedures. Node-splitting analysis was performed to test the inconsistency of the main results and publication bias was assessed by examining funnel-plot symmetry.; Results: After a detailed review, 8 RCTs containing 5 different procedures were finally included for network meta-analysis. The results indicated that hysteroscopic morcellation possessed the highest possibility of revealing best clinical effects on operative time (SUCRA, 0.49), success rate (SUCRA, 0.90) and complications (SUCRA, 0.50). Moreover, node-splitting analysis and funnel-plot symmetries illustrated no inconsistency or obvious publication bias in the current study.; Conclusions: Current evidence demonstrated that hysteroscopic morcellation showed optimal potential superior clinical effects for endometrial polypectomy compared to other procedures. However, high-quality large sample trials are still expected, and new investigations on other relative procedures in this field should be included in the future. (Copyright © 2019. Published by Elsevier Ltd.)

Guo, W., et al. (2023). "Compare the Efficacy of Dienogest and the Levonorgestrel Intrauterine System in Women with Adenomyosis." Clinical therapeutics 45(10): 973-976.
	Purpose: The goal of this study was to examine the efficacy and safety of the levonorgestrel intrauterine system (LNG-IUS) versus dienogest (DNG) in female subjects with symptomatic uterine adenomyosis.; Methods: This study enrolled 117 women with symptomatic adenomyosis who visited our hospital from May 1, 2019, to June 30, 2022. Participants were randomized to either the LNG-IUS group (n = 48) or the DNG group (n = 79) in an as-controlled clinical trial for 36 months. Visual analog scale (VAS) scores, uterine volume, endometrial thickness, serum carcinoma antigen 125 level, estradiol, follicle-stimulating hormone, luteinizing hormone, and side effects were assessed to compare the efficacy of LNG-IUS and DNG.; Findings: The VAS pain score was significantly decreased in both groups after 3 months of treatment. Three months later, patients receiving DNG reported significantly lower VAS scores compared with those treated with LNG- IUS (P < 0.05). Compared with LNG-IUS, DNG effectively controlled uterine volume growth after 12 months of treatment but neither significantly reduced uterine volume. During the treatment period, endometrial thickness in both groups was maintained at 0.4 to 0.7 cm.; Implications: Both DNG and LNG-IUS significantly improved adenomyosis-associated pain after 3 months of treatment. Compared with LNG-IUS, DNG was shown to continuously relieve the symptoms of pain and effectively control the growth of uterine volume.; Competing Interests: Declaration of Competing Interest None declared. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Guo, X. L., et al. (2020). "Acupuncture for pain relief of women undergoing transvaginal oocyte retrieval: A meta analysis and systematic review protocol." Medicine (United States) 99(39): E22383.
	Background:Pain during oocyte retrieval, which can make the in-vitro fertilization process an unpleasant experience, is becoming a common problem. Although there are many analgesic methods available in the clinical setting, they are not therapeutically equivalent, and some are associated with varying adverse reactions. In recent years, acupuncture analgesia has been used in the perioperative period of oocyte retrieval because of its perceived efficacy and safety. The purpose of this systematic review and meta-Analysis is to provide evidence that acupuncture is effective in the treatment of vaginal oocyte retrieval pain. Method(s):Electronic searches of the following six databases will be conducted by two qualified reviewers: MEDLINE, EMBASE, China National Knowledge Infrastructure, Chinese Biomedical Medicine database, VIP database and Wanfang database. Three clinical trial registries will also be searched: World Health Organization International Clinical Trial Registry Platform, Chinese Clinical Trial Registry, Cochrane Central Register of Controlled Trials and ClinicalTrials.Gov. All searches will cover the period from inception of the database/registry to March 2020 and will be limited to publications in English and Chinese. Data identification, data selection, data extraction, and bias risk assessment will be conducted independently by3v two or more qualified reviewers, including those who selected the studies. Visual analogue scale scores will be calculated as the primary outcome. Secondary outcomes will include results of other subjective pain rating scales, including Likert scales or other defined numerical or non-numerical scales, self-Assessed by patients before, during, and after oocyte retrieval. We will use STATA software (Version 16) to perform meta-Analyses, and the Grading of Recommendations, Assessment, Development and Evaluations framework to grade the quality of evidence. If quantitative analysis is not available, a systematic narrative synthesis will be provided.PROSPERO registration number:CRD42020170095.Copyright © 2020 Lippincott Williams and Wilkins. All rights reserved.

Guo, Y., et al. (2023). "Current research of assisted reproductive technology for women with early endometrial carcinoma and atypical endometrial hyperplasia after conservative treatment." Chinese Journal of Reproduction and Contraception 43(3): 311-315.
	In recent years, the incidence of endometrial carcinoma (EC) and atypical endometrial hyperplasia (AEH) has increased than before and showed a tendency to be younger. Meanwhile, young women diagnosed with EC or AEH have strong desires to preserve their fertilities, so that they may choose the conservative treatment. After achieving complete remission, many of them are recommended to undergo assisted reproductive technology (ART) treatment to conceive. At present, the research on ART after conservative treatment of EC and AEH is increasing year by year, but most of them are small sample studies. This article reviewed existing studies to explain the effectiveness, safety and influencing factors of ART after conservative treatment of EC and AEH.Copyright © 2023 Authors. All rights reserved.

Guo, Y.-J., et al. (2020). "Efficacy of transcranial magnetic stimulation and fluoxetine in the treatment of postpartum depression: A protocol for systematic review and meta-analysis." Medicine 99(21): e20170.
	Background: Numerous studies have reported that transcranial magnetic stimulation (TMS) and fluoxetine is used in the treatment of postpartum depression (PPD). Currently, no study has systematically investigated the efficacy and safety of TMS and fluoxetine for the treatment of patients with PPD. Thus, this study will assess the efficacy and safety of TMS and fluoxetine for treating PPD.; Methods: Relevant studies involving TMS and fluoxetine for the treatment of patients with PPD will be comprehensively searched from the electronic databases from inception to the February 1, 2020: Cochrane Library, EMBASE, MEDILINE, CINAHL, AMED, WANGFANG, VIP, and CNKI databases. No language and publication time restrictions will be applied. RevMan 5.3 software will be utilized for data pooling, data analysis, and risk of bias evaluation. If necessary, we will also assess reporting bias using funnel plot and Egger test.; Results: This study will comprehensively summarize the existing evidence to assess the efficacy and safety of TMS and fluoxetine for treating PPD.; Conclusion: The findings of this study may help to establish a better approach to treat PPD using TMS and fluoxetine.; Dissemination and Ethics: This study will be disseminated through a peer-reviewed journal. This study does not need ethical approval as no primary patient data will be used.; Systematic Review Registration: INPLASY202040017.

Guokai, Z., et al. (2023). "Effectiveness and safety of lactic acid bacteria in improving cervical HPV infection&#xff1a;a systematic review and meta-analysis."
	
Gupta, A., et al. (2023). "Changes in Pelvic Floor Symptoms After Procedural Interventions for Uterine Leiomyomas: A Systematic Review." Obstetrics and Gynecology 142(2): 319-329.
	Objective: To conduct a systematic review to evaluate the effect of procedural interventions for leiomyomas on pelvic floor symptoms.; Data Sources: PubMed, EMBASE, and ClinicalTrials.gov were searched from inception to January 12, 2023, searching for leiomyoma procedures and pelvic floor disorders and symptoms, restricted to primary study designs in humans.; Methods of Study Selection: Double independent screening for studies of any study design in all languages that reported pelvic floor symptoms before and after surgical (hysterectomy, myomectomy, radiofrequency volumetric thermal ablation) or radiologic (uterine artery embolization, magnetic resonance-guided focused ultrasonography, high-intensity focused ultrasonography) procedures for management of uterine leiomyomas. Data were extracted, with risk-of-bias assessment and review by a second researcher. Random effects model meta-analyses were conducted, as feasible.; Tabulation, Integration, and Results: Six randomized controlled trials, one nonrandomized comparative study, and 25 single-group studies met criteria. The overall quality of the studies was moderate. Only six studies, reporting various outcomes, directly compared two procedures for leiomyomas. Across studies, leiomyoma procedures were associated with decreased symptom distress per the UDI-6 (Urinary Distress Inventory, Short Form) (summary mean change -18.7, 95% CI -25.9 to -11.5; six studies) and improved quality of life per the IIQ-7 (Incontinence Impact Questionnaire, Short Form) (summary mean change -10.7, 95% CI -15.8 to -5.6; six studies). There was a wide range of resolution of urinary symptoms after procedural interventions (7.6-100%), and this varied over time. Urinary symptoms improved in 19.0-87.5% of patients, and the definitions for improvement varied between studies. Bowel symptoms were inconsistently reported in the literature.; Conclusion: Urinary symptoms improved after procedural interventions for uterine leiomyomas, although there is high heterogeneity among studies and few data on long-term outcomes or comparing different procedures.; Systematic Review Registration: PROSPERO, CRD42021272678.; Competing Interests: Financial Disclosure Ethan Balk is a paid consultant to the Society for Gynecologic Research Systematic Review Group for his role as methodology expert. Sadikah Behbehani received payment from Intuitive Surgical. Mikio Nihira received payment from HealthTrust. David Sheyn receives research support from Renalis and consulting fees from Caldera Medical. He also received payment from CollaMedix. Alexandriah Alas receives payments for expert testimony and consulting. Kate Meriwether receives royalties from Elsevier publishing, is a consultant for RBI Medical and an unpaid investigator for Caldera Medical. The other authors did not report any potential conflicts of interest. (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Gupta, D., et al. (2020). "Myo-Inositol's Role in Assisted Reproductive Technology: Evidence for Improving the Quality of Oocytes and Embryos in Patients With Polycystic Ovary Syndrome." Cureus 12(5): e8079.
	Polycystic ovary syndrome (PCOS) is one of the most common causes of subfertility, and it is characterized by hormonal dysregulation like insulin resistance. Various measures have been taken in the past to overcome this insulin resistance to improve fertility treatment outcomes. The current paper aims to review and compare the existing studies and literature to assess the impact of myo-inositol (MI) on oocyte and embryo quality in assisted reproductive technology (ARTs). We thoroughly searched the PubMed and Google Scholar databases by using the keywords "PCOS, polycystic ovarian syndrome, inositol, oocyte quality, embryo quality, assisted conception, ART, IVF, and in vitro fertilization." Nine articles were finalized for review in this paper. Many of the reviewed studies have shown a trend toward the improvement of embryo quality in women with PCOS after MI supplementation; however, there is a lack of statistically significant evidence to support the use of MI in enhancing the quality of oocyte and/or embryo. Clear evidence regarding the role of MI in enhancing the quality of oocyte and embryo in PCOS is limited. A well-controlled, large, randomized controlled trial is required to definitively accept or refute its role.

Gurung, A., et al. (2022). "Effectiveness of Zingiber Officinale(ginger) compared with non-steroidal anti-inflammatory drugs and complementary therapy in primary dysmenorrhoea: A systematic review." Clinical Epidemiology and Global Health 18: 101152.
	Problem considered: The empirical evidence suggested the usage of ginger (zingiber officinale), complementary therapies and Non-steroidal anti-inflammatory drugs (NSAIDs) for dysmenorrhoea compared to self-administration of NSAIDs alone in alleviating the symptoms of dysmenorrhoea. However, there is a need for strong evidence to compare the effectiveness of ginger to that of complementary therapies like exercise, herbs (other than ginger) and NSAIDs. Thus, this systematic review aimed to compare the effectiveness of ginger with NSAIDs and other complementary therapies and suggests an effective dose of ginger in oral form that can be taken during dysmenorrhoea. Method(s): A systematic literature search was conducted using electronic databases, namely MEDLINE via PubMed, Cochrane central, Scopus, CINHAL, EBSCOhost, ProQuest Central, and Google Scholar search engine. The search terms were combined keywords related to menstrual pain, complementary therapy, NSAIDs, and ginger. Randomized or quasi-randomized controlled trials that included ginger as a comparator to assess the effect on primary dysmenorrhea were included in this systematic review. Data were extracted, and the findings were narratively synthesised. Result(s): An initial search from the electronic database identified 394 studies, of which eleven studies met the eligibility criteria, where seven were randomised controlled trials, and four were quasi-experimental studies. There was no significant difference between ginger and NSAIDs in decreasing pain intensity during menstruation. Ginger and exercises like muscle relaxation techniques, stretching, and sub-maximal aerobic exercise effectively reduce pain when combined. Dill seeds (Anethum graveolens, an aromatic herb used for flavouring and medical purposes) and ginger alone were effective in dysmenorrhoea, but no effect of valerian, peppermint and cumin (spices) seeds were observed. The effect of ginger was inclusive compared to placebo. Conclusion(s): The usage of ginger up to two grams per day in divided doses of powder or dietary form for three days from the first day of the menstrual cycle can be used safely for primary dysmenorrhoea. Ginger can be combined with complementary therapies like exercise for increased effectiveness in relieving menstrual pain. The alternative therapy can reduce dependency on synthetic drugs for controlling dysmenorrhoea. However, there is a need to carry out rigorous randomized controlled trials of longer duration to evaluate the effectiveness of ginger and auxiliary therapies other than ginger in controlling menstrual pain.Copyright © 2022 The Authors

Gurunthalingam, M. P., et al. (2023). "Prednisone and Live Birth Rate in Patients With Recurrent Implantation Failure." JAMA 330(10): 971-972.
	
Gurusamy, K., et al. (2020). "Cytoreductive surgery (CRS) with hyperthermic intraoperative peritoneal chemotherapy (HIPEC) versus standard of care (SoC) in people with peritoneal metastases from colorectal, ovarian or gastric origin: protocol for a systematic review and individual participant data (IPD) meta-analyses of effectiveness and cost-effectiveness." BMJ Open 10(5): e039314.
	Introduction: There is uncertainty about whether cytoreductive surgery (CRS)+hyperthermic intraoperative peritoneal chemotherapy (HIPEC) improves survival and/or quality of life compared with standard of care (SoC) in people with peritoneal metastases who can withstand major surgery.; Primary Objectives: To compare the relative benefits and harms of CRS+HIPEC versus SoC in people with peritoneal metastases from colorectal, ovarian or gastric cancers eligible to undergo CRS+HIPEC by a systematic review and individual participant data (IPD) meta-analysis.; Secondary Objectives: To compare the cost-effectiveness of CRS+HIPEC versus SoC from a National Health Service (NHS) and personal social services perspective using a model-based cost-utility analysis.; Methods and Analysis: We will perform a systematic review of literature by updating the searches from MEDLINE, Embase, Cochrane library, Science Citation Index as well as trial registers. Two members of our team will independently screen the search results and identify randomised controlled trials comparing CRS+HIPEC versus SoC for inclusion based on full texts for articles shortlisted during screening. We will assess the risk of bias in the trials and obtain data related to baseline prognostic characteristics, details of intervention and control, and outcome data related to overall survival, disease progression, health-related quality of life, treatment related complications and resource utilisation data. Using IPD, we will perform a two-step IPD, that is, calculate the adjusted effect estimate from each included study and then perform a random-effects model meta-analysis. We will perform various subgroup analyses, meta-regression and sensitivity analyses. We will also perform a model-based cost-utility analysis to assess whether CRS+HIPEC is cost-effective in the NHS setting.; Ethics and Dissemination: This project was approved by the UCL Research Ethics Committee (Ethics number: 16023/001). We aim to present the findings at appropriate international meetings and publish the review, irrespective of the findings, in a peer-reviewed journal.; Prospero Registration Number: CRD42019130504.; Competing Interests: Competing interests: The clinical practice of the clinicians in the project: TM, MM, MS, OA and SO may be altered by the findings of the review. (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Gustavo, F., et al. (2021). "Evaluation of safety and effectiveness of Gestrinone in the treatment of endometriosis: a systematic review."
	
Gutierrez, M., et al. (2023). "Open-label, phase I, dose escalation/expansion trial of the anti-SIRPalpha monoclonal antibody BI 770371 in patients with advanced solid tumours, alone or in combination with the anti-PD-1 monoclonal antibody ezabenlimab." Annals of Oncology 34(Supplement 2): S485.
	Background: BI 770371, a pan-specific anti-signal regulatory protein alpha (SIRPalpha) monoclonal antibody (mAb), reactivates innate and adaptive anti-tumour immune responses. This phase I, non-randomised, open-label, multicentre trial (NCT05327946) aimed to determine the maximum-tolerated dose (MTD) and recommended dose for expansion of BI 770371 +/- ezabenlimab. Method(s): BI 770371 was administered alone or in combination with ezabenlimab IV once every 3 weeks in patients with advanced solid tumours. Treatment continued until progressive disease, unacceptable toxicity or other withdrawal criteria. Dose escalation was guided by a Bayesian Logistic Regression Model with overdose control. Primary endpoint was dose-limiting toxicities (DLTs) in the MTD evaluation period. Secondary endpoints were adverse events (AEs) and DLTs in the on-treatment period. Result(s): As of 31 March 2023, 18 patients (monotherapy, n=15; combination therapy, n=3) have been treated in Canada, Japan and the US. In the patients who received monotherapy, the most common tumour types were colorectal, ovarian and prostate cancer (n=2 patients with each). 53% of patients were male, 53% had ECOG PS 0 and all had received >2 prior lines of treatment. AEs were reported in 12 patients (80%) and grade 3 AEs were reported in one patient (peripheral oedema, atrial fibrillation). Treatment-related AEs were observed in 10 patients (67%; all grade 1/2); the most common were pruritus (n=5) and peripheral oedema (n=2). Serious AEs were reported in four patients (27%; atrial fibrillation, decreased appetite, encephalitis, hypoxia, disease progression). Only one patient had an AE leading to treatment discontinuation (encephalitis). In 14 evaluable patients, 11 (73%) achieved a best response of stable disease. In the MTD evaluable set (n=15 monotherapy, n=3 combination therapy), no DLTs were reported during the MTD evaluation period. The MTD has not been reached; dose escalation is ongoing. Conclusion(s): BI 770371 showed manageable toxicity alone and in combination with ezabenlimab. The trial is ongoing. Clinical trial identification: NCT05327946. Editorial acknowledgement: Medical writing support for the development of this abstract, under the direction of the authors, was provided by Frans Everson, of Ashfield MedComms, an Inizio Company, and funded by Boehringer Ingelheim Legal entity responsible for the study: Boehringer Ingelheim. Funding(s): Boehringer Ingelheim. Disclosure: M. Gutierrez: Financial Interests, Personal, Advisory Board: Sanofi, Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker: Guardant; Financial Interests, Personal, Other, Consulting: Celularity, Merck. R. Jamal: Financial Interests, Personal, Advisory Board: BMS, Medison Pharma; Financial Interests, Institutional, Research Grant: Merck Sharp & Dohme, Bristol Myers Squibb, Iovance Biotherapeutics; Financial Interests, Institutional, Principal Investigator: Princiapal Investigaor in multiple industry led trial. N. Yamamoto: Financial Interests, Personal, Invited Speaker: ONO, Chugai, Daiichi Sankyo, Eisai; Financial Interests, Personal, Advisory Board: Eisai, Takeda, Boehringer Ingelheim, Cimic, Chugai, Healios; Financial Interests, Institutional, Local PI, Principal Investigator in industry sponsored trial: Astellas, Chugai, Eisai, Taiho, BMS, Pfizer, Novartis, Eli Lilly, AbbVie, Daiichi Sankyo, Bayer, Boehringer Ingelheim, Kyowa-Hakko Kirin, Takeda, ONO, Janssen Pharma, MSD, Merck, GSK, Sumitomo Dainippon, Chiome Bioscience, Otsuka; Financial Interests, Institutional, Local PI, Principal investigator in industry sponsored trial: Carna Biosciences, Genmab, Shionogi, TORAY; Financial Interests, Institutional, Research Grant, Principal investigator in industry sponsored trial: Rakuten Medical, InventisBio Co., Ltd. T. Doi: Financial Interests, Personal, Other, Advisory Role: Noile-Immune Biotech, Oncolys BioPharma, Boehringer Ingelheim, A2 Healthcare, Nano Carrier, PRA Health Sciences, Kaken Pharma, Chugai Pharma, Sumitomo Pharma, Shionogi, Otsuka Pharma, Takeda, Kyowa rin, Rakuten Medical, Giliad; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Taiho, MSD, AbbVie, Eisai, Pfizer, BMS, Janssen Pharma, Daiichi Sankyo, Chugai Pharma, Boehringer Ingelheim, PRA Health Sciences, Amgen, GSK, Shionogi, RIN Institute, ONO Pharma. M. Elgadi: Financial Interests, Personal, Full or part-time Employment: Boehringer Ingelheim. J.L. Ferrada: Financial Interests, Personal, Full or part-time Employment: Boehringer Ingelheim. S.M. Wojciekowski: Financial Interests, Personal, Full or part-time Employment: Boehringer Ingelheim. M.R. Patel: Financial Interests, Personal, Leadership Role: ION Pharma; Financial Interests, Personal, Other, Honoraria: Janssen Oncology; Financial Interests, Personal, Speaker, Consultant, Advisor: Olema Pharmaceuticals; Financial Interests, Institutional, Research Funding: Acerta Pharma, ADC Therapeutics, Agenus, Aileron Therapeutics, AstraZeneca, BioNTech AG, Boehringer Ingelheim, Celgene, CicloMed, Clovis Oncology, Cyteir Therapeutics, Daiichi Sankyo, Lilly, Evelo Therapeutics, Evelo Therapeutics, Genentech/Roche, Gilead Sciences, GSK, H3 Biomedicine, Hengrui Therapeutics, Hutchison MediPharma, Jacobio, Janssen, Klus Pharma, Kymab, Loxo, LSK Biopartners, Lycera, Macrogenics, Merck, Millennium, Mirati Therapeutics, Moderna Therapeutics, Pfizer, Prelude Therapeutics, Ribon Therapeutics, Seven and Eight Biopharmaceuticals, Syndax, Taiho Pharmaceutical, Tesaro, TopAlliance BioSciences Inc., Vigeo, ORIC, Artios, Treadwell, Mabspace, IgM Biosciences, Puretech, Artios, BioTheryX, Black Diamond Therapeutics, IgM Biosciences, NGM Biopharmaceuticals, Novartis, nurix, Relay Therapeutics, Samumed, Silicon Therapeutics, TeneoBio, Treadwell Therapeutics, Zymeworks, Olema, Adagene, Astellas, NGM, Accutar Biotech, Nurix, Novartis, Compugen, Black Diamond Therapeutics, Relay Therapeutics, Artios, Treadwell Therapeutics, MabSpace Biosciences, Immunogen, Blueprint Pharmaceuticals, Accutar, Artios, Bayer, Bicycle Therapeutics, BioTheryX, Compugen, Cullinan Oncology, Erasca, Inc., Immune-Onc Therapeutics, Immunitas, Jazz Pharmaceuticals, NGM Biopharmaceuticals, Novartis, ORIC Pharmaceuticals, Pionyr, Revolution Medicines, Ribon Therapeutics, Step Pharma, Syndax, Synthorx, Xencor.Copyright © 2023 European Society for Medical Oncology

Güven Cenk, M. and D. Uysal (2023). "In-bag abdominal manual morcellation versus contained power morcellation in laparoscopic myomectomy: a comparison of surgical outcomes and costs." BMC surgery 23(1): 106.
	Background: To compare the surgical outcomes and costs of in-bag abdominal manual morcellation (AMM) and contained power morcellation (PM) in laparoscopic myomectomy.; Methods: A total of 61 patients were divided into two groups based on their myomectomy specimen extraction methods: AMM group (n = 33) and electromechanical contained PM group (n = 28). The surgical outcomes and cost were compared between groups. During AMM, a glove bag (in 27 patients) and an endo bag were used (in 6 patients) according to the myoma size.; Results: Morcellation time (18 ± 9.2 min vs. 37.4 ± 14.1 min) and total operation time (100 ± 24.3 min vs. 127 ± 33.1 min) were significantly lower in the AMM group compared to those in the PM group. Other surgical outcomes, which were similar between groups, included delta hemoglobin, length of hospital stay and VAS score at 12 and 24 h postoperatively. There were no per- or postoperative complications in both group with no conversion to laparotomy. One patient was transfused with two units of erythrocyte suspension postoperatively in the PM group. Sarcoma was not diagnosed in any of the cases in both group.; Conclusion: The in-bag AMM or contained PM for specimen extraction resulted in similar outcomes in terms of delta hemoglobin, postoperative pain intensity (VAS score at 12 and 24 h postoperatively), the need for additional analgesia, and the length of hospital stay; however, total operation time and morcellation time were significantly shorter in the AMM group, indicating a prominent advantage. Significant cost-effectiveness is also a critical advantage of in-bag AMM compared to containing PM. (© 2023. The Author(s).)

Guy, L., et al. (2019). "Effectiveness of Pacing as a Learned Strategy for People With Chronic Pain: A Systematic Review." The American journal of occupational therapy : official publication of the American Occupational Therapy Association 73(3): 7303205060p7303205061-7303205060p7303205010.
	IMPORTANCE: Pacing is a key pain management strategy used by occupational therapy practitioners when working with people with chronic pain. However, there is a paucity of evidence and a lack of consensus regarding the effectiveness of pacing as a pain management strategy for people with chronic pain. OBJECTIVE: To evaluate the evidence for the effectiveness of pacing as a learned strategy for people with chronic pain. DATA SOURCES: Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used to undertake a systematic review. Six databases were searched in March 2016 for randomized controlled trials (RCTs). Combinations of keywords and MeSH terms were used as search terms. STUDY SELECTION AND DATA COLLECTION: We sought intervention studies that included participants using pacing as a strategy. Studies were assessed for eligibility on the basis of predetermined criteria. Of the 2,820 articles located, 7 RCTs met inclusion criteria. FINDINGS: Pacing does not reduce the severity of pain or alter psychological traits; however, it can assist in lessening joint stiffness and the interference of fatigue and in decreasing the variability of physical activity. CONCLUSIONS AND RELEVANCE: Current evidence supports the delivery of a learned pacing intervention to reduce the interference of fatigue, reduce joint stiffness, and decrease physical activity variability but does not support the use of learned pacing to reduce pain severity. Future research should investigate the effectiveness of pacing as a pain management strategy within the International Classification of Functioning, Disability and Health domains of activity and participation. WHAT THIS ARTICLE ADDS: This systematic review examines existing research on pacing as a learned intervention strategy. The findings will support the clinical reasoning of occupational therapy practitioners, to determine when a learned pacing strategy is indicated, and considerations for how it may be delivered.

Guzek, D., et al. (2023). "Effect of Vitamin D Supplementation on Depression in Adults: A Systematic Review of Randomized Controlled Trials (RCTs)." Nutrients 15(4).
	Vitamin D is a nutrient potentially beneficial in the treatment of depression. The study aimed to carry out a systematic review of the studies assessing the influence of vitamin D supplementation on depression within Randomized Controlled Trials (RCTs). The systematic review was prepared on the basis of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and was registered in the International Prospective Register of Systematic Reviews (PROSPERO) database (CRD42020155779). The peer-reviewed studies available within PubMed or Web of Science databases until September 2021 were taken into account. The number of screened records was 8514, and 8 records were included. Two independent researchers conducted screening, including, reporting, and risk of bias assessment using the revised Cochrane risk-of-bias tool for randomized trials. The included studies presented a population of patients with major depressive disorders or general depression, as well as bipolar depression or postpartum depression. The majority of included studies were conducted for 8 weeks or 12 weeks, while one study was conducted for 6 months. Within the large number of included studies, a daily dose of 1500 IU, 1600 IU, or 2800 IU was applied, while within some studies, a vitamin D dose of 50,000 IU was applied weekly or biweekly. Among applied psychological measures of depression, there were various tools. In spite of the fact that the majority of included studies (five studies) supported the positive effect of vitamin D supplementation for the psychological measure of depression, for three studies the positive influence was not supported. A medium risk of bias was indicated for six studies, while a high risk of bias was defined for only two studies, due to deviations from the intended interventions and in measurement of the outcome, as well as for one study, also arising from the randomization process and due to missing outcome data. Based on conducted assessment, it should be emphasized that there are only four studies supporting the positive influence of vitamin D supplementation for the psychological measure of depression of the medium risk of bias, while two studies of a medium risk of bias did not support it. Taking this into account, the conducted systematic review is not a strong confirmation of the effectiveness of vitamin D supplementation in the treatment of depression.

Guzene, L., et al. (2023). "Assessing Interobserver Variability in the Delineation of Structures in Radiation Oncology: A Systematic Review." International journal of radiation oncology biology physics 115(5): 1047-1060.
	Purpose: The delineation of target volumes and organs at risk is the main source of uncertainty in radiation therapy. Numerous interobserver variability (IOV) studies have been conducted, often with unclear methodology and nonstandardized reporting. We aimed to identify the parameters chosen in conducting delineation IOV studies and assess their performances and limits. Methods and Materials: We conducted a systematic literature review to highlight major points of heterogeneity and missing data in IOV studies published between 2018 and 2021. For the main used metrics, we did in silico analyses to assess their limits in specific clinical situations. Result(s): All disease sites were represented in the 66 studies examined. Organs at risk were studied independently of tumor site in 29% of reviewed IOV studies. In 65% of studies, statistical analyses were performed. No gold standard (GS; ie, reference) was defined in 36% of studies. A single expert was considered as the GS in 21% of studies, without testing intraobserver variability. All studies reported both absolute and relative indices, including the Dice similarity coefficient (DSC) in 68% and the Hausdorff distance (HD) in 42%. Limitations were shown in silico for small structures when using the DSC and dependence on irregular shapes when using the HD. Variations in DSC values were large between studies, and their thresholds were inconsistent. Most studies (51%) included 1 to 10 cases. The median number of observers or experts was 7 (range, 2-35). The intraclass correlation coefficient was reported in only 9% of cases. Investigating the feasibility of studying IOV in delineation, a minimum of 8 observers with 3 cases, or 11 observers with 2 cases, was required to demonstrate moderate reproducibility. Conclusion(s): Implementation of future IOV studies would benefit from a more standardized methodology: clear definitions of the gold standard and metrics and a justification of the tradeoffs made in the choice of the number of observers and number of delineated cases should be provided.Copyright © 2022 Elsevier Inc.

Gwacham Nnamdi, I., et al. (2021). "Neoadjuvant chemotherapy followed by fertility sparing surgery in cervical cancers size 2-4 cm; emerging data and future perspectives." Gynecologic Oncology 162(3): 809-815.
	Background: Approach to the management of early stage cervical cancers with tumor size >2 cm in women who desire fertility preservation has been fraught with controversy. Fertility sparing surgery for FIGO 2018 stage IB cancers has been validated most for tumors ≤2 cm. In this review, our objective was to evaluate the oncologic and obstetric outcomes for women that underwent neoadjuvant chemotherapy (NACT) before fertility sparing surgery for tumors 2-4 cm.; Methods: We performed a systematic literature review and searched PubMed, Google Scholar, Cochrane Reviews and UpToDate (from January 2000 to February 2021) using the terms: cervical cancer, fertility preservation, trachelectomy, radical trachelectomy, neoadjuvant chemotherapy, cervical cancer treatment, stage IB1 or IB2 cervical cancer, and cervical cancer size 2-4 cm. We included manuscripts with information on patients with tumor sizes 2-4 cm, lymph node status, follow-up, obstetric and oncologic outcome. We excluded review articles or articles without all pertinent patient information.; Results: Eighteen articles were identified including 249 patients. For final analysis, 114 met inclusion criteria. All included patients had FIGO 2018 stage IB2 cervical cancer, underwent neoadjuvant chemotherapy and subsequent fertility sparing surgery. Vaginal radical trachelectomy, cold knife conization, abdominal radical trachelectomy, laparoscopic radical trachelectomy, simple vaginal trachelectomy, and cone laser were performed in 46 (40.4%), 26 (22.8%), 14 (12.3%), 13 (11.4%), 8 (7%), and 7 (6.1%) women, respectively. The most common regimen of chemotherapy was platinum-based therapy with cisplatin. The follow-up time reported in all studies ranged from 1 to 225 months. Of 64 attempted pregnancies, there were 49 (76.6%) viable deliveries which included 6 preterm births (9.4%). The recurrence rate was 6.1% and two patients (1.8%) died of disease.; Conclusion: Fertility sparing surgery following NACT is an option for women with cervical cancers that are 2-4 cm that wish to preserve fertility without sacrificing oncologic or obstetric outcomes. Confirmation of these findings are anticipated from an ongoing international phase II clinical trial [1].; Competing Interests: Declaration of competing interest The authors declare that they have no conflicts of interest associated with this review article. (Copyright © 2021 Elsevier Inc. All rights reserved.)

gykpj, R. B. R. (2022). "The Effect of Hypopressive training improves Postpartum Belly, urine Loss and Abdominal Strength." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: G11.427.410.698.277 This is a randomized, controlled, blinded clinical trial. Intervention Group (IC): 22 women selected, randomized by a blinded researcher, who present at least 2 cm of diastasis of the rectus abdominis at some point in the linea alba, measured by ultrasound at rest. The measurement will be taken at the umbilical line, 2 centimeters above and 2 centimeters below the navel line. They will receive the original hypopressive method training for 12 weeks, 2 times a week for 30 minutes by a trainer qualified for the hypopressive method. Control Group (CG): 22 women selected randomly by a blinded researcher, who present at least 2 cm of diastasis of the rectus abdominis at some point in the linea alba, measured by ultrasound at rest. The measurement will be made at the umbilical line, 2 centimeters above and 2 centimeters below the navel line at rest in the supine position and in trunk flexion. They will not receive any type of intervention during the period under analysis and after the IC intervention they will receive the same treatment in the same period. Both groups will not be able to do physical exercises concomitantly with the intervention period and did not use any type of orthosis, belt or abdominal band. The ultrasound evaluation will be performed before the beginning of the intervention and shortly after 12 weeks of the first group by a blinded researcher. CONDITION: M62.0 Unspecified urinary incontinence PRIMARY OUTCOME: The hypopressive training method is expected to approach 5% of the borders of the rectus abdominis at one of the diastasis points along the linea alba assessed by imaging ultrasound.; SECONDARY OUTCOME: It is expected that the hypopressive training method will improve abdominal function by 5%, assessed by the plank test, in addition to improving the pelvic floor complaints by 5% of the Pelvic Floor Questionnaire scores. INCLUSION CRITERIA: Will be included women aged 18 or over; between 45 days and si Xmonths postpartum; with diagnosis of diastasis, considered as from 2 cm of distance at a point of the extension of the linea alba, no history of previous abdominal aesthetic surgeries; do not have musculoskeletal disease that makes it impossible to perform the requested exercises.

H Al Wattar, B., et al. (2022). "Lifestyle interventions in women with polycystic ovary syndrome: A scoping systematic review of randomised evidence." Semergen 48(3): 186-194.
	Objective: Lifestyle interventions (LSI) are recommended as first-line treatment for polycystic ovary syndrome (PCOS), yet the strength of evidence underpinning LSIs effectiveness remains unclear. We systematically reviewed the literature on LSIs in PCOS, evaluated evidence quality and summarised recommendations for clinical practice.; Material and Methods: We searched MEDLINE, EMBASE and CENTRAL for all randomised trials evaluating any LSI in PCOS until April 2021. We extracted data on the LSIs' characteristics, dietary composition, duration, implementation, compliance assessment, and reported outcomes. We evaluated the evidence gap using a network-map of evaluated interventions.; Results: We screened 550 citations and included 79 trials (n=4659 women). Most trials were from high-income countries (57/79, 72%) over a decade ago (48/79, 61%) and enrolled obese/overweight women (57/77, 74%). BMI was the commonest reported outcome (58/79, 73%), followed by weight (49/79, 62%), and testosterone (45/79, 57%). More than half of the trials had high-risk of randomisation (51/79, 65%) and allocation bias (49/79, 62%). Only 27 were registered prospectively (27/79, 34%). Two-thirds evaluated a dietary intervention (70/79, 88%), most commonly a hypocaloric diet (32/70, 46%); nineteen evaluated a combined dietary with pharmacological intervention (19/79, 24%), six combined diet with physical or behavioural intervention (6/79, 8%), and only one trial included all four elements.; Conclusions: Evidence on LSI in PCOS is of poor quality with high variations in trial design, comparisons, and outcome reporting. Hypocaloric diet is the most commonly recommended LSI intervention for primary care. Future trials are needed to evaluate pragmatic and simple LSIs in robust multicenter studies.; Prospero Registration: CRD42020186571. (Copyright © 2021 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.)

Haahr, T., et al. (2023). "Effect of clindamycin and a live biotherapeutic containing lactobacilli on the reproductive outcomes of IVF patients with abnormal vaginal microbiota: a double-blind, placebo-controlled multicentre trial." Human Reproduction 38(Supplement 1): i160-i161.
	Study question: Does treatment of abnormal vaginal microbiota improve the reproductive outcomes of IVF patients? Summary answer: Data is being analysed and will be presented at ESHRE 2023. What is known already: An increasing number of studies reported an association between abnormal genital tract microbiota and adverse reproductive outcomes in IVF patients. One hypothesis could be that vaginal microbiota ascend to the endometrium where the microbiota hampers implantation. To the best of our knowledge, this is the first study powered to investigate causality between abnormal genital tract microbiota-in this study defined by a bacterial vaginosis like vaginal microbiota-and clinical pregnancy rate in IVF patients. Study design, size, duration: Double-blind, placebo-controlled multicentre trial in IVF patients diagnosed with abnormal vaginal microbiota and subsequently randomised into three parallel groups 1:1:1. The first group received clindamycin 300 mg x2 daily for 7 days followed by vaginal Lactobacillus crispatus until the clinical pregnancy scan. The second group received clindamycin and placebo, whereas the third group received placebo/placebo. A total of 1518 patients were screened, and 338 patients were randomised. The study duration was from 2017 to 2023. Participants/materials, setting, methods: IVF patients with any cause of infertility embarking on their first, second or third IVF stimulation cycle or embryo transfer were approached for inclusion. At a minimum 12 days prior to embryo transfer, patients were screened for abnormal vaginal microbiota defined by a qPCR assay, targeting high quantitative loads of Fannyhessea vaginae and Gardnerella spp. Patients were excluded if they had intrauterine malformations like polyps, septum, and fibroma. Main results and the role of chance: Data and safety monitoring board has decided not to open the randomization code yet. The final dataset is being completed. Data is being analysed and will be presented at ESHRE 2023. Limitations, reasons for caution: Data is being analysed and will be presented at ESHRE 2023. Wider implications of the findings: The present drug intervention study used clindamycin and a live biotherapeutic containing Lactobacillus crispatus. The results of the study could have a worldwide important clinical impact on daily IVF practice as currently there is no evidence that screening and treating IVF patients with abnormal vaginal microbiota improves the reproductive outcome.

Haase Christiane, L., et al. (2023). "Association between body mass index, weight loss and the chance of pregnancy in women with polycystic ovary syndrome and overweight or obesity: a retrospective cohort study in the UK." Human reproduction (Oxford, England) 38(3): 471-481.
	Study Question: What are the associations between baseline BMI (Study 1) and change in body weight (Study 2) with the likelihood of pregnancy in women with polycystic ovary syndrome (PCOS).; Summary Answer: In women with PCOS, higher baseline BMI was associated with a lower chance of pregnancy; however, weight loss was associated with an increased chance of pregnancy versus maintaining a stable weight or gaining weight.; What Is Known Already: Two studies in large cohorts of Danish women with the intention to become pregnant showed a decline in fecundability ratios with higher BMI. Furthermore, a meta-analysis found that overweight/obesity significantly worsened metabolic and reproductive outcomes in women with PCOS.; Study Design, Size, Duration: Data were extracted from the UK Clinical Practice Research Datalink GOLD database. Patients included women aged 18-45 years with BMI ≥18.5 (Study 1) or ≥25 kg/m2 (Study 2) at time of PCOS diagnosis (index date). The primary outcome was the time to first pregnancy recorded during 36-months' follow-up, analysed with Cox proportional hazard models and presented as hazard ratios (HRs).; Participants/materials, Setting, Methods: Study 1 included 9955 women with PCOS. Study 2 included 7593 women with PCOS and median BMI of 34.0 kg/m2.; Main Results and the Role of Chance: Higher BMI was associated with a lower chance of pregnancy in the 3 years following diagnosis. It was estimated that 41% of women with normal weight (18.5-24.9 kg/m2) would become pregnant compared to 17% of women with obesity class III (BMI ≥40.0 kg/m2) during follow-up. Furthermore, the chance of pregnancy for women with obesity class III was estimated to be 63% lower than for women with normal weight, with the same age and glycaemic status (HR 0.37, 95% CI 0.31-0.44; P < 0.0001). A significant inverse association was found between BMI change and chance of pregnancy: 10% weight loss was estimated to increase the chance of pregnancy by 68% for women with baseline BMI of 40 kg/m2 (HR 1.68, 95% CI 1.49-1.90).; Limitations, Reasons for Caution: Multiple factors influence the chance of pregnancy (the ability and willingness to become pregnant), which was addressed by exclusion criteria employed. The real-world nature of the study means that use of non-prescription contraceptives was not available. Bias may have been introduced by the fact that only around 40% of women with PCOS in the CPRD GOLD database had their BMI recorded during the year prior to PCOS diagnosis. BMI categories used in the analyses may not be applicable to women of all ethnicities. The study population was only representative of women in the UK and results may not be generalizable to other regions. PCOS diagnoses were based on codes entered into the system by primary care providers, and no information was available regarding the criteria used for diagnosis, although symptoms used to diagnose PCOS have not changed over time.; Wider Implications of the Findings: Our observations provide further evidence of the benefits of weight loss in women with overweight/obesity and PCOS who are seeking to become pregnant.; Study Funding/competing Interest(s): Novo Nordisk A/S. A.H.B. declares fees for consultancy from Novo Nordisk. P.N.L. and C.L.H. are employees of Novo Nordisk. V.S. and A.V. are employees of, and hold shares in, Novo Nordisk.; Trial Registration Number: N/A. (© The Author(s) 2023. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Habib, N., et al. (2022). "Impact of lifestyle and diet on endometriosis: a fresh look to a busy corner." Przeglad menopauzalny = Menopause review 21(2): 124-132.
	Endometriosis is a chronic inflammatory disorder with a prevalence of six to ten percent in women of childbearing age. As long as the aetiology of endometriosis is not fully understood and the disease has no definitive treatment, an examination of the environmental factors or interventions that could modify or cure endometriosis would greatly benefit women suffering from this chronic condition. This literature review utilized the electronic databases PubMed, EMBASE, and MEDLINE until February 2021. Studies indicate that fish oil may have a positive effect on reducing endometriosis-related pain due to the effects of pro-inflammatory prostaglandins derived from omega-3 fatty acids. The same effect was seen with the introduction of antioxidant vitamins C, D, and E. There is clinical viability of a low fermentable oligo-, di-, and mono-saccharides and polyols diet to successfully reduce the symptoms of patients who suffer from both endometriosis and irritable bowel syndrome. Despite the low level of evidence, there are frequent associations between endometriosis and gastrointestinal conditions in addition to the influence of various nutritional factors on the disease. The management of endometriosis requires a holistic approach focused on reducing overall inflammation, increasing detoxification, and attenuating troublesome symptoms. A dietician may provide great benefit in the management of these patients, especially at younger ages and in early stages. High-level evidence and well-designed randomized studies are lacking when it comes to studying the effect of lifestyle and dietary intake on endometriosis. Inarguably, further research with a more extensive focus is needed.; Competing Interests: The authors report no conflict of interest. (Copyright © 2022 Termedia.)

Habiburrahman, M., et al. (2023). "Quercetin as a noteworthy treatment for polycystic ovary syndrome: An evidence-based review from molecular basis mechanism to clinical perspective." Obesity Medicine 39: 100490.
	Polycystic ovary syndrome (PCOS) is a complex endocrinopathy that often occurs in reproductive-age women and causes anovulatory infertility problems. Current management guidelines, including fertility medications, hormonal therapy, and glycemic control, have drawbacks due to their limited efficacy and undesirable outcomes. Therefore, this review intended to scrutinise the mechanism and potential benefits of a candidate herbal therapy for PCOS, quercetin, as an adjunctive medication to alleviate disease manifestations. Articles were searched in PubMed, EBSCOHost, ProQuest, and Scopus databases and screened based on their titles and abstracts. A critical appraisal was done using an Evidence-Based Medicine worksheet. Fourteen eligible articles were obtained, including one systematic review, four randomized clinical trials; eight experimental studies; and one systematic pharmacological strategy-based research. It was shown that quercetin alleviated insulin resistance via activating phosphatidylinositol 3-kinase (PI3-K) signalling, reduced testosterone, controlled luteinising hormone, and had anti-inflammatory effects on the ovaries. This antioxidant also altered catabolism and steroidogenesis, regulated AMP-activated protein kinase (AMPK), and decreased oocyte nucleation failure. Furthermore, the lipid profile was reduced by quercetin through the modulation of adiponectin receptors. Ultimately, quercetin successfully improved the pregnancy rate. Due to its potential to modulate several pathways involved in metabolic disease and infertility, quercetin is a promising candidate in clinical practice as adjunctive therapy for PCOS.Copyright © 2023 Elsevier Ltd

Hadi, A., et al. (2020). "Effect of probiotics and synbiotics on selected anthropometric and biochemical measures in women with polycystic ovary syndrome: a systematic review and meta-analysis." European Journal of Clinical Nutrition 74(4): 543-547.
	This study aimed to systematically review randomized clinical trials (RCTs) to clarify the effects of pro-/synbiotic supplementation on anthropometric and biochemical measurements in women with polycystic ovary syndrome (PCOS). PubMed, Scopus, ISI Web of Science, Cochrane Library, and Google Scholar were searched through September 2018. Eight RCTs (nine treatment arms) were included. Pro-/synbiotic supplementation significantly reduced fasting blood sugar (-2.52 mg/dl, 95% confidence interval (CI): -4.10 to -0.95), insulin (-2.27 µIU/mL, 95% CI: -3.40 to -1.14), homeostasis model assessment for insulin resistance index (-0.69, 95% CI: -0.98 to -0.40), C-reactive protein (-1.69 Hedges', 95% CI: -3.00 to -0.38), and total testosterone (-0.12 ng/mL, 95% CI: -0.17 to -0.08) in women with PCOS. However, changes in the mean difference of weight and body mass index did not reach a statistically significant level. The findings suggest that pro-/synbiotic supplementation may improve glucose homeostasis parameters, hormonal, and inflammatory indices in women with PCOS.

Hafermann, J., et al. (2024). "Efficacy and safety of V-LocTM barbed sutures versus conventional suture techniques in gynecological surgery: a systematic review and meta-analysis." Archives of Gynecology and Obstetrics 309(4): 1249-1265.
	Purpose: One of the most challenging tasks in laparoscopic gynecological surgeries is suturing. Knotless barbed sutures are intended to enable faster suturing and hemostasis. We carried out a meta-analysis to compare the efficacy and safety of V-LocTM barbed sutures (VBS) with conventional sutures (CS) in gynecological surgeries. Method(s): We systematically searched PubMed and EMBASE for studies published between 2010 and September 2021 comparing VBS to CS for OB/GYN procedures. All comparative studies were included. Primary analysis and subgroup analyses for the different surgery and suturing types were performed. Primary outcomes were operation time and suture time; secondary outcomes included post-operative complications, surgical site infections, estimated blood loss, length of stay, granulation tissue formation, and surgical difficulty. Results were calculated as weighted mean difference (WMD) or risk ratio (RR) and 95% confidence intervals (CI) with a random effects model, and a sensitivity analysis for study quality, study size, and outlier results was performed. PROSPERO registration: CRD42022363187. Result(s): In total, 25 studies involving 4452 women undergoing hysterectomy, myomectomy, or excision of endometrioma. VBS were associated with a reduction in operation time (WMD - 17.08 min; 95% CI - 21.57, - 12.59), suture time (WMD - 5.39 min; 95% CI - 7.06, - 3.71), surgical site infection (RR 0.26; 95% CI 0.09, 0.78), estimated blood loss (WMD - 44.91 ml; 95% CI - 66.01, - 23.81), granulation tissue formation (RR 0.48; 95% CI 0.25, 0.89), and surgical difficulty (WMD - 1.98 VAS score; 95% CI - 2.83, - 1.13). No difference between VBS and CS was found regarding total postoperative complications or length of stay. Many of the outcomes showed high heterogeneity, likely due to the inclusion of different surgery types and comparators. Most results were shown to be robust in the sensitivity analysis except for the reduction in granulation tissue formation. Conclusion(s): This meta-analysis indicates that V-LocTM barbed sutures are safe and effective in gynecological surgeries as they reduce operation time, suture time, blood loss, infections, and surgical difficulty without increasing post-operative complications or length of stay compared to conventional sutures.Copyright © The Author(s) 2023.

Hafidh, B., et al. (2022). "Vasopressin to Control Blood Loss during Hysterectomy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." Journal of Minimally Invasive Gynecology 29(3): 355-364.e352.
	Objective: Minimizing intraoperative blood loss during hysterectomy is crucial to lessen associated perioperative morbidity. The aim of this investigation is to conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) that compared vasopressin versus normal saline in controlling intraoperative blood loss during hysterectomy. Data Sources: We screened 5 major databases (PubMed, Scopus, Web of Science, Embase, and the Cochrane Central Register of Controlled Trials) from inception till July 18, 2021. We used the following query search in all databases: (vasopressin OR arginine vasopressin OR argipressin OR antidiuretic hormone) AND (hysterectomy) AND (saline OR placebo OR control OR no treatment) AND (randomized OR randomised OR randomly). There was no language restriction during database screening. Methods of Study Selection: We considered all studies that met the following evidence-based criteria: (1) patients: individuals undergoing hysterectomy for any indication, (2) intervention: vasopressin, (3) comparator: normal saline, placebo, or no treatment, (4) outcomes: reliable extraction of any of our endpoints, and (5) study design: RCTs. We assessed risk of bias of included studies and pooled endpoints as mean difference (MD) or risk ratio (RR) with 95% confidence interval (CI). We performed statistical analysis using the Review Manager software, version 5.4.0. Tabulation, Integration, and Results: Seven RCTs with an overall low risk of bias met the inclusion criteria. This meta-analysis included a total of 455 patients; 232 and 223 patients were allocated to vasopressin and control group, respectively. The majority of RCTs were vaginal hysterectomy (n = 5), few abdominal hysterectomy, (n = 2) and no laparoscopic hysterectomy. The mean estimated intraoperative blood loss was significantly lower in favor of the vasopressin group compared with the control group (n = 6 RCTs, MD = -119.85 mL, 95% CI [-177.55, -62.14], p <.001). However, there was no significant difference between both groups regarding mean operating time, mean change in postoperative hemoglobin, mean hospital stay, rate of febrile morbidity, rate of pelvic infection, rate of perioperative blood transfusion, and rate of perioperative complications. Conclusion(s): Compared with normal saline, vasopressin significantly reduced the estimated blood loss during hysterectomy but did not change any clinically significant outcomes. In addition, vasopressin was safe and did not correlate with an increase in the rates of febrile morbidity or pelvic infection.Copyright © 2021 AAGL

Hagen, S., et al. (2019). "Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: Protocol for the OPAL randomised trial." BMJ Open 9(2): e024153.
	Introduction Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence. Methods and analysis This multicentre randomised controlled trial will compare the effectiveness and cost-effectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score. Ethics and dissemination Approval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed consent will be obtained from participants by the local research team. Serious adverse events will be reported to the data monitoring and ethics committee, the ethics committee and trial centres as required. A Standard Protocol Items: Recommendations for Interventional Trials checklist and figure are available for this protocol. The results will be published in international journals and included in the relevant Cochrane review. Trial registration number ISRCTN57746448; Pre-results.Copyright © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

Hagovska, M., et al. (2021). "A randomized, intervention parallel multicentre study to evaluate duloxetine and innovative pelvic floor muscle training in women with uncomplicated stress urinary incontinence-the DULOXING study." International Urogynecology Journal 32(1): 193-201.
	INTRODUCTION AND HYPOTHESIS: The aim of our study was to evaluate the effect of a combination of innovative pelvic floor muscle training (iPFMT) and duloxetine compared with the use of duloxetine alone on women with stress urinary incontinence (SUI) after 12 weeks of treatment. METHODS: We conducted a parallel multicentre study with randomized intervention in 45 national urological outpatient clinics. Patients with an enrolment ratio of 1:1 were divided into the experimental and control groups. The following were used for evaluation: incontinence episode frequency (IEF)/week, the International Consultation on Incontinence Questionnaire (ICIQ-SF), the Urinary Incontinence Quality of Life Scale (I-QoL) and the Patient Global Impression of Improvement (PGI-I). The experimental group received oral treatment with duloxetine (a daily dose of 40 mg BID) and innovative pelvic floor muscle training (iPFMT). The control group received only oral treatment with duloxetine at a daily dose of 40 mg BID. RESULTS: The number of women who were evaluated was 158. The control group comprised 79 women with an average age of 56.8 ± 13.8 years and the experimental group comprised 79 women with an average age of 53.4 ± 11.9 years. There were no significant differences in pre-treatment parameters. For the intent-to-treat analysis after 12 weeks' treatment, significant differences were observed between the experimental vs. control group (p < 0.001) for the following variables: IEF/week decrease (66.7% vs. 50.0%); ICIQ-UI SF decrease (8.3 ± 3.8 vs. 9.7 ± 4.2); PGI-I (70.8% vs. 65.6%); I-QoL score increase (19.3% vs. 6.6%). CONCLUSION: The addition of iPFMT to duloxetine treatment improves SUI syndrome in women compared with duloxetine treatment alone. REGISTRATION: Clinical Trials.gov NCT04140253.

Hagovska, M., et al. (2023). "A randomised interventional parallel study to evaluate the effect of different frequencies of pelvic floor muscle exercises with core stabilisation using three-dimensional ultrasound: the PELSTAB study." International Urogynecology Journal 34(9): 2049-2060.
	Introduction and hypothesis: The primary objective was to compare high- and low-frequency pelvic floor muscle training (PFMT) with the impact on urinary incontinence episode frequency over 1 week (IEF/week). The secondary objective was to compare the two groups with regard to pelvic floor muscle function, morphometry, incontinence quality of life, and patient global impression. Method(s): This was a randomised parallel controlled study. The setting was regional gynaecological and urological outpatient clinics. The subjects consisted of a sample of 86 women with stress urinary incontinence (SUI). Group A underwent high-frequency PFMT and group B underwent low-frequency PFMT for 12 weeks. We recorded the IEF/week. The International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) was used. Pelvic floor muscle function was evaluated using a perineometer. Pelvic floor muscle morphometry was evaluated with 3D/4D ultrasound. The Urinary Incontinence Quality of Life Scale (I-QoL) was used. Result(s): Significant differences between group A and B after treatment (p<0.001) were noted in favour of group A in IEF/week (group A 10.2+/-7.0/2.3+/-3.0 vs group B 9.3+/-4.7/6.3+/-4.9), in the ICIQ-UI SF (group A 9.7+/-3.0/3.7 +/- 3.6 vs group B 9.9+/-3.2/9.4+/-3.4). Significant differences between groups A and B after treatment were noted in favour of group A for pelvic floor muscle function in terms of maximal voluntary contraction and its duration, and also for pelvic floor muscle morphometry in terms of a reduction of the hiatal area during rest, contraction, and the Valsalva manoeuvre. Conclusion(s): High-frequency PFMT for 12 weeks significantly decreased IEF/week in comparison with low-frequency PFMT. In the high-frequency exercise group, women had significantly better pelvic floor muscle function, morphometry and quality of life than the low-frequency exercise group.Copyright © 2023, The International Urogynecological Association.

haihong, w., et al. (2023). "Efficacy and safety of pabolizumab in the treatment of common cancers of the female reproductive tract: a systematic review and meta-analysis of randomized controlled trials."
	
Hailan, Y., et al. (2022). "Oral Gonadotropin-Releasing Hormone Antagonists in the treatment of Endometriosis-Associated pain: A Systematic Review and Network Meta-analysis of Efficacy and Safety Parameters." PROSPERO International prospective register of systematic reviews.
	
Haiyu, Z., et al. (2021). "Efficacy and safety of External Therapy of TCM for primary dysmenorrhea: a protocol for systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Hajek, J., et al. (2021). "A randomised, multi-center, open trial comparing a semi-automated closed vitrification system with a manual open system in women undergoing IVF." Human reproduction (Oxford, England) 36(8): 2101‐2110.
	STUDY QUESTION: What are outcome and procedural differences when using the semi‐automated closed Gavi® device versus the manual open Cryotop® method for vitrification of pronuclear (2PN) stage oocytes within an IVF program? SUMMARY ANSWER: A semi‐automated closed vitrification method gives similar clinical results as compared to an exclusively manual, open system but higher procedure duration and less staff convenience. WHAT IS KNOWN ALREADY: A semi‐automated closed vitrification device has been introduced to the market, however, little evaluation of its performance in a clinical setting has been conducted so far. STUDY DESIGN, SIZE, DURATION: This prospective, randomised, open non‐inferiority trial was conducted at three German IVF centers (10/2017‐12/2018). Randomization was performed on day of fertilization check, stratified by center and by indication for vitrification (surplus 2PN oocytes in the context of a fresh embryo transfer (ET) cycle or 'freeze‐all' of 2PN oocytes). PARTICIPANT/MATERIAL, SETTING, METHODS: The study population included subfertile women, aged 18‐40 years, undergoing IVF or ICSI treatment after ovarian stimulation, with 2PN oocytes available for vitrification. The primary outcome was survival rate of 2PN oocytes at first warming procedure in a subsequent cycle and non‐inferiority of 2PN survival was to be declared if the lower bound 95% CI of the mean difference in survival rate excluded a difference larger than 9.5%; secondary, descriptive outcomes included embryo development, pregnancy and live birth rate, procedure time and staff convenience. MAIN RESULTS AND THE ROLE OF CHANCE: The randomised patient population consisted of 149 patients, and the per‐protocol population (patients with warming of 2PN oocytes for culture and planned ET) was 118 patients. The survival rate was 94.0% (±13.5) and 96.7% (±9.7) in the Gavi® and the Cryotop® group (weighted mean difference ‐1.6%, 95% CI ‐4.7 to 1.4, P = 0.28), respectively, indicating non‐inferiority of the Gavi® vitrification/warming method for the primary outcome. Embryo development and the proportion of top‐quality embryos was similar in the two groups, as were the pregnancy and live birth rate. Mean total procedure duration (vitrification and warming) was higher in the Gavi® group (81 ± 39 min vs 47 ± 15 min, mean difference 34 min, 95% CI 19 to 48). Staff convenience assessed by eight operators in a questionnaire was lower for the Gavi® system. The majority of respondents preferred the Cryotop® method because of practicality issues. LIMITATIONS, REASON FOR CAUTION: The study was performed in centers with long experience of manual vitrification, and the relative performance of the Gavi® system as well as the staff convenience may be higher in settings with less experience in the manual procedure. Financial costs of the two procedures were not measured along the trial. WIDER IMPLICATIONS OF THE FINDINGS: With increasing requirements for standardization of procedures and tissue safety, a semi‐automated closed vitrification method may constitute a suitable alternative technology to the established manual open vitrification method given the equivalent clinical outcomes demonstrated herein. STUDY FUNDING/COMPETING INTERESTS: The trial received no direct financial funding. The Gavi® instrument, Gavi® consumables and staff training were provided for free by the distributor (Merck, Darmstadt, Germany) during the study period. The manufacturer of the Gavi® instrument had no influence on study protocol, study conduct, data analysis, data interpretation or manuscript writing. J.H. has received honoraria and/or non‐financial support from Ferring, Merck and Origio. G.G. has received honoraria and/or non‐financial support from Abbott, Ferring, Finox, Gedeon Richter, Guerbet, Merck, MSD, ObsEva, PregLem, ReprodWissen GmbH and Theramex. The remaining authors have no competing interests. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT03287479. TRIAL REGISTRATION DATE: 19 September 2017. A E OF FIRST PATIENT’S ENROLMENT: 10 October 2017.

Hajibandeh, S., et al. (2021). "Meta-analysis of laparoscopic mesh rectopexy versus posterior sutured rectopexy for management of complete rectal prolapse." International Journal of Colorectal Disease 36(7): 1357-1366.
	Objectives: To evaluate comparative outcomes of laparoscopic mesh rectopexy (LMR) and laparoscopic posterior sutured rectopexy (LPSR) in patients with rectal prolapse.; Methods: We conducted a systematic search of electronic databases and bibliographic reference lists with application of a combination of free text and controlled vocabulary search adapted to thesaurus headings, search operators, and limits. Recurrence, Cleveland Clinic Incontinence Score (CCIS), Cleveland Clinic Constipation Score (CCCS), surgical site infections, procedure time, and length of hospital stay were the evaluated outcome measures.; Results: We identified 5 comparative studies reporting a total of 307 patients evaluating outcomes of LMR (n=160) or LPSR (n=147) in patients with rectal prolapse. LMR was associated with significantly lower recurrence rate (OR: 0.28, P=0.009) but longer procedure time (MD: 23.93, P<0.0001) compared to LPSR. However, there was no significant difference in CCIS (MD: -1.02, P=0.50), CCCS (MD: -1.54, P=0.47), surgical site infection (OR: 1.48, P=0.71), and length of hospital stay (MD: -1.54, P=0.47) between two groups. No mesh erosion was reported in any of the included studies at maximum follow-up point. Sub-group analyses with respect to ventral mesh rectopexy, posterior mesh rectopexy, randomised studies, and adult patients were consistent with the main analysis.; Conclusions: LMR seems to be associated with lower recurrence but longer procedure time compared to LPSR. Although no mesh-related complications have been reported by the included studies, no definitive conclusions can be made considering that the included studies were inadequately powered for such outcome. Future high-quality randomised studies with adequate sample size are required.

Hajizadeh-Sharafabad, F., et al. (2019). "Selenium and Polycystic Ovary Syndrome; Current Knowledge and Future Directions: A Systematic Review." Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme 51(5): 279-287.
	Polycystic ovary syndrome (PCOS), as the most common endocrine disorder in reproductive-aged women, is recognized by hyperandrogenism and insulin resistance. Selenium (Se) potentially possesses therapeutic effects on PCOS due to antioxidant and insulin-like properties. This systematic review evaluates the potential role of Se in the complications of PCOS. A systematic review was performed on published studies reporting the effects of Se on PCOS. Three major databases including PubMed, Scopus, and Google Scholar were searched until December 2018. A total of 7 human studies and two in vitro studies met the inclusion criteria. Two out of three case-control studies showed that serum Se levels tend to decrease in patients with PCOS. Of four studies that evaluated the impact of Se supplementation on insulin resistance, only one study showed protective effects of Se against insulin resistance. Two out of three studies reported the antioxidant effect of Se. Few studies investigating anti-androgenic effect of Se presented controversial results. There were three studies that evaluated the anti-hyperlipidemic effect of Se, of which two surveys indicated the lowering effects of Se on VLDL and LDL-cholesterol. The reviewed studies confirmed inverse relationships between serum Se levels and some androgenic hormones in PCOS. Se is able to attenuate insulin resistance and dyslipidemia. The available data are currently insufficient to support the protective effects of Se on PCOS.; Competing Interests: The authors declare that they have no conflict of interest. (© Georg Thieme Verlag KG Stuttgart · New York.)

Halder, G., et al. (2022). "Cost effectiveness of additional preoperative telephone visit: Analysis of a randomized trial on surgical preparedness." International Urogynecology Journal 33(Supplement 1): S19-S20.
	Introduction: Surgical preparedness improves patient satisfaction and perioperative outcomes. We performed a RCT of a provider-initiated telephone visit in addition to usual preoperative counseling (TELE) versus usual preoperative counseling alone (usual care) and found that a supplemental preoperative telephone visit improved patient surgical preparedness. Objective(s): In this ancillary analysis our objective was to assess the costeffectiveness of a preoperative telephone visit versus usual preoperative counseling alone. Method(s): We performed a planned prospective economic evaluation concurrent with a RCT of 132 women randomized to either TELE (n=63) or usual care (n=69) followed for 8 weeks after surgery for stress urinary incontinence and/or pelvic organ prolapse. A within-trial analysis from the health care sector (HCS) - formal medical costs borne by third-party payers and patients - and societal perspectives (SP) - all costs regardless of who incurs - was performed as recommended by the Second Panel on Cost- Effectiveness in Health and Medicine. Costs are in 2019 U.S. dollars and include medical care, complications, patient and caregiver time, transportation, and lost productivity. A macro-costing approach was used; medical resource use was multiplied by price weights based on national Medicare reimbursement rates or published prices. Effectiveness measures include 1) quality-adjusted life-years (QALYs), calculated from the EuroQol 5D (EQ-5D), and 2) surgical preparedness, measured by the Preoperative Patient Questionnaire; with a response of "strongly agree" to "Overall, I feel prepared for my upcoming surgery." Our primary outcome was the incremental cost effectiveness ratio (ICER) of TELE vs. usual care, defined as the difference between groups in mean cost divided by the difference in mean QALYs (i.e., QALY ICER). A secondary ICER was also calculated using surgical preparedness as the measure of effectiveness (i.e., preparedness ICER). Costs and QALYs were not discounted because of the 8- week analysis time horizon. Result(s): Baseline characteristics and peri-operative course were similar between groups (Table 1). QALYs gained were similar between groups, 0.132 + 0.023for TELE and 0.131 + 0.017 for usual care (p=0.881). The TELE group was more prepared for surgery (83% vs 59%, p<0.05). The cumulative mean per-person cost over 8 weeks was similar between groups from the HCS ($8,707 + 3,278 TELE vs. $8,433 + 3,099 usual care, p=0.623) and SP ($11,119 + 5,105 TELE vs. $11,052 + 4,850 usual care, p=0.938). The preoperative telephone intervention was cost-effective from the SP (ICER = $67,000/QALY) but not from the HCS perspective (ICER = $274,000/QALY) using the generally accepted maximum willingness to pay threshold of $150,000/QALY. The incremental cost per percentage patient surgical preparedness gained was $2.79 from the SP and $11.42 from the HCS. Conclusion(s): A provider-initiated preoperative telephone visit significantly improves patient surgical preparedness and is cost-effective from the SP.

Halder, G. E., et al. (2021). "20 Cost effectiveness of additional preoperative telephone visit: Analysis of a randomized trial on surgical preparedness." American Journal of Obstetrics and Gynecology 224(6 Supplement): S739-S740.
	Objectives: Surgical preparedness improves patient satisfaction and perioperative outcomes. We performed a RCT of a provider-initiated telephone visit in addition to usual preoperative counseling (TELE) versus usual preoperative counseling alone (usual care) and found that a supplemental preoperative telephone visit improved patient surgical preparedness. In this ancillary analysis our objective was to assess the cost-effectiveness of a preoperative telephone visit versus usual preoperative counseling alone. Material(s) and Method(s): We performed a planned prospective economic evaluation concurrent with a RCT of 132 women randomized to either TELE (n = 63) or usual care (n = 69) followed for 8 weeks after surgery for stress urinary incontinence and/or pelvic organ prolapse. A within-trial analysis from the health care sector (HCS) - formal medical costs borne by third-party payers and patients - and societal perspectives (SP) - all costs regardless of who incurs - was performed as recommended by the Second Panel on Cost-Effectiveness in Health and Medicine. Costs are in 2019 U.S. dollars and include medical care, complications, patient and caregiver time, transportation, and lost productivity. A macro-costing approach was used; medical resource use was multiplied by price weights based on national Medicare reimbursement rates or published prices. Effectiveness measures include (1) quality-adjusted life-years (QALYs), calculated from the EuroQol 5D (EQ-5D), and (2) surgical preparedness, measured by the Preoperative Patient Questionnaire; with a response of "strongly agree" to "Overall, I feel prepared for my upcoming surgery." Our primary outcome was the incremental cost effectiveness ratio (ICER) of TELE vs. usual care, defined as the difference between groups in mean cost divided by the difference in mean QALYs (i.e., QALY ICER). A secondary ICER was also calculated using surgical preparedness as the measure of effectiveness (i.e., preparedness ICER). Costs and QALYs were not discounted because of the 8-week analysis time horizon. Result(s): Baseline characteristics and peri-operative course were similar between groups (Table 1). QALYs gained were similar between groups, 0.132 + 0.023 for TELE and 0.131 + 0.017 for usual care (P = 0.881). The TELE group was more prepared for surgery (83% vs 59%, P < 0.05). The cumulative mean per-person cost over 8 weeks was similar between groups from the HCS ($8,707 + 3,278 TELE vs. $8,433 + 3,099 usual care, P = 0.623) and SP ($11,119 + 5,105 TELE vs. $11,052 + 4,850 usual care, P = 0.938). The preoperative telephone intervention was cost-effective from the SP (ICER = $67,000/QALY) but not from the HCS perspective (ICER = $274,000/QALY) using the generally accepted maximum willingness to pay threshold of $150,000/QALY. The incremental cost per percentage patient surgical preparedness gained was $2.79 from the SP and $11.42 from the HCS. Conclusion(s): A provider-initiated preoperative telephone visit significantly improves patient surgical preparedness and is cost-effective from the SP. [Formula presented]Copyright © 2021

Hall, L. M., et al. (2020). "Do features of randomized controlled trials of pelvic floor muscle training for postprostatectomy urinary incontinence differentiate successful from unsuccessful patient outcomes? A systematic review with a series of meta-analyses." Neurourology and Urodynamics 39(2): 533-546.
	AIMS: Efficacy of pelvic floor muscle training (PFMT) for postprostatectomy incontinence (PPI) differs between randomized clinical trials (RCT). This might be explained by variation in content/delivery of PFMT (eg, biofeedback, muscles targeted, and time of commencement of training). This review investigated whether outcome of meta-analysis differs based on presence or not of specific RCT features. METHODS: PubMed, CINAHL, EMBASE, Physiotherapy Evidence Database (PEDro), and Cochrane were searched for RCTs that investigated efficacy of PFMT on PPI. PFMT details and outcomes were extracted. Methodological quality and comprehensiveness of PFMT reporting was assessed using the PEDro scale and Consensus on Reporting Template, respectively. Effect size and 95% confidence intervals were calculated for incontinence rate at 3 months. To identify features that influenced efficacy, separate meta-analyses were performed for studies with and without specific features. RESULTS: Twenty-two trials were included, and 15 were used for meta-analysis of 3-month outcomes. Overall, meta-analysis showed reduced incontinence with PFMT (risk ratio [RR] = 0.85; I2 = 55%; P = .005). Meta-analyses showed better outcomes for PFMT than control groups when the study included preoperative PFMT (RR = 0.76; I2 = 30%; P = .006), biofeedback (RR = 0.73; I2 = 58%; P = .006), instruction to contract around the urethra (RR = 0.9; I2 = 43%; P = .009), a control group without PFMT instruction (RR = 0.85; I2 = 69%; P = .05), inclusion of all men irrespective of continence status (RR = 0.84; I2 = 30%; P = .003) and continence defined as no leakage (RR = 0.85; I2 = 48%; P = .05). CONCLUSIONS: Preoperative PFMT, biofeedback, urethral instructions, no PFMT instruction for controls, inclusion of all men, and continence defined as no leakage are features associated with successful patient outcomes. Future studies should consider these features in design of interventions and pooling data for meta-analysis.

Hamada, M., et al. (2022). "A novel orally active gonadotropin-releasing hormone antagonist, relugolix, is a potential substitute for injectable GnRH antagonists in controlled ovarian stimulation in assisted reproductive technology." Reproductive Medicine and Biology 21(1): e12424.
	Purpose: To evaluate the efficacy of an oral gonadotropin-releasing hormone antagonist (GnRH Ant), relugolix (R), for assisted reproductive technology (ART). Method(s): We enrolled women undergoing ART using a GnRH Ant for controlled ovarian stimulation. We compared R; 20 mg/day with cetrorelix acetate (C); 0.125 mg. C was administered to 88 women in 2019, and R to 93 women in 2020. Clinical outcomes associated with ART were assessed in both groups. Result(s): The luteinizing hormone levels on the day of human chorionic gonadotropin injection in the R group (1.26 +/- 0.93 IU/L) were significantly lower than those in the C group (2.85 +/- 3.02 IU/L). There were no cases in which egg retrieval was canceled in both groups. The total doses of gonadotropins administered were greater in the R group compared with the C group. The number of days of GnRH Ant administration in the R group (1.71 +/- 0.57 days) was significantly longer compared with the C group (1.48 +/- 0.58 days). The number of oocytes collected, fertilization rates, and pregnancy rates (R; 47.1% vs C; 45.8%) did not differ between the two groups. Conclusion(s): An orally active GnRH Ant, relugolix, when used in controlled ovarian stimulation for ART, showed comparable clinical outcomes with cetrorelix.Copyright © 2021 The Authors. Reproductive Medicine and Biology published by John Wiley & Sons Australia, Ltd on behalf of Japan Society for Reproductive Medicine.

Hamdaoui, N., et al. (2021). "Pain Associated With Cervical Priming for First-Trimester Surgical Abortion: a Randomized Controlled Trial." Obstetrics and Gynecology 137(6): 1055‐1060.
	OBJECTIVE: To compare the effect of cervical priming with mifepristone with that of misoprostol on pain perception during surgical induced abortion under paracervical block. METHODS: We conducted a randomized, single‐blind, two‐center study of women undergoing surgical induced abortion at less than 14 weeks of gestation under paracervical block. Participants were randomized to receive cervical priming with 200 mg of oral mifepristone 36 hours or 400 micrograms buccal misoprostol 3 hours before surgery. The primary outcome was pain during mechanical cervical dilation evaluated by a 100‐mm visual analog scale (VAS). Secondary outcomes were pain during aspiration, preoperative and postoperative pain, participant satisfaction, duration of the procedure, occurrence of complications, and ease of performing the procedure (assessed by a 100‐mm VAS). We estimated that 110 women would have to be included to have 90% power to detect a 13mm‐difference of VAS for pain. RESULTS: Between June 2017 and May 2019, 314 women were eligible and 110 were randomized (55 in each group). Patient characteristics were similar in the two groups. The mean VAS score during mechanical cervical dilation was lower in the mifepristone group (35.6±21 vs 43.5±21, P=.04) as was the mean VAS during aspiration (34±24 vs 47.8±23, P=.003). The preoperative and postoperative mean VAS, satisfaction and duration of procedures were similar between groups. The procedure was significantly easier to perform in the mifepristone group (88±16 vs 80±23, P=.004). CONCLUSION: Cervical priming with mifepristone for surgical induced abortion under paracervical block up to 14 weeks of gestation is more effective than misoprostol in reducing pain perception. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03043014.

Hameed, R. H. (2019). "VTE risk in postmenopausal women receiving oral and non-oral hormone therapy systematic review and meta-analysis." Indian journal of forensic medicine and toxicology 13(1): 302-306.
	Hormone replacement therapy can improve the quality of life for women with hypo-oestrogenic symptoms. Many women are still prescribed oestrogen therapy to treat postmenopausal symptoms. Venous thromboembolism (VTE), either deep vein thrombosis or pulmonary embolism, is a main harmful effect of HT among postmenopausal women. We aim to evaluate the risk of VTE in postmenopausal women using hormonal therapy either oral or non-oral types. Systematic review of MEDLINE, Cochrane CENTRAL, EMBASE, and ClinicalTrials.gov according to PRISMA guidelines. 22 studies were included in the metaanalyses (9 case-control studies, 9 cohort studies, and 4 randomized controlled trials). VTE risk was not increased with non-oral HT, including users of estrogens and estrogens plus progestins (OR 0.97 [0.9-1.06]), non-oral estrogen therapy (ET)-only (OR 0.95 [0.81-1.10]), and non-oral combined estrogen-progestin therapy (OR 0.92 [0.77-1.09]). The comparison of non-oral vs. oral HT showed increased VTE risk with oral HT (OR 1.66 [1.39-1.98]). Increase the risk of VTE in postmenopausal women who using oral HT versus non oral HT.Copyright © 2019, Indian Journal of Forensic Medicine and Toxicology. All rights reserved.

Hamid, O., et al. (2022). "First-in-human study of an OX40 (ivuxolimab) and 4-1BB (utomilumab) agonistic antibody combination in patients with advanced solid tumors." Journal for Immunotherapy of Cancer 10(10).
	Background: Ivuxolimab (PF-04518600) and utomilumab (PF-05082566) are humanized agonistic IgG2 monoclonal antibodies against OX40 and 4-1BB, respectively. This first-in-human, multicenter, open-label, phase I, dose-escalation/dose-expansion study explored safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of ivuxolimab+utomilumab in patients with advanced solid tumors.; Methods: Dose-escalation: patients with advanced bladder, gastric, or cervical cancer, melanoma, head and neck squamous cell carcinoma, or non-small cell lung cancer (NSCLC) who were unresponsive to available therapies, had no standard therapy available or declined standard therapy were enrolled into five dose cohorts: ivuxolimab (0.1-3 mg/kg every 2 weeks (Q2W)) intravenously plus utomilumab (20 or 100 mg every 4 weeks (Q4W)) intravenously. Dose-expansion: patients with melanoma (n=10) and NSCLC (n=20) who progressed on prior anti-programmed death receptor 1/programmed death ligand-1 and/or anti-cytotoxic T-lymphocyte-associated antigen 4 (melanoma) received ivuxolimab 30 mg Q2W intravenously plus utomilumab 20 mg Q4W intravenously. Adverse events (AEs) were graded per National Cancer Institute Common Terminology Criteria for Adverse Events V.4.03 and efficacy was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) V.1.1 and immune-related RECIST (irRECIST). Paired tumor biopsies and whole blood were collected to assess pharmacodynamic effects and immunophenotyping. Whole blood samples were collected longitudinally for immunophenotyping.; Results: Dose-escalation: 57 patients were enrolled; 2 (3.5%) patients with melanoma (0.3 mg/kg+20 mg and 0.3 mg/kg+100 mg) achieved partial response (PR), 18 (31.6%) patients achieved stable disease (SD); the disease control rate (DCR) was 35.1% across all dose levels. Dose-expansion: 30 patients were enrolled; 1 patient with NSCLC achieved PR lasting &gt;77 weeks. Seven of 10 patients with melanoma (70%) and 7 of 20 patients with NSCLC (35%) achieved SD: median (range) duration of SD was 18.9 (13.9-49.0) weeks for the melanoma cohort versus 24.1 (14.3-77.9+) weeks for the NSCLC cohort; DCR (NSCLC) was 40%. Grade 3-4 treatment-emergent AEs were reported in 28 (49.1%) patients versus 11 (36.7%) patients in dose-escalation and dose-expansion, respectively. There were no grade 5 AEs deemed attributable to treatment. Ivuxolimab area under the concentration-time curve increased in a dose-dependent manner at 0.3-3 mg/kg doses.; Conclusions: Ivuxolimab+utomilumab was found to be well tolerated and demonstrated preliminary antitumor activity in selected groups of patients.; Trial Registration Number: NCT02315066.; Competing Interests: Competing interests: OH reports consulting fees from Aduro, Akeso, Amgen, Beigene, Bioatia, Bristol Myers Squibb, Roche Genentech, GlaxoSmithKline, Immunocore, Idera, Incyte, Janssen, Merck, Nextcure, Novartis, Pfizer, Sanofi Regeneron, SeaGen, Tempus, and Zelluna; honoraria for speaker bureaus from Bristol Myers Squibb, Novartis, Pfizer, and Sanofi Regeneron; and participation on a data safety monitoring board or advisory board for Aduro, Akeso, Amgen, Beigene, Bioatia, Bristol Myers Squibb, Roche Genentech, GlaxoSmithKline, Immunocore, Idera, Incyte, Janssen, Merck, Nextcure, Novartis, Pfizer, Sanofi Regeneron, SeaGen, Tempus, and Zelluna. AAC reports grants or contracts from AstraZeneca and Bristol Myers Squibb; consulting fees from Jazz, Janssen, and Pfizer; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Amgen, Blueprint, Genentech, Merck, Novartis, and Takeda; and participation on a data safety monitoring board or advisory board for AstraZeneca, Bristol Myers Squibb, Ipsen, and Novartis. JAT reports grants or contracts from Pfizer. TD reports grants or contracts to his institution from AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eisai, Eli Lilly, IQVIA, Janssen Pharma, Merck Serono, MSD, Novartis, Pfizer, Sumitomo Dainippon, and Ta ho; consulting fees from AbbVie, Bayer, Chugai Pharma, Otuska Pharma, Rakuten Medical, Sumitomo Dainippon, Taiho, and Takeda; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Bristol Myers Squibb, Oncolys Bio Pharma, Ono Pharma, Rakuten Medical, and Taiho; and participation on a data safety monitoring board or advisory board for AbbVie, Amgen, Astellas Pharma, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Janssen Pharma, MSD, and Novartis. SH-L reports consulting fees from Amgen, Astellas, Bristol Myers Squibb, Genmab, Merck, Regeneron, and Xencor; and research grants from Astellas, Boehringer Ingelheim, Checkmate, Dragonfly, F Star, Kite Pharma, Merck, OncoC4, Vedanta, and Xencor. AD reports grants or contracts from Apexigen, Idera, and Nektar; and consulting fees from Idera and Nektar. J-PS reports consulting fees from AstraZeneca, Bristol Myers Squibb, Daiichi-Sakyo, Gilead, GlaxoSmithKline, LeoPharma, Eli Lilly, MSD, Mylan, Novartis, Pierre Fabre Oncology, Pfizer, Roche Genentech; and support for attending meetings and/or travel from Amgen, AstraZeneca, and Pfizer. NR reports research grants from Pfizer; personal fees from AbbVie, Apricity Therapeutics, AstraZeneca, Bellicum Pharmaceuticals, Boehringer Ingelheim, Brooklyn ImmunoTherapeutics, Calithera Biosciences, Dracen Pharmaceuticals, Editas Medicine, Eli Lilly and Company, EMD Serono Inc, G1 Therapeutics, Genentech, Gilead Sciences, GlaxoSmithKline, Gritstone Bio, Illumina, Merck, Neogenomics Laboratories, Novartis, Takeda Pharmaceutical Company, and Synthekine; and royalties related to a patent filed by Memorial Sloan Kettering Cancer Center: determinants of cancer response to immunotherapy, (PCT/US2015/062208) licensed to Personal Genome Diagnostics. EA reports consulting fees from Celgene Research, GlaxoSmithKline, MedImmune, and Merck Sharp & Dohme; and support for attending meetings and/or travel from AbbVie, MedImmune, Pfizer, Roche, and Sanofi. ABE-K reports personal fees from Agenus, ABL Bio, Bayer, BMS, Exelixis, Eisai, and AstraZeneca; grants and personal fees from Astex, Pieris, Cytomx, Gilead, EMD Serono, Roche/Genentech, and Merck; and grants from Fulgent outside the submitted work. PAO reports grants or contracts from Amgen, Armo BioSciences, Array, AstraZeneca/MedImmune, Bristol Myers Squibb, Celldex, CytomX, Merck, Neon Therapeutics, Novartis, Oncorus, Pfizer, Roche Genentech, and Xencor; consulting fees from Array, Merck, Bristol Myers Squibb, Evaxion, and Novartis; and participation on a data safety monitoring board or advisory board for Array, Merck, Bristol Myers Squibb and Novartis. FALME, WR, and JSW have nothing to disclose. JC and AF were employees of Pfizer at the time of the study and hold stock or stock options in Pfizer. CG and WY are employees of Pfizer and hold stock or stock options in Pfizer. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Hamilton, J., et al. (2021). "A randomized, controlled pilot study of cognitive analytic therapy for stressed pregnant women with underlying anxiety and depression in a routine health service setting." Clinical Psychology & Psychotherapy 28(2): 394-408.
	A pilot study of cognitive analytic therapy (CAT) plus treatment as usual (TAU), versus TAU in stressed pregnant women with anxiety and depression, was undertaken as an essential preliminary to any definitive, randomized controlled trial (RCT). The trial was pragmatic, multicentre, parallel, randomized, controlled, and unblinded. Participants were pregnant women screened using the Hospital Anxiety and Depression Scale (HADS). Treatment was standard 16-session CAT. Main outcome measures were Spielberger State/Trait Anxiety Inventory (STAI) (primary outcome measure) at 24 weeks after randomization, therefore 1 month after therapy for the CAT group; HADS; Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM); Edinburgh Postnatal Depression Scale (EPDS); 36-item Short Form Health Survey (SF-36); and a brief Experiences of Therapy Questionnaire, completed at baseline and on average at 12, 24, 40, and 82 weeks after randomization. Thirty-nine patients (CAT + TAU, n = 20; TAU, n = 19) were randomized with mean baseline STAI State scores of 50.8 (SD 11.4) and 51.1 (SD 13.3), respectively. Sixteen patients had missing primary outcome data leaving 23 (n = 11 and n = 12) patients for analysis. The mean STAI State score was 38.5 (SD 13.8) and 45.7 (SD 16.8) in the CAT and TAU groups respectively at 24 weeks after randomization, with an adjusted difference in means of 7.2 (95% confidence interval [CI]: -7.9 to 20.6). No safety issues were reported. Patient retention for the CAT group was high (18/20; 90% of patients completed therapy). Ten out of 11 (90.9%) respondents 'agreed' or 'strongly agreed' that having CAT had been 'very helpful'. The study demonstrated the feasibility of safely undertaking CAT in this setting. Outcomes showed positive trends compatible with a clinically important effect, although statistically definitive conclusions cannot be drawn in such a study.

Hamilton Kacey, M., et al. (2023). "Surgical management of endometriosis to optimize fertility." Current opinion in obstetrics & gynecology 35(4): 389-394.
	Purpose of Review: Surgery is an integral element of treatment for infertility caused by endometriosis. This review summarizes the purported mechanisms of infertility in endometriosis, as well as the impacts of surgery for endometriosis on fertility, including pregnancy achieved spontaneously and with assisted reproductive technology (ART).; Recent Findings: Endometriosis' effect on fertility is multifactorial. The sequela of increased inflammation resulting from endometriosis causes alterations in ovarian, tubal, and uterine function. Removing or destroying these lesions reduces inflammation. Surgical treatment of both early-stage endometriosis and deeply infiltrating endometriosis improves spontaneous pregnancy rates and ART pregnancy rates. Conventional or robotic laparoscopy is the preferred surgical approach.; Summary: Endometriosis has detrimental effects on fertility, including negative impacts on oocyte, tubal, and endometrial function. Laparoscopic surgery for endometriosis elevates both spontaneous and ART pregnancy rates above those achieved with expectant management alone. The resection or destruction of endometriosis implants reduces inflammation, which likely improves the multifactorial infertility related to endometriosis. This topic is complex and controversial; more research in the form of high-quality randomized control trials is needed. (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Hammoud, D., et al. (2020). "Comparative efficacy of first-line maintenance PARP inhibitors (PARPI) in advanced ovarian cancer (OC): A network meta-analysis." Ann. Oncol. 31: S623-None.
	
Hamoda, H. and A. Sharma (2024). "Premature ovarian insufficiency, early menopause, and induced menopause." Best practice & research. Clinical endocrinology & metabolism 38(1): 101823.
	Premature ovarian insufficiency (POI) is a condition in which there is a decline in ovarian function in women who are younger than 40 years resulting in a hypo-oestrogenic state with elevated gonadotrophins and oligomenorrhoea/amenorrhoea. This leads to short term complications of menopausal symptoms and long-term effects on bone and cardiovascular health, cognition as well as the impact of reduced fertility and sexual function associated with this condition. It is managed by sex steroid replacement either with HRT or combined hormonal contraception until the age of natural menopause (51) and this can provide a beneficial role with both symptom control and minimising the long-term adverse effects associated with this condition. Women who undergo a menopause between 40 and 45 years are deemed to have an "early menopause". The limited data available for this group suggest that they also have an increased morbidity if not adequately treated with hormone therapy. As such, women who have an early menopause should be managed in a similar way to those with POI, with the recommendation that they should take HRT at least until the natural age of menopause. This is the same for induced menopause that is caused by medical or surgical treatment that impacts the ovaries. It is important to ensure early diagnosis and access to specialist care to help support and manage these patients to reduce the symptoms and risks of long-term complications. This review looks at the diagnosis, causes, short and long-term complications and management of POI, early and induced menopause. (Copyright © 2023. Published by Elsevier Ltd.)

Hamulyak, E. N., et al. (2021). "Heavy menstrual bleeding on direct factor Xa inhibitors: rationale and design of the MEDEA study." Research and practice in thrombosis and haemostasis 5(1): 223‐230.
	Background: In premenopausal women, treatment with direct oral factor Xa inhibitors is associated with an increased risk of heavy menstrual bleeding (HMB) compared with vitamin K antagonists (VKA). Treatment with the direct oral thrombin inhibitor dabigatran appears to be associated with a reduced risk of HMB compared with VKA. These findings come from small observational studies or post hoc analyses of trials in which HMB was not a primary outcome. Use of tranexamic acid during the menstrual period may be effective in patients with HMB, but prospective data regarding efficacy and safety in patients on anticoagulant treatment are lacking. Rationale and Design: A direct comparison of a factor Xa inhibitor and a thrombin inhibitor with HMB as primary outcome, as well as an evaluation of the effects of adding tranexamic acid in women with anticoagulant‐associated HMB is highly relevant for clinical practice. The MEDEA study is a randomized, open‐label, pragmatic clinical trial to evaluate management strategies in premenopausal women with HMB associated with factor Xa inhibitor therapy. Outcomes: Women using factor Xa inhibitors with proven HMB, as assessed by a pictorial blood loss assessment chart (PBAC) score of >150, will be randomized to one of three study arms: (i) switch to dabigatran; (ii) continue factor Xa inhibitor with addition of tranexamic acid during the menstrual period; or (iii) continue factor Xa inhibitor without intervention. The primary outcome is the difference in PBAC score before and after randomization. Here, we present the rationale and highlight several unique features in the design of the study.

Hamulyák Eva, N., et al. (2021). "Antithrombotic therapy to prevent recurrent pregnancy loss in antiphospholipid syndrome-What is the evidence?" Journal of thrombosis and haemostasis : JTH 19(5): 1174-1185.
	Aspirin and heparin are widely used to reduce the risk of recurrent pregnancy loss in women with antiphospholipid syndrome. This practice is based on only a few intervention studies, and uncertainty regarding benefits and risk remains. In this case-based review, we summarize the available evidence and address the questions that are most important for clinical practice. We performed a systematic review of randomized controlled trials assessing the effect of heparin (low molecular weight heparin [LMWH] or unfractionated heparin [UFH]), aspirin, or both on live birth rates in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Eleven trials including 1672 women met the inclusion criteria. Aspirin only did not increase live birth rate compared to placebo in one trial of 40 women (risk ratio [RR] 0.94; 95% confidence interval [CI] 0.71-1.25). One trial of 141 women reported a higher live birth rate with LMWH only than with aspirin only (RR 1.20; 95% CI 1.00-1.43). Five trials totaling 1295 women compared heparin plus aspirin with aspirin only. The pooled RR for live birth was 1.27 (95% CI 1.09-1.49) in favor of heparin plus aspirin. There was significant heterogeneity between the subgroups of LMWH and UFH (RR for LWMH plus aspirin versus aspirin 1.20, 95% CI: 1.04-1.38; RR for UFH plus aspirin versus aspirin 1.74, 95% CI: 1.28-2.35; I 2 78.9%, p = .03). Characteristics of participants and adverse events were not uniformly reported. Heparin (LMWH or UFH) plus aspirin may improve live birth rates in women with recurrent pregnancy loss and antiphospholipid antibodies, but evidence is of low certainty. (© 2021 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis.)

Han, A. and H. Kim Tae (2023). "Effects of self-compassion interventions on reducing depressive symptoms, anxiety, and stress: A meta-analysis." Mindfulness: 1-29.
	Objectives A growing body of evidence shows self-compassion can play a key role in alleviating depressive symptoms, anxiety, and stress in various populations. Interventions fostering self-compassion have recently received increased attention. This meta-analysis aimed to identify studies that measured effects of self-compassion focused interventions on reducing depressive symptoms, anxiety, and stress.MethodsA comprehensive search was conducted within four databases to identify relevant randomized controlled trials (RCTs). The quality of the included RCTs was assessed using the Cochrane Collaboration risk-of-bias tool. Either a random-effects model or fixed-effects model was used. Subgroup analyses were conducted according to types of control groups, intervention delivery modes, and the involvement of directly targeted populations with psychological distress symptoms.ResultsFifty-six RCTs met the eligibility criteria. Meta-analyses showed self-compassion focused interventions had small to medium effects on reducing depressive symptoms, anxiety, and stress at the immediate posttest and small effects on reducing depressive symptoms and stress at follow-up compared to control conditions. The overall risk of bias across included RCTs was high.ConclusionsFewer studies were conducted to compare effects of self-compassion interventions to active control conditions. Also, fewer studies involved online self-compassion interventions than in-person interventions and directly targeted people with distress symptoms. Further high-quality studies are needed to verify effects of self-compassion interventions on depressive symptoms, anxiety, and stress. As more studies are implemented, future meta-analyses of self-compassion interventions may consider conducting subgroup analyses according to intervention doses, specific self-compassion intervention techniques involved, and specific comparison or control groups.PreregistrationThis study is not preregistered. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Han, A. and T. H. Kim (2022). "Efficacy of Internet-Based Acceptance and Commitment Therapy for Depressive Symptoms, Anxiety, Stress, Psychological Distress, and Quality of Life: Systematic Review and Meta-analysis." Journal of Medical Internet Research 24(12): e39727.
	BACKGROUND: Acceptance and commitment therapy (ACT) is an empirically supported transdiagnostic approach that involves mindfulness processes and behavior change processes for valued living. OBJECTIVE: This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to assess the efficacy of internet-based ACT (iACT) for depressive symptoms, anxiety, stress, psychological distress, and quality of life (QoL). METHODS: PubMed, CINAHL, PsycINFO, and SCOPUS databases were searched to identify relevant RCTs published up to June 5, 2021. The included RCTs were assessed using the Cochrane Collaboration risk-of-bias tool. The use of either a random effects model or fixed effects model was determined using I2 statistic values for heterogeneity. Subgroup analyses were conducted according to the type of control group, the use of therapist guidance, delivery modes, and the use of targeted participants, when applicable. RESULTS: A total of 39 RCTs met the inclusion criteria. Meta-analyses found small effects of iACT on depressive symptoms, anxiety, stress, psychological distress, and QoL at the immediate posttest and follow-up. There was no significant effect of iACT on stress at follow-up. Subgroup analyses showed small to medium effects of iACT on all the outcomes at the immediate posttest and follow-up compared with the passive control groups. In contrast, subgroup analyses that compared iACT with active control groups found no differences between groups on stress, psychological distress, and QoL at the immediate posttest or on depressive symptoms, anxiety, and stress at follow-up. In addition, subgroup analyses conducted according to the use of therapist guidance, delivery modes, and the use of targeted participants found no statistically significant subgroup differences among studies in all the outcomes, except for the subgroup difference among studies according to the use of targeted participants for depressive symptoms at the immediate posttest (ie, a statistically significant, larger effect of iACT when studies targeted people with depressive symptoms). The overall risk of bias across the studies was unclear. CONCLUSIONS: The findings of this study contribute to the body of evidence regarding the effects of iACT on depressive symptoms, anxiety, stress, psychological distress, and QoL and may be applicable in any population, as ACT is a transdiagnostic approach. Few studies have compared iACT with active control conditions, especially for stress and psychological distress at the immediate posttest and follow-up. In addition, the active control conditions varied among the included studies. Further high-quality studies are needed to better understand whether iACT is comparable or superior to other evidence-based interventions, such as cognitive behavioral therapy, in decreasing depressive symptoms, anxiety, stress, and psychological distress and improving QoL.

Han, B., et al. (2021). "Observation on the effect of self-made Yishen Zhuyu Decoction on uterine involution after artificial abortion." 广西中医药 44(1): 21‐23.
	Objective: To observe the effect of self‐made Yishen Zhuyu Decoction on uterine involution after artificial abortion. Methods: 90 patients after induced abortion were randomly divided into the experimental group of 45 cases and the control group of 45 cases. Results: The postoperative vaginal bleeding time in the experimental group was shorter than that in the control group, and the endometrial thickness and the time of the first menstrual cramp in the experimental group were better than those in the control group. Conclusion: Self‐made Yishen Zhuyu Decoction is beneficial to uterine involution after induced abortion.

Han, E. J., et al. (2022). "Efficacy and safety of newly developed ganirelix acetate in infertile women for assisted reproductive technology: a prospective, randomised, controlled study." Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology 42(6): 2197-2202.
	This study aimed to investigate the efficacy of Ganilever pre-filled syringe (PFS), a newly developed ganirelix acetate, for the inhibition of premature luteinising hormone (LH) surge in in vitro fertilisation (IVF). A prospective randomised controlled study was conducted (NCT03051087). A total of 236 women (Ganilever group: 114, Orgalutran group: 122) were finally analysed. The patients with LH of >10 mIU/mL on the day of human chorionic gonadotropin (hCG) injection were 0 (0.0%) and 3 (2.5%) in the Ganilever and Orgalutran groups, respectively ( p = .25). The number of retrieved oocytes from two groups did not show any significant difference (12.0 ± 6.4 vs. 11.8 ± 6.3, p = .73). Furthermore, the two groups did not show significant differences in the number of good-quality oocytes and embryo, and the rate of fertilisation. Similar safety profiles were also observed. In conclusion, Ganilever PFS showed comparable IVF outcomes and safety profile in IVF, as compared to the Orgalutran. Impact Statement What is already known on this subject? Premature LH surge during controlled ovarian stimulation results in the induction of luteinisation of the immature follicles. Thus, gonadotrophin-releasing hormone (GnRH) antagonist protocol was suggested as an option for suppression of premature LH surge. Currently, one of GnRH antagonists being widely used is ganirelix acetate (Orgalutran ® ; Organon, Oss, The Netherlands). Ganilever pre-filled syringe (PFS) is a newly developed GnRH antagonist containing ganirelix acetate as an active ingredient. What do the results of this study add? Our study demonstrated that Ganilever PFS showed comparable IVF outcomes and patient safety profile in infertile women undergoing in IVF-ET, as compared to the Orgalutran. What are the implications of these findings for clinical practice and/or further research? The results of our study will provide another available GnRH antagonist to be used in patients with IVF.

Han, J. (2021). "Comparison of clinical efficacy of painless induced abortion with visualized and painless induced abortion under B ultrasonography." 医药前沿 11(26): 10‐12.
	Objective: To compare the effect of B‐ultrasound surveillance and visual abortion in women undergoing painless induced abortion. Methods: Selected 520 cases of painless artificial abortion who were admitted to our hospital from January 2019 to January 2021, and divided them into routine group (260 cases) and experimental group (260 cases) by random number table method, and the routine group was selected. Painless abortion was monitored by B‐ultrasound, and painless abortion could be seen in the experimental group. The clinical indicators, second uterine clearance rate and postoperative intrauterine adhesion rate were compared between the two groups. Results: The operation time, the duration of vaginal bleeding after operation and the first menstrual rehydration time after operation in the experimental group were shorter than those in the conventional group, and the amount of bleeding during the operation was lower than that in the conventional group (P<0.05). The rate of secondary uterine removal in the experimental group and the routine group were 1.15% and 4.62%, respectively, and the rates of intrauterine adhesion were 1.15% and 4.23%, respectively. The experimental group was lower than the routine group (P<0.05). CONCLUSION: Compared with painless abortion under B‐ultrasound monitoring, visual abortion for women undergoing painless induced abortion can shorten the operation time and postoperative recovery time, reduce intraoperative blood loss, and reduce the rate of secondary uterine removal. and intrauterine adhesions.

Han, J., et al. (2023). "Pregnancy outcome of intravenous immunoglobulin in women with recurrent pregnancy loss." Journal of Reproductive Immunology 156: 103847.
	Purpose: The objective of this study was first to compare the treatment outcome of recurrent pregnancy loss (RPL) women who received intravenous immunoglobulin (IVIG) treatment due to abnormal cellular immunity. We aimed to confirm the effect of IVIG in each subgroup of abnormal cellular immunity. Moreover, while our previously set cut-off value of NK(natural killer) cell level is 16.1%, in Korea, 12% is the widely used cut-off value. We, therefore, aimed to verify the adequacy of treating the patients in the "grey zone" (12-16%). Method(s): RPL was defined as women with 2 or more spontaneous abortions and in total, 987 RPL women visited our clinic from January 2007 to December 2020. Only those with a full evaluation and known treatment outcome were included. A total 204 idiopathic RPL and 209 RPL women with known etiology were enrolled. We investigated the pregnancy outcome by sorting the patients into 7 groups depending on abnormal cellular immunity including NK cell level, NK cell cytotoxicity and TNF-alpha/IL-10 ratio. Then, to verify the cut-off value(16.1%) of NK cell level which we set in our previous study, 152 patients were classified into three groups according to their NK cell level: 1) <12%(low), 2) 12-16%(moderate), 3) >16%(high). Result(s): Among all RPL women with at least one abnormal cellular immunity were treated with IVIG and the overall live birth rate (LBR) was 80.2%. The group which did not have IVIG treatment showed an overall LBR of 78.0%. Within the seven groups with abnormal cellular immunity, the group with both high NK cell cytoxicity and TNF-alpha/IL-10 ratio showed the highest LBR, 100% of LBR and the group with both high NK cell level and TNF-alpha/IL-10 ratio showed the lowest treatment outcome, 71.4%. The live birth rate according low, moderate, and high level of NK cells were 81.0%, 72.5%, and 76.9%. Conclusion(s): IVIG treatment can increase the live birth rate of RPL women with abnormal cellular immunity. The study may provide evidence in selecting RPL patients with immune abnormalities to be treated with IVIG and raise their pregnancy outcomes. Keywords: Recurrent pregnancy loss, abnormal cellular immunity, natural killer cellCopyright © 2023

Han, K., et al. (2022). "A Phase II Randomized Trial of Chemoradiation with or without Metformin in Locally Advanced Cervical Cancer." Clinical cancer research : an official journal of the American Association for Cancer Research 28(24): 5263-5271.
	Purpose: Tumor hypoxia is associated with poor response to radiation (RT). We previously discovered a novel mechanism of metformin: enhancing tumor RT response by decreasing tumor hypoxia. We hypothesized that metformin would decrease tumor hypoxia and improve cervical cancer response to RT.; Patients and Methods: A window-of-opportunity, phase II randomized trial was performed in stage IB-IVA cervical cancer. Patients underwent screening positron emission tomography (PET) imaging with hypoxia tracer fluoroazomycin arabinoside (FAZA). Only patients with FAZA uptake (hypoxic tumor) were included and randomized 2:1 to receive metformin in combination with chemoRT or chemoRT alone. A second FAZA-PET/CT scan was performed after 1 week of metformin or no intervention (control). The primary endpoint was a change in fractional hypoxic volume (FHV) between FAZA-PET scans, compared using the Wilcoxon signed-rank test. The study was closed early due to FAZA availability and the COVID-19 pandemic.; Results: Of the 20 consented patients, 6 were excluded due to no FAZA uptake and 1 withdrew. FHV of 10 patients in the metformin arm decreased by an average of 10.2% (44.4%-34.2%) ± SD 16.9% after 1 week of metformin, compared with an average increase of 4.7% (29.1%-33.8%) ± 11.5% for the 3 controls (P = 0.027). Those with FHV reduction after metformin had significantly lower MATE2 expression. With a median follow-up of 2.8 years, the 2-year disease-free survival was 67% for the metformin arm versus 33% for controls (P = 0.09).; Conclusions: Metformin decreased cervical tumor hypoxia in this trial that selected for patients with hypoxic tumor. See related commentary by Lyng et al., p. 5233. (©2022 American Association for Cancer Research.)

Han, L., et al. (2022). "Clinical outcome of lymphadenectomy in malignant ovarian germ cell tumors: a systematic review and meta-analysis." American journal of cancer research 12(9): 4458-4467.
	Malignant ovarian germ cell tumors (MOGCTs) are predominately diagnosed in young patients and account for most preadolescent malignant ovarian tumors. Currently, due to the high sensitivity of MOGCTs to chemotherapy and the optimal survival rate after chemotherapy, some researchers have recommended opting for non-surgical treatment. However, the effect of lymphadenectomy (LND) on the survival of patients with MOGCT remains controversial. We conducted a systematic review and meta-analysis to compare the clinical outcomes of LND and non-LND in MOGCT surgeries in order to summarize the clinical experience. PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), International Clinical Trials Registry Platform (ICTRP), and Clinical Trials.gov were searched from inception to December 26, 2021. Data on the rates of survival, relapse, and adverse effects were evaluated using Review Manager software. Fourteen studies with 10,759 participants were included in this review. There were 5863 and 4896 patients in the LND- and LND+ groups, respectively. Pooled results showed that although disease-free survival (DFS) was significantly improved in the LND+ group compared to the LND- group (HR: 0.74; 95% CI: 0.56 to 0.97; 2091 participants), LND did not significantly affect overall survival (OS) (HR: 0.82; 95% CI: 0.51 to 1.31; 5298 participants). The operation time was significantly longer in the LND+ group than in the LND- group (P<0.001). Blood loss (P=0.004) and complication rate (P=0.003) were also significantly higher in the LND+ group than in the LND- group. There was no significant difference in mortality rate (P=0.500). LND was associated with an improvement in DFS. However, there was no significant difference in OS in MOGCTs. We recommend that LND should not be a routine surgery for children or young patients with MOGCTs; although it may be beneficial for older people, advanced stage tumors, specific pathological types, and non-chemotherapy patients.; Competing Interests: None. (AJCR Copyright © 2022.)

Han, L., et al. (2023). "Effect of preoperative cervical conization before hysterectomy on survival and recurrence of patients with cervical cancer: A systematic review and meta-analysis." Gynecologic Oncology 174: 167-174.
	Objective: Conization plays a therapeutic and diagnostic role in cervical cancer. We conducted a systematic review and meta-analysis to compare the clinical outcomes of patients with cervical cancer who underwent hysterectomy with versus without preoperative cervical conization.; Methods: In this meta-analysis, we analyzed studies published in PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), International Clinical Trials Registry Platform (ICTRP), and Clinical Trials. gov that appeared in our search from inception to May 1, 2022.; Results: Eleven studies with 4184 participants were included in this review. There were 2122 patients in the preoperative conization group and 2062 patients in the non-conization group. The meta-analysis showed that disease free survival (DFS) (hazard ratio [HR]: 0.23; 95% CI: 0.12-0.44; 1616 participants; P = 0.030) and overall survival (OS) (HR: 0.54; 95% CI: 0.33-0.86; 1835 participants; P = 0.597) were improved in the preoperative conization group compared with those in the non-conization group. The risk for recurrence was lower in the preoperative conization group than in the non-conization group (odds ratio [OR]: 0.29; 95% CI: 0.17-0.48; 1099 participants; P = 0.434). There was no significant statistical difference regarding intraoperative adverse events (OR: 0.81; 95% CI: 0.18-3.70; 530 participants; P = 0.555) and postoperative adverse events (OR: 1.24; 95% CI: 0.54-2.85; 530 participants; P = 0.170) between the preoperative conization group and non-conization group. In subgroup analysis, patients who benefited more from preoperative conization, had underwent minimally invasive surgery, had smaller local tumor lesions, and had no lymph node involvement.; Conclusions: Preoperative conization before radical hysterectomy may have a protective effect in the treatment of early cervical cancer, with better survival and less recurrence, especially when the patient is at an early stage and undergoes minimally invasive surgery.; Competing Interests: Declaration of Competing Interest The author declares no conflict of interest. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Han, L., et al. (2023). "Minimally invasive versus abdominal radical trachelectomy for early-stage cervical cancer: a systematic review and meta-analysis." American journal of cancer research 13(9): 4466-4477.
	The safety of minimally invasive surgery (MIS) for cervical cancer has been questioned. This systematic review and meta-analysis aimed to compare the clinical outcomes of patients with cervical cancer who underwent MIS and abdominal trachelectomy. We searched for and subsequently analyzed studies published in PubMed, Embase, Cochrane Central Register of Controlled Trials, International Clinical Trials Registry Platform, and Clinical Trials.gov from their inception until April 10, 2023. Six studies with 1,079 participants were included, constituting 512 and 567 patients in the MIS and abdominal surgery groups, respectively. No significant difference was observed in the overall survival (hazard ratio [HR], 0.51; 95% confidence interval [CI], 0.16-1.65; I 2 =0.0%; P=0.881), recurrence rate (RR, 1.26; 95% CI, 0.68-2.33; I 2 =0.0%; P=0.815), and death rate (RR, 0.54; 95% CI, 0.23-1.31; I 2 =0.0%; P=0.680) between the MIS and abdominal surgery groups. No significant difference was found in urinary tract complication (RR, 0.78; 95% CI, 0.28-2.17; I 2 =0.0%; P=0.603), cerclage erosion (RR, 0.90; 95% CI, 0.34-2.43; I 2 =0.0%; P=0.650), or cervical stenosis (RR, 0.69; 95% CI, 0.22-2.18; I 2 =0.0%; P=0.885) between both groups. However, significant differences in blood loss and length of hospital stay were observed between both groups. Among 49 females who attempted to get pregnant, 31.3% (5/16) and 51.5% (17/33) in the MIS and abdominal surgery groups, respectively, succeeded in conceiving. We established that laparoscopic and abdominal radical trachelectomy had similar efficacies for treating patients with early cervical cancer, with no significant differences in survival, tumor recurrence, and mortality rates. Additionally, they showed no significant differences in pregnancy-related outcomes. However, owing to the limited number of studies, more high-quality cohort studies are required to confirm these findings.; Competing Interests: None. (AJCR Copyright © 2023.)

Han, L., et al. (2021). "Effect evaluation of sterile distilled water in the nursing process of patients with abdominal incision endometriosis." Indian journal of pharmaceutical sciences 82: 78‐82.
	Han et al.: Evaluation of sterile distilled water in patients with abdominal incision endometriosis To explore the value of sterile distilled water in the care of patients with endometriosis in abdominal wall incision.120 patients who underwent cesarean section under combined lumbar and rigid anesthesia in our hospital from August 2017 to January 2018 were selected as study subjects, and all patients were treated surgically, and were randomly divided into three experimental groups according to their nursing treatment after surgery, control group I (n=40): using saline rinse; control group II (n=40): using 0.5 % povidone‐iodine rinse; experimental Group (n=40): sterile distilled water rinses were used. Observation and comparison of patients' pain status before and after care, quality of life after care and satisfaction with care and the occurrence of complications. The pain and quality of life scores of the three groups of patients before nursing were not significantly different, and after nursing, the pain of patients in all groups was reduced, and the pain and quality of life of patients in the control II group and the test group were significantly reduced compared with the control I group (p<0.05), and there was a significant difference in the quality of life comparison between the control II group and the experimental group (p<0.05), while the difference in pain was not statistically significant (p>0.05). After care, the satisfaction of patients in the control II group and the test group was significantly higher (p<0.05) compared to the control I group, and the test group had the highest satisfaction, but the difference between the control II group and the experimental group was not statistically significant (p>0.05). Compared with the control I group, patients in the control II and test groups had significantly lower complication rates, but the difference between the control II and experimental groups was not statistically significant (p>0.05). The application of sterile distilled water rinsing in the care of patients with abdominal wall incision endometriosis can reduce the pain and alleviate the suffering of patients, while also effectively preventing complications and helping to shorten the recovery process.

Han, Q.-W., et al. (2020). "Efficacy of clomifene citrate for the treatment of patients with polycystic ovary syndrome: A protocol of systematic review." Medicine 99(25): e20590.
	Background: This study aims to assess the efficacy and safety of clomifene citrate (CC) for the treatment of patients with polycystic ovary syndrome (PCOS).; Methods: In this study, we will comprehensively search MEDLINE, EMBASE, The Cochrane Library, Web of Science, CINAHL, ACMD, PsycINFO, and China National Knowledge Infrastructure for original articles published from their inceptions to the January 1, 2020 without language restrictions. All studies will undergo relevance and a design selecting process. Data from qualified studies will be collected by 2 independent authors. Additionally, we will conduct a risk of bias evaluation using a Cochrane risk of bias tool. We will undertake statistical analysis utilizing RevMan 5.3 software.; Results: This study will summarize the up-to-date evidence to investigate the efficacy and safety of CC for the treatment of patients with PCOS.; Conclusion: The findings of this study will provide helpful evidence of CC for the treatment of patients with PCOS, as well as may help develop treatment guidelines.; Prospero Registration Number: PROSPERO CRD42020162818.

Han, S., et al. (2023). "Effectiveness and safety of PD-1/PD-L1 inhibitors in advanced or recurrent endometrial cancer: a systematic review and meta-analysis." Frontiers in Pharmacology 14: 1330877.
	Background: Studies in recent years have shown that PD-1/PD-L1 inhibitors may have better effectiveness in patients with advanced or recurrent endometrial cancer. The effectiveness of PD-1/PD-L1 inhibitors is thought to be related to mismatch repair-deficient (dMMR) and mismatch repair-proficient (pMMR) classification in advanced or recurrent endometrial cancer. This study aims to evaluate the effectiveness of PD-1/PD-L1 inhibitors in patients classified as dMMR and pMMR. Methods: Medical databases were searched to identify relevant publications up to 30 November 2022. The primary outcome was comparison of objective response rate (ORR) in patients with dMMR and pMMR following treatment with PD-1/PD-L1 inhibitors; secondary outcomes were single-group ORR in patients with dMMR and in patients with pMMR, respectively. Results: Eleven studies were eligible for analysis and patients with advanced or recurrent endometrial cancer with molecular classification of dMMR had a higher total ORR than those with pMMR [odds ratio (OR), 7.70; 95% confidence interval (CI), 3.22-18.38; p < 0.01], with low evidence of between-study heterogeneity (I 2 = 0%). The total ORR of patients with advanced or recurrent endometrial cancer with molecular type dMMR was 51.9% (95% CI, 33.6%-69.9%). The overall ORR of patients with advanced or recurrent endometrial cancer with molecular type pMMR was 16.1% (95% CI, 5.5%-30.3%). Conclusion: In our including studies, the patients with advanced or recurrent endometrial cancer with molecular types of dMMR and pMMR, following treatment with PD-1/PD-L1 inhibitors, the total ORR of patients with dMMR was higher than that of patients with pMMR. Since the current number of studies is not very large, it is possible that more studies will be published in the future and more precise results will be discussed further.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2023 Han, Guo, Song, Ouyang and Wang.)

Han, S., et al. (2019). "Transcutaneous electrical nerve stimulation (TENS) for pain control in women with primary dysmenorrhoea." Cochrane Database of Systematic Reviews 2019(5): CD013331.
	This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To evaluate the efficacy and safety of TENS on the basis of its frequency and acupoints, in comparison with placebo, no treatment, and other medical treatments for primary dysmenorrhoea.Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Han, X., et al. (2022). "Immune checkpoint inhibitors in advanced and recurrent/metastatic cervical cancer." Frontiers in Oncology 12: 996495.
	Cervical cancer (CC) poses a serious threat to women's health. Although many early-stage patients have a good prognosis, there are still a lack of effective therapies for advanced and recurrent/metastatic CC. In this context, immunotherapy and immune checkpoint inhibitors (ICIs) are particularly likely to play a role in the treatment of cervical tumors in a variety of disease settings. Some promising immune checkpoints include programmed cell death 1 (PD-1), programmed death ligand 1 (PD-L1) and cytotoxic T lymphocyte antigen 4 (CTLA-4), which exert immunomodulatory effects as negative regulators of T-cell activation and suppress immune responses in cervical cancer through cancer cell immune evasion. Initial trials of ICIs for CC have shown encouraging results in terms of objective response rate (ORR), progression-free survival (PFS), and overall survival (OS), both monotherapy and combination strategies. Meanwhile, human papillomavirus, vaginal microecology and intestinal microenvironment play an important role in CC, which provides new treatment directions. This review analyzed a number of completed or ongoing clinical trials of ICIs in the treatment of advanced and recurrent/metastatic CC. And we also analyzed the important relationship between vaginal microecology and intestinal microecology with CC and their related immunotherapy prospects.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Han, Chang and Xia.)

Han, Y., et al. (2022). "Effect of vitamin D supplementation on reproductive biomarkers in polycystic ovary syndrome (PCOS) women: a systemic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Han, Y., et al. (2021). "Transcutaneous electrical acupoint stimulation for pregnancy outcomes in women undergoing in vitro fertilization: a protocol of systematic review and meta-analysis."
	
Hana, S., et al. (2021). "A Systematic Review of Behaviour Change Techniques in Digital Health for Midlife Women." PROSPERO International prospective register of systematic reviews.
	
Hanach, N., et al. (2021). "The effectiveness of telemedicine interventions, delivered exclusively during the postnatal period, on postpartum depression in mothers without history or existing mental disorders: A systematic review and meta-analysis." Midwifery 94: 102906.
	Background: Postpartum depression, one of the most common forms of depression, is highly prevalent worldwide among women during childbirth. Despite available treatments for postpartum depression, numerous barriers hinder women to access care including time, financial constraints, and childcare concerns. Telemedicine interventions are suggested to be feasible to prevent and improve postpartum depression.; Objective: To examine the effectiveness of telemedicine interventions - delivered exclusively during the postnatal period, on postpartum depression symptomatology in women with no history of mental disorders.; Design: A systematic review and meta-analysis of randomized controlled trials.; Methods: PubMed, Web of Science, Cochrane Library, and ProQuest Dissertations & Theses databases were used to identify relevant randomized controlled trials, until 7 January 2020. Studies were quality assessed using the Cochrane Library Risk of Bias Tool. The results of postpartum depression scores were pooled using a random-effects model. Intervention completion rate and participants' satisfaction were reported in a narrative form, as secondary outcomes.; Results: Ten trials including a total of 2366 participants, contributed data to the review. Seven studies were included in the quantitative synthesis. Women who received technology-based interventions, regardless of the type (web-based versus telephone-based), had a statistically significant improvement in postpartum depression (mean difference: -1.81, 95% CI: -2.68 to -0.93; P<.0001). The completion rate was 80% in the intervention groups compared to 76% in the control groups. Three studies reporting participants' satisfaction revealed that the participants were highly satisfied with the technology-based interventions.; Conclusion: Overall, telemedicine interventions appear to be promising in preventing and improving postpartum depression. Further larger-scale high-quality research is required to establish an evidence-based telemedicine approach, in terms of structure, content, and providers. Future economic evaluation is also vital to evaluate the long-term use of telemedicine in improving postpartum depression.; Competing Interests: Declaration of Competing Interest None declared. (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Hande, V., et al. (2020). "Conventional vs. Volumetric Brachytherapy in the Treatment of Cervix Cancer: A Meta-Analysis of 30 Clinical Studies." Int. J. Radiat. Oncol. Biol. Phys. 108(3): e423-None.
	
Hande, V., et al. (2022). "Point-A vs. volume-based brachytherapy for the treatment of cervix cancer: A meta-analysis." Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology 170: 70-78.
	Background & Purpose: To report disease-free survival (DFS) for volume-based and point-A based brachytherapy (BT) in locally advanced cervical cancer.; Materials & Methods: We conducted a meta-analysis of studies assessing the effects of point-A and volume-based brachytherapy on 3-year DFS. Studies including stage I-IVA cervical cancer patients were included if standard treatment of concomitant chemo-radiotherapy and high-dose- or pulsed dose rate BT was delivered. The primary outcome was 3-year DFS, and secondary outcomes were 3-year local control (LC), 3-year overall survival (OS) and late toxicity. A random-effects subgroup meta-analysis was done.; Results: In total, 5499 studies were screened, of which 24 studies with 5488 patients were eligible. There was significant heterogeneity among point-A studies (1538 patients) (I 2 = 82%, p < 0.05) relative to volume-based studies (3950 patients) (I 2 = 58, p = 0.01). The 3-year DFS for point-A and volume-based studies were 67% (95% CI 60%-73%) and 79% (95% CI 76%-82%) respectively (p = 0.001). Three-year LC for point-A and volume-based studies were 86% (95% CI 81%-90%) and 92% (91%-94%) respectively (p = 0.01). The difference in 3-year OS (72% vs. 79%, p = 0.12) was not statistically significant. The proportion of prospectively enrolled patients was 23% for point-A studies and 33% for volume-based studies. There was no difference in late grade 3 or higher gastrointestinal (3% vs. 4%, p = 0.76) genitourinary toxicities (3% vs. 3% p = 0.45) between the two groups.; Conclusion: Volume-based BT results in superior 3-year DFS and 3-year LC. In the absence of randomized trials, this meta-analysis provides the best evidence regarding transition to 3D planning. (Copyright © 2022 Elsevier B.V. All rights reserved.)

Hanna, M. and Y. Moon Jee (2019). "A review of dexketoprofen trometamol in acute pain." Current medical research and opinion 35(2): 189-202.
	Objective: Dexketoprofen trometamol is a modified non-selective COX inhibitor with a rapid onset of action that is available as both oral and parenteral formulations. The aim of this narrative review was to assess the efficacy and tolerability/safety of dexketoprofen trometamol in acute pain states using the best available published scientific evidence (randomized controlled clinical trials and systematic reviews/meta-analyses).; Methods: Literature retrieval was performed via Medline, Embase and the Cochrane Library (from inception up to March 2017) using combinations of the terms "randomized controlled trials", "dexketoprofen", "celecoxib", "etoricoxib", "parecoxib" and "acute pain".; Results: Single-dose dexketoprofen trometamol provides effective analgesia in the treatment of acute pain, such as postoperative pain (dental and non-dental surgery), renal colic, acute musculoskeletal disorders and dysmenorrhea, and reduces opioid consumption in the postoperative setting. It has a rapid onset of action (within 30 minutes) and is well tolerated during short-term treatment. Direct comparisons with COX-2 inhibitors are lacking; however, the efficacy and tolerability of single-dose dexketoprofen trometamol appears to be consistent with that seen with celecoxib, etoricoxib and parecoxib in the acute pain setting.; Conclusion: In conclusion, dexketoprofen trometamol appears to provide similar analgesic efficacy to COX-2 inhibitors when used to treat acute pain, has a rapid onset of action, is well tolerated, and has an opioid-sparing effect when used as part of a multimodal regimen in the acute pain setting.

Hanna, T. P., et al. (2020). "Mortality due to cancer treatment delay: systematic review and meta-analysis." BMJ (Clinical research ed.) 371: m4087.
	OBJECTIVE: To quantify the association of cancer treatment delay and mortality for each four week increase in delay to inform cancer treatment pathways. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Published studies in Medline from 1 January 2000 to 10 April 2020. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Curative, neoadjuvant, and adjuvant indications for surgery, systemic treatment, or radiotherapy for cancers of the bladder, breast, colon, rectum, lung, cervix, and head and neck were included. The main outcome measure was the hazard ratio for overall survival for each four week delay for each indication. Delay was measured from diagnosis to first treatment, or from the completion of one treatment to the start of the next. The primary analysis only included high validity studies controlling for major prognostic factors. Hazard ratios were assumed to be log linear in relation to overall survival and were converted to an effect for each four week delay. Pooled effects were estimated using DerSimonian and Laird random effect models. RESULT(S): The review included 34 studies for 17 indications (n=1272681 patients). No high validity data were found for five of the radiotherapy indications or for cervical cancer surgery. The association between delay and increased mortality was significant (P<0.05) for 13 of 17 indications. Surgery findings were consistent, with a mortality risk for each four week delay of 1.06-1.08 (eg, colectomy 1.06, 95% confidence interval 1.01 to 1.12; breast surgery 1.08, 1.03 to 1.13). Estimates for systemic treatment varied (hazard ratio range 1.01-1.28). Radiotherapy estimates were for radical radiotherapy for head and neck cancer (hazard ratio 1.09, 95% confidence interval 1.05 to 1.14), adjuvant radiotherapy after breast conserving surgery (0.98, 0.88 to 1.09), and cervix cancer adjuvant radiotherapy (1.23, 1.00 to 1.50). A sensitivity analysis of studies that had been excluded because of lack of information on comorbidities or functional status did not change the findings. CONCLUSION(S): Cancer treatment delay is a problem in health systems worldwide. The impact of delay on mortality can now be quantified for prioritisation and modelling. Even a four week delay of cancer treatment is associated with increased mortality across surgical, systemic treatment, and radiotherapy indications for seven cancers. Policies focused on minimising system level delays to cancer treatment initiation could improve population level survival outcomes.Copyright © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Hansen, S., et al. (2021). "Impact of exercise on pain perception in women with endometriosis: A systematic review." Acta Obstetricia et Gynecologica Scandinavica 100(9): 1595-1601.
	Introduction: Endometriosis is challenging to treat. It is a painful and chronic inflammatory disorder that impacts up to 10% of women of reproductive age. Despite available surgical and medical treatment options, recurrence of symptoms is common. Available studies suggest that exercise may have a therapeutic effect on chronic inflammation and thereby on pain perception. This review evaluates whether exercise can decrease pain perception in women with symptomatic endometriosis.; Material and Methods: This systematic review was conducted according to PRISMA by searching databases Medline and Embase to locate randomized controlled trials and observational studies. Risk of bias was investigated using the Cochrane Collaboration Tool for the Evaluation of Randomized Controlled Trials and the ROBINS-I quality assessment scale. Inclusion criteria were women of reproductive age, laparoscopically confirmed diagnosis of endometriosis, and intervention of any type of exercise. All manuscripts were evaluated by two of the authors and when in doubt a third author was consulted. This review was registered in PROSPERO on November 14, 2020 (CRD42020212309).; Results: Six articles fulfilled the inclusion criteria and were included in this systematic review. Concerning exercise, two studies showed significant decrease in pain relief but the remaining studies showed either negative or no impact on pain relief. A meta-analysis could not be conducted because of the considerable heterogeneity among the included studies.; Conclusions: The present review does not indicate any beneficial effect of exercise on pain in women with endometriosis. There is a need for randomized controlled trials with correct power calculation, well-defined study groups and training programs to be able to answer the question of whether exercise can improve the pain experience in patients with endometriosis. (© 2021 Nordic Federation of Societies of Obstetrics and Gynecology (NFOG). Published by John Wiley & Sons Ltd.)

Hanstede, M. M. F., et al. (2023). "Hormonal support in women with Asherman syndrome does not lead to better outcomes: A randomized trial." Reproductive Medicine and Biology 22(1): e12526.
	Purpose: The purpose of the study was to investigate if adjuvant hormones after successful adhesiolysis lead to a reduction in spontaneous recurrence of adhesions and influence reproductive outcomes. Method(s): A single-blind randomized controlled trial comparing administration of oral estrogen (the usual care group) with not giving estrogen (no estrogen) in women after successful adhesiolysis for Asherman syndrome. Women were included between September 2013 and February 2017, with a follow-up of 3 years to monitor recurrences and reproductive outcomes. Analyses were based on an intention to treat analyses. This study was registered under NL9655. Result(s): A total of 114 women were included. At 1 year, virtually all patients (except 3) were either having a recurrence or were pregnant. Women who did not receive estrogen did not have more recurrences of adhesions in the first year prior to pregnancy (66.1% in the usual care group, 52.7% in the no-estrogen group, p = 0.15). Of the women in usual care, 89.8% got pregnant within 3 years, and 67.8% got a living child; this was 83.6% and 60.0%, respectively, in the no-estrogen group (p = 0.33 and p = 0.39, respectively). Conclusion(s): Usual care does not lead to better outcomes as compared with not giving exogenous estrogen but is associated with side effects.Copyright © 2023 The Authors. Reproductive Medicine and Biology published by John Wiley & Sons Australia, Ltd on behalf of Japan Society for Reproductive Medicine.

Hao, D., et al. (2022). "Neuromodulation for Management of Chronic Pelvic Pain: A Comprehensive Review." Pain and therapy 11(4): 1137-1177.
	Introduction: Chronic pelvic pain (CPP) is a symptom that derives from a complex group of heterogeneous pathologies of the pelvic organs. The aim of this study was to review the available evidence on efficacy of neuromodulatory modalities including sacral neuromodulation, dorsal root ganglion stimulation, dorsal column neuromodulation, and pudendal nerve stimulation.; Methods: This narrative review focuses on updated information on neuromodulation for management of chronic pelvic pain. In 2022, we searched English-language studies on neuromodulation, pelvic pain, and chronic pain in a comprehensive search. We searched the following databases: PubMed, Medline, SciHub, Cochrane Database of Systematic Reviews, and Google Scholar. We used the following combinations of keywords: neuromodulation, pelvic pain, chronic pain, chronic pelvic pain, pelvic pain treatment. We tried to include as many recent manuscripts as possible (within the last 3 years) but also included papers older than 3 years if they were particularly relevant to our topic. We also attempted to search for, use, and cite primary manuscripts whenever possible.; Results: CPP is a challenging entity to treat because of diagnostic inconsistencies and limited evidence for therapeutic modalities. Our review found evidence suggestive of benefit for all modalities reviewed but the data was of overall low quality with numerous limitations. The literature highlights a lack of randomized controlled trials for neuromodulatory therapies but suggests a growing role for such techniques in treating refractory chronic pelvic pain syndrome (CPPS).; Conclusions: This review explores the available evidence on efficacy of neuromodulatory modalities for CPPS and contextualizes the results with information about the type of neuromodulation, lead location and waveform, pain outcomes and assessment timepoints, and reported adverse effects. (© 2022. The Author(s).)

Hao, H. J., et al. (2023). "Reproductive outcomes of ectopic pregnancy with conservative and surgical treatment: A systematic review and meta-analysis." Medicine (United States) 102(17): E33621.
	Background: Ectopic pregnancy (EP), one of the most common gynecological emergencies, is the major cause of maternal death in the first trimester and increases the incidence of infertility and repeat ectopic pregnancy (REP). The aim of this study was to compare the effects of different treatment methods for tubal EP on natural pregnancy outcomes. Method(s): We systematically searched PubMed, Embase, Cochrane Library, Web of Science, and Clinical Trials for observational studies on EP (published until October 30,2022 in English) comparing methotrexate (MTX) versus surgery, MTX versus salpingostomy, MTX versus salpingectomy, salpingostomy versus salpingectomy, and MTX versus expectant treatment. Our main endpoints included subsequent natural intrauterine pregnancy (IUP) and REP. We assessed the pooled data using Review Manager software (version 5.3) with a random effects model. Result(s): Of 1274 identified articles, 20 were eligible and 3530 participants were included in our analysis. There was a significant difference in the odds of subsequent IUP in tubal EP patients who underwent MTX compared with those who were treated with surgery [odds ratios (OR) = 1.52, 95% confidence interval (CI):1.20-1.92]. No significant difference was found in the odds of REP between the 2 groups (OR = 1.12, 95% confidence interval [CI]: 0.84-1.51). There was no significant difference in the odds of subsequent IUP and REP in patients after MTX compared to those after salpingostomy (OR = 1.04,95% CI: 0.79-1.38; OR = 1.10, 95% CI: 0.64-1.90). There was a significant difference in the odds of subsequent IUP in patients after MTX compared with those after salpingectomy (OR = 2.11, 95% CI: 1.52-2.93). No significant difference was found in the odds of REP between the 2 groups (OR = 0.98, 95% CI: 0.57-1.71). There was a significant difference in the odds of subsequent IUP between patients who underwent salpingostomy and those who underwent salpingectomy (OR = 1.61, 95% CI: 1.29-2.01). No significant difference was found in the odds of REP between the 2 groups (OR = 1.21, 95% CI: 0.62-2.37). There was no significant difference in the odds of subsequent IUP and REP in patients after MTX compared with those after expectant treatment (OR = 1.25, 95% CI: 0.64-2.45; OR = 0.69, 95% CI: 0.09-5.55). Conclusion(s): For hemodynamically stable tubal EP patients, MTX has advantages over surgery, particularly salpingectomy, in improving natural pregnancy outcomes. However, MTX is not inferior to salpingostomy and expectant treatment.Copyright © 2020 American Heart Association, Inc.

Hao, J., et al. (2024). "Pelvic floor muscle training in telerehabilitation: a systematic review and meta-analysis." Archives of Gynecology and Obstetrics.
	PURPOSE: This systematic review aims to identify, critically appraise, and summarize current evidence regarding the feasibility and efficacy of pelvic floor muscle training in telerehabilitation. METHODS: Three bibliographic databases, PubMed, Embase, and Scopus were searched from inception to October 1, 2023. Clinical trials assessing the feasibility and efficacy of pelvic floor muscle training in telerehabilitation were eligible for inclusion. The Physiotherapy Evidence Database scale and National Institutes of Health Study Quality Assessment Tool were used for methodological quality assessment. Study selection, data extraction, and quality assessment were completed by two independent reviewers. Meta-analyses were performed to determine the effects of pelvic floor muscle training in telerehabilitation. RESULTS: Five randomized controlled trials and three single cohort clinical trials were included in this review. Four studies were evaluated as good quality, and four as fair. Pelvic floor telerehabilitation was well tolerated and demonstrated good patient compliance and satisfaction. Pooled analysis indicated significant effects of pelvic floor telerehabilitation on the severity of urinary incontinence with a large effect size, pelvic floor muscle strength with a large effect size, and quality of life with a medium effect size. CONCLUSION: This systematic review demonstrates that pelvic floor muscle training in telerehabilitation is a feasible and effective approach and highlights its efficacy in patients with urinary incontinence. This review supports the application of pelvic floor muscle training in telerehabilitation and informs further clinical and research endeavors to incorporate digital health technologies in managing pelvic floor dysfunction.

Hao, J., et al. (2021). "Direct comparisons of efficacy and safety between actinomycin-D and methotrexate in women with low-risk gestational trophoblastic neoplasia: a meta-analysis of randomized and high-quality non-randomized studies." BMC Cancer 21(1): 1122.
	Background: Actinomycin-D (Act-D) and Methotrexate (MTX) are both effective first-line agents for low-risk gestational trophoblastic neoplasia (LRGTN) with no consensus regarding which is more effective or less toxic. The primary objective of this meta-analysis is to compare Act-D with MTX in the treatment of LRGTN. Method(s): We systematically searched electronic databases, conferences abstracts and trial registries for randomized controlled trials (RCTs) and high-quality non-randamized controlled trials (non-RCTs), comparing Act-D with MTX for patients with LRGTN. Studies were full-text screened for quality assessment and data extraction. Eligible studies must have reported complete remission rate. A fixed-effects meta-analysis was conducted to quantify the efficacy and safety of Act-D and MTX on odds ratios (ORs) and 95% confidence intervals (95%CIs), respectively. Result(s): A total of 8 RCTs and 9 non-RCTs (1674 patients) were included. In terms of efficacy, Act-D is superior to MTX in complete remission (80.2% [551/687] vs 65.1% [643/987]; OR 2.15, 95%CI 1.70 to 2.73). In the stratified analysis, patients from RCTs and non-RCTs both had a better complete remission from Act-D-based regimen (RCTs: 81.2% [259/319] vs 66.1% [199/301], OR 2.17, 95%CI 1.49 to 3.16; non-RCTs: 79.3% [292/368] vs 65.0% [444/686], OR 2.14, 95%CI 1.57 to 2.92). In terms of safety, patients receiving Act-D had higher risks of suffering nausea (OR 2.35, 95%CI 1.68 to 3.27), vomiting (OR 2.40, 95%CI 1.63 to 3.54), and alopecia (OR 2.76, 95%CI 1.60 to 4.75). Notably, liver toxicity (OR 0.38, 95%CI 0.19 to 0.76) was the only one that was conformed to have a higher risk for patients receiving MTX. In addition, the pooled results showed no significant difference of anaemia, leucocytopenia, neutropenia, thrombocytopnia, constipation, diarrhea, anorexia, and fatigue between Act-D and MTX. Conclusion(s): Our meta-analysis suggests that Act-D had better efficacy profile in general, and MTX had less toxicities in LRGTN. Future clinical trials should be better orchestrated to provide more valid data on efficacy and toxicity.Copyright © 2021, The Author(s).

Haouzi, D., et al. (2021). "Customized Frozen Embryo Transfer after Identification of the Receptivity Window with a Transcriptomic Approach Improves the Implantation and Live Birth Rates in Patients with Repeated Implantation Failure." Reproductive sciences (Thousand Oaks, Calif.) 28(1): 69-78.
	The aim of this prospective study was to evaluate outcome benefits expected in repeated implantation failure (RIF) patients (n = 217) after customized embryo transfer based upon identification of the receptivity window by transcriptomic approach using the Win-Test. In this test, the expression of 11 endometrial genes known to be predictive of endometrial receptivity is assessed by RT-PCR in biopsies collected during the implantation window (6-9 days after the spontaneous luteinizing hormone surge during natural cycles, 5-9 days after progesterone administration during hormone replacement therapy cycles). Then, patients underwent either customized embryo transfer (cET, n = 157 patients) according to the Win-Test results or embryo transfer according to the classical procedure (control group, n = 60). Pregnancy and live birth rates were compared in the two groups. The Win-Test showed that in 78.5% of women, the receptivity window lasted less than 48 h, although it could be shorter (< 24 h, 9.5%) or longer (> 48 h, 12%). This highlighted that only in 20% of patients with RIF the endometrium would have been receptive if the classical embryo transfer protocol was followed. In the other 80% of patients, the receptivity window was delayed by 1-3 days relative to the classical timing. This suggests that implantation failure could be linked to inadequate timing of embryo transfer. In agreement, both implantation (22.7% vs. 7.2%) and live birth rates per patient (31.8% vs. 8.3%) were significantly higher in the cET group than in the control group. cET on the basis of the Win-Test results could be proposed to improve pregnancy and live birth rates.ClinicalTrials.gov ID: NCT04192396; December 5, 2019, retrospectively registered.

Hardesty Melissa, M., et al. (2022). "OVARIO phase II trial of combination niraparib plus bevacizumab maintenance therapy in advanced ovarian cancer following first-line platinum-based chemotherapy with bevacizumab." Gynecologic Oncology 166(2): 219-229.
	Objective: To assess safety and efficacy of niraparib + bevacizumab as a first-line maintenance therapy for patients with newly diagnosed advanced ovarian cancer.; Methods: This multicenter, phase II, single-arm, open-label study enrolled adult patients with stage IIIB to IV ovarian, fallopian tube, or primary peritoneal cancer (NCT03326193). Patients were required to have an attempt at debulking surgery and have a complete response, partial response, or no evidence of disease following first-line, platinum-based chemotherapy with ≥3 cycles of bevacizumab. The primary endpoint was the progression-free survival (PFS) rate at 18 months. Secondary endpoints included PFS, overall survival, and safety.; Results: Among the 105 evaluable patients, the PFS rate at 18 months was 62% (95% CI 52-71%) in the overall population and 76% (95% CI 61-87) in the homologous recombination deficient (HRd), 47% (95% CI 31-64%) in the HR proficient (HRp), and 56% (95% CI 31-79%) in the HR not determined (HRnd) subgroups (December 24, 2020, cutoff). After a median follow-up time of 28.7 months (IQR, 23.9-32.5 months), median PFS was 19.6 months (95% CI 16.5-25.1) in the overall population (N = 105) and 28.3 months (95% CI 19.9-NE), 14.2 months (95% CI 8.6-16.8), and 12.1 months (95% CI 8.0-NE) in the HRd, HRp, and HRnd subgroups, respectively (June 16, 2021, cutoff). The most common any-grade treatment-related adverse events (related to niraparib and/or bevacizumab) were thrombocytopenia (74/105), fatigue (60/105), and anemia (55/105; December 24, 2020, cutoff).; Conclusion: Niraparib + bevacizumab first-line maintenance therapy displayed promising PFS results. Safety was consistent with the known safety profiles of niraparib and bevacizumab as monotherapy.; Competing Interests: Declaration of Competing Interest MMH reports honoraria from Clinical Care Operations and GlaxoSmithKline; and advisory board fees from AstraZeneca-Merck, Immunogen and GlaxoSmithKline. TCK reports consulting and speakers' bureau fees from GlaxoSmithKline. GSW reports she served as PI for a clinical trial for which the institute received payment for conducting the trial from Abbvie, Astellas, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Cascadian Therapeutics, Celgene, Celldex Therapeutics, Daiichi Sankyo Pharma, Dana Farber Cancer Institute, G1Therapeutics, Genentech, H3BioMedicine Inc., Hoffmann-LaRoche, ImmunoGen, Incyte, Innocrin Pharm, Jansen, Lilly, Macrogenics, Medivation, Merrimack, NanoString Technologies, Novartis, Nucana, Odonate Therapeutics, Pfizer, Seattle Genetics, Sermonix Pharm, Taiho Oncology, and Tesaro. EH reports institutional research grant from Tesaro/GSK, Abbvie, Acerta Pharma, ADC Therapeutics, AKESOBIO Australia, Amgen, Aravive, ArQule, Arvinas, AtlasMedX, Black Diamond, Boehringer Ingelheim, Clovis, Compugen, Curis, CytomX, Dana Farber Cancer Inst, Deciphera, eFFECTOR Therapeutics, Ellipses Pharma, EMD Serono, Fochon, FujiFilm, G1 Therapeutics, H3 Biomedicine, Harpoon, Hutchinson MediPharma, Immunogen, Immunomedics, Incyte, InvestisBio, Jacobio, Karyopharm, Leap Therapeutics, Lilly, Lycera, Mabspace Biosciences, Macrogenics, MedImmune, Merck, Mersana, Merus, Millenium, Molecular Templates, Myraid Genetic Labs, Novartis, Nucana, Olema, OncoMed, Onconova Therapeutics, ORIC Pharmaceuticals, Orinove, Pfizer, PharmaMar, Pieris Pharmaceuticals, Pionyr Immunotherapeutics, Plexxikon, Radius Health, Regeneron, Repertoire Immune Medicine, Rgenix, Roche/Genentech, SeaGen, Sermonix Pharmaceuticals, Shattuck Labs, Silverback, StemCentRx, Sutro, Syndax, Syros, Taiho, TapImmune, Treadwell Therapeutics, Verastem, Vincerx Pharma, Zenith Epigenetics, Zymeworks and institional consulting fees from Arcus, Arvinas, Black Diamond, Boehringer Ingelheim, CytomX, Dantari, Deciphera Pharmaceuticals, Eisai, H3 Biomedicine, iTeos, Janssen, Lilly, Loxo, Merck, Mersana, Novartis, Pfizer, Puma Biotechnology, Relay Therapeutics, Roche/Genentech, SeaGen, Silverback Therapeutics. ELF has nothing to disclose. JB is an employee of GlaxoSmithKline. EKK is a fo mer employee of GlaxoSmithKline and reports stock and stock option ownership at the time of GSK employment. PW is an employee of GlaxoSmithKline. DG is an employee of GlaxoSmithKline. AC reports consulting fees from Tempus and advisory board fees from GlaxoSmithKline. HJG has nothing to disclose. GEK reports speaker bureau fees from AstraZeneca, Clovis, GlaxoSmithKline/Tesaro, and Myriad Genetics. RGM reports personal fees from Fujirebio Diagnostics Inc., and Humphries Pharmaceutical; and institutional grants from Angle Plc. DLR reports research contracts paid to her institution from Aravive, Arch Oncology, Celsion, Clovis, Deciphera, Fujifilm, GlaxoSmithKline, Harpoon, Karyopharm, Mersana, Plexxikon, Roche, Shattuck Labs, Syros, and Tesaro; honoraria fees from GOG Foundation; travel support from Tesaro; advisory board fees from AstraZeneca, Bayer, Deciphera, Foundation Medicine, Genentech, Mersana, and Tesaro/GlaxoSmithKline; and unpaid leadership as the vice chair of board of directors for National Ovarian Cancer Coalition. (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Harendarczyk, L., et al. (2020). "[Impact of hysterectomy on urinary incontinence: A systematic review]." Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie.
	INTRODUCTION: The impact of a hysterectomy on urinary incontinence is a controversial subject in the literature. OBJECTIVE: To evaluate the prevalence and incidence of urinary incontinence after a hysterectomy as well as associated risk factors such as the type of hysterectomy, the surgical approach, urodynamic criteria and uterine disease. STUDY DESIGN: We conducted a systematic review in Pubmed database with the following keywords and MeSH term: hysterectomy, urinary incontinence. RESULTS: A total of 1340 articles were retrieved, 42 articles were selected for the final text analysis. The results of the different studies were heterogeneous. Hysterectomy seemed to increase the rate of sphincter deficiency (VLPP<60mmH2O for 20% of cases versus 1,7% without hysterectomy, P=0.003). The vaginal route could increase the incidence of UI with OR of 2.3 (95%CI 1.0-5.2). Subtotal hysterectomy appears to increase UI with a 0,74 RR for total hysterectomy (95%CI 0.58-0.94). A radical hysterectomy with nerve conservation would preserve urinary functions, unlike pelvic radiotherapy, which is responsible for irreversible nerve damage by demyelination and bladder fibrosis.

Harjee, R., et al. (2021). "Reproductive outcomes following surgical management for isthmoceles: A systematic review." Journal of Minimally Invasive Gynecology 28(7): 1291-1302.e1292.
	OBJECTIVE: To evaluate the efficacy of surgical management for isthmoceles in patients presenting with secondary infertility. DATA SOURCES: A systematic search was performed in MEDLINE, EMBASE and Cochrane Library databases from inception to May 2020. The search was limited to studies published in English. METHODS OF STUDY SELECTION: After the removal of duplicates, 3380 articles were screened for inclusion independently by two authors for studies. These two authors assessed for studies which focussed on reproductive aged women with a diagnosed isthmocele and secondary infertility who underwent any surgical intervention for defect repair with at least one of the goals being fertility restoration. TABULATION, INTEGRATION, AND RESULTS: 13 studies, comprised of 1 randomized controlled trial (RCT), 6 prospective case series and 6 retrospective case series describing 234 patients who underwent surgical management for an isthmocele and secondary infertility were included. The methodological quality of the included studies was assessed independently by both reviewers. Next, the data extraction was performed independently and then compared to ensure no discrepancies. 188 patients were treated by hysteroscopy, 36 by laparoscopy, 7 by laparotomy, and 3 through a vaginal approach. In total, 153 of the 234 patients (65.4%) achieved pregnancy across all studies within their respective study periods.. Pregnancy rates in the RCT were 21/28 (75%) for those treated via hysteroscopy compared to 9/28 (32%) for those untreated. Among studies reporting pregnancy outcomes, 101/116 (87.1%) pregnancies resulted in a live birth. The incidence of adverse events was 2%, including risk of reoperation. CONCLUSION: The results of this systematic review suggest that surgical treatment of isthmocele, particularly via hysteroscopy in patients with residual myometrial thickness (RMT) of at least 2.5mm, may be effective in treating isthmocele-associated secondary infertility with a relatively low complication rate. Further high-quality studies are needed due to the small sample sizes and observational nature of most available data.

Harris, E. (2023). "Nonhormone Treatment for Menopausal Hot Flashes Receives FDA Approval." JAMA 329(22): 1907.
	
Harris, M. L., et al. (2022). "Contraceptive use and contraceptive counselling interventions for women of reproductive age with cancer: a systematic review and meta-analysis." BMC Medicine 20(1): 489.
	Background: A lack of clarity exists regarding contraceptive uptake and counselling among women with cancer, despite these women having unique family planning needs. This study aimed to systematically review the available literature and produce an overall summary estimate of contraceptive use and counselling among women with cancer across the cancer care continuum. Method(s): A systematic search of articles reporting on contraceptive counselling and/or contraceptive use among women of reproductive age (15-49 years) with cancer across the cancer care continuum (e.g. diagnosis, treatment, survivorship) was conducted in MEDLINE, Embase, CINAHL, Maternity and Infant Care and Cochrane Library. Two independent reviewers conducted the data screening, data extraction and risk of bias assessment. Qualitative synthesis and meta-analyses were conducted to summarise the key findings. Result(s): We included 21 articles involving 3835 participants in this review. Studies varied according to the cancer population and time along the cancer care continuum it was assessed. Of the studies that reported the overall contraceptive prevalence among women diagnosed with cancer (n = 8), contraceptive use ranged from 25 to 92%. Of the four studies that focused on cancer survivors, the contraceptive prevalence ranged from 47 to 84%. When the prevalence of these studies was pooled, a crude summary prevalence of 64% (62% among women with cancer versus 68% among cancer survivors) was found. The rate of contraceptive counselling was assessed in ten studies. A pooled prevalence of 50% (44% among women with cancer versus 58% among cancer survivors) was found, with the prevalence ranging from 12 to 78% among individual studies depending on the point in the cancer care continuum that it was provided. When contraceptive counselling was provided, it was found to significantly increase contraceptive use although biases were identified in its application. Conclusion(s): Contraceptive counselling interventions as part of standard cancer care have the potential to not only empower women with cancer and cancer survivors to make informed choices regarding their reproductive health but also provide the ability to plan future pregnancies for times of better health.Copyright © 2022, The Author(s).

Harris, W. S., et al. (2021). "Effects of menopausal hormone therapy on erythrocyte n-3 and n-6 PUFA concentrations in the Women's Health Initiative randomized trial." American journal of clinical nutrition 113(6): 1700‐1706.
	BACKGROUND: The factors other than dietary intake that determine tissue concentrations of EPA and DHA remain obscure. Prior studies suggested that, in women, endogenous estrogen may accelerate synthesis of DHA from ɑ‐linolenic acid (ALA), but the effects of exogenous estrogen on RBC n‐3 (ɷ‐3) PUFA concentrations are unknown. OBJECTIVE: We tested the hypothesis that menopausal hormone therapy (HT) would increase RBC n‐3 PUFA concentrations. METHODS: Postmenopausal women (ages 50‐79 y) were assigned to HT or placebo in the Women's Health Initiative (WHI) randomized trial. The present analyses included a subset of 1170 women (ages 65‐79 y) who had RBC PUFA concentrations measured at baseline and at 1 y as participants in the WHI Memory Study. HT included conjugated equine estrogens (E) alone for women without a uterus (n = 560) and E plus medroxyprogesterone acetate (P) for those with an intact uterus (n = 610). RBC n‐3 and n‐6 (ɷ‐6) PUFAs were quantified. RESULTS: Effects of E alone and E+P on PUFA profiles were similar and were thus combined in the analyses. Relative to the changes in the placebo group after 1 y of HT, docosapentaenoic acid (DPA; n‐3) concentrations decreased by 10% (95% CI: 7.3%, 12.5%), whereas DHA increased by 11% (95% CI: 7.4%, 13.9%) in the HT group. Like DHA, DPA n‐6 increased by 13% from baseline (95% CI: 10.0%, 20.3%), whereas linoleic acid decreased by 2.0% (95% CI: 1.0%, 4.1%; P values at least <0.01 for all). EPA and arachidonic acid concentrations were unchanged. CONCLUSIONS: HT increased RBC concentrations of the terminal n‐3 and n‐6 PUFAs (DHA and DPA n‐6). These findings are consistent with an estrogen‐induced increase in DHA and DPA n‐6 synthesis, which is consistent with an upregulation of fatty acid elongases and/or desaturases in the PUFA synthetic pathway. The clinical implications of these changes require further study. The Women's Health Initiative Memory Study is registered at clinicaltrials.gov as NCT00685009. Note that the data presented here were not planned as part of the original trial, and therefore are to be considered exploratory.

Harrison, R. F., et al. (2021). "Cost-effectiveness of laparoscopic disease assessment in patients with newly diagnosed advanced ovarian cancer." Gynecologic Oncology 161(1): 56-62.
	Objective: To determine if laparoscopy is a cost-effective way to assess disease resectability in patients with newly diagnosed advanced ovarian cancer. Method(s): A cost-effectiveness analysis from a health care payer perspective was performed comparing two strategies: (1) a standard evaluation strategy, where a conventional approach to treatment planning was used to assign patients to either primary cytoreduction (PCS) or neoadjuvant chemotherapy with interval cytoreduction (NACT), and (2) a laparoscopy strategy, where patients considered candidates for PCS would undergo laparoscopy to triage between PCS or NACT based on the laparoscopy-predicted likelihood of complete gross resection. A microsimulation model was developed that included diagnostic work-up, surgical and adjuvant treatment, perioperative complications, and progression-free survival (PFS). Model parameters were derived from the literature and our published data. Effectiveness was defined in quality-adjusted PFS years. Results were tested with deterministic and probabilistic sensitivity analysis (PSA). The willingness-to-pay (WTP) threshold was set at $50,000 per year of quality-adjusted PFS. Result(s): The laparoscopy strategy led to additional costs (average additional cost $7034) but was also more effective (average 4.1 months of additional quality-adjusted PFS). The incremental cost-effectiveness ratio (ICER) of laparoscopy was $20,376 per additional year of quality-adjusted PFS. The laparoscopy strategy remained cost-effective even as the cost added by laparoscopy increased. The benefit of laparoscopy was influenced by mitigation of serious complications and their associated costs. The laparoscopy strategy was cost-effective across a range of WTP thresholds. Conclusion(s): Performing laparoscopy is a cost-effective way to improve primary treatment planning for patients with untreated advanced ovarian cancer.Copyright © 2021 Elsevier Inc.

Harrison, T. N. H. and R. J. Chang (2022). "Ovarian response to follicle-stimulating hormone in women with polycystic ovary syndrome is diminished compared to ovulatory controls." Clinical Endocrinology 97(3): 310-318.
	Objective: The mechanisms underlying ovarian dysfunction in polycystic ovary syndrome (PCOS) have not been definitively established. Our objective was to perform a detailed examination of ovarian responses to recombinant follicle-stimulating hormone (rFSH) in women with PCOS and controls. Design(s): This prospective, crossover, dose-response study included three rFSH stimulation periods. Each stimulation period involved three consecutive, daily, subcutaneous injections of rFSH administered at a single dose. Low, medium and high rFSH doses were weight-adjusted, corresponding to 0.5, 1.1 and 2.2 IU/kg/d, respectively. Stimulation periods occurred in randomized order and were separated by 8-week washouts. Patient(s): Thirty participants (8 PCOS and 22 controls) were studied. PCOS was defined by oligomenorrhea and clinical or biochemical androgen excess, excluding other aetiologies of ovulatory dysfunction. Measurements: Blood samples were obtained for hormone measurements before and 24 h after each rFSH injection. Result(s): Participants with PCOS had significantly greater body mass index, antral follicle count and circulating testosterone, anti-mullerian hormone (AMH) and luteinizing hormone concentrations compared with controls participants. Baseline estradiol (E2) concentrations were similar in both groups. At the lowest dose of rFSH, PCOS participants did not demonstrate E2 increments, whereas a significant increase occurred in controls. rFSH-induced E2 production per follicle was significantly reduced in PCOS participants compared with controls at all rFSH doses. Increasing T and decreasing AMH concentrations were associated with augmented E2 production per follicle. CoONCLUSIONS: Women with PCOS exhibited diminished initial E2 responses to rFSH compared with controls. These findings suggest that the mechanism of anovulation in PCOS may involve altered ovarian response to gonadotropins.Copyright © 2022 John Wiley & Sons Ltd.

Harter, P., et al. (2022). "Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer." Obstetrical and Gynecological Survey 77(4): 216-218.
	(Abstracted from N Engl J Med 2021;385:2123–2131) Standard of care treatment for advanced ovarian cancer involves primary macroscopic resection of all tumor followed by platinum-based combination chemotherapy with or without additional systemic therapy including bevacizumab or a poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor. The Descriptive Evaluation of Preoperative Selection Criteria for Operability in Recurrent Ovarian Cancer (DESKTOP) series aims to assess the role of surgery in management of recurrent ovarian cancer.

Harter, P., et al. (2023). "Durvalumab with paclitaxel/carboplatin (PC) and bevacizumab (bev), followed by maintenance durvalumab, bev, and olaparib in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumor BRCA1/2 mutation (non-tBRCAm): Results from the randomized, placebo (pbo)-controlled phase III DUO-O trial." Journal of Clinical Oncology 41(17 Supplement).
	Background: Olaparib (ola) maintenance (mtx) improved outcomes in pts with newly diagnosed AOC and a BRCAm (DiSilvestro J Clin Oncol 2023;41:609-17) or with bev in pts with homologous recombination deficiency (HRD+) tumors (Ray-Coquard Ann Oncol 2022: LBA29) in response to 1L treatment, but an unmet need remains. Combining an immune checkpoint inhibitor with an antiangiogenic agent and a PARP inhibitor may enhance antitumor effect (Banerjee Ann Oncol 2022: 529MO). The Phase III DUO-O trial (NCT03737643) evaluates PC + bev + durva, followed by mtx bev + durva + ola, in pts with non-tBRCAm AOC in the 1L setting. Method(s): Pts had newly diagnosed FIGO stage III or IV, high-grade epithelial, non-tBRCAm AOC and had completed upfront, or were planned to receive interval, debulking surgery and 1 cycle of PC 6 bev. At Cycle 2, pts were randomized 1:1:1 to Arm 1: PC + bev (15 mg/kg IV q3w) + durva pbo (up to 6 cycles) followed by mtx bev (15 mg/kg IV q3w; total 15 months [mo]) + durva pbo (total 24 mo) + ola pbo (total 24 mo); Arm 2: PC + bev + durva (1120 mg IV q3w) followed by mtx bev + durva (1120 mg IV q3w) + ola pbo; or Arm 3: PC + bev + durva followed by mtx bev + durva + ola (300 mg bid tablets). The primary endpoint, progression-free survival (PFS; modified RECIST 1.1 per investigator) in Arm 3 vs Arm 1, was tested first in the non-tBRCAm HRD+ population (GIS $42, Myriad MyChoice CDx) and then the intent-to-treat (ITT) population. Result(s): 1130 pts were randomized: 378 Arm 1, 374 Arm 2, and 378 Arm 3. At a prespecified interim analysis (DCO Dec 5, 2022), a statistically significant improvement in PFS was observed for Arm 3 vs Arm 1: HR 0.49 (95% CI 0.34-0.69; P,0.0001) and HR 0.63 (95% CI 0.52-0.76; P,0.0001) in the HRD+ and ITT populations, respectively; a consistent PFS effect was observed in the HRDsubgroup (HR 0.68, 95% CI 0.54-0.86). A numerical improvement in PFS was shown for Arm 2 vs Arm 1 (ITT population), but statistical significance was not reached (Table). During the study, any serious adverse events were reported in 34%, 43% and 39% of pts in Arms 1, 2 and 3, respectively. Conclusion(s): PC + bev + durva followed by mtx bev + durva + ola in pts with newly diagnosed non-tBRCAm AOC resulted in a statistically significant and clinically meaningful improvement in PFS vs PC + bev followed by mtx bev. Safety was generally consistent with the known profiles of each agent.

Hartner, G., et al. (2023). "The latest advances in the pharmacological management of endometriosis." Expert Opinion on Pharmacotherapy 24(1): 121-133.
	Introduction: Endometriosis is a benign disease, characterized by a wide range of symptoms and different degrees of severity, which is why therapy should be individually adapted to the patient's needs. Over the years, a lot of research has gone into finding new therapeutic approaches for this enigmatic disease.; Areas Covered: This review presents the latest advances in pharmacological management of endometriosis and is solely focused on studies published from 2010 to 2021.; Expert Opinion: Clinicians and researchers are constantly searching for new therapeutic strategies for endometriosis patients. As there are well-established treatments, however, any new medication should fulfill at least one of the three criteria: increased efficacy, comparable efficacy but a better safety profile, or treatments that have a lack of accompanying contraceptive effects that are seen in most endometriosis treatments. While some new substances show promising results, further studies are needed to demonstrate the fulfillment of one of the above-mentioned criteria.

Harvey, R. E., et al. (2022). "Impact of Estrogen Dosing on Cardiovascular Disease Risk Parameters in Women Experiencing Early Menopause due to Bilateral Oophorectomy." Menopause 29(12): 1450.
	Objective: Women who undergo early menopause (prior to age 46 years) secondary to bilateral oophorectomy experience an abrupt decrease in estrogen and other ovarian hormones, which is associated with an increased risk of cardiovascular disease (CVD). Administration of estrogen therapy (ET) given until the average age of natural menopause partially mitigates this risk. However, it is unclear whether standard dose ET, which is typically titrated to relieve vasomotor symptoms, is adequate to protect against development of CVD. It is not known whether ET titrated to a goal estradiol level characteristic of premenopausal women, performs better with respect to CVD risk reduction. The goal of this study was to compare the effect of standard dose ET versus ET titrated to premenopausal estradiol levels on blood pressure and subclinical CVD risk parameters in women experiencing early menopause due to bilateral oophorectomy. Design(s): We conducted a randomized, open-label trial to study 15 women who underwent bilateral oophorectomy prior to age 46 years. Eight women were treated with standard dose ET that was adjusted to manage their vasomotor symptoms (typically 2 mg oral estradiol or 100 mcg estradiol patch daily); and the other 7 were treated with titrated ET with a goal estradiol of 80-120 pg/ml (the average estradiol level in a premenopausal woman), irrespective of their symptoms. All participants were studied at baseline, and then at 6 and 12 months after the bilateral oophorectomy. At each time point, we assessed peripheral blood pressure and subclinical parameters of CVD (arterial stiffness and blood pressure reactivity to isometric handgrip and cold stress). Result(s): Women who were treated with standard dose ET and women treated with titrated ET did not differ in age (39+/-5 vs. 39+/-5 years, respectively; p=0.89). Serum estradiol levels did not change across time (baseline, 6-months, and 12-months); however, serum estradiol levels were lower in women receiving standard dose ET (69.3+/-46.7, 52.9+/-32.5, and 81.6+/-16.4 pg/mL, across time respectively) compared to women receiving titrated ET (98.0+/-45.0, 179.4+/-81.1, and 146.9+/-105.1 pg/mL, across time respectively; group effect p=0.005, time effect p=0.20, interaction p=0.058). Systolic blood pressure did not differ across time or between the two groups: standard group: 120+/-10, 115+/-8, and 114+/-14 mmHg; titrated group: 127+/-15, 122+/-19, and 133+/-18 mmHg (group effect p=0.09, time effect p=0.35, interaction p=0.17). Diastolic blood pressure also did not differ: standard group: 77+/-5, 71+/-5, and 71+/-8 mmHg; titrated group: 80+/-8, 76+/-12, and 84+/-16 mmHg (group effect p=0.12, time effect p=0.07, interaction p=0.07). Arterial stiffness (group effect p=0.54, time effect p=0.29, interaction p=0.94), blood pressure reactivity to isometric handgrip (group effect p=0.47, time effect p=0.86, interaction p=0.20), and blood pressure reactivity to cold stress (group effect p=0.68, time effect p=0.57, interaction p=0.50) did not differ across time or between groups. Conclusion(s): In women experiencing early menopause due to bilateral oophorectomy prior to the age of 46 years, standard dose ET, adjusted to manage vasomotor symptoms, resulted in lower estradiol levels than titrated ET, which resulted in estradiol levels characteristic of the premenopausal stage. Despite the differences in estradiol levels, blood pressure, arterial stiffness, and blood pressure reactivity to isometric handgrip and cold stress were not different in the two ET groups. This could either signify a lack of effect of estradiol dose and level on these parameters, or this could be a result of the short duration of study. Differences in the CVD risk parameters may become apparent in the standard dose ET versus titrated ET group with a longer duration of comparison.

Hasegawa, H., et al. (2021). "Gonadotroph Pituitary Adenoma Causing Treatable Infertility and Ovarian Hyperstimulation Syndrome in Female Patients: Neurosurgical, Endocrinologic, Gynecologic, and Reproductive Outcomes." World neurosurgery 150: e162-e175.
	Background: Gonadotroph pituitary adenoma (Gn-PA) may rarely cause ovarian hyperstimulation syndrome, leading to infertility in women, although this remains poorly described.; Methods: We present a quantitative systematic review including 2 patients from our institutional and 48 from the literature with Gn-PA causing ovarian hyperstimulation syndrome to thoroughly describe the clinical features and therapeutic outcomes from multidisciplinary aspects.; Results: The patients had a mean age of 31.5 years and a mean follicle-stimulating hormone level of 14.4 IU/L. Estradiol level was high in 82% of patients, at >350 pg/mL. The mean maximal adenoma diameter was 22 mm, with a Knosp grade ≥3 in 10 patients. Abdominal surgery preceded adenoma resection in 24 patients (48%). Among 25 patients for whom extent of resection was recorded, total adenoma resection was achieved in 12. Through a mean follow-up of 25 months, adenoma recurrence was observed in 5 patients, who were treated with re-resection (n = 2), radiation (n = 2), and medical therapy followed by bilateral oophorectomy (n = 1). Medical therapies were partially effective or ineffective, and adenoma shrinkage did not follow; gonadotropin-releasing hormone agonists/antagonists were partially effective in 20% of patients (2/10), dopamine agonists in 44% (8/18), and somatostatin analogues in 50% (1/2). Four experienced swelling of tumor/ovaries after gonadotropin-releasing hormone agonists/antagonists administration. Overall, chemical remission was obtained in 26 of 28 patients, normalization of ovaries in 25 of 27, and successful pregnancy in 12 of 14.; Conclusions: Adenoma resection is the main treatment, leading to reduction in ovarian size and biochemical remission, with a high likelihood of subsequent spontaneous pregnancy. Increased awareness of this rare condition may help avoid unnecessary abdominal procedures. (Copyright © 2021 Elsevier Inc. All rights reserved.)

Hashim, H. A., et al. (2023). "Retraction Note: laparoscopic ovarian diathermy after clomiphene failure in polycystic ovary syndrome: is it worthwhile? A randomized controlled trial [Retraction notice for CN-00835360]." Archives of Gynecology and Obstetrics 307(5): 1661.
	The Editor‐in‐Chief has retracted this article. The study reported in this article was included as part of the PhD thesis of Hatem Abu Hashim entitled “Ovulation induction in polycystic ovary syndrome (PCOS): An appraisal of different strategies” submitted to Vrije Universiteit Brussel (VUB) in 2013. In 2020 [1] serious concerns were raised about the data reported and Hatem Abu Hashim responded [2]. An investigation by VUB was followed by a request for Second Advice from the Flemish Commission for Research Integrity (VCWI). The investigations by VUB and the VCWI concluded that there had been serious violations of scientific integrity including fabrication, and recommended retraction. Hatem Abu Hashim does not agree with this retraction and has provided a copy of their submission to the VUB and VCWI investigations to the Editor‐in‐Chief. None of the other authors has responded to correspondence from the Publisher about this retraction.

Hassan, F., et al. (2023). "Neurokinin 1/3 receptor antagonists for menopausal women: A current systematic review and insights into the investigational non-hormonal therapy." Medicine 102(23): e33978.
	Background: Over 75% of menopausal women experience vasomotor symptoms (VMS), such as night sweats and hot flashes. Despite the prevalence of these symptoms, there is limited data on non-hormonal therapies to alleviate them.; Methods: PubMed, Cochrane, Scopus, Ovid, Web of Science, and ClinicalTrials.Gov were searched for relevant studies. The search was performed using the following keywords, which were customized to suit the specific databases/registers: menopause, women, neurokinin 3, and/or Fezolinetant. The search was conducted until December 20, 2022. This systematic review was conducted in compliance with the PRISMA Statement 2020 guidelines.; Results: A total of 326 records were found, with 10 studies (enrolling 1993 women) selected for inclusion. The women received 40-mg doses of NK1/3 receptor antagonists twice daily, with follow-ups at 1 to 3 weeks. Moderately strong evidence was found suggesting that NK1/3 receptor antagonists can help limit the frequency and severity of hot flashes in menopausal women.; Conclusion: While the results should be interpreted with caution until further clinical trials validate the efficacy and safety of NK1/3 receptor antagonists among menopausal women, these findings suggest that they are promising targets for future pharmacological and clinical studies in addressing vasomotor symptoms.; Competing Interests: The authors have no funding and conflicts of interest to disclose. (Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.)

Hassan, H., et al. (2024). "Long-term outcomes of hysterectomy with bilateral salpingo-oophorectomy: a systematic review and meta-analysis." American Journal of Obstetrics and Gynecology 230(1): 44-57.
	Objective: This study aimed to provide an up-to-date systematic review of "the long-term outcomes of bilateral salpingo-oophorectomy at the time of hysterectomy" and perform a meta-analysis for the reported associations.; Data Sources: Our study updated a previous systematic review by searching the literature using PubMed, Web of Science, and Embase for publications between January 2015 and August 2022.; Study Eligibility Criteria: Our study included studies of women who had a hysterectomy with bilateral salpingo-oophorectomy vs women who had a hysterectomy with ovarian conservation or no surgery.; Methods: The quality of the evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations. Adjusted hazard ratios were extracted and combined to obtain fixed effect estimates.; Results: Compared with hysterectomy or no surgery, hysterectomy with bilateral salpingo-oophorectomy in young women was associated with decreased risk of breast cancer (hazard ratio, 0.78; 95% confidence interval, 0.73-0.84) but with an increased risk of colorectal cancer (hazard ratio, 1.27; 95% confidence interval, 1.10-1.47). In addition, it was associated with an increased risk of total cardiovascular diseases, coronary heart disease, and stroke with hazard ratios of 1.18 (95% confidence interval, 1.11-1.25), 1.17 (95% confidence interval, 1.10-1.25), and 1.20 (95% confidence interval, 1.10-1.31), respectively. Compared with no surgery, hysterectomy with bilateral salpingo-oophorectomy before the age of 50 years was associated with an increased risk of hyperlipidemia (hazard ratio, 1.44; 95% confidence interval, 1.25-1.65), diabetes mellitus (hazard ratio, 1.16; 95% confidence interval, 1.09-1.24), hypertension (hazard ratio, 1.13; 95% confidence interval, 1.06-1.20), dementia (hazard ratio, 1.70; 95% confidence interval, 1.07-2.69), and depression (hazard ratio, 1.39; 95% confidence interval, 1.22-1.60). The evidence on the association with all-cause mortality in young women showed substantial heterogeneity between the studies (I 2 =85%; P<.01).; Conclusion: Hysterectomy with bilateral salpingo-oophorectomy was associated with multiple long-term outcomes. The benefits of the addition of bilateral salpingo-oophorectomy to hysterectomy should be balanced against the risks. (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Hassanzadeh, R., et al. (2023). "The effect of fenugreek on the severity of dysmenorrhea: a systematic review and meta-analysis." Current drug research reviews.
	Introduction: Dysmenorrhea is the most common periodic pain, which affects more than 50% of women with regular menstruation. Fenugreek is one of the medicinal plants with analgesic properties. This study aimed to determine the effect of fenugreek application in the severity of dysmenorrhea and its side effects in women with dysmenorrhea. PICO: population: women with dysmenorrhea; intervention: fenugreek; comparison: control groups; and outcome: reduction in the severity of dysmenorrhea and its side effects Methodology: English database (PubMed, Cochrane Library, Scopus, and Web of Science) and Persian database [SID (Scientific Information Database) and Magiran] were used for research until February 11, 2023, using the keywords "Dysmenorrhea [Mesh]," "Foenum [Mesh]," "fenugreek [Mesh]," and "Trigonella [Mesh]." The reference list of the selected articles was also checked. The quality assessment was conducted through the Cochrane Handbook for Systematic Reviews of Interventions version 5.2.0. The RevMan 5.3 software was used to analyze and report the data of the entered studies. Meta-analysis results were reported with the standardized mean difference (95% confidence interval). A subgroup analysis was performed based on the type of control groups. The quality of evidence was assessed using the GRADE approach.; Results: After removing duplicates and ineligible cases, four articles were included in the systematic review out of the 1526 records obtained. The results showed that the pain intensity caused by primary dysmenorrhea decreased with fenugreek compared to placebo (pooled result SMD: -2.21; 95% CI: -3.26 to -1.17; Z: 4.17; P <0.001). There was no significant difference between fenugreek with mefenamic acid (SMD: 0.05; 95% CI: -0.57 to 0.67; Z: 0.17; P = 0.86) and fenugreek with Chandrasura churna (SMD: 0.06; 95% CI: -0.56 to 0.68; Z: 0.19; P = 0.85). Bias, in terms of incomplete outcome data and selective reporting, was low risk in all studies, and the available evidence was low quality according to the GRADE approach.; Conclusion: The results showed that the effect of fenugreek on pain intensity in dysmenorrhea is highly uncertain. The true effect is likely to be substantially different from the estimate of effect. Regarding the importance of the health and quality of life of women of reproductive age and the low quality of evidence of the studies, clinical trials with stronger methodology are suggested in this field. (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Hatfield, E., et al. (2020). "Use of low-dose naltrexone in the management of chronic pain conditions: A systematic review." Journal of the American Dental Association (1939) 151(12): 891.
	Background: The authors aimed to evaluate the efficacy of low-dose naltrexone in the management of chronic pain conditions and determine its potential use in orofacial pain management.; Methods: A comprehensive literature review was completed in the PubMed/MEDLINE, Embase, Cumulated Index to Nursing and Allied Health Literature, Dentistry and Oral Sciences Source Library databases up through June 17, 2019, using terms such as neurogenic, inflammation, naltrexone, temporomandibular, and chronic pain. The primary outcome was reduction in pain intensity and, secondarily, improvement in quality of life.; Results: A total of 793 studies were obtained with the initial search and 8 articles were selected for evaluation. Of these 8 articles, 4 were case reports, 3 were clinical studies, and 1 was a randomized controlled trial. Six studies included data on fibromyalgia, 2 studies included data on chronic regional pain syndrome, and 1 examined multiple diagnoses, including fibromyalgia, interstitial cystitis, and chronic pelvic pain. The primary outcome of all of the studies was pain intensity reduction.; Conclusions and Practical Implications: Low-dose naltrexone provides an alternative in medical management of chronic pain disorders as a novel anti-inflammatory and immunomodulator. It can offer additional management options, as orofacial pain conditions share characteristics with other chronic pain disorders. Owing to the size and heterogeneity of the studies, more large-scale studies are needed, along with additional studies assessing orofacial pain response to low-dose naltrexone. (Copyright © 2020 American Dental Association. Published by Elsevier Inc. All rights reserved.)

Hatırnaz, Ş., et al. (2022). "Oocyte maturation abnormalities - A systematic review of the evidence and mechanisms in a rare but difficult to manage fertility pheneomina." Turkish Journal of Obstetrics and Gynecology 19(1): 60-80.
	A small proportion of infertile women experience repeated oocyte maturation abnormalities (OMAS). OMAS include degenerated and dysmorphic oocytes, empty follicle syndrome, oocyte maturation arrest (OMA), resistant ovary syndrome and maturation defects due to primary ovarian insufficiency. Genetic factors play an important role in OMAS but still need specifications. This review documents the spectrum of OMAS and to evaluate the multiple subtypes classified as OMAS. In this review, readers will be able to understand the oocyte maturation mechanism, gene expression and their regulation that lead to different subtypes of OMAs, and it will discuss the animal and human studies related to OMAS and lastly the treatment options for OMAs. Literature searches using PubMed, MEDLINE, Embase, National Institute for Health and Care Excellence were performed to identify articles written in English focusing on Oocyte Maturation Abnormalities by looking for the following relevant keywords. A search was made with the specified keywords and included books and documents, clinical trials, animal studies, human studies, meta-analysis, randomized controlled trials, reviews, systematic reviews and options written in english. The search detected 3,953 sources published from 1961 to 2021. After title and abstract screening for study type, duplicates and relevancy, 2,914 studies were excluded. The remaining 1,039 records were assessed for eligibility by full-text reading and 886 records were then excluded. Two hundred and twenty seven full-text articles and 0 book chapters from the database were selected for inclusion. Overall, 227 articles, one unpublished and one abstract paper were included in this final review. In this review study, OMAS were classified and extensively evaluatedand possible treatment options under the light of current information, present literature and ongoing studies. Either genetic studies or in vitro maturation studies that will be handled in the future will lead more informations to be reached and may make it possible to obtain pregnancies.

Haussmann, J., et al. (2024). "Premenstrual syndrome and premenstrual dysphoric disorder-Overview on pathophysiology, diagnostics and treatment." Nervenarzt.
	Premenstrual syndrome and premenstrual dysphoric disorder become episodically manifest during the second half of the female menstrual cycle and are characterized by psychological and physical symptoms causing relevant functional and social impairments. Mood swings, depression and dysphoria are associated depressive symptoms. Therefore, affective disorders should be considered as a differential diagnosis. Of women in reproductive age 3-8% suffer from premenstrual syndrome and 2% of women are affected by premenstrual dysphoric disorder. Genetic and sociobiographical risk factors are discussed. Furthermore, genetic polymorphisms of specific hormone receptors are considered to be genetic risk factors. From a pathophysiological perspective premenstrual syndrome and premenstrual dysphoric disorder are caused by a complex interaction between cyclic changes of ovarian steroids and central neurotransmitters. An imbalance of estrogen and progesterone in the luteal phase is believed to cause the symptoms. Therefore, the first treatment approach consists of regulation of the menstrual cycle or luteal support with progesterone or synthetic progestins even if their effectiveness has not yet been proven in randomized controlled studies and meta-analyses. The administration of combined oral contraceptives is also an option. Especially treatment with selective serotonin reuptake inhibitors (SSRI) represent an evidence-based approach. In severe cases the administration of gonadotropin releasing hormone (GnRH) agonists with add back treatment can also be considered. In the field of affective disorders premenstrual syndromes represent clinically relevant differential diagnoses and comorbidities, which confront the treating physician with particular clinical challenges. Therefore, this literature review gives the readership a clinical orientation for dealing with these disorders.Copyright © The Author(s) 2024.

Hawkins Summer, S. (2023). "Screening and the New Treatment for Postpartum Depression." Journal of obstetric, gynecologic, and neonatal nursing : JOGNN 52(6): 429-441.
	In August 2023, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone) as the first oral medication to treat postpartum depression. Despite recommendations to screen and treat depression during pregnancy and after birth, perinatal depression is still considered under-detected and under-treated. In this column, I review screening recommendations and the new pharmacological treatment for postpartum depression, research findings on gaps in the cascade of mental health care, integrative care models, and recommendations from professional organizations on screening and treating postpartum depression within broader systems of mental health care. (Copyright © 2023. Published by Elsevier Inc.)

hazem, s., et al. (2023). "The efficacy of intrauterine infusion of platelet rich plasma in women undergoing assisted reproduction: A systematic review and meta-analysis."
	
Hazimeh, D., et al. (2023). "53 Planned interim analysis of a randomized trial comparing epidural to surgical site infiltration with liposomal bupivacaine for gynecologic oncology patients undergoing laparotomy." Gynecologic Oncology Reports 48(Supplement 1): S27.
	Objectives: Efficacy interim analysis of a randomized trial comparing epidural analgesia (EA) to surgical site infiltration with liposomal bupivacaine (LB) in patients undergoing laparotomy on a gynecologic oncology enhanced recovery after surgery (ERAS) program. This is an investigator-initiated study funded by a research grant from Pacira Biosciences; NCT04117074). Method(s): Patients (n=40) with suspected or known gynecologic cancer and planned for laparotomy were randomized 1:1 to EA or surgical site inifiltration with LB. Participants rated their postoperative pain intensity on a scale of 0 to 10 every 6 hours and immediately before opioid medication. Coprimary enpoints were mean area under the curve (AUC) of visual analog scale (VAS) pain intensity scores and total opioid consumption from 0 to 48 hours postoperatively. The mean AUC of VAS pain intensity scores incorporates opioid consumption. Quality of recovery was assayed daily using the quality of recovery-15 (QoR-15) survey instrument. Two sample t-tests and Wilcoxon rank-sum tests were used to compare the arms. Result(s): Two of 20 patients randomized to EA were found ineligible for enrollment and one withdrew. All patients randomized to surgical site infiltration with LB enrolled. Mean age and BMI were 56+/-14 years and 30.6+/-13.6 kg/m2. The majority had invasive cancer (81%). Participants reported race as White (72.2%), Black (19.4%) and Asian (5.6%). Mean estimated blood loss was 659+/-987 mL and mean duration of surgery was 6.7+/-2.0 hours. Median length of stay was 4 days and did not differ between the two arms. Mean pain intensity scores were similar for EA and LB (mean 3.7 vs 3.9), but total opioid consumption was lower in the LB arm compared to EA (mean IV MME 34.1 vs 48.2). QOR-15 scores on postoperative day 1 and on day of discharge did not differ between the arms (Table 1). One case of dural puncture occured in the EA arm. The incidence of hypotension was similar between the arms; grade 1-2 and grade 3-4 hypotension were observed with EA in 31.3% and 12.5% of cases and in 25% and 10% of patients who received LB. [Formula presented] Conclusion(s): Interim efficacy data suggest that surgical site infiltration with LB may be a valuable alternative to EA for gynecologic oncology patients undergoing laparotomy on ERAS protocols. The trial has exceeded 50% of the accrual goal (n=106) for final analysis.Copyright © 2023 Elsevier Inc.

He, J. and X. Ke (2023). "Efficacy and toxicity of Mirvetuximab Soravtansine in second-line and above treatment of advanced ovarian cancer: a meta-analysis."
	
He, M., et al. (2023). "Effect of resistance training on lipid profile in postmenopausal women: A systematic review and meta-analysis of randomized controlled trials." European Journal of Obstetrics, Gynecology, and Reproductive Biology 288: 18-28.
	Objective: Physical exercise decreases cardiovascular risk and can alter the lipid profile in postmenopausal women. Although it is believed that resistance training can potentially decrease serum lipid levels in postmenopausal females, the evidence remains inconclusive. The aim of this systematic review and meta-analysis of randomized controlled trials (RCTs) was to clarify the impact of resistance training on the lipid profile in postmenopausal women.; Methods: Web of Science, Scopus, PubMed/Medline and Embase were searched. RCTs that evaluated the effect of resistance training on total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglyceride (TG) levels were included in this review. Effect size was estimated using the random effects model. Subgroup analyses based on age, duration of intervention, pre-enrolment serum lipid levels and body mass index were performed.; Results: Data pooled from 19 RCTs revealed that resistance training can reduce TC [weighted mean difference (WMD) -11.47 mg/dl; p = 0.002], LDL-C (WMD -8.48 mg/dl; p = 0.01) and TG (WMD -6.61 mg/dl; p = 0.043) levels. TC levels decreased particularly in subjects aged < 60 years (WMD -10.77 mg/dl; p = 0.003), in RCTs lasting < 16 weeks (WMD -15.70 mg/dl; p = 0.048), and in subjects with hypercholesterolaemia (WMD -12.36 mg/dl; p = 0.001) or obesity (WMD -19.35 mg/dl; p = 0.006) before RCT enrolment. There was a significant decrease in LDL-C (WMD -14.38 mg/dl; p = 0.002) levels in patients with LDL-C ≥ 130 mg/dl before trial enrolment. Resistance training reduced HDL-C (WMD -2.97 mg/dl; p = 0.01) levels particularly in subjects with obesity. TG (WMD -10.71 mg/dl; p = 0.01) levels decreased particularly when the intervention lasted < 16 weeks.; Conclusion: Resistance training can decrease TC, LDL-C and TG levels in postmenopausal females. The impact of resistance training on HDL-C levels was small, and was only observed in individuals with obesity. The effect of resistance training on the lipid profile was more notable in short-term interventions and in postmenopausal women with dyslipidaemia or obesity before trial enrolment.; Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2023 Elsevier B.V. All rights reserved.)

He, Q., et al. (2020). "The efficacy and safety of acupuncture for perimenopause symptom compared with different sham acupuncture control groups: A protocol of systematic review and meta-analysis." Medicine 99(10): e19366.
	Background: Perimenopause is a period that every woman must go through, most people are more or less affected by perimenopausal symptoms, it to affect women's health, work, life, and economy. As acupuncture treatment is more and more increasing in perimenopausal symptoms, there have also been many clinical trials about it. But the results of the trials are inconsistent. Therefore, we will conduct a systematic review and meta-analysis of the safety and efficacy of perimenopausal symptoms treated with acupuncture.; Methods: The protocol followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. RCT study on different acupuncture interventions for perimenopausal symptoms will be searched in 8 databases (PubMed, EMBASE, the Cochrane Library, the web of science, CBM, CNKI, WAN FANG, and VIP). Besides, the search will also be performed on the clinical trial research platform if necessary. The primary outcome that will be extracted: the Flushes per 24 hours, the Frequency of hot flashes, the severity of hot flashes, the menopause-related symptom score, the treatment efficacy, the adverse event. Endnote software X8 will be used for study selection, STATA 13.0 and Review Manager software 5.3 will be used for analysis and synthesis. These studies selection, data extraction, and risk of bias assessment will be conducted by 2 independent reviewers.; Results: This study will provide the results: 1. the primary and secondary outcome indicators of different acupuncture intervention measures (traditional hand acupuncture, moxibustion, ear acupuncture, laser, acupressure points) for perimenopausal symptoms. 2. The effects of different control groups (medicine control, routine care, waiting, and sham acupuncture control) on the analysis results will be reported, especially the effects of different sham acupuncture control (invasive/noninvasive) on the analysis results.; Conclusion: This systematic review and meta-analysis study hopes to provide useful evidence for better use of different types of acupuncture in treat perimenopausal symptoms and better design of control groups in related clinical trials. In addition, the research conclusion will be published in peer journals.OSF REGISTRATION NUMBER DOI 10.17605/OSF.IO/VZCKU Ethics and dissemination This conclusion of the study will be published in peer journals. The ethical approval is not required because there is no direct involvement of human.

He, Q.-D., et al. (2021). "Efficacy and Safety of Acupuncture Vs. Hormone Therapy for Menopausal Syndrome: A Systematic Review and Meta-Analysis." The American journal of Chinese medicine 49(8): 1793-1812.
	Menopausal syndrome (MPS) is a common gynecological disorder around the time of menopause, and hormone therapy (HT) is the first-line treatment for it. However, HT is prone to cause adverse reactions in MPS patients treated with HT. Acupuncture is a popular non-pharmaceutical therapy for MPS, but the differences in the efficacy and safety between acupuncture and HT remain unclear. The purpose of this evidence-based study is to address this issue. Five databases were searched for potentially eligible RCTs. All RCTs comparing acupuncture with HT in the treatment of MPS were included in this study. The clinical effective rate was the primary outcome. Kupperman index, serum follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E[Formula: see text], and side effects were the secondary outcomes. A total of 15 RCTs recruiting 1376 MPS patients were included. Results of meta-analysis showed that compared with HT, acupuncture significantly improved clinical effective rate (RR = 1.09, 95% CI 1.03 to 1.16, [Formula: see text] = 0.005), decreased the Kupperman index (WMD = -2.55, 95% CI = -2.93 to -2.17, [Formula: see text] < 0.00001) and the incidence of side effects (RR = 0.14, 95% CI = 0.06-0.32, [Formula: see text] < 0.00001). There were no statistically significant differences in serum FSH (WMD = -1.36, 95% CI = -3.25-0.53, [Formula: see text] = 0.16), E 2 (WMD = -1.11, 95% CI = -2.59-0.37, [Formula: see text] = 0.14), or LH (WMD = -1.87, 95% CI = -4.58-0.83, [Formula: see text] = 0.17) between the acupuncture and HT groups. Based on the current evidence, manual acupuncture is safer and more effective than HT and is recommended for the treatment of MPS, but the evidence for the efficacy of other types of acupuncture is inconclusive.

He, X. and Z. Li (2022). "Ostomy Does Not Lead to Worse Outcomes After Bowel Resection With Ovarian Cancer: A Systematic Review." Frontiers in Oncology 12: 892376.
	Background: Debulking cytoreduction surgery with bowel resection is a common intervention for ovarian cancer. It is controversial whether ostomy causes worse survival outcomes and how clinical physicians should choose which patients to undergo ostomy. During this study, we performed a systematic review to determine whether ostomy leads to worse outcomes after bowel resection compared to anastomosis. We also summarized the possible indications for ostomy.; Methods: We searched PubMed, Embase, and Cochrane for articles containing the phrase "ovarian cancer with bowel resection" that were published between 2016 and 2021. We included studies that compared primary anastomosis with ostomy. We mainly focused on differences in the anastomotic leakage rate, length of hospital stay, overall survival, and other survival outcomes associated with the two procedures.; Results and Conclusion: Of the 763 studies, three were ultimately included in the systematic review (N=1411). We found that ostomy did not contribute to worse survival outcomes, and that the stoma-related complications were acceptable. Indications for ostomy require further study. Bowel resection segment margins and the distance from the anastomosis to the anal verge require consideration.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 He and Li.)

He, X., et al. (2021). "Protective Effect of Mannitol on Cisplatin-Induced Nephrotoxicity: A Systematic Review and Meta-Analysis." Frontiers in Oncology 11: 804685.
	Introduction: Cisplatin, a chemotherapeutic drug, is widely used for the treatment of various malignant tumors with good effects. However, cisplatin-induced nephrotoxicity is a major dose-limiting factor and a significant adverse event. Mannitol is used to reduce cisplatin-induced nephrotoxicity, which is controversial. This study aimed to evaluate the efficacy and safety of a hydration regimen containing mannitol against cisplatin-induced nephrotoxicity through a meta-analysis. Method(s): Potential records from PubMed, EMBASE, Cochrane Library, and ClinicalTrials that met the inclusion criteria were included from inception to May 2021. Cochrane Collaboration tools were used to assess the risk of bias in the included studies. Jadad's and NOS scores were applied to assess the quality of randomized controlled trials (RCTs) and case-control studies. A random-effects model or fixed-effects model was used depending on the heterogeneity. Subgroup analyses were performed to evaluate the potential study characteristics. The pooled odds ratios (ORs) and 95% confidence intervals (CIs) were evaluated. Result(s): Four RCTs and seven case-control studies involving 4168 patients were included. Pooled results showed that mannitol use could reduce the incidence of cisplatin-induced nephrotoxicity (OR = 0.66, 95% CI [0.45-0.97], p = 0.03), especially reducing grade 3 nephrotoxicity events according to CTCAE 4.0 (OR = 0.37,95% CI [0.16-0.84]). Moreover, mannitol use was not significantly associated with creatinine clearance, serum creatine, and electrolyte disturbance (p > 0.05). Gastrointestinal cancer (OR = 0.36, 95% CI [0.15-0.83], p = 0.02) and urinary tract cancer (OR = 0.32,95% CI [0.14-0.73], p = 0.007) may be more sensitive to mannitol, although the test for overall effect was significantly different (OR = 0.66, 95% CI [0.49-0.89], p = 0.007). For patients with diabetes and hypertension, mannitol may worsen renal function (OR = 1.80, 95% CI [1.18-2.72], p = 0.006; OR = 2.19, 95% CI [1.50, 3.19], p < 0.0001, respectively). Mannitol may have a better protective effect when doses of mannitol were >= 25 g (OR = 0.58, 95% CI [0.39-0.88], p = 0.01) and doses of cisplatin < 75 mg/m2 (OR = 0.59, 95% CI [0.36-0.94], p = 0.03). It revealed that mannitol use was likely to cause nausea or vomiting (OR = 1.86, 95% CI [1.20-2.89], p = 0.006). Conclusion(s): Current evidence revealed that mannitol was an effective and safe drug to reduce cisplatin-induced nephrotoxicity events, especially Grade 3 events. However, it may cause more nausea/vomiting events and deteriorate renal function in patients with diabetes or hypertension. We also found that mannitol had the best effect when mannitol was >= 25 g in total or cisplatin was < 75 mg/m2. Meanwhile, mannitol may have a better effect on gastrointestinal and urinary tract cancers. Systematic Review Registration: crd. york. ac. uk/PROSPERO, CRD 42021253990Copyright © 2021 Li, He, Ruan, Ye, Wen, Song, Hu, Chen, Peng and Li.

He, Y., et al. (2024). "Comparison of the Efficacy and Safety of Ultrasound-Guided Sclerotherapy versus Cystectomy for the Treatment of Ovarian Endometriomas: A Systematic Review and Meta-Analysis." Current Women's Health Reviews 20(2): e280323215050.
	Background: Ultrasound-guided sclerosis has been used to treat ovarian endometriotic cysts since 1988. However, compared with cystectomy, sclerotherapy's effectiveness and safety are questionable. Objective(s): To compare ultrasound-guided sclerotherapy and ovarian cystectomy in the treatment of ovarian endometriosis through a systematic review and meta-analysis. Method(s): PubMed-MEDLINE, EMBASE, Cochrane, and Scopus databases were searched, and related literature was collected. The two treatments' recurrence rate, pain relief rate, pregnancy rate, tech-nical success rate, and complication rate were directly compared. Result(s): Six studies (386 patients) were included. The risk of recurrence with sclerotherapy was higher than that with cystectomy (OR 1.57, p = 0.52). Subgroup analysis showed that an indwelling time > 10 min was not significantly different regarding recurrence risk between sclerotherapy and cystectomy (OR 1.01, p = 0.99). When the indwelling time was <= 10 min, the risk of recurrence with sclerotherapy was significantly higher than that with cystectomy (OR 22.01, p = 0.001). The pregnancy rate after cystectomy was lower than that after sclerosis (OR 1.67, p = 0.22). Complications in the study were graded according to the Clavien-Dindo classification and statistical analysis showed that the probabil-ity of serious complications (Grade III-V) with cystectomy was higher than that with sclerosis (16.67% vs. 0%). Conclusion(s): Ultrasound-guided sclerotherapy was not inferior to cystectomy in terms of recurrence rate or pregnancy rate, and the incidence of severe complications was lower than that in the cystectomy group. Sclerotherapy is a safe and effective alternative treatment for ovarian endometriosis.Copyright © 2024 Bentham Science Publishers.

He, Z. and A. Miao (2024). "Lymph node dissection before initial treatment for locally advanced cervical cancer: a systematic review and meta-analysis."
	
Health, B., et al. (2022). Herbal Nutraceutical Supplementation on Vasomotor Symptoms in Menopausal Women.
	No Results Available Dietary Supplement: JDS-HF 3.0|Dietary Supplement: Placebo To determine the effects of the Test Product (TP) compared to placebo on hot flash symptoms as determined by the Hot Flash Related Daily Interference Scale (HFRDIS).|To determine the effect of the TP compared to the placebo on overall menopausal symptoms as determined by the Greene Climacteric Scale (GCS).|To determine the effect of the TP compared to the placebo on overall menopausal symptoms as determined by the Menopausal Rating Scale (MRS).|To determine the effect of the TP compared to the placebo on sleep quality as determined by the Pittsburgh Sleep Quality Index (PSQI).|To determine the effect of the TP compared to the placebo on quality of life as determined by the Menopause-Specific Quality of Life (MENQOL) questionnaire. Female Not Applicable 64 Industry|Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Supportive Care B01-22-01-T0032 October 1, 2023

Health, F. (2021). Preoperative Analgesia by Infiltration of the Pudendal Nerve Prior to Sacrospinous Ligament Suspension.
	No Results Available Procedure: Pudendal nerve block|Procedure: Sham Pudendal nerve block|Drug: Bupivacaine Injectable Product Post-operative Pain Score|Readiness for discharge|Patient satisfaction|Functional Recovery Index|Post-operative Analgesic use Female Not Applicable 50 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment FHREB2020-143 June 2022

Health, N. Y. U. L. (2022). The Using Postoperative Ketamine and Exploring the Effect on Endometriosis Pain (UPKEEEP) Study.
	This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6 mg/kg) of ketamine versus placebo (saline) on postoperative pain and pain on adult female chronic pelvic pain patients undergoing robotic removal of endometriosis. The objective of the study is to explore the effect of a sub anesthetic dose of ketamine (0.6 mg/kg) vs. saline control on postoperative pain and recovery in chronic pelvic pain patients who have undergone robotic removal of endometriosis. Primary Outcome: Pelvic Pain

Heer, K., et al. (2024). "Prevalence, Risk Factors, and Interventions of Postpartum Depression in Refugees and Asylum-Seeking Women: A Systematic Review and Meta-Analysis." Gynecologic and Obstetric Investigation 89(1): 11-21.
	Introduction: Refugee women are at an increased risk of developing postpartum depression (PPD) due to a combination of various psychosocial stressors. This systematic review aimed to outline the prevalence of PPD among refugee women and explore related risk factors and interventions currently in practice. Method(s): A search was conducted using MEDLINE, Embase, PsycINFO, CINAHL, and Core Collection (Web of Science) for articles published until August 2022, yielding 1,678 records. Result(s): The prevalence of refugee and asylum-seeking women was 22.5% (n = 657/ 2,922), while the prevalence of non-refugee/asylum-seeking women with PPD was 17.5% (n = 400/2,285). Refugee/ asylum-seeking women face a unique set of issues such as domestic abuse, separation and lack of support, stress, pre-migrational experiences, prior history of mental illness, low income, and discrimination. Refugee/asylum-seeking women may benefit from support groups, individual support, self-coping mechanisms, and familial support. Conclusion(s): This review identifies that a higher prevalence of PPD in refugee and asylum-seeking women compared to other groups can potentially be attributed to the unique risk factors they face. This warrants the need for further research as studies on interventions for this condition are limited among this population.Copyright © 2024 The Author(s). Published by S. Karger AG, Basel.

Heidari, H., et al. (2022). "A meta-analysis of effects of vitamin E supplementation alone and in combination with omega-3 or magnesium on polycystic ovary syndrome." Scientific Reports 12(1): 19927.
	Vitamin E supplementation might have favorable effects on risk factors of polycystic ovary syndrome (PCOS). This systematic review and meta-analysis aimed to summarize the effects of vitamin E supplementation or vitamin E in combination with omega-3 or magnesium on PCOS. PubMed, Scopus, ISI Web of Science, Cochrane, Embase electronic databases, and Google scholar were searched for all available articles up to September 2022. Randomized controlled trials (RCTs) that examined the effect of vitamin E supplementation or vitamin E in combination with omega-3 or magnesium on lipid and glycemic profiles, anthropometric measurements, biomarkers of inflammation and oxidative stress, hormonal profile, and hirsutism score in patients with PCOS were included. Ten RCTs (with 504 participants) fulfilled the eligible criteria. Vitamin E supplementation or vitamin E in combination with omega-3 or magnesium in comparison to placebo could significantly reduce serum levels of TG (weighted mean difference: - 18.27 mg/dL, 95% CI - 34.68 to - 1.87), VLDL (- 5.88 mg/dL, 95% CI - 8.08 to - 3.68), LDL-c (- 12.84 mg/dL, 95% CI - 22.15 to - 3.52), TC (- 16.30 mg/dL, 95% CI - 29.74 to - 2.86), TC/HDL-c ratio (- 0.52, 95% CI - 0.87 to - 0.18), hs-CRP (- 0.60 ng/mL, 95% CI - 0.77 to - 0.44), hirsutism score (- 0.33, 95% CI - 0.65 to - 0.02) and significantly increase nitric oxide levels (2.79 µmol/L, 95% CI 0.79-4.79). No significant effect was found on HDL-c, glycemic indices, hormonal profile, anthropometric measurements, and other biomarkers of inflammation or oxidative stress. This meta-analysis highlights the potential anti-hyperlipidemic, anti-oxidant, and anti-inflammatory properties of vitamin E supplementation alone or in combination with omega-3 or magnesium on PCOS patients. (© 2022. The Author(s).)

Heidinger, M., et al. (2023). "Therapeutic approaches in patients with bone metastasis due to endometrial carcinoma - A systematic review." Journal of bone oncology 41: 100485.
	Background: Bone metastases (BM) are uncommon in endometrial carcinoma (EC), without information on the optimal oncologic management of patients with BM in EC. Here, we systematically review clinical characteristics, treatment approaches and prognosis in patients with BM in EC.; Methods: We conducted a systematic literature search until 27th March 2022 on PubMed, MEDLINE, Embase and clinicaltrials.gov. Outcomes included treatment frequency and survival after BM with comparators being treatment approaches (local cytoreductive bone surgery, systemic therapy, and local radiotherapy). Risk of bias was assessed using the NIH Quality Assessment Tool and Navigation Guide methodology.; Results: We retrieved 1096 records of which 112 retrospective studies (12 cohort studies, 12/12 fair quality; 100 case studies, 100/100 low quality) with a total of 1566 patients were included. The majority had a primary diagnosis of FIGO stage IV, grade 3 endometrioid EC. Singular BM were present in a median of 39.2%, multiple BM in 60.8% and synchronous additional distant metastases in 48.1% of patients respectively. In patients with secondary BM median time to bone recurrence was 14 months. Median survival after BM was 12 months. Local cytoreductive bone surgery was assessed in 7/13 cohorts and performed in a median of 15.8% (interquartile range [IQR] 10.3-43.0) of patients. Chemotherapy was assessed in 11/13 cohorts and administered in a median of 55.5% (IQR 41.0-63.9), hormonal therapy (7/13 cohorts) in 24.7% (IQR 16.3-36.0), and osteooncologic therapy (4/13 cohorts) in 2.7% (IQR 0.0-7.5) of patients respectively. Local radiotherapy was assessed in 9/13 cohorts and performed in a median of 66.7% (IQR 55.6-70.0) of patients. Survival benefits were seen in 2/3 cohorts after local cytoreductive bone surgery, and in 2/7 cohorts after chemotherapy without survival benefits in the remaining cohorts and investigated therapies. Limitations include the lack of controlled intervention studies, the heterogeneity and retrospective nature of the investigated populations.; Conclusions: This systematic review shows heterogenous therapeutic approaches in clinical practice without clear evidence for optimal oncologic management for patients with BM in EC.; Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2023 The Author(s).)

Heinemeier Ina Isabell, K., et al. (2023). "Impact of combined endometrial resection or ablation and levonorgestrel intrauterine device on postoperative bleeding pattern." Archives of Gynecology and Obstetrics 307(2): 493-499.
	Purpose: The aim of this study was to describe the rate of amenorrhea in women treated with transcervical endometrial resection (TCER) or radiofrequency endometrial ablation combined with levonorgestrel intrauterine contraceptive device (LNG-IUD) six months post-operatively.; Methods: The study was performed as a prospective cohort study. All patients were included at four gynecological centers in Region of Southern Denmark. In total, 162 women referred due to menorrhagia, metrorrhagia or menometrorrhagia and offered TCER or radiofrequency endometrial ablation in combination with or without LNG-IUD included during November 2018 to June 2021 at the women's own discretion and without any cost (covered by the hospital). Data were analyzed using a multivariate regression model.; Results: In total, 58 women were offered TCER and 31 (53.4%) combined treatment with TCER + LNG-IUD. Among 104 women who received radiofrequency endometrial ablation, 46 (44.2%) underwent combined treatment with LNG-IUD. The incidence of amenorrhea was 26% among women who underwent treatment with TCRE and 52% when treated with TCER + LNG-IUD (adjusted OR 5.16; 95% CI 1.35-19.6; P < 0.016). Radiofrequency endometrial ablation was followed by a 41% incidence of amenorrhea, and when radiofrequency endometrial ablation was combined with LNG-IUD, the incidence of amenorrhea was 63% (adjusted OR 2.15; 95% CI 0.86-5.37; P < 0.1). We observed no statistically significant differences when comparing the groups across.; Conclusion: Our study suggests that the combination of TCER or radiofrequency endometrial ablation with LNG-IUD was superior to TCER. However, the combined treatment of radiofrequency endometrial ablation with LNG-IUD did not reach statistical significance. Further studies are needed to evaluate the effects of different ablation techniques on the amenorrhea rate. (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Heinz-Partington, S., et al. (2021). "Conservative vs radical bowel surgery for endometriosis: A systematic analysis of complications." The Australian & New Zealand Journal of Obstetrics & Gynaecology 61(2): 169-176.
	Background: Endometriosis of the bowel can be associated with significant morbidity. Surgery to remove it carries risks. Options include conservative shaving or discoid resection and more radical segmental bowel resection.; Aims: To determine if more conservative shaving or discoid bowel resection is associated with fewer risks than more radical segmental resection.; Material and Methods: This study is a systematic review. We considered eligible any cohort, observational or randomised controlled trial (RCT) study of at least ten women per arm comparing conservative vs radical bowel surgery for endometriosis. We divided complications into two groups, major and minor. One additional article was added due to its significance in answering our study question as well as the high quality of the study design as an RCT.; Results: There were 3041 studies screened. Eleven studies were included (n = 1648). For major complications, the risk ratio for shaving and disc excision vs segmental resection is 0.31 (95% CI 0.21-0.46), while the risk difference is -0.25 (95% CI -0.41 to 0.10). For minor complications, the risk ratio is 0.63 (95% CI 0.36-1.09), while the risk difference is -0.03 (95% CI -0.12 to 0.05).; Conclusions: Conservative shaving or discoid excision surgery is associated with reduced complications. Previous studies demonstrated a trend toward this finding, but suffered from relatively low participant numbers, increasing the risk of type one statistical error. Our results allow surgeons to make informed choices about potential complications when deciding how to approach bowel endometriosis. The results also allow patients to have more information about the risks. However, outcomes in the studies analysed are heterogenous and are from low-quality evidence. (© 2021 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Heitz, N., et al. (2023). "A Review of Tisotumab Vedotin-tftv in Recurrent or Metastatic Cervical Cancer." The Annals of Pharmacotherapy 57(5): 585-596.
	Objective: To evaluate the safety and efficacy of tisotumab vedotin-tftv (TV), a first-in-class vectorized anti-tissue factor (TF) antibody-drug conjugate (ADC), for the treatment of recurrent or metastatic cervical cancer.; Data Sources: A literature search of ClinicalTrials.gov, Embase, and PubMed was conducted using the terms tisotumab vedotin AND cervical cancer from inception to June 30, 2022.; Study Selection and Data Extraction: All applicable publications, package inserts, meeting abstracts, and clinical trials involving TV in the treatment of cervical cancer were reviewed.; Data Synthesis: TV is a fully human TF-specific monoclonal antibody conjugated to monomethyl auristatin E, which serves as a highly potent cytotoxic payload. In the pivotal phase II InnovaTV 204 clinical trial, TV demonstrated an objective response rate of 24% (95% confidence interval [CI], 16%-33%). The mean duration of response was 8.3 months. Common toxicities included abdominal pain, alopecia, conjunctivitis, constipation, decreased appetite, diarrhea, dry eye, epistaxis, nausea/vomiting, and peripheral neuropathy. Unique and/or serious adverse events warranting careful monitoring include ocular complications, hemorrhaging, peripheral neuropathies, fetal-embryo toxicity, pneumonitis, and immunogenicity.; Relevance to Patient Care and Clinical Practice: Recurrent or metastatic cervical cancer remains a high-risk disease with limited treatment options. Using ADCs to target tumors with aberrant expression of TF appears to be a viable treatment strategy.; Conclusions: TV is the first Food and Drug Administration-approved TF-directed ADC. With a manageable safety profile and promising anticancer activity, TV warrants consideration as a novel targeted agent for the treatment of recurrent or metastatic cervical cancer. Further studies are required to determine the optimal place in therapy for TV.

Helgers, R. J. A., et al. (2021). "Lymphedema and post-operative complications after sentinel lymph node biopsy versus lymphadenectomy in endometrial carcinomas-a systematic review and meta-analysis." Journal of Clinical Medicine 10(1): 1-16.
	Background: Lymph node dissection (LND) is recommended as staging procedure in presumed low stage endometrial cancer. LND is associated with risk of lower-extremity lymphedema and post-operative complications. The sentinel lymph node (SLN) procedure has been shown to have high diagnostic accuracy, but its effects on complication risk has been little studied. This systematic review compares the risk of lower-extremity lymphedema and post-operative complications in SLN versus LND in patients with endometrial carcinoma. Method(s): A systematic search was conducted in PubMed and Cochrane Library. Result(s): Seven retrospective and prospective studies (total n = 3046 patients) were included. Only three studies reported the odds ratio of lower-extremity lymphedema after SLN compared to LND, which was 0.05 (95% CI 0.01-0.37; p = 0.067), 0.07 (95% CI 0.00-1.21; p = 0.007) and 0.54 (95% CI 0.37-0.80; p = 0.002) in these studies. The pooled odds ratio of any post-operative complications after SLN versus LND was 0.52 (95% CI 0.36-0.73; I2 = 48%; p < 0.001). For severe post-operative complications the pooled odds ratio was 0.52 (95% CI 0.28-0.96; I2 = 0%; p = 0.04). Conclusion(s): There are strong indications that SLN results in a lower incidence of lower-extremity lymphedema and less often severe post-operative complications compared to LND. In spite of the paucity and heterogeneity of studies, direction of results was similar in all studies, supporting the aforementioned conclusion. These results support the increasing uptake of SLN procedures in endometrial cancer.Copyright © 2020 by the authors. Licensee MDPI, Basel, Switzerland.

Hellier Susan, D. and F. Wrynn Alexander (2023). "Beyond fluconazole: A review of vulvovaginal candidiasis diagnosis and treatment." The Nurse practitioner 48(9): 33-39.
	Abstract: Vaginitis symptoms are among the most common reasons for patients to seek acute gynecological care. NPs who care for women and other patients with vaginas need to be up-to-date on diagnosis and treatment of vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC). Two new antifungal medications for VVC are available. This article reviews vaginal physiology and provides an overview of VVC and RVVC pathophysiology, diagnosis, and treatment options. (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Helm, S., et al. (2021). "Peripheral Nerve Stimulation for Chronic Pain: A Systematic Review of Effectiveness and Safety." Pain and therapy 10(2): 985-1002.
	Peripheral nerve stimulation (PNS) was the first application of neuromodulation. Widespread application of PNS was limited by technical concerns. Recent advances now allow the percutaneous placement of leads with ultrasound or fluoroscopic guidance, while the transcutaneous powering of these leads removes the need for leads to cross major joints. This systematic review was written to assess the current status of high-quality evidence supporting the use of PNS for pain conditions treated by interventional pain physicians. The available literature on PNS, limited to conditions treated by interventional pain physicians, was reviewed and the quality assessed. Literature from 1966 to June 2021 was reviewed. The outcome measures were pain relief and functional improvement. One hundred and two studies were identified. Five randomized controlled trials (RCT) and four observational studies, all case series, met the inclusion criteria. One RCT was of high quality and four were of moderate quality; all four case series were of moderate quality. Three of the RCTs and all four case series evaluated peripheral nerve neuropathic pain. Based upon these studies, there is level II evidence supporting the use of PNS to treat refractory peripheral nerve injury. One moderate-quality RCT evaluated tibial nerve stimulation for pelvic pain, providing level III evidence for this indication. One moderate-quality RCT evaluated surgically placed cylindrical leads for cluster headaches, providing level III evidence for this indication. The evidence suggests that approximately two-thirds of patients with peripheral neuropathic pain will have at least 50% sustained pain relief. Adverse events from PNS are generally minor. A major advantage of PNS over spinal cord stimulation is the absence of any risk of central cord injury. The study was limited by the paucity of literature for some indications. No studies dealt with joint-related osteoarthritic pain. (© 2021. The Author(s).)

Hemmerling, A., et al. (2023). "Response to antibiotic treatment of bacterial vaginosis predicts the effectiveness of LACTIN-V (Lactobacillus crispatus CTV-05) in the prevention of recurrent disease." MedRxiv.
	Objectives: Live biotherapeutic products (LBPs) containing vaginal Lactobacillus crispatus are promising adjuvant treatments to prevent recurrent bacterial vaginosis (BV) but may depend on the success of initial antibiotic treatment. Method(s): A post hoc analysis of data collected during the phase 2b LACTIN-V randomized control trial (L. crispatus CTV-05) explored the impact of clinical BV cure defined as Amsel criteria 0 of 3 (excluding pH, per 2019 FDA guidance) two days after completion of treatment with vaginal metronidazole gel on the effectiveness of an 11-week LACTIN-V dosing regimen to prevent BV recurrence by 12 and 24 weeks. Result(s): At enrollment, 88% of participants had achieved clinical BV cure. The effect of LACTIN-V on BV recurrence compared to placebo differed by initial clinical BV cure status (p=0.02 by 12 weeks, and p=0.08 by 24 weeks). The LACTIN-V to placebo risk ratio of BV recurrence by 12 weeks was 0.56 (CI: 0.35, 0.77) among participants with initial clinical BV cure, and 1.34 (CI: 0.47, 2.23) among participants without clinical BV cure. Among women receiving LACTIN-V, those who had achieved clinical BV cure at enrollment reached higher levels of detectable L. crispatus CTV-05 compared to women failing to achieve clinical BV cure. Conclusion(s): LACTIN-V appears to only decrease BV recurrence in women with clinical cure of BV following antibiotic treatment. Future trials of LBPs should consider limiting enrollment to these women.Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license.

Hend, H., et al. (2022). "Long term outcomes of hysterectomy and bilateral salpingo-oophorectomy: a systematic review and meta-analysis."
	
Hendrickson, W. K., et al. (2021). "Comparison of 100 U With 200 U of Intradetrusor OnabotulinumToxinA for Nonneurogenic Urgency Incontinence." Female Pelvic Medicine & Reconstructive Surgery 27(3): 140‐146.
	OBJECTIVES: The objective of this study was to compare efficacy and adverse events between 100 U and 200 U of onabotulinumtoxinA for 6 months in women with nonneurogenic urgency incontinence. METHODS: This is a secondary analysis of 2 multicenter randomized controlled trials assessing efficacy of onabotulinumtoxinA in women with nonneurogenic urgency incontinence; one compared 100 U to anticholinergics and the other 200 U to sacral neuromodulation. Of 307 women who received onabotulinumtoxinA injections, 118 received 100 U, and 189 received 200 U. The primary outcome was mean adjusted change in daily urgency incontinence episodes from baseline over 6 months, measured on monthly bladder diaries. Secondary outcomes included perceived improvement, quality of life, and adverse events. The primary outcome was assessed via a multivariate linear mixed model. RESULTS: Women receiving 200 U had a lower mean reduction in urgency incontinence episodes by 6 months compared with 100 U (‐3.65 vs ‐4.28 episodes per day; mean difference, 0.63 episodes per day [95% confidence interval (CI), 0.05‐1.20]). Women receiving 200 U had lower perceptions of improvement (adjusted odds ratio, 0.32 [95% CI, 0.14‐0.75]) and smaller improvement in severity score (adjusted mean difference, 12.0 [95% CI, 5.63‐18.37]). Upon subanalysis of only women who were treated with prior anticholinergic medications, these differences between onabotulinumtoxinA doses were no longer statistically significant. There was no statistically significant difference in adverse events in women receiving 200 U (catheterization, 32% vs 23%; adjusted odds ratio, 1.4 [95% CI, 0.8‐2.4]; urinary tract infection, 37% vs 27%; adjusted odds ratio, 1.5 [95% CI, 0.9‐2.6]). CONCLUSIONS: A higher dose of onabotulinumtoxinA may not directly result in improved outcomes, but rather baseline disease severity may be a more important prediction of outcomes.

Hendrix, Y. M. G. A., et al. (2021). "Postpartum Early EMDR therapy Intervention (PERCEIVE) study for women after a traumatic birth experience: study protocol for a randomized controlled trial." Trials 22(1): 599.
	Background: Up to 33% of women develop symptoms of posttraumatic stress disorder (PTSD) after a traumatic birth experience. Negative and traumatic childbirth experiences can also lead to fear of childbirth, avoiding or negatively influencing a subsequent pregnancy, mother-infant bonding problems, problems with breastfeeding, depression and reduced quality of life. For PTSD in general, eye movement desensitization and reprocessing (EMDR) therapy has proven to be effective. However, little is known about the preventive effects of early intervention EMDR therapy in women after a traumatic birth experience. The purpose of this study is to determine the effectiveness of early intervention EMDR therapy in preventing PTSD and reducing PTSD symptoms in women with a traumatic birth experience.; Methods: The PERCEIVE study is a randomized controlled trial. Women suffering from the consequences of a traumatic birth experience will be randomly allocated at maximum 14 days postpartum to either EMDR therapy or 'care-as-usual'. Patients in the EMDR group receive two sessions of therapy between 14 (T0) and 35 days postpartum. All participants will be assessed at T0 and at 9 weeks postpartum (T1). At T1, all participants will undergo a CAPS-5 interview about the presence and severity of PTSD symptoms. The primary outcome measure is the severity of PTSD symptoms, whereas the secondary outcomes pertain to fear of childbirth, mother-infant bonding, breastfeeding, depression and quality of life. The study will be conducted at a large city hospital and at multiple midwifery practices in Amsterdam, the Netherlands.; Discussion: It is to be expected that the results of this study will provide more insight about the safety and effectiveness of early intervention EMDR therapy in the prevention and reduction of PTSD (symptoms) in women with a traumatic birth experience.; Trial Registration: Netherlands Trial Register NL73231.000.20 . Registered on 21 August 2020. (© 2021. The Author(s).)

Hengxi, C. and H. Lin (2023). "Minimally invasive radical trachelectomy versus abdominal radical trachelectomy for early-stage cervical cancer: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Henkel, A., et al. (2023). "Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial." Obstetrics and Gynecology 141(6): 1115-1123.
	Objective: To assess cabergoline's efficacy at decreasing breast symptoms after second-trimester abortion or pregnancy loss.; Methods: This was a double-blinded, block-randomized superiority trial comparing cabergoline 1 mg once to placebo for preventing bothersome breast engorgement after second-trimester uterine evacuation. We enrolled pregnant people at 18-28 weeks of gestation who were English- or Spanish-speaking and without contraindication to the study drug. Participants completed a validated, piloted, electronic survey at baseline and at multiple timepoints through 2 weeks postprocedure to assess breast symptoms, side effects, and bother. Our primary outcome was any breast symptoms (a composite of engorgement, milk leakage, tenderness, and need for pain relief) on day 4; we planned to enroll 80 patients to show a 30% difference in breast symptoms (80% power, α=0.049). A subgroup of participants returned for serum prolactin levels.; Results: After screening 150 patients from April 2021 to June 2022, we enrolled 73 participants. Baseline demographics were balanced between groups: median gestational age was 21 weeks (range 18-26 weeks), 56.2% of participants were nulliparous, 34.2% self-identified as Hispanic, and 37.0% had public insurance. At baseline, reported breast symptoms were similar between groups. Among 69 participants who returned surveys on day 4, significantly fewer participants receiving cabergoline reported any breast symptoms compared with placebo (27.8% vs 97.0%, P<.001) (primary outcome) and fewer reported significant bother (2.8% vs 33.3%, P=.001) (secondary outcome). These differences persisted through day 14. Reported incidence and severity of bother from side effects were similar between groups: most common were constipation, fatigue, and headache. Serum prolactin levels were similar at baseline. On day 4, mean serum prolactin level was 6.5 ng/mL (SD 2.2) for those who received cabergoline and 18.0 ng/mL (SD 5.9) for placebo (P=.049).; Conclusion: Cabergoline is an effective and well-tolerated strategy to prevent breast symptoms after second-trimester abortion or pregnancy loss.; Clinical Trial Registration: ClinicalTrials.gov, NCT04701333.; Competing Interests: Financial Disclosure This article discusses off-label use of cabergoline. Matthew F. Reeves reports receiving payments from GemBioPro (distributor of mifepristone, unrelated to cabergoline). The other authors did not report any potential conflicts of interest. (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Hensler, M., et al. (2022). "Peripheral gene signatures reveal distinct cancer patient immunotypes with therapeutic implications for autologous DC-based vaccines." Oncoimmunology 11(1): 2101596.
	Dendritic cells (DCs) have received considerable attention as potential targets for the development of novel cancer immunotherapies. However, the clinical efficacy of DC-based vaccines remains suboptimal, largely reflecting local and systemic immunosuppression at baseline. An autologous DC-based vaccine (DCVAC) has recently been shown to improve progression-free survival and overall survival in randomized clinical trials enrolling patients with lung cancer (SLU01, NCT02470468) or ovarian carcinoma (SOV01, NCT02107937), but not metastatic castration-resistant prostate cancer (SP005, NCT02111577), despite a good safety profile across all cohorts. We performed biomolecular and cytofluorometric analyses on peripheral blood samples collected prior to immunotherapy from 1000 patients enrolled in these trials, with the objective of identifying immunological biomarkers that may improve the clinical management of DCVAC-treated patients. Gene signatures reflecting adaptive immunity and T cell activation were associated with favorable disease outcomes and responses to DCVAC in patients with prostate and lung cancer, but not ovarian carcinoma. By contrast, the clinical benefits of DCVAC were more pronounced among patients with ovarian carcinoma exhibiting reduced expression of T cell-associated genes, especially those linked to T H2 -like signature and immunosuppressive regulatory T (T REG ) cells. Clinical responses to DCVAC were accompanied by signs of antitumor immunity in the peripheral blood. Our findings suggest that circulating signatures of antitumor immunity may provide a useful tool for monitoring the potency of autologous DC-based immunotherapy.; Competing Interests: IV declares consulting for AstraZeneca, Clovis Oncology Inc., Carrick Therapeutics, Deciphera Pharmaceuticals, Elevar Therapeutics, F. Hoffmann-La Roche Ltd, Genmab, GSK, Immunogen Inc., Jazzpharma, Mersana, Millennium Pharmaceuticals, MSD, Novocure, Octimet Oncology NV, Oncoinvent AS, Sotio a.s., Verastem Oncology, Zentalis; contracted research for: Oncoinvent AS, Genmab; and research funding from Amgen and Roche. RS and JB are minority shareholders of Sotio. ADG received fees for consultancy, lectures or services from Boehringer Ingelheim (Germany), Miltenyi Biotec (Germany), Isoplexis (USA) and Novigenix (Switzerland). AR declares advisory services and invited lectures for Amgen, AstraZeneca, BMS, Eli-Lilly, Janssen-Cilag, MSD, and Roche. AC is a contracted researcher for Oncoinvent AS and Novocure and a consultant for Sotio Biotech a.s. MH, JR, LK, TL, JF, PH, MH, TH, PK, KS, DR, LS, JB, RS, and JF are employees of Sotio a.s. The other authors declare no conflicts of interest. (© 2022 Sotio Biotech. Published with license by Taylor & Francis Group, LLC.)

Heo, S. J., et al. (2023). "Effects of phytoncide on immune cells and psychological stress of gynecological cancer survivors: randomized controlled trials." Journal of exercise rehabilitation 19(3): 170-180.
	This study aimed to identify neuroendocrine substances and natural killer (NK) cells, including their subsets and receptors, to determine whether phytoncides scented in an urban hospital could help improve stress in cancer survivors. Fifty-five gynecological cancer survivors were assigned to either the control group (CG, n=28) or phytoncide group (PTG, n=27). The PTG meditated by lying down in a space scented with phytoncide for 1 hr a day, 5 days a week for 8 weeks. Stress levels in both groups were high prior to the experiment and decreased by 9.31%±45.98% (P=0.003) only in the PTG after the experiment. Although the parasympathetic nerve activity of the PTG increased, the epinephrine and cortisol levels were significantly (P<0.001) decreased by 5.29%±25.5% and by 24.94%±11.62%. Moreover, the PTG showed a significant increase in the levels of NK cell subsets after 8 weeks, whereas there was no improvement in the CG. In conclusion, phytoncide fragrance reduces stress, increases the number of NK cells and their family even in a nonforest environment, and improves innate immunocytes in gynecological cancer survivors; parasympathetic nerve activity and cortisol hormones play critical roles in this process. That is, a phytoncide essential oil helps to stimulate changes in immunocytes' mobility by affecting the human nervous and endocrine systems, thereby providing relief for psychological stress among cancer survivors who previously had cancer cells.

Herbert, S. and K. Woolf (2023). "Moving beyond Weight: A Narrative Review of the Dietary and Lifestyle Management for Reducing Cardiometabolic Risk in Polycystic Ovary Syndrome (PCOS)." Nutrients 15(24).
	Polycystic ovary syndrome (PCOS) is the most common endocrine disorder experienced by women. PCOS is a lifelong condition associated with reproductive, metabolic, and psychological presentations. PCOS is also linked with increased prevalence of cardiometabolic risk factors. While an association between body weight and PCOS has been noted, cardiometabolic risk factors are prevalent in individuals with PCOS across body weights. Currently, no consensus exists as to the most appropriate lifestyle strategy for mitigating cardiometabolic risk in PCOS. A large proportion of the literature is focused on weight loss for individuals with PCOS who are overweight or experience obesity, despite PCOS being prevalent across body sizes. The aim of this narrative review is to assess dietary and lifestyle interventions aimed at reducing cardiometabolic risk in individuals with PCOS across body sizes. A total of 51 articles are included in this review. Overall, randomized controlled trials are limited and most studies focus on weight loss, excluding individuals classified within a healthy body weight range. Studies that modified the dietary pattern without an energy deficit saw improvements in cardiometabolic risk. Thus, less restrictive dietary approaches may be effective at reducing cardiometabolic risk in this population. This review also highlights the need for more sustainable lifestyle interventions that meet the needs of individuals with PCOS of varying body weights.

Herlev Copenhagen University Hospital, a., et al. (2021). Estradiol and Progestrone Levels Following Frozen Embryo Transfer.
	No Results Available Drug: Estradiol Tablets|Drug: Progesterone|Drug: Follitropin Alfa|Drug: Chorionic Gonadotropin, Alpha Serum estradiol|Serum progesterone|Gestational age at delivery|Child birth weight|Obstetric complications|Child malformations Female Phase 4 300 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Health Services Research 2020-001218-39 December 2024

Hernández Alberto, V., et al. (2022). "Ghost Ileostomy: Safe and Cost-effective Alternative to Ileostomy After Rectal Resection for Deep Infiltrating Endometriosis." In vivo (Athens, Greece) 36(3): 1290-1296.
	Background/aim: Endometriosis infiltrating the rectum often requires resection with a protecting stoma. A ghost ileostomy (GI) is an alternative to prevent the psychological burden for the young women affected. The present study evaluated the safety and cost-effectiveness of the ghost ileostomy (GI) procedure in a group of patients after rectal resection for deep infiltrating endometriosis.; Patients and Methods: The prospective controlled interventional trial was conducted in 54 consecutive patients with deep infiltrating endometriosis of the rectum. GI was considered after ultra-low resection with primary anastomosis, previous colorectal anastomosis, or pelvic redo surgery. Loop ileostomy (LI) was performed after simultaneous colpotomy with suture, only. Operating time, morbidity according to the Clavien-Dindo classification (CDC), duration of hospital stay, and patient satisfaction were obtained. Individual costs were estimated for the endometriosis procedure with or without a GI or LI, including stoma supply and closure expenses.; Results: Of the 54 patients, 27 received GI (50%), whereas 4 underwent LI (7%). The remaining 23 patients received no outlet (NO). The complication rate did not differ among the GI, LI, and NO groups. Two cases were re-operated and required a diverting stoma, one in the GI and the NO group each. The additional healthcare expenses for each patient receiving a LI averaged 6,000 €. The patients were very satisfied with the option of a GI.; Conclusion: GI is a cost-effective and safe alternative to LI after rectal resection for deep infiltrating endometriosis in cases where it is required. The individual costs per patient were reduced substantially, with a cumulative savings of 160,000 € in healthcare expenditure. Additionally, the method clearly lowers the psychological burden on the young women concerned. (Copyright © 2022, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Hernandez, M., et al. (2021). "A multicenter clinical study with myo-inositol and alpha-lactalbumin in Mexican and Italian PCOS patients." European Review for Medical and Pharmacological Sciences 25(8): 3316-3324.
	- OBJECTIVE: This open-label non-randomized clinical study aimed at evaluating the effects of myo-inositol plus alpha-lactalbumin in two groups of PCOS women, treated in Mexico and Italy. Alpha-lactalbumin was used being effective in increasing myo-inositol intestinal absorption. This effect is very useful in greatly reducing the therapeutic failure of myo-inositol in some patients (inositol resistant subjects). PATIENTS AND METHODS: The study involved 34 normal weight or overweight patients (14 in Mexico and 20 in Italy), aged 18 to 40 years, with anovulation and infertility > 1 year and insulin resistance diagnosed by HOMA-Index. Patients were administered orally with 2 g myo-inositol, 50 mg alpha-lactalbumin, and 200 microg of folic acid twice a day for 6 months. Controls were the same patients at t0 (baseline). The primary outcome was HOMA-index decrease after 3 and 6 months of treatment. Other parameters monitored were BMI, progesterone, LH, FSH, total testosterone, free testosterone, androstenedione, total cholesterol, HDL, LDL, triglycerides. RESULT(S): Recovery was general, and its relevance was higher when the starting point was further away from the normal range. The most important results were obtained with insulin, HOMA-index, LH, and androstenedione. No significant adverse effects were detected in both groups of patients. CONCLUSION(S): This clinical trial demonstrated for the first time that myo-inositol and alpha-lactalbumin improve important parameters in PCOS patients characterized by different metabolic profiles.Copyright © 2021 Verduci Editore s.r.l. All rights reserved.

Hernandez-Aranda, D., et al. (2023). "Analgesia Using Transcutaneous Electric Nerve Stimulation in Office Bladder Chemodenervation, a Randomized Controlled Trial." Urogynecology (Philadelphia, Pa.).
	IMPORTANCE: Office bladder chemodenervation, performed via cystoscopy with intradetrusor onabotulinumtoxinA (BOTOX) injections, is a common treatment for overactive bladder/urge urinary incontinence. Transcutaneous electric nerve stimulation (TENS) has shown to provide analgesia during office hysteroscopy. Adjuvant analgesia using TENS during bladder chemodenervation has not been studied. OBJECTIVE(S): The primary outcome is a clinically significant (10-mm) difference in pain visual analog scale (VAS) measurements during injections for chemodenervation using active TENS compared with placebo TENS. We hypothesize that active TENS use will significantly change pain VAS scores. Secondary outcomes include 5-point pain Likert scale, satisfaction 10-point scale, and adverse events. STUDY DESIGN: This was a double-blind randomized control trial of men and women with urinary urge incontinence undergoing office chemodenervation performed in an academic and private setting. Participants were randomized into 2 groups: chemodenervation with active TENS or placebo TENS. Power calculation determined 100 patients would be required detect a difference of 10 mm on pain VAS. RESULT(S): One hundred one (85 female and 16 male) participants were recruited. No differences were noted in the demographics. Participants in the active TENS group reported a difference of greater than 10 mm in pain VAS scores (48 +/- 23 vs 31 +/- 23, P = 0.01). Satisfaction index scores were high but no difference was noted between groups (8.6 vs 8.7, P = 0.68). CONCLUSION(S): Most participants were eligible to use TENS units. Transcutaneous electric nerve stimulation is a safe and noninvasive adjuvant analgesia option for patients undergoing this procedure. Lower pain levels and high satisfaction rates suggest that this is an additional analgesic option during outpatient chemodenervation.Copyright © 2023 American Urogynecologic Society. All rights reserved.

Herzog Thomas, J. (2022). "Maintenance therapy with PARP inhibition in ovarian cancer." Clinical advances in hematology & oncology : H&O 20(9): 539-541.
	
Herzog Thomas, J., et al. (2023). "Optimizing disease progression assessment using blinded central independent review and comparing it with investigator assessment in the PRIMA/ENGOT-ov26/GOG-3012 trial: challenges and solutions." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 33(11): 1733-1742.
	Objective: Progression-free survival is an established clinically meaningful endpoint in ovarian cancer trials, but it may be susceptible to bias; therefore, blinded independent centralized radiological review is often included in trial designs. We compared blinded independent centralized review and investigator-assessed progressive disease performance in the PRIMA/ENGOT-ov26/GOG-3012 trial examining niraparib monotherapy.; Methods: PRIMA/ENGOT-ov26/GOG-3012 was a randomized, double-blind phase 3 trial; patients with newly diagnosed stage III/IV ovarian cancer received niraparib or placebo. The primary endpoint was progression-free survival (per Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), determined by two independent radiologists, an arbiter if required, and by blinded central clinician review. Discordance rates between blinded independent centralized review and investigator assessment of progressive disease and non-progressive disease were routinely assessed. To optimize disease assessment, a training intervention was developed for blinded independent centralized radiological reviewers, and RECIST refresher training was provided for investigators. Discordance rates were determined post-intervention.; Results: There was a 39% discordance rate between blinded independent centralized review and investigator-assessed progressive disease/non-progressive disease in an initial patient subset (n=80); peritoneal carcinomatosis was the most common source of discordance. All reviewers underwent training, and as a result, changes were implemented, including removal of two original reviewers and identification of 10 best practices for reading imaging data. Post-hoc analysis indicated final discordance rates between blinded independent centralized review and investigator improved to 12% in the overall population. Median progression-free survival and hazard ratios were similar between blinded independent centralized review and investigators in the overall population and across subgroups.; Conclusion: PRIMA/ENGOT-ov26/GOG-3012 highlights the need to optimize blinded independent centralized review and investigator concordance using early, specialized, ovarian-cancer-specific radiology training to maximize validity of outcome data.; Competing Interests: Competing interests: TJH has served on advisory boards (Aravive, AstraZeneca, Caris, Clovis Oncology, Eisai, Epsilogen, GSK, Immunogen, Johnson & Johnson, Merck, Roche Genentech, Seagen) and as a consultant for Abbvie. SAW reports consulting fees (GSK and BioClinica). MRM reports personal fees and other (Karyopharm Therapeutics, Sera Prognostics, Roche); institutional grants and no financial interest (Apexigen, AstraZeneca, Deciphera, GSK, Ultimovacs); personal fees and invited speaker (AstraZeneca, GSK); personal fees and advisory boards (AstraZeneca, Biocad, Boehringer Ingelheim, GSK, Karyopharm, Merck, Mersana, ImmunoGen, Clovis Oncology, Roche, Zailab); personal fees, stocks and a member of board of directors (Karyopharm). BP reports research funding (AstraZeneca, Celgene, Celsion, Clovis, Genentech, SeaGen, GSK, Merck, Mersana, SeaGen, Takada, Toray) and consulting fees (AstraZeneca, Celsion, Eisai, GSK, GOG Foundation, Immunogen, Inxmed, Lily, Merck, Mersana, SeaGen, Toray). IV reports consulting fees (Agenus, Akesobio, AstraZeneca, Bristol Myers Squibb, Deciphera Pharmaceuticals, Eisai, Elevar Therapeutics, Exelixis, F. Hoffmann-La Roche, Genmab, GSK, Immunogen, Jazzpharma, Karyopharm, Mersana, MSD, Novocure, Novartis, Oncoinvent, OncoXerna, Regeneron, Sanofi, Seagen, Sotio, Verastem Oncology, Zentalis), travel grants (Karyopharm, Genmab, Novocure), and contracted research grants (Amgen, Roche, Oncoinvent AS). WSG reports advisory board and speaker fees (GSK). IAM, WY, and DG are employees of GSK. JAH is an employee of GSK and reports stocks in GSK. AGM reports personal fees for educational/advisory-related activities (Alkermes, Amgen, AstraZeneca, Clovis, Genmab, GSK, Immunogen, Mersana, MSD, Novocure, Oncoinvent, PharmaMar, Roche, SOTIO, Takeda). BJM repor s consulting fees (Acrivon, Adaptimmune, Agenus, Akeso Bio, Amgen, Aravive, AstraZeneca, Bayer, Clovis, Eisai, Elevar, EMD Merck, Genmab/Seagen, GOG Foundation, Gradalis, Heng Rui, ImmunoGen, Karyoparm, Iovance, Laekna, Macrogenics, Merck, Mersana, Myriad, Novartis, Novocure, OncoC4, Panavance, Pieris, Pfizer, Puma, Regeneron, Roche/Genentech, Sorrento, GSK, US Oncology Research, VBL, Verstem, Zentalis); speakers honoraria (AstraZeneca, Clovis, Eisai, Merck, Myriad, Roche/Genentech, GSK); investigator honoraria (Gradalis). (© IGCS and ESGO 2023. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)

Heshmati, J., et al. (2019). "The Effects of Probiotics or Synbiotics Supplementation in Women with Polycystic Ovarian Syndrome: a Systematic Review and Meta-Analysis of Randomized Clinical Trials." Probiotics and Antimicrobial Proteins 11(4): 1236-1247.
	We searched bibliographic databases from inception through May 2018 to evaluate the effect of probiotics (or synbiotics) supplementation in women suffering from polycystic ovary syndrome (PCOS). Seven trials involving 236 women with PCOS and 235 controls were included in the meta-analysis. Comparing with the control group, probiotics (or synbiotics) may improve Quantitative insulin sensitivity check index (QUICKI) (standardized mean difference (SMD) 0.41, 95% confidence intervals (CI) 0.01 to 0.82, P = 0.04), decrease triglyceride (TG) level (mean difference (MD) - 17.51 mg/dL, 95% CI - 29.65 to - 5.36); fasting insulin: (MD - 2.14 μIU/mL, 95% CI - 4.24 to - 0.04), and increase high-density lipoprotein (HDL) (SMD 1.55 mg/dL, 95% CI 0.28 to 2.81). No significant effect of probiotics (or synbiotics) on homeostatic model assessment-insulin resistance (HOMA-IR), fasting plasma glucose (FPG), low-density lipoprotein (LDL), total cholesterol (TC), and anthropometric indices was found in women with PCOS. Although probiotic (or synbiotics) supplementation was effective on some metabolic indices, the effect was negligible and not clinically significant.

Hess, E., et al. (2021). "Internet-based treatment for vulvodynia (EMBLA) - Study protocol for a randomised controlled study." Internet interventions 25: 100396.
	Background: Vulvodynia is defined as vulvar pain for at least 3 months without a clear cause. To the best of our knowledge, there are no trials investigating the effects of internet treatment using CBT (Cognitive behavioural therapy) treatment with Acceptance and Commitment Therapy (ACT) components for women with vulvodynia. The aim of this study is to examine the effects of such a guided internet-based intervention on provoked vulvar pain during the waiting period before clinical treatment.; Methods: We will randomise 52 patients to either guided internet-based intervention with CBT with (ACT) components or no intervention during the waiting period for treatment as usual. Online assessments are conducted at baseline, posttreatment, and at follow-up after 9 months. The primary outcome measure is provoked vulvar pain. Secondary outcomes are depression, anxiety, sexual function, and quality of life. Linear-mixed effect models will be used to assess the effect of the internet-based intervention on vulvar pain, pain acceptance, depression, anxiety, sexual function, and quality of life over time, by applying the intention-to-treat approach. Continuous data will be analysed with general linear models using intention-to-treat and also per protocol approaches to assess the effects of the intervention at different time points. Ordinal and binary data will be analysed with Mann Whitney's test, Fischer's exact test and multivariate logistic regression, respectively.; Discussion: As a randomised controlled trial with short- and long-term follow-up points, the EMBLA study intends to provide a novel and better understanding regarding the treatment of vulvodynia and the role of internet-based treatment as a complement to standard care for women suffering from vulvodynia. The effects of vulvodynia on pain, sexual function, quality of life, depression, and anxiety are investigated. The study's results are expected to be of value in the planning of clinical care in the medical area. High dropout rates and technical difficulties associated with using the platform are common in similar studies.; Trial Registration Number: NCT02809612.; Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2021 The Author(s).)

Hewawasam, E., et al. (2020). "Assessing Whether Meditation Improves Quality of Life for Adolescent Girls With Polycystic Ovary Syndrome: Protocol for a Randomized Controlled Trial." JMIR Research Protocols 9(1): e14542.
	Background: Polycystic Ovary Syndrome (PCOS) is a common endocrine condition characterized by irregular periods and hyperandrogenism. Adolescents with PCOS have impaired quality of life (QOL) and increased psychological distress. Transcendental Meditation (TM) is a well-established self-management strategy that has been used to improve stress and well-being. A meta-analysis of TM trials has shown beneficial effects on stress and blood pressure in adults. Recent data are suggesting that another self-management strategy called a mindfulness stress management program has a role in improving QOL in women with PCOS, but there are no studies in adolescents.; Objective: This study aims to evaluate the effect of TM on QOL and psychological distress in adolescent girls with PCOS.; Methods: This study is a randomized controlled trial that will be conducted over eight weeks at the Women's and Children's Hospital in Adelaide, South Australia, to determine the effect of TM on QOL and psychological distress in adolescent girls (aged 12-20 years) with PCOS. A total of 40 girls will be randomized into either the TM (n=20) or control group (n=20). The TM group will be asked to practice TM in a comfortable sitting position with the eyes closed, for 15 minutes twice daily over eight weeks. The control group will be asked to sit quietly for 15 minutes twice daily for eight weeks. The primary outcomes are any effects on improving QOL and psychological distress, and the secondary outcomes are any effects on lowering blood pressure and salivary cortisol levels.; Results: The recruitment of study participants began in May 2019 and is expected to be completed by June 2020. It is expected that the adolescent girls with PCOS practicing TM over eight weeks will have a significant improvement in QOL and psychological distress compared to adolescents in the control group. Also, it is expected that adolescent girls in the TM group will have lower salivary cortisol levels and lower blood pressure.; Conclusions: This study will be the first to evaluate the effect of TM on QOL in adolescent girls with PCOS. The study will provide valuable information on a potential self-management strategy to improve QOL and well-being in adolescent girls with PCOS.; Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN1261900019010; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376657&amp;isReview=true.; International Registered Report Identifier (irrid): PRR1-10.2196/14542. (©Erandi Hewawasam, Leah Brennan, Lynne Giles, Mary Louise Hull, Asha Short, Robert Norman, Alexia S Peña. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 28.01.2020.)

Hewett, R. (2022). "Effects of visceral manipulation treatment on women with infertility and adults with low back pain." Dissertation Abstracts International: Section B: The Sciences and Engineering 83(5-B): No-Specified.
	Background. Visceral manipulation (VM) is a manual therapy treatment approach applied to the abdominal region that focuses on releasing restrictions around the visceral tissue. There are many benefits of this treatment, ranging from improved digestion to improvement of women's health conditions, such as endometriosis. Over 6.7 million women currently struggle with the devastating effects of infertility worldwide. Current treatment options include hormone therapy, in-vitro fertilization (IVF), and acupuncture. These options tend to be expensive, carry a variety of short- and long-term health risks, and have not proven to always be effective. Current research suggests that many of the issues contributing to infertility are connected to restrictions within the fascia, scar tissue build-up, and lymphatic congestion. Therefore, we conducted a systematic review (SR) to synthesize the current research on VM. Our purpose was to determine if VM is a more effective treatment option than acupuncture in helping to increase rates of pregnancy in women struggling with infertility.Adult low-back pain (LBP) is a worldwide challenge that has led to a decrease in quality of life and physical activity as well as detrimental increases in health-related costs. Currently, the most common treatments for LBP are prescription medications and therapeutic exercise. However, even with the use of these treatments, there are still people who are unable to find relief from their pain, leading us to question what other treatments could be effective. Therefore, the purpose of the critically appraised topic (CAT) was to examine the current research in order to assess if VM is more effective than the current treatment options in assisting adults struggling with LBP. Methods. We conducted the search for the SR over five databases from May 2020 to January 2021. Two independent reviewers screened abstracts and full-text articles about this topic that included human female subjects and full-text articles in English. Exclusion criteria included articles that were not relevant, treatment options other than acupuncture and IVF, pilot studies, premature ovarian failure, and polycystic ovary syndrome. Two investigators independently rated the risk of bias using the PEDro and NIH-NHLBI tools.We conducted the search for the CAT from January 2010 to January 2021. Two independent reviewers screened the resulting articles about the topic that included human subjects, adults, and in English. Articles that included patients with pre-existing conditions or additional treatment options besides osteopathic manipulative treatment (OMT), VM, or therapeutic exercise were excluded from the results. Two investigators independently rated the risk of bias using the PEDro and NIH-NHLBI tools. P-values and confidence intervals are reported in this paper. Results. For the SR, there were a total 1,346 articles screened, and, of those, 152 full-text articles were assessed for eligibility, resulting in 11 articles included in the SR. The results of the SR revealed that VM could be a potential non-invasive treatment option for women struggling with infertility. Kramp (2012), Wurn et al. (2008), and Rice et al. (2015) assessed pregnancy rates after a manual therapy treatment program and showed significantly improved pregnancy rates.For the CAT, there were a total of 187 articles screened, and only three of those full-text articles were appraised. Tamer et al. (2017) and Licciardone and Gatchel (2020) revealed significant improvements in patients who received VM or OMT for their LBP (p < 0.05). Santos et al. (2019) also recorded improvements in LBP within the VM group. However, there was not significant differences in improvement when compared to the control. Conclusions. The results appeared to be promising for the use of VM. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

Hiam, D., et al. (2019). "The effectiveness of high intensity intermittent training on metabolic, reproductive and mental health in women with polycystic ovary syndrome: study protocol for the iHIT- randomised controlled trial." Trials 20(1): 221.
	Background: Polycystic ovary syndrome (PCOS) is a reproductive-metabolic condition. Insulin resistance is a hallmark of PCOS and is related to increased hyperandrogenism that drives inherent metabolic, reproductive and psychological features of the syndrome. Insulin resistance in women with PCOS is managed by weight loss, lifestyle interventions (i.e. exercise, diet) and insulin-sensitising medications. This manuscript describes the protocol of our study evaluating the effectiveness of high intensity intermittent training (HIIT) or moderate intensity exercise on cardiometabolic, reproductive and mental health in overweight women with PCOS.; Methods/design: We will employ a three arm, parallel-group, randomised controlled trial recruiting 60 women diagnosed with PCOS, aged between 18 and 45 years and with a body mass index (BMI) greater than 25 kg/m 2 . Following screening and baseline testing, women will be randomised by simple randomisation procedure using computer generated sequence allocation to undergo one of two 12-week supervised interventions: either HIIT or moderate intensity exercise (standard supervised exercise), or to standard care [Con] (unsupervised lifestyle advice) at a 1:1:1 allocation ratio. The primary outcome for this trial is to measure the improvements in metabolic health; specifically changes in insulin sensitivity in response to different exercise intensities. Baseline and post-intervention testing include anthropometric measurements, cardiorespiratory fitness testing, reproductive hormone profiles (anti-müllerian hormone and steroid profiles), metabolic health, health-related quality of life and mental health questionnaires and objective and subjective lifestyle monitoring. Reporting of the study will follow the CONSORT statement.; Discussion: This trial aims to demonstrate the comparative efficacy and maintenance of different exercise intensities to advance the understanding of PCOS management and provide insight into the optimal exercise intensity for improved cardiometabolic outcomes. Secondary outcomes will include the impact of different exercise protocols on reproductive hormone profiles, mental health and health-related quality of life.; Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12615000242527 . Registered on 17 March 2015.

Hiba, M., et al. (2021). "Systematic Review and Meta-Analysis of the efficacy and safety of Tramadol in pain management during outpatient hysteroscopy."
	
Hicks, L. E. and S. Yeo (2023). "Longitudinal Changes of Depressive Symptoms in Sedentary Women Who Exercised During Pregnancy." Women's health reports (New Rochelle, N.Y.) 4(1): 523-530.
	INTRODUCTION: Prenatal depression is a common disorder; however, little is known about how depressive symptoms manifest during pregnancy, including when symptoms present and what symptoms are common. This study aimed to better understand prenatal depressive symptoms during pregnancy in the postpartum period, as well as how exercise, such as walking and stretching, can improve depressive symptoms during pregnancy and the postpartum period. METHODS: A total of 55 women were assessed using the Beck Depression Inventory-II for depressive symptoms at 16 weeks, 28 weeks, and 2 months postpartum. Sedentary pregnant women at-risk for preeclampsia were randomly assigned to either a stretching or walking group for 40 minutes five times a week from 18 weeks of gestation until birth. The primary analyses were analysis of variance and mixed-effects models. RESULTS: All depressive symptoms decreased throughout pregnancy during the postpartum period, although this trend was not statistically significant. Cognitive-affective and somatic depressive symptoms had different trajectories during pregnancy into the postpartum period, but no significant difference was found. Statistically significant improvements were observed in loss of energy and change in sleeping pattern for the walking and stretching groups. CONCLUSION: The finding that physical activity improves the depressive symptoms' loss of energy and changes in sleeping patterns during pregnancy aligns with the existing literature, but little research has examined how individual depressive symptoms change throughout pregnancy into the postpartum period. Gaining a better understanding of the trajectories and manifestations of depressive symptoms during pregnancy and the postpartum period is essential for improving detection and treatment practices. Understanding when and how depressive symptoms are present is critical for the clinical diagnosis of this disorder.

Hidalgo-Padilla, L., et al. (2023). "Association between maternity leave policies and postpartum depression: a systematic review." Archives of Women's Mental Health 26(5): 571-580.
	PURPOSE: Working mothers are at greater risk for postpartum depression. Maternity leave characteristics, including length, wage replacement and employment protection, could have relevant implications for mothers' mental health. We propose to explore whether there is an association between maternity leave characteristics and postpartum depression. METHODS: We conducted a systematic review searching for randomized controlled trials, quasi-experimental, cohort or cross-sectional studies on five databases using search terms including maternity and parental leave and depression, as well as references in relevant articles. We identified 500 articles and included 23 of those. We used the EPHPP Quality Assessment Tool for Quantitative Studies to assess the quality of the studies. RESULTS: Paid and longer maternity leaves tend to be associated with a reduction of postpartum depression symptoms in high-income countries. No studies explored the association between employment protection and postpartum depression. The quality of studies ranged from strong to weak, mostly influenced by study design. CONCLUSION: More restrictive maternity leave policies tend to be associated with higher rates of postpartum depression, although more research needs to be conducted in the Global South.

Hidayat Yudi, M., et al. (2021). "Analysis of Curcumin as a Radiosensitizer in Cancer Therapy with Serum Survivin Examination: Randomised Control Trial." Asian Pacific journal of cancer prevention : APJCP 22(1): 139-143.
	Objective: One of the important treatments for cervical cancer is radiation therapy. This study sought to determine the role of curcumin as a radio-sensitizing agent for use with radiation therapy for cervical cancer. To accomplish this, we assessed the levels of survivin, which is an anti-apoptotic protein that plays a role in cell division and apoptosis inhibition.; Method: This study used a quasi-experimental design, including a pretest-posttest control group design approach. The study subjects included cervical carcinoma stage IIB-IIIB patients who were scheduled to undergo surgery at the Hasan Sadikin Hospital Bandung during the research period. The advanced cervical cancer patients were assigned to two groups: i) those who received curcumin + radiation therapy and ii) those who received placebo + radiation therapy.; Results: In the group treated with curcumin + radiation, 15 (75%) patients showed decreased survivin levels and 5 (25%) showed increased survivin levels. Whereas, in the placebo + radiation group, there were 8 (40%) patients who showed decreased survivin levels and 12 (60%) who showed increased survivin levels.; Conclusion: In conclusion, curcumin is an effective, alternative radiosensitizer agent for application in cervical cancer treatment.<br />.

Hill, A. M., et al. (2022). "Chlorhexidine Versus Iodine for Vaginal Preparation Before Hysterectomy: A Randomized Clinical Trial." Female Pelvic Medicine and Reconstructive Surgery 28(2): 77-84.
	Objective: The American College of Obstetricians and Gynecologists does not provide a recommendation regarding the preferred vaginal preparation solution. We intended to compare the effectiveness of chlorhexidine versus iodine in decreasing vaginal bacterial counts. Method(s): In this institutional review board-approved study, participants undergoing total hysterectomy via vaginal or laparoscopic approach were randomized to 4% chlorhexidine or 10% iodine for presurgical vaginal preparation. Swabs were collected from the vaginal mucosa before, then 30, 60, and 90 minutes after preparation. Our primary outcome was the number of positive cultures (>=5,000 bacteria) at 90 minutes. The secondary outcomes included the presence of selected pathogens, postoperative complications, and infections. The sample size of 71 per arm was calculated using P = 0.05, 80% power, and anticipating a 22% difference in positive cultures. Result(s): Between May 2018 and August 2019, 85 participants were randomized. The average age was 59.8 years (SD, 11.4), and the median Charlson Comorbidity Index score was 2 (minimum, 0; maximum, 6). Baseline bacterial counts were similar in both groups. Chlorhexidine demonstrated a lower percentage of positive cultures at 90 minutes (47.6% vs 85.4%; odds ratio, 10.6; P = 0.001). In addition, the median bacterial count in the chlorhexidine group was significantly lower than the iodine group (3,000 vs 24,000 colony-forming units, P < 0.001) at 90 minutes. No surgical site infections were identified in either group during the 30-day postoperative period, and there were no reported adverse reactions to either solution. Conclusion(s): Chlorhexidine resulted in substantially lower bacterial counts after preparation compared with iodine. Gynecologic surgeons may consider switching to 4% chlorhexidine for vaginal preparation before hysterectomy.Copyright © 2021 American Urogynecologic Society. All rights reserved.

Hillemanns, P., et al. (2023). "Innovative surgical concepts for cervical cancer." Onkologie 29(11): 956-966.
	Background: Three main topics have dominated the surgical treatment of early cervical cancer in recent years. The trend towards minimally invasive surgery has suffered a severe setback with the publication of the LACC trial (Laparoscopic Approach to Cervical Cancer, 2018). Reduced surgical radicalism with sentinel diagnostics and avoidance of radical hysterectomy are the two other topics. Material(s) and Method(s): Selective literature research, evaluation of own patient collectives and current congress reports are presented. Result(s): Abdominal radical hysterectomy became the standard procedure for the surgical treatment of early cervical cancer. This was followed by a plethora of secondary analyses ranging from registry-based data, proprietary data, to multicenter retrospective studies to identify the causes of laparoscopy's poor performance. However, only the initiated prospective randomized trials will give us the answer. Another trend is the avoidance of complete lymphadenectomy by sentinel diagnostics in early cervical cancer up to 4cm, which are mainly based on indocyanine green. Fortunately, this question will be answered with the SENTICOL-III study. Even with the introduction of trachelectomy for cervical carcinoma up to 2cm, we know that this stage has a very good prognosis. However, this FIGO (Federation Internationale de Gynecologie et d'Obstetrique) stage in the laparoscopic arm of the LACC study also had a significantly worse recurrence-free survival-although not significant due to the small number of cases. With the presentation of the SHAPE study comparing simple and radical hysterectomy at the American Society of Clinical Oncology (ASCO) 2023 congress, a further chapter on the reduction of surgical radicalism was opened.Copyright © 2023, The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.

Hilton, J., et al. (2022). "BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extraterminal Domain Proteins, in Patients with Selected Advanced Solid Tumors: Results from a Phase 1/2a Trial." Cancers 14(17): 4079.
	This phase 1/2a, open-label study (NCT02419417) evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of BMS-986158, a selective bromodomain and extraterminal domain (BET) inhibitor. Dose escalation was performed with 3 BMS-986158 dosing schedules: A (5 days on, 2 days off; range, 0.75-4.5 mg), B (14 days on, 7 days off; 2.0-3.0 mg), and C (7 days on, 14 days off; 2.0-4.5 mg). Eighty-three patients were enrolled and received >=1 BMS-986158 dose. Diarrhea (43%) and thrombocytopenia (39%) were the most common treatment-related adverse events (TRAEs). A lower incidence of TRAEs was found with schedules A (72%) and C (72%) vs. B (100%). Stable disease was achieved in 12 (26.1%), 3 (37.5%), and 9 (31.0%) patients on schedules A, B, and C, respectively. Two patients on schedule A with a 4.5-mg starting dose (ovarian cancer, n = 1; nuclear protein in testis [NUT] carcinoma, n = 1) experienced a partial response. BMS-986158 demonstrated rapid-to-moderate absorption (median time to maximum observed plasma concentration, 1-4 h). As expected with an epigenetic modifier, expression changes in select BET-regulated genes occurred with BMS-986158 treatment. Schedule A dosing (5 days on, 2 days off) yielded tolerable safety, preliminary antitumor activity, and a dose-proportional PK profile.Copyright © 2022 by the authors.

Himiniuc Loredana Maria, M., et al. (2021). "Transradial Embolization, an Underused Type of Uterine Artery Embolization Approach: A Systematic Review." Medicina (Kaunas, Lithuania) 57(2).
	Background and Objectives: The most utilized approach for the embolization of uterine arteries is the transfemoral path. However, the transradial approach (TRA) has been gaining popularity among cardiologic interventions in the last years but only few studies have shown its applicability in uterine myoma treatment. The objective of this paper is to assess the feasibility, safety and efficacy of TRA when compared with the transbrachial, transulnar or transfemoral approach (TFA) for uterine arteries embolization (UAE). Materials and methods: A systematic review of the literature that analyzes the TRA for UAE it was carried out, in order to assess its safety and effectiveness. It was systematically searched the literature (Google Scholar, PubMed/MEDLINE, Cochrane Library and Embase) using the words ''uterine artery embolization''/''uterine embolization'' and ''transradial''/''radial''. All the relevant papers published until March 2020 were retrieved and analyzed. Results: Ten studies were considered eligible for this topic. TRA is a comparable method with TFA for uterine artery embolization. Conclusions: These studies allowed us to conclude that TRA is as safe and efficient as TFA. Its advantages include few complications, shorter hospitalization period, and rapid mobilization but a steeper learning curve has the disadvantage of a longer learning curve compared to TFA. Yet, these findings are built on few reports and more research is needed.; Competing Interests: The authors declare no conflict of interest.

Hinchcliff, E., et al. (2022). "State of the science: Contemporary front-line treatment of advanced ovarian cancer." Gynecologic Oncology 166(1): 18-24.
	
Hinchcliff Emily, M., et al. (2023). "Randomized phase 2 trial of tremelimumab and durvalumab in combination versus sequentially in recurrent platinum-resistant ovarian cancer." Cancer.
	Background: Single-agent immune checkpoint inhibitors (ICIs) have demonstrated limited responses in recurrent ovarian cancer; however, 30%-40% of patients achieve stable disease. The primary objective was to estimate progression-free survival (PFS) after sequential versus combination cytotoxic T-lymphocyte antigen 4 and programmed death ligand 1 ICIs in patients with platinum-resistant high-grade serous ovarian cancer (HGSOC).; Methods: Patients were randomized to a sequential arm (tremelimumab followed by durvalumab on progression) or a combination arm (tremelimumab plus durvalumab, followed by durvalumab) via a Bayesian adaptive design that made it more likely for patients to be randomized to the more effective arm. The primary end point was immune-related PFS (irPFS).; Results: Sixty-one subjects were randomized to sequential (n = 38) or combination therapy (n = 23). Thirteen patients (34.2%) in the sequential arm received durvalumab. There was no difference in PFS in the sequential arm (1.84 months; 95% CI, 1.77-2.17 months) compared with the combination arm (1.87 months; 95% CI, 1.77-2.43 months) (p = .402). In the sequential arm, no responses were observed, although 12 patients (31.6%) demonstrated stable disease. In the combination arm, two patients (8.7%) had partial response, whereas one patient (4.4%) had stable disease. Adverse events were consistent with those previously reported for ICIs. Patient-reported outcomes were similar in both arms.; Conclusions: There was no difference in irPFS for combination tremelimumab plus durvalumab compared to tremelimumab alone (administered as part of a sequential treatment strategy) in a heavily pretreated population of patients with platinum-resistant HGSOC. Response rates were comparable to prior reports, although the combination regimen did not add significant benefit, as has been previously described. (© 2023 American Cancer Society.)

Hintz Graeme, C., et al. (2019). "Sclerotherapy for rectal prolapse in children: A systematic review and meta-analysis." Journal of pediatric surgery 54(5): 1083-1088.
	Background: Sclerotherapy is a commonly utilized treatment for rectal prolapse in children. This study systematically evaluates the effectiveness and complications of various sclerosing agents in treating pediatric rectal prolapse.; Methods: After protocol registration (CRD-42018088980), multiple databases were searched. Studies describing injection sclerotherapy for treatment of pediatric rectal prolapse were included, with screening and data abstraction duplicated. The methodological quality of included papers was assessed using the Methodological Index for Non-Randomized Studies (MINORS) score.; Results: Nineteen studies were identified, published between 1970 and 2017. Most studies were single institution case series, with median "N" 57+/-88.9 and mean MINORS score of 0.51+/-0.17 (perfect score = 1). 1510 patients with a mean age of 4.5 years were accounted for: 36.2% female, most without comorbidities. Mean follow up length was 30 months. The most common sclerosing agent described was ethanol (45%), followed by phenol (33%). The mean number of treatments per patient was 1.1+/-0.34. The overall success rate after a single sclerotherapy treatment was 76.9%+/-8.8%. The overall complication rate was 14.4%+/-2%.; Conclusions: Injection sclerotherapy appears effective and low-risk in the treatment of pediatric rectal prolapse and should be considered before more invasive surgical options. The available evidence is of relatively poor quality, and prospective comparative investigations are warranted.; Level of Evidence: 3 (meta-analysis of level 3 studies). (Copyright © 2019. Published by Elsevier Inc.)

Hipólito-Reis, M., et al. (2022). "Impact of curcumin, quercetin, or resveratrol on the pathophysiology of endometriosis: A systematic review." Phytotherapy research : PTR 36(6): 2416-2433.
	Endometriosis, a gynecological disease that affects reproductive age women is difficultly controlled in the long term by currently available treatments, prompting patients to adopt self-controlled interventions including dietary changes. The aim of this review is to provide evidence of how curcumin, quercetin, and resveratrol can act as natural interventions to control endometriosis. The review followed PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. A comprehensive search was carried out in PubMed, Scopus, and Web of Science to gather together all the articles that study the specific actions of curcumin, resveratrol, or quercetin in endometriosis pathophysiology. All types of study designs including experimental data were considered. Thirty articles, including a clinical trial, were included. For the assessment of the quality of the selected studies that globally have "good quality", the GRADE (Grading of Recommendations Assessment, Development and Evaluation) and the SYRCLE ROB tool criteria were used. By acting on mechanisms of inflammation, oxidative stress, cell proliferation, invasion and adhesion, apoptosis, angiogenesis and glucose and lipid metabolism, curcumin, quercetin, and resveratrol showed to have beneficial effects, evidencing their potential application in the endometriosis treatment. However, future clinical studies are necessary to determine the real efficacy of these compounds in human endometriosis. (© 2022 John Wiley & Sons Ltd.)

Hirata, T., et al. (2020). "Clinical practice guidelines for the treatment of extragenital endometriosis in Japan, 2018." The Journal of Obstetrics and Gynaecology Research.
	The aim of this publication is to disseminate the clinical practice guidelines for the treatment of intestinal, bladder/ureteral, thoracic and umbilical endometriosis, already published in Japanese, to non-Japanese speakers. For developing the original Japanese guidelines, the clinical practice guideline committee was formed by the research team for extragenital endometriosis, which is part of the research program of intractable disease of the Japanese Ministry of Health, Labor and Welfare. The clinical practice guideline committee formulated eight clinical questions for the treatment of extragenital endometriosis, which were intestinal, bladder/ureteral, thoracic and umbilical endometriosis. The committee performed a systematic review of the literature to provide responses to clinical questions and developed clinical guidelines for extragenital endometriosis, according to the process proposed by the Medical Information Network Distribution Service. The recommendation level was determined using modified Delphi methods. The clinical practice guidelines were officially approved by the Japan Society of Obstetrics and Gynecology and the Japan Society of Endometriosis. This English version was translated from the Japanese version. (© 2020 The Authors. Journal of Obstetrics and Gynaecology Research published by John Wiley & Sons Australia, Ltd on behalf of Japan Society of Obstetrics and Gynecology.)

Hiroaki, Y., et al. (2023). "Multicenter phase II investigator initiated trial (STATICE TRIAL, NCCH1615, UMIN 000029506) ; A novel anti-HER2 therapy of trastuzumab deruxtecan in HER2-expressing uterine carcinosarcoma." Journal of Obstetrics and Gynaecology Research 49(1): 369.
	[Objective] Uterine carcinosarcoma (UCS) is an aggressive malignant tumor. Previous studies reported that human epidermal growth factor receptor 2 (HER2) expression was detected in 20-50% of UCS patients. Here, we conducted a phase 2, multi-center clinical trial to evaluate the efficacy of trastuzumab deruxtecan (T-DXd) by targeting HER2. [Methods] Between February 2018 and June 2020 at 7 institutions in Japan, we enrolled standard chemotherapy-refractory UCS patients with HER2-expression assessed by immunohistochemistry. T-DXd was administered every 3 weeks until progressive disease (PD) or intolerable toxic effects were confirmed. The primary end-point was overall response rate (ORR) inHER2 2+/3+(2+/3+) on central review, and the secondary endpoints were ORR in HER2 1 + (1+) or more, progression-free survival, overall survival and incidence of adverse events. The trial design was based on the Bayesian strategy. [Results] 34 patients were enrolled, 22 patients with 2+/3+ and 10 patients with 1+ were included in the efficacy analysis. The number of complete response and partial response (PR) was 12 (55%), stable disease (SD) was 10 (45%) and no PD in 2+/3+, therefore, it exceeded the minimum required number of responders (4 out of 22 patients). In 1+ patients, the number of PR was 7 (70%), SD was 3 (30%) and no PD. Pneumonitis or interstitial lung disease with grade 1 to 3 occurred in 9 patients (27%) and no grade 4/5 events were reported. [Conclusion] The primary endpoint of ORR in 2+/3+ patients was met. T-DXd has also shown a promising efficacy in 1+ patients.

Hirte, H., et al. (2022). "Neoadjuvant and Adjuvant Systemic Therapy for Newly Diagnosed Stage II-IV Epithelial Ovary, Fallopian Tube, or Primary Peritoneal Carcinoma: A Practice Guideline." Current oncology (Toronto, Ont.) 29(1): 231-242.
	Background: This study aims to provide guidance for the use of neoadjuvant and adjuvant systemic therapy in women with newly diagnosed stage II-IV epithelial ovary, fallopian tube, or primary peritoneal carcinoma.; Methods: EMBASE, MEDLINE, and Cochrane Library were investigated for relevant systematic reviews and phase III trials. Articles focusing on consolidation and maintenance therapies were excluded.; Results: For women with potentially resectable disease, primary cytoreductive surgery, followed by six to eight cycles of intravenous three-weekly paclitaxel and carboplatin is recommended. For those with a high-risk profile for primary cytoreductive surgery, neoadjuvant chemotherapy can be an option. Adjuvant chemotherapy with six cycles of dose-dense weekly paclitaxel plus three-weekly carboplatin can be considered for women of Japanese descent. In women with stage III or IV disease, the incorporation of bevacizumab concurrent with paclitaxel and carboplatin is not recommended for use as adjuvant therapy unless bevacizumab is continued as maintenance therapy. Intravenous paclitaxel plus intraperitoneal cisplatin and paclitaxel can be considered for stage III optimally debulked women who did not receive neoadjuvant chemotherapy. However, intraperitoneal administration of chemotherapy with bevacizumab should not be considered as an option for stage II-IV optimally debulked women.; Discussion: The recommendations represent a current standard of care that is feasible to implement and valued by both clinicians and patients.

Hisano, M., et al. (2023). "Multicenter, 2-dose single-group controlled trial of tacrolimus for the severe infertility patients." Medicine 102(32): e34317.
	Introduction: Infertility is estimated to affect 8% to 12% of reproductive-aged couples worldwide. While approximately 85% of infertile couples have an identified cause, the remaining 15% suffer physically and emotionally from unexplained intractable infertility. In recent years, maternal-to-fetal immunological abnormalities have attracted attention as mechanisms that differ from the conventional factors contributing to infertility and pregnancy loss. A T-helper 2 (Th2)-dominant immune state has been proposed as a maternal immune alteration to eliminate rejection and induce tolerance to a semi-allogeneic fetus. An imbalance in Th1 responses would not induce adequate maternal immune tolerance to the fetus or early embryos. Tacrolimus, widely used as an immunosuppressant agent in solid organ transplant recipients, is expected to suppress maternal rejection and promote tolerance to early embryos after assisted reproductive technology by modulating the immunological environment of the preimplantation endometrium. We planned an exploratory clinical trial to determine the efficacy, safety, and dosage of tacrolimus in women with intractable infertility.; Methods and Analysis: This is a multicenter, 2-dose, single-group controlled trial in infertile women who failed to achieve a chemical pregnancy despite multiple in vitro fertilization (IVF) and embryo transfer (ET) treatment cycles. The following 2 key selection criteria were set: no underlying factors of infertility despite appropriate evaluation and presence of Th1-dominant immune state, defined as a Th1/Th2 cell ratio ≥ 10.3 in the peripheral blood. A total of 26 eligible participants are randomly assigned (in a 2:1 ratio) to receive immunosuppressive therapy with oral tacrolimus at a daily dose of 2 mg or 4 mg. Tacrolimus is administered for 16 days starting from 2 days before ET. The primary endpoint is the presence of clinical pregnancy 3 weeks after IVF/ET treatment, and the secondary endpoint is the presence of biochemical pregnancy 2 weeks after IVF/ET treatment. Safety evaluation and biomarker discovery for tacrolimus treatment in infertile women will be conducted simultaneously.; Trial Registration Number: Japan Registry of Clinical Trials (jRCT; jRCTs031220235).; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.)

Hitova-Topkarova, D., et al. (2023). "Electronic brachytherapy for gynecological cancers - a systematic review." Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology 28(1): 79-87.
	Background: The purpose of this manuscript is to provide an in-depth literature review of the management of endometrial and cervical cancers with electronic brachytherapy.; Materials and Methods: An extensive literature search was performed and 9 articles were selected based on preset criteria.; Results: The reviewed studies provided dosimetric and clinical results. Patient populations were diverse and prescribed doses varied. When treatment plans were compared to those using cobalt 60 ( 60 Co) and iridium 192 ( 192 Ir) sources researchers found lower or equivalent doses in organs at risk while the doses at the applicator surface were significantly higher for electronic brachytherapy. In the eligible studies, a total of 72 patients received treatment with AxxentXoft vaginal applicator, 29 were treated with the Intrabeam vaginal applicator, and 8 with AxxentXoft cervical applicator.; Conclusions: All authors found that electronic brachytherapy was safe and well tolerated as higher mucosal doses did not present as adverse clinical effects. Electronic brachytherapy for gynecological cancers has the potential to achieve equivalent tumor control while minimizing bowel and urinary toxicity thus improving the quality of life. More clinical data is needed to stratify patients who would benefit the most.; Competing Interests: Conflict of interest None declared. (© 2023 Greater Poland Cancer Centre.)

Hlinecká, K., et al. (2022). "Uterus sparing surgery in adenomyosis and its impact on reproductive outcomes." Ceska gynekologie 87(4): 282-288.
	OBJECTIVE: The purpose of this study was to evaluate the appropriate surgical treatment of adenomyosis and its impact on reproductive outcomes. CONCLUSION: Patients with adenomyosis and fibroids may show a lower pregnancy rate and higher miscarriage rate than healthy individuals. However, there is no standard protocol for their optimal treatment, particularly in pregnancy-seeking or infertile women. Myomectomy is generally a commonly performed procedure that preserves fertility. On the other hand, the role of surgery in extensive uterine adenomyosis remains controversial, because adenomyosis often involves the whole uterus diffusely. It is almost impossible to remove all pathological tissue from the surrounding myometrium. Therefore, this procedure is called debulking/cytoreductive surgery. However, adenomyomectomy has also become a more common type of surgical intervention in recent years.

Hoare Joseph, I., et al. (2022). "Carvedilol targets β-arrestins to rewire innate immunity and improve oncolytic adenoviral therapy." Communications biology 5(1): 106.
	Oncolytic viruses are being tested in clinical trials, including in women with ovarian cancer. We use a drug-repurposing approach to identify existing drugs that enhance the activity of oncolytic adenoviruses. This reveals that carvedilol, a β-arrestin-biased β-blocker, synergises with both wild-type adenovirus and the E1A-CR2-deleted oncolytic adenovirus, dl922-947. Synergy is not due to β-adrenergic blockade but is dependent on β-arrestins and is reversed by β-arrestin CRISPR gene editing. Co-treatment with dl922-947 and carvedilol causes increased viral DNA replication, greater viral protein expression and higher titres of infectious viral particles. Carvedilol also enhances viral efficacy in orthotopic, intraperitoneal murine models, achieving more rapid tumour clearance than virus alone. Increased anti-cancer activity is associated with an intratumoural inflammatory cell infiltrate and systemic cytokine release. In summary, carvedilol augments the activity of oncolytic adenoviruses via β-arrestins to re-wire cytokine networks and innate immunity and could therefore improve oncolytic viruses for cancer patient treatment. (© 2022. The Author(s).)

Hodgetts, M., et al. (2022). "Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial." Lancet (London, England) 400(10361): 1426-1436.
	Background: Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed to determine the effectiveness of a monofilament suture thread compared with braided suture thread on pregnancy loss rates in women undergoing a cervical cerclage.; Methods: C-STICH was a pragmatic, randomised, controlled, superiority trial done at 75 obstetric units in the UK. Women with a singleton pregnancy who received a vaginal cervical cerclage due to a history of pregnancy loss or premature birth, or if indicated by ultrasound, were centrally randomised (1:1) using minimisation to receive a monofilament suture or braided suture thread for their cervical cerclage. Women and outcome assessors were masked to allocation as far as possible. The primary outcome was pregnancy loss, defined as miscarriage, stillbirth, or neonatal death in the first week of life, analysed in the intention-to-treat population (ie, all women who were randomly assigned). Safety was also assessed in the intention-to-treat population. The trial was registered with ISRCTN, ISRCTN15373349.; Findings: Between Aug 21, 2015, and Jan 28, 2021, 2049 women were randomly assigned to receive a monofilament suture (n=1025) or braided suture (n=1024). The primary outcome was ascertained in 1003 women in the monofilament suture group and 993 women in the braided suture group. Pregnancy loss occurred in 80 (8·0%) of 1003 women in the monofilament suture group and 75 (7·6%) of 993 women in the braided suture group (adjusted risk ratio 1·05 [95% CI 0·79 to 1·40]; adjusted risk difference 0·002 [95% CI -0·02 to 0·03]).; Interpretation: Monofilament suture did not reduce rate of pregnancy loss when compared with a braided suture. Clinicians should use the results of this trial to facilitate discussions around the choice of suture thread to optimise outcomes.; Funding: National Institute of Health Research Health Technology Assessment Programme.; Competing Interests: Declaration of interests VHM is a National Institute for Health and Care Research (NIHR) clinical lecturer and has received an honorarium from Hologic. JD reports membership of the NIHR Clinical Trials Unit Standing Advisory Committee (May 1, 2016, to Sept 30, 2023). JEN is a member of the Health Technology Assessment (HTA) Maternal, Neonatal and Child Health Panel; receives funding from NIHR Efficacy and Mechanism Evaluation programme; participates in a Data Monitoring and Ethics Committee for GlaxoSmithKline; and is a paid consultant for DILAFOR. RKM receives funding from NIHR HTA and programme grants for Applied Health Research schemes; is a steering committee member of the Saving Babies Lives Care Bundle; and a paid Clinical Advisory Board member for Surepulse (a company designing neonatal monitors). All other authors declare no competing interests. (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Hodgetts-Morton, V., et al. (2021). "C-STICH2: emergency cervical cerclage to prevent miscarriage and preterm birth-study protocol for a randomised controlled trial." Trials 22(1): 529.
	Background: Cervical cerclage is a recognised treatment to prevent late miscarriage and pre-term birth (PTB). Emergency cervical cerclage (ECC) for cervical dilatation with exposed unruptured membranes is less common and the potential benefits of cerclage are less certain. A randomised control trial is needed to accurately assess the effectiveness of ECC in preventing pregnancy loss compared to an expectant approach.; Methods: C-STICH2 is a multicentre randomised controlled trial in which women presenting with cervical dilatation and unruptured exposed membranes at 16 + 0 to 27 + 6 weeks gestation are randomised to ECC or expectant management. Trial design includes 18 month internal pilot with embedded qualitative process evaluation, minimal data set and a within-trial health economic analysis. Inclusion criteria are ≥16 years, singleton pregnancy, exposed membranes at the external os, gestation 16 + 0-27 + 6 weeks, and informed consent. Exclusion criteria are contraindication to cerclage, cerclage in situ or previous cerclage in this pregnancy. Randomisation occurs via an online service in a 1:1 ratio, using a minimisation algorithm to reduce chance imbalances in key prognostic variables (site, gestation and dilatation). Primary outcome is pregnancy loss; a composite including miscarriage, termination of pregnancy and perinatal mortality defined as stillbirth and neonatal death in the first week of life. Secondary outcomes include all core outcomes for PTB. Two-year development outcomes will be assessed using general health and Parent Report of Children's Abilities-Revised (PARCA-R) questionnaires. Intended sample size is 260 participants (130 each arm) based on 60% rate of pregnancy loss in the expectant management arm and 40% in the ECC arm, with 90% power and alpha 0.05. Analysis will be by intention-to-treat.; Discussion: To date there has been one small trial of ECC in 23 participants which included twin and singleton pregnancies. This small trial along with the largest observational study (n = 161) found ECC to prolong pregnancy duration and reduce deliveries before 34 weeks gestation. It is important to generate high quality evidence on the effectiveness of ECC in preventing pregnancy loss, and improve understanding of the prevalence of the condition and frequency of complications associated with ECC. An adequately powered RCT will provide the highest quality evidence regarding optimum care for these women and their babies.; Trial Registration: ISRCTN Registry ISRCTN12981869 . Registered on 13th June 2018. (© 2021. The Author(s).)

Hoe, V., et al. (2021). "Urethral bulking agents for the treatment of stress urinary incontinence in women: A systematic review." Neurourology and Urodynamics 40(6): 1349-1388.
	Aims: To perform a systematic review to assess and compare the efficacy and safety of all urethral bulking agents (UBAs) available for the treatment of stress urinary incontinence (SUI) in women. Method(s): This systematic review was conducted in accordance with the PRISMA guideline. A systematic search was conducted using the Ovid Medline, Embase and PubMed databases. Studies were included if they involved women who underwent either Bulkamid, Macroplastique, Durasphere, Coaptite, or Urolastic injections for the treatment of SUI. A total of 583 articles were screened with 56 articles included. A qualitative analysis was performed. Result(s): The newer synthetic UBAs are not inferior to Contigen, with variable mean success rates of 30%-80% in the short-term. Better long-term success rates were found with Bulkamid (42%-70%), Coaptite (60%-75%), and Macroplastique (21%-80%) on qualitative review. Urinary tract infection rates were similar between bulking agents (4%-10.6%) although temporary acute urinary retention was more commonly associated with Coaptite (mean: 34.2%), and de novo urgency in Durasphere (mean: 24.7%). Significant complications such as migration into lymph nodes was reported with Durasphere. Erosion was reported with Macroplastique, Coaptite, and Urolastic, with a rate as high as 24.6% in one study of Urolastic. Conclusion(s): Available data support the use of Bulkamid and Macroplastique, which has shown a short-term efficacy of 30%-90% and 40%-85% respectively, and long-term efficacy of 42%-70%, and 21%-80%, respectively. Bulkamid appears to have a more favorable safety profile, with no cases of erosion or migration of product associated with its use. Direct comparisons of UBAs have not been performed.Copyright © 2021 Wiley Periodicals LLC

Hoegl, J., et al. (2022). "Peritoneal carcinomatosis after minimally invasive surgery versus open radical hysterectomy: systematic review and meta-analysis." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 32(12): 1497-1504.
	Objective: To assess the incidence of peritoneal carcinomatosis in patients undergoing minimally invasive or open radical hysterectomy for cervical cancer.; Methods: The MEDLINE (accessed through Ovid), Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Clinical Trials, and Scopus databases were searched for articles published from inception up to April 2022. Articles published in English were considered. The included studies reported on patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA-IIA squamous cell carcinoma, adenocarcinoma, and/or adenosquamous carcinoma of the cervix who underwent primary surgery. Studies had to report at least one case of peritoneal carcinomatosis as a recurrence pattern, and only studies comparing recurrence after minimally invasive surgery versus open surgery were considered. Variables of interest were manually extracted into a standardized electronic database. This study was registered in PROSPERO (CRD42022325068).; Results: The initial search identified 518 articles. After the removal of the duplicate entries from the initial search, two authors independently reviewed the titles and abstracts of the remaining 453 articles. Finally, 78 articles were selected for full-text evaluation; 22 articles (a total of 7626 patients) were included in the analysis-one randomized controlled trial and 21 observational retrospective studies. The most common histology was squamous cell carcinoma in 60.9%, and the tumor size was <4 cm in 92.8% of patients. Peritoneal carcinomatosis pattern represented 22.2% of recurrences in the minimally invasive surgery approach versus 8.8% in open surgery, accounting for 15.5% of all recurrences. The meta-analysis of observational studies revealed a statistically significant higher risk of peritoneal carcinomatosis after minimally invasive surgery (OR 1.90, 95% CI 1.32 to 2.74, p<0.05).; Conclusion: Minimally invasive surgery is associated with a statistically significant higher risk of peritoneal carcinomatosis after radical hysterectomy for cervical cancer compared with open surgery.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Hoek, A., et al. (2022). "Effects of preconception weight loss after lifestyle intervention on fertility outcomes and pregnancy complications." Fertility and Sterility 118(3): 456-462.
	It is well documented that obesity decreases natural fertility among men and women as well as pregnancy chances after conventional infertility and assisted reproductive technology (ART)-based treatments. Moreover, pregnancy complications are increased in women with overweight and obesity. General guidelines on the treatment of obesity recommend lifestyle intervention, including diet and exercise as the first-line treatment, coupled with or without medical treatments, such as weight loss medication or bariatric surgery, to reduce complications of obesity in adults. In the context of infertility in various countries and infertility clinics, there is a body mass index limit for public refund of infertility treatment of women with obesity. In this respect, it is important to investigate the evidence of effects of lifestyle intervention preceding infertility treatment on reproductive outcomes. The combined results of 15 randomized controlled trials (RCTs) of the effectiveness of preconception lifestyle intervention on reproductive outcomes documented in the latest systemic review and meta-analysis, together with the most recent RCT performed in 2022 are discussed. The current evidence suggests that greater weight loss and increase in clinical pregnancy, live birth, and natural conception rates after lifestyle intervention compared with no intervention were observed, but it seems no beneficial effect of lifestyle intervention preceding ART was observed on these parameters. With respect to potential harm of lifestyle intervention, there is no significant increased risk of early pregnancy loss, although the most recent RCT (not included in the systematic review and meta-analysis) showed a trend toward an increased risk. Complications during pregnancy, such as early pregnancy loss and maternal as well as fetal and neonatal complications, are underreported in most studies and need further analysis in an individual participant data meta-analysis. Limitations of the studies as well as future perspectives and challenges in this field of research will be highlighted. (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Hofmann, K., et al. (2023). "Combinatory Effects of Training and Nutritive Administration of Carbohydrates and Protein via Food on Strength in Postmenopausal Women, and Old Men and Women." Nutrients 15(6).
	The age-related loss of muscle mass promotes many impairments. Training and protein supplementation are suggested to prevent muscle wasting, but recommendations for all populations are not based on scientific evidence. This study combines protein/carbohydrate supplementation (PCS) and training for seniors and postmenopausal women. Project A: 51 postmenopausal women (PMW, 57.3 ± 3.0 years old) underwent health-oriented training (12 weeks, moderate-strength training + moderate-endurance training). The intervention group (IG) additionally received 110 g sour milk cheese (SMC) and toast. Project B: 25 women and 6 men (65.9 ± 4.9 years old) performed intense sling training (12 weeks). The IG additionally received 110 g SMC, toast, and buttermilk. Strength was tested before and after in both studies. Project A: there was significant increase in strength, no additional effect of PCS, and a reduction in body fat in the controls. Project B: there was significant increase in strength, significant additional effects of PCS for trunk strength, and a significant reduction in body weight. Combining training and PCS may counteract strength loss. Combined endurance/resistance training is recommended to PMW for whom the benefits of PCS are restricted. Aged subjects may benefit from PCS when training intensely, but these benefits may be strongly individual.

Hogwood Austin, C., et al. (2023). "The acute effects of exercise intensity and inorganic nitrate supplementation on vascular health in females after menopause." Journal of applied physiology (Bethesda, Md. : 1985) 135(5): 1070-1081.
	Menopause is associated with reduced nitric oxide bioavailability and vascular function. Although exercise is known to improve vascular function, this is blunted in estrogen-deficient females post-menopause (PM). Here, we examined the effects of acute exercise at differing intensities with and without inorganic nitrate (NO 3 - ) supplementation on vascular function in females PM. Participants were tested in a double-blinded, block-randomized design, consuming ∼13 mmol NO 3 - in the form of beetroot juice (BRJ; n = 12) or placebo (PL; n = 12) for 2 days before experimental visits and 2 h before testing. Visits consisted of vascular health measures before ( time point 0 ) and every 30 min after ( time points 60, 90, 120, 150 , and 180 ) calorically matched high-intensity exercise (HIE), moderate-intensity exercise (MIE), and a nonexercise control (CON). Blood was sampled at rest and 5-min postexercise for NO 3 - , NO 2 - , and ET-1. BRJ increased N-oxides and decreased ET-1 compared with PL, findings which were unchanged after experimental conditions ( P < 0.05). BRJ improved peak Δflow-mediated dilation (FMD) compared with PL ( P < 0.05), defined as the largest ΔFMD for each individual participant across all time points. FMD across time revealed an improvement ( P = 0.05) in FMD between BRJ + HIE versus BRJ + CON, while BRJ + MIE had medium effects compared with BRJ + CON. In conclusion, NO 3 - supplementation combined with HIE improved FMD in postmenopausal females. NO 3 - supplementation combined with MIE may offer an alternative to those unwilling to perform HIE. Future studies should test whether long-term exercise training at high intensities with NO 3 - supplementation can enhance vascular health in females PM. NEW & NOTEWORTHY This study compared exercise-induced changes in flow-mediated dilation after acute moderate- and high-intensity exercise in females postmenopause supplementing either inorganic nitrate (beetroot juice) or placebo. BRJ improved peak ΔFMD postexercise, and BRJ + HIE increased FMD measured as FMD over time. Neither PL + MIE nor PL + HIE improved FMD. These findings suggest that inorganic nitrate supplementation combined with high-intensity exercise may benefit vascular health in females PM.

Hoke, T. P., et al. (2019). "Evidence-based review of vaginal native tissue hysteropexy for uterovaginal prolapse." Obstetrical and Gynecological Survey 74(7): 429-435.
	Importance As surgical techniques evolve in the treatment of pelvic organ prolapse and patient preferences are better understood, more studies are investigating uterine-sparing procedures for efficacy, safety, and potentially improved quality of life. Much of the literature reflects the use of mesh material in uterine-sparing procedures, and there is a paucity of data regarding the safety and efficacy of native tissue uterine-sparing procedures for the treatment of pelvic organ prolapse. Objective To summarize existing evidence regarding objective and subjective outcomes of uterine-preserving procedures including the Manchester procedure (MP) as well as native tissue uterovaginal hysteropexy with repairs, namely, uterosacral hysteropexy (USH) and sacrospinous hysteropexy (SSH), compared with outcomes of total vaginal hysterectomy (TVH) with repairs for the management of uterovaginal prolapse. Evidence Acquisition A review of the literature included MEDLINE, Cochrane, and clinicaltrials.gov databases. Results Few level 1 data exist comparing outcomes of native tissue hysteropexy to vaginal hysterectomy for management of uterovaginal prolapse. In general, outcomes of the MP for the management of uterovaginal prolapse revealed that compared with TVH it is associated with shorter operative times, lower estimated blood loss and risk of blood transfusion with no difference in hospital stay, and similar quality of life and sexual function outcomes. Retrospective data suggest no difference with respect to recurrent prolapse of any compartment between USH and TVH with repairs. Level 1 data reveal that SSH has been shown to have similar 1-year outcomes and safety compared with TVH with native tissue suspension. Women with stage 4 prolapse who undergo an SSH may be at higher risk of recurrence and may benefit from an alternative method of apical prolapse repair. Conclusions and Relevance More level 1 data are needed in order to robustly understand long-term differences in outcomes between native tissue uterine-conserving versus vaginal hysterectomy surgical approaches in women with uterovaginal prolapse. Target Audience Obstetricians and gynecologists, family physicians. Learning Objectives After completing this activity, the learner should be better able to explain why uterine-sparing procedures for uterovaginal prolapse are becoming more popular in the United States; compare similarities and differences in subjective and objective outcomes between the MP and TVH; describe subjective and objective outcomes between vaginal native tissue USH and SSH to TVH; and analyze if uterine-sparing surgical procedures impact pregnancy outcomes.Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

Hollebecque, A., et al. (2021). "Safety and Antitumor Activity of α-PD-L1 Antibody as Monotherapy or in Combination with α-TIM-3 Antibody in Patients with Microsatellite Instability-High/Mismatch Repair-Deficient Tumors." Clinical cancer research : an official journal of the American Association for Cancer Research 27(23): 6393-6404.
	PURPOSE: Immune checkpoint inhibitors show high response rates and durable clinical benefit in microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) tumors. However, 50%-60% do not respond to single-agent anti-programmed death-1/programmed death ligand 1 (PD-1/PD-L1) antibodies, and approximately 50% of responders relapse within 6-12 months. This phase Ib trial evaluated safety and antitumor activity of anti-PD-L1 antibody LY3300054 monotherapy or in combination with anti-TIM-3 antibody LY3321367 in patients with MSI-H/dMMR advanced solid tumors. PATIENTS AND METHODS: Eligible patients ≥18 years without prior anti-PD-1/PD-L1 therapy received LY3300054 monotherapy (N = 40) or combination (N = 20); patients with PD-1/PD-L1 inhibitor-resistant/refractory tumors received the combination (N = 22). LY3300054 (700 mg) and anti-TIM-3 antibody (cycles 1-2: 1,200 mg, cycle 3 onward: 600 mg) were administered intravenously every 2 weeks. Primary endpoints were safety and tolerability. RESULTS: Eighty-two patients were enrolled. Most had colorectal (n = 39, 47.6%) or endometrial (n = 14, 17.1%) tumors. More than 70% of patients in the PD-1/PD-L1 inhibitor-resistant/refractory combination cohort had received ≥3 treatment lines. Treatment-related adverse events (TRAE) occurred in 22 patients (55.0%) receiving monotherapy, 13 (65.0%) in the PD-1/PD-L1 inhibitor-naïve combination cohort, and 6 (27.3%) in the PD-1/PD-L1 inhibitor-resistant/refractory combination cohort. A total of 2 patients (5.0%) receiving monotherapy and 3 (7.1%) receiving the combination experienced grade ≥3 TRAEs. Objective responses occurred in 13 patients (32.5%) with monotherapy, 9 (45.0%) in the PD-1/PD-L1 inhibitor-naïve combination cohort, and 1 patient (4.5%) in the PD-1/PD-L1 inhibitor-resistant/refractory combination cohort. CONCLUSIONS: LY3300054 monotherapy and combined LY3300054/anti-TIM-3 had manageable safety profiles. Both regimens showed promising clinical activity against PD-1/PD-L1 inhibitor-naïve MSI-H/dMMR tumors. The combination had limited clinical benefit in patients with PD-1/PD-L1 inhibitor-resistant/refractory MSI-H/dMMR tumors.

Holloway Robert, W., et al. (2023). "Clinical Activity of Olvimulogene Nanivacirepvec-Primed Immunochemotherapy in Heavily Pretreated Patients With Platinum-Resistant or Platinum-Refractory Ovarian Cancer: The Nonrandomized Phase 2 VIRO-15 Clinical Trial." JAMA Oncology 9(7): 903-908.
	Importance: Patients with platinum-resistant or platinum-refractory ovarian cancer (PRROC) have limited therapeutic options, representing a considerable unmet medical need.; Objective: To assess antitumor activity and safety of intraperitoneal (IP) olvimulogene nanivacirepvec (Olvi-Vec) virotherapy and platinum-based chemotherapy with or without bevacizumab in patients with PRROC.; Design, Setting, and Participants: This open-label, nonrandomized multisite phase 2 VIRO-15 clinical trial enrolled patients with PRROC with disease progression following their last prior line of therapy from September 2016 to September 2019. Data cutoff was on March 31, 2022, and data were analyzed between April 2022 and September 2022.; Interventions: Olvi-Vec was administered via a temporary IP dialysis catheter as 2 consecutive daily doses (3 × 109 pfu/d) followed by platinum-doublet chemotherapy with or without bevacizumab.; Main Outcomes and Measures: Primary outcomes were objective response rate (ORR) via Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) and cancer antigen 125 (CA-125) assay, and progression-free survival (PFS). Secondary outcomes included duration of response (DOR), disease control rate (DCR), safety, and overall survival (OS).; Results: Twenty-seven heavily pretreated patients with platinum-resistant (n = 14) or platinum-refractory (n = 13) ovarian cancer were enrolled. The median (range) age was 62 (35-78) years. The median (range) prior lines of therapy were 4 (2-9). All patients completed both Olvi-Vec infusions and chemotherapy. Median follow-up duration was 47.0 months (95% CI, 35.9 months to NA). Overall, ORR by RECIST 1.1 was 54% (95% CI, 33%-74%), with a DOR of 7.6 months (95% CI, 3.7-9.6 months). The DCR was 88% (21/24). The ORR by CA-125 was 85% (95% CI, 65%-96%). Median PFS by RECIST 1.1 was 11.0 months (95% CI, 6.7-13.0 months), and the PFS 6-month rate was 77%. Median PFS was 10.0 months (95% CI, 6.4-NA months) in the platinum-resistant group and 11.4 months (95% CI, 4.3-13.2 months) in the platinum-refractory group. The median OS was 15.7 months (95% CI, 12.3-23.8 months) in all patients, with a median OS of 18.5 months (95% CI, 11.3-23.8 months) in the platinum-resistant group and 14.7 months (95% CI, 10.8-33.6 months) in the platinum-refractory group. Most frequent treatment-related adverse events (TRAEs) (any grade, grade 3) were pyrexia (63.0%, 3.7%, respectively) and abdominal pain (51.9%, 7.4%, respectively). There were no grade 4 TRAEs, and no treatment-related discontinuations or deaths.; Conclusions and Relevance: In this phase 2 nonrandomized clinical trial, Olvi-Vec followed by platinum-based chemotherapy with or without bevacizumab as immunochemotherapy demonstrated promising ORR and PFS with a manageable safety profile in patients with PRROC. These hypothesis-generating results warrant further evaluation in a confirmatory phase 3 trial.; Trial Registration: ClinicalTrials.gov Identifier: NCT02759588.

Holt-Kentwell, A., et al. (2022). "Evaluating interventions and adjuncts to optimize pregnancy outcomes in subfertile women: an overview review." Human Reproduction Update 28(4): 583-600.
	Background: There is a wealth of information regarding interventions for treating subfertility. The majority of studies exploring interventions for improving conception rates also report on pregnancy outcomes. However, there is no efficient way for clinicians, researchers, funding organizations, decision-making bodies or women themselves to easily access and review the evidence for the effect of adjuvant therapies on key pregnancy outcomes in subfertile women.; Objective and Rationale: The aim was to summarize all published systematic reviews (SRs) of randomized controlled trials (RCTs) of interventions in the subfertile population, specifically reporting on the pregnancy outcomes of miscarriage and live birth. Furthermore, we aimed to highlight promising interventions and areas that need high-quality evidence.; Search Methods: We searched the Cochrane Database of Systematic Reviews and PubMed clinical queries SR filter (inception until July 2021) with a list of key words to capture all SRs specifying or reporting any miscarriage outcome. Studies were included if they were SRs of RCTs. The population was subfertile women (pregnant or trying to conceive) and any intervention (versus placebo or no treatment) was included. We adopted Grading of Recommendations, Assessment, Development and Evaluation (GRADE) for determining the quality of the evidence. Exclusion criteria were overview reviews, reviews that exclusively reported on women conceiving via natural conception, reviews including non-randomized study designs or reviews where miscarriage or live birth outcomes were not specified or reported.; Outcomes: The primary outcome was miscarriage, defined as pregnancy loss <24 weeks of gestation. Data were also extracted for live birth where available. We included 75 published SRs containing 121 251 participants. There were 14 classes of intervention identified: luteal phase, immunotherapy, anticoagulants, hCG, micronutrients, lifestyle, endocrine, surgical, pre-implantation genetic testing for aneuploidies (PGT-As), laboratory techniques, endometrial injury, ART protocols, other adjuncts/techniques in the ART process and complementary interventions. The interventions with at least moderate-quality evidence of benefit in reducing risk of miscarriage or improving the chance of a live birth are: intrauterine hCG at time of cleavage stage embryo transfer, but not blastocyst transfer, antioxidant therapy in males, dehydroepiandrosterone in women and embryo medium containing high hyaluronic acid. Interventions showing potential increased risk of miscarriage or reduced live birth rate are: embryo culture supernatant injection before embryo transfer in frozen cycles and PGT-A with the use of fluorescence in situ hybridization.; Wider Implications: This review provides an overview of key pregnancy outcomes from published SRs of RCTs in subfertile women. It provides access to concisely summarized information and will help clinicians and policy makers identify knowledge gaps in the field, whilst covering a broad range of topics, to help improve pregnancy outcomes for subfertile couples. Further research is required into the following promising interventions: the dose of progesterone for luteal phase support, peripheral blood mononuclear cells for women with recurrent implantation failure, glucocorticoids in women undergoing IVF, low-molecular-weight heparin for unexplained subfertility, intrauterine hCG at the time of cleavage stage embryo or blastocyst transfer and low oxygen concentrations in embryo culture. In addition, there is a need for high-quality, well-designed RCTs in the field of reproductive surgery. Finally, further research is needed to demonstrate the integrated effects of non-pharmacological lifestyle interventions. (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Holtzman, S., et al. (2023). "Outcomes for patients with high-risk endometrial cancer undergoing sentinel lymph node assessment versus full lymphadenectomy." Gynecologic Oncology 174: 273-277.
	Objective: The objective of this study was to determine the progression free survival (PFS) and overall survival (OS) among patients with high-risk endometrial cancer (EC) who underwent sentinel lymph node (SLN) mapping and dissection compared to patients who underwent pelvic +/- para-aortic lymphadenectomy (LND).; Methods: Patients with newly diagnosed high-risk EC were identified. Inclusion criteria included patients who underwent primary surgical management from January 1, 2014 to September 1, 2020 at our institution. Patients were categorized into either the SLN or LND group based on their method of planned lymph node assessment. Patients in the SLN group had dye injected followed by successful bilateral lymph node mapping, retrieval, and processing per our institutional protocol. Clinicopathological and follow-up data were extracted from patient's medical records. The t-test or Mann-Whitney test was used to compare continuous variables and Chi-squared or Fisher's exact test were used for categorical variables. Progression-free survival (PFS) was calculated from the date of initial surgery to the date of progression, death, or last follow-up. Overall survival (OS) was calculated from the date of surgical staging to the date of death or last follow-up. Three-year PFS and OS were calculated using the Kaplan-Meier method, and the log-rank test was used to compare cohorts. Multivariable Cox regression models were used to assess the relationship between nodal assessment cohort and OS/PFS while adjusting for age, adjuvant therapy, and surgical approach. A result was considered statistically significant at the p < 0.05 level of significance and all statistical analysis was done using SAS version 9.4 (SAS Institute, Cary, NC).; Results: Out of 674 patients diagnosed with EC during the study period, 189 were diagnosed with high-risk EC based on our criteria. Forty-six (23.7%) patients underwent SLN assessment and 143 (73.7%) underwent LND. No difference was observed between the two groups in regards to age, histology, stage, body mass index, tumors myometrial invasion, lymphovascular space invasion, or peritoneal washing positivity. Patients in the SLN group underwent robotic-assisted procedures more frequently than those in the LND group (p < 0.0001). The three-year PFS rate was 71.1% (95% CI 51.3-84.0%) in the SLN group and 71.3% (95% CI 62.0-78.6%) in the LND group (p = 0.91). The unadjusted hazard ratio (HR) for recurrence in the SLN versus LND group was 1.11 (95% CI 0.56-2.18; p = 0.77), and after adjusting for age, adjuvant therapy, and surgical approach, the HR for recurrence was 1.04 (95% CI 0.47-2.30, p = 0.91). The three-year OS rate was 81.1% (95% CI 51.1-93.7%) in the SLN group and 95.1% (95% CI 89.4-97.8%) in the LND group (p = 0.009). Although the unadjusted HR for death was 3.74 in the SLN vs LND group (95% CI 1.39-10.09; p = 0.009), when adjusted for age, adjuvant therapy, and surgical approach, it was no longer significant with a HR of 2.90 (95% CI 0.94-8.95, p = 0.06).; Conclusions: There was no difference in three-year PFS in patients diagnosed with high-risk EC who underwent SLN evaluation compared to those who underwent full LND in our cohort. The SLN group did experience shorter unadjusted OS; however, when adjusting for age, adjuvant therapy and surgical approach, there was no difference OS in patients who underwent SLN compared to LND. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Hong David, S., et al. (2023). "Autologous T cell therapy for MAGE-A4 + solid cancers in HLA-A*02 + patients: a phase 1 trial." Nature medicine 29(1): 104-114.
	Affinity-optimized T cell receptors can enhance the potency of adoptive T cell therapy. Afamitresgene autoleucel (afami-cel) is a human leukocyte antigen-restricted autologous T cell therapy targeting melanoma-associated antigen A4 (MAGE-A4), a cancer/testis antigen expressed at varying levels in multiple solid tumors. We conducted a multicenter, dose-escalation, phase 1 trial in patients with relapsed/refractory metastatic solid tumors expressing MAGE-A4, including synovial sarcoma (SS), ovarian cancer and head and neck cancer ( NCT03132922 ). The primary endpoint was safety, and the secondary efficacy endpoints included overall response rate (ORR) and duration of response. All patients (N = 38, nine tumor types) experienced Grade ≥3 hematologic toxicities; 55% of patients (90% Grade ≤2) experienced cytokine release syndrome. ORR (all partial response) was 24% (9/38), 7/16 (44%) for SS and 2/22 (9%) for all other cancers. Median duration of response was 25.6 weeks (95% confidence interval (CI): 12.286, not reached) and 28.1 weeks (95% CI: 12.286, not reached) overall and for SS, respectively. Exploratory analyses showed that afami-cel infiltrates tumors, has an interferon-γ-driven mechanism of action and triggers adaptive immune responses. In addition, afami-cel has an acceptable benefit-risk profile, with early and durable responses, especially in patients with metastatic SS. Although the small trial size limits conclusions that can be drawn, the results warrant further testing in larger studies. (© 2023. The Author(s).)

Hong, X., et al. (2024). "Combined use of Anlotinib with chemotherapy in patients with advanced ovarian cancer: a real-world cohort study and meta-analysis." Therapeutic advances in medical oncology 16: 17588359231221336.
	Background: Anlotinib is a novel oral small-molecule receptor tyrosine kinase inhibitor. However, the efficacy and safety of its combined use with chemotherapy remain unclear in patients with advanced ovarian cancer.; Objectives: To assess the efficacy and safety of the combined use of Anlotinib with chemotherapy in patients with advanced ovarian cancer.; Design: A multi-center retrospective real-world analysis and a meta-analysis.; Data Sources and Methods: We enrolled patients with advanced ovarian cancer who received a combination therapy of Anlotinib and chemotherapy from 15 medical centers. We also searched electronic databases for studies assessing the efficacy and safety of the combined use of Anlotinib with chemotherapy in patients with ovarian cancer. The outcomes of interest included objective response rate (ORR), disease control rate (DCR), and median progression-free survival (mPFS).; Results: A total of 71 patients, who were predominantly recurrent cases, were included in the real-world study. The ORR and DCR of the included patients were 40.8% and 76.1%, respectively; and their mPFS was 4.6 months. The log-rank test showed that previous antiangiogenic therapy was related to a longer mPFS (p < 0.05). Five studies in total were eligible for meta-analysis. The random-effects meta-analysis model showed that the ORR, DCR, and mPFS were 33.8% [95% confidence interval (CI) 22.7-44.8% from four studies], 90.6% (95% CI 73.6-99.9% from five studies), and 6.6 months (95% CI 4.9-8.4 months from five studies). The most common adverse events were hand-foot syndrome and hypertension.; Conclusion: The combined use of Anlotinib with chemotherapy showed potential in treating patients with advanced ovarian cancer, with a tolerable safety profile.; Competing Interests: The authors declare that there is no conflict of interest. (© The Author(s), 2024.)

Hong Yeon, H., et al. (2022). "Clinical efficacy of dual trigger with human chorionic gonadotropin and a gonadotropin-releasing hormone agonist for women undergoing fertility preservation." Reproductive Medicine and Biology 21(1): e12440.
	Purpose: To determine the optimal maturation method to increase the yield of mature oocytes, especially for cancer patients with fewer chances of fertility preservation (FP) before gonadotoxic therapy.; Methods: A total of 373 cycles in 293 patients undergoing controlled ovarian stimulation (COS) for FP using a gonadotropin-releasing hormone (GnRH) antagonist protocol were enrolled. The control group ( n = 225) received 250 µg of recombinant human chorionic gonadotropin (rhCG) while the study group ( n = 148) received 250 µg of rhCG and 0.2 mg of triptorelin for triggering. Subgroup analyses were performed for stimulation cycles with diminished ovarian reserve (DOR; anti-Müllerian hormone (AMH) levels <1.1 ng/ml, n = 86), with endometrioma ( n = 104), or with breast cancer and endometrial cancer using 5 mg of letrozole during the COS cycles ( n = 84).; Results: There was no significant difference in the baseline characteristics or the number of total and mature oocytes between the two groups. Subgroup analyses for women with endometrioma or DOR showed similar results. However, the dual trigger group had a significantly higher number of mature oocytes than the rhCG trigger group in breast and endometrial cancer patients using letrozole during the COS cycles (6.9 ± 6.0 vs. 4.6 ± 3.6, p = 0.034). The maturation rate was higher in the dual trigger group, although the difference was not statistically significant (59.3 ± 26.7 vs. 50.0 ± 28.0, p = 0.124).; Conclusions: Dual triggering can be an efficient maturation method to maximize the yield of mature oocytes in breast or endometrial cancer patients using letrozole-combined GnRH antagonist protocol for FP.; Competing Interests: None. (© 2022 The Authors. Reproductive Medicine and Biology published by John Wiley & Sons Australia, Ltd on behalf of Japan Society for Reproductive Medicine.)

Hongyi, W. and M. Caihong (2022). "Outcomes of women treated with levonorgestrel-releasing intrauterine system for early endometrial cancer: a systematic review and meta-analysis."
	
Hongyu, Y., et al. (2022). "Acupuncture combined with metformin for polycystic ovary syndrome: a protocol for systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Hoogstad-van Evert, J. S., et al. (2020). "Harnessing natural killer cells for the treatment of ovarian cancer." Gynecologic Oncology 157(3): 810-816.
	Introduction: Adoptive cellular immunotherapy could be an interesting new treatment option for ovarian carcinoma (OC), as research has demonstrated that OC is an immunogenic disease. In particular, natural killer (NK) cells have attracted attention due to their ability to kill tumor cells without prior sensitization. The therapeutic value of allogeneic NK cells has been first observed in hematological cancers and is increasingly being explored in solid tumors. Method(s): To substantiate the rationale for NK cell therapy in OC we performed a literature search in the Pubmed database and in the international trial register clinicaltrials.gov with attention for the effect of OC on NK cell function, the effect of current treatment on NK cell biology and the evidence on the therapeutic value of NK cell therapy against OC. Result(s): In six clinical trials only 31 OC patients have been reported that received NK cell adoptive transfer. The majority of patients reached stable disease after NK cell therapy, with a mild pattern of side effects. In patients who received repeated infusions, more complete responses are described. All reported studies investigated the intravenous infusion of NK cells. Whereas the studies that are currently recruiting, investigate intraperitoneal infusion of allogeneic NK cells. Conclusion(s): In this review the pre-clinical evidence and current trials on NK cell immunotherapy in OC patients are summarized. Furthermore, challenges that have to be overcome for NK cell adoptive therapy to have a significant impact on disease outcome are discussed.Copyright © 2020 The Authors

Hooker Angelo, B., et al. (2022). "The link between intrauterine adhesions and impaired reproductive performance: a systematic review of the literature." BMC Pregnancy and Childbirth 22(1): 837.
	Background: Intrauterine adhesions (IUAs) are one of the main reproductive system diseases in women worldwide. Fusion between the injured opposing walls leads to partial-to-complete obliteration of the cavity and/or cervical canal. The main clinical manifestations in case of IUAs are menstrual disturbances, cyclic pain and reproductive disorders. The reproductive outcomes of women with IUAs remain limited and inefficient compared to women without IUAs, even after adhesiolysis. An exact understanding of the underlying mechanisms and processes to explain the compromised reproductive performance and outcomes in case of IUAs are lacking.; Methods: A systematic literature review of MEDLINE-PubMed (1966 to January 2022) and EMBASE (1974 to January 2022) was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies were included if they reported underlying causes, related mechanisms and processes to explain the association between IUAs and impaired reproductive performance, pregnancy and obstetric complications.; Results: After an extensive review of the literature, 58 articles were identified reporting underlying mechanisms to explain the association between IUAs and impaired fertility. Intrauterine scarring influences the process of fertilization, reproductive performance and ultimately reproductive outcome. IUAs can disturb the cervico-utero-tubal sperm transport and result in an avascular and unresponsive endometrium with decreased receptivity and thickness. Abnormal decidualization and abnormal trophoblastic infiltration leads to placental attachment disorders. Moreover, the risk for premature delivery, intrauterine fetal growth restriction and fetal anomalies is increased in case of IUAs.; Conclusion: The impact of IUAs on reproductive performance, even after adhesiolysis, is becoming more apparent. The postulated mechanisms to explain the association are related to sperm transport, embryo implantation and placentation. Prevention, by preserving the basal layer of the endometrium is essential. Effective and evidence-based strategies for the prevention of endometrial injury and formation of IUAs, are urgently needed. (© 2022. The Author(s).)

Hooker Angelo, B., et al. (2021). "Reproductive performance of women with and without intrauterine adhesions following recurrent dilatation and curettage for miscarriage: long-term follow-up of a randomized controlled trial." Human reproduction (Oxford, England) 36(1): 70-81.
	Study Question: Are the long-term reproductive outcomes following recurrent dilatation and curettage (D&C) for miscarriage in women with identified and treated intrauterine adhesions (IUAs) comparable to women without IUAs.; Summary Answer: Reproductive outcomes in women with identified and treated IUAs following recurrent D&C for miscarriage are impaired compared to women without IUAs; fewer ongoing pregnancies and live births are achieved with a prolonged time to a live birth.; What Is Known Already: The Prevention of Adhesions Post Abortion (PAPA) study showed that application of auto-crosslinked hyaluronic acid (ACP) gel, an absorbable barrier in women undergoing recurrent D&C for miscarriage resulted in a lower rate of IUAs, 13% versus 31% (relative risk 0.43, 95% CI 0.22 to 0.83), lower mean adhesion score and significant less moderate to severe IUAs. It is unclear what the impact is of IUAs on long-term reproductive performance.; Study Design, Size, Duration: This was a follow-up of the PAPA study, a multicenter randomized controlled trial evaluating the application of ACP gel in women undergoing recurrent D&C for miscarriage. All included women received a diagnostic hysteroscopy 8-12 weeks after randomization to evaluate the uterine cavity and for adhesiolysis if IUAs were present. Here, we present the reproductive outcomes in women with identified and treated IUAs versus women without IUAs, 46 months after randomization.; Participants/materials, Setting, Methods: Between December 2011 and July 2015, 152 women with a first-trimester miscarriage with at least one previous D&C, were randomized for D&C alone or D&C with immediate intrauterine application of ACP gel. Participants were approached at least 30 months after randomization to evaluate reproductive performance, obstetric and neonatal outcomes and cycle characteristics. Additionally, the medical files of all participants were reviewed. Main outcome was ongoing pregnancy. Outcomes of subsequent pregnancies, time to conception and time to live birth were also recorded.; Main Results and the Role of Chance: In women pursuing a pregnancy, 14/24 (58%) ongoing pregnancies were recorded in women with identified and treated IUAs versus 80/89 (90%) ongoing pregnancies in women without IUAs odds ratio (OR) 0.18 (95% CI 0.06 to 0.50, P-value <0.001). Documented live birth was also lower in women with IUAs; 13/24 (54%) with versus 75/89 (84%) without IUAs, OR 0.22 (95% CI: 0.08 to-0.59, P-value 0.004). The median time to conception was 7 months in women with identified and treated IUAs versus 5 months in women without IUAs (hazard ratio (HR) 0.84 (95% CI 0.54 to 1.33)) and time to conception leading to a live birth 15 months versus 5.0 months (HR 0.54 (95% CI: 0.30 to 0.97)). In women with identified and treated IUAs, premature deliveries were recorded in 3/16 (19%) versus 4/88 (5%) in women without IUAs, P-value 0.01. Complications were recorded in respectively 12/16 (75%) versus 26/88 (30%), P-value 0.001. No differences were recorded in mean birth weight between the groups.; Limitations, Reasons for Caution: In the original PAPA study, randomization was applied for ACP gel application. Comparing women with and without IUAs is not in line with the randomization and therefore confounding of the results cannot be excluded. IUAs, if visible during routine hysteroscopy after randomization were removed as part of the study protocol; the influence of IUAs on reproductive outcome may therefore be underestimated. Women undergoing a recurrent D&C for miscarriage were included, a specific group likely to generate clinically significant adhesions. The findings should therefore not be generalized to all women undergoing D&C for miscarriage.; Wider Implications of the Findings: As IUAs have an impact on reproductive performance, even after hysteroscopic adhesiolysis, primary prevention is essential. Expectative and medical management should therefore be considered as serious alternatives for D&C in women with a miscarriage. In case D&C is necessary, application of ACP gel should be considered.; Study Funding/competing Interest(s): The original PAPA study (NTR 3120) was an investigator initiated study that was funded by the Foundation for scientific investigation in Obstetrics and Gynaecology of the Saint Lucas Andreas Hospital (currently renamed OLVG Oost), SWOGA. The syringes containing ACP gel were received from Anika Therapeutics, the manufacturer of Hyalobarrier® Gel Endo. The current follow-up study was also an investigator-initiated study without funding. The funder and sponsor had no role in the design of this follow-up study, data collection, data analysis, data interpretation, trial design, patient recruitment, writing of the report or any aspect pertinent to the study. ABH, RAL, JAFH and JWRT have no conflict to declare. HAMB reports being a member of safety board research Womed.; Trial Registration Number: Netherlands Trial Register NTR 3120. (© The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Hooker Angelo, B., et al. (2022). "Reproductive outcomes in women with mild intrauterine adhesions; a systematic review and meta-analysis." The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians 35(25): 6933-6941.
	Background: Moderate to severe intrauterine adhesions (IUAs) may greatly impact fertility, predisposing to pregnancy and obstetric complications. The impact of mild IUAs on reproductive performance remains unclear. A systematic review and meta-analysis was performed to examine the long-term reproductive outcomes in women with hysteroscopic identified and treated mild IUAs mild intrauterine adhesions (IUAs).; Methods: An electronic literature search was conducted using MEDLINE and EMBASE from inception to June 2019. All prospective cohort, cross-sectional studies or randomized controlled trials Clinical trials in which reproductive outcomes of women with mild IUAs, were reported were included.; Results: Five studies, reporting on reproductive outcomes of 229 women with hysteroscopic identified and treated mild IUAs, were included. The pregnancy rate was 62.3% (142 of 228; 95% CI: 0.55-0.72, I 2 25%, p = .21) and in 86.6% (123 of 142) a live birth was encountered (95% CI: 0.71-0.97) with 83.1% (108 out of 130) term deliveries (95% CI: 0.53-0.95). A miscarriage was reported in 10% (13 of 130; 95% CI: 0.02-0.26). Due to the lack of a control group, reproductive outcomes were compared to a general population. Pregnancy and live birth rates were significantly lower in women with identified and treated mild IUAs, 90% versus 62.3% and respectively 99.5% versus 86.6%. The miscarriage rate was similar. Data on obstetric and neonatal outcomes are lacking.; Conclusions: Women with hysteroscopic identified and treated mild IUAs seem to have lower pregnancy and live birth rate compared to the general population. Future studies consisting of a large cohort of women with hysteroscopic identified and treated IUAs with structural follow-up and a control group are needed to confirm our findings.

Hoover, S. E., et al. (2021). "Changes in Ghrelin and Glucagon following a Low Glycemic Load Diet in Women with PCOS." The Journal of Clinical Endocrinology and Metabolism 106(5): e2151-e2161.
	CONTEXT: Altered satiety hormones in women with polycystic ovarian syndrome (PCOS) may contribute to obesity. Diets with a low glycemic load (GL) may influence appetite-regulating hormones including glucagon and ghrelin. OBJECTIVE: To test the hypothesis that following a 4-week, eucaloric low vs high GL diet habituation, a low vs high GL meal will increase glucagon and decrease ghrelin to reflect greater satiety and improve self-reported fullness. METHODS: Secondary analysis of a randomized crossover trial. PARTICIPANTS: Thirty women diagnosed with PCOS. INTERVENTION: Participants were provided low (41:19:40% energy from carbohydrate:protein:fat) and high (55:18:27) GL diets for 8 weeks each. At each diet midpoint, a solid meal test was administered to examine postprandial ghrelin, glucagon, glucose, insulin, and self-reported appetite scores. RESULTS: After 4 weeks, fasting glucagon was greater with the low vs high GL diet (P = .035), and higher fasting glucagon was associated with lesser feelings of hunger (P = .009). Significant diet effects indicate 4-hour glucagon was higher (P < .001) and ghrelin was lower (P = .009) after the low vs high GL meal. A trending time × diet interaction (P = .077) indicates feelings of fullness were greater in the early postprandial phase after the high GL meal, but no differences were observed the late postprandial phase. CONCLUSION: These findings suggest after low GL diet habituation, a low GL meal reduces ghrelin and increases glucagon in women with PCOS. Further research is needed to determine the influence of diet composition on ad libitum intake in women with PCOS.

Hope Medicine, C. and Ltd (2021). A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain.
	No Results Available Drug: HMI-115|Drug: Placebo Change of dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) from Baseline to Week 12|Change in DYS measured by NRS from Baseline to Week 24|Change of non-menstrual pelvic pain (NMPP) measured by NRS from Baseline to Week 12 and 24|Change in dyspareunia (DYSP) measured by NRS from Baseline to Week 12 and 24|Change from Baseline (CFB) in the monthly mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP|CFB by visit in permitted rescue medication use|Change in menstrual period heaviness (bleeding) from Baseline by visit Female Phase 2 152 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment HMI-115EM201 April 2025

Hori, K., et al. (2021). "A phase II, open-labeled, single-arm study of dose-dense paclitaxel plus carboplatin in advanced or recurrent uterine endometrial cancer treatment: a KCOG-G1303, DOENCA trial." Journal of Gynecologic Oncology 32(4): e64.
	OBJECTIVE: To determine the safety and efficacy of dose-dense (dd) paclitaxel (PTX) and carboplatin (CBDCA) in treating advanced or recurrent endometrial cancer. METHODS: Women aged 20-75 years with histologically confirmed endometrial cancer, the International Federation of Gynecology and Obstetrics (FIGO) stage III disease with some residual tumor, FIGO stage IV disease, recurrence after front-line curative treatment, or recurrence after second-line chemotherapy or radiotherapy were enrolled in this study. PTX (80 mg/m²) was administered intravenously (IV) to every participant on days 1, 8, and 15, and CBDCA (area under the curve of 5) was administered IV on day 1 once every 3 weeks until the disease progressed, unacceptable adverse events occurred, or consent was withdrawn. The primary endpoint was the response rate (RR), while the secondary endpoints were progression-free survival, overall survival, and adverse effects. RESULTS: Forty-eight participants were enrolled, and 46 were eligible to receive treatment. The patients' median age was 61 years (range, 43-76 years). Twenty-two participants had experienced recurrence, and the remaining patients had primary advanced endometrial cancer. There were 10 cases of serous carcinoma, 3 cases of endometrioid carcinoma G3, 2 cases of carcinosarcoma, and 2 cases of clear-cell carcinoma according to histology. Twenty-nine participants (63.0%) received ≥6 cycles of chemotherapy. The RR (complete, 13 cases; partial, 20 cases) was 71.3% (95% confidence interval: 59.0%-84.5%). CONCLUSION: The dd PTX with CBDCA is feasible and available as a treatment option for advanced or recurrent endometrial cancer. TRIAL REGISTRATION: UMIN Clinical Trials Registry Identifier: UMIN000017138.

Horne, A. W., et al. (2020). "Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial." Lancet 396: 909–917.
	
Horowitz, E., et al. (2021). "A randomized controlled trial of vaginal progesterone for luteal phase support in modified natural cycle - frozen embryo transfer." Gynecological Endocrinology 37(9): 792‐797.
	Objective: Our aim was to study whether luteal phase support (LPS) increases the live‐birth rate (LBR) in women undergoing modified natural cycle (mNC) frozen‐thawed embryo transfer (FET). Methods: In a randomized controlled trial, conducted at a university‐affiliated tertiary medical center, a total of 59 patients aged 18–45 years, underwent mNC‐FET. FET was performed in mNC following ovulation triggering by hCG. Patients were randomized into two groups; The No‐LPS Group included 28 women who did not receive LPS, and the LPS Group included 31 women who received vaginal progesterone for LPS. The main outcome measure was LBR. Results: Baseline demographic and clinical characteristics were comparable between the study groups. The no‐LPS group and the LPS group did not differ with regard to clinical pregnancy rate (21.4% vs. 32.3%; respectively, p =.35), LBR (17.9% vs. 19.4%; respectively, p =.88), or spontaneous miscarriage rate (3.6% vs. 12.9%; respectively, p =.35). On multivariate logistic regression analysis, LPS was not associated with LBR after controlling for confounders. Conclusion: The results of our study suggest that LPS after mNC‐FET does not improve the reproductive outcome, and therefore, might not be necessary.Clinicaltrials.gov identifier: NCT01483365.

Horowitz, E. and A. Weissman (2020). "The stair-step approach in treatment of anovulatory PCOS patients." Therapeutic advances in reproductive health 14: 2633494120908818.
	Clomiphene citrate (CC) is a widely accepted first-line treatment for anovulatory patients with polycystic ovarian syndrome (PCOS). The current practice is to prescribe CC with gradual dose increments until ovulation is achieved. Typically, progesterone withdrawal bleeding is induced between each dose increment and before the commencement of gonadotropin therapy in CC-resistant patients. It has been recently suggested that dose increments of CC can be administered once failure to induce ovulation at a certain dose has been documented, without induction of progesterone withdrawal bleeding, and this approach has been nicknamed the clomiphene-citrate stair-step (CC-SS) protocol. The same principle has been found feasible before introducing gonadotropin therapy in CC-resistant PCOS patients. Our objective was to review the world literature on the CC-SS protocol and to summarize our own experience with extending the CC-SS approach to initiation of gonadotropin therapy. Studies on CC-SS protocol ( n = 4) have found that this approach leads to a significant reduction of the time to ovulation and to an increased ovulation rate. In our own retrospective case series, 18 CC-resistant PCOS patients initiated gonadotropin stimulation without induction of progesterone withdrawal bleeding, using the chronic low-dose regimen. The time to ovulation in the study group was 54.2 ± 6.2 days, while the estimated time to ovulation calculated according to the traditional approach was approximately 110 days. The clinical pregnancy rate was 44% (8/18), and all pregnancies were singletons. One patient miscarried; hence, the live birth rate was 38.9% (7/18). In summary, the CC-SS approach and its extension to the initiation of gonadotropin therapy results in considerable reduction of the time to ovulation, and favorable ovulation rates and reproductive outcome. Large-scale confirmation of these findings by properly designed randomized controlled trials may lead to a change of practice in the treatment of anovulatory infertility in PCOS patients, allowing simplification of treatment and a shorter time to ovulation and pregnancy.; Competing Interests: Conflict of interest statement: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. (© The Author(s), 2020.)

Hospital Aalborg, U., et al. (2021). Intravenous Immunoglobulin and Prednisolone for RPL After ART.
	No Results Available Drug: Human Intravenous Immunoglobulins, (Privigen (R), CLS Behring)|Drug: Prednisolone Tablets|Drug: Human Albumin Solution|Drug: Placebo tablet A normal live fetus at nuchal scan in ITT population|A normal live fetus at nuchal scan in PP population|Live birth rate in ITT population|Live birth rate in the PP population|A normal live fetus at nuchal scan among participants who become pregnant after embryo transfer in the ITT population|A normal live fetus at nuchal scan among participants who become pregnant after embryo transfer in the PP population|Maternal adverse reactions|Negative pregnancy test|Miscarriage rate|Rate of Abnormal karyotype in Miscarried fetuses|Rate of Stillbirth rate|Rate of Congenital deformities|Rate of Preterm birth|Rate of Low birth weight (BW)|Rate of Preeclampsia|Rate of Gestational diabetes|Rate of gestational hypertension|Rate of abnormal embryonic/fetal karyotype|Frequency of a boy Female Phase 2 74 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment CNPOBC2020|2020-000256-35|U1111-1273-8585 August 1, 2023

Hospital Adiyaman University, R. (2021). Effect of Laughter Yoga Therapy on Postpartum Depression.
	No Results Available Other: Laughter yoga Effect of Laughter Yoga therapy on postpartum Depression Female Not Applicable 104 Other Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: Single (Participant)|Primary Purpose: Supportive Care lokman hekim September 10, 2021 Laughter yoga sessions, stretches and stretches, songs, clapping and body It starts with light warm-up techniques that include movements. These are to break down all kinds of inhibitions and It is aimed at developing the feelings of childlike play. breathing exercises lungs they are ready to laugh and are combined with the following series of laughing exercises. LY In order to provide group dynamics in therapy, the group should consist of at least 5-12 people. provided. Real laughter is often experienced during laughter meditation; it's contagious and may trigger laughter in other people in the group, hence the group can establish greater connections with its members. Laughter yoga sessions are always held at the same time and in the same place to encourage the participation of individuals.

Hospital, B. C. W. s. and H. Centre (2021). Pathways for Patient-centered Diagnosis and Management of Endometriosis-associated Deep Dyspareunia.
	No Results Available Device: Phallus Length Reducer|Other: Self-assessment of dyspareunia Acceptability of the phallus length reducer (PLR)|Severity of dyspareunia|Change in sexual function|Change in sexual distress|Change in level of general anxiety (GAD-7)|Change in level of general depression (PHQ-9)|Acceptability of self-measurement of dyspareunia|Validity of self-measurement of dyspareunia|Feasibility - Recruitment|Feasibility - Retention|Feasibility - Intervention Fidelity All Not Applicable 30 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Other H19-00294 December 31, 2021

Hospital Boston, C. s. (2024). IUD and Norethindrone Acetate for Treatment of Endometriosis.
	No Results Available Drug: norethindrone acetate (NETA)|Drug: Placebo Change in Pain-Physical functioning assessed by the BPI|Change in pain severity measured by Visual Analog Scale (VAS)|Change in pain measured by Biberoglu and Behrman patient ratings scale (B&B pain scale)|Change in Emotional functioning, assessed by the Beck Depression Inventory-II (BDI)|Change in Participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale (PGIC)|Change in high sensitivity C-reactive protein|Change in interleukin-8|Change in tumor necrosis factor alpha|Change in Tissue factor pathway inhibitor (TFPI)|Change in von Willebrand factor antigen|Change in Factor VIII activity|Change in soluble P-selectin|Change in interleukin-6 (IL-6)|Change in lipoprotein[a]|Change in Measure of arterial stiffness by pulse wave velocity|Change in Bone mineral density Z-scores by dual energy Xray absorptiometry (DXA)|Change in measures of central hypersensitization measured by quantitative sensory testing. Female Phase 2 80 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment IRB-P00037934 September 1, 2028

Hospital Erzincan, M. (2022). Use of Chitosan Powder in Loop Electrosurgical Excision Procedure.
	No Results Available Drug: Chitosan median early postoperative blood loss|Wound healing score Female Phase 4 130 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Prevention MUGLA-9 January 31, 2024

Hospital Gemelli, M., et al. (2021). Efficacy and Safety of SBRT in Oligo-metastatic/Persistent/Recurrent Ovarian Cancer.
	No Results Available Radiation: Stereotactic body radiotherapy Clinical complete response to SBRT by imaging|2-yr actuarial LC rate|2-yr progression-free survival|2-yr overall survival|treatment free interval|rate of toxicity|2-yr actuarial late toxicity free survival Female Not Applicable 200 Other Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CE 07-14-2020 December 31, 2024

Hospital, H. (2022). Laser Treatment of Genito-urinary Syndrome in Women.
	No Results Available Procedure: Vaginal laser treatment|Device: sham|Device: laser system Visual analogue score on vaginal symptoms|histopathology|microbiology Female Not Applicable 160 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Supportive Care Laser treatment December 31, 2026

Hospital Istanbul Medipol, U. (2021). Comparison of the Efficacy of Pharmacology and Non-pharmacological Treatment in Women With Primary Dysmenorrhea.
	No Results Available Other: Conservative and Non-conservative treatments Demographic Information Form|Visual Analogue Scale (VAS)|McGill Pain Questionnaire|Ultrasonography (US)|Menstrual Attitude Questionnaire Female Not Applicable 85 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 10840098-604.01.01-E.66761 December 10, 2021

Hospital Istanbul Medipol, U. (2021). Investigation of the Effect of Online Yoga Based Exercise Program on Women With Primary Dysmenorrhea.
	No Results Available Other: Exercise Program|Other: Education Program Sociodemographic Evaluation|Pain Intensity|Life Quality|Menstrual Attitude|Body Awareness|Satisfaction survey|Weight|Height Female Not Applicable 50 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 10840098-772.02-E.60605 January 30, 2022

Hospital Konya Meram, S. (2022). Comparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage.
	No Results Available Drug: Duphastone Miscarriage rate Female Phase 4 140 Other Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 351508 November 2024

Hospital Korea University, G., et al. (2023). Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance.
	No Results Available Procedure: secondary cytoreductive surgery|Drug: chemotherapy progression-free survival|Overall survival Female Phase 2 124 Other|Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment KGOG3067 February 28, 2028

Hospital Massachusetts, G., et al. (2023). Vaginal lIve Biotherapeutic RANdomized Trial.
	No Results Available Drug: LC106|Drug: LC115|Drug: Placebo|Drug: Metronidazole Oral Detection of LBP strains by metagenomic sequencing|Adverse events|Kinetics of colonization|Recurrent BV by Amsel and Nugent criteria|Non-iners Lactobacillus dominance and abundance|Alpha and beta diversity of the microbial community|Proportion of participants reporting product was acceptable to use Female Early Phase 1 60 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment VMRC001 September 2024

Hospital Odense, U., et al. (2023). FRAGINOC Study: Screening and Geriatric Assessment and Intervention in Older Patients With Epithelial Ovarian Cancer.
	No Results Available Other: Comprehensive geriatric assessment and individualised physical training Interval Debulking Surgery|Frailty screening questionnaires|Completion of chemotherapy treatment|Effect of training: Physical capacity and endurance|Effect of training: Physical function and strength|Effect of physical training: Physical function in relation to basic mobility|Effect of physical training: Physical function in relation to balance|Effect of physical training: Clinical reported measurements|Effect of physical training: Self-reported measurements|Patient-reported outcomes measures (PROMs)|Frailty screening combined tool|Postoperative complications|Progression Free-Survival Female Not Applicable 300 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment OUHAgeCareOvarian December 31, 2027

Hospital Tampere, U., et al. (2023). Measuring Oncological Value of Exercise and Statin.
	No Results Available Behavioral: Guided physical exercise|Drug: Atorvastatin|Other: Independent exercise Time to cancer progression|Mortality|Hypoxia markers in serum (VEGF, HIF1-alpha, carboanhydrase IX, LADH)|Tolerability of treatment|Fat/muscle ratio as measured with impedance test|Physical performance with standardized muscle strength tests|Changes in tissue hypoxia|Changes in quality of life|Depressive symptoms|Severity of pain|Nutritional status|Relationship satisfaction All Phase 3 240 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2019-001982-34 December 31, 2027

Hospital The, M. and I. Foundation Rhode (2023). Mindful Movement for Pelvic Pain.
	No Results Available Other: Mindful Movement Change in Pelvic Pain Level|Impact on Quality of Life|Change in Kinesiophobia and Pain Catastrophizing Female Not Applicable 60 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 1979873|7141745 March 2024

Hospital Women's, C., et al. (2021). RCT of At-Home tDCS for Depression in Pregnancy.
	No Results Available Device: active tDCS|Other: workbook|Device: sham tDCS Depressive symptoms post treatment|Remission of depression|Depressive symptoms|Self-reported depressive symptoms|Self-reported anxiety symptoms|Maternal Quality of Life (QoL)|Health Service Use: Health System Costs|Health Service Use: Productivity Loss|Health Service Use: Participant Cost|Dyadic Relationship|Maternal Birth Outcomes|Neonatal Birth Outcomes|Maternal Child Relationship|Infant Temperament|Child Development Female Not Applicable 156 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment CTO Project ID: 3263 October 2026

Hou, C., et al. (2021). "A Comparison of Chemotherapy Used with and without Apatinib for Patients with Ovarian Carcinoma Who Progressed after Standard Regimens: A Systematic Review and Meta-Analysis." Evidence-based complementary and alternative medicine : eCAM 2021: 2292907.
	Objective: This meta-analysis was conducted to compare the therapeutic efficacy and clinical safety of the combination therapy of apatinib plus chemotherapy with that of chemotherapy alone in patients with refractory or recurrent ovarian carcinoma (OC).; Methods: Relevant randomized controlled trials (RCT) or case-control studies (CCS) were identified by searching Chinese and English databases up to October 31, 2020. The risk of methodological bias tool and Newcastle-Ottawa scale (NOS) were used to assess trial quality. Pooled odds ratios (OR) and 95% confidence intervals (CI) were calculated to evaluate the therapeutic effects and adverse drug reactions. Subgroup analyses of study type, study sample size, dosage of apatinib, and chemotherapy regimen between treatment group and control group were performed. Publication bias was assessed by funnel plot symmetry, Begg-Mazumdar test, and Egger test. The robustness of our results was presented by removing the trial one by one.; Results: Fifteen eligible studies covering 1,020 patients were included in this review and meta-analysis. Among these studies, 8 were RCTs, and 7 were CCSs. Compared with chemotherapy alone, apatinib plus chemotherapy significantly increased objective response rate (OR = 3.55; 95% CI 2.31 to 5.47), disease control rate (OR = 3.04; 95% CI 2.12 to 4.36), and overall survival (OR = 5.03; 95% CI 3.16 to 6.90).; Conclusions: The combination treatment of apatinib plus chemotherapy provides better clinical benefits for OC patients when compared to chemotherapy alone and should be recommended for suitable patients with OC after the failure of standard regimens. However, further investigation into future large-scale prospective randomized research is still needed.; Competing Interests: The authors declare that they have no conflicts of interest. (Copyright © 2021 Chao Hou et al.)

Hou, Q., et al. (2021). "Early response to neoadjuvant chemotherapy helps decrease recurrence rate of cervical cancer: a systematic review and meta-analysis." Annals of Palliative Medicine 10(6): 6092-6103.
	Background: Neoadjuvant chemotherapy has been used for treatment of cervical cancer for a long time; however, the role of early non-response on prognosis is still confusing. This study was designed to assess its impact on disease-free survival (DFS).; Methods: Databases "PubMed", "Embase" and the "Cochrane Library" were searched out through May 2020, and both random effects model and fixed effect model were employed to calculate the main pooled results. I2 and Cochrane Q test were used to test the heterogeneity among the studies. Funnel plot with Begg's and Egger's tests was used to assess the publication bias that may exist in the study. Sensitivity analysis was performed to detect the origin of the heterogeneity.; Results: A total of 1,349 articles were found at first; then, after several rounds of exclusion, we identified 8 articles with 9 studies which were accordant with the standards of the inclusion. A combined analysis was performed among the 1,462 responders and 490 non-responders. For 1-year DFS, sub-analysis showed hazard ratio (HR) was 0.25 (95% CI: 0.14-0.43) using RECIST criteria; and HR was 0.52 (95% CI: 0.36-0.75) using WHO criteria; Egger's test showed that P=0.35 for RECIST criteria and P=0.57 for WHO criteria; Begg's test showed P=0.34 for RECIST criteria and P=0.60 for WHO criteria. For 3-year DFS, HR was 0.26 (95% CI: 0.16-0.43) using RECIST criteria and was 0.47 (95% CI: 0.30-0.73) using WHO criteria. For 5-year DFS, HR was 0.26 (95% CI: 0.16-0.42) using RECIST criteria and was 0.49 (95% CI: 0.33-0.71) using WHO criteria.; Discussion: Early non-response to neoadjuvant chemotherapy was significantly associated with higher recurrence of cervical cancer. Prospective randomized studies are warranted to validate this finding.

Hou, T., et al. (2019). "Efficacy and safety of moxibustion in female infertility patients undergoing in vitro fertilization and embryo transfer: A systematic review protocol." Medicine 98(44): e17560.
	Introduction: The purpose of this paper is to evaluate the efficacy and safety of moxibustion in infertility females/women undergoing in vitro fertilization and embryo transfer (IVF-ET).; Methods and Analysis: We will electronically search PubMed, Medline, Embase, Web of Science, the Cochrane Central Register of Controlled Trial, China National Knowledge Infrastructure, China Biomedical Literature Database, China Science Journal Database, and Wan-fang Database from their inception. Also, we will manually retrieve other resources, including reference lists of identified publications, conference articles, and grey literature. The clinical randomized controlled trials or quasi-randomized controlled trials related to moxibustion in female infertility patients undergoing IVF-ET will be included in the study. The language is limited to Chinese and English. Research selection, data extraction, and research quality assessment will be independently completed by 2 researchers. Data were synthesized by using a fixed effect model or random effect model depend on the heterogeneity test. The clinical total effective rate and the clinical pregnancy rate will be the primary outcomes. Ovulation rate, endometrial thickness, hormone level, traditional Chinese medicine (TCM) Syndrome Integral Scale and the adverse event will also be assessed as secondary outcomes. RevMan V.5.3 statistical software will be used for meta-analysis, and the level of evidence will be assessed by Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Continuous data will be expressed in the form of weighted mean difference or standardized mean difference with 95% confidence intervals (CIs), while dichotomous data will be expressed in the form of relative risk with 95% CIs.; Results: This study will provide a high-quality comprehensive evaluation of the efficacy and safety of moxibustion in the treatment of female infertility patients undergoing IVF-ET.; Conclusion: This review will provide evidence to judge for judging whether moxibustion is effective in treating female infertility patients undergoing IVF-ET.; Systematic Review Registration: PROSPERO, CRD42019135593.

Houston Charlotte, G., et al. (2024). "A Cost Savings Analysis of Topical Estrogen Therapy in Urinary Tract Infection Prevention Among Postmenopausal Women." Urology practice 11(2): 257-266.
	Introduction: UTIs are some of the most common infections in geriatric patients, with many women experiencing recurrent infections after menopause. In the US, annual UTI-related costs are $2 billion, with recurrent infections creating a significant economic burden. Given the data published on topical estrogen in reducing the number of infections for postmenopausal women with recurrent UTI, we sought to evaluate how this would translate to cost savings.; Methods: We performed a systematic literature review of UTI reduction secondary to topical estrogen utilization in postmenopausal female patients. The cost per UTI was determined based on published Medicare spending on UTI per beneficiary, weighted on reported likelihood of complicated and resistant infections. For a patient with recurrent infections, topical estrogen therapy reported on average can reduce infections from 5 to 0.5 to 2 times per person per year.; Results: At a calculated cost per UTI of $1222, the reduction in UTI spending can range between $3670 and $5499 per beneficiary per year. Per-beneficiary spending on topical estrogen therapies was $1013 on average ($578-$1445) in 2020. After including the cost of the therapy, overall cost savings for topical estrogen therapies were $1226 to $4888 annually per patient.; Conclusions: Topical estrogens are a cost-conscious way to improve the burden of UTI on postmenopausal women with the potential for billions of dollars in Medicare savings. System-wide efforts should be made to have these therapies available as prophylaxis for postmenopausal patients and to ensure they are affordable for patients.

Howard Louise, M., et al. (2022). "Perinatal mental health services in pregnancy and the year after birth: the ESMI research programme including RCT." Programme Grants for Applied Research.
	Background: It is unclear how best to identify and treat women with mental disorders in pregnancy and the year after birth (i.e. the perinatal period).; Objectives: (1) To investigate how best to identify depression at antenatal booking [work package (WP) 1]. (2) To estimate the prevalence of mental disorders in early pregnancy (WP1). (3) To develop and examine the efficacy of a guided self-help intervention for mild to moderate antenatal depression delivered by psychological well-being practitioners (WP1). (4) To examine the psychometric properties of the perinatal VOICE (Views On Inpatient CarE) measure of service satisfaction (WP3). (5) To examine the clinical effectiveness and cost-effectiveness of services for women with acute severe postnatal mental disorders (WPs 1–3). (6) To investigate women’s and partners’/significant others’ experiences of different types of care (WP2).; Design: Objectives 1 and 2 – a cross-sectional survey stratified by response to Whooley depression screening questions. Objective 3 – an exploratory randomised controlled trial. Objective 4 – an exploratory factor analysis, including test–retest reliability and validity assessed by association with the Client Satisfaction Questionnaire contemporaneous satisfaction scores. Objective 5 – an observational cohort study using propensity scores for the main analysis and instrumental variable analysis using geographical distance to mother and baby unit. Objective 6 – a qualitative study.; Setting: English maternity services and generic and specialist mental health services for pregnant and postnatal women.; Participants: Staff and users of mental health and maternity services.; Interventions: Guided self-help, mother and baby units and generic care.; Main Outcome Measures: The following measures were evaluated in WP1(i) – specificity, sensitivity, positive predictive value, likelihood ratio, acceptability and population prevalence estimates. The following measures were evaluated in WP1(ii) – participant recruitment rate, attrition and adverse events. The following measure was evaluated in WP2 – experiences of care. The following measures were evaluated in WP3 – psychometric indices for perinatal VOICE and the proportion of participants readmitted to acute care in the year after discharge.; Results: WP1(i) – the population prevalence estimate was 11% (95% confidence interval 8% to 14%) for depression and 27% (95% confidence interval 22% to 32%) for any mental disorder in early pregnancy. The diagnostic accuracy of two depression screening questions was as follows: a weighted sensitivity of 0.41, a specificity of 0.95, a positive predictive value of 0.45, a negative predictive value of 0.93 and a likelihood ratio (positive) of 8.2. For the Edinburgh Postnatal Depression Scale, the diagnostic accuracy was as follows: a weighted sensitivity of 0.59, a specificity of 0.94, a positive predictive value of 0.52, a negative predictive value of 0.95 and a likelihood ratio (positive) of 9.8. Most women reported that asking about depression at the antenatal booking appointment was acceptable, although this was reported as being less acceptable for women with mental disorders and/or experiences of abuse. Cost-effectiveness analysis suggested that both the Whooley depression screening questions and the Edinburgh Postnatal Depression Scale were more cost-effective than with the Whooley depression screening questions followed by the Edinburgh Postnatal Depression Scale or no-screen option. WP1(ii) – 53 women with depression in pregnancy were randomised. Twenty-six women received modified guided self-help [with 18 (69%) women attending four or more sessions] and 27 women received usual care. Three women were lost to follow-up (follow-up for primary outcome: 92%). At 14 weeks post randomisation, women receiving guided self-help reported fewer depressive symptoms than women receiving usual care (adjusted effect size −0.64, 95% confidence interval −1.30 to 0.06). Costs and quality-adjusted life-years were similar, resulting in a 50% probability of guided self-help being cost-effective compared with usual care at National Institute for Health and Care Excellence cost per quality-adjusted life-year thresholds. The slow recruitment rate means that a future definitive larger trial is not feasible. WP2 – qualitative findings indicate that women valued clinicians with specialist perinatal expertise across all services, but for some women generic services were able to provide better continuity of care. Involvement of family members and care post discharge from acute services were perceived as poor across services, but there was also ambivalence among some women about increasing family involvement because of a complex range of factors. WP3(i) – for the perinatal VOICE, measures from exploratory factor analysis suggested that two factors gave an adequate fit (comparative fit index = 0.97). Items loading on these two dimensions were (1) those concerning aspects of the service relating to the care of the mother and (2) those relating to care of the baby. The factors were positively correlated (0.49; p < 0.0001). Total scores were strongly associated with service (with higher satisfaction for mother and baby units, 2 degrees of freedom; p < 0.0001) and with the ‘gold standard’ Client Service Questionnaire total score (test–retest intraclass correlation coefficient 0.784, 95% confidence interval 0.643 to 0.924; p < 0.0001). WP3(ii) – 263 of 279 women could be included in the primary analysis, which shows that the odds of being readmitted to acute care was 0.95 times higher for women who were admitted to a mother and baby unit than for those not admitted to a mother and baby unit (0.95, 95% confidence interval 0.86 to 1.04; p = 0.29). Sensitivity analysis using an instrumental variable found a markedly more significant effect of admission to mother and baby units ( p < 0.001) than the primary analysis. Mother and baby units were not found to be cost-effective at 1 month post discharge because of the costs of care in a mother and baby unit. Cost-effectiveness advantages may exist if the cost of mother and baby units is offset by savings from reduced readmissions in the longer term.; Limitations: Policy and service changes had an impact on recruitment. In observational studies, residual confounding is likely.; Conclusions: Services adapted for the perinatal period are highly valued by women and may be more effective than generic services. Mother and baby units have a low probability of being cost-effective in the short term, although this may vary in the longer term.; Future Work: Future work should include examination of how to reduce relapses, including in after-care following discharge, and how better to involve family members.; Trial Registration: This trial is registered as ISRCTN83768230 and as study registration UKCRN ID 16403.; Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research ; Vol. 10, No. 5. See the NIHR Journals Library website for further project information. (Copyright © 2022 Howard et al. This work was produced by Howard et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.)

Howard, Z., et al. (2022). "A group program for overweight and obese women with urinary incontinence (ATHENA): an implementation-effectiveness hybrid type 3 study." International Urogynecology Journal 33(4): 991-1000.
	Introduction and hypothesis: Supervised pelvic floor muscle training (PFMT), weight loss and exercise are recommended for overweight/obese women with urinary incontinence (UI). This study aimed to implement and evaluate the feasibility, acceptability and effectiveness of a 12-week group exercise and healthy eating program (ATHENA) for overweight/obese women with UI. Method(s): This study, using an implementation-effectiveness hybrid type 3 design, was conducted within a Women's Health Physiotherapy outpatient service at an Australian tertiary public hospital. Intervention feasibility and acceptability were assessed through process evaluation of implementation, while clinical effectiveness was assessed via pre-/post-clinical and quality of life surveys. Process data were analyzed using descriptive statistics and effectiveness data were compared pre-/post-intervention using inferential statistics. Result(s): Of 156 eligible patients, 37 (24%) agreed to participate; 29 (78%) completed the ATHENA program. Median (IQR) age and body mass index were 53 (47-65) years and 30.8 (29.1-34.8) kg/m2 respectively. ATHENA was feasible to implement, with all components delivered as intended and high participant satisfaction. Ninety-seven percent of participants reported improved UI symptoms (global rating of change) and significant improvements in overall pelvic floor dysfunction and quality of life utility scores (p = 0.001). While weight did not change, significant improvements were found in body-food choice congruence (intuitive eating scale-2; p < 0.01). Conclusion(s): The ATHENA intervention was feasible, acceptable and clinically effective for overweight and obese women with urinary incontinence at a tertiary public hospital in Australia. Further research into longer term outcomes and the cost effectiveness of this group intervention is recommended. Trial registration: N/A. Ethics approval, HREC/2018/QGC/46582, date of registration 14/11/2018.Copyright © 2021, Crown.

Hroncová, M. (2023). "Pelvic pain in women after childbirth and physiotherapy." Ceska gynekologie 88(3): 214-220.
	Objective: There are many types of pelvic pain. Pelvic plexus pain, coccyx pain, pain from episiotomy scars, and vulvodynia are frequently seen in postpartum women. The aim of this study was to conduct a systematic review of studies on pelvic pain in postpartum women to assess the effect of physiotherapy interventions on each type of pain.; Methods: A comprehensive literature review was conducted by searching on PubMed, Ovid Embase and Scopus Web of Science using the key words - pelvic pain, women after childbirth, pelvic girdle pain, coccygodynia, episiotomy, vulvodynia, and physiotherapy. The author reviewed all the identified articles and selected articles for inclusion according to relevance to the topic.; Conclusion: Based on the analysis of the above studies, it can be concluded that a comprehensive physiotherapy designed for postpartum women that includes manual techniques, behavioral techniques, relaxation of hypo-tonic and shortened muscles and strengthening of hypotonic muscles can positively affect a wide range of pain and associated dysfunctions of the pelvic floor and trunk muscles.

https, et al. (2021). "Acupressure for Cancer-fatigue in Ovarian Cancer Survivor (AcuOva) Study: A community-based clinical trial study protocol examining the impact of self-acupressure on persistent cancer-related fatigue in ovarian cancer survivors." Contemporary Clinical Trials 107: 106477.
	Background Persistent cancer-related fatigue is one of the most common and burdensome symptoms experienced by ovarian cancer survivors. Despite the high burden of fatigue in ovarian cancer survivors, there are few available treatments. Previous research has shown self-acupressure to be a safe method for improving persistent fatigue, sleep, and quality of life among fatigued breast cancer survivors, yet there are no studies examining self-acupressure for fatigue in ovarian cancer survivors. Methods A three group parallel, randomized controlled trial will be conducted to evaluate the efficacy of self-acupressure taught and delivered via a patient-designed, custom-built mobile app ("MeTime") and accompanying hand-held device ("AcuWand") to help guide correct pressure application. A sample of 165 ovarian cancer survivors, who have completed primary cancer treatment will be recruited from tumor registries in Michigan and Los Angeles. Participants will be mailed a tablet preloaded with the app and a device, and all visits will be conducted remotely. Participants will be randomized to 6-weeks of daily self-acupressure via the app and device, or a sham app and device, or no care group. Self-report measures will be completed at baseline, 6-weeks (post-intervention), 3-, and 6-months. Primary outcome is the Brief Fatigue Inventory; secondary outcomes are sleep, quality of life, and symptoms commonly associated with persistent fatigue. Discussion An app based self-acupressure treatment may be an easily-accessible and inexpensive treatment to reduce fatigue in ovarian cancer survivors. The results of the study will provide information on the possible benefits of app-based self-acupressure for fatigue in ovarian cancer survivors. Trial registration: This study is registered at ClinicalTrials.gov Identifier: NCT03763838, date registered on December 4, 2018. (Copyright © 2021 Elsevier Inc. All rights reserved.)

Htut Thura, W., et al. (2022). "Meta-analysis of randomized controlled trials on primary ambulatory thromboprophylaxis in patients with ovarian cancer receiving chemotherapy." Proceedings (Baylor University. Medical Center) 35(3): 332-336.
	Ovarian cancer (OC) is highly associated with venous thromboembolism (VTE). The OC cells stimulate thrombin generation, and chemotherapy potentiates the prothrombotic effect of cancer cells by damaging endothelium and enhancing hypercoagulability. Recently, primary ambulatory thromboprophylaxis (PATP) has been studied as a potential treatment in cancer patients undergoing chemotherapy with an aim of reducing the incidence of VTE and potentially prolonging survival. A meta-analysis was performed of randomized controlled trials of PATP vs control in patients with OC receiving chemotherapy. The primary outcome measure was the incidence of VTE. The secondary outcome measure was the incidence of major bleeding complications. Two articles published between 2012 and 2020 fulfilled selection criteria. The incidence of VTE was 0.9% in the PATP group and 1.8% in the control group. However, the pooled risk ratio was not statistically significant at 0.69 (95% CI: 0.08 to 5.67; P = 0.73). The absolute risk difference was -0.03 (95% CI, -0.17 to 0.11; P = 0.66). There was no statistically significant reduction in VTE by providing PATP to patients with OC receiving chemotherapy. Routine PATP should not be recommended in ambulatory OC patients. Future randomized trials are necessary to define the high-risk subset of OC patients who may benefit from PATP. (Copyright © 2022 Baylor University Medical Center.)

Hu, J., et al. (2023). "Evidenced summary for comprehensive detumescence treatment for lower limb lymphedema in patients with gynecological malignant tumor." Chinese Journal of Practical Nursing 39(15): 1167-1174.
	Objective To evaluate and summarize the relevant evidence of comprehensive detumescence treatment of lower limb lymphedema in patients with gynecological malignant tumors, and to provide evidence-based basis for clinical intervention of comprehensive detumescence treatment of lymphedema. Methods This study was an evidence - based nursing research. Databases such as BMJ Best Practice, UpToDate, PubMed, CNKI, Wanfang and other domestic and foreign databases, as well as websites such as the Australian Lymphology Society, the International Lymphedema, and the European Clinical Oncology Association were searched for relevant evidence and evaluation of comprehensive treatment of gynecological malignant tumor-related lower limb lymphedema. The search time was from the establishment of the database to April 1, 2022. Results A total of 18 articles were included, including 2 guidelines, 5 systematic reviews, 4 expert consensus, 2 evidence summaries, 4 randomized controlled trials and 1 best practice. Twenty-eight evidence were summarized from 7 aspects: treatment cycle and edema stage, free-hand lymphatic drainage, graduated compression stockings, skin care, elastic socks, functional exercise and health education. Conclusions The evidence summarized in this study can provide reference for clinical medical staff to formulate comprehensive treatment plans for lower limb lymphedema. Evidence-based practice should consider the individual status of patients and clinical scenarios, and provide personalized comprehensive treatment plans for patients with lower limb lymphedema of gynecological malignant tumors as soon as possible to improve the quality of life of patients.Copyright © 2023 The authors.

Hu, J., et al. (2021). "The best evidence for the prevention and management of lower extremity deep venous thrombosis after gynecological malignant tumor surgery: A systematic review and network meta-analysis." Journal of B.U.ON. 26(6): 2365-2372.
	Purpose: To search and obtain the relevant evidence of prevention and management of lower extremity deep venous thrombosis after gynecological malignant tumor operation, and to summarize the relevant evidence. Method(s): We searched JBI evidence summary, up to date, the national comprehensive cancer network of the United States, the guide library of the National Institute of clinical medicine of the United Kingdom, PubMed, the Chinese biomedical literature database, CNKI, Wanfang and other relevant evidence on the prevention and management of deep venous thrombosis in patients with gynecological malignant tumors. It includes clinical practice guidelines, best practice information book, expert consensus, evidence summary, original research, etc. The retrieval time limit is from database establishment to August 20, 2021. Two researchers independently evaluated the literature quality, combined with professional judgment, and extracted the literature that met the standards. Result(s): Finally, 18 articles were included, including 8 guidelines, 3 evidence summaries, 4 systematic evaluations, 2 expert consensus and 1 best practice information volume. A total of 26 pieces of best evidence on the prevention and management of postoperative venous thrombosis in gynecological malignant tumors were summarized. This included risk assessment, drug prevention, mechanical prevention, management strategy and health education. Conclusion(s): This study summarized the best evidence of risk, prevention and health management of deep venous thrombosis in postoperative patients with gynecological malignant tumors, so as to provide evidence-based basis for clinical nurses and improve nursing level.Copyright © 2021 Zerbinis Publications. All rights reserved.

Hu, J., et al. (2021). "Efficacy and safety of Buzhong Yiqi Decoction in improving cancer-related fatigue and immunity of cervical carcinoma patients: A protocol of randomized controlled trial." Medicine 100(49): e27938.
	Background: Cancer-related fatigue (CRF) is essentially universal in cervical carcinoma patients. It develops rapidly, with physical and mental manifestations including generalized weakness, diminished concentration or attention, and it has a negative impact in overall quality of life. Buzhong Yiqi Decoction (BYD), a classical Chinese medical prescription, could be used for allergic rhinitis, gut microbiota disorders, and chronic obstructive pulmonary disease. We preliminarily found that BYD could relieve CRF in cervical carcinoma patients. However, there are few trials on whether BYD could relieve CRF and improve immunity in cervical carcinoma patients.; Methods: This is a double-blinded, randomized, controlled clinical trial. From December 1, 2021 to May 31, 2022, cervical carcinoma patients with CRF will be assessed for randomization into treatment group (BYD) and control group (BYD simulation) in a 1:1 ratio. The outcomes are cancer fatigue scale, self-rating anxiety scales, self-rating depression scales, Pittsburgh sleep quality index, and immunity index (CD3+, CD4+, and CD8+) before and after the treatment. Statistical analysis will be performed using SPSS v22.0 software.; Results and Conclusions: The study will clarify the efficacy and safety of BYD in improving CRF and immunity in cervical carcinoma patients.; Trial Registration: OSF Registration number: DOI 10.17605/OSF.IO/QFNMD.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Hu, J., et al. (2021). "Complementary and Alternative Medicine for the Treatment of Abnormal Endometrial Conditions in Women with PCOS: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." Evidence-based complementary and alternative medicine : eCAM 2021: 5536849.
	Background: Endometrial lesions in patients with polycystic ovary syndrome (PCOS) exhibit complex pathological features, and these patients are at risk of both short-term and long-term complications. Complementary and alternative medicine (CAM), which is gradually becoming more accepted and is believed to be clinically effective, claims to be promising for treating PCOS, and thus its effect on the abnormal endometrium of PCOS patients should be assessed. The present meta-analysis sought to evaluate the efficacy and safety of CAM in treating endometrial lesions in patients with PCOS.; Methods: Randomized trials on CAM were identified in four Chinese and seven English-language databases from their establishment to January 2020. The present study included patients diagnosed with PCOS and abnormal endometrial conditions who underwent CAM therapy independently or in combination with traditional western medicine. Data were extracted, and the Cochrane "risk of bias" tool was used to assess methodological quality. Effects were expressed as the relative risk (RR) or mean difference (MD/SMD) with 95% confidence interval (CI) as calculated with Rev Man 5.3.; Results: A total of 13 randomized controlled trials were included, involving 1,297 PCOS patients treated for endometrial abnormalities. Methodological quality was generally unclear or had a low risk of bias. The trials tested four different types of CAM therapies (i.e., traditional Chinese medicine treatment, acupuncture treatment, traditional Chinese medicine in combination with western medicine treatment, and acupuncture in combination with western medicine treatment). CAM treatment could significantly reduce the endometrial thickness in PCOS patients compared to western medicine alone (SMD -0.88, 95% CI [-0.12, -0.57]; I 2 = 64%). Compared with clomiphene treatment for the induction of ovulation, CAM treatment showed a clear improvement in endometrial thickness during ovulation (SMD 2.03, 95% CI [1.64, 2.02]; I 2 = 48%). Moreover, CAM was more effective than western medicine alone in reducing the endometrial spiral artery pulsatility index. No significant difference was seen between CAM and traditional treatment when these were used to improve traditional Chinese medicine syndrome scores. Acupuncture alone or traditional Chinese medicines (taken orally) in combination with western medicine significantly increased the pregnancy rate of PCOS patients (RR 1.59, 95% CI [1.30, 1.93]; I 2 = 51%, P < 0.00001), and CAM was more effective than western medicine alone for improving hormone levels. No serious adverse events were reported in 11 of the 13 trials.; Conclusions: CAM may effectively ameliorate the endometrial condition of PCOS patients, and it can regulate the level of hormone secretion to increase the ovulation rate and the pregnancy rate.; Competing Interests: The authors declare that they have no relevant conflicts of interest. (Copyright © 2021 Jiayu Hu et al.)

Hu, L., et al. (2024). "Stem cell therapy for premature ovarian insufficiency: a systematic review and meta-analysis of animal and clinical studies." Archives of Gynecology and Obstetrics 309(2): 457-467.
	Purpose: The aim of this systematic review and meta-analysis is to evaluate the efficacy of stem cell therapy in mouse models of POI and patients with POI. Method(s): The PubMed, Web of Science, and Embase databases were searched from inception to February 2022 for relevant animal and clinical studies. The reference lists of the included reviews were manually searched to identify additional eligible studies. Data were independently extracted by two investigators, and disagreements were resolved by discussion. SYRCLE's risk of bias tool and the MINORS tool were used to assess the quality of animal and clinical studies by two independent investigators. All statistical analyses were conducted using Review Manager 5.3 software. Result(s): A total of twenty animal studies and six clinical studies were included in this meta-analysis. In animal studies, the results showed that stem cells could improve hormone levels, follicle count, estrous cycle and pregnancy outcome. For hormone levels, stem cells increased serum E2 and AMH levels and decreased serum FSH and LH levels compared with the control group (serum E2 level: SMD: 5.05, 95% CI 4.21-5.90, P < 0.00001; serum AMH level: SMD: 4.42, 95% CI 3.06-5.79, P < 0.00001; serum FSH level: SMD: - 3.79, 95% CI - 4.87 to - 2.70, P < 0.00001; serum LH level: SMD: - 1.31, 95% CI - 1.65 to - 0.96, P < 0.00001). All follicle counts, except for the antral follicle count, were significantly changed compared with the control group. (primordial follicle count: SMD: 4.61, 95% CI 3.65-5.56, P < 0.00001; primary follicle count: SMD: 3.35, 95% CI 1.08-5.63, P = 0.004; secondary follicle count: SMD: 3.23, 95% CI 1.92-4.55, P < 0.00001; total follicle count: SMD: 4.84, 95% CI 2.86-6.83, P < 0.00001; oocyte count: SMD: 7.56, 95% CI 5.92-9.20, P < 0.00001; atretic follicle count: SMD: - 1.79, 95% CI - 2.59 to - 1.00, P < 0.00001). For the estrous cycle, stem cell therapy increased the number of estrous cycles (WMD: 2.72, 95% CI 2.07-3.37, P < 0.00001) and decreased the duration of the estrous cycle (WMD: - 1.26, 95% CI - 1.84 to - 0.69, P < 0.0001) compared with the control group. For pregnancy outcomes, stem cell therapy increased the fertility rate (RR: 3.00, 95% CI 1.74-5.17, P < 0.0001) and litter size (WMD: 3.82, 95% CI 0.36-7.28, P = 0.03) compared with the control group. In animal studies, the asymmetric funnel plot of serum E2 and FSH levels indicated the possibility of publication bias. Unpublished and negative studies may be the source of publication bias. In clinical studies, the results showed that stem cell therapy could decrease serum FSH level (MD: - 30.32, 95% CI - 59.03 to - 1.01, P = 0.04) and increase AFC (MD: 1.07, 95% CI 0.70-1.43, P < 0.00001), pregnancy rate (RD: 0.19, 95% CI 0.04-0.34, P = 0.01) and live birth rate (RD: 0.19, 95% CI 0.07-0.31, P = 0.001) in POI patients. In addition, there was no significant difference in menstrual function regained (RD: 0.22, 95% CI - 0.03-0.46, P = 0.09), oocytes retrieved (MD: 1.00, 95% CI - 0.64-2.64, P = 0.23) and embryos (MD: 0.80, 95% CI - 0.15-1.76, P = 0.10) between different groups. Conclusion(s): This meta-analysis suggested that stem cell therapy might be effective in POI mouse models and patients and could be considered a potential treatment to restore fertility capability in POI patients.Copyright © 2023, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Hu, M., et al. (2024). "Modified Xiaoyao powder for postpartum depression: A systematic review and meta-analysis." Journal of Traditional Chinese Medical Sciences 11(1): 120-130.
	Objective: To evaluate the effectiveness and safety of modified Xiaoyao powder for postpartum depression (PPD) by conducting a systematic review of randomized controlled trials (RCTs). Method(s): The Chinese National Knowledge Infrastructure Databases (CNKI), the Chinese Scientific Journals Database (VIP), Wanfang, Google Scholar, the SinoMed, Embase, Cochrane Library, and PubMed databases were searched from their inception to April 25, 2023. The Cochrane Risk of Bias tool was used to assess the quality of the trials. We applied the risk ratio to present dichotomous data and the mean difference to present continuous data. Data with similar characteristics were pooled for meta-analysis and heterogeneity was assessed using I2. Result(s): This review included 35 trials involving 2848 participants. The quality of the included studies was low (unclear randomization processes and insufficient reporting of blinding). Participants treated with modified Xiaoyao powder plus Western medicine showed lower Hamilton Depression Scale (HAMD) depression score than those who used Western medicine alone (mean difference = -2.15; 95% confidence interval:-2.52 to 1.78; P <.00001), and higher effective rate (relative risk = 1.19; 95% confidence interval: 1.15 to 1.24; P <.00001), When comparing modified Xiaoyao alone with Western medicine, the HAMD depression score remained low, however, the efficacy rate was higher in the modified Xiaoyao group. Regarding adverse events, the modified Xiaoyao group reported weight gain, nausea, and diarrhea, but no severe adverse events were reported. Conclusion(s): Modified Xiaoyao may help relieve depression in PPD when used alone or in combination with Western medicine, with minor side effects. Therefore, future high-quality, large-sample size RCTs are warranted.Copyright © 2024 Beijing University of Chinese Medicine

Hu, S., et al. (2022). "Effects of Intrauterine Infusion of Autologous Platelet-Rich Plasma in Women Undergoing Treatment with Assisted Reproductive Technology: a Meta-Analysis of Randomized Controlled Trials." Geburtshilfe und Frauenheilkunde 83(4): 453-462.
	Purpose This meta-analysis was conducted to systematically retrieve relevant randomized controlled trials (RCTs) and evaluate the effects of intrauterine infusion of autologous platelet-rich plasma (PRP) in women with thin endometrium, implantation or pregnancy failure undergoing treatment with assisted reproductive technology (ART). Methods We conducted a systematic review and meta-analysis of the retrieved RCTs. Studies on the intrauterine infusion of PRP in women undergoing treatment with ART that were published in PubMed, the Cochrane library, Web of Science, and Embase from inception until June 2022 were included. The data were extracted and analyzed independently using the fixed-effects or random-effects model according to heterogeneity. Results Seven RCTs involving 861 patients (435 in the intervention group and 426 in the control group) were included. The rates of clinical pregnancy (risk ratio [RR]: 2.51; 95% confidence interval [CI]: 2.0-3.13; P < 0.00001), chemical pregnancy (RR: 1.96; 95% CI: 1.58-2.45; P < 0.00001), live births (RR: 7.03; 95% CI: 3.91-12.6; P < 0.00001), and implantation (RR: 3.27; 95% CI: 1.42-7.52; P = 0.005) were significantly higher in the women who received PRP infusion than in the control group. No significant differences were noted in the miscarriage rate (RR: 0.98; 95% CI: 0.39-2.42; P = 0.96) between the two groups. Conclusion In summary, intrauterine infusion of PRP may be an effective therapy for women with thin endometrium and recurrent implantation failure (RIF) undergoing treatment with ART. More population-based RCTs are warranted to verify the efficacy of our evidence.; Competing Interests: Conflict of Interest The authors declare that they have no conflict of interest. (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Hu, T. and X. Wan (2021). "Clinical value of chemoradiotherapy in patients with endometrial cancer based on health informatics: A meta-analysis." Acta Medica Mediterranea 37(2): 1289-1295.
	Objective: Based on the meta-analysis of health informatics, the effects of combined chemoradiotherapy and radiotherapy alone on postoperative survival rate and complications of endometrial cancer patients were compared. Method(s): Study engineering and computer by health interest rates in ten thousand medi cal, PubMed database, domestic research on medical journals such as health and biomedical literature database for information retrieval, the direction of radiation in the combined chemotherapy in patients with endometrial carcinoma postoperative survival rate and the influence of complications such as indicators of health information related literature, on the basis of health informatics chosen Rev Man 5.2 software for Meta analysis. Result(s): According to the research object,method, disease type and other criteria,the retrieval literatures were screened,and a total of 7 literatures that met the criteria were finally included, with low publication bias. Meta analysis results showed that the 5-year OS,5-year progression-free rate and treatment complication rate of the radiotherapy combined with chemotherapy group were all higher than those of the radiotherapy alone group, and the 5-year recurrence rate of the radiotherapy combined with chemotherapy group was significantly lower than that of the radiotherapy alone group, with statistically significant differences (P<0.05). The sensitivity test results showed that the heterogeneity of the literature was small and had high reference value. Conclusion(s): Radiotherapy in combination with chemotherapy can obviously reduce postoperative recurrence rate, endometrial cancer patients can prolong the overall survival and progression-free rate at the same time,is worth popularization and application, but the combination therapy may increase the risk of patients with postoperative complications, is a new challenge in the field of health care, is creating a new era in medical areas must overcome one difficulty, should actively learn the new complication protection knowledge and skills, adopt effective protective measures to reduce the incidence of complications and complications for patients life security, create a new era of the radiation and chemotherapy treatment.Copyright © 2021 A. CARBONE Editore. All rights reserved.

Hu, T.-M., et al. (2022). "Effectiveness of aromatherapy for intrapartum and postpartum emotional problems among parturient women: A meta-analysis of randomized controlled trials." Japan journal of nursing science : JJNS 19(3): e12471.
	Aim: Perinatal negative emotions are common in parturient women, but the problems are often ignored. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) that investigated the effectiveness of aromatherapy for intrapartum anxiety (IPA) and postpartum emotional symptoms (PES).; Methods: We searched PubMed, Embase, Cochrane library, and ClinicalTrials.gov to identify suitable RCTs for analysis, and the study was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses.; Results: Nine RCTs were included. The meta-analysis showed aromatherapy reduced IPA during the early to active phase (standardized mean difference [SMD]: -1.56 [-2.55, -0.61]) and during the transition phase (SMD: -3.30 [-4.97, -1.63]) when compared with controls. For the postpartum period, the meta-analyses showed a reduction of postpartum depression (PPD) at week 2 (SMD: -0.43 [-0.82, -0.03]), and a non-significant trend toward the reduction of PPD at weeks 4-6 (SMD: -0.70 [-1.40, 0.01]).; Conclusion: Our study found some evidence supporting the effectiveness of aromatherapy in reducing intrapartum anxiety and PES. We recommend the optional use of aromatherapy for intrapartum and postpartum care. (© 2022 Japan Academy of Nursing Science.)

Hu, X., et al. (2020). "Effects of exercise therapy for pregnancy-related low back pain and pelvic pain: A protocol for systematic review and meta-analysis." Medicine 99(3): e17318.
	Background: Pregnancy-related low back pain (PLPB) and pelvic pain (PP) are common in pregnancy. In spite of its high prevalence rate, treatment of the disorder is a challenging topic. Women commonly utilize complementary exercise therapies such as yoga, motor control exercises, breathing exercises, core stability exercise, pelvic stability exercise, and so on to manage their symptoms. However, it is currently unknown whether exercise produces more beneficial effects than other treatment in patients with PLPB and PP. The aim of this study is to explore the therapeutic effect of exercise for pregnancy-related low back pain and PP.; Methods: This review will only include randomized controlled trials. Published articles from July 1999 to July 2019 will be identified using electronic searches. Search strategy will be performed in 3 English databases, 1 Chinese database, and the World Health Organization International Clinical Trials Registry Platform. Two reviewers will screen, select studies, extract data, and assess quality independently. The methodological quality including the risk of bias of the included studies will be evaluated using a modified assessment form, which is based on Cochrane assessment tool and Physiotherapy Evidence Database scale. Review Manager Software (Revman5.3) will be used for heterogeneity assessment, generating funnel-plots, data synthesis, subgroup analysis, and sensitivity analysis. We will use GRADE system to evaluate the quality of our evidence.; Results: We will provide some more practical and targeted results investigating the effect of exercise therapy (ET) for PLPB and PP in the current meta-analysis. Meanwhile, we will ascertain study progress of ET for PLPB and PP and find out defects or inadequacies of previous studies, so that future researchers could get beneficial guidance for more rigorous study.; Conclusion: The stronger evidence about PLPB and PPs rehabilitative effect and safety will be provided for clinicians and policymakers.; Systematic Review Registration: PROSPERO CRD 42017075099.

Hu, Y., et al. (2021). "Interventions for vaginal bleeding irregularities with contraceptive implant." Cochrane Database of Systematic Reviews(3).
	- Objectives This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effectiveness and safety of different treatments compared to no treatment or placebo for vaginal bleeding irregularities associated with the use of contraceptive implants.

hua, y. and z. yuan (2023). "The Significance of noninvasive therapies for cervical infection of high-risk human papilloma virus : A systematic review and meta-analysis."
	
Huan, T., et al. (2021). "Effects of transcutaneous tibial nerve stimulation on female with Overactive Bladder Syndrome in Multiple Sclerosis: A protocol for a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Huan, Y. U., et al. (2023). "Efficacy and Safety of Immune Checkpoint Inhibitors on Advanced Cervical Cancer: A Systematic Review and Meta-analysis."
	
Huang, A., et al. (2024). "Effects of a Pelvic Yoga Program on Genitourinary Quality of Life in Midlife and Older Women with Urinary Incontinence: a Multisite Randomized Trial." Journal of Neurosurgical Anesthesiology 36(1): 1263-1264.
	Objective: Pelvic yoga has been recommended as a complementary behavioral treatment strategy for women with genitourinary symptoms such as urinary incontinence that frequently emerge in midlife, but there is little evidence of its impact on women's genitourinary quality of life (QOL). We examined changes in genitourinary QOL among midlife and older women in a randomized trial of a group-based pelvic yoga program versus non-specific physical conditioning program for incontinence. Design(s): The Lessening Incontinence with Low-impact Activity (LILA) study is a multisite trial of a group-based yoga program designed by an expert yoga and clinician panel to improve pelvic function in midlife and older women. Ambulatory women aged 45 or older with incontinence were recruited from the general communities surrounding three study sites in California in 2019-2022. Eligible women were randomly assigned to a therapeutic yoga program consisting of twice weekly group instruction by trained yoga instructors and once weekly individual practice of study-specific Hatha yoga techniques for 3 months, versus a general physical conditioning program involving equivalent-time group instruction and individual practice of skeletal muscle stretching and strengthening exercises. Linear mixed models examined change in scores on multiple validated self-report measures of genitourinary symptom bother or quality of life over 3 months, including the Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire (IIQ), and Patient Perception of Bladder Condition (PPBC), adjusting for site and intervention cohort. Result(s): Among the 240 participants randomized (121 to yoga, 119 to physical conditioning), mean age was 62.0 (+/-8.7) years (total range 45 to 90 years), and 40% self-identified as racial or ethnic minorities (14% Latina/Hispanic, 6% African American, 16% Asian American, 4% multiracial). At baseline, mean scores on genitourinary QOL measures were 38.8 (+/-19.2) for the UDI-6, 101.0 (+/-.7) for the IIQ, and 3.4 (+/-1.0) for the PPBC. Over 3 months, scores on all genitourinary QOL measures improved by more than the minimum important difference thresholds in the pelvic yoga group (Table), and improvements in UDI-6 scores were modestly greater in the pelvic yoga than the physical conditioning group (estimated between-group difference of 5.8 (95%CI 1.0-10.6) points in favor of yoga, P=.02). However, no significant between-group differences in change in overall IIQ or PPBC scores were detected (Table). Conclusion(s): Among midlife and older women with urinary incontinence, genitourinary QOL assessed by multiple self-reported measures improved over 3 months among women assigned to a group-based pelvic yoga program, but improvements were only modestly greater than or similar to those observed with a non-specific muscle conditioning program. Findings from this multisite trial provide new evidence to support benefits of engagement in pelvic yoga among midlife and older women with genitourinary symptoms, but also suggest that women may derive benefit from other general physical-based interventions. (Table Presented).

Huang Allan, B., et al. (2021). "Neoadjuvant chemotherapy for advanced stage endometrial cancer: A systematic review." Gynecologic Oncology Reports 38: 100887.
	Objective: While primary cytoreductive surgery (PCS) is considered the standard of care for women who present with stage IV endometrial cancer, neoadjuvant chemotherapy (NACT) followed by interval cytoreductive surgery (ICS) has emerged as an alternative treatment strategy. We summarized the literature and compared outcomes of PCS compared to NACT and ICS.; Methods: We conducted a systematic search on PubMed, Embase, Web of Science, and Scopus for articles published from January 1, 1990 to December 31, 2020. Key search terms included multiple descriptors of advanced disease status in combination with "endometrial cancer" and "neoadjuvant chemotherapy". Our review included studies that examined survival and surgical outcomes of patients with stage III or IV endometrial cancer treated with neoadjuvant chemotherapy followed by interval cytoreductive surgery versus those who received primary cytoreductive surgery. We excluded studies examining only patients with leiomyosarcomas, carcinosarcomas, and stromal sarcomas due to the biologic heterogeneity of these malignancies.; Results: The nine included studies encompassed 5,844 patients, of which 1,317 (22.5%) received NACT and 4,527 received PCS (77.5%). With the exception of a single study, all were retrospective observational studies or case series. Use of NACT in patients with stage IV EC increased from 16.0% in 2010 to 23.9% in 2015. Five studies analyzed median overall survival and all but one reported no significant difference between NACT + ICS vs. PCS. Optimal cytoreduction (<1 cm of residual disease) rates were similar across both treatment groups in three separate analyses, however pooled data suggest improved rates of optimal cytoreduction for NACT + ICS vs. PCS patients (81.9% vs. 51.5% respectively). Patients receiving NACT experienced significantly shorter hospital admissions and lower operative times compared to PCS counterparts.; Conclusions: NACT followed by ICS reduces perioperative morbidity while offering similar overall survival.; Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2021 The Authors.)

Huang, G., et al. (2022). "A Systematic Review of the Cost of Chronic Pelvic Pain in Women." Journal of Obstetrics and Gynaecology Canada 44(3): 286-293.e283.
	Objective: To systematically summarize the evidence on costs related to chronic pelvic pain (CPP) for women. Data sources: Electronic databases (MEDLINE, EMBASE, PubMed, and Cochrane Library) were searched for English and French articles published from 1990 to January 2021 Study selection: Of 1304 articles screened, 67 were screened in full-text form, and a total of 13 articles were included in the final analysis. Articles included involved cost studies that estimated hospital or health system costs for pelvic pain, dysmenorrhea, dyspareunia, endometriosis with pain, interstitial cystitis, or painful bladder syndrome. Data extraction and synthesis: A standardized form was created to extract study setting, design, and population; patient demographics; study duration; and reported costs of CPP components and amounts. Two independent reviewers completed the data extraction, and discrepancies were resolved through discussion with a third reviewer. Conclusion(s): Estimated health care costs ranged from US$1367 to US$7043 per woman per year. Prescription costs ranged from US$193 to US$2457 per woman per year. Indirect costs ranged from US$4216 to US$12 789 per woman per year. Combined costs ranged from US$1820 to US$20 898 per woman per year. The yearly costs of CPP varied according to country; yearly costs were estimated to be $2.8 billion, 191,680 to 246,488, and $16 970 to $20 898 per woman per year in the United Sates, Japan, and Australia, respectively. The literature suggests that CPP represents a considerable economic burden on women and health care systems internationally, with indirect costs contributing a significant portion of total costs.Copyright © 2021 The Society of Obstetricians and Gynaecologists of Canada/La Societe des obstetriciens et gynecologues du Canada.

Huang, H., et al. (2021). "Hepatic hilar lymph node resection in cytoreductive surgery for advanced ovarian cancer: A necessity or not?" Cancer Management and Research 13: 7981-7988.
	Objective: This review aims to clarify the necessity of hepatic hilar lymph node resection on advanced ovarian cancer patients. Background(s): PARP inhibitors and surgery have significantly improved the survival of patients with ovarian cancer. However, for patients with advanced ovarian cancer, there are often extensive epigastric disseminated metastatic lesions, especially the lymph nodes in the hepatic hilar area. Because of the complicated anatomical relationship and lack of experience in this area, this is easily ignored by gynecological oncologists. Method(s): Through the retrieval and analysis of the current database, namely PubMed, Medline, Web of Science, EMBASE, Cochrane Library, and Wangfang, etc., the literature regarding this topic published before March 2021 were thoroughly investigated. Conclusion(s): For the hepatic hilar regional lymph node surgery, through careful preoperative evaluation, surgical-indication clarification, appropriate case selection, standardized surgical operations and multidisciplinary cooperation with general surgeons, the prognosis of patients is significantly improved. Postoperative complications are also safe and controllable and convincing. To conclude, the application of hilar region lymph node cytoreductive surgery for patients with advanced ovarian cancer is a feasible and preferred choice.Copyright © 2021 Huang et al.

Huang, J., et al. (2023). "Global incidence, risk factors and trends of vulvar cancer: A country-based analysis of cancer registries." International journal of cancer 153(10): 1734-1745.
	Vulvar cancer is an uncommon malignancy. Vulvar cancer alarmed the public health problem in terms of the cost of diagnostic and medical treatments and psychical health of females. Our study aims to provide a thorough analysis of the global disease burden, related risk factors and temporal incidence trends of vulvar cancer in population subgroups. Data from Global Cancer Observatory and the Cancer Incidence in Five Continents Plus were used for the vulvar cancer incidence. Age-standardized rates (ASR) were used to depict the incidence of vulvar cancer. The 10-year trend of incidence was assessed using joinpoint regression with average annual percentage change and 95% confidence intervals in various age groups, while its correlations with risk factors were investigated using linear regression. Higher ASR were found in Western Europe (2.4), Northern America (1.9), Northern Europe (1.9), Australia and New Zealand (1.8) and Eastern Africa (1.4). The associated risk factors of higher vulvar cancer incidence were gross domestic product per capita, Human Development Index, higher prevalence of smoking, alcohol drinking, unsafe sex and human immunodeficiency virus infection. The overall trend of vulvar cancer incidence was increasing. An increasing trend was found in older females while a mixed trend was observed in younger females. The disease burden of vulvar cancer follows a bimodal pattern according to its two histologic pathways, affecting women in both developed and developing regions. Smoking cessation, sex education and human papillomavirus vaccination programs should be promoted among the general population. Subsequent studies can be done to explore the reasons behind the increasing trend of vulvar cancer. (© 2023 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)

Huang, J., et al. (2022). "Comparative Efficacy of Neuromodulation Technologies for Overactive Bladder in Adults: A Network Meta-Analysis of Randomized Controlled Trials." Neuromodulation : journal of the International Neuromodulation Society.
	OBJECTIVE: The aim of this study was to investigate the comparative efficacy of neuromodulation technologies for overactive bladder (OAB) syndrome in adults. DATA SOURCES: A computerized search was conducted of Cochrane Library, EMBASE, MEDLINE (via PubMed), Web of Science, CNKI, Wan Fang Data, and ClinicalTrials.gov up to April 21, 2022. STUDY SELECTION: The search selected clinical trials with random allocation to percutaneous tibial nerve stimulation (PTNS), transcutaneous tibial nerve stimulation (TTNS), vaginal electrical stimulation (VES), sacral neuromodulation (SNM), parasacral stimulation (PS), pudendal neuromodulation, or placebo. DATA EXTRACTION: The main outcomes were the voiding diary, OAB-related quality of life, and positive response rate. The Cochrane Risk of Bias tool (RoB 2.0) was used to assess the risk of bias of each included study, and the Grading of Recommendations Assessment, Development, and Evaluation tool was used to evaluate the overall evidence quality of key outcomes. DATA SYNTHESIS: The study included 21 randomized controlled trials involving 1433 participants, and all trials were used for the meta-analysis. In the network meta-analyses, five of six neuromodulation technologies, including PTNS, TTNS, VES, SNM, and PS, were related to higher efficacy than the placebo. Ranking probability showed that SNM was the most efficacious therapy for improving OAB-related quality of life, urinary episodes, and urinary frequency. For urgency incontinence episodes and the number of pads, PTNS and TTNS were the most efficacious modalities, respectively. CONCLUSION: Neuromodulation technologies, including PTNS, TTNS, VES, SNM, and PS, may be effective and safe solutions for OAB syndrome in adults. Moreover, SNM is the most efficacious regimen for OAB-related quality of life, urinary episodes, and urinary frequency. PTNS and TTNS are the most efficacious modalities for reducing urgency incontinence episodes and the number of pads, respectively. Future studies should pay more attention to the quality of study design and report, patients who may benefit the most from neuromodulation, and the long-term effect, cost-effectiveness, and satisfaction of neuromodulation.

Huang, J., et al. (2023). "Effect of robotic versus laparoscopic surgery on postoperative wound infection in patients with cervical cancer: A meta-analysis." International wound journal.
	The objective of this research is to evaluate the risk of postoperative infection and other risks associated with robotic radical hysterectomy (RRH) compared with laparoscopic radical hysterectomy (LRH). Recent studies on RRH versus LRH have not been conclusive for cervical carcinoma. Our group attempted to use meta-analyses to evaluate the effects of both RRH and LRH on postoperative outcomes in order to make sure that the best operative method was used to prevent wound infections. We looked up Cochrane Library and published databases for this research and found 594 findings. Articles were screened by title and abstract and then carefully examined for inclusion and exclusion criteria. Data extraction was performed independently by two researchers. Comparison studies were used to describe the incidence of wound complications after surgery. The publication bias was assessed using Egger regression correlation analysis. There were six trials eligible for inclusion, of which 491 RRH and 807 LRH. Depending on surgery for cervical carcinoma, it is true that there is a difference in the way that surgery affects the postoperative complications. Our analysis demonstrated that the use of robotic operation can decrease the amount of blood loss during operation as compared with routine laparoscopy (MD, -77.69; 95% CI, -132.08, -23.30; p = 0.005). However, there were no statistical differences in the incidence of postoperative wound infections (OR, 0.54; 95% CI, 0.25, 1.19; p = 0.13) and intraoperative operative time (MD, 13.01; 95% CI, -41.38, 67.41; p = 0.64) among the two procedures. There was no statistically significant difference between these two groups of patients with severe postoperative complications. Unlike other research, the findings of this meta-analysis are not consistent with the findings of the present study, which suggest that robotic operations cannot lower the rate of postoperative wound infections. However, because of the limitations and the retrospective character of the trials covered, these findings should be interpreted with care and more extensive research is required. (© 2023 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Huang, J.-X., et al. (2022). "Impact of intracytoplasmic sperm injection in women with non-male factor infertility: A systematic review and meta-analysis." Frontiers in Reproductive Health 4: 1029381.
	Objective: The purpose of this study is to determine whether intracytoplasmic sperm injection (ICSI) is beneficial in patients with non-male factor infertility.; Methods: This systematic review and meta-analysis included articles from inception to May 2022. Published studies of non-male factor infertile women undergoing ICSI or in vitro fertilization (IVF) included in PubMed, Embase, web of science, Wanfang Database, and CNKI were searched by computer, without language restrictions. A random-effect model was applied to calculate the risk ratios (RRs) and their 95% confidence intervals (CIs). Letters, case reports, and review articles including meta-analyses and expert opinions were excluded. The primary endpoints were laboratory outcomes and pregnancy outcomes. The Secondary endpoints were neonatal outcomes.; Results: Six randomized controlled studies and 20 retrospective cohort studies met the inclusion criteria. In meta-analytic forest plots, compared with IVF, those who received ICSI treatment were not different in fertilization rate (RR = 0.99, 95% CI [0.90-1.09], P = 0.88), total fertilization failure rate (RR = 1.30, 95% CI [1.17-1.45], P < 0.00001), and good quality embryo rate (RR = 0.94, 95% CI [ 0.86-1.02], P = 0.15), clinical pregnancy rate (RR = 0.84, 95% CI [0.70-1.01], P = 0.06), live birth rate (RR = 0.89, 95% CI [0.77-1.03], P = 0.13), miscarriage rate (RR = 1.06, 95% CI [0.78-1.43], P = 0.71), preterm neonatal delivery rate (RR = 0.92, 95% CI [0.67-1.26], P = 0.61), and low neonatal weight rate (RR = 1.13, 95% CI [0.80-1.61], P = 0.48). However, the implantation rate of IVF was better than ICSI (RR = 0.77, 95% CI [0.64-0.93], P = 0.005). In the subgroup analysis of the live birth rate of fresh embryo transfer, IVF performed in those ≥35 years had a higher live birth rate (RR = 0.82, 95% CI [0.78-0.83], P < 0.001).; Conclusion: The findings of this study indicate that ICSI is not superior to IVF in the treatment of infertility related to non-male factors. In order to confirm this result, more high-quality clinical studies are needed.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (© 2022 Huang, Gao, Chen, Han, Song and Sun.)

Huang, K., et al. (2023). "Efficacy and safety of different thermal ablative therapies for desmoid-type fibromatosis: a systematic review and metaanalysis." Quantitative Imaging in Medicine and Surgery 13(10): 6683-6697.
	Background: Desmoid-type fibromatosis (DF) is a locally aggressive tumor characterized by peripheral infiltration of neoplastic cells and remote metastasis disability. This systematic review examined the efficacy and safety of thermal ablative therapy for DF tumors. Method(s): A literature search was conducted using PubMed, Web of Science, Cochrane Library, and Embase from January 1, 2000, to November 12, 2022. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was used to guide literature selection. The inclusion criteria were the following: (I) the patients were diagnosed with aggressive fibromatosis pathologically, (II) the patients were treated by thermal ablations, and (III) a focus on treatment efficacy and safety. Meanwhile, the exclusion criteria were the following: (I) cohorts of patients with hypertrophic scar, Gardner fibroma, or nodular fasciitis; (II) conference abstracts, reviews, case reports, letters to editors, comments, or editorials; (III) number of patients <5; (IV) in vitro or animal experiments; and (V) non-English language articles. The inverse variance method with a random effects model was used to obtain the pooled data. Subgroup analyses were performed to identify treatment factors. Egger test was conducted to assess the risk of publication bias. Result(s): After literature selection, 694 DF tumors were identified in 23 studies. In terms of modality, 13 studies used cryoablation, 9 studies used high-intensity focused ultrasound (HIFU), and 1 study used microwave ablation (MWA). The pooled symptom relief rate was 90% [95% confidence interval (CI): 80-97%], with that for HIFU being 100% (95% CI: 85-100%), that for cryoablation being 87% (95% CI: 74-97%), and that MWA being 89% (95% CI). The pooled major complication rate was 3% (95% CI: 1-7%), and that for each modality was as follows: HIFU =2% (95% CI: 0-6%), cryoablation =4% (95% CI: 1-8%), MWA =11%, ultrasound =6% (95% CI: 1-13%), computed tomography (CT) =2% (95% CI: 0-7%), and magnetic resonance imaging (MRI) =3% (95% CI: 0-14%). The pooled nonperfused volume rate (NPVR) was 76% (95% CI: 71-81%), and that for each modality was as follows: HIFU =77% (95% CI: 71-85%), cryoablation =74% (95% CI: 69-79%), ultrasound =75% (95% CI: 67-83%), CT =76% (95% CI: 67-87%), and MRI =78% (95% CI: 70-87%). The pooled local control rate was 88% (95% CI: 79-94%) and that for each modality was as follows: HIFU =99% (95% CI: 96-100%), cryoablation =80% (95% CI: 68-90%), and MWA =78%. The differences in major complication rate (P=0.77) and NPVR between imaging-guided modalities (P=0.40) were not significant, nor were the differences in symptom relief rate (P=0.32) and major complication rate (P=0.61) between ablative techniques; however, the differences in local control rate (P=0.01) were significant between ablative techniques. Conclusion(s): Imaging-guided thermal ablative therapies contribute to symptom relief with a duration of more than 6 months and a low major complication rate of DF tumors.Copyright © 2023 AME Publishing Company. All rights reserved.

Huang, L., et al. (2019). "Acupuncture for patients with premature ovarian insufficiency: A systematic review protocol." Medicine 98(18): e15444.
	Background: Premature ovarian insufficiency (POI) is a difficult-to-treat gynecological disorder with complex etiologies. Although acupuncture has gained increased popularity for the management of POI, evidence regarding its efficacy is lacking. This systematic review protocol aims to describe a meta-analysis to assess the effectiveness and safety of acupuncture for patients with POI.; Methods: The following 10 databases will be searched from the publishment to July 2019: PubMed, Embase, the Web of Science, the Cochrane Central Register of Controlled Trials, 4 Chinese databases (China National Knowledge Infrastructure, Wanfang Digital Periodicals, Chinese Biomedical Literature Database, Chinese Scientific Journal Database database), 1 Korean medical database (KoreaMed), 1 Japanese medical database (National Institute of Informatics). The primary outcomes will be the resumption of menstruation and the serum FSH levels, and the secondary outcomes include the serum Estradiol levels, anti-Mullerian hormone levels, antral follicle count, follicular growth, endometrial thickness, and adverse events. We will use RevMan V.5.3 to conduct the meta-analysis, if possible. If it is not allowed, a descriptive analysis or a subgroup analysis will be conducted. Risk ratio for dichotomous data and mean differences or standardized mean differences for continuous data will be calculated with 95% confidence intervals using a random effects model or a fixed effects model.; Results: This study will provide the latest analysis of the currently available evidence for the efficacy of acupuncture in treating POI.; Prospero Registration Number: CRD42019125996.

Huang, L., et al. (2020). "Adjuvant therapy of Chinese herbal medicine for the treatment of adenomyosis: A protocol for systematic review." Medicine 99(25): e20560.
	Background: Adenomyosis is benign gynecologic condition with complex etiologies. Common symptoms associated with adenomyosis (AM) include menorrhagia, dysmenorrhea, chronic pelvic pain, metrorrhagia, and dyspareunia. Although Chinese herbal medicine (CHM) has often been utilized for managing AM in clinical practice in China, evidence regarding its efficacy is lacking. This systematic review protocol aims to describe a systematic review to assess the effectiveness and safety of CHM combined with Levonorgestrel-releasing intrauterine system for AM.; Methods: The following 7 databases will be searched from the publishment to December 2019: the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, China National Knowledge Infrastructure (CNKI), Wanfang Digital Periodicals (WAN FANG), Chinese Biomedical Literature Database (CBM), Chinese Scientific Journal Database (VIP). The primary outcomes will be relief in pain and uterine bleeding. The secondary outcomes include the adverse effects, CA125 variation in peripheral blood, reduction in uterine volume, and endometrial thickness. We will use RevMan V.5.3 to conduct the meta-analysis, if possible. If it is not allowed, a descriptive analysis will be conducted. We will use risk ratio with 95% confidence interval for dichotomous data and the mean difference for continuous data.; Results: This study will provide the latest analysis of the currently available evidence for the efficacy of the adjuvant therapy of CHM for the treatment of AM.; Registration Number: OSF (DOI 10.17605/OSF.IO/A2GHY) ETHICS AND DISSEMINATION:: No ethical issues are required. The findings will be published in a peer-reviewed scientific journal.

Huang, M. L., et al. (2023). "A systematic review and meta-analysis of CT and MRI radiomics in ovarian cancer: methodological issues and clinical utility." Insights into imaging 14(1): 117.
	OBJECTIVES: We aimed to present the state of the art of CT- and MRI-based radiomics in the context of ovarian cancer (OC), with a focus on the methodological quality of these studies and the clinical utility of these proposed radiomics models. METHODS: Original articles investigating radiomics in OC published in PubMed, Embase, Web of Science, and the Cochrane Library between January 1, 2002, and January 6, 2023, were extracted. The methodological quality was evaluated using the radiomics quality score (RQS) and Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). Pairwise correlation analyses were performed to compare the methodological quality, baseline information, and performance metrics. Additional meta-analyses of studies exploring differential diagnoses and prognostic prediction in patients with OC were performed separately. RESULTS: Fifty-seven studies encompassing 11,693 patients were included. The mean RQS was 30.7% (range - 4 to 22); less than 25% of studies had a high risk of bias and applicability concerns in each domain of QUADAS-2. A high RQS was significantly associated with a low QUADAS-2 risk and recent publication year. Significantly higher performance metrics were observed in studies examining differential diagnosis; 16 such studies as well as 13 exploring prognostic prediction were included in a separate meta-analysis, which revealed diagnostic odds ratios of 25.76 (95% confidence interval (CI) 13.50-49.13) and 12.55 (95% CI 8.38-18.77), respectively. CONCLUSION: Current evidence suggests that the methodological quality of OC-related radiomics studies is unsatisfactory. Radiomics analysis based on CT and MRI showed promising results in terms of differential diagnosis and prognostic prediction. CRITICAL RELEVANCE STATEMENT: Radiomics analysis has potential clinical utility; however, shortcomings persist in existing studies in terms of reproducibility. We suggest that future radiomics studies should be more standardized to better bridge the gap between concepts and clinical applications.

Huang, R., et al. (2020). "Effectiveness of peer support intervention on perinatal depression: A systematic review and meta-analysis." Journal of Affective Disorders 276: 788-796.
	Background: It has been suggested that peer support intervention may offer an alternative approach to prevent or treat perinatal depression, but little is known about its effectiveness, economics, and satisfaction in the prenatal and postpartum populations. This review summarizes available evidence on the effectiveness, economics, and satisfaction of peer support intervention on perinatal depression. Method(s): Multiple electronic databases were searched in five English databases (MEDLINE, Embase, Cochrane Library, Psyc INFO, and CINAHL) and three Chinese databases (Wang Fang, China National Knowledge Infrastructure, and Chinese Biomedical Literature Database) from inception to April 2019. Hand searching of references was also performed. Randomized controlled trials reporting peer support intervention targeting on perinatal depression were included. The quality of evidence was assessed using the Cochrane risk of bias tool. Result(s): Ten randomized controlled trials met the inclusion criteria and were included in the final analysis. Peer support intervention reduced standardized mean depressive scores (-0.37, 95% CI -0.66 to -0.08) and reduced risk ratio (0.69, 95% CI 0.49-0.96) of depression. Limitation(s): Clinical heterogeneity was observed among the included studies in peer support intervention, suggesting the existence of potential mediators, such as intensity, frequency, or type of peer support intervention. Conclusion(s): Peer support intervention may have the potential to effectively prevent perinatal depression or reduce the harm of perinatal depression. Future studies with better design/execution and larger sample size are needed to investigate potential mediators associated with the beneficial effects of peer support intervention on perinatal depression.Copyright © 2020

Huang, R., et al. (2020). "The short- and long-term effectiveness of mother-infant psychotherapy on postpartum depression: A systematic review and meta-analysis." Journal of Affective Disorders 260: 670-679.
	Background: It has been suggested that mother-infant psychotherapy may offer an alternative approach to treating postpartum depression, but little is known about its effectiveness. This review presents a summarized effectiveness of mother-infant psychotherapy on postpartum depression. Method(s): Multiple electronic databases were searched including Pubmed, Cochrane Library, EMBase, MEDLINE, et al. Hand searching of references was also performed. Randomized controlled trials reporting on mother-infant psychotherapy targeting postpartum depression were included if they used a validated measure of prescribing appropriateness. Evidence quality was assessed using the Cochrane risk of bias tool. Result(s): A total of 13 randomized controlled trials met inclusion criteria and were included in the final analysis. In the short-term effect analysis, mother-infant psychotherapy reduced standardized mean depressive scores (-0.25, 95% CI -0.40, -0.09) and risk ratio (0.71, 95% CI 0.55, 0.91). In the long-term effect analysis, mother-infant psychotherapy did not improve maternal mood, mother-infant interaction and infant attachment. Limitation(s): Clinical heterogeneity was observed among included studies in mother-infant psychotherapy intervention, suggesting the existence of potential moderators such as intensity, frequency, trimester of pregnancy or type of mother-infant psychotherapy. Conclusion(s): Mother-infant psychotherapy appears to be effective for the treatment of maternal depression in the short-term. Future studies with better design/execution and larger sample size are needed to confirm the effect of mother-infant psychotherapy on short-term and to explore its effect on long-term depression.Copyright © 2019 Elsevier B.V.

Huang, S. and F. Qiu (2022). "Nursing of Vulvar Cancer Radical Operation Combined with Laparoscopic Inguinal Lymph Node Dissection [retracted]." Emergency Medicine International 2022: 8091114.
	Purpose. The application, development, and care of radical surgery combined with laparoscopic inguinal lymph node dissection for vulvar cancer. Methods. We searched the PubMed, Web of Science, the Cochrane Library, and EMBASE databases for published literature on the care of radical surgery combined with laparoscopic inguinal lymph node dissection for vulvar cancer up to June 2022. We used the following search terms and terms: "vulvar cancer,""injury,""radical vulvar cancer surgery,""laparoscopic inguinal lymph node dissection,"and "care."Results. Laparoscopic inguinal lymph node dissection has become a new surgical method for the treatment of vulvar cancer, and it effectively avoids all the problems associated with traditional surgery. In addition, radical vulvar cancer surgery and laparoscopic inguinal lymph node dissection combined with high-quality nursing interventions can promote patients' recovery and reduce the occurrence of complications, which has important clinical significance. Conclusion. This article reviews the application, development, and nursing care of radical vulvar cancer surgery combined with laparoscopic inguinal lymph node dissection.Copyright © 2022 Simei Huang and Feifei Qiu.

Huang, S., et al. (2021). "Efficacy of acupuncture for PCOS infertility: A systematic review." Chinese Journal of Evidence-Based Medicine 21(4): 431-437.
	Objective To systematically review the efficacy of acupuncture for PCOS infertility. Methods PubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, VIP and CBM databases were electronically searched to collect randomized controlled trials (RCTs) of acupuncture for PCOS infertility from inception to January 5th, 2020. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Meta-analysis was then performed using RevMan 5.3 software. Results A total of 28 RCTs involving 2 192 patients were included. The results of meta-analysis showed that compared with western medicine alone, acupuncture could increase the pregnancy rate (RR=1.80, 95%CI 1.45 to 2.23, P<0.000 01) and ovulation rate (RR=1.33, 95%CI 1.15 to 1.54, P=0.000 1), and reduce levels of LH (SMD=-0.62, 95%CI -0.96 to -0.28, P=0.000 4) and LH/FSH (SMD=-0.65, 95%CI -1.02 to -0.29, P=0.000 5). Acupuncture combined with western medicine could increase the pregnancy rate (RR=1.75, 95% CI 1.50 to 2.03, P<0.000 01) and ovulation rate (RR=1.29, 95%CI 1.18 to 1.41, P<0.000 01), decrease levels of LH (SMD=-1.09, 95%CI -1.64 to -0.53, P=0.000 1), LH/FSH (SMD=-1.30, 95%CI -2.35 to -0.25, P=0.02), and levels of T (SMD=-1.13, 95%CI -1.59 to -0.66, P<0.000 01). Conclusions Current evidence shows that acupuncture alone or combined with western medicine can significantly improve ovulation rate, pregnancy rate and reduce hormone level. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.Copyright © 2021 West China University of Medical Science. All rights reserved.

Huang, W., et al. (2022). Acupuncture Combined with Chinese Herbal Medicine for Tubal Obstructive Infertility: A Systematic Review and Meta-Analysis, Research Square.
	Background: Tubal obstruction is the leading cause of infertility. Acupuncture and Chinese herbal medicine (CHM) are widely used in treating tubal obstruction infertility (TOI), and clinical research is increasing. However, there is still controversy about its efficacy and safety. This systematic review aimed to assess the efficacy and safety of acupuncture and CHM in treating TOI. Methods: We searched eight databases to collect randomized controlled trials comparing Hydrotubation with Acupuncture combined with CHM from inception to July 31, 2022. A total of 1580 papers were collected, and the methodological quality of the included trials was assessed in line with the criteria of the Cochrane risk of the bias assessment tool. In the end, only 18 randomized clinical trials met the requirements and were included. Results: Meta-analysis showed that acupuncture and CHM was associated with a higher pregnancy rate [RR 1.74, 95% CI (1.54, 1.95), P &amp;lt; 0.00001] and a lower ectopic pregnancy rate [OR 0.61, 95 % CI (0.19, 1.92), P＜0.0001]. The success rate of tubal recanalization was significantly improved with acupuncture combined with CHM treatment[RR 1.37, 95 % CI (1.20, 1.57), P＜0.0001], and signs and symptoms were better relieved [OR 3.44, 95 % CI (2.22, 5.33), P＜0.00001]. Conclusions: This meta-analysis suggests that acupuncture and CHM can be used as complementary therapies to treat tubal obstructive infertility with better outcomes than Hydrotubation.

Huang, W., et al. (2022). "Emerging Roles of m 6 A RNA Methylation Regulators in Gynecological Cancer." Frontiers in Oncology 12: 827956.
	Gynecological cancers seriously affect the reproductive system of females; diseases include ovarian tumors, uterine tumors, endometrial cancers, cervical cancers, and vulva and vaginal tumors. At present, the diagnosis methods of gynecological cancer are insufficiently sensitive and specific, leading to failure of early disease detection. N 6 -methyladenosine (m 6 A) plays various biological functions in RNA modification and is currently studied extensively. m 6 A modification controls the fate of transcripts and regulates RNA metabolism and biological processes through the interaction of m 6 A methyltransferase ("writer") and demethylase ("erasers") and the binding protein decoding m 6 A methylation ("readers"). In the field of epigenetics, m 6 A modification is a dynamic process of reversible regulation of target RNA through its regulatory factors. It plays an important role in many diseases, especially cancer. However, its role in gynecologic cancers has not been fully investigated. Thus, we review the regulatory mechanism, biological functions, and therapeutic prospects of m 6 A RNA methylation regulators in gynecological cancers.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Huang, Kong, Li, Chen and Wang.)

Huang, W., et al. (2023). "Comparative efficacy of acupuncture-related interventions for tubal obstructive infertility: A systematic review and Bayesian meta-analysis of randomized controlled trials." Complementary Therapies in Medicine 79: 103003.
	Background: Tubal obstructive infertility (TOI) is a challenging condition affecting many women worldwide. Acupuncture and herbal medicine have emerged as potential therapeutic options for enhancing fertility outcomes in these patients. However, the evidence regarding their efficacy remains inconclusive, necessitating a comprehensive systematic review and meta-analysis. Method(s): Computer searches were conducted in PubMed, Cochrane, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), VIP Information, Wanfang Database, and China Biology Medicine (CBM) databases to retrieve relevant literature on the efficacy and safety of acupuncture and related therapies for the treatment of tubal obstructive infertility. The search period extended from the inception of the databases to December 2022. Two researchers independently screened the literature based on strict inclusion criteria, extracted relevant data, and utilized Cochrane Collaboration tools and the Jadad scale to comprehensively assess the quality of the included studies. Subsequently, pairwise meta-analysis and network meta-analysis were performed using statistical software such as StataSE and Rstudio, and graphical representations were generated to present the results. Result(s): The network meta-analysis included 1580 articles, with 23 meeting the criteria. These studies involved 2355 patients and explored 13 intervention measures. Acupuncture-related therapies outperformed control interventions in improving pregnancy rates, tubal patency rates, and overall effectiveness while demonstrating a lower incidence of adverse events. EA+CHM was identified as the most effective for pregnancy rates, MOX for tubal patency rates, and MOX+AP for overall effectiveness. The safety profile of acupuncture-related interventions was acceptable. These findings support acupuncture-related therapies as effective and safe options for tubal obstructive infertility management. Further high-quality research is needed to validate and expand upon these results. Conclusion(s): These findings offer novel treatment strategies for acupuncture-related interventions, providing practitioners with evidence-based guidance. Addressing limitations through future research is crucial, including diverse literature, emphasizing higher-quality RCTs, and exploring a broader range of interventions with long-term follow-up data. Systematic assessment of adverse events, standardized techniques, and robust ranking methods should be considered.Copyright © 2023 The Authors

Huang, Y., et al. (2022). "Feasibility and safety of performing cesarean myomectomy: a systematic review and meta-analysis." The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians 35(13): 2619-2627.
	Purpose: To examine the feasibility and safety of performing cesarean myomectomy on pregnant women with myomas compared to cesarean section only.; Methods: We retrieved English articles in the PubMed, Cochrane Library, Medline and EMBASE databases from inception to April 2020. Observational studies including the comparison of patients who underwent cesarean myomectomy and cesarean section, as well as those reporting perioperative outcomes were selected. Data extraction was conducted using RevMan 5.3.; Results: Twenty-three studies comprising 8,016 women were included in the meta-analysis. Of these, 3,955 underwent cesarean myomectomy, while 4,061 underwent cesarean section only. Cesarean myomectomies were associated with a greater decline in mean hemoglobin (mean difference [MD] 0.20 g/dL, 95% confidence intervals [CI] 0.06, 0.35, p = .007), greater incidence of hemorrhage (odds ratio [OR] 1.46, 95% CI 1.06, 2.01, p = .02), greater volume of blood loss (MD 45.54 ml, 95% CI 2.68, 88.41, p = .04), higher transfusion rate (OR 1.47 95%CI 1.09, 1.99, p = .01), longer operation duration (MD 10.40 min, 95% CI 8.54, 12.25, p < .001), or longer postoperative hospitalization (MD 0.18 d, 95% CI 0.12, 0.24, p < .001), compared to those who underwent cesarean section only. There was no statistical difference in postoperative fever rates (OR 1.12, 95% CI 0.77, 1.62).; Conclusion: Hemorrhage represents a risk factor which should not be overlooked by surgeons performing cesarean myomectomy. Intramural myomas, myomas ≥7 cm in size, and multiple myomas are associated with more intraoperative hemorrhage and prolonged operation duration. We suggest that, with appropriate hemostatic techniques and when performed by experienced surgeons, cesarean myomectomy may be safe and feasible in selected patients with myomas, regardless of size and locations, except if they are located at the cornual or close to large vessels, and in the absence of uterine atony during surgery.

Huang, Y., et al. (2023). "Impact of metformin on survival in patients with ovarian cancer: a meta-analysis." Chinese Journal of Cancer Prevention and Treatment 30(20): 1242-1249.
	Objective The effect of metformin on the survival rate of ovarian cancer patients was analyzed, which provided a reference for reducing the risk of cancer and improving the survival rate of patients. Methods We searched PubMed,Em-base, and Web of Science databases as of 2022-10-25. The medical subject terms and text terms included metformin, bigua-nides,diabetic medications, ovarian, ovary, cancer, neoplasms, tumor, carcinoma, survival, mortality, prognosis and death. The data and features were extracted for each study,and 95%CI and HR values were calculated to assess the effects of metformin on overall survival (OS) and progression-free survival (PFS) in diabetic patients with ovarian cancer,and finally 10 articles were included. Results Metformin had significant benefits on the survival rate of ovarian cancer patients, HR=0. 59,95%CI:0. 49-0. 72. Subgroup analysis showed that metformin could improve OS in diabetic ovarian cancer patients, Hi? = 0. 65 , 95% CI: 0. 53 - 0. 81. However, metformin was not associated with PFS in diabetic ovarian cancer patients,HR=0. 48, 95%CI:0. 22 - 1. 05. Compared with patients without diabetic ovarian cancer,metformin was associated with OS and PFS in diabetic ovarian cancer patients,and the combined HR values were 0. 39 (95%CJ:0. 20 - 0. 76) and 0. 39 (95%CJ:0. 26 - 0. 57) , respectively. The use of metformin >720 days can improve the OS of diabetic ovarian cancer patients, Hi? = 0. 31,95%CI:0. 16 - 0. 57. Metformin was not associated with disease-specific survival in diabetic o-varian cancer patients, HR = 0. 59 , 95% CI: 0. 31 - 1. 12. Conclusion The current study has tentatively confirmed that metformin may be associated with survival benefits in patients with ovarian cancer,but more research is required for confirmation.Copyright © 2023 Chinese Journal of Cancer Prevention and Treatment, Editorial board. All rights reserved.

Huang, Y., et al. (2023). "Effect of hysterectomy on ovarian function: a systematic review and meta-analysis." Journal of Ovarian Research 16(1): 35.
	Background: Hysterectomy is one of the most frequently gynecologic surgeries performed in premenopausal women. Many premenopausal patients are unwilling to undergo hysterectomy due to the probable decreased ovarian function. The aim of this study is to determine the effect of hysterectomy on ovarian function.; Methods: A meta-analysis has been reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 and the A Measurement Tool to Assess Systematic Reviews (AMSTAR) guidelines. We mainly searched the Embase, PubMed and Web of Science databases for eligible studies. The outcomes were the levels of common indicators of ovarian function, such as anti-müllerian hormone (AMH), follicle stimulating hormone (FSH), inhibin B, estradiol (E2) and luteinizing hormone (LH). The evidence was synthesized using meta-analysis via fixed or random effect model according to heterogeneity. Subgroup analyses were performed to examine the potential sources of heterogeneity.; Results: The 14 included studies were conducted between 1989 and 2021, involving a total of 1,457 premenopausal women with 760 and 697 in the hysterectomy and control group, respectively. We found that hysterectomy damage ovarian function compared to the control group, with lower AMH level [Weighted mean difference (WMD) = -0.56, 95% confidence interval (95% CI): -0.72 to -0.39, P = 0.000], higher FSH levels (WMD = 2.96, 95% CI: 1.47 to 4.44, P = 0.000), lower inhibin B levels (WMD = -14.34, 95% CI: -24.69 to -3.99, P = 0.000) and higher LH levels (WMD = 4.07, 95% CI: 1.78 to 6.37, P = 0.000). In addition, E2 levels have a decreasing trend (WMD = -17.13, 95% CI: -35.10 to 0.85, P = 0.631) in the hysterectomy group but were not statistically significant.; Conclusion: Hysterectomy has a negative impact on ovarian function, especially in female patients over 40 years old. So, the older patients should closely monitor their ovarian function for early diagnosis and treatment of menopausal symptoms. (© 2023. The Author(s).)

Huang, Y. and X. Zhang (2023). "Meta-analysis of the efficacy of ω-3 polyunsaturated fatty acids when treating patients with polycystic ovary syndrome." Medicine 102(39): e35403.
	Objective: To systematically assess the efficacy of ω-3 polyunsaturated fatty acids (PUFAs) when treating polycystic ovary syndrome (PCOS).; Methods: This meta-analysis follows Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria. We searched PubMed, EMBASE, ScienceDirect, Cochrane Library, China journal full-text database, VIP full-text Database, Wanfang Database, and Chinese Biomedical Literature Data for clinical trials on ω-3 PUFAs' efficacy in treating PCOS. Two independent reviewers examined and analyzed studies, resolving inconsistencies through discussion. RevMan5.3 software performed heterogeneity-based fixed and random-effects meta-analysis. We assessed bias using the Cochrane bias risk assessment tool.; Results: Our meta-analysis included 7 clinical control studies comprising 574 samples to evaluate the impact of ω-3 PUFAs on various metabolic markers in PCOS patients. We observed a significant reduction in total cholesterol (TC) and triglyceride (TG) levels (P < .05), along with a decrease in insulin resistance as measured by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) (P < .05). Testosterone (T) levels were also lowered in the study group post-treatment (P < .05). However, no notable effects were found on body mass index (BMI), fasting blood sugar (FBS), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and Ferriman-Gallwey (mFG) scores (P > .05). Publication bias was not detected, enhancing the robustness of our results. Our study suggests that ω-3 PUFAs could be beneficial in managing specific metabolic markers in PCOS, although the results showed marked heterogeneity.; Conclusion: In PCOS patients, PUFAs can enhance reproductive endocrine, glucose, and lipid levels. However, additional research and extended follow-up are required to confirm this.; Competing Interests: The authors have no funding and conflicts of interest to disclose. (Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.)

Huang, Y., et al. (2022). "Bone marrow mesenchymal stem cells in premature ovarian failure: Mechanisms and prospects." Frontiers in Immunology 13: 997808.
	Premature ovarian failure (POF) is a common female reproductive disorder and characterized by menopause, increased gonadotropin levels and estrogen deficiency before the age of 40 years old. The etiologies and pathogenesis of POF are not fully clear. At present, hormone replacement therapy (HRT) is the main treatment options for POF. It helps to ameliorate perimenopausal symptoms and related health risks, but can't restore ovarian function and fertility fundamentally. With the development of regenerative medicine, bone marrow mesenchymal stem cells (BMSCs) have shown great potential for the recovery of ovarian function and fertility based on the advantages of abundant sources, high capacity for self-renewal and differentiation, low immunogenicity and less ethical considerations. This systematic review aims to summarize the possible therapeutic mechanisms of BMSCs for POF. A detailed search strategy of preclinical studies and clinical trials on BMSCs and POF was performed on PubMed, MEDLINE, Web of Science and Embase database. A total of 21 studies were included in this review. Although the standardization of BMSCs need more explorations, there is no doubt that BMSCs transplantation may represent a prospective therapy for POF. It is hope to provide a theoretical basis for further research and treatment for POF.; Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Huang, Zhu, Liu, Hu, Li, Song, Geng, Ma, Song and Zhang.)

Huang, Z., et al. (2021). "Efficacy of tamoxifen for infertile women with thin endometrium undergoing frozen embryo transfer: A meta-analysis." Clinical and Experimental Obstetrics and Gynecology 48(4): 806-811.
	Background: This study aims to compare the effect of tamoxifen (TMX) vs. other regimens on endometrial thickness (EMT), clinical pregnancy, implantation, miscarriage, and live birth rates in women with thin endometrium undergoing frozen-thawed embryo transfer (FET). Method(s): We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and CINAHL from inception to November 2020 and cross-checked the references of relevant articles. We included randomized controlled trials (RCTs) and nonrandomized controlled trials (non-RCTs) to compare TMX with other regimens for endometrium preparation in women with thin endometrium undergoing FET. We pooled weighted mean differences (WMD) with 95% confidence intervals (CI) for continuous variables (EMT) and odds ratios (OR) with 95% CI for binary variables (i.e., clinical pregnancy rate, implantation rate, and first trimester miscarriage rate). Result(s): An RCT and three controlled trials (2 beforeafter and 1 retrospective controlled trials) were included in the final review. One study including 154 women and comparing TMX-FET with natural cycle (NC)-FET showed a significant increase in EMT in the TMX cycle (7.87 +/- 1.48 mm vs. 6.11 +/- 0.98 mm, P < 0.05). Three studies compared the EMT in the TMX and the hormone replacement treatment (HRT) cycles. The pooled analysis showed beneficial effect of TMX on EMT (WMD = 2.06, 95% CI = 1.86-2.27, P < 0.00001). An RCT and a retrospective controlled trial compared TMX and ovulation induction (OI) with Letrozole/human menopause gonadotropin (hMG) for endometrium preparation in women with thin endometrium undergoing FET. No significant difference in clinical pregnancy rates (OR = 1.03, 95% CI = 0.71-1.51), implantation rate (OR = 1.03, 95% CI = 0.76-1.38), or miscarriage rate (OR = 0.91, 95% CI = 0.40-2.06) was observed. No significant difference in EMT was found between TMX and OI with Letrozole/hMG in the included studies. Conclusion(s): In women with thin endometrium undergoing FET, the use of TMX may result in improved EMT than other regimens. At present, evidence supporting the preferred use of TMX over other regimens as clinical pregnancy rate, implantation rate, or the first trimester miscarriage rate is insufficient.Copyright © 2021 The Author(s).

Huaqian, W., et al. (2022). "network meta-analysis of three different surgical strategies for cesarean scar defect."
	
Huddleston Heather, G. and A. Dokras (2022). "Diagnosis and Treatment of Polycystic Ovary Syndrome." JAMA 327(3): 274-275.
	
Huepenbecker, S., et al. (2022). "Cost-utility analysis of management strategies after frontline treatment of women with epithelial ovarian cancer (339)." Gynecologic Oncology 166(Supplement 1): S174-S175.
	Objectives: Performed a cost-utility analysis comparing maintenance therapies for advanced epithelial ovarian cancer to surveillance based on genetic mutation. Method(s): We developed Markov models of post-frontline treatment disease course until death for women diagnosed with stage III-IV epithelial ovarian cancer to compare niraparib, olaparib, bevacizumab, and olaparib+bevacizumab with active surveillance. Four subgroups were analyzed: (1) all-comers, (2) BRCA, (3) non-BRCA homologous recombination deficiency (HRD), and (4) homologous recombination proficient (HR proficient). Transition probabilities for progression-free survival and adverse events were derived from randomized controlled trials, for all-cause mortality from US life tables, and for disease-specific mortality after recurrence from SEER. Utilities for maintenance treatment, grade 3-4 adverse events, disease-free off treatment, recurrence, and death were derived from ovarian cancer-specific time trade-off studies. Costs of treatment, adverse events, recurrence, and death were obtained from Centers for Medicare & Medicaid Services (CMS) fee schedules and published studies. Analysis was conducted from CMS's perspective. We considered a 3-month cycle length, a lifetime time horizon and applied a 3% annual discount rate. The primary outcome of interest was the incremental cost-effectiveness ratio (ICER), defined as the ratio of incremental cost to incremental quality-adjusted life-year (QALY). Uncertainty was evaluated using deterministic and probabilistic sensitivity analyses and represented by cost-effectiveness at willingness-to-pay (WTP) thresholds up to $200K/QALY. Result(s): For all-comers, surveillance and olaparib+bevacizumab were undominated (more effective and less costly), and the ICER of olaparib+bevacizumab in reference to surveillance was $182,823/ QALY. The probability of cost-effectiveness of olaparib+bevacizumab at a WTP threshold of $100K/QALY was 20%. For BRCA patients, surveillance and olaparib were nominated, and the ICER of olaparib was $49,896/QALY. The probability of olaparib being cost-effective at a WTP threshold of $100K/QALY was 71%. For non-BRCA HRD patients, surveillance and olaparib+bevacizumab were both undominated, and the ICER of olaparib+bevacizumab was $98,685/QALY. At a WTP threshold of $100,000/QALY, olaparib+bevacizumab had a higher probability of being cost-effective (48%) than niraparib (6%) or bevacizumab alone (4%). For HR proficient patients, surveillance was undominated and had the highest probability of being cost-effective at all WTP thresholds. Conclusion(s): Compared to active surveillance, olaparib+bevacizumab was the most cost-effective maintenance strategy for all-comers and non-BRCA HRD patients. At the same time, olaparib was most costeffective for women with BRCA mutations. The likelihood of any maintenance therapy being cost-effective for women with HR proficient disease was low.Copyright © 2022 Elsevier Inc.

Huepenbecker, S. P., et al. (2024). "Longitudinal perioperative patient-reported outcomes in open compared with minimally invasive hysterectomy." American Journal of Obstetrics and Gynecology 230(2): 241.e241-241.e218.
	Background: There are few prospective studies in the gynecologic surgical literature that compared patient-reported outcomes between open and minimally invasive hysterectomies within enhanced recovery after surgery pathways. Objective(s): This study aimed to compare prospectively collected perioperative patient-reported symptom burden and interference measures in open compared with minimally invasive hysterectomy cohorts within enhanced recovery after surgery pathways. Study Design: We compared patient-reported symptom burden and functional interference in 646 patients who underwent a hysterectomy (254 underwent open surgery and 392 underwent minimally invasive surgery) for benign and malignant indications under enhanced recovery after surgery protocols. Outcomes were prospectively measured using the validated MD Anderson Symptom Inventory, which was administered perioperatively up to 8 weeks after surgery. Cohorts were compared using Fisher exact and chi-squared tests, adjusted longitudinal generalized linear mixed modeling, and Kaplan Meier curves to model return to no or mild symptoms. Result(s): The open cohort had significantly worse preoperative physical functional interference (P=.001). At the time of hospital discharge postoperatively, the open cohort reported significantly higher mean symptom severity scores and more moderate or severe scores for overall (P<.001) and abdominal pain (P<.001), fatigue (P=.001), lack of appetite (P<.001), bloating (P=.041), and constipation (P<.001) when compared with the minimally invasive cohort. The open cohort also had significantly higher interference in physical functioning (score 5.0 vs 2.7; P<.001) than the minimally invasive cohort at the time of discharge with no differences in affective interference between the 2 groups. In mixed modeling analysis of the first 7 postoperative days, both cohorts reported improved symptom burden and functional interference over time with generally slower recovery in the open cohort. From 1 to 8 postoperative weeks, the open cohort had worse mean scores for all evaluated symptoms and interference measures except for pain with urination, although scores indicated mild symptomatic burden and interference in both cohorts. The time to return to no or mild symptoms was significantly longer in the open cohort for overall pain (14 vs 4 days; P<.001), fatigue (8 vs 4 days; P<.001), disturbed sleep (2 vs 2 days; P<.001), and appetite (1.5 vs 1 days; P<.001) but was significantly longer in the minimally invasive cohort for abdominal pain (42 vs 28 days; P<.001) and bloating (42 vs 8 days; P<.001). The median time to return to no or mild functional interference was longer in the open than in the minimally invasive hysterectomy cohort for physical functioning (36 vs 32 days; P<.001) with no difference in compositive affective functioning (5 vs 5 days; P=.07) between the groups. Conclusion(s): Open hysterectomy was associated with increased symptom burden in the immediate postoperative period and longer time to return to no or mild symptom burden and interference with physical functioning. However, all patient-reported measures improved within days to weeks of both open and minimally invasive surgery and differences were not always clinically significant.Copyright © 2023 Elsevier Inc.

Huerga, L., et al. (2023). "Management of uterine fibroids: Approach to medical treatment." Medicina clinica 161 Suppl 1: S15-S21.
	
Hughes, O., et al. (2023). "Living With Physical Health Conditions: A Systematic Review of Mindfulness-Based Interventions for Children, Adolescents, and Their Parents." Journal of pediatric psychology 48(4): 396-413.
	Objectives: This systematic review aimed to identify and appraise studies investigating the efficacy of mindfulness-based interventions (MBIs) for improving depression, anxiety and parental stress in families affected by childhood